chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 02-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1 , lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sore arm; slight fever in the evening (under 100 degrees); fatigue; headache.  Treated with an Aleve.
12x10 cm well circumscribed area of redness and tender induration, swelling of arm by 1 inch compared to left.
dizziness; vertigo; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (vertigo) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness) and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided).  Subsequently the patient experienced an unspecified adverse event.  At the time of this report, the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  Additional information has been requested.
CONVULSION; FEVER; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer via social media by company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose (1 total), start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 14-JUN-2021, the patient received second dose of covid-19 vaccine ad26.cov2.s vaccine (inappropriate schedule of vaccine administered), On 14-JUN-2021, the patient experienced convulsion after a couple of hours of getting the vaccine and was hospitalized.  On JUN-2021, the patient experienced fever, and was hospitalized (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of convulsion and inappropriate schedule of vaccine administered was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210634102-covid-19 vaccine ad26.cov2.s-convulsion. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210634102-covid-19 vaccine ad26.cov2.s-fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Pt had a red circle around the arm at injection site. Pt got a prescription for clindamycin from the MD. The circle was inflamed and enlarged another day, patient will start antibiotics today (4/14).
A report was received from a healthcare professional on 10/08/2003 concerning a 40 year old female vaccinee who experienced fever, chills and joint ache and developed an edematous rash following vaccination with 0.5ml Fluvirin vaccine on 10/06/2003. On 10/06/2003, the vaccinee was administered 0.5 ml Fluvirin vaccine in her deltoid muscle.  The vaccinee self-administered ibuprofen and her symptoms improved.  On the morning of 10/08/2003, approximiately 36 hours after Fluvirin administration, the vaccinee developed an edematous rash (not maculopapular) which appeared as patches on her trunk, shoulder and back.  The rash was not described as pruritic but is currently progressing and worsening. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/07/2003: Further information received from a healthcare professional on 11/07/2003 indicated that the vaccinee's rash was probably due to an allergy to neomycin.  The vaccinee also experienced myalgias within 12 hours of receiving Fluvirin.  The rash resolved within 48 hours and the fever and chills and the myalgias resolved following treatment with ibuprofen. No follow up pending, all information received.
Administered after temperature excursion; No additional AE reported; This spontaneous report was received from a vaccine coordinator and refers to a 15 patients of unknown age and gender. Information regarding the patients'  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028923 (x 1 dose) and S028926 (x 14 doses), expiration date 16-SEP-2021 for prophylaxis (dose, frequency and route of administration were not reported).    The improperly stored suspect vaccines experienced all a temperature of -14.6 degree Celcius (°C) for 6 minutes, -12.7°C  for 27 minutes, -3.5°C  for 48 minutes, -14°C  for 52 minutes and -14.6°C  for 5 minutes.  The call was made due to a digital data logger. No additional adverse effect reported.
Patient reports pain that radiates from her shoulder down her arm. She feels this when she reaches her arm behind her back (like when trying to zip her dress her undo her bra). She describes the pain a excruciating. She says pain is worsening not improving.
I had a chest x-ray and the doctor saw calcium around my heart chamber. He had me take a calcium score, it was high and he bad. I was sent to a cardiologist. He ordered a stress test and I have an Abnormal EKG and they now want catharize my heart. I go into that next week. I had no symptoms.
Dizziness, lightheaded, nausea, vomit, body ache, head ache, stomach ache, diarrhea
He died around 5 o clock; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Mar2021 13:00 at a single dose (lot number was reported as NEEU200, the reporter did not know if its 2 or Z) for COVID-19 immunization. Medical history allergic to Penicillin, has a long list of allergies, neck pain and sleep disorder (sleep aid). Concomitant medications included diphenhydramine hydrochloride (BENADRYL), clopidogrel bisulfate, calcitriol, melatonin (MELATONIN) taken for sleep aid, Phillips Laxative tablet Magnesium (not appropriately paraphrased and clarified, as reported), simvastatin, terazosin hydrochloride, tizanidine hydrochloride (TIZANIDINE HCL) for when he had the pain in neck (he didn't take that hardly ever), vitamin C [ascorbic acid] and Multivitamin one a day. On Friday 12Mar2021, the reporter and the patient went to get the Covid shot. Their appointment was at 12:30 but they were in line long time before they got the shot. They got the shot around 13:00 and then they have to wait 15 minutes before they could leave. They drove up, they were ready to shoot us with the needle and they asked the patient, asked was he allergic to anything and the reporter answered for him and said yes, Penicillin and other long list and then they gave him the shot. They never did go over his allergies. They got home about 13:30, so which would take us about that long to get home. The patient died around 5 o clock and the reporter didn't know if this was connected or not with his death. The patient died on 12Mar2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: This case of death was provided with minimal details and autopsy results not available. However, drug causality cannot be completely excluded for BNT162B2 injection, only due to plausible chronological relation. Otherwise, information received was so limited to prevent a thorough medical assessment for patient death. The impact of this report on the benefit/risk profile of the Pfizer drugs is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: He died around 5 o clock
7:30 laid down on changing table;shook all over;head, arms, leg shaking/thrashing 10-15 sec;screamed, calmed rt down;APAP given but had thrown up APAP;felt warm, not hot;11:30 g-mom holding pt; body shaking 10 sec;leg still shakes
Undereye swelling.  On the day of the vaccination, I only felt sore at the injection site (left arm).  The following morning, however, I awoke and noticed significant swelling in the undereye area.  I had some body aches and fatigue, but was able to run some errands and do some chores.  This morning, two days after the injection, my undereye area is still swollen, and possibly slightly more so, than yesterday.  My vision seems unaffected except possibly a very slight blurriness.  I have had no such side effect after the prior Covid vaccinations; I received all possible vaccinations including one prior bivalent booster, all by Moderna.  I plan to see my PCP today if possible. Please feel free to contact me by phone or by email if you have any questions.  Thank you.
Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subside after 30 minutes, but still lingering; symptoms lasted 1 day.
79-year-old male with history of Parkinson's disease who has become extremely weak since his second Covid vaccination 2 days prior to admission.  He has chronic gait instability from his Parkinson's and he had difficulties walking over the last couple days.  He slid from the couch onto the floor and was brought into the ECC for further evaluation.  He could have been down about 48 hours per his wife and daughter.  He injured his buttocks.  He has chronic peripheral edema and is not using his compression stockings because they are too difficult.  In the ECC, his temperature was 99.2.  He did fall to 89% on room air but improved with nasal cannula. Patient was treated for 4 days an
This spontaneous report as received from registered nurse refers to a 60 year old male patient with drug reaction/allergy to honey who was also a friend of the reporter. Pertinent medical history and concomitant medication were reported as none. On 09-NOV-2013, the patient was vaccinated with ZOSTAVAX vial (19400 PFU), in his deltoid muscle of the left arm by the intramuscular route. On 12-NOV-2013, the patient experienced knot and reddened area at the left arm, administration site. No treatment was given for events. Lab diagnostics studies performed were none. The outcome of events was reported as not resolved. Patient did not seek medical attention. Additional information has been requested.
No additional AE details are available.; a dose which expired on 6/10/2021 was administered to a patient on 6/17/2021; This spontaneous report has been received from an administrator referring to a 6 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 17-JUN-2021, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 mL, lot # S029542 has been verified to be a valid lot number, expiration date: 10-JUN-2021; strength and route were not provided) for prophylaxis (expired product administered). The reporter denied any temperature excursions for the product. No additional adverse event (AE) details are available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient's PCP called the pharmacy today to notify the patient experienced some swelling and a bruise around the injection site from the shots 1 month ago on 11/2/18.
Pt awoke approx 18 hours after vaccination with (R) upper arm (elbow to over shoulder area) red and hot. Pt did not complain to father other than pruritus. Was taken to ER 9/10/09 Rx KEFLEX - Dx Cellulitis.  9/14 Reported no reaction and child back to normal.
Vaccines were given in early afternoon. Redness and firmness began later that same day, and the following morning it was much more red and widespread to the Lt upper arm. Today 9/26/18 it was worse, warm to the touch indurated and tender. Had limited ability to fully abduct Lt. arm due to pain.
Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination (manufacturer unknown). Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refers to one of the 4 year old male patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine (manufacturer unknown), which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 76-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). Concomitant products included Aspirin, LIPITOR, NORVASC, vitamin D and AVAPRO. On 26th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, less than  day after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, lethargy, weakness and nausea. On an unknown date, the outcome of the muscle pain, weakness and nausea were recovered/resolved and the outcome of the influenza-like symptoms and lethargy were unknown. The reporter considered the muscle pain, influenza-like symptoms, lethargy, weakness and nausea to be probably related to SHINGRIX. Additional details were reported as follows: The patient received the injection at a pharmacy in left deltoid.
Little bit sick; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little bit sick) and VACCINATION SITE PAIN (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis since December 1994, Fibromyalgia since 2000 and Allergy to chemicals (Gadolinium). Concomitant products included DIMETHYL FUMARATE (TECFIDERA), PANTOPRAZOLE, AMANTADINE, CLONAZEPAM, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CYANOCOBALAMIN (B 12), VITAMIN B3 and VITAMIN D3 for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Little bit sick). an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION COMPLICATION (Little bit sick) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.            Treatment for the event included ice on arm. Action taken with mRNA-1273 in response to the events was not applicable.  The patient reported that she was not taking Amantadine a few days before the shot and stated that she should not have stopped the Amantadine at all.   This case was linked to MOD-2021-019087 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Added HCP contact information, patient demographics, start date of current medical condition, new concomitant drugs (Clonazapam, Protonix, Vitamin D3)
196 patients received 0.25mL of Moderna COVID-19; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
pt recvd vax 27JUL93-29JUL93 exhibited temp w/small clusters of what the pt mom described as hives; mom applied calamine lotion d/t extreme discomfort & itching;
Rolls over in bed it feels like he is going to pass out even though he is lying down; Sleep over a whole day, for more than 24 hours; Severe fatigue; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV infection.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down) (seriousness criterion medically significant), SOMNOLENCE (Sleep over a whole day, for more than 24 hours) and FATIGUE (Severe fatigue). At the time of the report, LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down), SOMNOLENCE (Sleep over a whole day, for more than 24 hours) and FATIGUE (Severe fatigue) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given Flu vaccine on 10/25/17. Presented to clinic on 10/26/17 with swelling, warmth and erythema, 7 x 6.5 cm. Had appointment for follow up today with Dr. and worsened to 11 x 10 cm.
This spontaneous report was received from a physician via Center regarding a baby of an unknown demographics. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, frequency, lot# and expiry date were not reported) route of administration was reported as unknown, for prophylaxis. On an unknown date, an office staff inadvertently administered an expired M-M-R II to the baby. The patient's relevant lab data was unknown. At the time of report (04-MAY-2018), it was unknown if the baby would continue to receive M-M-R II. It was reported that the baby was okay.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAY-2017 the patient was vaccinated with ROTATEQ lot # M040268 for prophylaxis. On 25-MAY-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937: US-009507513-1709USA001552: US-009507513-1709USA001553: US-009507513-1708USA003630.