chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site pain, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his arm/ the whole arm itself just hurts; pain at the top of his arm going down his arm/ arm hurts/when he turn had pain up his armpit; when he turns his neck to the right he has pain up his armpit; This is a spontaneous report from a two contactable consumer (patient and his wife). A 65-year-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Jan2021 (age at the time of vaccine 65-year-old) as 1st dose, 0.3 mL, single dose on right arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not specified but taking for blood pressure unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the pfizer suspect. On 01Feb2021, the patient experienced pain at the top of his arm going down his arm/ the whole arm itself just hurts/when he turns his neck to the right, he had pain up his armpit. On an unspecified date, the patient could not really sleep and had injection site pain on his right arm had kept him awake. The patient stated he was calling about the Pfizer BioNTech COVID19 vaccine and stated he had been having a reaction of side effects and asking how long the side effects could last. The patient stated that for the first couple of days after getting the vaccine he had nothing and then the pain started a little bit on Monday and then on Tuesday the pain got a little worse; stated that last night the pain was beginning to keep him up from sleep. The patient stated all the adverse events are ongoing. The patient's wife stated the indication for which the patient received the vaccine was they are trying to be safe, and the patient's HCP called him and asked the patient if he wanted to take the shot. The patient's wife stated they both received the vaccine. The patient stated he was given paperwork down at the site location where he got the shot but was given the paperwork after he was administered the shot and the paperwork was a list of side effects; stated if he had seen the list of side effects before, he was administered the shot, he probably would not have taken the shot. The patient's wife stated the patient received no testing or treatment for the reported events. The patient did not visit emergency room. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal.  Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal.  Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal.  Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; runny nose after getting the first dose of Pfizer COVID-19 vaccine/her nose was just running and dripping; I have allergies but never have one like that; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, NDC number and Expiry Date: Unknown), via an unspecified route of administration in Arm Left on 02Feb2021 (Tuesday) at 14:30 as a 1ST DOSE, SINGLE for covid-19 immunisation (age at vaccination was 77 year old). The patient's medical history included allergies. Concomitant medications included montelukast 10mg at bedtime she had been on it a while and fexofenadine hydrochloride (ALLEGRA), 180mg in the morning (It is over the counter. Count Size: 70 tablets. Lot number: 20F211C, expiry: Nov2022), both were taken for allergies. She didn't take Allegra Tuesday morning when she went to get the vaccine, but she did take it yesterday (on unknown date). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines was Administered on Same Date of the Pfizer Suspect. Prior Vaccinations within 4 weeks and AE) following prior vaccinations was None. On 02Feb2021 the patient experienced sneezing and runny nose after getting the first dose of Pfizer COVID-19 vaccine. "her nose was dripping, dripping, dripping quiet a lot but this morning it's better but she was still sneezing (On 02Feb2021). She had allergies but never have one like that on an unspecified date in Feb2021. Patient wanted to know if she can receive the second dose of the vaccine. Upon follow up patient reported that, she got her shot on 02Feb2021. That night she started sneezing. Then her nose was just running and dripping. It is a lot better this morning (date unspecified). It just drips a little. She wanted to know if that mean she is allergic to COVID 19 vaccine and she should get the next one or not. She called the doctor because she was going to ask him because she took allergy pills. She had never had that reaction before where her nose runs and runs. The sneezing and the nose running and dripping has improved. She had only sneezed once this morning. It is not running as bad today (date unspecified). Events did not require a visit to Emergency Room or Physician Office. Outcome of the sneezing and runny nose after getting the first dose of pfizer covid-19 vaccine/her nose was just running, and dripping were recovering, and she had allergies but never had one like that was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: someone my husband knowns got sick a couple days after getting the vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. Medical history included she has allergies to: sulfa drugs/sulfate, MRI contrast/dye "Blue dye different numbers, hives, difficulty breathing. The patient's concomitant medications were not reported. The patient previously took metoprolol for drug hypersensitivity. It reporter, reported that 'someone my husband knowns got sick a couple days after getting the vaccine'. Reporter wants to know there was a certain population that has allergies that increase risk of allergy to vaccine. she does not have allergy to eggs but uses egg allergy as an example. The outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: if these medications can be taken to alleviate the aching and body aches.; This is a spontaneous report from a contactable other hcp (nurse). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection;Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced if these medications can be taken to alleviate the aching and body aches on an unspecified date. It was reported that, patients were asking if they can take acetaminophen (tylenol) or Advil after they had the Pfizer COVID-19 vaccine. Patient was well aware that it was not recommended before taking the shot.She wanted to know if these medications can be taken to alleviate the aching and body aches. The outcome for the event was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Decreased appetite, Erythema, Fatigue, Feeling hot
Clinical narrative: her arm was red; her arm was swollen; Has blisters where it is hot, red and swollen; her arm is still hot; Low grade fever; Exhaustion; Lack of appetite; acting like she has a cold; This is a spontaneous report from a contactable other hcp. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), second dose via an unspecified route of administration on 01Feb2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical dose included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. Patient had no reaction at all from the first dose. On an unspecified date at night patient experienced her arm was red, swollen, along with blisters where it is hot, red and swollen, arm was still hot. low grade fever, exhaustion, lack of appetite, acting like she has a cold and called because she was concerned about her reaction. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Peripheral swelling, Pyrexia
Clinical narrative: her arm was red; her arm was swollen; Has blisters where it is hot, red and swollen; her arm is still hot; Low grade fever; Exhaustion; Lack of appetite; acting like she has a cold; This is a spontaneous report from a contactable other hcp. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), second dose via an unspecified route of administration on 01Feb2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical dose included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. Patient had no reaction at all from the first dose. On an unspecified date at night patient experienced her arm was red, swollen, along with blisters where it is hot, red and swollen, arm was still hot. low grade fever, exhaustion, lack of appetite, acting like she has a cold and called because she was concerned about her reaction. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sneezing
Clinical narrative: Head cold; Sneezing; This is a spontaneous report from a contactable consumer (patient's husband). An unspecified age (76, units: unknown) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 03Feb2021, as 2nd dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the second dose of the vaccine. Later in the day, on 03Feb2021, patient started sneezing and today on 04Feb2021, patient had a head cold. Her husband was asking if the vaccine was effective or compromised and what should be done if it is compromised. he was asking how to know it was effective and if the patient need to get a covid test. what can she take for the head cold. The outcome of the events was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: bigger red spots on [her] arms; mild rash on [her] chest and stomach; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jan2021, the patient experienced bigger red spots on her arms, 2 days after the injection, and she cannot tell if they were there before. She added she now has a mild rash on her chest and stomach (in 2021). She asked if rashes can appear 2 weeks after the receipt of the vaccine, as a side effect. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Heart rate, Oxygen saturation
Clinical narrative: Tachycardia heart rate 135 bpm at rest; shortness of breath oxygen saturation 90%; Chest tightness; burning; This is a spontaneous report from a contactable other hcp/nurse (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EK9231 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 14:30 as SINGLE DOSE for covid-19 immunisation. Medical history included female pattern hair loss. The patient previously took clindamycin and experienced drug hypersensitivity, compazine [prochlorperazine edisylate] and experienced drug hypersensitivity. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not tested covid post vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), vitamin d3 (VITAMIN D3), folic acid (VITAMIN B12 & FOLIC ACID) and finasteride (FINASTERIDE). The patient experienced tachycardia heart rate 135 bpm at rest, shortness of breath oxygen saturation 90%, Chest tightness and burning on 13Jan2021 23:45. The patient underwent lab tests and procedures which included heart rate: 135 bpm at rest on an unknown date, oxygen saturation: 90 % on an unknown date. No treatment received for the events. Outcome of all the events was recovered with lasting effects.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia heart rate 135 bpm at rest; shortness of breath oxygen saturation 90%; Chest tightness; burning; This is a spontaneous report from a contactable other hcp/nurse (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EK9231 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 14:30 as SINGLE DOSE for covid-19 immunisation. Medical history included female pattern hair loss. The patient previously took clindamycin and experienced drug hypersensitivity, compazine [prochlorperazine edisylate] and experienced drug hypersensitivity. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not tested covid post vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), vitamin d3 (VITAMIN D3), folic acid (VITAMIN B12 & FOLIC ACID) and finasteride (FINASTERIDE). The patient experienced tachycardia heart rate 135 bpm at rest, shortness of breath oxygen saturation 90%, Chest tightness and burning on 13Jan2021 23:45. The patient underwent lab tests and procedures which included heart rate: 135 bpm at rest on an unknown date, oxygen saturation: 90 % on an unknown date. No treatment received for the events. Outcome of all the events was recovered with lasting effects.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: swollen and today it remains a tiny bit swollen; cheek was a little bit swollen; This is a spontaneous report from a non-contactable consumer. This female consumer (patient) reported herself that a female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 02Feb2021 (Tuesday) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She did not have a reaction on 02Feb2021. The next day, which was yesterday, her cheek was a little bit swollen and today it remains a tiny bit swollen. She was asking what to do and if this was normal. Will it go away on its own? Can I still get the second dose? She declined consent to contact. She declined to provide mailing address and email. The outcome of the events was unknown.  Follow-up (04Feb2021): This is a follow-up spontaneous report from a non-contactable consumer.   No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: mouth tingling; swelling; numbness; body tingling; blood pressure was checked and it was high; This is a spontaneous report from a contactable consumer (patient's mother) reported for a female patient.  A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot/Batch number: unknown), via an unspecified route of administration on 17Jan2021 as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. On 17Jan2021, the patient immediately developed mouth tingling, swelling and numbness and well as all over body tingling. The reporter stated that the patient's blood pressure was checked and it was high and took Benadryl as treatment. The next day, the patient visited her primary care provider, and was prescribed prednisone. The reporter stated that the patient was still experiencing tingling. The patient also visited to an allergist, and had a reaction to the Miralax, which was still very red and itchy. The caller stated that the allergist suggested the patient to double up on Claritin and Benadryl. The reporter stated that the patient also experienced difficulty breathing from allergist inoculations and was prescribed an EpiPen. The reporter wanted to know whether the patient can receive the second vaccine dose. The patient had a physician office visit for the events. The patient received treatment for the events. The outcome of the events was not resolved for tingling and unknown for all other events.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: mouth tingling; swelling; numbness; body tingling; blood pressure was checked and it was high; This is a spontaneous report from a contactable consumer (patient's mother) reported for a female patient.  A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot/Batch number: unknown), via an unspecified route of administration on 17Jan2021 as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. On 17Jan2021, the patient immediately developed mouth tingling, swelling and numbness and well as all over body tingling. The reporter stated that the patient's blood pressure was checked and it was high and took Benadryl as treatment. The next day, the patient visited her primary care provider, and was prescribed prednisone. The reporter stated that the patient was still experiencing tingling. The patient also visited to an allergist, and had a reaction to the Miralax, which was still very red and itchy. The caller stated that the allergist suggested the patient to double up on Claritin and Benadryl. The reporter stated that the patient also experienced difficulty breathing from allergist inoculations and was prescribed an EpiPen. The reporter wanted to know whether the patient can receive the second vaccine dose. The patient had a physician office visit for the events. The patient received treatment for the events. The outcome of the events was not resolved for tingling and unknown for all other events.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 21Jan2021, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took shingrix and experienced rash, swelling and had past drug- ibuprofen. On an unspecified date, the patient reported the details of her cold, which she thinks was unrelated to her Pfizer-BioNTech COVID-19 vaccination. The patient stated she took her first shot on 21Jan2021. Two hours before, she took 600mg Ibuprofen, now the patient seeing that it was not recommended, nobody told me and asked a doctor at the facility where the patient got vaccinated and she said it was okay, she was not my personal doctor. The patient had a little bit of a cold right now, I got it on the 29th, I already reported it to Safety, got a little cold and have an appointment with my doctor on Monday at 3 o'clock. The second dose was scheduled for Tuesday at 1 o'clock. Ok so it's okay to take Ibuprofen but after your vaccine. The reason why I'm asking was not for me; 3 years ago, or so, I had Shingrix first shot of 2, and got a big rash on my arm, and was swollen. Doctor said it was not a normal response, so that was the first shot. After that the doctor told me that don't go for the second shot. I did not like that doctor very much, so I called somebody, a nurse practitioner who gives vaccines for when you travel and she told me to take an Ibuprofen and Benadryl before, so that's what I did and had no reaction no problem. It was not considered an allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: muscle soreness; tiredness; chills; flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 22Jan2021 as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced muscle soreness, tiredness, chills and flu-like symptoms. The patient was calling to ask how long she can expect her side effects to last. She states she started experiencing symptoms which include muscle soreness that was worse at night, tiredness, chills, and flu-like symptoms. She states her MD was not concerned and told her that it was her immune system working after receiving the vaccine. Outcome of the events were unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain
Clinical narrative: lower back pains/lower back started hurting; hips started hurting; the pain has moved around and changed; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 79; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on 29Jan2021 (Friday) as single dose for covid-19 immunization. The patient's medical history included back pain. The patient's concomitant medications were not reported. On 31Jan2021 (Sunday), the patient experienced lower back pains/lower back started hurting, hone of her hips started hurting and the pain has moved around and changed. She is still having trouble. She can barely lean over and get up. She wanted to know if that is a side effect from vaccine or what. She is going back in two weeks for her second shot. She wants to know if it is safe to take the second shot. She has been down in her back before so she doesn't know if it is a coincidence or what. The outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Neuropathy peripheral, Pain of skin
Clinical narrative: neuropathy; pain on her skin on the left side of her rib cage with no rash; sensitive to the touch; This is a spontaneous report from a contactable consumer or other non hcp (the patient, reported for self)  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (COMIRNATY) on unknown date for COVID-19 immunisation. The patient enquired if there were any reports of skin pain by the left side of the rib cage or any reports of neuropathy. The experienced pain on her skin on the left side of her rib cage with no rash on an unspecified date. She stated it has gotten worse as the days go by and is sensitive to the touch. Last night, she took a Gabapentin thinking it may help. She started having this reaction 3 to 5 days after receiving the vaccine. Therapeutic measures were taken as a result of pain on her skin on the left side of her rib cage with no rash includes Gabapentin. The outcome for event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Cyst rupture, Erythema, Pain
Clinical narrative: she has had a cyst on her labia for the past 4 years now.after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she said that the cyst started becoming painful and red.; she said that the cyst started becoming painful and red. Eventually, it also popped.; the cyst started becoming painful; the cyst started becoming red; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9265 and expiration date was not reported), via intramuscular route, administered in arm left on 03Feb2021 10:00 (at the age of 36 years) as 1st dose, single for preventative. Medical history included ongoing high blood pressure which was diagnosed at least 6 or 7 years ago, ongoing anxiety which was diagnosed about 5 years ago and patient had a cyst on her labia for the past 4 years, she had it checked a couple of weeks ago last 19Jan2021 and was told it was fine nothing to worry about. Concomitant medications included hydroxyzine 25mg tablet, up to three times a day as needed by mouth taken for anxiety, but patient does not take every day and Buspirone 15mg tablet three time a day by mouth taken for anxiety followed by hydralazine hcl 25mg tablet three times a day by mouth taken for high blood pressure and Clonidine 0.3mg tablet three times a day by mouth taken for high blood pressure. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the 1st dose of the Pfizer vaccine, at night (03Feb2021) the cyst was red and painful and this morning(04Feb2021) the cyst burst. Family doctor of patient prescribed her antibiotic. Patient informed that She would go see her gynaecologist tomorrow as her gynaecologist did not think it was bad enough to go to the ER. Patient was asking if there is a chance this could be a reaction from the vaccine. Patient also checked in with her doctors and they were unsure. Patient is looking for any information and had not heard of anything similar regarding a side effect. Patient will go tomorrow to Physician Office. Patient had scheduled for a second dose. The patient underwent lab tests and procedures which included blood pressure measurement as high. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose, clear yellow from left nostril; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3249 and expiration dates were not reported), via an unspecified route of administration in arm left on 26Jan2021 at 12:30 as 1st dose, single for COVID-19 immunisation. Medical history included obesity, hypertension, coronary artery disease and atrial fibrillation. The patient previously took daptomycin and experienced drug hypersensitivity. The patient experienced runny nose, clear yellow from left nostril on 03Feb2021. The patient did not receive any treatment for the event. Facility type vaccine: Hospital. No COVID prior vaccination and No COVID tested post vaccination. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This is a spontaneous report from a contactable consumer(patient).A 77 (unknown units) old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number : not provided), via an unspecified route of administration on an unspecified date Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date Feb2021, Patient experienced muscle pain. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday (at the point of this report) and when he filled the consent form, he read that you should mention your HCP if you are immunocompromised or are on a medicine that affects your immune system before receiving the vaccine, this list included steroid medications. At that time, he was not using this medications however he has an appointment with his doctor scheduled today about a problem he has in his hand and usually he receives a steroid injection to treat this condition. He would like to know if the steroid shot will affect the vaccine he received. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a rash on her wrist; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified) via an unspecified route of administration on 30Jan2021, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a rash on her wrist on an unspecified date. She heard the second dose may cause a more severe reaction and was wondering if she should get the second vaccine or not? Patient asking what was the percentage of efficacy for the first vaccine for protection? The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: PT TESTED POSITIVE FOR COVID 19 AFTER BEING FULLY VACCINATED.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Cardiac discomfort, Cough, Muscle spasms
Clinical narrative: Spasms in leg and thigh, joint pain, heart pain. My heart feel like a feeling I can't quite describe, it feels scary to even think to express appropriately. I know it hurts, and somewhat feels something like flooding. It feels I can't quite describe. It is a feeling I never felt. I lost my taste buds and have a sore throat now. my cough hurts. My chest and heart. I have a lot of mucus in my chest l.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Secretion discharge
Clinical narrative: Spasms in leg and thigh, joint pain, heart pain. My heart feel like a feeling I can't quite describe, it feels scary to even think to express appropriately. I know it hurts, and somewhat feels something like flooding. It feels I can't quite describe. It is a feeling I never felt. I lost my taste buds and have a sore throat now. my cough hurts. My chest and heart. I have a lot of mucus in my chest l.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Started feeling SOB, denies rashes/throat tightness taken to the ER
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pruritus, Paraesthesia
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: feels like arm is "asleep" from injection site down
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Blood glucose decreased, Blood pressure decreased, Feeling cold, Hyperhidrosis
Clinical narrative: During the 15-minute observation period, the patient had a fainting episode. He was briefly not aware of his surroundings and felt cool and sweaty to the touch. After a couple minutes, the patient slowly started regaining his mental status and was able to tell us his name, date, and the name of his kids. The EMTs arrived and did a thorough assessment; they determined that because the patient had not had anything to eat or drink all day up until his vaccine appointment, coupled with the fact that the patient had walked 5 minutes to the pharmacy and the weather was warm, the patient's blood pressure and sugar likely bottomed out and caused him to faint. The patient was given an ice pack to cool down and orange juice to normalize his blood sugar. After waiting in the pharmacy for another 15 minutes, the patient was deemed fit enough to walk back home. He was advised to have something to eat and take a cool shower.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: During the 15-minute observation period, the patient had a fainting episode. He was briefly not aware of his surroundings and felt cool and sweaty to the touch. After a couple minutes, the patient slowly started regaining his mental status and was able to tell us his name, date, and the name of his kids. The EMTs arrived and did a thorough assessment; they determined that because the patient had not had anything to eat or drink all day up until his vaccine appointment, coupled with the fact that the patient had walked 5 minutes to the pharmacy and the weather was warm, the patient's blood pressure and sugar likely bottomed out and caused him to faint. The patient was given an ice pack to cool down and orange juice to normalize his blood sugar. After waiting in the pharmacy for another 15 minutes, the patient was deemed fit enough to walk back home. He was advised to have something to eat and take a cool shower.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Coronary artery disease, Death
Clinical narrative: Death  4/26/2021 Causes of death listed on death certificate: 1) Pneumonia  2) Coronary Artery Disease  Other: Covid 19
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate abnormal, Heart rate increased
Clinical narrative: Short of breath in recent weeks, heart rate on June 9,2021 was up to 135 resting rate, abnormal heart rhythms (extreme fast or slow beating)
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Muscle twitching, Sleep disorder
Clinical narrative: Roughly 8 weeks post second-vaccination, left (the side of injection) deltoid and brachioradialis began experiencing sudden onset of muscle tightness and twitching. What started as an occasional occurrence throughout the the day has progress to a nonstop event that has persisted day and night for a week and a half straight. Sleep is being affected. Even through proper hydration, potassium, calcium, and Vitamin D supplementation, the symptoms persist.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow abnormal, Blood count abnormal, Fatigue, Haematocrit decreased
Clinical narrative: beginning mid March fatigue, progressively worse, admitted to hospital May, blood counts substantially below bottom line of standards, (RBC, WBC, Hemoglobin, Hemocrit, Platelets)....bone marrow biopsy diagnoses AML
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Laboratory test abnormal, Platelet count decreased, Red blood cell count decreased, White blood cell count decreased
Clinical narrative: beginning mid March fatigue, progressively worse, admitted to hospital May, blood counts substantially below bottom line of standards, (RBC, WBC, Hemoglobin, Hemocrit, Platelets)....bone marrow biopsy diagnoses AML
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: After finishing his visit and receiving vaccinations, the individual accompanied by his mother at the reception told his mother that he felt a little dizzy, the mother expressed that it was probably because he had not eaten and suddenly the child began to get dizzy. The individual fainted without answering his mother's questions. Immediately without waiting, the receptionist and the staff called the doctors, and the child was transferred to the exam room. Vital signs were taken, alcohol was used to awaken from fainting, the individual had normal vital signs, and his reaction to fainting was momentary without consequences. The individual was evaluated and sent home in good health by Dr, MD (pediatrician).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 after being fully vaccinated.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-