chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza virus test, Pain in extremity, Pyrexia
Clinical narrative: she had a fever of 102.8 for a couple of days; had a slight headache for a couple of days; a sore arm for a few days; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 10Mar2021 21:40 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no prior vaccination within 4 weeks. She had no adverse events prior to vaccination. The patient had a slight headache for a couple of days on 11Mar2021 then was good, a sore arm for a few days on 10Mar2021 stopped 3 or 4 days later and had recovered completely then was good. 12 days after the first dose on 22Mar2021 she had a fever of 102.7 on Monday and Tuesday then it started to trend down until Saturday on 27Mar2021. She saw the doctor on Thursday and since she had taken Advil for fever in the office her temperature was normal but an hour before her temperature was 101. She wanted to know if there was information on this and asked if she needed to delay her second dose because she was sick. She went to Urgent care, and they said it was suspicious of a delayed response to the vaccine. She said the symptoms were completely gone like the doctor suspected. She stated that doctor said it was good her temperature was going down but that she should follow up with Pfizer and would like to know if it was consistent with a delayed response. She was tested for COVID and the flu in which both were negative. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, body temperature: 101 and flu test: negative on an unspecified date; Fever: 102.7 on 22Mar2021. The patient received Advil, Tylenol as treatment for adverse events. The outcome of event had a slight headache for a couple of days was recovered on 12Mar2021, a sore arm for a few days was recovered on an unspecified in Mar2021 and the outcome of the event she had a fever of 102.8 for a couple of days was recovered on 27Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she had a fever of 102.8 for a couple of days; had a slight headache for a couple of days; a sore arm for a few days; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 10Mar2021 21:40 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no prior vaccination within 4 weeks. She had no adverse events prior to vaccination. The patient had a slight headache for a couple of days on 11Mar2021 then was good, a sore arm for a few days on 10Mar2021 stopped 3 or 4 days later and had recovered completely then was good. 12 days after the first dose on 22Mar2021 she had a fever of 102.7 on Monday and Tuesday then it started to trend down until Saturday on 27Mar2021. She saw the doctor on Thursday and since she had taken Advil for fever in the office her temperature was normal but an hour before her temperature was 101. She wanted to know if there was information on this and asked if she needed to delay her second dose because she was sick. She went to Urgent care, and they said it was suspicious of a delayed response to the vaccine. She said the symptoms were completely gone like the doctor suspected. She stated that doctor said it was good her temperature was going down but that she should follow up with Pfizer and would like to know if it was consistent with a delayed response. She was tested for COVID and the flu in which both were negative. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, body temperature: 101 and flu test: negative on an unspecified date; Fever: 102.7 on 22Mar2021. The patient received Advil, Tylenol as treatment for adverse events. The outcome of event had a slight headache for a couple of days was recovered on 12Mar2021, a sore arm for a few days was recovered on an unspecified in Mar2021 and the outcome of the event she had a fever of 102.8 for a couple of days was recovered on 27Mar2021.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Rash
Clinical narrative: didn't feel anything on the first one, just very lightly; a lot of fatigue; developed a rash in the neck; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing cellulitis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced didn't feel anything on the first one, just very lightly, a lot of fatigue, developed a rash in the neck. Consumer stated that she had ongoing cellulitis and was taking antibiotics. She was received her 1st dose of the vaccine. About the 1st dose, she said she didn't feel anything on the first one, just very lightly. Caller declined her age. Caller stated she was scheduled to get the second dose of the Pfizer Covid 19 vaccine. She was taking antibiotics for treatment of a wound, Doxycycline mono twice a day. She noticed she developed a rash in the neck after taking the antibiotic. Can she still get the second dose? Caller stated she felt a lot of fatigue after the first dose. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Fatigue, Myalgia
Clinical narrative: chills; muscle aches; slight cough; feeling like tired; these symptoms have worsened throughout the day; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:00 (age at the time of vaccination 25-year-old), as a single dose for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medication included ethinylestradiol, levonorgestrel (Setlakin) taken 1 pill daily dosing unknown for oral contraception from 2014 and ongoing. On 29Mar2021 07:30, the patient experienced chills, muscle aches, slight cough, feeling like tired, and these symptoms have worsened throughout the day. Upon follow up patient mention she woke up with a cough in morning, just a little bit, and just feeling like tired. Then, she got the muscle aches and chills. She explained these symptoms have worsened throughout the day. she scheduled a COVID test for tomorrow. The outcome of the events was not recovered. : Caller provided with as well as phone number (withheld) and hours of operation M-F 8a-8p EDT, Sat-Sun 9a-3p and closed on Easter Sunday prior to transfer to . Warm transfer attempted but hold time longer than usual.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On Feb 6, 2021, second dose was administered to his shoulder bursa instead of deltoid muscle. On an unspecified date in 2021, he had shoulder pain. At the time of report, his shoulder was still very painful. He already consulted to an orthopedic doctor and prescribed with steroid injection and oxycodone. The outcome of shoulder pain: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse food reaction, Chest pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; burning in my chest; had a reaction to something I ate; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support via medical information team. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, on an unspecified date (at the age of 59-years-old), at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore throat, burning in chest and the patient had a reaction to something he ate. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Dizziness, Influenza like illness, Lacrimation increased
Clinical narrative: cold-like symptoms; sneezing; sore throat; eyes were watery; water was coming out of her nose; feels like having the flu; cough; nausea; back aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 14:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Mar2021, by 5-6, patient had cold-like symptoms, she was sneezing, had a sore throat, her eyes were watery and water was coming out of her nose. She feels like having the flu, with cold symptoms, cough, nausea, back aches and dizziness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: cold-like symptoms; sneezing; sore throat; eyes were watery; water was coming out of her nose; feels like having the flu; cough; nausea; back aches; dizziness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 14:00 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Mar2021, by 5-6, patient had cold-like symptoms, she was sneezing, had a sore throat, her eyes were watery and water was coming out of her nose. She feels like having the flu, with cold symptoms, cough, nausea, back aches and dizziness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: feeling like pins and needles in like when you sit on your foot and it is sleeping; Headache; tingling in her left calf and foot; vaccination site pain; soreness from left shoulder from injection site down to elbow/shoulder pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER2613) via an intramuscular route of administration on 25Mar2021,14:10into left arm as DOSE 2, SINGLE for covid-19 immunization(at an age of 58 years).The patient medical history included Sciatica for which she underwent surgical procedures congestive heart failure ,allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity .Patient concomitant medication included TDAP via an intramuscular route on 10Mar2021 into left arm for the indication of whooping cough and experienced arm soreness just at injection site for approximately a day ending on 11Mar2021. It was reported that patient had a family history of congestive heart failure and diabetes. The patient took Retasis for unknown indication been taking for two or three years and also received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunization . The patient also took another vaccine within 4 weeks prior to vaccination.On 25Mar2021the patient had experienced soreness from left shoulder from injection site down to elbow(shoulder pain). On 26 mar2021 the patient had experienced tingling in her left calf and foot .On an unspecified date the patient had experienced tingling in left foot like pins and needles like when you sit on your foot and it is sleeping and experienced headache. On 24Feb2021 the patient underwent lab test and procedures which included SARS-CoV-2 test and diagnosed with positive on 26Feb2021 and stated that the only symptoms she had was a stuffy nose like she had a cold for 2 days.The patient had received treatment for the event headache, soreness from left shoulder from injection site down to elbow and treatment included with Advil.The outcome of the events soreness from left shoulder from injection site down to elbow was recovered on 28mar2021,outcome of event tingling in her left calf and foot was not recovered and outcome of event headache and tingling in left foot like pins and needles like when you sit on your foot and it is sleeping were unknown. No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; swollen arm; itching; tightness in the chest/tightness in her chest which kind of panicked her for a minute; tickle in her throat on the left side; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left arm on 25Mar2021 09:00 (at the age of 64 year old) as dose 1, single for COVID-19 immunization. Medical history included RH negative type O and she has low thyroid; where she is not sure if she has hyperthyroid or low thyroid. Concomitant medication included ongoing levothyroxine taken for thyroid disorder from Dec2020. No prior vaccinations within 4 weeks of vaccination. On 25Mar2021, at 9:00, patient took injection on her left arm, that arm did swell considerably and was tender, sore in the swollen area, where it was not in the injection site itself. It was reported that, about 11:30 or an hour later, in the same arm, that in her left arm, between the pointer finger and index finger there was itching quite a bit, where she thought she cut it on something, and when she looked at her hand, it was swollen up for that area and continued to itch and swell in that hand. Also, she felt like a tickle in her throat on the left side but knows sometimes anyway that could occur, so she did not pay any attention to that. Later, on that same evening, while she was driving, she had feeling in her chest, tightness in her chest which panicked her for a minute and she held out and she was going to go to the emergency room if it got worse, so she was aware what was happening then it got resolved on Saturday 27Mar2021. At the time of report, patient has no longer itching, and the swelling has gone down and looks like a little deflated balloon. She took an allergy medication, Allegra D 800mg to help with the scratching and took one of those for the itching which helped a little but not a bunch. Patient wanted to know if side effects are associated with a specific blood type; that is any interactions with the blood type, where she was RH negative type O. No relevant tests were done for the events. The outcome of the events tenderness and pain in extremity was recovering and of throat irritation was unknown and of other events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; arm did swell considerably and was tender and sore in the swollen area that is not where the injection site itself is; swollen arm; itching; tightness in the chest/tightness in her chest which kind of panicked her for a minute; tickle in her throat on the left side; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left arm on 25Mar2021 09:00 (at the age of 64 year old) as dose 1, single for COVID-19 immunization. Medical history included RH negative type O and she has low thyroid; where she is not sure if she has hyperthyroid or low thyroid. Concomitant medication included ongoing levothyroxine taken for thyroid disorder from Dec2020. No prior vaccinations within 4 weeks of vaccination. On 25Mar2021, at 9:00, patient took injection on her left arm, that arm did swell considerably and was tender, sore in the swollen area, where it was not in the injection site itself. It was reported that, about 11:30 or an hour later, in the same arm, that in her left arm, between the pointer finger and index finger there was itching quite a bit, where she thought she cut it on something, and when she looked at her hand, it was swollen up for that area and continued to itch and swell in that hand. Also, she felt like a tickle in her throat on the left side but knows sometimes anyway that could occur, so she did not pay any attention to that. Later, on that same evening, while she was driving, she had feeling in her chest, tightness in her chest which panicked her for a minute and she held out and she was going to go to the emergency room if it got worse, so she was aware what was happening then it got resolved on Saturday 27Mar2021. At the time of report, patient has no longer itching, and the swelling has gone down and looks like a little deflated balloon. She took an allergy medication, Allegra D 800mg to help with the scratching and took one of those for the itching which helped a little but not a bunch. Patient wanted to know if side effects are associated with a specific blood type; that is any interactions with the blood type, where she was RH negative type O. No relevant tests were done for the events. The outcome of the events tenderness and pain in extremity was recovering and of throat irritation was unknown and of other events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Swelling face, Swelling of eyelid
Clinical narrative: My face was a little puffy for a few hours; Rash on both forearms; Puffy eyelids; I'm allergic; This is a spontaneous report from a contactable other hcp from a Pfizer Sponsored Program. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity, allergic to gentamycin from an unknown date and unknown if ongoing I am allergic to antibiotics, food allergy from an unknown date and unknown if ongoing Reminded me of my food allergies that I avoid. The patient's concomitant medications were not reported. On an unspecified date, patient experienced my face was a little puffy for a few hours, rash on both forearms, puffy eyelids, i'm allergic. The case was reported as non serious. The outcome of the event my face was a little puffy for a few hours was recovered on an unspecified date and the outcome of rash on both forearms, puffy eyelids, I am allergic was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in left armpit. Resolved 5 days after vaccination.; This is a spontaneous report received from a contactable consumer (Patient herself) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 56 years old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in left arm on 23Mar2021 at 13:30 (56-year-old at vaccination) as Dose 2, Single for Covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications included ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTI VITAMIN), calcium and ergocalciferol (VITAMIN D) within 2 weeks of vaccination. The patient was non-pregnant at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. The patient did not had Covid prior to vaccination and was not tested for Covid post vaccination. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in left arm on 02Mar2021 (56-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. On 24Mar2021, the patient experienced swelling in left armpit. Resolved 5 days after vaccination. No treatment was received for adverse event. The clinical outcome of the event was recovered on an unspecified date in 2021. The reporter mentioned the seriousness of the events was non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for Immunization. The patient medical history and concomitant medications were not reported.  The patient experienced hives on an unspecified date with outcome of unknown. Caller was inquiring if patient can have the covid-19 vaccine.  No follow-up attempts are needed. No further information expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness
Clinical narrative: She didn't want to get sick again because she was sick; She has pain in the joints of her arms and her legs/joint pain in her fingers/have a history of joint pain but this is worse; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 23Mar2021 (at the age of 44-years-old), at dose 2, single for covid-19 immunization. Medical history included arthralgia and covid-19; she was infected with the Covid 19 virus on an unspecified date. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6202, expiration date was not reported) via an unspecified route of administration, in left arm, on 02Mar2021 (at the age of 44-years-old), at dose 1, single for covid-19 immunization and had the joint pain. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. On 25Mar2021, the joint pain came back, and patient experienced she has pain in the joints of her arms and her legs/ right arm and right arm joints she had pain/ joint pain in her fingers; her right arm is bothering more, joints are hurting more; patient had a history of joint pain, but this is worse. It was reported that, on an unspecified date the patient infected with the Covid 19 virus before, and she didn't want to get sick again because she was sick. Therapeutic measures included Tylenol. There were no investigation assessments. The outcome of the event joint pain was not recovered, and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Pruritus, Swelling, Urticaria
Clinical narrative: itching on her back/horrible itching on her legs, arms and feet; Severe hives and welts/whelps; really sick with hives; had a bump on her leg and her buttock; felt yucky; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534), intramuscular, administered in Left arm on 22Mar2021 14:00 (at the age of 63 year old) as dose 1, single for COVID-19 immunization. Medical history included she has had spider bites in the past and went into anaphylactic reaction. She did have a couple of times where she went to the hospital where she did go into anaphylactic shock but that was many years ago and has high blood pressure, diagnosed many years ago. Patient has family history of heart disease. Also, has Celery allergy and she thinks she had an allergy to Penicillin. Historical vaccine included MMR booster intramuscularly in left arm, 2 weeks prior and had flu vaccines and all sort of vaccines and never had any reactions. Concomitant medication included unspecified high blood pressure medication for 15 years. On 22Mar2021 patient had the first dose. On 23Mar2021, she felt yucky. On 25Mar2021, when she went to bed, she had a bump on her leg and her buttock, where she thought it was a spider bite. On 26Mar2021, in the morning at 3:30 she woke up and was itching on her back; that was severe hives and saw welts in the mirror. She had horrible itching on her legs, arms and feet. She did not go anaphylactic shock. She was just really sick with hives. She took Benadryl and went back to sleep. She had to go to her physician on 27Mar2021 (Friday) and get some Prednisone for it. It was so bad. They were like giant whelps. They were not on face or chest, but were on her lower back, buttocks, legs, stomach arms and feet. She believes it was a reaction from the shot. No relevant lab tests were done. It is improving only because she has been on massive doses of Prednisone and Benadryl. She believes that prednisone was started on 6 and then decreasing each day and took Benadryl as needed. It was reported, she is concerned about the second dose. At the time of report, she is still not 100% but improving. The outcome of the events swelling and feeling abnormal was unknown and of other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Vaccination site mass, Vaccination site pain
Clinical narrative: Itching; sore like the flu shot; sore in left deltoid; quarter sized knot inside, slightly raise like pinwheel; Redness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Deltoid Left on 24Mar2021 13:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. Medical history included major neck and back issues, severe allergic asthma, samters triad, disposition with lungs, and eosinophils were all over the place, all started from an unspecified date. Previously, last year, patient has taken Flu shot. No prior vaccinations within four weeks. Concomitant medications included omalizumab (XOLAIR) started over a year ago, for his immune system and his eosinophils are all over the place and for lungs; furosemide (LASIX) for an unspecified indication and regular medications like blood pressure medication and 2 allergy medications. On 24Mar2021, after vaccination, patient was okay for one day. But on 25Mar2021 the patient experienced sore in left deltoid on his left arm where he got the shot, also he noticed quarter sized knot inside, slightly raise like pinwheel and redness. He was sore like the flu shot. On 26Mar2021, patient started to have itching. At the time of report, sore in left deltoid and other symptoms was getting worse. No relevant tests had done. The outcome of the events was not recovered.  No follow-up attempts are possible; no further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Lymphadenopathy
Clinical narrative: left armpit has swelling in it like lymph nodes; redness in her armpit; little discomfort in her armpit/it is in the fold so when she puts her arm down it is a little sore; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Left arm on 13Mar2021 17:00 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation.  Medical history included diabetes, asthma, high cholesterol  and breast cancer. There were no concomitant medications. No prior vaccinations has done.  On 25Mar2021, the patient noticed swelling in her left armpit like lymph nodes, redness in her armpit, and had little discomfort in her armpit, where it was in the fold, so when she puts her arm down it was a little sore. At the time of report, the events reported to be still there and was persisting. No relevant lab tests has done. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Eye swelling, Lip swelling, Swelling
Clinical narrative: swelling to his eyes, lips and down on his neck; swelling to his eyes, lips and down on his neck; swelling to his eyes, lips and down on his neck; hoarseness in the throat and his voice is hoarse; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medication included power bowl (which had seaweed and all kinds of crap like that for health). The patient experienced swelling to his eyes, lips and down on his neck and hoarseness in the throat and his voice is hoarse on an unspecified date in Mar2021. It was reported that patient's wife blamed it on a power bowl, it had seaweed and all kinds of crap like that in it for health; she just dismissed it. Reporter was asking, this may not be related, but if it is, it will be a relief. She was not sure if this is related to the vaccine, but she thought it was weird. No relevant tests were performed. No treatment was received for the events. Outcome of events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Hypersensitivity, Rash pruritic
Clinical narrative: The next day he noticed itchy bumps of dry skin on his face; Itchy rash/The next day he noticed itchy bumps of dry skin on his face; having an allergic reaction on his face and other parts of his body; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 14:00 (at the age of 22-years-old), at dose 1, single for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously took augmentin [amoxicillin;clavulanate potassium] and Omnesa (as reported) and had similar allergic reactions. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. There was no history of previous immunization with the bnt162b2 vaccine, and no additional vaccines administered on same date of vaccination. On 25Mar2021, the patient experienced itchy rash on his face; the patient thought of having an allergic reaction on his face and other parts of his body and the next day (26Mar2021), he noticed itchy bumps of dry skin on his face; he thought it was shaving irritation, but it continued to spread and getting worse. There was no investigation assessment. The outcome of itchy rash was not recovered, and outcome of other events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pruritus
Clinical narrative: terrible itching on my neck, arms, hands (the inside is worse) legs and feet; muscle pain effects my entire left side in the manner of stiffing and pain; muscle pain effects my entire left side in the manner of stiffing and pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:45 (at the age of 34-year-old), as dose 2, single for COVID-19 immunisation in hospital. Medical history included PCOS (Polycystic ovarian syndrome), GERD (gastrooesophageal reflux disease), IBS (irritable bowel syndrome), asthma, depression, allergies to kiwi, pineapple, oranges, bananas, dogs, cats, and latex. Concomitant medications included multivitamins [vitamins NOS] and birth control pill. The patient previously took norco, dilaudid, zofran [ondansetron and acetaminophen and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM 9809 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 34-year-old), as dose 1, single for COVID-19 immunisation in hospital and experienced extreme itching on neck. Patient had no other vaccines in four weeks. Patient had no COVID prior vaccinations. Patient was not tested for COVID post vaccination. On 27Mar2021, the patient received second dose of the Pfizer vaccine and since the second dose was administered, at 08:45 the patient had terrible itching on neck, arms, hands (the inside was worse), legs and feet. The muscle pain effects entire left side in the manner of stiffing and pain. The patient visited physician office on 29Mar2021 as the itching had become worse over the past few days and informed primary care doctor. The patient was treated with over-the-counter medication. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; soreness in her arm at the injection site; Tiredness; bit of a headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration in left arm on 26Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included none. Patient has not had any other recent vaccinations or started any new medications. There were no concomitant medications. The patient experienced soreness in her arm at the injection site, tiredness, and bit of a headache on 26Mar2021 at night. Patient also experienced fever and chills on 27Mar2021. Patient said on Sunday she was a bit better and had slight fatigue and a little headache other than her arm being sore at the injection site. Patient said her work is now saying that she has experienced signs of COVID and have required a note saying that these things are expected when you have the shot before she can return to work. Patient took Advil three 200 mg by mouth every 4 hours or so on Saturday. Outcome of events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: fever; Abnormal sensation of limb; Nausea; Eye Headache; Headache in eye; She doesn't have any energy; Rash; Underneath the skin It is sore and hard; exhausted; Pain in extremity; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:15 (at the age of 56-years-old) at dose 1, single for covid-19 immunization. Medical history included blood pressure. Concomitant medication included hydrochlorothiazide taken for blood pressure abnormal. After vaccination, on 22Mar2021, patient had a rash, the rash was underneath the actual place where she was shot and she put some alcohol on the area, she feels it did not help. Rash was growing, was persisting, underneath the skin was sore and hard and was spreading. She got an eye headache on 25Mar2021. It felt like she has been punched in the eye. She was also noticing some nausea on 25Mar2021. She had just eaten. She mentioned she went with her sister to get the shot and she had no problems. Caller went on to mention, after she got the shot, she started to feel sensation at her elbow and went all the way around up to the shot, the area where the shot was given. At night her arm was extremely sore on 21Mar2021. The next day around evening time she was on the prail line and it shot down to her finger, she has never had arthritis before, it went down her finger. She also felt exhausted, as if she doesn't have any energy. She felt better yesterday but today she is like she was on Monday (at the time of report). She first noticed it on Monday (22Mar2021) evening when she tried to walk. Soreness happened Sunday night (21Mar2021), it was spreading and when she touches it, it was like sit has a fever in it. Eye headache, it was like a headache in her eye. This started today before her conference call, maybe 10 or 10:30. Now at the time of report it was not as agitated. Nausea she tried to eat around 12:40, she ate and she felt like she was getting sick to the stomach. Vaccine was not administered at Military Facility. The adverse events was not resulted in Physician Office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events Rash, Underneath the skin it is sore and hard and Soreness was not recovered; Exhausted, does not have energy was unknown; Eye Headache, Nausea was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Sensory disturbance, Skin disorder
Clinical narrative: fever; Abnormal sensation of limb; Nausea; Eye Headache; Headache in eye; She doesn't have any energy; Rash; Underneath the skin It is sore and hard; exhausted; Pain in extremity; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:15 (at the age of 56-years-old) at dose 1, single for covid-19 immunization. Medical history included blood pressure. Concomitant medication included hydrochlorothiazide taken for blood pressure abnormal. After vaccination, on 22Mar2021, patient had a rash, the rash was underneath the actual place where she was shot and she put some alcohol on the area, she feels it did not help. Rash was growing, was persisting, underneath the skin was sore and hard and was spreading. She got an eye headache on 25Mar2021. It felt like she has been punched in the eye. She was also noticing some nausea on 25Mar2021. She had just eaten. She mentioned she went with her sister to get the shot and she had no problems. Caller went on to mention, after she got the shot, she started to feel sensation at her elbow and went all the way around up to the shot, the area where the shot was given. At night her arm was extremely sore on 21Mar2021. The next day around evening time she was on the prail line and it shot down to her finger, she has never had arthritis before, it went down her finger. She also felt exhausted, as if she doesn't have any energy. She felt better yesterday but today she is like she was on Monday (at the time of report). She first noticed it on Monday (22Mar2021) evening when she tried to walk. Soreness happened Sunday night (21Mar2021), it was spreading and when she touches it, it was like sit has a fever in it. Eye headache, it was like a headache in her eye. This started today before her conference call, maybe 10 or 10:30. Now at the time of report it was not as agitated. Nausea she tried to eat around 12:40, she ate and she felt like she was getting sick to the stomach. Vaccine was not administered at Military Facility. The adverse events was not resulted in Physician Office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events Rash, Underneath the skin it is sore and hard and Soreness was not recovered; Exhausted, does not have energy was unknown; Eye Headache, Nausea was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm right on 27Mar2021 08:00 as dose 1, single for COVID-19 immunization (at the age of 58-year-old). Medical history included ongoing asthma, ongoing blood pressure increased and codeine-based medications from and unknown date to unknown date. The patient was not pregnant at the time of vaccination and was healthy before vaccination. The patient did not take any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. Patient took other medications in two weeks which includes medication for asthma. On 27Mar2021 16:00, the patient experienced severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace. Seriousness of the events was reported as non serious. The patient did not received any treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: have arthritis in her knee on 08Apr2021; This is a spontaneous report from the COVAX US Support. A contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she was scheduled to receive the second dose of the PFIZER-BIONTECH COVID-19 VACCINE on 14Apr2021. She was also scheduled to get a cortisone shot because she have arthritis in her knee on 08Apr2021. The patient asked if it was ok to get her cortisone shot. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.