chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dry throat, Head discomfort, Lymphadenopathy, Nausea
Clinical narrative: fever; nausea; pressure on her head; chest pain on the side where she received the shot; swelling and a little lump down her armpit on the side where she received the shot; swelling on her face on the side where she received the shot; thirsty; dry throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history ongoing high levels of thyroid hormones. Concomitant medications were not reported. She received the first dose on Saturday (17Apr2021) and developed the following side effects: fever, nausea, pressure on her head, chest pain on the side where she received the shot, the presence of swelling and a little lump down her armpit on the side where she received the shot, 3 days ago in the morning she presented swelling on her face on the side where she received the shot in Apr2021. The first day after receiving the first dose she was really thirsty, yesterday and the day before yesterday she had a dry throat, her physician prescribed her with Benadryl for this, and indicated that this could be a reaction to the vaccination. Her physician wanted to know if high levels of thyroid hormones could affect the response to the vaccination. She also wanted to know if the patients who develop an allergic reaction to the vaccine might have a lower response to the vaccination. She also wants to know how long could these side effects last. Patient was referred to her physician to speak about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine considering the side effects that she presented with the first dose of the vaccine. The events assessed as non-serious. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Thirst
Clinical narrative: fever; nausea; pressure on her head; chest pain on the side where she received the shot; swelling and a little lump down her armpit on the side where she received the shot; swelling on her face on the side where she received the shot; thirsty; dry throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history ongoing high levels of thyroid hormones. Concomitant medications were not reported. She received the first dose on Saturday (17Apr2021) and developed the following side effects: fever, nausea, pressure on her head, chest pain on the side where she received the shot, the presence of swelling and a little lump down her armpit on the side where she received the shot, 3 days ago in the morning she presented swelling on her face on the side where she received the shot in Apr2021. The first day after receiving the first dose she was really thirsty, yesterday and the day before yesterday she had a dry throat, her physician prescribed her with Benadryl for this, and indicated that this could be a reaction to the vaccination. Her physician wanted to know if high levels of thyroid hormones could affect the response to the vaccination. She also wanted to know if the patients who develop an allergic reaction to the vaccine might have a lower response to the vaccination. She also wants to know how long could these side effects last. Patient was referred to her physician to speak about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine considering the side effects that she presented with the first dose of the vaccine. The events assessed as non-serious. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity
Clinical narrative: He found out a few minutes ago that a person he was with yesterday has Covid 19; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 22Apr2021 (Lot Number: EW0170) as a single dose for covid-19 immunisation. The patient received the first dose on 01Apr2021 (Lot number: ER8727) for Covid-19 immunisation in the left arm. The patient's medical history and concomitant medications were not reported. The patient inquired if he should get tested tomorrow (23Apr2021) and what do he do if he is positive. He also inquired if he needs to do anything different and If he had Covid, would he need to get a third vaccine. The patient reported that he received the second dose of the Pfizer Covid 19 vaccine today (22Apr2021). He found out a few minutes ago that a person he was with yesterday has Covid 19. He heard you shouldn't get the vaccine if you've been exposed. He inquired what was recommended. He is asymptomatic for Covid 19 at this time and only has some arm soreness from his second vaccine. The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have increase in tinnitus; This is a spontaneous report received from a contactable consumer (Patient) via Medical Information Team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 31Mar2021 (at the age of 63-years), as a single dose for COVID-19 immunisation. Medical history included tinnitus, stroke years before and her math skills are off. Concomitant medications were not reported. On an unspecified date in 2021 (after first dose), the patient experienced increase in tinnitus. It was reported that, patient developed tinnitus a year ago, and calmed down a bit, but has come back a bit after the vaccine. Patient was not sure if she need to have second dose as she read all of forums that say that either have or seen increase in tinnitus. Upon questioning, patient received details about administration of second dose. The patient appreciated the response she received. 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: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient, self-reported). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 07Apr2021, as single dose for COVID-19 immunization. Patient's medical history included COVID-19 positive (patient and her husband were positive) 3 weeks before they took their first dose of COVID-19 vaccine. Concomitant medications were not reported. On an unknown date in Apr2021, the patient had fever. Patient was asking if they still need to take the 2nd dose scheduled on 28Apr2021. Outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from contractable consumer from Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiration date were not provided), via an unspecified route of administration, on 07Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive on Covid, 3 weeks before they took their 1st dose of Covid-19 vaccine last 07Apr2021. On unknown date, after taking the vaccine patient had fever. Reporter asked if they still need to take the 2nd dose scheduled on 28Apr2021. The outcome of event was unknown.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Panic attack, Paraesthesia, Vision blurred
Clinical narrative: Had dizziness/felt dizzy and light headed; Tingling left hand/arm feeling of pins and needle/pins and needle feeling in left hand; I had blurred vision; Headache/frontal headache; Panic attack/it was scary and strange; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller, called in because she received her 1st dose about a couple weeks ago and she thinks that she may have a delayed reaction to the Pfizer vaccine and had a panic attack in Apr2021, She has a 9 month daughter and her husband is deployed, she is scheduled to get the 2nd dose on 27Apr2021 but she has no child care or help, so she is seeking some advice if she can delay her 2nd shot until she have some support if that would be okay. Caller received her first dose of the Pfizer covid on 06Apr2021 and 1 week later (13Apr2021) had dizziness and tingling left hand/arm feeling of pins and needle. On the 13Apr2021 when patient had those strange experience patient had blurred vision before patient felt dizzy and light headed then the pins and needle feeling in patient's left hand then a headache; a frontal headache. Once patient took Tylenol and drank lot of water it went away. Patient have never had any symptoms like that before so it was scary and strange. Patient's doctor told patient  that patient had a delayed reaction and panic attack from the vaccine. Patient's next shot is on 27Apr2021. Patient's husband is deployed and patient had a 9 month old with no help. It was asked if patient should delay patient's 2nd shot until patient get help. Patient had a side effect after the first dose of the vaccine. It was asked if patient should get the second dose. Therapeutic measures were taken as a result of had dizziness/felt dizzy and light headed, tingling left hand/arm feeling of pins and needle/pins and needle feeling in left hand, i had blurred vision, headache/frontal headache. The outcome of event panic attack/it was scary and strange was unknown. The outcome of other events was recovered in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457367 Same drug and different patient/event.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: developed lump on the same side where the vaccine was administered; This is a spontaneous report received from a contactable consumer (patient's mother) via medical information team. A 26-year-old male patient (reporter's son) received first and second doses BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got his first dose and developed a lump after the administration initially which did not disappear (just got smaller) not until his 2nd dose where he developed the same lump on the same side where the vaccine was administered on an unspecified date. Reporter would like to know how long do they need to wait until they seek further medical treatment or medical advice from their doctor. Also, if the lump will resolve on its own. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Mobility decreased, Muscle spasms, Rotator cuff syndrome
Clinical narrative: leg cramps/cramp cause because it is harder to get in and out now; rotator cuff; back problems; it is hard to get in and out now; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing allergies (are acting up), ongoing sinuses is really draining a lot. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergy and sinuses. The patient previously took levocetirizine dihydrochloride (XYZAL) and experienced headaches, jittery and no sleep. She stated that she got her Pfizer shot and the next day stated that she had leg cramps and took some highlands leg cramp and than 2 hours later she had another leg cramp. she also has a cramp cause because it is harder to get in and out now. She has rotator cuff and back problems. She later stated that she is home bound. The outcome of events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea
Clinical narrative: Tiredness; Migraine; Nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is calling to report some side effects after receiving the first dose of the Pfizer Covid-19 vaccine. These side effects are tiredness, migraine, and nausea. She also mentioned she got the first dose of the vaccine on 27Mar2021.  The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 on 27Mar2021 for COVID-19 immunization and experienced tiredness, migraine and nausea. She mentioned that she felt the stomach aches in Apr2021 only after the second dose and none after the first dose. She also mentioned she got the second dose on 17Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Joint swelling, Paraesthesia, Peripheral swelling
Clinical narrative: Chills; Swelling in my arms, legs, feet and ankles and its getting worse each day (over the last 3 days); I'm starting to feel a tingling in my feet I feel like it's gone to sleep and its going into my leg; Runny nose; Swelling in my arms, legs, feet and ankles; Swelling in my arms, legs, feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 08Apr2021 (at the age of 72-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021 Tuesday, the patient started having swelling in her arms, legs, feet and ankles and it got worsened each day (over the last 3 days). Patient felt tingling in her feet, felt like it is gone to sleep, and it is gone into her leg. She enquired whether this was normal and how long would it last. Patient also reported runny nose and chills. She was supposed to have surgery on 12May2021 and hoped this would resolve by then. The clinical outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Chills; Swelling in my arms, legs, feet and ankles and its getting worse each day (over the last 3 days); I'm starting to feel a tingling in my feet I feel like it's gone to sleep and its going into my leg; Runny nose; Swelling in my arms, legs, feet and ankles; Swelling in my arms, legs, feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 08Apr2021 (at the age of 72-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021 Tuesday, the patient started having swelling in her arms, legs, feet and ankles and it got worsened each day (over the last 3 days). Patient felt tingling in her feet, felt like it is gone to sleep, and it is gone into her leg. She enquired whether this was normal and how long would it last. Patient also reported runny nose and chills. She was supposed to have surgery on 12May2021 and hoped this would resolve by then. The clinical outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Oral pruritus
Clinical narrative: her lips and inside of her mouth started to swell; her lips and inside of her mouth started to swell/ just looked like I had lip fillers; she felt an itching sensation in her mouth; This is a spontaneous report from a contactable consumer (Patient).  The female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 01Apr2021 as a single dose for Covid-19 immunization. Medical history included anaphylactic reactions to animal products. She's wondering why she responded to the vaccine this way. Concomitant medications were not reported. On 01Apr2021 within 10 minutes after first dose, her lips and inside of her mouth started to swell and resolved within 20 minutes of the shot. On 01Apr2021, she felt an itching sensation in her mouth. It was stated that her symptoms were never really bad, just looked like she had lip fillers and it was never escalated to an emergency situation. It was stated that she was scheduled for second dose a day next to this report. The outcome of the events was recovered on 01Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 57-year-old female patient received BNT162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date: not reported, ), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported side effect after the first dose of Pfizer-BioNTech COVID-19 vaccine. Patient had diarrhea. Patient asked what is the likelihood that you'll experience diarrhea again on you second dose, after getting it in the first dose. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: some pain problems; This is a spontaneous report from a contactable pharmacist. A 16-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient experienced some pain problems on an unspecified date in Apr2021. On 21Apr2021 patient started taking Medrol (Methylprednisolone) dosepack 4mg. The patient's mom was concerned if there was an interaction with the COVID vaccine, if her daughter was going to be immunocompromised by taking a steroid. Later caller specified that the patient was not immunocompromised, she was healthy, she just had some pain problems and the doctor prescribed the steroid. Outcome of the event was unknown.    No follow-up attempts are needed. No further information is expected. Batch/lot num-ber not obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: got the covid vaccine and has a red spot on the arm that is getting bigger and itchy; got the covid vaccine and has a red spot on the arm that is getting bigger and itchy; feeling sick; nausea; feel lightheaded and dizzy; This is a spontaneous report from a contactable other HCP and consumer.  A 44-years-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the Covid vaccine and had a red spot on the arm that was getting bigger and itchy. She was feeling sick and nausea started exercising and nausea went away but after exercising she felt lightheaded and dizzy. The outcome of the event nausea was recovered. The outcome of the other events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: coughing; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0162; Expiration Date: Jul2021) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, he takes medication for a heart condition, but he has taken them for a long time. The patient concomitant medications were not reported. On 21Apr2021 the patient experienced coughing and fever. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: Hurt to turn her neck; Laryngitis/ Could not talk; Arm pits lymph nodes are horribly sore/ attacked all her lymph nodes; Ache all over; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. An 88-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient have had a terrible reaction to the first shot she was terrified to get the second shot. It attacked her neck (hurt to turn her neck), laryngitis, could not talk, her arm pits lymph nodes are horribly sore, ache all over on an unspecified date. It was attacked all her lymph nodes. Patient was very afraid of the second shot. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Lip swelling
Clinical narrative: pharmacist denied giving her the second dose; developed swollen lips for approximately 3 days.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot number was not reported) via an intramuscular route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient was 60-years-old at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, the day after receiving the vaccine on 31Mar2021, she developed swollen lips for approximately 3 days. She had no difficulty breathing and didn't go to urgent care. She wanted to receive her second dose but the pharmacist denied giving her the second dose stating she needed more medical supervision than what was available at the pharmacy. When she called the hospital they told her she had to receive her second dose where she received her first dose. Her primary care doctor said he could not advise her to get the second dose of the vaccine or not because he did not see the lip swelling. The outcome of the event lip swelling was recovered and for pharmacist denied giving her the second dose was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysphagia, Eye contusion, Fall
Clinical narrative: He fell after his first dose and Rite Aid called the paramedics who took his blood pressure and wanted to go to the hospital.; He had difficulty swallowing after the vaccine; black eye; This is spontaneous report from a non-contactable consumer. This consumer reported that a male patient (brother) in his 60's received the first dose of at single dose for COVID-19 immunization on 16Apr2021. Relevant history and concomitant drugs were unknown.  The patient fell after his first dose and called the paramedics who took his blood pressure and wanted to go to the hospital. his brother felt was a psychosomatic. He had difficulty swallowing after the vaccine. The neighbor text me a picture of him with a black eye after he fell. Outcome of the events was unknown.    No follow-up attempts are needed. Information on batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood immunoglobulin M increased
Clinical narrative: I recently took the IGM test and it came with a result of  1000 instead of the expected average 300; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that this patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization. Medical history and concomitant drugs were not provided. Historical vaccine included flu shot a month before. The patient recently took IGM test and it came with a result of 1000 instead of the expected average 300. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: leg cramps in upper leg; muscle aches in his upper legs at night; This is a spontaneous report from a contactable consumer (patient's sister). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer said the patient took the COVID shot, and has taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him. She said that with the first shot he had some leg cramps at the top of his legs at night and that was it.  He had it for like 2 nights and then it went away. She stated that she didn't know his age when he got the 1st vaccine because she didn't know when he got it, but that it was sometime in March (Mar2021). She stated he did receive the vaccine at hospital. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm hurt for a few days; This is a spontaneous report from a contactable consumer. This reporter reported at a male patient (her son) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis. He got RA out of nowhere and had to change his diet completely and start the medicine about 2 years ago (at 40 years old). Concomitant drugs included tofacitinib citrate (XELJANZ) for rheumatoid arthritis. The patient's doctor told him to stop taking tofacitinib for a week before the vaccine and don't take it for a week after the shot. Additionally, he works 15-18 hour days which is also not good for his immune system. The patient got his first shot and felt great and got the second one and his arm hurt for a few days but that's it. The outcome of the event was unknown.  No follow up attempts are needed. Information for lot/batch number can not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Eustachian tube dysfunction, Tinnitus
Clinical narrative: my ears built up tremendous pressure behind them; my eustachian tubes collapsed; Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received the first dose of BNT162B2 and within 7 hours ears built up tremendous pressure behind them, eustachian tubes collapsed and patient had to continually try to pop ears for 2 weeks. Patient's ears were sensitive to the slightest pressure change. Patient had to pop ears frequently. Shortly after eustachian tubes collapsed, patient developed tinnitus in both ears. It had not gone away. Patient had never had any problems with ears prior to receiving this vaccine so patient had made the assumption this was the result of the vaccine. Patient decided not to take the second dose. For fear, the side effects would worsen. Outcome of tinnitus was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Tinnitus
Clinical narrative: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tinnitus in both ears within 15 minutes or so after 1st dose (going on 4 weeks now). Patient had odd sensations in the top and back of our head. Outcome of tinnitus in both ears was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: pretty much all day fever like it goes up and down;  pretty regularly in and out; It was like spot; They are like something red spots; They are on my hands and you know they have spread from my hands to my elbows; I have them on my feet and also some on my thighs; I don't know they are actually rash or something else I am having; This is a spontaneous report from a contactable consumer (Patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The reported not clarified about the vaccine. On Friday (date unspecified) patient having some side effects before made sure it was okay. On an unspecified date, patient experienced pretty much all-day fever like it goes up and down, pretty regularly in and out, patient also had red spot that pops up very soon after got the vaccine alone couple of hours. They are on hands have spread from hands to elbows. Now patient have them on feet and some on thighs that can be seen. So, they were like something red spots, patient does not know if that was rash or something else. Patient wanted to know if it was a normal reaction. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Muscle and joint pain; Muscle and joint pain; Moderate fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Covid 19 Vaccine, lot number: EL9263), via an unspecified route of administration in right arm on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included osteopenia. Concomitant medications included meloxicam from 2016, vitamin D nos (VITAMIN D) for osteopenia from 2019, and vitamin nos (MULTIVITAMIN) at 2 multivites daily from 01Jan2016. The patient previously received the first dose of BNT162B2 (lot: EL3246) in right arm on 14Jan2021 for COVID-19 immunization and side effects began 24 hours later. The patient experienced moderate fatigue on 05Feb2021. Patient also experienced muscle and joint pain 3 weeks later and lasting 4 days. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Increased appetite, Urine output decreased
Clinical narrative: This is a spontaneous report from a non-contactable consumer.  A 55-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced increased appetite afterward, decreased urination despite drinking more fluids than usual, and headache in front, then in back of head. Patient took acetaminophen. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Feeling hot
Clinical narrative: The first time highest temperature about 101; Dizzy; felt like someone punched her ten times at injection site; fatigue; Muscle pain; joint pain had increased; arm pain; felt really hot and sweaty for 2 days; felt really hot and sweaty for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular in the left arm on 25Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing autoimmune issues, ongoing psoriatic arthropathy, ongoing rheumatoid arthritis, appendix removed a few days before Christmas, joint pain, stops palpations or arrhythmias from mitral valve, replace thyroid hormone after hysterectomy, vitamin d deficiency. Concomitant medications included ongoing acetaminophen for arthralgia, ongoing atenolol for stops palpations or arrhythmias from  mitral valve, ongoing levothyroxine for replace thyroid  hormone after hysterectomy, ongoing alprazolam for anxiety, and ongoing vitamin D for vitamin D deficiency. Historical vaccine included flu shot and experienced unconscious. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had the first time highest temperature about 101, dizzy, felt like someone punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days on 25Mar2021. The patient did not require a visit to ER or Physician Office for the events. Treatment for events fever and punched her ten times at injection site included acetaminophen. The outcome of the events fever, punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days was recovered in Mar2021. The outcome of the event dizzy was recovered on 25Mar2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pain in extremity, Pyrexia, Vaccination site discomfort
Clinical narrative: The first time highest temperature about 101; Dizzy; felt like someone punched her ten times at injection site; fatigue; Muscle pain; joint pain had increased; arm pain; felt really hot and sweaty for 2 days; felt really hot and sweaty for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular in the left arm on 25Mar2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing autoimmune issues, ongoing psoriatic arthropathy, ongoing rheumatoid arthritis, appendix removed a few days before Christmas, joint pain, stops palpations or arrhythmias from mitral valve, replace thyroid hormone after hysterectomy, vitamin d deficiency. Concomitant medications included ongoing acetaminophen for arthralgia, ongoing atenolol for stops palpations or arrhythmias from  mitral valve, ongoing levothyroxine for replace thyroid  hormone after hysterectomy, ongoing alprazolam for anxiety, and ongoing vitamin D for vitamin D deficiency. Historical vaccine included flu shot and experienced unconscious. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had the first time highest temperature about 101, dizzy, felt like someone punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days on 25Mar2021. The patient did not require a visit to ER or Physician Office for the events. Treatment for events fever and punched her ten times at injection site included acetaminophen. The outcome of the events fever, punched her ten times at injection site, fatigue, muscle pain, joint pain had increased, arm pain, felt really hot and sweaty for 2 days was recovered in Mar2021. The outcome of the event dizzy was recovered on 25Mar2021.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Arm pain; Joint pain; Muscle pain; Sore throat; Headache is so bad; I don't feel good; I am not ready and even I can't  stand up; Body aches; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 20Apr2021 (Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. The patient experienced arm pain, joint pain, muscle pain, sore throat, headache is so bad, he/she didn't feel good; he/she was not ready and even he/she can't stand up, body aches on an unspecified date with outcome of unknown. Clinical course: the patient calling because he/she took the Pfizer (vaccine) yesterday and not only his/her arm (pain) but do you supposed to have side effects like you have the Covid (vaccine) like in the joint (pain), in the muscles (pain), sore throat and headache. The patient wondered if they supposed to have these symptoms. When paraphrased the concern with Covid-19 vaccine, consumer added, "Yes because I don't feel good at all, I can't even stand up." Consumer stated, "What do you want to ask, I am not ready, I can't even stand up, my headache is so bad." When probed for any treatment for event, consumer stated he/she took Ibuprofen 100mg, 2 tablet.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain; Joint pain; Muscle pain; Sore throat; Headache is so bad; I don't feel good; I am not ready and even I can't  stand up; Body aches; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 20Apr2021 (Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. The patient experienced arm pain, joint pain, muscle pain, sore throat, headache is so bad, he/she didn't feel good; he/she was not ready and even he/she can't stand up, body aches on an unspecified date with outcome of unknown. Clinical course: the patient calling because he/she took the Pfizer (vaccine) yesterday and not only his/her arm (pain) but do you supposed to have side effects like you have the Covid (vaccine) like in the joint (pain), in the muscles (pain), sore throat and headache. The patient wondered if they supposed to have these symptoms. When paraphrased the concern with Covid-19 vaccine, consumer added, "Yes because I don't feel good at all, I can't even stand up." Consumer stated, "What do you want to ask, I am not ready, I can't even stand up, my headache is so bad." When probed for any treatment for event, consumer stated he/she took Ibuprofen 100mg, 2 tablet.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives and welts; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose 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 single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her second Covid vaccine 3 weeks ago. She is at the salon getting her hair colored and is having a reaction of hives and welts. Her colorist states she has not changed anything and is using the same products she has always used and has not had issues with this before. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Taste disorder, Weight
Clinical narrative: things tasting funny and they tasted odd; Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6205 and expiration date not reported) via an unspecified route of administration at right arm on 27Feb2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included ongoing diabetic (adult onset). Concomitant medications included Metformin at a dose of 500 mg, 2x/day, for several years for diabetic (does not think this would cause a funny taste). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date not reported) via an unspecified route of administration at right arm on 30Jan2021 as a single dose for COVID-19 immunisation. On 27Feb2021, on the same day of vaccination, patient experienced the taste of food that was odd and was not normal and Sore arm (started right away after the vaccine). Patient was treated with tylenol or ibuprofen, whatever was in the medicine cabinet. Patient was not visited to emergency room or physicians office due to events. Outcome for the event things tasting funny and they tasted odd was recovered (reported as lasted about 1 day and went away) and sore arm was unknown (lasted several days).  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she had covid-19 vaccine 1st then tired; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer for BNT162B2. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she had covid-19 vaccine 1st then tired on an unspecified date with outcome of unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Oral pruritus, Pruritus
Clinical narrative: itching head to toe eyes roof of mouth; itching head to toe eyes roof of mouth; itching head to toe eyes roof of mouth; This is a spontaneous report from a contactable consumer. This 68-years-old consumer (patient) reported that he/she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8731) single dose at right arm on 12Apr2021 for COVID-19 immunization. Medical history included obesity, obesity hypertension, penicillin allergy. Historical vaccine included 1st dose of BNT162B2 (lot EN6207, Right arm) on 15Mar2021 for COVID-19 immunization (24 hrs after injection developed generalized itching). Concomitant drugs were not provided. 2 1/2 hours after shot, itching started again on 12Apr2021. The patient has been taking diphenhydramine hydrochloride (BENADRYL) every 6 hours. The patient had itching head to toe, eyes, roof of mouth. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a non-contactable consumer. A 55 years old female patient received bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue with unknown outcome.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.