chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of a swelling at the injection site in a 4 year old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 12/22/2004, the patient received the fifth dose of Infanrix in the arm.  The physician stated that during the administration of the fifth dose of Infanrix, the needle was not attached to the syringe properly and the dose squirted out.  On the same date, the nurse administered another dose of Infanrix properly.  The physician stated the patient may have received slightly more than 0.5ml of Infanrix, but no 1.0ml.  On 12/22/2004, the patient also received an injection of poliomyelitis virus vaccine in a different arm from the arm that was injected with Infanrix.  At an unknown time following the administration of Infanrix, on 12/22/2004, the patient experienced a local reaction at the injection site of the Infanrix injections manifested as swelling, redness, and itching.  The injection site reaction resolved on an unspecified date on or before 01/26/2005.  The reporting physician considered the events to be related to vaccination with Infanrix.
4/1/2022- Presents to ED, c/o SOB and productive cough, saw PCP yesterday  for suspicion of pneumonia (ordered Romycin and cefdinir), spoke to PCP today advised to go to ED.  Covid + test. CXR: bibasilar atelectasis . Afebrule and 92% on RA. CRP:2.5. Admit Covid 19.  Start IV ceftriaxone and doxycycline and home dose of Eliquis, given bebtelovimab infusion in ED. Held steroid due to pt not meeting protocol.  4/2/2022- Continue OBS stay, currently on 2L NC @ 93% sat. VSS . IV Decadron 4/3/2022- VSS. O2 maintained on RA at 94% on exertion, 97$ at rest. Changed to Po Decadron and doxy.  4/4/2022- VSS, improved. Discharge to home on PO doxy and decadron.
felt weak; COVID rash on her arm; was very tired; had a terrible headache; was nauseated; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache) and NAUSEA (was nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 0306Z0A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt). The patient was treated with PARACETAMOL (TYLENOL) in October 2021 for Headache, at an unspecified dose and frequency. On 20-Oct-2021, ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt) had resolved.            No concomitant medication information was provided.
After the vaccine I have been having trouble with my asthma. Every night I get asthma problems out of nowhere; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "After the vaccine I have been having trouble with my asthma. Every night I get asthma problems out of nowhere".  Additional information: The Seriousness criteria reported as NO included: results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Reason why batch/lot is Unknown: Unable to locate or read the details. The seriousness of the adverse events reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site pain with all three doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Feb2021 (Lot number: EL9269) at the age of 67 years as dose 1, single and administered in arm left, administration date 26Feb2021 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "injection site pain with all three doses".  Additional information: The patient has not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, and patient has not administered additional Vaccines on same date of the Pfizer suspect. Is report related to a study or programme- Yes.  No follow-up attempts are possible. No further information is expected.
Within 8 hours of receiving 2nd vaccine, Pt developed sudden & intense global muscle & joint pain, headache, chills, fatigue, swollen & painful glands (L chest wall, L neck, jawline). Pt self-medicated w/ alternating Tylenol & Ibuprofen about every  4 hours. Symptoms began to decrease/ subside 36 hours after onset.
10 weeks pregnant. Due date Oct 31st 2021.  Red circle at injection site. Approximately 1.5 inches and getting bigger. Hot to the touch.
hurt my shoulder,affected my shoulder; little bit of  headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 016MZ0A and 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache). The patient was treated with IBUPROFEN on 25-Jan-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (hurt my shoulder,affected my shoulder) and HEADACHE (little bit of  headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2022-461490 (Patient Link).
Patient reported significant pain that made it difficult for her to lift her arm to get dressed. She said she took hydrocodone, but that did not help with the pain. She said that at the time of the vaccine her elbow twitched/jerked, which made her think that a nerve was hit. She said that her pain is still excrutiating.
This spontaneous report as received from healthcare professional refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date in June 2013 the patient was vaccinated with the first dose of GARDASIL. On date of this report (reported as currently) the patient was in the office to receive her second dose. No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.
I started having sinus pressure and a sore throat. I just thought it was a sinus infection. I had a lot of congestion and runny nose. My lymph nodes were a little swollen, but not bad. This stated on March 1, 2022 and ended on March 4th, 2022. I ended up testing positive for COVID-19. I received the antibody treatment the next week.
Blurred vision, dizziness for several days.  Developed  Ringing of the ears and some chest pains. Vision disturbance and ear ring still present on this date Of report.
Stridor; Having a cough which was productive sometimes and very difficult to expectorate/ Coughed up a lot of green sputum; This is a spontaneous report from a contactable nurse (patient). A 71-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm right on 22Feb2021 16:00 (Batch/Lot number was not reported) (at the age of 71-years-old) as SINGLE for covid-19 immunization at pharmacy or drug store. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm left on 01Feb2021 16:00 (Batch/Lot number was not reported) (at the age of 71-years-old) as SINGLE for covid-19 immunization due to which patient developed bronchitis, low grade fever and fatigue. 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 vaccine. The patient did not have any allergies to medications, food, or other products. Patient Medical history included asthma from an unknown date and unknown if ongoing. Patient Concomitant medication(s) included amlodipine besilate (NORVASC); doxepin; omeprazole (PRILOSEC [OMEPRAZOLE]); formoterol fumarate, mometasone furoate (DULERA); montelukast sodium (SINGULAIR) all were taken for an unspecified indication, start and stop date were not reported for any. On 02Mar2021 at 17:00, the patient started having a cough which was productive sometimes and very difficult to expectorate, which started about 5pm and continued all evening. On 02Mar2021 at 23:00 to patient began having strider which continued until about 5am when the strider let up and was able to fall asleep. On 03Mar2021, When she awoke at 8am she coughed up a lot of green sputum but the strider was gone. She had just weaned off of a steroid taper about 4 days before this. The reporter considered the event as non-serious. Patient took nebulizer and sat in front of a cold mist as a treatment for the events. The outcome of event for stridor was recovered on 03Mar2021 at 05:00 am whereas for other event it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received on 14-JUL-2017 from a nurse who reported that an unspecified patient received a dose of GARDASIL 9 (lot#/expiration unspecified) on 29-JUN-2017 and a second dose of GARDASIL 9 (lot#/expiration unspecified) on 14-JUL-2017. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Right arm very sore; Overall aches/sore; Slight headache; Slight fatigue; Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IUD NOS; IVERMECTIN; NEXIUM 1-2-3; B12 [CYANOCOBALAMIN]; COLLAGEN; TURMERIC [CURCUMA LONGA]; OMEGA 100; ALLEGRA 12 HOUR. Vaccination history included: pfizer/biontech (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Right), administration date: 15Dec2021, for COVID-19 immunization; pfizer/biontech (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 30Mar2021, for COVID-19 immunization; pfizer/biontech (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 09Mar2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Overall aches/sore"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Right arm very sore"; FATIGUE (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight fatigue"; PYREXIA (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight fever"; HEADACHE (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight headache". Therapeutic measures were not taken as a result of pain in extremity, pain, headache, fatigue, pyrexia.  Additional information: Report was non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the following other medications within 2 weeks of vaccination: IUD, Ivermectin cream (rosacea), Nexium, Allegra, Probiotic, B12, Collagen, Turmeric, Omega. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Less than 5 minutes after receiving vaccines patient passed out on the bed, fell down from the bed to floor and became unconscious, stiff, fingers and hand turned outward, face turned white and blue, eyes rolled back, tongue was sticking out and she became completely soaked in urine. I (parent) screamed and called for help. Head was stuck under wooden board found at the bottom of examining table and her head had to be pulled out. About 5 minutes later came around, put hands on head, seemed unaware of what had occurred. Blood pressure was taken after that. She was observed and sent home. For next 2 days had headache and body was weak and sore.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 14th November 2018, the patient received SHINGRIX. On 15th November 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on left deltoid and experienced redness and swelling at the injection site the next day. On the day of reporting, the area of the redness and swelling is about 4 inches in diameter.
pt recv vax & devel chronic fatigue immune dysfunction synd;pt out of work x 5yr;pt was working full time a/the vax;  3/6/08 Reviewed outpatient clinic records of 8/2006-1/2008.  Clinic states only records available.  These records indicated chronic fatigue syndrome initially diagnosed 11/1991 s/p flu shot.  Moved to MH group home 4/2007.  Several ER visits for UTI & asthma. PMH: atopic dermatitis/ateatotic dermatitis; rosacea; skin tags; depression; chronic dysthymia disorder w/insomnia & anxiety; alcohol abuse; migraines; asthma; genital herpes; seasonal allergies; GERD; IBS; impaired fasting glucose;  family hx of diabetes; umbilical hernia repair w/mesh; obesity; uterine fibroids; pre-glaucoma;  ALLERGIES: PCN, sulfa, vaccines Per 60 day follow up: Residual symptoms are chronic fatigue, cognitive function problems, calculation difficulties, memory disturbance, spatial disorientation, frequently saying the wrong word, depression, insomnia, migrane, muscular weakness, severe allergies & asthma, joint pain, IBS, multiple sensitivities to chemicals, meds & food, recurring yeast bacterial infections. It is required by law that a doctor report vaccine reactions, did they? I have been son sick since Nov. 1991 that I have not even been able to get help and no money to get it. I have to live off of $356.00 a month. Are they going to help me.  Follow-up: I do not have the information you requested. I have not been able to work since the flu shot in November 91. (I think it was the day before Thanksgiving I can't think of anything more cruel than to not help someone after they have a reaction. I was to sick to do anything but go to doctors. 02/05/2010 Follow up: Fatigue, cognitive function problems and calculation difficultiesm memory problems, depression, anxiety, insomnia, can't work anymore, myalgic encephalomyelitis (chronic).
sore throat; eyes were crying; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
pt recv vax & devel a quick upward swelling of eyelashes, facial cyanosis & suddenly stopped crying;had blank stare & facial color started to return;started to cry;
5FEB97 went to ER w/t103;was told to give APAP q 4hr that pt was reacting to vax;started hallucinating later that day 7FEB97;returned to ER 4AM w/fever 103 again & hallucinating again;c/o burning in arms & legs;thought worms & snakes on her
Patient was outside with class peers and staff. While sitting and having snack, she was observed by her teacher to suddenly stop eating. Her head dropped forward with Left side of her mouth pulled downward and arm dropped to her lap. This lasted approximately 2-3 seconds. When patient "woke", she was agitated - crying but calmed after climbing into teacher's lap. Patient was taken to school nurse's office, and once she appeared to be back at baseline. I (Mom) was called. I picked patient up from school, called her neurologist, and made an appointment for her to be seen.
Very sore muscles especially shoulders and upper arms. Extreme fatigue.   Initial arm pain subsided after day 2. Progressively been getting worse.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 26Aug2023 to 01Sep2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from an office manager concerning an 87 year old male, with no drug reactions or allergies, who "5 - 6 years ago", was vaccinated with a first dose of PNEUMOVAX 23 (lot # and expire date unknown). On 19-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 665402/1339Y, expire date 22-MAY-2011), subcutaneously. Concomitant therapy included COUMADIN. Patient complained of a swollen and red arm after receiving second dose of PNEUMOVAX 23. There were not laboratory diagnostics studies performed. The patient sought medical attention by telephone. At the time of the report, the patient was recovering. This is one from several reports from the same source. Additional information is not expected.
Patient only  complains of a very sore arm.  During submission of vaccine it was discovered that the patient had already received a new Covid Booster 3 days prior.  When requesting a vaccine, she told the pharmacy clerk RSV but Moderna was written on the paper and it was not confirmed before administration.  Physician alerted of error.
Information has been received from a nurse practitioner concerning one of three girls in the same family who "a few months ago" in 2008, were vaccinated with GARDASIL.  Subsequently, the patient became lactose intolerant after receiving GARDASIL. It was not specified whether the patient sought medical attention.  The patient's lactose intolerance persisted.  Additional information has been requested.  This is one of several reports from the same source.
patient did that and was sick for a week; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown age who did that and was sick for a week (illness), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site.   On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient did that and was sick for a week (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
2/12/2021 @ 5:30 started to develop rapid heartbeat, high pulse of 175, called 911, transported to hospital, treated by shocking(incorrect term) kept overnight discharged 2/13 afternoon. Next incident was 2/15 @ 5:00am same series of events and is still currently at hospital still being treated as of 2/16/21 afternoon.
Pt experienced fever, sore arm 24 - 72 hours post vax. Pt seen in ER diagnosed with cellulitis. Pt given IV and PO antibiotics.
This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September of 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified0 at a clinic associated with a hospital. No adverse event was reported. This is one of three reports from the same source. Additional information has been requested.