chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient experienced dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included drug allergy (allergic to Compazine).   On 06-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). In SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: the patient experienced dizziness).  The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-SEP-2023 The reporter was the spouse of the patient.  The patient was administered the vaccine at a local pharmacy.  After an hour of administering the vaccine, the patient experienced dizziness. Reporter stated that it had not resolved almost a week after.  Lot and expiration date of the vaccine were unknown. The reporter was a retired physician assistant and states that patient could not receive medication for dizziness ( Meclizine or Dramamine) because patient was allergic to Compazine.  The reporter provided consent to follow up with health care professional (HCP).
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001918: US-009507513-1709USA001919.
Client  presented to receive Pfizer Dose 1 Lot#FJ6369. At approximately 1440 Client was in observation area when she alerted LPN that she felt itchiness in both eyes. RN was informed, and client stated she also had a headache. Client was AAOx3. Client denied trouble swallowing or shortness of breath. Client denied dizziness. Client was given 50mg Oral Benadryl. Vitals taken . Client stated her left arm was feeling itchy and felt chest tightness. EMS was activated .  Client stated the headache and itchy eyes had gone away, but arm was still itchy. Client stated she has allergies to medications but didn?t disclose which ones. Client has high blood pressure and has an arrhythmia.  EMS arrived and assumed care.
patient experience a seizure; This spontaneous report was received from registered nurse and refers to a pediatric patient of an unknown gender and age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experience a seizure. At the time of reporting, the outcome of the event was not known.   The causal relationship between the seizure and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Upon internal review, the event of seizure was determined to be medically significant.
Patient reported cellulitis after co-administration of Pneumovax-23 and Fluvirin '15-'16.  She had to go to urgent care to obtain antibiotics and is fine now.
Just a sudden onset of pain and tenderness  in the area shot was administered 11 days after receiving 2nd dose,  like receiving a shot all over again but the pain is more pronounced and lingering.  No treatment as of right now just a dull pain that?s lasted 2 days so far.
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 68-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN, in Dec1995. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "not recovered" and all described as "Treatment of covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Chest pain, troponin I elevation to 40.15, with diffuse ST-elevations on ECG. The patient was vaccinated on 5/29, developed chest pain on 5/30 and presented to our hospital on 6/1.
hives on back, neck, face, and shoulders. Very itchy scalp. Developed 10 days after moderna booster shot. Hot ears to the touch and very red. Sore behind ears from itchy/rash. Anywhere you put contact would results in a line of raised hives/rashes. Benadryl works to resolve hives and rash, but reoccur when Benadryl wears off.  Woke up sunday morning 12/19/2021 with left side of my face swollen.
10 minutes after receiving vaccine pt. c/o severe itching on face and neck.  No hives, shortness of breath or distress noted.  Pt. declined to take Benadryl or Epinephrine - requested to go to hospital for evaluation.
A non-serious report of expired FluMist administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FluMist vaccine.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessment are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered.  Information on the lot/batch number has been requested.
swelling around the injection site; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and VACCINATION SITE SWELLING (swelling around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling around the injection site). At the time of the report, HEADACHE (headache), CHILLS (chills) and VACCINATION SITE SWELLING (swelling around the injection site) outcome was unknown.            The action taken with the event, headache, chills, swelling around the injection site was not applicable. No concomitant medications reported. No treatment reported.
ACHE; SORE; GROGGY; TIRED; OCCASIONAL NAUSEA; This spontaneous report received from a patient concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced ache. On 13-APR-2021, the subject experienced sore. On 13-APR-2021, the subject experienced groggy. On 13-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced occasional nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache, sore, tired, groggy, and occasional nausea. This report was non-serious.
COVID booster vaccine; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; pain and swelling in her fingers, wrists and legs; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (AE00540121).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster vaccine"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain and swelling in her fingers, wrists and legs".  Additional information: Patient missed 5 days of her dose 04Dec2021-08Dec2021. Recommendation of missing her dose of Xeljanz was made by her physician because patient received COVID booster vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
About 12 hours after vaccine I experienced extreme joint and muscle pain and fever. Rash developed on my arm about 32 hours after vaccination
Severe chills/shakes; tremors; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9266), via an unspecified route of administration into the left arm on 16Feb2021, at 14:30 as single dose for covid-19 immunization.  Medical history included pacemaker since an unknown date, stent from an unknown date.  Concomitant medication included rosuvastatin calcium (CRETOR), metoprolol (METOPROLOL).  The patient previously received the first dose of BNT162B2 (Lot number EL9262)on 26Jan2021 for covid-19 immunization. The patient experienced severe chills/shakes on 17Feb2021, at 09:00 with outcome of recovered in Feb2021; tremors on 17Feb2021, at 09:00 with outcome of recovered in Feb2021; body aches on 17Feb2021, at  09:00 with outcome of recovered in Feb2021; soreness at injection site in Feb2021 with outcome of recovered in Feb2021.  No treatments were given for the events. The patient recovered from all of the events in Feb2021.   No follow-up attempts are possible. No further information is expected.
C/o fever, chills, joint pain, and severe leg cramps on Friday night.  Approx. 12 hr. after receiving TDAP shot.  This gradually lessened to fatigue and an itchy red hot area @ insertion site.  Stated all signs/symptoms resolved by Monday 8/31/09.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 05:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
when the person administered the vaccine there was liquid leakage on my shoulder/have an uneasy feeling about whether I have the full dosage/undervaccinated; when the person administered the vaccine there was liquid leakage on my shoulder/have an uneasy feeling about whether I have the full dosage/undervaccinated; A spontaneous report was received from a consumer who was a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced liquid leakage on the shoulder (vaccine underdose) and device connection issue.   No past medical history nor concomitant medications were reported.   On 28 Jan 2021 the patient received their first scheduled dose of the Moderna vaccine (LOT: 004M20A).  On 24 Feb 2021, the patient received their second dose of the Moderna vaccine.  He reported that when the person administered the second vaccine, there was liquid leakage on his shoulder.  He stated that it took two separate wipes to dry his shoulder and that the line was long and he felt pressured to move on.  He reported that he had an uneasy feeling about whether or not he received the full dose.   No treatment information was reported.   The patient received both scheduled doses of the vaccine, therefore, action taken with the drug in response to the events was not applicable.   At the time of this report, the outcome of the events, liquid leakage on the shoulder and device connection issue, were considered recovered/resolved.; Reporter's Comments: This case concerns a 67-year-old male patient who received their second of two planned doses of mRNA-1273 (Lot # 004M20A), reporting (device connection issue and underdose) without any associated adverse events. The event occurred the same day as vaccine administration. Events considered resolved.
black spots on his skin; His anxiety is so severe; rash all over his arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms). At the time of the report, RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   This case was linked to MOD-2021-073191, MOD-2021-074893, MOD-2021-223506 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up 01-SEP-2021,  contain no new information.
Rapid heart rate of 140 BPM for an hour while I was sitting and watching TV!  It took almost 3 hours to get back to my normal 63 BPM.
Chest pain and diffuse, severe myalgias, as well as persistent tachycardia to 110's and hypertension resulting in ER evaluation. No abnormalities found on basic labs and studies. Symptoms started one hour after injection and worsened over the next 24 hours.
Patient became dizzy, diaphoretic, blurred vision and hypotensive within minutes of vaccine.
a green circle appeared on her forearm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a green circle appeared on her forearm) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (a green circle appeared on her forearm). At the time of the report, SKIN DISCOLOURATION (a green circle appeared on her forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
little soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on the arm of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on the arm of the injection). At the time of the report, VACCINATION SITE PAIN (little soreness on the arm of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication information was reported. No treatment medications were provided.  The event subsided in less than 24 hours. The second dose has scheduled on 28-AUG-2021.   This case was linked to MOD-2021-274563 (Patient Link).
Immediately after receiving the vaccine there was swelling at the injection site.  After a few minute the swelling had gone down at the immediate injection site, but the entire deltoid area appeared inflamed.  Advised patient to apply ice.  If the the area got worse or didn't improve after an hour, I advised them to contact their physician.  The patient's wife called at 9:45 pm and said that the patient felt fine, but the area was still swollen.  The patient didn't have any shortness of breath.  She said that she talked to some nurses at the Emergency Room where she worked for advise.
Information has been received from a father concerning his 8 year old son with an excessive amount of aluminum in his blood who was vaccinated with a dose of varicella virus vaccine live. The patient's father reported that his son was diagnosed with autism as he went from talking to no talking for no specific reason. Unspecified medical attention was sought and at the time of this report the outcome was unknown. The father also reported that his 12 year old son was also diagnosed with autism after being vaccinated with varicella virus vaccine live (WAES0502USA02642). Upon internal review, autism was considered to be an other important medical event (OMIC). No further information is available.
Very sore arm; nausea; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6203), as single dose, for COVID-19 immunisation. The patient's medical history was none. Patient had no known allergies. Patient did not have COVID-19 prior to vaccination. Concomitant medications included loratadine (unknown manufacturer), vitamin d3 (unknown manufacturer) and men multivitamin 1x/day. The patient experienced very sore arm (non-serious) in Feb2021 at 12:00 PM with outcome of unknown and nausea (non-serious) in Feb2021 at 12:00 PM with outcome of unknown. Patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Memory changes, cognitive decline. Personality changes Progressive aphasia Patient/wife feel the above started shortly after the patient was vaccinated for COVID.
pt recv vax 17JAn97 & 29JAN97 pt devel greater than 100 bumps on trunk & a fever of 100-103;the bumps were not scabbed or blistered;MD impression was probably viral exanthema;
Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment.  Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness.  Received Doppler scan, X-rays,  and MRI with no know problems seen.  Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
One day post vaccine 3 inch by 1 in red, swollen itchy skin lesion at site of injection
Pain and discomfort at the injection site immediately. That evening temperature was 100.3. Did not sleep well. Next morning noted redness, swelling and induration moving down her arm.
Subsequent to receiving vax, mom states that pt cried painful cry inconsolably  for over 3 hours. Pt was given Tylenol  prior to and every 4 hours without relief. No temperature taken however, mom states that pt was warm to the touch. Referred to PCP.
On 04/28/2023 patient came into urgent care for a right thumb laceration at 12pm. Writer administered TDAP vaccination at approximately 1:45 pm  instead of ordered TD vaccination. Patient did not have any abnormal signs or symptoms at time  after vaccine was administered.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 48 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FD0809) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 15Dec2022 to 19Dec2022.