chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168, 32 and R; 840, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
The patient was feeling relatively normal after vaccine, reporting minimal pain at injection site and no fever at 1900 on 11/14. On 11/16 he was found obtunded on the floor at his home and was transported via ambulance to Medical Center, where he died on 11/18 at 3:20 a.m.
Within 5 minutes, developed herpetic non-blanching rash bilateral face. No other sx.
Rash in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced VACCINATION SITE RASH (Rash in the vaccination site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in the vaccination site) outcome was unknown.            Concomitant medication included blood pressure medication.
I felt incredibly dizzy as soon as I received the vaccine, the pharmacist made me stay for 30 minutes to make sure nothing else would occur. Every single day after that I would wake up incredibly dizzy and fatigued, brain fog, loss of concentration, Its like the vaccine turned me into a total moron, I've had zero brain function for months! I've seen my PCP 3 times over this matter and my neurologist as well, nobody seems to have any sort of remedy for me or for my suffering. This is going on month 4 I have felt like this, I have a very strict diet/lifesyle I follow for my condition and never in my life have I ever had these symptoms in the 4 years I've had multiple sclerosis!  I am now a full-time student suffering more than ever because I have no brain function/power. This vaccine has destroyed my quality of life for 4 months, and is now affecting my ability to finish my college degree. **People Need to see that NOT everyone has no side effect from the Covid19 vaccine**
Red, hot itchy spot where the vaccine was given. COVID arm. Not resolved within 24 hours so contacted PCP.
Had 2 shingles vaccines and had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 2 shingles vaccines and had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and experienced mild case of shingles. The patient stated that he or she received first dose of Shingles vaccine 2 months before the receiving second dose of Shingles vaccine. The patient reported that all those over 50 years old should receive the Shingles vaccine as soon as possible you will be glad that you did. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous report received from a consumer via other company concerned a 71 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drugs included: fluticasone propionate/salmeterol xinafoate (inhalation powder, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for chronic obstructive pulmonary disease (COPD). No concomitant medications were reported.  On 20-JAN-2022, the patient experienced covid and on 11-OCT-2022 the patient had covid again (coded as covid twice). It was reported that the patient had a high probability of getting epilepsy from this. On an unspecified date, the patient had black out/fainting episodes. The patient continued to have side effects from it and her memory has been affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of fluticasone propionate/salmeterol xinafoate was not changed. The outcome of the covid twice, black out or fainting episodes and memory has been affected was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221251348- black out or fainting episodes. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Began feeling short of breath and dizzy. Taken to urgent care and monitored. Symptoms resolved without intervention. Provider stated that it appeared to be anxiety, not ADR.
PATIENT MOVED WHILE GIVING SHOT, DIDNT END UP GETTING INJECTION IN, SCRAPED ARM AND PART OF SHOT RAN DOWN ARM. MOM OPTED TO NOT REINJECT AT THIS TIME.
administered vaccine prior to confirming expiration date; administered vaccine prior to confirming expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine prior to confirming expiration date) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (administered vaccine prior to confirming expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   HCP stated they eventually found the expiration date after they had given a vaccine. No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
After vaccine that night I had chest pain and fast breathing.  Didn?t feel well for a few days called my cardiologist and told me to come in.  But on the 29th of that month I started feeling dizzy light headed double vision. On the 30th it got worse and on top of those symptoms I had balance lose.  I was admitted  in hospital and stayed 2 days.    I had no balance and could not see.  They said I have vertigo. I  Never had it in my life.  It started when I took vaccine.  I was sent home with a walker and shower chair.   Could not function for weeks.   I still have dizziness and don?t feel ok my ears are killing me now.  It?s July 31st and still sick.  I meet with neurologist and he is sending me for a balance test in August along with going to see an ent.  I spend most my days in bed
Fatigue, headache, body ache, nausea, sore throat, pneumonia and a bad cough, chills.
also left chest pain; red rush on the left side of her chest in the back and front; itchy rush on the left side of her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (also left chest pain), RASH ERYTHEMATOUS (red rush on the left side of her chest in the back and front) and RASH PRURITIC (itchy rush on the left side of her chest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN and METFORMIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Jan-2021, the patient experienced CHEST PAIN (also left chest pain), RASH ERYTHEMATOUS (red rush on the left side of her chest in the back and front) and RASH PRURITIC (itchy rush on the left side of her chest).   On 31-Jan-2021, CHEST PAIN (also left chest pain), RASH ERYTHEMATOUS (red rush on the left side of her chest in the back and front) and RASH PRURITIC (itchy rush on the left side of her chest) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
A female patient (age unspecified) experienced laryngeal edema following treatment with RabAvert for an unspecified indication. The dates and dosages of RabAvert, past medical history, and concomitant medications were not specified. The patient developed laryngeal edema necessitating hospitalization. The outcome was unknown at the time of this report.
Patients boyfriend called and stated that the patient was unable to get out of bed and complaining of paralysis on her right side from the waist down as well as horrible pain, pins and needles feeling all over, and low grade fever.  Advised representative for patient to call ER and report symptoms to see if they wanted her to come in since her PCP is closed.  Requested representative call us and keep us informed as to what steps they were taking and let us know how the patient is doing.
Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to patient) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The vial was initially stored in the refrigerator was on 24-Jan-2022. The Pharmacist wrote an expiration date of 24-MAR-2022 on the Moderna Covid-19 vaccine instead of 24-FEB-2022. Vial did not undergo any temperature excursions.  The Pharmacist did not have any other adverse events or side effects to report.  No treatment medications were provided by the reporter.
flushing, vertigo, tremors  Narrative:  Patient received 1st dose of COVID vaccine on 1/13/21. During PCP phone appt on 1/28, wife reports Pt had pain in his neck the day after dose 1 was administered. On day 2 patient had severe pain in his neck on the left side (same side as injection) and felt "sick". Pt was able to explain exact symptoms but stated feeling unwell and wife reports his face was beet red. The night of day 2 wife reports patient's pain radiated from his L neck down his arm. During days 1-3 after vaccine administration, Pt did nothing but lay down in bed. On day 4 post- vaccination Pt experienced severe tremors and wife reported his entire body was shaking- Spouse stated symptoms looked similar to Parkinson's in that his head was "bobbing" and he could not stop shaking. Pt refused to go to the ED. The night of day 4 post-vaccination patient experienced nausea, HA and vertigo. Spouse stated symptoms lasted approximately 2 weeks.
Covid like symptoms; Breathing issues; Complete bed rest; Body aches; A spontaneous report was received on 25-Jan-2021 from a consumer regarding his mother, a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Covid like symptoms, body aches, and breathing issues and complete bed rest.  The patient medical history was not reported. The information about concomitant medication was not reported.  On an unknown date in Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date in Jan-2021, about 2 weeks ago to the day, the patient experienced Covid like symptoms and had been tested negative several times. The patient was not able to do everyday activities, had body aches, and breathing issues. The patient was on complete bed rest and does not seem to be getting better and also informed that it was very severe. The patient visited the hospital. Information about the treatment was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events Covid like symptoms, body aches, and breathing issues were not provided. The outcome of event complete bed rest was considered to be not resolved at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
expired DAPTACEL was administered to a patient with no reported AE; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old female patient who reported that expired daptacel was administered to a patient with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5828AA,Expiry date: 30-Mar-2023) (strength : unknown) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed a non-serious event of expired daptacel was administered to a patient with no reported ae (expired product administered) (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered to a patient with no reported ae.  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.
About an hour and a half after the innoculation, the deltoid muscle area of my arm started to ache and felt hot.  This lasted about a week. The other events included itching in the area of the injection. A redness of the skin started at the location of the injection and over the next few hours, spread to about an 8 inch diameter area.  This continued for about a week. I sent a photo to my doctor and described the reaction I was having that seemed to not be getting better. She told me that it was an adverse reaction and take ibuprofin for any pain. And let her know if it didn't go away.  A few days later the redness and heat subsided .
Red/pinkish circle around the injection site that lasted several weeks; Soreness around the site for several days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the site for several days) and VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2(Z?)04) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the site for several days). On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks). On 27-Feb-2021, VACCINATION SITE PAIN (Soreness around the site for several days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red/pinkish circle around the injection site that lasted several weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt awoke with a "lump" on his Left posterior shoulder (injection in L deltoid--pt felt "shot" was high on his arm). Was a little warm to touch that morning. Now pt has a soft, raised, non-tender, no redness or warmth area ~2.54cm in diameter.
patient presented to emergency department on 11/5/21 with shortness of breath, cough and fever. covid-19 specimen taken and came back positive patient was admitted for further management of covid-19 patient did require treatment for symptoms associated with covid-19 infection. treatment with dexamethasone patient was intubated on 11/9/21 and extubated on 11/13/21 patient's condition worsened requiring transfer to the intensive care unit on 11/7/21 patient expired on 11/13/21
Swelling and pain of left upper arm and neck per provider visit note 10/17/2014.
Pt. rec'd. BEXSERO #2 in office 06/29/16 approximately 11:00 AM. Rec'd C/from mom at 16:20 stating she had found pt. on ground outside with c/o feeling cold, weak and with N/V (x2). Mom C/'d 911 - Pt. taken to ED and syncope. R/T cardiac hx. (No adverse reactions sot dose #1) Dx as vasovagal reaction.
After the 2nd shot, about 17 hours after, my body went numb and I had a hard time breathing.  I could barely breath for about 10 minutes, along with a shooting headache and body numbness.  I was going in and out of awareness.  Finally, I threw up and was then able to breathe a little better and had feeling in my body again.  For the next few days, I had the more typical symptoms of exhaustion and achy.  However, a couple days later, I also had stomach pain, bloated feeling, unable to eat much - not sure if that was related to the vaccine or not.
chills; body aches; still felt a bit sluggish; sore arm; woke up with night sweats only not as severe as before; woke up sweating drenched wet in what she describes as "night sweats"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (woke up with night sweats only not as severe as before), CHILLS (chills), MYALGIA (body aches) and SLUGGISHNESS (still felt a bit sluggish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, OLMESARTAN, SODIUM CITRATE ACID (ALBACIT), CLONAZEPAM and TRAZODONE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced NIGHT SWEATS (woke up sweating drenched wet in what she describes as "night sweats"). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (woke up with night sweats only not as severe as before). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), MYALGIA (body aches) and SLUGGISHNESS (still felt a bit sluggish). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form, qd. At the time of the report, PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (woke up with night sweats only not as severe as before), CHILLS (chills), MYALGIA (body aches), SLUGGISHNESS (still felt a bit sluggish) and NIGHT SWEATS (woke up sweating drenched wet in what she describes as "night sweats") outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable
Information has been received from a nurse practitioner concerning two patients who on unspecified dates were vaccinated with ZOSTAVAX (Merck) (lot# not reported). The nurse practitioner was told by one of her patients that patient's two friends came down with painful rash after receiving ZOSTAVAX (Merck). The nurse practitioner did not know if rash appeared around injection site or other parts of the body. At the time of the report, the patients' outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Covid monitoring documentation. PT admitted 12/08/21 documented to have positive covid. PT received Pfizer 4/21/21 Lot EW0158 for dose 1. Dose 2 was Pfizer given on 5/21/21 Lot EW0158.
Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.