chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Darkening and dark marking on her arch on the side of her left foot; This is a spontaneous report from a contactable consumer (the patient). A 55-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0172), via an unspecified route of administration, administered in right arm on 26Apr2021 (at the age of 55-years-old) at pharmacy as a single dose for COVID-19 immunisation (reported as advised and being she was at high risk do not want to die and it would cut severity). Medical history included the patient was diabetic since 20 years. There were no concomitant medications. No history of previous immunisation with the other vaccines. No prior vaccinations within 4 weeks. On 26Apr2021, immediately that evening (after first dose), the patient experienced darkening and dark marking on her arch on the side of her left foot. Caller stated she went to the doctor the next day to report that since she was a diabetic and she always notices her feet and thought it was strange. No pain or anything just darkening that she thought was strange. The outcome of event was not recovered.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dry throat, Epistaxis, Fatigue, Headache
Clinical narrative: Kind of tired; Very thirsty; Bleeding nose; Very dry throat; Big strong headaches; Could not sleep; She had to pee a lot; Pressure on chest; This is a spontaneous report from a non-contactable consumer (patient). This non-contactable female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, the side effects she has been experiencing for the last 3 days. She received her vaccine on the first of this month. She began experiencing heavy side effects. They were kind of tired. After the 11th day, she was very thirsty. She drank 2 cups of tea and 5 glasses of big water at nighttime. She had to pee a lot. Her throat was not sore, but it was very dry. Before that, she went back to the library studying. When she arrived home, she experienced a bleeding nose. She thought her mucus was very dry. Her nose was bleeding for quite a bit and then it stopped. During the night, she began experiencing a lot of big strong headaches. She could not sleep. The thirstiness and she got pressure on her chest. It was like when someone is walking very fast and breathing. She managed to get through the night. The patient was recovered from bleeding nose and outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pollakiuria, Thirst
Clinical narrative: Kind of tired; Very thirsty; Bleeding nose; Very dry throat; Big strong headaches; Could not sleep; She had to pee a lot; Pressure on chest; This is a spontaneous report from a non-contactable consumer (patient). This non-contactable female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, the side effects she has been experiencing for the last 3 days. She received her vaccine on the first of this month. She began experiencing heavy side effects. They were kind of tired. After the 11th day, she was very thirsty. She drank 2 cups of tea and 5 glasses of big water at nighttime. She had to pee a lot. Her throat was not sore, but it was very dry. Before that, she went back to the library studying. When she arrived home, she experienced a bleeding nose. She thought her mucus was very dry. Her nose was bleeding for quite a bit and then it stopped. During the night, she began experiencing a lot of big strong headaches. She could not sleep. The thirstiness and she got pressure on her chest. It was like when someone is walking very fast and breathing. She managed to get through the night. The patient was recovered from bleeding nose and outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (Patients wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: 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 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and kind of tired on an unspecified date. The Caller stated she went on the next day to get the vaccine with her husband for the Pfizer. They received the vaccines at (withheld) and it said BioNTech EW0187 on a document the caller was reading from. Caller confirmed the vaccine was the Pfizer BioNTech COVID-19 Vaccine. Caller stated her husband had a headache and kind of tired. Caller did not specify if this lot number also pertained to her husband's vaccine. The outcome for the events was unknown. No follow attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Period started 11 days earlier than normal; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had period 11 days earlier than normal. Patient stated she received the first dose of the Pfizer COVID vaccine 5 days ago and then her period started 11 days earlier than normal. Patient would like to know if this has been reported before or is normal before receiving her second dose. Response: No information in PI regarding period starting 11 days earlier than normal. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Serious and unexpected side effects may occur. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is still sick and is not recovered; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient taken the first dose of the Pfizer COVID-19 vaccine. She has heard people had adverse reactions right after getting the vaccine, but her adverse events occurred right now, which was 15 days after her first dose. Her second shot appointment was due in 4 days and she was still sick and was not recovered. She said that she has all the COVID-19 symptoms, and she has taken a test today and still waiting for the results. She wanted to know if she can take the vaccine even if she was sick. As noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The patient should speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the event was not resolved.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: 6 migraines after the first vaccine/Increased migraines; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: GR8736 or GR8136), via an unspecified route of administration, administered in Arm Left on 04May2021 (at the age of 79-years-old), as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included chronic migraine which she had them for years and then 5 years ago they came back with vengeance, herpes zoster from 01Feb2021 had shingles on her head and shingles pain. The patient's migraines got worse when she lost her husband 3 years ago, she thought it a stress migraine. The patient previously took amoxicillin and experienced drug hypersensitivity and botox for the past year for migraines. The patient was having around 8-10 migraines a month prior to starting Botox. The patient was late to get her dose of Botox because of covid and would have to go into the fourth month before she could get it instead of the usual 3 months. The Botox didn't seem to cover the patient with the vaccine. The patient was due 12Jul2021 for the next dose of Botox, but she had these migraines before then. The Botox had been working very well for the patient prior to the vaccines. The patient didn't know why the last dose of Botox didn't cover her like it usually does. The Botox dose was 125 units. They start on the lower dose and up it and see how you're doing, the highest was 150. Concomitant medications included gabapentin taken for herpes zoster from an unspecified start date to 28May2021; ibuprofen taken for shingles pain from 12May2021 to 28May2021. On 04May2021 (10 minutes after vaccine), the patient experienced dizziness and waiter for 30 minutes and then it went away. On 05May2021, the patient experienced first migraine after vaccine, had migraine yesterday and had migraine brain. The patient had 6 migraines after the first vaccine and 8 migraines after the second dose. The outcome of the event migraines was not recovered and for event dizziness was recovered on an unspecified date.  Information on lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: increasing pain at injection site; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient (daughter) that: A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 07May2021 15:45 (at the age of 16-year-old) as second dose, single dose for covid-19 immunization. The patient Medical history included coeliac disease from 2007 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and Expiry Date was not reported) via an unspecified route of administration, administered in Arm Left on 16Apr2021 as single for covid-19 immunisation. On 07May2021 the patient had increasing pain at injection site a month later, started day of vaccine. It was reported that, she put ice on it and she took some Advil. The outcome of the event was not recovered.  Information regarding the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Hypoaesthesia, Nasopharyngitis, Renal disorder
Clinical narrative: kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness in his arm.; lower back pain/but started hurting again.; difficulty walking/He was also unable to walk the first week.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 14:00 (Lot Number: EW0176) (at the age of 50-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 administered in left arm on 21Apr2021 (lot number: ER8731) for COVID-19 Immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Illness at time of vaccination was reported as none. On 13May2021, the patient complaints of lower back pain, difficulty walking, and numbness of left upper arm. The patient was wondering how the pain can be resolved. The patient was asking and wanted to know if he was having kidney issues due to his lower back pain. On reply Pfizer did not provide any recommendations regarding the management or treatment of potential adverse events. The patient was advised healthcare provider was in the best position to provide appropriate action to take as healthcare provider was most familiar with medical condition, clinical history and treatment and any relevant information to specific case. He had lower back pain. He didn't know that this was a side effect at the time. The pain was in in his left lower back, and he was also unable to walk the first week. After receiving the second dose the patient started to feel something but didn't know exactly what it was. A few days ago, he found that it was cold be a side effect. He also had numbness in his arm. For that he requested that he receive the vaccine in his left arm. He had numbness for 2-3 days that he remembered. It did not bother him after 7 days. He took Advil or Ibuprofen. He has not gone for treatment. He thought it was something else. He went back to where he received the vaccine. They were unable to tell him anything. Outcome of the event for difficulty walking/He was also unable to walk the first week was recovered on 15May2021, for numbness of left upper arm/He also had numbness in his arm was recovered on an unknown date in 2021, for lower back pain/but started hurting again was not recovered, while unknown for rest of the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Micturition disorder, Urinary tract infection
Clinical narrative: UTI; some issues with continuing to empty bladder; This is a spontaneous report from a contactable consumer (patient herself). A 38-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration at (upper) arm left (at the age of 38-year-old) on 07Jun2021 10:00 as single dose for covid-19 immunisation. Medical history included ongoing ehlers-danlos syndrome (she was diagnosed with this many many years ago since it is genetic). Concomitant medications were not reported. The patient had no AE and Prior Vaccinations (within 4 weeks). On 07Jun2021, patient had first dose last week on Monday which was given at approximately 10:00 am and by late afternoon and after that she reported that she had some issues with continuing to empty her bladder which resulted in really bad UTI and she has been struggling with it ever since. The patient stated this significantly worsened and so she saw an urgent care doctor and they were not sure if the antibiotics would be strong enough because there was a possibility of it going to her kidneys. The patient also stated for UTI, it has improved since getting (unspecified) antibiotics. The patient did not visit to emergency room. The patient went to the urgent care. The outcome of the event some issues with continuing to empty bladder was not recovered and urinary tract infection was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Loss of personal independence in daily activities, Pain, Vaccination site haematoma, X-ray
Clinical narrative: hematoma; bruising in the left arm; really hurt; she had limited use and could only raise it so far.; This is a spontaneous report from a Pfizer sponsored marketing Program COVAX US SUPPORT a stimulated report reported by contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 09Feb2021 as 2nd dose, single dose and dose 1 via an unspecified route of administration, administered in arm left on 17Jan2021 as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. States she received her first dose of the Pfizer Covid-19 vaccine on 17Jan2021 in her left arm. States she developed a hematoma on an unspecified date in 2021 immediately after administration that soon settled into a bruise. States that she received her second dose of the Pfizer Covid-19 vaccine 09Feb2021 in her right arm due to the bruising in the left arm on an unspecified date in 2021. On an unspecified date in 2021, states the left arm "really hurt" and that she had limited use and "could only raise it so far." States she was on workman's comp light duty and has been told not to use her left arm. States she sought out medical attention and had two sets of Xrays due to her arm pain. States the first set of Xrays showed nothing abnormal, but the second set of Xrays show "what looks like cottage cheese right in the middle of the deltoid muscle." The consumer clarifies and confirms that it was not a bruise, it was something growing in her arm, it came up on the x-ray. She had no issues at all at first dose. After she had the first injection, it was a giant hematoma at the injection site and people said it would go away with heat, so she did. When she went to get her second dose, her left arm was still bruised from the previous shot. She decided to get the second dose in the right arm because of this. The left arm still hurt, and something was wrong with it. She went to work man's comp and they sent her out to an orthopedic guy, and they took an x-ray. The x-ray showed that there was something growing at the injection site in the muscle. The first set of x-rays showed nothing, but the second one showed that there was something in the muscle. The outcome of the events was unknown.  Information about Lot/Batch number are requested, additional information requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: having tingling to her in face 2 days after receiving the first dose and is ongoing; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 25May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 27May2021, she began having tingling to her in face 2 days after receiving the first dose and was ongoing. The patient was scheduled to have the second dose on 15Jun2021 and wanted to know if she should take the second dose of the vaccine. The response included that as the prescribing information did not include all adverse reactions that have been reported or that may occur, please consulted with your doctor/healthcare provider about what you have experienced/were experiencing and because your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider was in the best position to advise you about the appropriate action to take. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain in the injection site; joint pain in the hand of the same side; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as second dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) in Apr2021 for covid-19 immunisation and patient did not experience any reaction. The consumer reported that after the administration of the second dose she experienced pain in the injection site and joint pain in the hand of the same side on Mar2021. The consumer reported that she thinks of herself as a healthy patient. Seriousness of the events was reported as non-serious. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pruritus
Clinical narrative: Her arm was "itchy that day"; Today the site "is unbearably itchy"; This is a spontaneous report from a contactable consumer (patient, self-reported). This is for the second dose. A 57-year-old female consumer received second dose of bnt162b2 (Pfizer COVID 19 vaccine, solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: unspecified) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Pfizer COVID 19 vaccine, solution for injection), via an unspecified route of administration on unspecified date, as 1st dose, single dose for covid-19 immunization. No reaction on previous exposure to drug. On11Jun2021, the patient experienced her arm was "itchy that day" (Friday) and she "did not think much about it." Saturday the itching continued, and it worsened yesterday, on 13Jun2021. On 14Jun2021, Today the site "was unbearably itchy" and the caller wants to know if this was normal. The patient was advised in clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site, injection site swelling, injection site redness however does not mention "itching" specifically. The event was reported as non-serious. The outcome of the events was not recovered.  Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation The patient medical history and concomitant medication were not reported. The patient experienced hair loss on an unspecified date. The Reporter stated that she had both doses of the Pfizer Covid vaccine with family. She stated that everything was fine but she had a reaction of hair loss. She didn't pay attention to when it started but did notice some hair loss, but didn't monitor it closely but is not sure if it was a week or two later. It lasted for 3 months after she took the vaccine. She stated the hair loss stopped and she is no longer experiencing this. She stated a family member saw on TV that people were experiencing this and she is not the only person to experience it. She is not sure what show or channel that was on though. She said, when the booster dose comes out in the fall, is it safer to go with Pfizer or another vaccine since she had this hair loss with this vaccine. The reporter asked if Pfizer has been able to find out what causes hair loss after the vaccine or fixed it to where that is not a symptom and response included Referred to the PI section 6 regarding this symptom not being reported in the clinical trials. No info on this symptom. There is no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines" Referred to the FAQ that a booster dose has not yet been authorized, and therefore we do not have additional recommendations regarding that dose. Referred her to her HCP for further discussion. The reporter stated Pfizer should investigate if it is safe to change companies for the covid vaccines. There needs to be a study. Especially if someone has had a reaction. In addition they need to look into hair loss, and see if there potentially is any ingredient in the vaccine that may cause this.  Follow-up attempts are needed; information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; This is a spontaneous report received from a contactable consumer (patient herself) or other non HCP via Medical Information Team. This consumer reported adverse events with similar suspect for 2 patients. This report is One of two patients.   A 59-years-old female patient received first dose of 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 29May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included covid-19 on an unknown date in Sep2020 (reported as last September). The patient's concomitant medications were not reported. On an unknown date, after 5 days, the patient was coughing, and it was for 11 days. The patient still having complaints of cough. The patient  scheduled for second dose of Pfizer Covid-19 Vaccine on 19JUN2021 and wanted to know if she should I take vaccine on Saturday. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021705255 same report/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Developed a reaction of spider/mosquito like bites; Swelling on the left arm, which is the same arm where he received the injection; Red "patchy areas" and itchiness on his leg; Red "patchy areas" and itchiness on his leg; Red "patchy areas" and itchiness on his leg; This is a spontaneous report from a contactable consumer (patient mother) or other non hcp. A 22-years-old male patient (reporters son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 11Jun2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in June2021, the patient developed a reaction of spider/mosquito like bites and swelling on the left arm, which is the same arm where he received the injection. He also has red patchy areas and itchiness on his leg. According to the caller, its all on his left side. Caller would like to know if these symptoms have been reported with the Pfizer BioNTech COVID-19 vaccine. The Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Mobility decreased, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm; muscles ached so bad; not been able to sleep since then; He is upset; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date (at the age of 49-year-old) at a 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was slightly sore after the injection on the day he got it, could not move nor lift his arm, muscles ached so bad, not been able to sleep since then, he is upset. Reporter is a 49 year old male patient who has received his 1st dose of the Pfizer COVID Vaccine on Tuesday last week. He mentioned that he has a side effect that has been on going for 6 days, with the 7th day being tomorrow. His arm was slightly sore after the injection on the day he got it. By the next day, he could not move nor lift his arm. His muscles ached so bad and he has not been able to sleep since then. He mentioned that he has never had anything like this before the vaccination. He thought he was doing the right thing but now he is in a very bad situation. He is upset because he can't even work. He and his family is very concerned because of this. He mentioned that there is absolutely no way in heck he is getting the 2nd shot. Outcome of the events was unknown.  Follow up (PRD14Jun2021/SRD15Jun2021): This is a follow up spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported that: When consumer was again informed about the role of Pfizer Drug Safety and requested to probe, consumer stated, consumer really just want to know, consumer really concerned about what happened. Consumer want to know whether he is going to be okay or consumer need to go to the hospital. Consumer don't want to file nothing for no safety or no stuff like that, consumer want to know whether he is okay. Because consumer thought consumer was doing the right thing by getting this and now consumer can't even move my arm for 6 days, so consumer am very concerned about it.  Information regarding the Lot/Batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: After receiving the vaccine, her subsequent period was anything but normal.; A cycle lasting twice as long and heavy with blood clots is not a fluke.; After receiving the first dose, we are going to delay the second dose until more data is collected; This is a spontaneous report from a contactable other HCP. A 14-years-old female patient 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 an unspecified date (14-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after receiving the vaccine, her subsequent period was anything but normal, a cycle lasting twice as long and heavy with blood clots is not a fluke, and after receiving the first dose, we are going to delay the second dose until more data is collected. The outcome of all the events was unknown.  Information about lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: metallic taste; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as unknown single dose for COVID-19 immunization. The patient medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. The patient concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. On May2021, the patient experienced metallic taste. The patient underwent lab tests and procedures which included: post the vaccination on May2021, the patient had sars-cov-2 test and result was unknown. The patient did not receive treatment for the event. The event was considered as non-serious by the reporter. The outcome of event was not resolved.  Information regarding the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin swelling, Tinnitus, Weight, Weight decreased
Clinical narrative: He has a rash all over his arm and its puffy.; He has a rash all over his arm and its puffy.; Ringing of the ears, tinnitus; weight loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Manufacturer: Unspecified, Formulation: Solution for injection) via an unspecified route of administration to his left arm on 24May2021 (at age of vaccination) (Lot number: EW0191, NDC number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient was taking Covid 19 shot as he was forced to do it or he would lose his job, against medical advice. The patient's medical history was not reported. Concomitant medications were reported as none (other products: no). On an unspecified date in May2021, the patient experienced rash all over his arm and ringing of the ears, tinnitus. Caller stated he was a healthcare professional, he sold Medicare and other healthcare plans. He said he was calling about the shot. He did not get the information for reporting until he got the second shot today. Caller stated it said Pfizer EW0191 for the first shot and then PFIZER EW0196 for the second one. He was not sure if it was a zero or an O. He stated he was calling about the Covid 19. He wanted to report the first one and he had a sheet and he was reading all of things. He had a rash all over his arm and it was puffy. Not just a rash it exploded since then. They keep growing and then they dry off and come up again. Caller stated his first shot was done on 24May2021. He did not know he lost a lot a weight he was 175. Caller clarified the weight loss if from his treatments. He had a rash all over his arm. He could not tell if it was the first or second day. Either 24May2021 or 25May2021. He woke up with it. Then he did not realize until the next day until midday. It was probably sometime at night. It was ongoing and persisting. It was not getting worse, well actually now it on the right just a few. It said CDC Covid 19 vaccination on a 2x3 card. He got his first shot on his left and the second on his right. Ringing of the ears, tinnitus. That night he experienced it and it had not stopped. It was not loud or making him mad or crazy but he was hearing it. Attempted to clarify with caller the start date. Caller stated that night or the next. It was ongoing and persisting. It was a low tone, still there. He guesses it helps the more adverse events that are reported when people call in with adverse events. Now if he were to call now that he got the second shot to report more rashes, he already had a rash on each arm. Treatment was reported as none. Treatment included acne, benzoyl peroxide to dry it up. Communication: Provided caller with Report Reference 7OUJST6G. Outcome of the event weight loss was unknown, whereas other events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Feeling hot, Pain, Pain in extremity
Clinical narrative: and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt warm.; joint pain; swelling that radiated from her arch; the mark was still there on 18May2021 but the area is wider but lighter; exhibiting slight pain on scale of 1 to 4 time to time; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: FW0168) via an unspecified route of administration, administered in Arm Right on 18May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included diabetic. There were no concomitant medications. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0172) on 26Apr2021 for covid-19 immunization and experienced dark marking over arch on side of foot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As after first dose she reported having a darkening and dark marking on her arch on the side of her left foot and after 2nd dose the mark was still there on 18May2021 but the area was wider but lighter and a pain and swelling on her left foot, with the pain level of 4 out of 10. She also felt warm. She also mentioned being diabetic and never having a problem on her feet before. Her HCP said that she would be undergoing tests. She also reiterated that joint pain was not same as foot pain and that her side effect should not be reported under joint pain. Reporter wanted to ask if these side effects have been reported yet. Reporter stated she got the second shot on 18May2021 and the mark was still there but maybe a week in a half after that she started exhibiting slight pain on scale of 1 to 4 time to time, swelling that radiated from her arch and it felt warm. Reporter also reported that, she went to see a podiatrist and she was prescribing a venous doppler to check it out. she wanted to notate this and how she had no issues with her feet previously. Patient stated felt warm started a week in a half after 18May2021. All events occurred in an unknown date in May2021. Patient visited to clinic. Patient stated she has taken Ibuprofen as treatment for felt warm, but she did not want to take it every day. The outcome of the events She also felt warm, swelling that radiated from her arch and exhibiting slight pain on scale of 1 to 4 time to time was not recovered and for other events was unknown  Follow up needed, further information was requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: and a pain and swelling on her left foot; and a pain and swelling on her left foot; She also felt warm.; joint pain; swelling that radiated from her arch; the mark was still there on 18May2021 but the area is wider but lighter; exhibiting slight pain on scale of 1 to 4 time to time; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: FW0168) via an unspecified route of administration, administered in Arm Right on 18May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included diabetic. There were no concomitant medications. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0172) on 26Apr2021 for covid-19 immunization and experienced dark marking over arch on side of foot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As after first dose she reported having a darkening and dark marking on her arch on the side of her left foot and after 2nd dose the mark was still there on 18May2021 but the area was wider but lighter and a pain and swelling on her left foot, with the pain level of 4 out of 10. She also felt warm. She also mentioned being diabetic and never having a problem on her feet before. Her HCP said that she would be undergoing tests. She also reiterated that joint pain was not same as foot pain and that her side effect should not be reported under joint pain. Reporter wanted to ask if these side effects have been reported yet. Reporter stated she got the second shot on 18May2021 and the mark was still there but maybe a week in a half after that she started exhibiting slight pain on scale of 1 to 4 time to time, swelling that radiated from her arch and it felt warm. Reporter also reported that, she went to see a podiatrist and she was prescribing a venous doppler to check it out. she wanted to notate this and how she had no issues with her feet previously. Patient stated felt warm started a week in a half after 18May2021. All events occurred in an unknown date in May2021. Patient visited to clinic. Patient stated she has taken Ibuprofen as treatment for felt warm, but she did not want to take it every day. The outcome of the events She also felt warm, swelling that radiated from her arch and exhibiting slight pain on scale of 1 to 4 time to time was not recovered and for other events was unknown  Follow up needed, further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensitive skin, Vaccination site pain
Clinical narrative: The injection site pain; Arm pain; There is a sensitivity; This is a spontaneous report from a contactable Nurse (patient herself) via Medical Information Team.   A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, Expiration date: unknown), via an unspecified route of administration on 29Mar2021 as, second dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199, Expiration date: unknown), via an unspecified route of administration on 8Mar2021 as, first dose single dose for covid-19 immunisation and experienced the event Arm pain and sensitivity at the injection. On unspecified date the patient experienced the injection site pain, there was a sensitivity and arm pain. It was reported that, Nurse calling on behalf of herself, received the first dose of the Pfizer Covid-19 vaccine on 08MAR2021 and the second dose on 29Mar2021. she reports within the last week and a half, she has been experiencing arm pain and sensitivity at the injection site. she states that she received one dose in each arm, in which both arms are experiencing pain. she states that she did not have much arm pain after the first dose, however with the second dose, she states the injection site pain went away and is now coming back, as if I just got the shot. she states that she doesn't have any heaviness in her arms and reports if she touches the injection sites, there is a sensitivity. she states the injection site pain went away after administration and now has come back. she asked if it is normal to experience this pain three months later. she states that she was really concerned about her arms. she clarified she was referring to the COVID 19 vaccine. she stated she was just called because she received the COVID vaccine shot in March and she has suddenly in the last week in a half been feeling arm pain. Caller stated she got the shots in different arms but now she having sensitivity in both sites where they put the vaccine. Caller stated she had initial arm pain, but it has not gone away, and it is June now. The outcome of the events injection site pain and arm pain was not recovered while outcome of sensitivity was unknown.   Information on the lot/ batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: had very bad symptoms and she in 'not well until today; This is a spontaneous report from a non-contactable female consumer reported for her mother. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The adverse events reported in this case belong to the mother of the caller. The reporter reported that her mother received the vaccine from Pfizer and had very bad symptoms and she is not well until today. The reporter reported the event as non-serious. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021703466 same reporter/drug/AE, different patient
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Cough, Erythema, Peripheral swelling
Clinical narrative: my hand is getting swollen and red; I felt coughing; I lost completely my taste; my hand is getting swollen and red; This is a spontaneous report received from a contactable consumer. A 66-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 23Mar2021 as 1st dose, single dose and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 23Apr2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he took vaccination, the first one on 23Mar2021, the second one 23Apr2021. The hands got swollen and red but after that he felt coughing and lost taste completely. He went to emergency clinic to a family doctor and did everything but could not complain because of the vaccination. The clinical outcome of the events unknown.  Information about batch no/lot no has been requested.