chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported .  Total number of vials or doses were reported as 173. Also no temperature excursion was reported. The date the vials were stored in the refrigerator was reported as unknown.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up was received and included non significant information
Information has been received from a health professional concerning a 7 year old female pt who was vaccinated on 22Aug1999 with a dose of varicella virus vaccine live. Subsequently, on approx 31Mar04, the pt developed breakthrough chickenpox with50v to 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
On 02/23/2001 the patient developed chicken pox. The patient had 14 lesions on the body, 13 of them were papular and one was vesicular. The patient developed a low grade fever of 99F, an ear infection, coughing, vomiting, hyperemic tonsillitis, papalar, vesicular rash over the chest and trunk. No further information is available.
This spontaneous report as received from a registered nurse refers to a "ton" of unspecified patients of unknown demographics. On unspecified dates, those patients received the doses of an unspecified Hepatitis B vaccine (manufacturer unknown) (strength, dose, route of administration, lot# and expiry date unspecified) (RECOMBIVAX could not be ruled out) out of schedule. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same reporter (linked to MARRS# 1501USA006830 and MARRS# 1501USA001237). Additional information is not requested as the reporter does not wish to receive any further follow-up letters.
Presents for generalized weakness & congestion. Admit for COVID pneumonia/acute hypoxemic resp failure, AKI, hypernatremia. Tx: dexamethasone, duonebs, vit c, zinc, tessalon, O2. DC to HCF.
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, pain at the injection site Narrative:  Other Relevant History:
Her joints are inflamed; Could not turn her neck; This spontaneous case  was received on 01-Dec-2022 via Communications (reference number: SEQW22-06192), from other non-healthcare professional and concerned a 67-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On 12-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v, dose: reported as 0.5 ml, route of administration: not reported, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346337 and expiry date: 29-Apr-2023.   On 12-Oct-2022, an unreported amount of time after receiving Fluad Quadrivalent vaccine, the patient reported not being able to turn her neck and her joints were inflamed. Treatment measures associated with events were ibuprofen, Tylenol (paracetamol), and Aspirin (acetylsalicylic acid).  On 14-Oct-2022, described as two days later, the patient recovered from the event neck stiffness. The patient reported her neck became fine, but her joints were still inflamed.   At the time of initial reporting, the patient had not recovered from the event of joint inflammation. As reported,  joints were still inflamed.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 67-year-old female patient experienced arthritis and musculoskeletal stiffness on the same day following vaccination with Fluad Quadrivalent. Causal relationship for the reported events is assessed as possibly related due to suggestive temporal relationship.; Sender's Comments: A 67-year-old female patient experienced arthritis and musculoskeletal stiffness on the same day following vaccination with Fluad Quadrivalent. Causal relationship for the reported events is assessed as possibly related due to suggestive temporal relationship.
Flush face and warm to touch. BENADRYL 50 mg PO taken as per ordered by doctor. S/sx relieved after 1 hour.
first dose 4/23, second dose 7/22; 4 weeks pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22). On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (4 weeks pregnant) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 4/23, second dose 7/22) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt was scheduled to repeat dose on 9/15/21, pt did not attend the appt..
The only thing I have with the first injection is soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3248, via unspecified route of administration in the left arm on 15Jan2021 (15:30) at single dose for COVID-19 immunization. Patient medical history included high blood pressure (HBP). Concomitant medications included latanoprostene bunod (VYZULTA 0.024%), losartan at 25 mg, and oxybutynin (5 mg ER) for unspecified indications. Patient is not pregnant at the time of vaccination. The patient reported that the only adverse event she had after first injection was soreness at injection site on 15Jan2021 at 3:30 pm. No treatment was received for the event. Outcome of the event was recovered on unspecified date in Jan2021.
fever;anaphylaxis > 6 hr;taken to ER;treated w/Epipen, Atarax by mouth & later IV fluids
Patient received flu vaccine in right deltoid on 12/7/06 and returned to clinic on 12/8/06 with redness and swelling from right shoulder to right elbow.
Received flu vaccine at 0945; noticed ocular pruritus around 1030 that progressed to pruritus around neck/upper chest and noticed red flushing rash around chest/neck and face. Returned to clinic. Initially given Zyrtec 10mg. Vital signs stable. No other symptoms. After 30 minutes new onset urticaria on face. Given 0.3mg Epinephrine intramuscularly. Symptoms resolved.
In August of 2022 I began having symptoms of low-fever and sore throat. I tested positive with PCR test at the doctor for COVID-19. Two days after that I began having difficulty breathing and a cough that moved into my chest. I was prescribed PAXLOVID, albuterol and benzonatate. My fever lasted about three or four days after I began taking medication. I continued testing positive for about two and half weeks. I had a continued cough for another three to four weeks. I am still experiencing decreased lung compacity. I notice this when I am exercising because I am not able to go as far in my cardio work as before. I have a shortness of breath and tightness in my chest.
I contracted covid.  I woke up with alittle scratchy throat but felt exhausted. I had a really intense pressure in my head.  I didn't have any sinus congestion, it just felt like my head was swelling. i had a fever of 103. I had a stomachache, nausea, an ache in lower abdomen and my heart and low back. everything lasted for a few days.  I was also prescribed paxlovid. after taking the meds, the sore throat became extreme. My tongue also swelled up and had red bumps on it. I went to urgent care and tested me for strep- negative.  by day 4, I felt pretty good after that but I was still testing positive. I then started getting sick again with runny nose, sneezing, congestion, developed a bit of cough in my chest.  energetically I feel fine but im still experiencing some throat/ congestion issues.
Because of history of allergies, facility had me wait 1/2 hour after; several hours after jab administered, sore arm at injection site.  Upon waking the next morning, I noticed a rash - diffuse red spots - developing :  Abdomen to lower back, few spots on breasts, some on arms, some have white heads; headache; several hours later saw MD for rash; had fever of 101.1, headache worse, arm very painful, body aches; later that day into evening had chills and fatigue.  Day 3 severe headache, body aches, bone pain, nausea diarrhea, fatigue, chills, arm pain.  These continued into Day 4 with sweating and fatigue worsening.  One week later I still have a dull headache, fatigue and intermittent sweating.
BLOOMING HEADACHE; This spontaneous report received from a patient via a company representative, concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 11-OCT-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-OCT-2022 following booster vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced blooming headache (Dose number in series: 2). The patient took took a 300 mg Tylenol (Treatment medication) (Tylenol unspecified). It was reported that the patient still hurts with event blooming headache at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s, and Tylenol was not applicable. The patient had not recovered from blooming headache. This report was non-serious. This case, involving the same patient is linked to 20221024366.
Swelling, tenderness, and red splotches at injection site just over a week past the injection
burning during vax (inj site pain) & very inflamed 1/2 hr p/vax;flu vax erroneously administered instead of PPD
got shingles after booster/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for reporter's sister-in-law. The age at vaccination was not reported. The patient got shingles after her booster Shingles vaccine. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation were unknown at the time of reporting.
This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age. On an unknown date the pediatric patient was inadvertently vaccinated with an expired third dose of RECOMBIVAX HB lot # 1259AA (Expiry: 19-DEC-2013) 0.5 ml, intramuscular. No adverse effects reported. No further information reported. Additional information has been requested.
Reports pain in left arm, radiates to left elbow, sometimes numbness and tingling in the left hand. hurts lifting more than 10 lbs. Pain was worse the first 3 days, has improved, but persists, is off and on.
This spontaneous report was received from a registered pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patient developed cellulitis at the injection site. The outcome of cellulitis at the ZOSTAVAX injection site was unknown. Causality was not reported. Additional information has been requested.
My left lower eyelid began to spasm after the onset of a severe headache just after 12 pm. Fatigue, nausea, body aches, and heaviness in my chest began around 4:30 pm.  Eye spasms stopped after taking ibuprofen but began again 7 hours later.
Patient has needle anxicty breifly passed out after recieving vacine. Onsite EMS was called vitals HR 54   BP 110/80. She quickly recovered and went home.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, ALPRAZOLAM (XANAX) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 02-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had not resolved. Not Provided          No treatment information was provided. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable. The patient had constant diarrhea since vaccination and said that every time she put something in her mouth it just went right through.Patient also thought that it might be because of the Vitamin D supplement that she was taking. Patient said that she would stop taking her Vitamin D supplement for the meantime.
Mostly it was nausea ad vomiting and weakness came on suddenly and i couldn't get up. and pain from my head to toe. head ache felt like i was frying my brain and everything hurt. there was no treatment i just stayed in bed. i was sicker with the reaction then i was when i had covid. I got better after about 2 days
Myalgia, Diarrhea, NauseaVomiting, fatigue, headache, chill, Narrative:
normal sore arm at injection site.  But then very bad headache, chills, possibly fever, achy all over for at least 24 hours.  After 24 hours sypmtoms subsided and then were gone after 2 days
had a reaction which she describes as her chest feeling funny; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 74 years old female patient who experienced a reaction which she describes as her chest feeling funny (Chest discomfort) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past treatment, vaccination and concomitant medication were unknown.  medical condition: allergic to everything including mycins, sulfa, phosphates, penicillin (drug allergy) and has food allergies (food allergy). It was reported that patient had annifilactic allergies.  On an unknown date in 2018, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot and expiry date: unknown), via unknown route and site of administration.  On an unknown date, who experienced a reaction which she describes as her chest feeling funny (Chest discomfort)unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Lab data not reported.  Corrective treatment included allergy pill..  At the time of reporting, event outcome was unknown.  Batch number was requested.
Headache, Myalgia, Arthralgia, Fever,  fatigue  Narrative:   Other Relevant History:
At around the 14 hour mark, I came down with severe chills, 102° fever, general pain all over, general weakness, no energy, vomited after I ate. This lasted until around midnight when I took nyquil and went to sleep. I slept for 12 hours without waking. I felt moderately better upon waking. I had a lingering headache and slight weakness.
lost their smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "lost their smell".  Additional information: It was reported that, both kids of reporter got their vaccination the 5 to 11:00 and they lost their smell and reporter didn't know if it was aware that was probably a side effect of it and didn't know if it is needed to know about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883348 for Same reporter / drug / event, different patients.
Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
did not feel like eating; low energy; fatigue; feeling sick; Overdose; This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included drug allergy (allergy to isoflurane).   On 10th December 2020, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 10th December 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced appetite absent, energy decreased, fatigue, feeling unwell and overdose. On an unknown date, the outcome of the appetite absent, energy decreased, fatigue and feeling unwell were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the appetite absent, energy decreased, fatigue and feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by patient herself. The patient received a dose of Shingrix and High Dose Infulenza vaccine on the same day, manufacturer not known and one injection of each in each arm., which led to overdose for Influenza vaccine. The patient reported that later in the day after the injection experienced feeling sick, defined as fatigue, low energy, and did not feel like eating.   All symptoms have resolved.   The patient had not had dose 2 yet. The reporter consented to follow up. This case was 1 of the 3 cases, reported by the same reporter. Note- even though description about overdose was not given (dosing amount) but since the statement is provided as high dose of influenza vaccine, overdose is conservatively coded.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063955:same reporter US-GLAXOSMITHKLINE-US2021063953:same reporter