chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal chest pain, Myalgia
Clinical narrative: Shingles diagnosis/Rash/Blister; Right ribcage bone and muscle pain; Right ribcage bone and muscle pain; This is a spontaneous report from a contactable consumer or other Non-HCP reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. It was unknown if the patient has received any other vaccine in four weeks. The patient experienced Right ribcage bone and muscle pain on 03Mar2021, developed rash on 07Mar2021, blister on 09Mar2021, and on 11Mar2021, diagnosed with Shingles and has been prescribed valacyclovir and naproxen. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and treatment was received. Therapeutic measures were taken for the adverse events which includes Valacyclovir and naproxen. It is unknown if the patient got Covid prior vaccination and unknown if tested for Covid-19 post vaccination. The reporter became aware of the adverse events on 12Mar2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration on 08Mar2021 (73-year-old at the time of vaccination) as first dose, single dose for COVID-19 immunization. The patient medical history included breast cancer survivor. The patient concomitant medications were not reported. The patient past medication included Tamoxifen and Femara those were pills that she took for 10 years. She took Tamoxifen for 5 years and Femara for 5 years. She remembers the first initial of one of the drugs for the actual chemo, it began with a C if she heard it, she would know it, but she cannot remember it. On 08Mar2021, about 2 hours after receiving the first dose, the patient had a metallic taste in her mouth, which did not last long and went way after she ate food. The patient thought that she had a metallic taste again today but went away. Patient stated that event made her think of her chemotherapy treatment which she went through with breast cancer, and she always had a metallic taste in her mouth. The patient tried to go online to find the fact but could not find anything and was not able to determine whether or not it could happen or if there was anything to be concerned about. The patient confirmed that she was calling to know whether the event was associated with the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster, SARS-CoV-2 antibody test
Clinical narrative: The patient has tested covid positive post vaccination; The patient has tested covid positive post vaccination; Shingles; This is a spontaneous report from a contactable (Patient). A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not had covid prior to vaccination. The patient has tested covid positive post vaccination on an unspecified date and shingles on 24Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the narrative information provided, there is a reasonable possibility that the reported events COVID-19, Drug Ineffective and Herpes zoster is related to BNT162B2 (COVID-19 mRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: aches, pains; nausea; lymph node swelling; This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patients. This is 1st of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that after the second dose, the patient (reporter's mother) described aches, pains, nausea and lymph node swelling on an unspecified date. On 15Mar2021, the reporter stated that her mother mentioned this to him/her (the reporter) on behalf of herself and his/her father. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276527 Same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: Aches and pains; Nausea; Lymph node swelling; This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the second dose, the patient experienced aches, pains, nausea, and lymph node swelling on an unspecified date after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276515 Same reporter, product, and event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: still experiencing ache in her arm/ very sore arm for 2-3 days, very sore arm for 2-3 days, with a dull ache for a week; chills; felt 'achy'; headache; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 26Feb2021 (at an unspecified age) at 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her first dose of the vaccine last 26Feb2021, and was still experiencing ache in her arm, which started on an unspecified date. On 17Mar2021, it was reported that the patient was scheduled to receive her second dose this Friday, 19Mar2021. On an unspecified date, after her first dose, the patient experienced very sore arm for 2 to 3 days with a dull ache for a week, headache for 24 hours, chills, and the patient felt 'achy'. Outcome of the events pain in arm and headache was recovered on an unspecified date, and for other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Headache, Influenza, Pyrexia
Clinical narrative: she attributed to pollen allergy; flu; cough; fever; headache; she is presenting suspected COVID symptoms.; she is presenting suspected COVID symptoms.; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of an unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 14Mar2021 she had cough and symptoms that she attributed to pollen allergy. She stated that she had headache and fever on 14Mar2021, feeling like she was going through the flu. It was reported that she had her second dose of vaccine scheduled on 25Mar2021 and currently she was presenting suspected COVID symptoms. The events were considered as non-serious by reporter. The events suspected covid and drug ineffective was considered as serious (medical significant). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Suspected COVID-19
Clinical narrative: she attributed to pollen allergy; flu; cough; fever; headache; she is presenting suspected COVID symptoms.; she is presenting suspected COVID symptoms.; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of an unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 14Mar2021 she had cough and symptoms that she attributed to pollen allergy. She stated that she had headache and fever on 14Mar2021, feeling like she was going through the flu. It was reported that she had her second dose of vaccine scheduled on 25Mar2021 and currently she was presenting suspected COVID symptoms. The events were considered as non-serious by reporter. The events suspected covid and drug ineffective was considered as serious (medical significant). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster
Clinical narrative: developed light case of Shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 68-years-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 26Feb2021 16:30 (at the age of 68-year-old non-pregnant) (Lot Number: en6198, Expiration date: unknown) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroid. Concomitant medication included unspecified medication. Patient has not covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced developed light case of shingles on an unspecified date. Patient was not tested positive for covid-19 after vaccination. Outcome of event was recovering.   No Follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included Lupus. The patient's concomitant medications were not reported.  Patient got her first dose of the vaccine last 03Mar2021. She experienced chills, fever and body pain on the second day after the first dose of the vaccine. Now, she feels weak and has no energy. She wanted to know if this was normal. She has a pre-existing condition which was lupus. She was worried that she might get a worse reaction after the second dose. Her second dose was scheduled on 24Mar2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: I can't smell and still I can't smell today either; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6499), via an unspecified route of administration on an unspecified date at an unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced I can't smell and still I can't smell today either on an unspecified date. Reporter stated, patient got the Pfizer vaccine on Tuesday and Thursday patient start experiencing, I can't smell and still I can't smell today either so, patient was wondering did the vaccine have anything is this one of the symptom, that's not listed. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable physician (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200), via intramuscular route, administered in left arm on 14Feb2021 at 12:45 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included crohn's disease, reflux gastritis, benign prostatic hyperplasia, arthritis and sulphur allergy. Concomitant medication(s) included mesalazine (PENTASA); Tamsulosin hydrochloride (FLOMAX); finasteride (PROSCAR); esomeprazole sodium (NEXIUM). On 01Mar2021 at 14:00, the patient experienced shingles. The patient received acyclovir as treatment for the adverse event. The patient visited physician's office for the event. The patient was not diagnosed with covid-19 prior vaccination and was not tested post vaccination. There was no other vaccine administered on the same day of the suspect vaccine. The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertensive crisis
Clinical narrative: Blood pressure jumped to 239 over 135; This is a spontaneous report received from a contactable consumer.   A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration, administered in left arm on 03Mar2021, at 10:30 as single dose for covid-19 immunization when the patient was 72-years-old . Medical history included hypertension from an unknown date. The patient was not pregnant Prior to vaccination, the patient was not diagnosed with COVID-19;  since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; indomethacin sodium (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; aspirin (ASPIRIN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced blood pressure jumped to 239 over 135 on 12Mar2021, at 14:30. Treatment received for the adverse event included additional amlodipine 10mg tablet given to lower blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: 239/135  on 12Mar2021  at 3:00 pm.  The clinical outcome of blood pressure jumped to 239 over 135 was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles after 2nd dose of Pfizer Covid vaccine; This is a spontaneous report from a contactable male consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: unknown), via an unspecified route of administration on 09Mar2021 at 13:45 (at the age of 54-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of bnt162b2, dose 1 on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other medications in 2 weeks. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested COVID-19 post vaccination. The patient experienced shingles after 2nd dose of Pfizer COVID vaccine on 12Mar2021 at 06:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received anti-viral as a treatment medication for the event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost sense of taste of smell; Lost sense of taste of smell; This is a spontaneous report from contactable male consumer reported for himself received from a Pfizer-sponsored program.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lost sense of taste of smell. Outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypertension, Muscle spasms, Nausea
Clinical narrative: Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of  BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration  in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of  BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration  in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Acne cystic, Aphthous ulcer, Blepharitis
Clinical narrative: sore left eye lid/ bump on lid/ irritation in corner of eye; canker sore on left side of tongue; cystic acne on left shoulder; This is a spontaneous report from a contactable consumer or non-HCP. A 34-year-old female patient received BNT162B2 (Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EN6208 as a second dose administered in arm Left for COVID-19 immunisation on date 13Mar2021 at 12 pm( patient is 34 years of age at the time of vaccination). Medical history was not reported. Concomitant medication was not reported. On 20Feb2021 at 1pm,patient received BNT162B2(Pfizer BIONTECH COVID 19 mRNA Vaccine; lot number EL9264, as 1st dose on left arm.  No allergies to medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 16Mar2021, patient experienced  canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye. No therapeutic measures were taken. The clinical outcome of the events canker sore on left side of tongue, cystic acne on left shoulder and sore left eye lid/ bump on lid/ irritation in corner of eye was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer or other non hcp.   A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Mar2021 as a SINGLE DOSE for covid-19 immunization. The patient's medical history included hypertension. The patient previously took diphenhydramine and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810, Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 07Fb2021 12:15PM, as a SINGLE DOSE for covid-19 immunization. Concomitant medications included Benazepril, baclofen, Hydrochlorothiazide and cyanocobalamin (B-12). No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On an unspecified date Mar2021, the patient experienced shingles. No treatment taken for adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: Diarrhea; headache; sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 32-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: EN6206), via an unspecified route of administration in his right arm on 12Mar2021 at 14:15 (at the age of 32-years-old) for COVID-19 immunisation. Medical history included anemia, blood pressure high, obesity and heart murmur. The patient did not have any allergies to medications, food or other products. 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 and the patient was not tested for COVID-19 since the vaccination. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN)), amlodipine Besylate (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) for an unknown indication. On 12Mar2021, the patient experienced diarrhoea, headache and sore arm. Therapeutic measures were not taken for events experienced. The clinical outcome of the diarrhoea, headache and sore arm was recovered.    No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling in neck on left side.; This is a spontaneous report from a contactable nurse.  A 34-year-old non-pregnant female patient received her dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an intramuscular route of administration in the left arm on 03Mar2021 at 12:30 pm (at the age of 34-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, drug or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks prior to the COVID vaccine. On 08Mar2021, the patient experienced lymph node swelling in neck on left side. Patient did not receive any treatment for the event. The clinical outcome of the event lymph node swelling in neck on left side was not resolved at the time of reporting.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Chest pain, Chills, Pain
Clinical narrative: Stomach crampy; Tingling sensations in feet and hands; Sharp pain on the right side of chest; Burning sensations in feet and hands; sore legs; Sore arm; Body aches; Chills; Slight fever; This is spontaneous report from a contactable patient. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the right arm on 06Mar2021 at 15:00, (at the age of 31-years-old) as a single dose for COVID-19 immunization. It was unknown whether the  patient was pregnant at the time of vaccination. Medical history included sinusitis, asthma, gastroesophageal reflux disease (GERD), allergy to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Symbicort , Budesonide (sinus rinse) (MANUFACUTRER UNKNOWN) and  Azelastine (MANUFACUTRER UNKNOWN), all for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient didn't received any other vaccines within 4 weeks prior to the COVID-19  vaccination. On 15Mar2021, the patient had a nasal swab (Covid antigen) test and the test result was negative. On 07Mar2021, the patient experienced  normal side effects such as sore arm, slight fever, chills and body aches and was fine after that. On 14Mar2021 at 12:00, the patient  experienced tingling and burning sensations in feet and hands, legs were  very sore like she had done a difficult work out which was actually not done and also had a sharp pain on the right side of chest and stomach was crampy. It was unknown whether the patient received any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events sore arm, slight fever, chills and body aches was resolved. The clinical outcome of the events sharp pain on the right side of chest, burning sensations in feet and hands, stomach crampy, tingling sensations in feet and hands and sore  legs was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Stomach crampy; Tingling sensations in feet and hands; Sharp pain on the right side of chest; Burning sensations in feet and hands; sore legs; Sore arm; Body aches; Chills; Slight fever; This is spontaneous report from a contactable patient. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the right arm on 06Mar2021 at 15:00, (at the age of 31-years-old) as a single dose for COVID-19 immunization. It was unknown whether the  patient was pregnant at the time of vaccination. Medical history included sinusitis, asthma, gastroesophageal reflux disease (GERD), allergy to penicillin and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Symbicort , Budesonide (sinus rinse) (MANUFACUTRER UNKNOWN) and  Azelastine (MANUFACUTRER UNKNOWN), all for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient didn't received any other vaccines within 4 weeks prior to the COVID-19  vaccination. On 15Mar2021, the patient had a nasal swab (Covid antigen) test and the test result was negative. On 07Mar2021, the patient experienced  normal side effects such as sore arm, slight fever, chills and body aches and was fine after that. On 14Mar2021 at 12:00, the patient  experienced tingling and burning sensations in feet and hands, legs were  very sore like she had done a difficult work out which was actually not done and also had a sharp pain on the right side of chest and stomach was crampy. It was unknown whether the patient received any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events sore arm, slight fever, chills and body aches was resolved. The clinical outcome of the events sharp pain on the right side of chest, burning sensations in feet and hands, stomach crampy, tingling sensations in feet and hands and sore  legs was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe body aches in all joints; This is a spontaneous report from a contactable healthcare professional from a Pfizer-sponsored program. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR, 11 mg Prolonged-release tablet), oral from 09Sep2020 and ongoing, at 11 mg, 1x/day for rheumatoid arthritis. Medical history and concomitant medications were not reported. The patient experienced severe body aches in all joints on an unspecified date, which lasted a few days and resolved. The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was resolved on an unspecified date.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Ep6955), via an unspecified route of administration in right arm on 07Jan2021 at 08:00 as a single dose (at the age of 33 years old) for COVID-19 immunisation. Medical history included asthma, recurrent pneumonia, chronic sinusitis, birch pollen allergy, some nuts allergy, and dust allergy. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received treatment with BENADRYL for the reported event. On 07Jan2021 at 08:45, tingling tongue. The clinical outcome of event tingling tongue was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Dysgeusia, Hypertension, Lip swelling
Clinical narrative: metallic taste; back ache; Neck & back ache; sore arm 3 hours after injection; tingling skin; racing heart; sore throat; high blood pressure; lower lip swelling; hives; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the arm right on 06Mar2021 at 13:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The medical history includes type 1 diabetes, thyroid disease, colitis, lichen sclerosis, carpel tunnel syndrome, legionnaire's disease, mixed hyperlipidemia and hx of Cdiff. Patient was allergic to PCN (penicillin), sulfa, IV iodine, codeine, blue cheese and adhesive bandage. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination she was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (BASAGLAR), gabapentin (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA) and levothyroxine sodium (SYNTHROID). On 06Mar2021, the patient developed lower lip swelling, tingling, hives and sore arms three hours after the vaccination, tingling skin, sore throat, high blood pressure and racing heart. On the same day (06Mar2021), the patient had visited the OPD clinic and was prescribed diphenhydramine hydrochloride (BENADRYL). On 13Mar2021, the symptoms had returned with metallic taste, swelling lip, neck & back ache and went to ER (emergency room) where patient was prescribed with famotidine (MANUFACTURER UNKNOWN) and can use diphenhydramine hydrochloride (BENADRYL). On 16Mar2021, the patient met the physician and was prescribed fexofenadine hydrochloride (ALLEGRA) and montelukast (MANUFACTURER UNKNOWN) as the symptoms were the same. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for the adverse events, including Benadryl/Famotidine/Allegra/montelucast. The clinical outcome of all the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: metallic taste; back ache; Neck & back ache; sore arm 3 hours after injection; tingling skin; racing heart; sore throat; high blood pressure; lower lip swelling; hives; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the arm right on 06Mar2021 at 13:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The medical history includes type 1 diabetes, thyroid disease, colitis, lichen sclerosis, carpel tunnel syndrome, legionnaire's disease, mixed hyperlipidemia and hx of Cdiff. Patient was allergic to PCN (penicillin), sulfa, IV iodine, codeine, blue cheese and adhesive bandage. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination she was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (BASAGLAR), gabapentin (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA) and levothyroxine sodium (SYNTHROID). On 06Mar2021, the patient developed lower lip swelling, tingling, hives and sore arms three hours after the vaccination, tingling skin, sore throat, high blood pressure and racing heart. On the same day (06Mar2021), the patient had visited the OPD clinic and was prescribed diphenhydramine hydrochloride (BENADRYL). On 13Mar2021, the symptoms had returned with metallic taste, swelling lip, neck & back ache and went to ER (emergency room) where patient was prescribed with famotidine (MANUFACTURER UNKNOWN) and can use diphenhydramine hydrochloride (BENADRYL). On 16Mar2021, the patient met the physician and was prescribed fexofenadine hydrochloride (ALLEGRA) and montelukast (MANUFACTURER UNKNOWN) as the symptoms were the same. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for the adverse events, including Benadryl/Famotidine/Allegra/montelucast. The clinical outcome of all the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: metallic taste; back ache; Neck & back ache; sore arm 3 hours after injection; tingling skin; racing heart; sore throat; high blood pressure; lower lip swelling; hives; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the arm right on 06Mar2021 at 13:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The medical history includes type 1 diabetes, thyroid disease, colitis, lichen sclerosis, carpel tunnel syndrome, legionnaire's disease, mixed hyperlipidemia and hx of Cdiff. Patient was allergic to PCN (penicillin), sulfa, IV iodine, codeine, blue cheese and adhesive bandage. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination she was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (BASAGLAR), gabapentin (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA) and levothyroxine sodium (SYNTHROID). On 06Mar2021, the patient developed lower lip swelling, tingling, hives and sore arms three hours after the vaccination, tingling skin, sore throat, high blood pressure and racing heart. On the same day (06Mar2021), the patient had visited the OPD clinic and was prescribed diphenhydramine hydrochloride (BENADRYL). On 13Mar2021, the symptoms had returned with metallic taste, swelling lip, neck & back ache and went to ER (emergency room) where patient was prescribed with famotidine (MANUFACTURER UNKNOWN) and can use diphenhydramine hydrochloride (BENADRYL). On 16Mar2021, the patient met the physician and was prescribed fexofenadine hydrochloride (ALLEGRA) and montelukast (MANUFACTURER UNKNOWN) as the symptoms were the same. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for the adverse events, including Benadryl/Famotidine/Allegra/montelucast. The clinical outcome of all the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain primarily in knees. Started day after vaccine was administered and is still happening.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 10Mar2021 at 15:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included Diabetes. Concomitant medication included Several diabetic related medicines (names unknown). Patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 11Mar2021 at 00:00, the patient experienced Joint pain primarily in knees. Started day after vaccine was administered and is still happening. The clinical outcome of the event knee pain was recovering.    No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report from a contactable consumer. An adult (18- 64years old) female non-pregnant patient (at unknown age) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 17 Mar2021 as a second single dose for COVID-19 immunisation. The patient's past medical history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) as a first single dose on 23Feb2021 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine 4 weeks prior to vaccination. On 18March2021 the patient was not feeling well and she missed work the next day of vaccination. No therapeutic measures were taken for the event. The clinical outcome of the event not feeling well was resolving.  Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pain at the injection site; sore arm; This is a spontaneous report received from a contactable consumer (patient) via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that vaccine was given, pain at the injection site and sore arm were reported. The events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Sore muscle at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old adult male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 17Mar2021 at 11:30 (at the age of 62years) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and blockage, major depression, posttraumatic stress disorder (PTSD), sleep apnea, tinnitus. The patient did not have any allergies to medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medication was not reported. On 17Mar2021, the patient experienced "sore muscle at injection site. Started developing a headache around 3pm, continued worsening. Around 8am it began to subside. Around 9 it was gone". The clinical outcome of the events sore muscle at injection site and headache was recovered.   No follow-up attempts are needed. No further information is expected.