chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Pharmacy Intern). This case involves a 21 years old male patient who was vaccinated with a first dose of IMOVAX RABIES](site of administration: intramuscular, batch number, expiration date and route was not reported) on 11-Nov-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IMMUNOGLOBULINS. It was an actual medication error due to expired vaccine used. The consumer received an expired dose of IMOVAX. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
The patient has reported to the pharmacy with the adverse event almost a month after the injection. I asked how long this has been going on and she had stated a week. I mentioned that muscle soreness is common after injections. She then told me it had been going on for some time. I asked her more than one week and she said a couple. I asked if she had it with us and looked up the date. She did not report the soreness radiating or all over. She stated it was getting worse. I asked if she could point to where it hurt on her arm or shoulder. She pointed to her arm about 3-4 inches below the top of the shoulder. I asked if her shoulder hurt at all and she stated no. She did mention that her arm didn't hurt at rest, but when she picked it up. I instructed her to follow up with her doctor. I also instructed her to ice it and to take an OTC pain reliever.
Patient had no known reaction. Patient was given a vaccine that had exp date of 12/30/2069 which was a place holder date. Vaccine was expired.
my mother got it every year and was sick for a week afterwards; Initial information received on 31-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) .  This case involved a female patient of an unknown age who got it every year and was sick for a week afterwards (Influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that patient got it every year and was sick for a week afterwards (Illness). No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of illness was unknown.  There will be no information available on the batch number for this case.
Initial and follow up information has been received from an office manager for the physician and a physician concerning a 70 year old female with no known adverse drug reactions, no known allergies and no pertinent medical history reported. On 7/18/05 the patient was vaccianted with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 650327/0792P. There were no concomitant medications reported. The same day, following vaccination, the patient developed pain and redness at the injection site, was warm to touch at injection site and had difficulty moving her arm. The patient sought unspecified medical attention. The office manager reported that she believed the patient had recovered from the events date unknown. The physician reported a concern regarding the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional follow up information has been received concerning the retired female patient, who on the morning of 7/18/05 received her second dose of Pneumococcal 23v polysaccharide vaccine into her left arm. It was reported that on the same day she developed pain and redness at injection site, warm to touch hurts to move up an down. The patient recovered on an unknown date. Additional information is not expected.
Patient became nauseated, feverish, severe heartburn which has remained 15+  hours later.
I had my vaccination on 09/07/2023. I started to experience 03/05/2023 unusual fatigue and cough. On 03/06/2023 I had congestion runny nose headache fatigue and cough. I tested COVID-19 Positive on 03/06/2023. I contacted my physicians office on 03/06/2023 and I was sent to the emergency room as I had trouble breathing. I was diagnosed with asthma. I was prescribed steroids and sent home for rest. I still feel lingering symptoms on 03/14/2023.
broke out in hives 24 hours later; This is a spontaneous report from a contactable physician. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for immunization and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date (lot number was not reported) dose 2, single for immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of Menactra and the first dose of Trumenba on the same visit and the patient broke out in hives 24 hours later. The patient took Benadryl for hives and no breathing problems was reported. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-AUG-2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Given immunizations for influenza and pneumonia vaccination due to prior history of asthma.  Following day developed redness at the right shoulder at the site of one injection and fevers to 102.  Has had persistent fevers for the last couple of days with 101-102 and tenderness at the site along with increasing redness.  Patient also has a history of dry sockets.  He had dental work done the previous week and was having pain so went in on Tuesday and saw his dentist.  Noted to have dry sockets but no evidence of infection.  He was not started on antibiotics.  He reports that he has also had had nightmares associated with anxiety coinciding with the illness.  He also started taking clonazepam and wondering if that could be associated.  Review of the medication shows that it has been associated with nightmares in the past. Bactrim Ds 800-160 Mg Tabs (Sulfamethoxazole-trimethoprim) .... Take one tab bid for skin infection.   Vicodin 5-500 Mg Tabs (Hydrocodone-acetaminophen) .... Take one tablet by mouth every four hours as needed for pain.
Delayed onset of mild pain, swelling, erythema, paroxysmal moderate to intense pruritus.
raised swollen rash on same arm (left) near vaccination site. detected 2/19/21 still occuring benign vertigo: detected  2/20/21 still occiring
Patient received his second dose of Pfizer Vaccine, Lot number, EW0179 at about 10:05. At approximately 1030 the patient developed a small hive on his left upper arm without any congruent signs or symptoms. Patient brought back to the observation unit. VS stable,    10:33 BP= 125/85 O2= 100% 97.9F R= 12 Temp= 98.9 F   Lung sounds clear, no stridor indicated.    Dr. Notified. Verbal order for 25 mg of Benadryl obtained and administered at 1040.    10:55 VS remain stable 110/67 100% on RA 95= pulse 99.3 F Resp=14   Patient denies any further symptoms Hives are dissipating. Lung sounds remain clear.    11:10 BP= 108/63 HR=97 O2=99% Resp=14 Temp= 99F   Dr. updated. Requests for patient to be observed another 30 minutes.    11:40 Follow up VS stable  BP 101/70 O2= 99% P=90 Temp = 99.1F   Followed up with Dr. who cleared the patient to go home. Advised the parents to bring the patient to the ER if the patient develops any further allergic or anaphylactic symptoms. They verbalized understanding.
had to treat him with an ammonia thing to wake him up; could not see/lost vision at one time immediately afterwards; vision got all spotty; pupils got bigger than normal; Blue lips; white face; blood pressure really dropped; felt cold; This is a spontaneous report from a contactable consumer (father) reported for a son. A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm in muscle on 07May2021 17:00 (Batch/Lot number was not reported) at age of 19-year-old as single dose for covid-19 immunisation. There was no medical history.   No family medical history relevant to events.  There were no concomitant medications.  No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 07May2021, his vision got all spotty and he could not see, pupils got bigger than normal after the vaccine, had blue lips, white face, blood pressure really dropped, and he lost vision at one time immediately afterwards, and he felt cold. The time of onset of events was around 5pm. Events did not require a visit to emergency room or physician office. They stated they had given a thousand of this vaccine and this had never happened before. They stated they had never seen what happened to his son before. The patient did not get the second one yet and was told not to get it. All events happened a few minutes after the vaccine during the sitting/waiting period. About after 5 minutes the most after administration this all started and they had to treat him with an ammonia thing to wake him up. It's the one you break it under the nose and they were ready to do an Epi Pen also if needed. He improved within half an hour to 45 minutes of this. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Mentioned they all in his family did the Covid vaccine.  The patient improved and they advised him not to get the second one. It was Facility to tell them that. The pharmacist from there just gave them a call wanting to know why the son didn't return for the second dose and he explained what happened since this pharmacist did not know what happened that day. Patient did not see doctor or go to emergency room since his condition improved dramatically after about 45 minutes or so. Father kept asking patient how he felt or if there was need to see doctor and patient declined. The outcome of events was recovering.   Information about lot/batch number has been requested.
Patient received only the diluent portion of Menveo; Patient received only the diluent portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   In AUG-2023, the patient received Menveo. In AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient received only the diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: Patient received only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that out of seven patients, 1 patient received only the diluent portion of Menveo vaccine. The reporter stated that it was unknown at the moment that which patient actually received the dose. The reporter reported that the possible administration date was from 14th August 2023 to 16th August 2023. The vaccine administration facility was the same as primary reporter. The reporter gave by error Menveo diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via postal.
Never had a reaction to shrimp.  One day after second covid 19 vaccine I had a bad reaction to the shrimp tacos. I had hives . Lips swelled and got numb. Cheek was numb. Throat was swelling. I took Benedryl . I took about 45 minutes to fully restore me
sx started 14MAR eve-then became worse On 15MAR95-took 2 Typhoid tabs., total sx were itching followed by hives/urticaria on arms., legs, back-only; DPH given; t99.3; A/P urticarial/allergic rxn to med;
Patient presented to the ED after going home from the vaccine clinic. Patient waited the recommended time before leaving the facility
Information has been received from a physician concerning a male twin with no other medical history who was vaccinated SC with a single dose of zoster vaccine live (Oka/Merck). The physician reported that the patient subsequently developed a rash. Medical attention was sought via telephone call. No laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. This is one of several reports from the same source. Additional information has been requested.
redness and a hard lump; redness and a hard lump; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and a hard lump) and VACCINATION SITE INDURATION (redness and a hard lump) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ROSUVASTATIN CALCIUM for Cholesterol, LISINOPRIL, CITALOPRAM, HYOSCYAMINE and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC).    On 05-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 VACCINATION SITE ERYTHEMA (redness and a hard lump) and VACCINATION SITE INDURATION (redness and a hard lump). At the time of the report, VACCINATION SITE ERYTHEMA (redness and a hard lump) and VACCINATION SITE INDURATION (redness and a hard lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicine included cephalexin 500mg for 7 days and antihistaminic.   Reporter did not allow further contact
Acute Infarct of R internal capsule and R basal ganglia; Acute Infarct of R internal capsule and R basal ganglia; Left (L) sided motor deficits; L facial droop; This is a spontaneous report from a contactable physician. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included truncus arteriosus (status post (s/p) right ventricle-to-pulmonary artery (RV-PA) conduit and prosthetic aortic valve s/p automatic implantable cardioverter defibrillator (AICD) placement) and arrhythmias. The patient have no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included sotalol taken for arrhythmias and warfarin. The patient was therapeutic on warfarin (INR 2.68) at admission and has been historically very compliant with medication. On 29Mar2021 14:00, the patient experienced acute infarct of right (R) internal capsule and R basal ganglia as diagnosed (dx) on magnetic resonance imagine (MRI), concerning for (C/f) cardio-embolic etiology in the setting of patient's complex cardiac history. However, cannot rule out other causes of infarct. Left (L) sided motor deficits on exam, L facial droop. Transthoracic echocardiogram (TTE) was unchanged from prior. The patient was hospitalized for the events from 29Mar2021 to 05Apr2021. The patient underwent other lab tests and procedures which included COVID-19 nasal swab test was negative on 29Mar2021 and on 30Mar2021. Therapeutic measures were taken as a result of the events and included treatment with anticoagulation. Outcome of the events was recovered with sequel on 2021.  The following information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. Consider also possible contributory effects from patient's pre-existing cardiac history. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Left armpit began feeling achy for about two days and then ache went away and now red bumps have popped up on my left bicep - not really bothering me but feel somewhat irritated if bicep is against body
Kidney Stones caused a cascade infection(s). Drain from Liver. Bladder infection. Cipro for 30 days and oxycodone. Still dealing with kidney stones and will be getting a surgical appointment soon.
No additional AE reported; vaccine expired on 05NOV2021 and was administered on 09NOV2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 09-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA))(M-M-R II) 0.5 milliliter, lot number S035356, expiration date 05-NOV-2021 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported. The vaccine had not had any temperature excursion.
29OCT92 pt recvd DT vax & 2NOV92 pt came in to see MD for local reaction states 31OCT92 noticed red, warm & sore area on lt deltoid; pt took ASA & used ice pack to arm; MD observed lt deltoid w/10cm area of erythema warm to touch-tender
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 at 17:00 as dose 4 (booster), single (Lot number: fp4554), in left 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's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN, start date: Jan2018. The patient previously received a COVID-19 Vaccine. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral details product-COVID 19 Treatment, brand-Paxlovid, treatment start date-01Jul2022, lot number-gc0603, indication-Treatment of COVID-19. Reported Event: dysgeusia: bitter taste in throat, started about an hour after first dose-thought I had swallowed a tabled wrong. The taste is persisting. Adverse events start date 01Jul2022. Adverse events start time 07:00 PM. Ae resulted in None of the above. If patient recovered Unknown. If treatment Ae was no.  No follow-up attempts are possible. No further information is expected.
Symptoms:  Fever, Flulike symptoms, lethargic, SEVERE memory loss, SEVERE hallucinations, vomiting. Injection site reactions:  Severe swelling, redness, bruising, blistering at the injection site, oozing, injection site very hard. She was taken to the emergency room Friday night 10/26/2012 at 6:00 for these symptoms.  Injections were given Tuesday morning 10/23/2012.  Followed up with physician who administered injections the following Monday 10/29/2012.  The hallucinations, memory loss, and injections site problems started Tuesday night are continuing through today 10/31/2012.
Patient had seizure and temp 99F the night after vaccines administered. Patient taken from home to ER by paramedics.
Flu like symptoms; Cant even concentrate; Pain all over; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache) in an adult 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DISTURBANCE IN ATTENTION (Cant even concentrate), PAIN (Pain all over), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No new information was reported.
lt arm swollen, legs and feet swollen, hissing sound in head, bruising on arm, swollen stomach, swollen hands, redness aeound neck and breast are
SWELLING, REDNESS, SWEATS, HEADACHE, INABILITY TO MOVE ARM, PAIN.