chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose, Vaccination site haemorrhage
Clinical narrative: Some blood trickled down the arm; Mom is concerned that he may have not received the entire dose of the vaccine, because he is not complaining of much pain to injection site or arm; Mom is concerned that he may have not received the entire dose of the vaccine, because he is not complaining of much pain to injection site or arm; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Reporter was a mother of a 13-year-old who received the second shot of the Pfizer COVID vaccine and some blood trickled down the arm. Reporter was concerned that patient might have not received the entire dose of the vaccine, because he was not complaining of much pain to injection site or arm. The patient's mother reported events are non-serious. No product quality complains. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: had the feeling that my right ear had a bit of pressure in it; This is a spontaneous report from a contactable consumer. A 56-years-old female (not pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6205) via unspecified route in the right arm, as a single dose on 19Mar2021 at 09:15 for COVID-19 immunization (at the age of 56-years). The patient's medical history included drug hypersensitivity, penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included estradiol, estriol (BI EST) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient stated that after first dose of the vaccine I felt fine but had the feeling that my right ear had a bit of pressure in it. The clinical outcome for the event was not recovered.  Information on Lot/Batch number is available; Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Aldolase, Aldolase increased, Biopsy muscle, Hepatic enzyme abnormal, Hepatic enzyme increased
Clinical narrative: Gradually increasing weakness and pain in the leg; Gradually increasing weakness and pain in the leg; liver hepatic enzymes were elevated; Aldolase elevated; This is a spontaneous report from a contactable physician reported for a patient via medical information team. A 48-year-old male patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 1st dose, single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer sated that they had a patient who was in the hospital who had both doses of the Pfizer-BioNTech COVID-19 vaccine and they were tracing his symptoms. Patient experienced a gradually increasing weakness and pain in the leg. They did not find an infection and the final cause of these symptoms. They conducted a muscle biopsy and no result provided. Aldolase and liver hepatic enzymes were elevated. Consumer wanted to know if there have been similar reports and how are patients treated and what could be done. Response: There are no information regarding how the vaccine affects test results or liver enzymes, and antipyretic. Also, pain relieving medications were used on the clinical trials, but Pfizer cannot give medication recommendations. The outcome of the events was unknown.  Information about lot/batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Gradually increasing weakness and pain in the leg; Gradually increasing weakness and pain in the leg; liver hepatic enzymes were elevated; Aldolase elevated; This is a spontaneous report from a contactable physician reported for a patient via medical information team. A 48-year-old male patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 1st dose, single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on unknown date as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer sated that they had a patient who was in the hospital who had both doses of the Pfizer-BioNTech COVID-19 vaccine and they were tracing his symptoms. Patient experienced a gradually increasing weakness and pain in the leg. They did not find an infection and the final cause of these symptoms. They conducted a muscle biopsy and no result provided. Aldolase and liver hepatic enzymes were elevated. Consumer wanted to know if there have been similar reports and how are patients treated and what could be done. Response: There are no information regarding how the vaccine affects test results or liver enzymes, and antipyretic. Also, pain relieving medications were used on the clinical trials, but Pfizer cannot give medication recommendations. The outcome of the events was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dysphonia, Feeling abnormal, Urticaria, Vaccination site discomfort
Clinical narrative: Her voice was a little rasped which may have been allergies; Her voice was a little rasped which may have been allergies; Felt bad; Hives on her left wrist, which was the arm of the vaccine; Feel a little stressed at the vaccination site due to poor safety precautions; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 61-year-old female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 07Jun2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history included allergies to trees, cats, and several foods. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10May2021 as 1st dose, single dose for COVID-19 immunization. Patient received her first Pfizer Covid 19 Vaccine on 10May2021. She took the second Pfizer Covid-19 Vaccine on 07Jun2021. On an unspecified date in Jun2021, her voice was a little rasped which may have been allergies. Within one hour of receiving the vaccine she felt bad and experienced hives on her left wrist, which was the arm of the vaccine. She reports eating a hamburger prior to her appointment yesterday (07Jun2021). Voiced she was not allergic to anything on the burger. She did feel a little stressed at the vaccination site due to poor safety precautions. She was not sure if the hives came from stress or not. Patient asked if hives have been reported. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dry skin, Fatigue, Herpes zoster, Pruritus
Clinical narrative: rash; dry, itchy scalp and hair loss; dry, itchy scalp and hair loss; dry, itchy scalp and hair loss; tired; shingles; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration on 21May2021 (64-year-old at the time of vaccination) as a 2nd dose, single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration on 20Apr2021, as a 1st dose, single dose for COVID-19 immunization. The patient's medical history included take blood pressure medicine for high blood pressure daily and also takes vitamins, but other than that she wasn't sick and she wasn't taking anything else. She was allergic to shellfish. On 08Jun2021, the patient experienced shingles, she says that the shingles happened yesterday and she thought that it was just a rash and then she decided to call the dermatologist. It got worse today and it was also painful. That's how she figured it out that it was shingles, on an unspecified date, rash, dry, itchy scalp and hair loss then she started seeing hair loss and she was also a little itchy but now it was worse than it has ever been. She has put on coconut oil to soothe it but it has been going on for about the last week or week and a half, and tired. The dermatologist told her it was due to the Pfizer vaccine and told to take Valtrex and use a Silvadene cream topical and other stuff for her head. Her main concern was that her doctor told her that this was a side effect and she was just going by what the doctor had said. She was not under stress, she has been tired for a long time and she lives a good life. She was lucky but it just popped up and she knows that shingles was related to stress and other issues but the doctor said that the COVID vaccine does bring it out. The outcome of the event tired was unknown and all the other events were not recovered.  No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; dry, itchy scalp and hair loss; dry, itchy scalp and hair loss; dry, itchy scalp and hair loss; tired; shingles; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration on 21May2021 (64-year-old at the time of vaccination) as a 2nd dose, single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration on 20Apr2021, as a 1st dose, single dose for COVID-19 immunization. The patient's medical history included take blood pressure medicine for high blood pressure daily and also takes vitamins, but other than that she wasn't sick and she wasn't taking anything else. She was allergic to shellfish. On 08Jun2021, the patient experienced shingles, she says that the shingles happened yesterday and she thought that it was just a rash and then she decided to call the dermatologist. It got worse today and it was also painful. That's how she figured it out that it was shingles, on an unspecified date, rash, dry, itchy scalp and hair loss then she started seeing hair loss and she was also a little itchy but now it was worse than it has ever been. She has put on coconut oil to soothe it but it has been going on for about the last week or week and a half, and tired. The dermatologist told her it was due to the Pfizer vaccine and told to take Valtrex and use a Silvadene cream topical and other stuff for her head. Her main concern was that her doctor told her that this was a side effect and she was just going by what the doctor had said. She was not under stress, she has been tired for a long time and she lives a good life. She was lucky but it just popped up and she knows that shingles was related to stress and other issues but the doctor said that the COVID vaccine does bring it out. The outcome of the event tired was unknown and all the other events were not recovered.  No follow-up attempts possible. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Crying, Injection site indentation, Mammogram, Pain in extremity
Clinical narrative: mark on her arm/"divit" in her arm; mark on her arm/"divit" in her arm and pain/The pain is getting worse; Is an indentation, like a divet, in the arm at the injection site; arm pain; everything is tanning except for that spot on left arm; crying; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via an unspecified route of administration, administered in left arm on 27Jan2021 10:30 as 1st dose, single dose(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No history previous immunizations, and vaccinations within 4weeks. The patient experienced mark on arm, is an indentation, like a divet, in the left arm at the injection site and reported the mark was for a week or two after; and had arm pain, this is the same arm where the pain is. Patient started to get tan and everything is tanning except for that spot on her left arm. The pain has been worse, It hurts her so bad she wakes up in pain crying. In her opinion, the divot looks like it is getting bigger. Patient reported she visited to emergency room or physician office, and also reported she had a bloodwork but that was after and in opposite arm, in the right arm not the left and mammogram done last month. Patient refused to take the second dose of vaccination. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site pain, Vaccination site scar
Clinical narrative: mark on her arm/"divit" in her arm; mark on her arm/"divit" in her arm and pain/The pain is getting worse; Is an indentation, like a divet, in the arm at the injection site; arm pain; everything is tanning except for that spot on left arm; crying; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1284; Expiration Date: Apr2021), via an unspecified route of administration, administered in left arm on 27Jan2021 10:30 as 1st dose, single dose(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No history previous immunizations, and vaccinations within 4weeks. The patient experienced mark on arm, is an indentation, like a divet, in the left arm at the injection site and reported the mark was for a week or two after; and had arm pain, this is the same arm where the pain is. Patient started to get tan and everything is tanning except for that spot on her left arm. The pain has been worse, It hurts her so bad she wakes up in pain crying. In her opinion, the divot looks like it is getting bigger. Patient reported she visited to emergency room or physician office, and also reported she had a bloodwork but that was after and in opposite arm, in the right arm not the left and mammogram done last month. Patient refused to take the second dose of vaccination. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe continous  headache; This is a spontaneous report from a contactable consumer, (the patient reported for self)  A 49-years-old (non-pregnant) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 03May2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Reason why batch/lot was Unknown: Not available/provided to reporter at the time of report completion (Unable to locate or read the details).  Medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing. Concomitant medication and List of any other medications the patient received within 2 weeks of vaccination included: celecoxib (CELEBREX) taken for adenomatous polyposis coli; pregabalin (LYRICA); embril; duloxetine hydrochloride (CYMBALTA); hydrocodone bitartrate, paracetamol (NORCO); albumin human (MO) all taken at unknown doses from unspecified dates and for unspecified indications and unknown if ongoing. The patient had no other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.   On 16Apr2021 14:00, the patient experienced severe continuous headache and this adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse event which includes: pain management, steroids. The patient was hospitalized for severe continuous headache for 3 days. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was considered as hospitalization, disability by reporter. Outcome of the event was reported as not resolved.   Device Date : 08Jun2021  Information about lot/batch number cannot be obtained.  Follow up attempts are possible, additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pruritus, Rash, Urticaria
Clinical narrative: rashes; hives; itching; headache; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. On 02Jun2021, patient experienced rashes, hives, itching, headache and swollen lymph nodes. The outcome of events was unknown.   Information about batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Headache, Limb injury, Tendonitis
Clinical narrative: Injured shoulder; She has chronic fatigue syndrome (CFS) for many years and has had bad flare ups; Tendinitis in her shoulder/which "hurts quite a bit"; Tendinitis in her shoulder; Wort headaches that "she ever had".; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (Formulation for injection; Batch/Lot number: unknown) via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing for many years. The patient's concomitant medications were not reported. On an unspecified date of May2021 patient explained chronic fatigue syndrome (CFS) for many years and has had bad flare ups. She added she also has tendinitis in her shoulder, which hurts quite a bit. She mentioned 2.5-3 weeks post vaccination she had her CSF flare up and the worst headaches that she ever had. She added she will be consulting her neurologist on the 17th (failed to confirm the month), which will approach the 42 days mark post vaccination. She explained she would like to wait for this consultation before getting the second dose. She asked if the second dose can be administered beyond the 42 days. Upon follow up, she also reported that, her shoulder was injured and at the very least has tendonitis. She was 32 days out from receiving the first injection, but she wanted to know if it's okay to get the second shot to complete the vaccination series. The outcome of the events was unknown.  Follow-up (08Jun2021): This is a follow-up spontaneous report from a Pfizer sponsored program Support via consumer (patient) which included new information such as: She is 32 days out from receiving the first injection, but she wants to know if it's okay to get the second shot to complete the vaccination series/ she has had chronic fatigue syndrome for years, but she had a bad fare up. Her shoulder is also injured and at the very least has tendonitis"  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: MY arm is a tad swollen; It kinda hurt. It doesn't hurt unless I lay or press on it/Arm was aching a little bit; headache; was actually worried of getting the shot because I am on 3 different main pill (Unspecified medications) that I take every day and now I have not taken them; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an intramuscular route on 07Jun2021 (at the age of 59-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included COPD, high blood pressure, chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis), moderate to severe asthma, smoker. When confirmed if the patient had any vaccination 4 weeks prior to Pfizer COVID 19 Vaccine, patient stated, "I am supposed to go back as far as I know for second dose, 3 weeks on 28th". The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was a tad swollen. It kinda hurt. It doesn't hurt unless she lay or press on it and arm was aching a little bit. Other than that she took it pretty well. She had a headache but didn't last too long. Patient stated that she has heart pills that she takes twice a day. She stopped taking it yesterday. She stated, I didn't know if it would interfere/ how it would interact with it. She also has blood thinner and acid reflux. Patient wants to knew when she can continue taking her medications. Patient was actually worried of getting the shot because she was on 3 different main pill (Unspecified medications) that she take every day and now she had not taken them. Patient stated that she didn't underwent any lab test but she took a scan like 3 or 4 month since she had anything like that then. The patient took Tylenol as a treatment for events. The outcome of the events was unknown.  Follow-up attempts are needed. Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypersensitivity, Sinusitis
Clinical narrative: Sinus infection; there are allergies right now; I'm assuming she can't get the vaccine; This is a spontaneous report from a contactable pharmacist. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sinus infection and assuming she can't get the vaccine, there are allergies right now on an unspecified date. The caller stated have a patient (female age unsure maybe 15 years) who was coming this friday for her vaccination and she had a sinus infection and on antibiotics. Pharmacist was assuming she can't get the vaccine. How long does she need to wait? It was her 2nd dose on Friday which will be at 3 weeks. She already got her first dose of the Pfizer covid vaccine. Pharmacist stated she need to talk to her patient more to find out if she was on any steroids and when her antibiotics ends. It makes sense to her that the immune system was fighting the infection. Caller stated she did not think the sinus infection was related (sounds like it was independent) to the Pfizer covid vaccine but she stated she will need to talk to her more and get more information from her patient. She stated she thinks she got the infection last week and she got her first dose of the Pfizer covid vaccine almost 3 weeks ago. She said in the withheld (where she was located) there are allergies right now. Therapeutic measures were taken as a result of sinus infection which include antibiotics. The outcome for event sinus infection was not recovered and rest of events outcome was unknown.  Information on Batch/Lot Number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Sinusitis, hypersensitivity. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Dyspnoea
Clinical narrative: Stomach discomfort; Anxiety; Shortness of breath; This is a spontaneous report from a contactable consumer (patient) via medical information team. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. No investigation Assessment was provided. Patient was called about the Pfizer covid vaccine. It was a personal question, asking if everything that was happening to her was normal or not. If the things that she was experiencing, or feeling was normal. This was her first dose. She got the vaccine on Tuesday and by Thursday she started to have some stomach discomfort, it was not like diarrhea, it was just the feeling like she needed to go to bathroom. Friday, she started having anxiety. At times it was a thing that comes from time to time where she feels anxiety, shortness of breath and the need to deep breathe or take deep breaths and then it goes away and it comes back again. Reporter did not specify any seriousness. The outcome of shortness of breath, anxiety was reported as not resolved and stomach discomfort was unknown.  Information about lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: Was much sicker when he was little and received small pox vaccine than with the Covid vaccine; Severe fever; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (patient). Communication: Report 2 of 2.   A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: ER2613) via an unspecified route of administration in right arm on 23Mar2021 as single dose (age at vaccination 60-year-old )and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: RE8736) via an unspecified route of administration in right arm on 29Apr2021 as single dose (age at vaccination 61-year-old ) for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. At age of 8-year-old, patient took smallpox vaccine on an unspecified date in 1968 in left arm for immunization and experienced sickness. When reporting on wife to agent, caller mentioned that he was much sicker when he was little and received the smallpox vaccine than with the Covid vaccine. Patient was sick for only a few days after he had the smallpox vaccine. Patient had severe fever and was throwing up. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High blood pressure readings; This is a spontaneous report from a non-contactable consumer Pfizer-sponsored program Support. A male patient of an unspecified age received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date 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 BNT162B2 for Covid-19 immunization. Caller had his second shot and since had high blood pressure readings. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Joint pain/knee pain; trouble walking; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, on 21May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine on 21May2021 and due for next dose on 11Jun2021. On an unspecified date in 2021, the patient experienced joint pain, knee pain, trouble walking. Reporter seriousness for Joint pain, knee pain and trouble walking were unspecified. Patient informed everything when she was leaving the doctor's office and heading to work, he had no time to answer question. She would just like to know if she should get the second shot on Friday. She stated that she understands about giving the information in the hopes to collect more data because she works in the medical field, but she is just not a registered nurse or Practitioner. Patient wanted the number for Medical information, and she will call them at another time. The outcome of events was unknown.  Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Lyme disease, Parvovirus B19 test, Red blood cell sedimentation rate increased
Clinical narrative: Joint pain/knee pain; trouble walking; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, on 21May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine on 21May2021 and due for next dose on 11Jun2021. On an unspecified date in 2021, the patient experienced joint pain, knee pain, trouble walking. Reporter seriousness for Joint pain, knee pain and trouble walking were unspecified. Patient informed everything when she was leaving the doctor's office and heading to work, he had no time to answer question. She would just like to know if she should get the second shot on Friday. She stated that she understands about giving the information in the hopes to collect more data because she works in the medical field, but she is just not a registered nurse or Practitioner. Patient wanted the number for Medical information, and she will call them at another time. The outcome of events was unknown.  Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Joint pain/knee pain; trouble walking; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, on 21May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine on 21May2021 and due for next dose on 11Jun2021. On an unspecified date in 2021, the patient experienced joint pain, knee pain, trouble walking. Reporter seriousness for Joint pain, knee pain and trouble walking were unspecified. Patient informed everything when she was leaving the doctor's office and heading to work, he had no time to answer question. She would just like to know if she should get the second shot on Friday. She stated that she understands about giving the information in the hopes to collect more data because she works in the medical field, but she is just not a registered nurse or Practitioner. Patient wanted the number for Medical information, and she will call them at another time. The outcome of events was unknown.  Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpatition/It has gotten worse over the past few days; This is a spontaneous report from a Pfizer sponsored program Pfizer RxPathways via a contactable consumer (patient, self-reported).  A 47-year-old female patient received second 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 01Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included 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 an unknown date, as a single dose for COVID-19 immunization. The patient reported that, after having the vaccine, she had noticed palpatition on an unknown date. It has gotten worse over the past few days. The patient asked to have you come across any similar cases and did you have any advice. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Injection site pain; headache; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2, 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 immunization. Historical vaccine included BNT162B2, first dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain, headache and body aches. The clinical outcome of events was unknown.  Information about lot/batch number requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EN0153 and Expiration date: unknown), dose 1 via an unknown route of administration, in left arm on 20Apr2021 at 13:45 as single dose, dose 2 via an unknown route of administration, in left arm on 20Apr2021 (Batch/Lot Number: EN0175) as single dose for COVID-19 immunization (at the age of 31-years-old). The patient's medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 88ug taken for an unspecified indication. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 23Apr2021 at 10:00, the patient experienced pain and swelling of supraclavicular lymph nodes. The patient was not tested for COVID-19 since the vaccination. No treatment was received for events. Outcome of events was not recovered.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; rashes from head to my toe.; This is a spontaneous report from a contactable consumer. A 25-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: EW0172), dose 1 via an unspecified route of administration, in Arm Right on 04Jun2021 (at the age of 25-year-old), as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient told the person about the allergic reactions she had to an antibiotic (name unspecified) and she think it was okay to get the vaccine. The reactions she had with the antibiotic was hives in her body, nothing life threatening. The patient got the vaccine on Friday (04Jun2021) and she felt fine no pain, no headache nothing. she was perfectly fine but Saturday afternoon (05Jun2021). The patient started getting rashes from head to toe and started feeling the same hives again, no other symptoms other than hives. she got it from her hip all the way to waist completely covered hives. Patient asked if they can get second dose of vaccine. The outcome of the event hives was not resolved and unknown for rash.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Took away the pain she had; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COVID VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jan2021 as 1ST DOSE, SINGLE DOSE and via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included coma when she was 19, father passed away from arthritis in 2002 and mother passed away from heart palpitations in 2003. The patient's concomitant medications were not reported. The patient reported that, vaccine took away the pain she had. The patient reported that, she took the COVID shot, and the COVID shot released the blocks and she felt the covid shot stopped at all different points inside her body after it was given to her. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not reported), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on 08Jun2021. It was reported that caller on the line that got the Pfizer COVID vaccine today and is experiencing a headache. Caller stated she has no information and has been on the call for 15 minutes. Caller stated the reason for the call is so she could get information. Caller stated she read and listened to the recording already and read everything on her paperwork. Caller stated she just wanted to see if it was ok to take Ibuprofen since everything, she sees says take Tylenol and she does not have Tylenol. 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: Hypersensitivity
Clinical narrative: Allergies acting up right now; This is a spontaneous report from a contactable consumer (patient's husband). A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on Mar2021 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on Feb2021 both as a single for COVID-19 immunization. The medical history was not reported. Concomitant medications included antihistamine for allergies, over the counter. Reporter stated that the patient started having symptoms about three weeks ago. The patient got her shots in February and March and her allergies acting up right now. Patient stated that she was fine, it's just her allergies, it's allergy season right now: ragweed, pollen, and mold was high. The outcome of the event was unknown.  Information about lot/Batch number is requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: body covered in rash/every time they try to stop the Prednisone the rash comes back; This is a spontaneous report from a Pfizer sponsored program. This consumer reported for a female patient (reporter's mother-in-law). An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on an unspecified date as second dose, single dose for covid-19 immunisation. prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown; formulation: solution for injection; expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as first dose, single dose for covid-19 immunisation. Patient reported that after getting the second Covid shot, her body was covered in a rash. They had been able to control it mildly with Prednisone, but every time they try to stop the Prednisone the rash came back. Looking for advice on treatment. They took her to the doctor, and he was the one to prescribe the Prednisone and then given loratadine for the rash, it was a pill and there was an ointment prescription also. consumer tried Calamine and some Neosporin where she had scratched it to like a blister. They will be done with the second dose of the Prednisone soon. She was to take 3 of the 5mg once a day the first time. Consumer wanted to know what they should did since had been done with the second dosed of prednisone. consumer Declined to provide further report details and would like to know what to do, what was next step. Recommended for patient to see further medical advice from medical provider since Pfizer was unable to provide medical advice. consumer stated that he will just be had to get her to see a specialist or allergist and thought that Pfizer could refer her or recommend one. Maybe there have been other people who had this rash. No further details provided. Action taken for prednisone was unknown. The outcome of event was unknown.  Information regarding the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt a little tired; This is a spontaneous report from a contactable consumer.   A female patient (reporter's sister) of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown), via unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient had no side effects. Patient felt a little tired but other than that she was okay. Outcome of the event was unknown.  No further details were provided or able to be obtained from caller due to her requesting to be transferred to USMI for her question.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pain
Clinical narrative: Mild headache; Ache; Joint pain; Nausea; Little bit of dizziness; This is a spontaneous report from a contactable consumer (patient) reported for self. A 25-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0178, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 07Jun2021 at around 15:00 to 16:00 pm (age at vaccination was 25 years) as 2nd dose, single dose for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0185, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient had mild headache, some aches and some joint pains and nausea and little bit of dizziness as well. The patient just took the Pfizer vaccine yesterday the second dose and the patient was experiencing a couple of side effects and wondered if it was okay for the patient to take Ibuprofen. The patient was informed about Pfizer Medical Information Department. The patient stated that the patient did actually take Ibuprofen yesterday but found out today that the patient might not, shouldn't have taken it that's why the patient was a bit concerned the patient wanted to know if that was okay for the patient to do. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea
Clinical narrative: Diarrhea; Pain in the lower right side of my back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 17-year-old female patient (age at vaccination: 17 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 13May2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included allergy to Biotin (big amounts of Biotin). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID. The patient reported that on 13May2021 at 16:00, she had diarrhea and pain in the lower right side of her back, the first few days after the first dose. There was no prolonged hospitalization. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in May2021.  Follow-up attempts are needed. Further information is expected.