chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) intramuscular, administered in Arm Left on 24Feb2021 13:30 (at the age of 33-years-old) as DOSE 2, SINGE for COVID-19 immunization. Medical history included diabetes mellitus, blood cholesterol increased, blood pressure increased from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), empagliflozin (JARDIANCE), fluoxetine (FLUOXETINE), lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), omeprazole (OMEPRAZOLE) taken for an unspecified indication. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) intramuscular, administered in Arm Left on 29Jan2021 13:30 (at the age of 33-years-old) as DOSE 1, SINGE for COVID-19 immunization. The patient experienced full body rash 4 days after the vaccine on 28Feb2021 22:00. AE resulted in emergency room/department or urgent care visit. Patient had received treatment for adverse event with cotisone shot and Zyrtec. Rash would not resolved with a cortisone shot. Benedryl helped somewhat. Since the vaccination, patient has not been tested for COVID-19. The outcome of event was recovered on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: rash; spots and bumps on his limbs and chest./he also has different spots on the chest and another one on the left leg, 2 on the right leg.; This is a spontaneous report from a contactable consumer. This male consumer reported about himself that:  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administration on left arm on 18Feb2021 14:00 as dose 1, single (at the age of 78-years) for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (age at vaccination 78-years-old), dose 1, on 28Jan2021 for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient got the first dose of the vaccine on 28Jan2021 and the second dose on 18Feb2021. On 04Mar2021, the patient started to break out in a rash and this rash was on left arm on the bottom part of the forearm on the tender skin, the patient clarified that there was more rash on the left arm than anywhere else on his body. The left arm was also where he got injection.  After the left arm the patient began to notice it on right arm and there was less rash on right arm. The patient had spots on chest and another one on the left leg, 2 on the right leg.  Later noticed the left arm pinky and ring finger got rash in between the 2 fingers. On the right arm, the rash was on ring finger on the top part. There was little spot on the left chest and little spots as big as finger on the left leg on the thigh and the patient also had it down around the ankle on the left leg.  The patient describe the spots  as being reddish pinkish spots and they was bumps and some was spread out. The patient tried putting Cortisone 10 on it and that made it worse so he washed it off. The patient started using Bactine pain relieving cleansing spray on 04Mar2021 and that helped to dry it up a little but it was still not well yet and the patient still using this. The patient stated that he called on Saturday and held for an hour and a half but the number of callers ahead of him did not change so he called back today but it still took a long time. The outcome of the events were unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.   .
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Saturday 06Mar started getting a few red bumps on butt.  Woke up on Sunday 07Mar had many more bumps on butt, stomach area, a few on the chest area, a few on each leg and about 30 on each side; Hives; This is a spontaneous report from a contactable Other HCP (Patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Latex: allergies. The patient's concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) and ibuprofen. The patient previously took Sulfonamide/sulfa antibiotics and Erythromycin and experienced known allergies. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. On Saturday 06Mar2021 (12:00 PM) started getting a few red bumps on butt. Woke up on Sunday 07Mar2021, the patient had many more bumps on butt, stomach area, a few on the chest area, a few on each leg end about 30 on each side of my torso. Looks like mosquito bites but most likely hives (on 06Mar2021). Size of red bumps are 1 to 5mm in diameter and raised with some looking to have a white center. As a result of event patient required Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for events. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Pruritus, Rash
Clinical narrative: rash all over his body; rash is a little itchy; This is a spontaneous report received from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration in Arm Right on 26Feb2021 (age at vaccination 65years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood cholesterol increased, thyroid disorder, drug hypersensitivity (Caller stated that he is not allergic to anything but penicillin that he is aware of), all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. On 05Mar2021 the patient experienced rash all over his body, rash is a little itchy. Clinical course was reported as he received the first dose of the Pfizer covid19 vaccine on 26Feb2021. He reported he developed a rash all over his body on 05Mar2021. His dermatologist took a sample of the rash and gave him Benadryl and a cream. He was not allergic to anything but penicillin that he was aware of. He wanted to know if this is a common side effect. The patient underwent lab tests and procedures which included blood potassium: level high, 5.9 on unspecified date, blood potassium: second time it 5.3 on unspecified date, blood potassium: came back 5.3 on unspecified date this was all way before the vaccine. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of rash all over his body, rash is a little itchy.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Rash on hands/it went on both arms, neck, and ears; raised red patches and they itch; raised red patches and they itch; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL9267) via an unspecified route of administration in right arm on 17Feb2021 at 12:00 (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Controlled high blood pressure, Heart arrhythmia. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. Patient previously took Cipro antibiotics and experienced allergy. On an unspecified date in 2021 after receiving vaccination, patient experienced rash on hands which went away in approximately 1 week, 2nd week it went on both arms, neck, and ears. Patient was still having it and she was scheduled for second shot tomorrow. On an unspecified date in 2021, patient experienced raised red patches and they itch. Patient have an appointment to see her Primary Care Doctor in 2 days. AE resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Erythema of eyelid, Eye pruritus, Swelling of eyelid
Clinical narrative: Swollen eyelids; red eyelids; dry itchy eyes; dry itchy eyes; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203), via an unspecified route of administration, administered in arm left on 06Mar2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included samter's triad and coronary artery disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took prednisone and ceclor and experienced known allergies. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as other while the facility type vaccine other was reported as fire house. On 07Mar2021 at 01:00, the patient experienced swollen eyelids, red eyelids, dry itchy eyes. The treatment was not received for all the events. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Circumstance or information capable of leading to medication error, Erythema, Pain in extremity, Swelling
Clinical narrative: is a 50-50 chance that he may receive either vials.; pain on his arm; swelling; redness; anxious; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a 50-50 chance that he may receive either vial, pain on his arm, swelling, redness (It was about 2cm of redness. On the third day, it got bigger), anxious. It was reported that something happened during vaccination. There were 2 nurses, the first one is the one administering the Pfizer COVID-19 vaccine to him while the second nurse asked the first nurse which vaccine vial did she use on the caller. The second nurse explained that only 1 vial contained the vaccine while the other one was used for training purposes and only contained the diluent (saline). The first nurse was confused on which vial she had used. Caller is anxious since there is a 50-50 chance that he may receive either vials. He wanted Pfizer to have an opinion on whether he had he vaccine vial or the vial that only contained diluent. The outcomes of events (is a 50-50 chance that he may receive either vial, anxious) were unknown, and the outcomes of events (pain on his arm, swelling, redness) were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Rash; skin blotchiness; This is a spontaneous report from a contactable consumer. This 69-years-old consumer (patient) of an unspecified gender reported that the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:00 as dose 1, single for covid-19 immunization. Medical history included multiple allergies. The patient's concomitant medications were not reported. No Covid prior vaccination and Covid tested post vaccination. No other vaccine in four weeks product. The patient experienced rash and skin blotchiness on 06Mar2021 at 10:00. No treatment received. Ae resulted in none of the above. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heart rate, Heart rate increased, Malaise
Clinical narrative: Tiredness; muscle pain; joint pain; fever; feeling unwell; fast heartbeat; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 03Mar2021 at 09.00 (73-year-old at the time of vaccination) as dose 2, single for covid-19 immunization at doctor's office/urgent care. The patient was not pregnant at time of vaccination. The patient's medical history included allergy to Penicillin. The patient's specific concomitant medications name were not reported. It was reported that the patient had other medications in two weeks (not specified). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration administered in left arm on 10Feb2021 at 09.15 (73-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 03Mar2021 at 20.00, the patient experienced tiredness, muscle pain, joint pain, fever, feeling unwell and fast heartbeat. No treatment was received for the events. The patient underwent lab tests and procedures which included heartbeat: fast, on an unspecified date. The outcome of the events was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Tiredness; muscle pain; joint pain; fever; feeling unwell; fast heartbeat; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 03Mar2021 at 09.00 (73-year-old at the time of vaccination) as dose 2, single for covid-19 immunization at doctor's office/urgent care. The patient was not pregnant at time of vaccination. The patient's medical history included allergy to Penicillin. The patient's specific concomitant medications name were not reported. It was reported that the patient had other medications in two weeks (not specified). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration administered in left arm on 10Feb2021 at 09.15 (73-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 03Mar2021 at 20.00, the patient experienced tiredness, muscle pain, joint pain, fever, feeling unwell and fast heartbeat. No treatment was received for the events. The patient underwent lab tests and procedures which included heartbeat: fast, on an unspecified date. The outcome of the events was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash erythematous
Clinical narrative: Red, inflamed rash to neck and portion of face; Red, inflamed rash to neck and portion of face; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: not reported) via an unspecified route of administration in Left arm on 04Mar2021 at 16:15 (age at vaccination: 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included long term diagnosis with eczema and rosacea. Concomitant medications included spironolactone 25 mg, gabapentin 500 mg and melatonin (in two weeks). The patient past drug included Tylenol 3 and codeine and the patient had known allergies with Tylenol 3 and codeine. On 05Mar2021 at 16:00, (began within 24 hours of vaccination) patient experienced red, inflamed rash to neck and portion of face. No treatment was received for the events. The events was lasted just under 48 hours. The patient did not receive other vaccine in four weeks. No covid present prior vaccination. Covid was not tested post vaccination. The outcome of events was recovered on an unspecified date in Mar2021.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Rash erythematous
Clinical narrative: a red rash appeared on my arm, which was very tender and sore.; It is still tender, although most of the rash is gone; chills; fever; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: En6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26Feb2021 at 01:00 PM (age at vaccination: 76 years), as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies Penicillin. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL ARTHRITIS), vitamin D NOS, and glucose. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021, the patient experienced chills, fever, nausea, and headache. Two days later on an unspecified date, a red rash appeared on my arm, which was very tender and sore. I had this rash for a week. It was still tender, although most of the rash was gone. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: a red rash appeared on my arm, which was very tender and sore.; It is still tender, although most of the rash is gone; chills; fever; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: En6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26Feb2021 at 01:00 PM (age at vaccination: 76 years), as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies Penicillin. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL ARTHRITIS), vitamin D NOS, and glucose. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021, the patient experienced chills, fever, nausea, and headache. Two days later on an unspecified date, a red rash appeared on my arm, which was very tender and sore. I had this rash for a week. It was still tender, although most of the rash was gone. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Skin rash; Swelling; This is a spontaneous report from a contactable consumer reported for himself. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via unspecified route of administration on 06Mar2021 at 13:45 (at age of 40-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. There were no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 07Mar2021 17:00 (1 day 3 hrs 15 min after vaccination) patient experienced Skin rash, and swelling. Patient did not receive any treatment for the events. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: Achy joints; tiredness; Sore arm where injection site; This is a spontaneous report from a non-contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: En6204, expiration date: not reported), dose 2 via an unspecified route of administration, administered in arm left on 04Mar2021 08:15 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. Concomitant medication included other mediation in two weeks (unspecified). Historical vaccine included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Em9810, expiration date: not reported) dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 08:15 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021 08:15, the patient experienced achy joints and tiredness, had sore arm where injection site. No treatment received for all the events. The outcome for all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Rash, Urticaria
Clinical narrative: having rash similar to hives; having rash similar to hives; noticed an increase in issues with my asthma; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 14:45 (Lot Number: EK 9231) (at the age of 42 years old) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Lot Number: EL 8982) (at the age of 42 years old) as dose 2, single, both for COVID-19 immunisation at hospital. Medical history included hypothyroidism, celiacs, allergies to Sulfa meds, seasonal, latex on hands. Patient received other medications within two weeks of COVID vaccine. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced having rash similar to hives, noticed an increase in issues with my asthma on 07Jan2021 08:00. Adverse event reported as, patient have been having rash similar to hives that seem to show up especially in areas of friction from clothes, if something heavy rest against patient skin. Patient have also noticed an increase in Isues with his asthma. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment were received for the events with Z pack. Patient did not tested for COVID post vaccination. Outcome of all the events were recovered with sequelae on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Ear swelling, Erythema, Hypersensitivity
Clinical narrative: Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; Allergic reaction to both ears/Rash with bumps on both ears and they're red; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route, administered in Left arm on 04Mar2021 at 13:00 (31-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. Facility type vaccine was reported as Pharmacy or Drug Store. Medical history was reported as none. No known allergies. There were no concomitant medications within two weeks of vaccination. The patient had not received any other vaccine in four weeks prior vaccination. The patient was not diagnosed with Covid prior vaccination. The patient was not tested for Covid post vaccination. On 06Mar2021 at 21:00, the patient experienced allergic reaction to both ears/rash with bumps on both ears and they're red. These adverse events did not result in emergency room/physician office visit. No treatment received for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; headache; Pain in right shoulder and elbow; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6200) via an unspecified route of administration, administered in right arm on 19Feb2021 at 13:15 (at the age of 75-year-old) as single for COVID-19 immunization and was administered at School or Student Health Clinic. Medical history included dialysis, sleep apnea and had known allergies. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication from 29Jan2021 to 29Jan2021, metoprolol, heparin, cetirizine hydrochloride (CETRIZINE), calcium citrate (CITRACAL [CALCIUM CITRATE]) and aloe vera, glycyrrhiza spp. root, linum usitatissimum, ulmus spp. (OMEGA FIBRE); all taken for an unspecified indication, start and stop date were not reported. On 19Feb2021, nausea and vomiting, fever and headache (slight headache continued). The patient had pain in right shoulder and elbow which started a few days after and continued for about two weeks. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received chiropractic treatment for shoulder and elbow pain. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: Had a reaction for three days which is a rash on his body; Rash has worsened; This is spontaneous report from a contactable consumer. This 77-years-old male consumer (patient) reported that.  A 77-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 at 11:40 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 09Feb2021 (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes type 2 diabetes mellitus from an unspecified date and unknown ongoing and concomitant medications include Janumet. Past drug event includes metformin induced unknown reaction, He used to take Metformin before he took Janumet, but his HCP changed him to take Janumet. On 06Mar2021, after the vaccination, the patient experienced rash on his body. Caller states the rash has worsened and is on his back and he has to take Benadryl for it and he used the Benadryl diphenhydramine HCP 25mg for two days; states he used the Benadryl one 06Mar2021 and one on 07Mar2021. Patient received the 2nd dose of the Pfizer Vaccine three days ago which was Friday 05Mar2021 and the rash began the next day on 06Mar2021. The outcome of the events was not recovered or resolved at the time of this report.  No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Skin warm, Swelling, Vaccination site reaction
Clinical narrative: Delayed skin reaction (Covid arm) at site of injection and on upper arm; red rash; swelling; warm to touch; itchy; This is a spontaneous report received from a non-contactable consumer or other health care professional (patient).  A 66-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot number: EN6201, expiry date not reported) via an unspecified route of administration, administered in Arm left on 01Mar2021 08:00 AM as dose 2, single for covid-19 immunization. Medical history included autoimmune hepatitis and concomitant medications included other medications taken in two weeks as Azathioprine, Paracetamol (TYLENOL), Cannabidiol (CBD oil), Palmitoylethanolamide (PEA), Milk thistle all were unspecified indication and from unknown start and stop date. Patient had known Allergies which included Lactose intolerance. Historical vaccine included as patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration and administered on in Arm left on 08Feb2021 08:00 AM as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. No other vaccines received on the same date of vaccination. On 05Mar2021 05:00 PM,  began on evening of 4th day after 2nd shot the patient experienced delayed skin reaction (Covid arm) at site of injection and on upper arm red rash, swelling, warm to touch, itchy. No treatment was received for the events caused. The outcome of the events was recovering.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Feeling hot, Palpitations
Clinical narrative: felt a rush of warmth throughout my body; Heart began racing for a minute; feeling short of breath and difficult breathing; Also felt like I couldn't swallow well; I felt weird all the way home; had a bit of  tingling in lips; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 14:00 (02:00 PM) (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included low thyroid, possibly asthma (recently got albuterol). The patient concomitant medications included levothyroxine sodium; cortisone shot a week before, both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro (ciprofloxacin) and experienced drug allergy. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 04Mar2021 at 14:00 (02:00 PM), the patient experienced felt a rush of warmth throughout my body, heart began racing for a minute, feeling short of breath and difficult breathing, also felt like I couldn't swallow well, I felt weird all the way home, had a bit of tingling in lips. Adverse event: Within 2 minutes after receiving shot, felt a rush of warmth throughout my body. Heart began racing for a minute or so but then seemed to go back to normal. Stayed the specified 15 minutes and then got in car to go home. Within a mile of the center started feeling short of breath and difficult breathing. Also felt like I couldn't swallow well. After a few more minutes it seemed to improve but I felt weird all the way home. At home got better but had a bit of tingling in lips. By 6:00 pm was totally fine. The patient did not receive treatment for the events. Outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: felt a rush of warmth throughout my body; Heart began racing for a minute; feeling short of breath and difficult breathing; Also felt like I couldn't swallow well; I felt weird all the way home; had a bit of  tingling in lips; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 at 14:00 (02:00 PM) (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included low thyroid, possibly asthma (recently got albuterol). The patient concomitant medications included levothyroxine sodium; cortisone shot a week before, both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro (ciprofloxacin) and experienced drug allergy. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 04Mar2021 at 14:00 (02:00 PM), the patient experienced felt a rush of warmth throughout my body, heart began racing for a minute, feeling short of breath and difficult breathing, also felt like I couldn't swallow well, I felt weird all the way home, had a bit of tingling in lips. Adverse event: Within 2 minutes after receiving shot, felt a rush of warmth throughout my body. Heart began racing for a minute or so but then seemed to go back to normal. Stayed the specified 15 minutes and then got in car to go home. Within a mile of the center started feeling short of breath and difficult breathing. Also felt like I couldn't swallow well. After a few more minutes it seemed to improve but I felt weird all the way home. At home got better but had a bit of tingling in lips. By 6:00 pm was totally fine. The patient did not receive treatment for the events. Outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash papular, Rash pruritic, Vaccination site erythema, Vaccination site induration
Clinical narrative: injection site began to itch; injection site began to itch and the coloring of the rash turned to a purplish hue; the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area; rash area itches and feels warm; rash area itches and feels warm; Injection site feels hard; Injection site was red; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authtoirty. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 29 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine; bisacodyl (DULCOLAX); iron; unspecified prenatal vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified medication reported as "b". The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021 at 11:30 AM, the patient reported that injection site was red, following injection within 24 hours. Injection site remained red and began to fade by day 7. On 08Mar2021 at 12:00 AM (also reported as day 9), the injection site began to itch and the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area. Area itched and felt warm to the touch. Injection site felt hard. The patient has not taken any treatment for the events. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site began to itch; injection site began to itch and the coloring of the rash turned to a purplish hue; the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area; rash area itches and feels warm; rash area itches and feels warm; Injection site feels hard; Injection site was red; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authtoirty. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Feb2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 29 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine; bisacodyl (DULCOLAX); iron; unspecified prenatal vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified medication reported as "b". The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021 at 11:30 AM, the patient reported that injection site was red, following injection within 24 hours. Injection site remained red and began to fade by day 7. On 08Mar2021 at 12:00 AM (also reported as day 9), the injection site began to itch and the coloring of the rash turned to a purplish hue with smaller somewhat raised bumped within the rash area. Area itched and felt warm to the touch. Injection site felt hard. The patient has not taken any treatment for the events. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Eye pain, Fatigue
Clinical narrative: 100 F fever; Chills; Fatigue; Muscle ache; Weakness; Headache; Eye pain; mild sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ex9231) via an unspecified route of administration, administered in left arm on 19Jan2021 at 14:00 (age at vaccination was 57-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19. Concomitant medications (medications in two weeks) were reported none. The patient did not receive any other vaccine within 4 weeks. Patient has no known allergies. Prior to vaccination, the patient has been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 20Jan2021 at 10:00, the patient experienced 100 F fever, chills, fatigue, muscle ache, weakness, headache, eye pain, and mild sore arm. The patient underwent lab test and procedure which included body temperature with a result of 100 Fahrenheit (fever) on 20Jan2021 at 10:00. No therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 100 F fever; Chills; Fatigue; Muscle ache; Weakness; Headache; Eye pain; mild sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ex9231) via an unspecified route of administration, administered in left arm on 19Jan2021 at 14:00 (age at vaccination was 57-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19. Concomitant medications (medications in two weeks) were reported none. The patient did not receive any other vaccine within 4 weeks. Patient has no known allergies. Prior to vaccination, the patient has been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 20Jan2021 at 10:00, the patient experienced 100 F fever, chills, fatigue, muscle ache, weakness, headache, eye pain, and mild sore arm. The patient underwent lab test and procedure which included body temperature with a result of 100 Fahrenheit (fever) on 20Jan2021 at 10:00. No therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206 6121, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 08Mar2021 at 11:15 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and diabetes both from an unknown date. Concomitant medications included montelukast and sitagliptin phosphate (JANUVIA) both taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced sore shoulder on 08Mar2021 at 16:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Fever 101.3; shaky; chills; muscle aches; slight headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 07Mar2021 at 15:00 (Batch/Lot Number: EN6955) (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient previously took amoxicillin and experienced drug allergies. The patient experienced fever 101.3, shaky, chills, muscle aches and slight headache on 07Mar2021 at 20:00. The patient received no treatment for the events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.