chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Malaise; joint pain; pain in the arm; fever; feeling horrible; flu-like symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced side effects like malaise, joint pain, pain in the arm, fever, feeling horrible and flu-like symptoms. Outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Malaise; joint pain; pain in the arm; fever; feeling horrible; flu-like symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced side effects like malaise, joint pain, pain in the arm, fever, feeling horrible and flu-like symptoms. Outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Visual impairment
Clinical narrative: blinding headache; blinding headache; nausea; dizziness; This is a spontaneous report from contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. On 30Jan2021 at 09:00, the patient experienced blinding headache, nausea, and dizziness. The outcome of the events was unknown.  Information about Lot/Batch has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: knee problems, Not sure if it's arthritis as per caller; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 29Jan2021 (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. The patient had the first shot yesterday and wanted to know if she can take Tylenol. She was experiencing knee problems, not sure if it was arthritis as per caller. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site bruising, Vaccination site mass, Vaccination site reaction
Clinical narrative: got her first dose and will be receiving a CT scan- is it okay to still get the second dose; Right next to the injection site- firmness or lump black and blue at the site and next to it and lump; Right next to the injection site- firmness or lump black and blue at the site and next to it and lump; Right next to the injection site- firmness or lump black and blue at the site and next to it and lump; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female Patient (Mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received her first dose and will be receiving a CT scan, her second dose of Pfizer-Biontech Covid19 vaccine 21Feb2021. Patient was also due for a CT scan with contrast dye, and wanted to know if there was an interaction between the dye and the vaccine's efficacy? CT scan- Iodine- contrast media for procedures like CT scans Right next to the injection site- firmness or lump black and blue at the site and next to it and lump. She reports a "firmness or lump" next to the injections site and some bruising "black and blue" at the injection site. On unspecified date the patient experienced Right next to the injection site- firmness or lump black and blue at the site and next to it and lump. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling dizzy and heavy; This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program. A patient of unspecified age and gender received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT: unknown), via unspecified route as a single dose on an unspecified date for covid-19 immunization. The patient's concomitant medications and medical history was not reported. On an unspecified date the patient had feeling dizzy and heavy after the first dose. The outcome of the events was Unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-there information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Weight
Clinical narrative: bloody nose; This is a spontaneous report from a contactable consumer(patient). A 16-year-old male patient received the first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date: unknown), via unspecified route at 27Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient did not take any medicines and does not have any underlying conditions. On 29Jan2021 (Friday), the patient wake up in the morning with a persistent bloody nose and had 5 intermittent bloody noses though-out the day. On the same date, in evening, the patient had no bloody noses. Outcome of the event was recovered on 29Jan2021. Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (reporting on herself) via Pfizer Sponsored Program. A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29Jan2021 14:15 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: (diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was Animal dander, Pollen and Asthmatic from 1966 to an unknown date. Family Medical History includes: Father Asthmatic and Mother Allergies. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 on 08Jan2021 and patient experience sore arm. It was reported that on 29Jan2021patient got the vaccine shot (yesterday) and said that she got a sore arm. On 30Jan2021 at 12:00 Extreme fatigue and at 15:00 Muscle aches. Patient took Advil on 29Jan2021 and stop on 31Jan2021. The outcome of the events recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pain, Pain in extremity, Rash
Clinical narrative: Sore arm; Major headache; Minor aches and pain; Rash on chest and stomach; Rapid heart beat; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non pregnant female patient received first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration in Arm Left on 31Jan2021 15:30 as single dose for covid-19 immunisation. Medical history included pre diabetic, Allergies to penicclun/amoxcicilun. Concomitant medications the patient received within 2 weeks of vaccination included multi vitamins,VC, VD, Zinc,krill oil, Magnesiam. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Feb2021 12:00, The patient experienced sore arm, major headache, minor aches and pain, rash on chest and stomach, rapid heartbeat. AE occurred as follows: sore arm that evening, next day major headache along with minor aches and pain, following day rash on chest and stomach that evening rapid heart-beat for about 20 min. Location of injection information is available for all vaccines received on the same date. No treatment was received for the adverse events occurred. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I had vision problems (very hazy vision); This is a spontaneous report from a contactable Consumer (patient, self-reported). A patient of an unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, on an unknown date, as single dose for unknown indication. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient had vision problems (very hazy vision). On an unknown date, next Friday, the patient will get the second dose. Patient mother and patient had vision problems after getting the vaccine. The patient deciding whether to get the second one, as the patient afraid to lose patient's vision. Need to decide quickly. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Both my mom and I had vision problems after getting the vaccine. I had vision problems (very hazy vision); This is a spontaneous report from a contactable consumer (reporter's mother).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Patient had vision problems (very hazy vision) after the second vaccination. Really bad. Outcome of the event was unknown.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Urticaria
Clinical narrative: hives; troubles with breathing; This is a spontaneous report from a non-contactable consumer. This consumer (Wife) reported for a male patient (Husband). A male patient of 6 decades (70s) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. The patient medical history included that he got sick of Covid-19 last Mar. The patient concomitant medications were not reported. The patient and his wife both received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 15Jan2021, experienced some bad reactions to COVID vaccine afterwards. She said these reactions included hives, and they had troubles with breathing for 3 days. She also said she has already consulted her doctor about it and was told that they should not receive the 2nd dose of the vaccine since she experienced an allergic reaction after the 1st dose. They were also told that they should not have received the 1st dose in the first place since they still have the antibodies from when they got sick of Covid-19 last Mar. Consumer is seeking clarification if this is true, and if this reaction is associated with the vaccine. They both had COVID in Mar2020. The blood test says they have antibodies. But they had opportunities to get the shots. His wife was  worse than him. It took her 3 days to come out of the reaction, and it took him 1 day. After this experience, they went to see their primary doctor. They told him what happened. He didn't have it as bad. His wife couldn't breathe, and she was heaving for 3 days. They are afraid the second shot will do the same. Caller doesn't want to document this with safety. He just wants to get over to Medical Information. The outcome of the events is unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: Medically significant information added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site got red and felt super itchy; injection site got red and felt super itchy; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. Caller said after her 2nd dose, the injection site got red and felt super itchy. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pruritus, Urticaria, Weight
Clinical narrative: chills; joint pain/Joint achiness/she fell off of her roof; hives/she broke out in hives; severely itchy; This is a spontaneous report from a contactable consumer reported that a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) intramuscularly in left shoulder as single dose on 04Feb2021 at 12 for COVID-19 vaccination. Medical history reported was ongoing asthma diagnosed at about age 21. Stated that it is under control and she gets her allergy shots. She stated that it was environmental, ongoing bee allergy and severe allergy. She carries an epipen. Concomitant medications were not reported. Caller received the first shot of the Pfizer covid vaccine yesterday at 12 and after staying for 45 mins did not experience any issue. Later on, she started developing hives all over her body (itchy palms, neck, scalp, stomach) which she took 2 Benadryl for. Her hives have gotten 90% better, but she was experiencing some chills and joint pain. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she went yesterday, 04Feb2021, for her first shot at 12:00 and stayed there for 45 minutes because she was allergic to certain things. She said that she had no issues when she left at 12:45. Caller said that at about 16:45, she started to get severely itchy, and she broke out in hives. Caller said that it was on her scalp, her lips, her neck, her stomach, her arms, the palms of her hands, and the pads of her feet. The caller stated that there was nothing on her legs. She said that she woke up with more symptoms today 05Feb2021, and said that she woke up with chills and like every joint in her body feels like she fell off of her roof. Caller said that she took 2 Benadryl, and the hives are better. She stated that it totally knocked her out and she passed out on the sofa. Caller stated that the hives and the itching are about 90 percent better. Caller estimated her weight at about 160lbs. Caller stated that she took Tylenol for the chills and stated that it did not help the achiness in her joints at all. Caller stated that her chills and her joint achiness are the same. She said that she is allergic to Tetracycline, Penicillin, and sulfa drugs. Caller does not have the NDC, Lot, or expiration date for the medications. She stated that it was a long time ago. She has not followed up with her physician. They told her at the facility that for a reaction she needed to call Pfizer. Caller stated that she has a EpiPen, nebulizer and a rescue inhaler at home with her if needed. There was no previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations was reported as non (within 4 weeks). Just takes her allergy shots, but that was 3 weeks prior, and it was cleared with the physician. Outcome of the events hives/she broke out in hives and severely itchy was recovering, chills and joint pain/Joint achiness/she fell off of her roof was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry mouth, Paraesthesia oral, Tongue dry
Clinical narrative: Dry tongue; For the past 3 days the Tingling was worse; Tingling on [her] tongue/tinging on the tongue; Dry mouth; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot number: EL9262, Expiry Date: Unknown) via an unspecified route of administration on left arm on 24Jan2021 at 12:15 as single dose for covid-19 immunisation. Medical history included monoclonal gammopathy, high blood pressure and cholesterol. Concomitant medications included Losartan and Metoprolol for high blood pressure and Lipitor for cholesterol which is under control with medication. Patient experienced dry mouth on 24Jan2021, tingling tongue on 26Jan2021. For the past 3 days the tingling was worse, then this morning it's better and dry mouth is about the same. Patient asked if her experience was a reported side effect of the vaccine. She replied she already spoke with HCP. She also asked if she could take Benadryl for the tingling on her tongue. She then indirectly questioned if she should receive the second dose of the vaccine after her reaction to the first dose. Patient also stated her second dose of the Pfizer-BioNTech COVID-19 vaccine is scheduled on 12Feb2021, 19 days after the first dose. She asked is 19 days too early to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine. She is concerned because that is only 19 days. She is not sure if that's okay. Patient declined to write down Pfizer websites stating that she is not tech savvy as she is 81 years old, she prefers talking to someone. Outcome for Dry mouth was not recovered and recovering for tingling tongue.  Patient enquired about the timing of the second dose of the Pfizer-BioNTech COVID-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pruritus, Urticaria
Clinical narrative: she had systemic urticaria; pruritus; indicated that she is breast feeding currently; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (breast feeding mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, at single dose on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced systemic urticaria and pruritus on an unspecified date. The patient indicated that she is breast feeding currently. The outcome of the events had systemic urticaria and pruritus was unknown.   Information on the Lot/Batch Number has been requested. No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Kindly review the seriousness of the case.(maternal exposure during breast feeding).
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: red welt under one breast; red spot on top of the other one; This is a spontaneous report from a contactable consumer or other non HCP.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation.  The patient medical history was not reported and concomitant medications were not reported. Caller (Patient) stated she got the first dose of the Covid vaccine on Friday (05Feb), 3 hours later (on an unknown date in Feb2021) she noticed a red welt under one breast an a red spot on top of the other one. She asked if it was the side effect of the vaccine and she asks if she should take the second dose. The action taken in response to the event s for bnt162b2 was not applicable. Outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: My right arm still has a red welt on it and it' 2/9.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration on 30Jan2021 16:45 as SINGLE DOSE (at the age of 42-years) in Arm Right for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccines four weeks prior to COVID vaccination. The patient did not receive other medications two weeks prior to COVID vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. On 30Jan2021, the patient's right arm still has a red welt on it and it' 2/9. The patient did not receive treatment for the event. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event was recovered with sequelae on an unspecified date in 2021 (recovered with lasting effects).
Sex: M
Vaccine: COVID19
Symptoms: Gingival disorder
Clinical narrative: Needed to go to the dentist for a gum injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non-health care professional.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient needed to go to the dentist for a gum injection on the 08Feb2021, Monday. The outcome of event was unknown. Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepiness day after vaccine and also on day 2.; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number and expiry date were not reported) via an unspecified route of administration in right arm on 06Feb2021 14:30 as single dose for COVID-19 immunisation. Patient had no medical history. The patient did not have any known allergies. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT) and omeprazole magnesium (PRILOSEC) (other medications in two weeks of vaccination. Patient did not have COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 07Feb2021 at 24:00, patient experienced extreme fatigue and sleepiness day after vaccine and also on day 2. No treatment was received. On an unknown date, the outcome of event was resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Broke out in hives; This is a spontaneous report from a non-contactable patient (other health care professional). A 48-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was El3246), intramuscular at arm left on 25Jan2021 19:30 as single dose for COVID-19 immunization. Previously patient received first dose of bnt162b2 as single dose for COVID-19 immunization. Patient did not receive any vaccine in 4 weeks. The patient did not take any medication in two weeks. The patient medical history was not reported. There were no concomitant medications reported. On 25Jan2021 the patient experienced broke out in hives. No treatment was received for the event. The patient did not have COVID prior to vaccination. On 25Jan 2021 the patient did COVID test as nasal swab, PCR test which results negative. Patient had no allergies. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate, Myalgia, Oxygen saturation
Clinical narrative: had fine hives on my forehead and also under neath my right eye and cheeks; Initially, while waiting posterior neck muscle soreness/ache from of ears downward to top of shoulder, but not affecting shoulder. only neck.; My BP 160s; repeat 1288/60; rash on my forehead; This is a spontaneous report from a contactable Nurse. A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW5318), via intramuscular route, administered in Arm Left on 26Jan2021 at 16:15 as single dose for COVID-19 immunization. Medical history included seasonal allergy, eczema, sinus disorder. Known allergies: PCN, Biaxin, Avelox, shellfish, salmon, latex. Concomitant medications included Gabapentin, levocetirizine, Multi-betic, Zetia, Crestor, Zinc, Super B complex, Biotin, D3. On 26Jan2021 at 16:30 patient experienced Initially, while waiting posterior neck muscle soreness/ ache from of ears downward to top of shoulder, but not affecting shoulder only neck. We waited over 30min. BP is 160s and repeat 1288/60, HR-66, and Sat100% per EMT. Left after over 30min being watched. Upon returning home, Dad noted that I had a rash on forehead. I removed my face mask noted in the mirror that I had fine hives on my forehead and also under neath my right eye and cheeks. On 26Jan2021 Lab data was noted as BP with 1288/60, Heart rate as 66 and oxygen saturation as 100. Treatment have been taken with Benadryl and applied cortisone to face and neck rash that developed. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: had fine hives on my forehead and also under neath my right eye and cheeks; Initially, while waiting posterior neck muscle soreness/ache from of ears downward to top of shoulder, but not affecting shoulder. only neck.; My BP 160s; repeat 1288/60; rash on my forehead; This is a spontaneous report from a contactable Nurse. A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW5318), via intramuscular route, administered in Arm Left on 26Jan2021 at 16:15 as single dose for COVID-19 immunization. Medical history included seasonal allergy, eczema, sinus disorder. Known allergies: PCN, Biaxin, Avelox, shellfish, salmon, latex. Concomitant medications included Gabapentin, levocetirizine, Multi-betic, Zetia, Crestor, Zinc, Super B complex, Biotin, D3. On 26Jan2021 at 16:30 patient experienced Initially, while waiting posterior neck muscle soreness/ ache from of ears downward to top of shoulder, but not affecting shoulder only neck. We waited over 30min. BP is 160s and repeat 1288/60, HR-66, and Sat100% per EMT. Left after over 30min being watched. Upon returning home, Dad noted that I had a rash on forehead. I removed my face mask noted in the mirror that I had fine hives on my forehead and also under neath my right eye and cheeks. On 26Jan2021 Lab data was noted as BP with 1288/60, Heart rate as 66 and oxygen saturation as 100. Treatment have been taken with Benadryl and applied cortisone to face and neck rash that developed. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous case received from a contactable consumer (patient). A 50-years-old female patient BNT162B2 received (Pfizer-BioNTech COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID-19 Vaccine first dose last week and was scheduled to receive the second dose on 24Feb2021. On unspecified date patient experienced Hives. Patient was scheduled to take Xolair for her hives and was asking should postpone or change the schedule. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a Pfizer-sponsored program. A female consumer (patient) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), lot number/batch number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, pharmacy tech after received the first dose of covid vaccine, broke out in hives and Inquired if that was a reported reaction. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pain in extremity, Urticaria
Clinical narrative: I felt hives on my forehead; With the 2nd shot my arm was definitely sore; I felt like I had a fever but it did not show on the thermometer; This is a spontaneous report from a contactable consumer(patient). A 67-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in Arm Right on 05Feb2021 at 08:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer survivor from an unknown date and unknown if ongoing, food allergy valium, strawberries, bananas, lobster, mahi, whiting fish from an unknown date and unknown if ongoing. The patient received other vaccines within 4 weeks prior to the COVID vaccine via right arm on 14Jan2021. There was no COVID prior vaccination. The patient was not tested post COVID-19 vaccination. Concomitant medications included turmeric [curcuma longa rhizome]; ergocalciferol (VIT D), vitamin c [ascorbic acid], collagen (collagen), olive oil (olive oil). The patient previously took bnt162b2, valium and experienced drug hypersensitivity. On 05Feb2021 at 15:00, The patient stated that, I got hives near my left eye with the first Pfizer shot but I wasn't sure if that was the cause as I do have food allergies. My arm was a little stiff but not significantly and I did not have any other side effects. On 5Feb21, With my second shot, I felt hives on my forehead which confirmed I did have a hive reaction from the first vaccine on 14Jan2021 shot, with the 2nd shot my arm was definitely sore, I wanted to just lay down and I felt like I had a fever but it did not show on the thermometer. However, it is a lot better 24 hours later. My hives have gone down and I feel fine. The patient underwent lab tests and procedures which included body temperature: fever but it did not show on the thermometer. Therapeutic measures were taken as a result of the 2nd shot my arm was definitely sore with Aleve to reduce the pain of the vaccine area on right arm. The events were considered as non-serious. The outcome of the events were reported as recovered.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122958 same patient, same product( different dose), similar events
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Headache, Pain in jaw
Clinical narrative: Yesterday is when it really started to increase and has gotten worse since starting; has "intense" pain on all the joints; intense pain that started in the left side of his jaw, in the joint; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 10Feb2021 13:30 as single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus had for 5-6 years , ongoing hypertension had for about 8 years. There were no concomitant medications. Reporter stated that he had covid vaccine on 10Feb Wednesday and afterward he has had joint pain which he explains was intense pain that started in the left side of his jaw, in the joint. He also has intense pain in his left thigh, in the joint socket. He stated that he also got a headache, but it was gone away. Patient wants to know if this was a side effect. Patient stated that he got the shot on 10Feb2021 and the joint pain was noticed that day, it was real faint that evening. Yesterday is when it really started to increase and has gotten worse since starting. Patient stated that his wife got the shot too when he did and had some joint pain but is has gone now. Reporter stated that on the back of the card it says After: 03Mar2021. This might be when he gets the next shot. The outcome of the event has "intense" pain on all the joints and intense pain that started in the left side of his jaw, in the joint was not recovered. The outcome of the event headache was recovered. The outcome of the event yesterday is when it really started to increase and has gotten worse since starting was unknown.  Follow up (12Feb2021): This is a follow up spontaneous report from a contactable Consumer. No new significant information was added.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable Pharmacist via medical information team. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives after the 1st dose of vaccine. The reporter asked should the patient receive the second dose. The reporter stated that he heard about the patient from another pharmacist and was asking question for information purposes. The outcome of the event was unknown.   Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: had numbness and tingling in her right arm; had numbness and tingling in her right arm; nausea/Nauseous; face tingling which is like a numb feeling; face tingling which is like a numb feeling; This is a spontaneous report from a contactable Consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unknown date as a single dose for covid-19 immunization. The patient's medical history included allergies to Latex, Azithromycin, Dipac, Prozac, crab and lobsters, egg  since she has a mild egg allergy, wheat intolerance, Irritable bowel syndrome(IBS). The patient's concomitant medications were not reported. Patient stated that after she got first Pfizer Covid shot, right away she was nauseous. Patient sat down and was monitored for 15 minutes. Patient had tingling and numbness 30 minutes later in her right arm. The patient further stated that 1.5 hours after her face had a tingling, numb feeling, she called her doctor and patient was asked if she can puff her cheek and scrunch her eyes.The patient stated that she was able to do it. Her doctor stated that she was okay and if it gets worse, asked her to call back in the morning. Patient stated that it was still there but just better a little tingling and numb. The patient stated that she can puff her cheeks and scrunch her eyes. Patient was asking whether she had an allergic reaction to the 1st shot as it was recommended for her not to get the 2nd shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; This is a spontaneous report from a contactable consumer. A 95-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for Injection; Lot number: Unknown) via an unknown route of administration in the left arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunization. The patient medical history included allergies to Penicillin, Bactrim and cholesterol medicines. The patient previously received the first dose of bnt162b2, via an unknown route of administration in the left arm on 07Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced rash and hives on stomach, hip arm and shoulder blades on 11Jan2021 at 09:00 (the events resulted in doctor or other healthcare professional office/clinic visit and outcome was not recovered). The patient was healthy. The patients concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021, at 11:45, the patient developed hives on back, arm and shoulder blade that are itchy and burning sometimes. It was two weeks since second vaccine and it was still bothering the patient. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events to be non-serious. The outcome for the events was not recovered.   Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Hives on her forehead and ear; This is a spontaneous report from a Contactable consumer. A 63-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Lot number, expiry date not reported) via intramuscular on left arm on 19Jan2021 at 24:00 as Single dose for COVID-19 Immunization. Patient medical history included she stated that she had hives on and off since her 30s and adds she was menopausal, allergy, Blood pressure from unspecified date. No prior vaccination taken within 4weeks. Patient concomitant medication included Zyrtec (CETIRIZINE HYDROCHLORIDE) 10mg one twice daily by mouth, taking a year and half; Aldactone (PIRONOLACTONE) taking for over a year, Singulair (MONTELUKAST SODIUM) 10mg; take once daily by mouth at night for allergy,taking for a year and half from unspecified date and still ongoing. On 22Jan2021, patient experienced broke out in hives; came on her forehead and right ear after receiving first dose of vaccine. She experienced itching from unspecified date. Hive came three days later on her forehead and right ear. Six days visited clinic. Treatment was given by Pepcia and Atarax for the itching and it worked definitely; All of her hive cleared up the next day. She was scheduled for the second dose on 09Feb2021. The Outcome of events was recovered on 30Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 12Feb2021 (at the age of 27-year-old), as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. On 13Feb2021 at 12:00, the patient experienced 3 hives on neck and 6 hives on right arm. There was no treatment received for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event  was recovering.  Follow-up (23Feb2021): This follow-up is being submitted to notify that the adverse event occurred date and PRD was 13Feb2021.  Information on the lot/batch number has been requested.