chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pollakiuria
Clinical narrative: Booster dose; When I get really relax my heart starts beating up; fast heart beat; I urinate; I get frequent urine; I have no control over it; it's is basically at night not so much during the day; Dizzy; Shortness of breath; but stated he went to ER twice for congestion but he is better now.; This is a spontaneous report from a contactable consumer. This consumer reported that, A patient of unspecified age and gender received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization and took second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date, the patient takes booster dose and patient get really relax his heart starts beating up; fast heartbeat, patient urinate; get frequent urine; have no control over it; it's basically at night not so much during the day, dizzy, shortness of breath, but stated he went to er twice for congestion, but he is better now. It was reported that patient had the booster shot then having side effects. When patient get really relax patient heart starts beating up. The biggest problem patient urinate mean get frequent urine. Patient have no control over it, it's is basically at night not so much during the day. Patient feel dizzy, shortness of breath and fast heartbeat. On an unspecified date. the patient underwent lab tests and procedures which included heart rate: increased. The outcome of the event but stated he went to ER twice for congestion but he is better now recovering and for the other event was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in hips and lower back; Severe pain in hips and lower back; 99.5 Degree Fever; Minor soreness in arm; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A 60-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/FF8839) via an unspecified route of administration, administered in Arm Right on 11Oct2021 (at 08:30) (age at time of vaccination was 60-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The relevant medical history included Asthma, known allergies to PENICILLIN, SULFA DRUGS, QUININE, GLUTEN, other medical history included allergies and Hormone replacement therapy from an unspecified date. Concomitant medications included INFLUENZA VACCINE administered in Arm Right on 04Oct2021 as a DOSE 1, SINGLE, FLONASE (FLUTICASONE PROPIONATE) and PROBIOTICS taken for an unspecified indication. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/EM9809) via an unspecified route of administration, administered in Left Arm on 24Feb2021 (at 08:15) (age at time of vaccination was 59-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/EL9265) via an unspecified route of administration, administered in Left Arm on 03Feb2021 (at 08:00) (age at time of vaccination was 59-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. On 11Oct2021 (at 20:00), the patient experienced Severe pain in hips and lower back, 99.5 Degree Fever and Minor soreness in arm. The patient received ADVIL, 600mg as a treatment medication for the adverse events. The patient underwent lab tests and medical procedures on 11Oct2021 which included Body temperature which showed result as 99.5 Degree Fever. The clinical outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Buttock injury, Chills, Diarrhoea, Eating disorder, Fatigue
Clinical narrative: was just tired; the booster knocked her on her butt; her right arm where she had the booster hurt; had headache; chills; fever; couldn''t eat at all; had diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3184), dose 3 via an unspecified route of administration, administered in Arm Left on 12Oct2021 11:00 AM (at the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Historical vaccine included 1st dose of the Pfizer COVID vaccine in right arm was on 06Mar2021 09:30 AM with lot EN6206, the 2nd dose was in right arm on 26Mar2021 10:00 AM with lot ER8730, and flu shot on 04Oct2021. Medical history included ongoing chronic obstructive pulmonary disease Verbatim: COPD 10 years ago. There were no concomitant medications. On 12Oct2021 21:00 the patient experienced was just tired, the booster knocked her on her butt, her right arm where she had the booster hurt, had headache, chills, fever, couldn''t eat at all, had diarrhea. The outcome of event the booster knocked her on her butt, her right arm where she had the booster hurt, chills, fever, couldn''t eat at all, had diarrhea was recovering. The outcome of event tired, had headache was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pyrexia
Clinical narrative: was just tired; the booster knocked her on her butt; her right arm where she had the booster hurt; had headache; chills; fever; couldn''t eat at all; had diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3184), dose 3 via an unspecified route of administration, administered in Arm Left on 12Oct2021 11:00 AM (at the age of 62-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Historical vaccine included 1st dose of the Pfizer COVID vaccine in right arm was on 06Mar2021 09:30 AM with lot EN6206, the 2nd dose was in right arm on 26Mar2021 10:00 AM with lot ER8730, and flu shot on 04Oct2021. Medical history included ongoing chronic obstructive pulmonary disease Verbatim: COPD 10 years ago. There were no concomitant medications. On 12Oct2021 21:00 the patient experienced was just tired, the booster knocked her on her butt, her right arm where she had the booster hurt, had headache, chills, fever, couldn''t eat at all, had diarrhea. The outcome of event the booster knocked her on her butt, her right arm where she had the booster hurt, chills, fever, couldn''t eat at all, had diarrhea was recovering. The outcome of event tired, had headache was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased, Immunisation
Clinical narrative: all three doses of the Pfizer COVID 19 Vaccine; if the vaccine could lower your testosterone/He did experience this as a side effect/He notes them to not be "low low" but are a "little low."; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single  for COVID-19 immunisation and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient call to the facility and was very impatient and had all three doses of the Pfizer COVID 19 Vaccine. The patient wanted to know if the vaccine could lower your testosterone. On an unspecified date the patient experienced lower testosterone levels as a side effect. The patient questions if his lower testosterone levels could be because of the vaccine. The patient also stated that his son also experienced the same low testosterone and questions it possibly be due to them being out of shape or possibly not eating the right things. The patient stated that he was older, and he knows why the patient was lower. The patient had the 1st 2 shots and caught a mild case of COVID19 afterwards. The patient noted that COVID19 can lower testosterone and he is wondering if in the form of the medication to fight it off has the same stuff as COVID 19 to build immunity. The Patient stated that might lowers testosterone as COVID 19 can lower testosterone. On an unspecified date the patient underwent lab tests and procedures which included blood testosterone: little low and the patient noted the facility to not be low,low but are a little low. The clinical outcome of the events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: Severe joint pain stiffness swelling; Severe joint pain stiffness swelling; Severe joint pain stiffness swelling; This is a spontaneous report from a contactable other health care professional (patient). This is the first of two reports. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis from an unspecified date. The patient had no known allergies. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via intramuscular route of administration in left arm on 01Jul2021 at 10:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization at Hospital. Patient had not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date the patient experienced severe joint pain stiffness swelling. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe joint pain stiffness swelling included change of the medicine. The outcome of the events was not resolved at the time of the report.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity
Clinical narrative: Allergies; Asthma; This is a spontaneous report via contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was wondering if she could get the booster shot after getting the regular flu shot and what will be the interval of both shots. She also mentioned that she had asthma before and got shots for allergies on an unspecified date in 2021 but she was better now. She mentioned that her main concern was to know if she could get the booster shot since it will be 8 months in November since she had her Covid-19 Vaccine doses. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Rash
Clinical narrative: more fatigue; chills; fever; nausea; had a COVID rash on arm; This is a spontaneous report from a contactable consumer. A 32-year-old female consumer patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Apr2021 (age at vaccination: 32 years), as dose number unknown, single dose for COVID-19 immunization. The patient's medical history included glucose intolerance and patient's concurrent condition included multiple sclerosis, spasms, low vitamin D and B, nerve pain, depression, migraines, fatigue, allergies, osteochondritis, bronchitis, pneumonia, strep throat, were ongoing from an unknown date. Patient's concomitant medication included oxybutynin, baclofen, colecalciferol(VITAMIN D), duloxetine hydrochloride(CYMBALTA), pregalin(LYRICA), methylphenidate hydrochloride(RITALIN), loratadine(CLARITIN), magnesium(MAGNESIUM), B MULTIVITAMIN, calcium(CALCIUM), were for unknown indication from an unknown date. On Apr2021, the patient experienced more fatigue, chills, fever, nausea, and had a COVID rash on arm. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: HSV/Zoster with SARS-CoV-2 mRNA Pfizer BioNTech vaccine; This is a spontaneous report from a contactable other hcp. A female patient 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 as DOSE NUMBER UNKNOWN, SINGLE for COVD-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hsv/zoster with sars-cov-2 mrna biontech vaccine. Outcome of the event was unknown.  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 completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Immunisation, Pyrexia
Clinical narrative: patient received her booster dose of the Pfizer COVID 19 Vaccine; Chills; Fevers; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer or other non-health professional. A 26-years-old female patient received bnt162b2 (COMIRNATY Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on unspecified date as Dose Number Unknown (Booster), Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included, patient received COVID-19 Vaccine (Primary Immunization series complete but unknown manufacturer) via an unspecified route of administration on an unspecified date for covid-19 immunization. On 20Oct2021, the patient experienced chills, fevers, loss of taste and smell, on unspecified date, patient received her booster dose of the Pfizer COVID 19 Vaccine. Reported as the patient received her booster dose of the Pfizer COVID 19 Vaccine and she was now having symptoms that represent the "virus." She had chills with fevers and loss of taste and smell. Also stated that this was the "3rd" day of symptoms. Reporter was trying to understood why this would happen with the booster. She understood the "other things, with fevers and chills, but not understood" why the patient would loose taste and smell. The clinical outcome of events was not recovered at the time of this report.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: After the second dose of the Pfizer covid vaccine, the caller was chilled during the night and it was one night; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 28Mar2021 (age at vaccination 70-year-old) as DOSE 2, SINGLE for covid-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 07Mar2021 (age at vaccination 70-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension, glaucoma, basal cell carcinoma (The caller had surgery on this). Reason for non availability of lot number as the caller was not having her vaccination card. The patient was taking Pfizer covid vaccine for the protection. Concomitant medications included hydrochlorothiazide, timolol, paracetamol. On 28Mar2021 after the second dose of the pfizer covid vaccine the patient experienced chilled during the night and it was one night. The clinical outcome of the event was recovered on 28Mar2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: 2nd shot, severe pain that started in hips went to knee and remains in right knee; This is a spontaneous report from a contactable consumer (Patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 11Sep2021 at 10:00 (age at vaccination 55 years old as dose 2, single for COVID-19 immunization. Medical history included Sensitive to gluten and covid-19 from an unknown date. Concomitant medication included ascorbic acid, vitamin d nos and zinc. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: fa7485), via an unspecified route of administration, administered in Arm Right on 21Aug2021 as dose 1, single for COVID-19 immunization and reported adverse reaction as Fatigue, Diarrhoea, Nauseous, Headache and severe arm pain. On 11Sep2021, the patient experienced 2nd shot, severe pain that started in hips went to knee and remains in right knee. The outcome of event was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Poor quality product administered, Product storage error, Product temperature excursion issue, Pyrexia
Clinical narrative: Refrigerator storage temperature was too cold; Refrigerator storage temperature was too cold; Refrigerator storage temperature was too cold; Fever; This is a spontaneous report from a contactable consumer (the patient) via Medical information team.  A female patient of an unspecified age received bnt162b2 (solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose (solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. On 24Sep2021, the patient received vaccine which is of Refrigerator storage temperature was too cold. On an unspecified date on 2021, the patient experienced fever. The reporter had her 2nd Pfizer BTC Vaccine on 24Sep2021. She was informed by the pharmacy that she needed to be revaccinated with her 2nd Vaccine dose because the "refrigerator storage temperature was too cold." She was informed this occurred between the following dates, 24Sep2021 to 02Oct2021. The reporter stated that she had a fever following the 2nd dose of the Pfizer. The patient stated that she was told that she needed to get revaccinated because their storage for the vaccine got too cold in the refrigerator. It was reported as that she had questions to ask about temperature range and if she needed to get revaccinated based on the temperature excursion. The patient underwent lab tests and procedures which included antibody test: 2000 on positive. The outcome the event fever was unknown.  No follow up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia
Clinical narrative: This is a spontaneous report from a contactable. A 68-years-old non-pregnant female patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 68-year-old) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, osteopenia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. On 01Mar2021the patient experienced diminished taste. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Inflammation, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: sciatica; Severe low back pain; stiffness; sitting was very difficult and painful; Inflammation; pain; Booster; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received third dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FC2589), via intramuscular route, administered in arm left on 04Oct2021 at 13:00 (at the age of 69-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at pharmacy or drug store. The patient medical history included glaucoma. Other Medical history was reported as None. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 30Sep2021, dose 1 on 01Oct2021 in left arm, LATANOPROST for glaucoma. Historical vaccine included first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6206), via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (at the age of 68-year-old) as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in arm right on 01Apr2021 at 13:00 (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient had no known allergies. On 10Oct2021, the patient experienced sciatica, severe low back pain at 09:00, stiffness, sitting was very difficult and painful and inflammation and had pain. On 04Oct2021, patient reported immunization.  Relevant test done was reported as none. The patient reported that she woke up on 10Oct2021 with lower back pain and stiffness. she  tried streatching to relieve it. Sitting was very difficult and painful. she used turmeric/ginger capsules and occasionally tried Delta 9 cannabis (low the /high cbd) to relieve the pain and inflammation, which relieved it temporarily to some degree. she also tried taking ibuprofen (2 tablets every 4-6 hours) for 1 days. But it upset her stomach and was not very effective, so she  went back to just turmeric/ginger capsules and cannabis 2x day. Nothing resolved the issue. Adverse events (sciatica and severe back pain) required a visit to physician office. Therapeutic measures were taken as a result of the events which included chiropractic treatment. The outcome of the event (sciatica) was not recovered, and other events were recovered with sequel on 10Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sciatica
Clinical narrative: sciatica; Severe low back pain; stiffness; sitting was very difficult and painful; Inflammation; pain; Booster; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received third dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: FC2589), via intramuscular route, administered in arm left on 04Oct2021 at 13:00 (at the age of 69-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at pharmacy or drug store. The patient medical history included glaucoma. Other Medical history was reported as None. Concomitant medications included influenza vaccine (FLU VACCINE VII) on 30Sep2021, dose 1 on 01Oct2021 in left arm, LATANOPROST for glaucoma. Historical vaccine included first dose of bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6206), via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (at the age of 68-year-old) as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in arm right on 01Apr2021 at 13:00 (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient had no known allergies. On 10Oct2021, the patient experienced sciatica, severe low back pain at 09:00, stiffness, sitting was very difficult and painful and inflammation and had pain. On 04Oct2021, patient reported immunization.  Relevant test done was reported as none. The patient reported that she woke up on 10Oct2021 with lower back pain and stiffness. she  tried streatching to relieve it. Sitting was very difficult and painful. she used turmeric/ginger capsules and occasionally tried Delta 9 cannabis (low the /high cbd) to relieve the pain and inflammation, which relieved it temporarily to some degree. she also tried taking ibuprofen (2 tablets every 4-6 hours) for 1 days. But it upset her stomach and was not very effective, so she  went back to just turmeric/ginger capsules and cannabis 2x day. Nothing resolved the issue. Adverse events (sciatica and severe back pain) required a visit to physician office. Therapeutic measures were taken as a result of the events which included chiropractic treatment. The outcome of the event (sciatica) was not recovered, and other events were recovered with sequel on 10Nov2021.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Headache; chills; muscle and joint pain; muscle and joint pain; tiredness; Dose Number: 3; This is a spontaneous report from a contactable consumer (patient) for herself via an agency. A 74-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in left arm on 28Oct2021 14:30(at age of 74-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization in Doctor's office/urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies were tetracycline, most statins. The patient medical history and concomitant medications were not reported. On 19Feb2021 10:00 AM (at age of 73-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in right arm as dose 2, single for covid-19 immunization. On 29Jan2021 10:00 AM(at age of 73-year-old), the patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in right arm as dose 1, single for covid-19 immunization. The patient experienced headache, chills, muscle and joint pain, tiredness, all events started on 29Oct2021. The outcome of all the events were recovered in Oct2021 without treatment. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Headache; chills; muscle and joint pain; muscle and joint pain; tiredness; Dose Number: 3; This is a spontaneous report from a contactable consumer (patient) for herself via an agency. A 74-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in left arm on 28Oct2021 14:30(at age of 74-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization in Doctor's office/urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies were tetracycline, most statins. The patient medical history and concomitant medications were not reported. On 19Feb2021 10:00 AM (at age of 73-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in right arm as dose 2, single for covid-19 immunization. On 29Jan2021 10:00 AM(at age of 73-year-old), the patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in right arm as dose 1, single for covid-19 immunization. The patient experienced headache, chills, muscle and joint pain, tiredness, all events started on 29Oct2021. The outcome of all the events were recovered in Oct2021 without treatment. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain
Clinical narrative: third vaccine (booster); Headache; Mild body aches; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient previously received dose 1 and dose 2 bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Numbers: not reported), both 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. The patient experienced headache for 2-3 days post administration of third vaccine and mild body aches on an unspecified date. The outcome of headache was recovered, the outcome of mild body aches was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: She is 7 weeks pregnant; sore arm; swollen lymph nodes.; This is a spontaneous report from a contactable consumer or other non HCP. This consumer or other non HCP reported information for both mother and fetus/baby.    A 38-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation (age at the vaccination 38 years old). The mother reported she became pregnant while taking bnt162b2. She was 7 weeks pregnant. The patient medical history concomitant medications were not reported. The patient experienced sore arm, and swollen lymph nodes. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Muscle swelling, Pain, Paraesthesia
Clinical narrative: Severe pain in wrist / It felt broken; it still hurts in certain movements and is hard to hold or push things.; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; my muscle in my left shoulder blade are swollen.; I feel random pain at the injection site in my upper left arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 05May2021 (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history or known allergies. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06May2021 at 01:00 am, the patient experienced severe pain in wrist in the middle of the night after receiving vaccine. It felt broken. Although pain had dulled, it still hurts in certain movements and was hard to hold or push things. Her whole arm tingles as if a nerve was pinched. It was so uncomfortable, she did mention to a PCP who didn't do anything. The patient proceeded to see a chiropractor who noticed her muscle in her left shoulder blade were swollen. Even that day, 06Nov2021, the patient felt random pain at the injection site in her upper left arm. She has never had issues with her left arm or had anything ever similar happen. This all started in the middle of the night the night after the vaccine and hadn't gone away. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient went to the Chiropractor received treatment for the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test which included COVID-19 test (nasal swab): Negative on 14Sep2021. The device date was reported as 06Nov2021. The case was assessed as non-serious. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Severe pain in wrist / It felt broken; it still hurts in certain movements and is hard to hold or push things.; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; My whole arm tingles as if a nerve is pinched. It was so uncomfortable; my muscle in my left shoulder blade are swollen.; I feel random pain at the injection site in my upper left arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 34-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 05May2021 (age at vaccination was 34 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history or known allergies. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06May2021 at 01:00 am, the patient experienced severe pain in wrist in the middle of the night after receiving vaccine. It felt broken. Although pain had dulled, it still hurts in certain movements and was hard to hold or push things. Her whole arm tingles as if a nerve was pinched. It was so uncomfortable, she did mention to a PCP who didn't do anything. The patient proceeded to see a chiropractor who noticed her muscle in her left shoulder blade were swollen. Even that day, 06Nov2021, the patient felt random pain at the injection site in her upper left arm. She has never had issues with her left arm or had anything ever similar happen. This all started in the middle of the night the night after the vaccine and hadn't gone away. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient went to the Chiropractor received treatment for the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test which included COVID-19 test (nasal swab): Negative on 14Sep2021. The device date was reported as 06Nov2021. The case was assessed as non-serious. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Interchange of vaccine products, Lymph node pain, Off label use
Clinical narrative: Historical Vaccine: Dose Number: 1, 2: Moderna, Dose Number: 3: Pfizer; Historical Vaccine: Dose Number: 1, 2: Moderna, Dose Number: 3: Pfizer; Tremendous pain in lymph gland in L armpit/side breast area. Same side as injection site.; Tremendous pain in lymph gland in L armpit/side breast area. Same side as injection site.; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590), via an unspecified route of administration in the left arm on 04Nov2021 at 12:00 (at the age of 57-years-old) as DOSE 3 (BOOSTER), single dose for COVID-19 immunisation. Medical history included allergies to Compazine (prochlorperazine maleate) and amoxicillin. Concomitant medications included medroxyprogesterone, montelukast, cetirizine hydrochloride (ZYRTEC) and calcium taken for an unspecified indication, start and stop date were not reported. Patient received two historical doses of Moderna vaccines (Dose 1 on 06Jan2021, lot no.025J20-2A and dose 2 on 03Feb2021, lot no.043L20A) prior to the vaccine. On 05Nov2021 at 02:00 the patient experienced Axillary pain, Lymph node pain. On an unspecified date the patient experienced off label use and interchange of vaccine products. The outcome of the events Axillary pain, Lymph node pain was not recovered. The outcome of the events off label use and interchange of vaccine products was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature
Clinical narrative: Extreme fatigue; joint pain; headache; fever of 103.4; increased blood pressure (138x 89); vivid dreams; This is a spontaneous report from a contactable consumer or other non hcp.  A 43-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot Number: FF8841), dose 3 intramuscularly, administered in Arm Right on 03Nov2021 10:15 as dose 3 (booster), single for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 04Oct2021 to 04Oct2021; lisinopril (LISINOPRIL). The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, carbamazepine and experienced hypersensitivity. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, the patient experienced extreme fatigue, joint pain, headache, fever of 103.4, increased blood pressure, vivid dreams   on 03Nov2021 18:00 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 138x89 on 03Nov2021, body temperature: 103.4 on 03Nov2021.  Therapeutic measures were taken advil 600 mg as a result of extreme fatigue (fatigue), joint pain (arthralgia), headache (headache), fever of 103.4 (pyrexia), increased blood pressure (138x 89) (blood pressure increased),vivid dreams (abnormal dreams).Case was assessed as non-serious and patient was not hospitalized. Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Extreme fatigue; joint pain; headache; fever of 103.4; increased blood pressure (138x 89); vivid dreams; This is a spontaneous report from a contactable consumer or other non hcp.  A 43-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot Number: FF8841), dose 3 intramuscularly, administered in Arm Right on 03Nov2021 10:15 as dose 3 (booster), single for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 04Oct2021 to 04Oct2021; lisinopril (LISINOPRIL). The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, carbamazepine and experienced hypersensitivity. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, the patient experienced extreme fatigue, joint pain, headache, fever of 103.4, increased blood pressure, vivid dreams   on 03Nov2021 18:00 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 138x89 on 03Nov2021, body temperature: 103.4 on 03Nov2021.  Therapeutic measures were taken advil 600 mg as a result of extreme fatigue (fatigue), joint pain (arthralgia), headache (headache), fever of 103.4 (pyrexia), increased blood pressure (138x 89) (blood pressure increased),vivid dreams (abnormal dreams).Case was assessed as non-serious and patient was not hospitalized. Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Lymphadenopathy, Off label use, Vaccination site pain
Clinical narrative: Sore arm at the injection site; Lymph nodes to swell and became more tender and continuing to swell into her breast area; Her 1st and 2nd dose and she states that she didn't get Pfizer, she did Johnson and Johnson; Her 1st and 2nd dose and she states that she didn't get Pfizer, she did Johnson and Johnson; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) on 02Nov2021 via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included cancer patient with a double mastectomy. There were no concomitant medications. Prior to the vaccine patient received two historical doses of Johnson and Johnson vaccine. On 02Nov2021 patient experienced Interchange of vaccine products and off label use. On 03Nov2021 sore arm at the injection site and lymph nodes to swell and became more tender and continuing to swell into the breast area. Anti-inflammatory therapeutic measures were taken because of lymph nodes to swell and became more tender and continuing to swell into the breast area.The outcome of the events Interchange of vaccine products and off label use was unknown. The outcome of the events vaccination site pain and Lymphadenopathy was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Vision blurred
Clinical narrative: Blurry Vision; dose_number=1 Johnson Johnson/ dose_number=2 product=COVID 19, brand=Pfizer; dose_number=1 Johnson Johnson/ dose_number=2 product=COVID 19, brand=Pfizer; This is a spontaneous report from a non-contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) and First dose of janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced blurry vision, off label use and Interchange of vaccine products. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot number cannot be obtained.