chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received call from pt. she had a PREVNAR13 and Flu shot this AM and she's having trouble breathing, it feels very heavy and she has a very rapid heartbeat. I advised pt call 911 and get to the ER pt's granddaughter was with her and pt said she would have her take her to the ER.
After first vaccine only soreness in arm.  After second vaccine the following day: muscle soreness, headache, fatigue, tinnitus.  Second vaccine was received on 3/22/2021.  The muscle soreness, headache, and fatigue were gone in about 24 hours but of concern is that the tinnitus is still present--and I certainly hope this is temporary as I hate the thought of having to learn to live with this.  My understanding is there is little that can be done for tinnitus.
This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Received First Dose Heplisav-B, and Received Second Dose Engerix; Initial report received on 17-Aug-2023  A pharmacist in the reported that a 22-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization for the first dose and ENGERIX as the second dose.  No relevant medical history or concomitant medications at the time of vaccination were reported. The patient had no known allergies.  On 28-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot # 941055, expiration date 29 Nov-2024, NDC # 43528-003-05; route and injection site not reported).   On 30-May-2023, 33 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX (no details provided) as the second dose. No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.   ?; Sender's Comments: The company assessed the event as non-serious.   ?
an improperly stored dose of Pedvax was administered to the patient; no adverse effects; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions or allergies, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (strength, dose, route of administration, anatomical injection site were not disclosed), lot # N024570 and expiration date 01-MAY-2020.  It was reported that this vaccine had been on a temperature excursion and was stored below 36 °F (32.1 °F) during 8 hours; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
This spontaneous report was received from a consumer as part of the Market Research Program conducted by Research Group referring to an about 60 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unknown day in 2016, the patient received a shot of ZOSTAVAX injection for shingles. (Strength, dose, route, lot number and expiration date were not provided). The reporter stated that she sat next to a women who told her that "2-3 days" after getting the shot (reported as sometime in June/ July 2016) her arm got swollen and turned red. Also mentioned it really hurt and had to put ice on it. The patient said she went back to her doctor and doctor said it was one of the side effects she could get with this vaccine. Back on an unspecified date in 2016, the reporter saw this woman again and by then her arm was getting better (was a little swollen and her skin was pink), so believe it was starting to resolve them, but not sure if the events was completely resolved; however the outcome of arm redness was unknown. The reporter relate the events with ZOSTAVAX. Additional information is not expected as there was no contact details provided.
Muscle aches throughout body, chills, nausea, vomiting. Muscle aches and chills worse the day after, almost completely gone day after that. Threw up around 7 hours after the vaccine. Only slight nausea after that.
Headache; injection site pain; nausea; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch no: not reported/Lot Number: EL9261; expiration date: unknown) via unspecified route of administration administered in left arm on 13Feb2021 03:45 PM (at the age of 52-year-old) as Dose 1, Single for covid-19 immunization. The patient medical history was reported as none, and patient received no other concomitant medications in two weeks. Patient had no known allergies. The patient did not take other vaccinations within 4 weeks and other medications within 2 weeks, prior to vaccination. Patient wasn't tested for COVID-19 prior to vaccination and not tested post vaccination. On 13Feb2021 at 09:00 PM, the patient experienced headache, injection site pain, nausea and fatigue. No treatment was received in response to events. The outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
Dtap administered in Right Deltoid IM on 4/15/2011, patient presented with redness, swelling, and pain at vaccine site on 4/17/11.  Treated with Antibiotic due to dx of cellultis.
States she is hypersensitive to any medications- every over the counter. After received MMR, joints felt achy, not clear headed, ran fever that night. Symptoms are relieved by Advil but came back. States bones ache, cold sweats and chills off and on. TC 11/12/08-no more achiness but broke out in measles like rash on torso-front and back no itching.
PATIENT RECEIVED A JANSSEN COVID-19 VACCINE PAST EXPIRATION DATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 212A21A, and expiry: 21-DEC-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced patient received a janssen covid-19 vaccine past expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received a janssen covid-19 vaccine past expiration date was not reported. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to three unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications were not reported. On an unknown date these three patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route of administration, lot number were not reported). No adverse events were noted. Additional information has been requested.
staff member misinterpret expiration date on Tenivac it's listed as 24Jun23 staff member thought means June 23, 2024; vaccine was administered to a patient with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 70 years old male patient who was administered expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Aug-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (batch number: U7092AA; expiry date: 24-Jun-2023) via intramuscular route in the left deltoid for Immunization (as the staff member misinterpret expiration date on tenivac it's listed as 24jun23 staff member thought means june 23, 2024) with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event staff member misinterpret expiration date on tenivac it's listed as 24jun23 staff member thought means june 23, 2024; vaccine was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
20 year old patient was administered Vaxelis instead of TD; 20 year old patient was administered Vaxelis instead of TD; This non-serious spontaneous safety report, with case number 2023SA085919/01534523, was received by partner on 15-MAR-2023 on 16-MAR-2023 from a physician.  Due to the nature of the event the causal relationship between Vaxelis and the reported event "20-year-old patient was administered Vaxelis instead of TD" was assessed as not applicable.  Case was considered off-label use due to Vaxelis being administered to a 20-year-old patient.  Further information is expected.
Information has been received from a registered nurse concerning a 6 months old patient who was intended to receive RECOMBIVAX HB and instead on 16-APR-2009 was inadvertently vaccinated IM with a 0.5 mL dose of VAQTA. The nurse stated that this was due to a human error and not to product confusion. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning "some of her patients" who on unspecified dates were vaccinated with ROTATEQ (human-bovine). Subsequently, the patients developed diarrhea after receiving the vaccination. At the time of the report, the patient's status were unknown. There was no product quality complaint involved. Follow-up information received from a registered nurse indicated that there was only one male patient that had diarrhea after receiving ROTATEQ (human-bovine). It was noted that the diarrhea was not related to the vaccine, but to the formula the patient was given. Additional information has been requested.
Right after vaccine I felt tingly in neck and started sweating and then I was shaking and slumped forward in chair, at this point I didn't know where I was (thought I was dreaming) couldn't see or hear but felt my arms moving. Then I could see and hear and sat upright realizing where I was. I felt nauseous and strange and continued to be very clammy. I was given cranberry juice and watched for 30 mins. Felt much better. Husband drove me home and took my blood pressure which was first 70/50 did again 76/52.  I layer down and retook about an hour later 89/59.  no more adverse effects other than sore arm. Today Feb 25th feel fine, little tired, sore arm.
No adverse events reported.  Pt received the 2 dose Moderna series in May and June of 2021. On September 29th, patient signed up online for Pfizer. Insurance and computer system did not flag the pfizer vaccination and patient did not mention they received moderna in the previous months. Patient was not given another dose of pfizer and told not to go to another pharmacy when pt questioned why they couldn't get both.
Reports pain in her left arm after injection. Inability to lift arm and pain that keeps her up at night. No bruising, edema or palpated lumps on exam. Positive radial pulses. Able to freely move fingers. Only able to raise arm by lifting with other arm she states.
Off-label use; Booster; Product use for unapproved combination; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; I am experiencing swelling and pain/tenderness at my armpit/breast; Lymph node swelling; I am experiencing swelling and pain/tenderness at my armpit/breast; This is a spontaneous report from a contactable consumer (patient).  A 34-years-old non pregnant female patient received third (Booster), dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 30155BA and expiry date was not reported), via intramuscularly, in Arm Left on 30Sep2021 at 11:30 AM (At the age of 34-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and influenza vaccine (FLU VACCINE VII, lot number was not reported), via an unspecified route of administration in right arm, on 30Sep2021, at DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history included known allergy: Nons from an unknown date and unknown if ongoing Known. Patient was not pregnant at the time of vaccination Concomitant medications included levothyroxine and birth control taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient was not diagnosed with COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0142 and expiry date was not reported), via intramuscularly, in Arm Left on 05Jan2021 at 05:30 PM, as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via intramuscularly, in Arm Left on 28Jan2021 at 05:30 PM, as dose 2, single for covid-19 immunisation. It was reported that patient had booster dose (off label use) and product use for unapproved combination (product use issue) on an unspecified date. It was reported that less than 48 hours of Pfizer booster on 02Oct2021 05:30 patient experiencing swelling and pain/tenderness at my armpit/breast on the side the vaccine was administered. Lymph node swelling. No Prolonged Hospitalization for events. It was unknown whether the patient receive any treatment for the events. The events were assessed as Non serious by reporter. The Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
At Hepatitis A Outreach, box of Hepatitis A vaccine in cooler was pediatric instead of adult formulation. Pediatric dose given instead of adult. Patient discharged 11/2/2018.
Rash (horseshoe) appeared near, not on, the injection site  about a week after the vaccine. Still present a week later but less itchy and starting to fade.
Rash on bilateral wrists (pinpoint erythematous papules) and itching on face, wrists, scalp.  No urticaria.
Pt developed zoster rash within 24hrs of receiving vaccine. Pt was seen in office 6/15/09 and started on Famciclovir and Prednisone.
This case was reported by a healthcare professional via GSK sales representative and described the occurrence of vomiting in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date in 2010 the subject received 2nd dose of ROTARIX (oral). On an unspecified date in 2010, 12 hours after vaccination with ROTARIX, the subject experienced severe rotavirus type symptoms of diarrhea and vomiting. The sales representative reports the 4-month-old subject received his second dose of ROTARIX and 12 hours hours later had severe rotavirus type symptoms of diarrhea and vomiting. "Few details were known at the time of the report. The exact date of the vaccination was unknown, but was implied to be within the last couple days" of this report. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the rotavirus diarrhea and vomiting was unspecified. The healthcare professional considered the events were possibly related to vaccination with ROTARIX.
Pt received dose of pneumovax 23 prior to prevnar 13 after being 65 years of age
Vaccine failure. Pt vaccinated 9-6-11 with VARIVAX. Came to clinic 11-22-11, diagnosed with chicken pox. He presented with diffuse crops of blanching erythematous papulo/vesicles on back, neck, trunk, arms & legs. Crops on elbows.
Severe muscle pain at injection site, radiating down arm (severity of 7 on 0-10 pain scale) which interfered with activities and sleep. Treated with ibuprofen, ice, heat, and a topical analgesic. This brought pain down to a 2 on 0-10 scale. Severe pain subsided approximately 27 hours later, though very mild pain remains.  Severe fatigue present approximately 48 hours after receiving the vaccine.
Took the shot and three months later I got shingles/ suspected vaccination failure; got shingles on right side of my face and it effected my eye; got shingles on right side of my face; painful; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, took the shot and three months later got shingles on right side of face and it effected eye, very painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Information has been received from a registered nurse concerning a 25 year old male with cystic fibrosis and a history of renal transplant and 2 or 3 shoulder muscle removal surgeries who was vaccinated with a dose of PNEUMOVAX (lot # 662662/0979X), intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). Five days after the vaccination date the patient experienced necrotizing fasciitis. The patient complained of pain at the injection site on his left deltoid. The patient was hospitalized for necrotizing fasciitis and pain at the injection site. He had been in the hospital for 3 weeks. The patient received 2 or 3 surgeries to remove the muscles on his shoulder. The reporter requested a lot check. The patient sought medical attention, he was in the hospital. The patient had not recovered. A lot check has been initiated. Necrotizing fasciitis was considered to be immediately life-threatening, an other important medical event and disabling. Additional information has been requested.
FEVER; slight headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix. On the day of reporting,  the patient experienced fever and slight headache. The patient asked anything to do.
I was very sick and I could not even go to work; I was very sick and I could not even go to work; I was very sick and I could not even go to work; Shivering; Shaking; Having body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: MALAISE (non-serious), ILLNESS (non-serious), IMPAIRED WORK ABILITY (non-serious) all with onset May2021, outcome "unknown" and all described as "I was very sick and I could not even go to work"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Shivering"; TREMOR (non-serious) with onset May2021, outcome "unknown", described as "Shaking"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Having body ache". The events "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "i was very sick and i could not even go to work", "shivering", "shaking" and "having body ache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, illness, impaired work ability, chills, tremor, pain.  Additional information: Reported that, Patient (Pt) took Pfizer shot on 06May2021 (also reported as 05May2021), that Monday could not even go to work because she was very sick. Pt was shaking and shivering and had body ache. Event stat date was reported as Pt had it like a day or a two. Pt was very sick today (at the time of report) and went to the doctor, and doctor told Pt can take Tylenol. Pt did not take anything other than some Tylenol. Patient was getting next one (second shot) on 29May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am seeing swelling in left lymph gland- near the collar bone; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 22Apr2021 09:00 (at the age of 30-year-old) as 2nd dose, single for COVID-19 immunization.  The patient medical history was not reported. The patient had no known allergies. Concomitant medication included paracetamol. The patient previously received the first dose of BNT162B2 (Lot Number: ER8737), administered in right arm on 31Mar2021 15:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was seeing swelling in left lymph gland- near the collar bone on 09May2021 19:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included an antibiotic that was prescribed by doctor, Cefdinir 300mg. The outcome of the event was not recovered.
After receiving a flu shot, patient fainted twice within a couple seconds. Paramedics came and took her blood pressure and gave her oxygen and fluids.