chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician who reported that her practice had returned 650 doses of vaccinated with VAQTA (reported as (VAQTA Pediatric, lot) lot # 670835/0628AA, Expiry date: 13-MAR-14, as expired to Merck. Physician reports that as soon as the practice heard back from the Merck Vaccine Customer Center, the expiration date should be interpreted as 13-MAR-2014, she realized that the practice had made a mistake in interpreting the expiration date. Physician reports that it would make it easier for providers to properly determine expiration dates if the year was expressed 4 digit number, states that if the expiration date had read 13-MAR-2014 the practice would not have made the mistake. Physician expressed concern that while this confusion about interpreting the expiration date led to an early return, and not administration of expired product, the inverse error could result in administration od expired vaccine. Physician encourages Merck to amend the expiration dates to include a four digit year. As the vaccine does not expire until March 2014, no patients received expired vaccine. Additional information is not expected.
had given an expired dose of Ipol, with no reported adverse event; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who had given an expired dose of ipol, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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  dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot number not reported in unknown administration site as immunization. Lot number was requested.  On an unknown date the patient had given an expired dose of ipol, with no reported adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).The nurse wanted what are the recommendations for course of action.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had given an expired dose of Ipol, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event had given an expired dose of ipol, 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 guidelines. 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.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot# R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Product storage error). The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Day 4 after shot neck pain developed.  Never experienced pain in my neck.  Went to Rothman on day 8.  They said it was arthritis. I never had an issue before.  Pain in neck is on left side the same side as shot.  Can sleep on that side.  Pain is unbearable if I try sleeping on right side.  Took a steroid for 5 days.  Pain immediately went away and then return  day 5 of steroid.   Still have pain on day 24 since shot.
I received 2 doses and the reactions were the same for both.  Flu-like symptoms starting about 24 hours after receiving shot including: nausea, all over aching, weakness, tired. These symptoms lasted for about two days.  I had very strong pain at the injection site -very  tender to the touch for days.   In addition, after the second shot (I don?t remember if this was an issue following the first shot) I?ve felt weak for several weeks following the vaccine.
30AUG sore throat, very tired, red raised area @ inject site, 10-12 hives, achey joints, rash on abd & legs, h/a, nausea, t101, cervical lymphadenopathy; 4SEP burning & itching abd & arm;
30 minutes after the injection,  I had tightness of chest, difficulty breathing, facial and neck swelling while I was heading straight home. The nurse advised me to go to the nearest Hospital. Treatment given: 3 different medications through an IV.  and 2 hours later they discharged me.
sudden fever spike followed by intense vomiting/dry heaves which lasted most of the day but has eased in the day following...
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319 and expiration date 28-SEP-2017; dose was not reported), orally for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 and 36 degrees Fahrenheit (0 to 2 degrees Celsius) for two hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
10 x 9cm swelling of left arm near left deltoid (area vaccine administered) area warm to touch and reddened.
2 1/2 weeks after immunization, pt developed petechiae and large bruises. He was seen in office on 10/12/06. Platelet count 10K. Admitted to hospital, given IVIG. . 10/12/06-seen in ER with bruising and petechia on his trunk and extremities but none on the head. Large bruise on right forearm, ecchymotic and petichia areas on the forearms.  DX:idiopathic thrombocytopenic purpura. Returned to ED 12 hours after DC on 10/14/06-C/O headache. Platelets at time of DC 22,000. Gradually headache seems to be behind eyes, light bothering his eyes. Multiple ecchymoses. Alert oriented. Observed in ER and DC home. Impression: headache, no evidence of bleeding in CT. Improving thrombocytopenia. Returned to hospital 10/27/06-After first hospitalization and treatment with IV Ig, platelets improved to 148,000, ecchymoses went away. No complaints of headaches. Over last few days developing more petechiae and few purpura. Platelets 13,000. Reamitted for IV Ig therapy.  Impression idiopathic thrombocytopenia. Follow-up: Platelets increase to 22k, then 148K by 10/15/06. Platelets decrease to 24K on 10/23/06. 1/4/10 Patient stil has intermittent Thrombocytopemia requiring oral steroid therapy. 4/1/10 Patient still has cycles of thrombocytopenia. has been treated with NIG and oral steroids. Platelets  drop to <20,000 about every 2 months.
Injection site is red, hard, and swollen.  Meds given for treatment were benadryl, and motrin.
arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported the case. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced worst arm pain, which patient thought was better than getting shingles. Consent to follow up was not possible as no contact details were available.
3-4 Inch Rash On My Right Upper Arm along side the injection site. The rash first appeared yesterday, which was 7 days after my vaccination.I have applied a topical antihistamine with some relief of the itching.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported.  On an unknown date the patient was vaccinated with M-M-R II intramuscular, lot # M045394, expiration date 14-NOV-2018, for prophylaxis (strenght, dose and frequency were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT).
Administered 0.5 mL of vaccine, instead of 0.3 mL
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. 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. The outcome is unknown. Additional information has been requested.
I got a UTI and had a fever and I had trouble urinating. I couldn't stand up, it knocked me on my feet. I went to the ER and they admitted me into the hospital for 3 days.
This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 22-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (47.5 degrees). Concomitant medications were not reported. No adverse effects were reproted. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE/ No PQC; Pharmacist called and informed a patient did not receive 1st dose of ROTATEQ until 8/2/2023.; This spontaneous report has been received from pharmacist, regarding a 6-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  Until 02-AUG-2023, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age)  No additional adverse event was reported.
I got the Pfizer booster in the morning of 10/31/22. At 6:30 PM of that day I got very dizzy and needed assistance to a chair. I began vomiting. I was ver dizzy and vomiting for 8 hours, in bed for 2 days. I went to a local urgent care on   11/4/22. I was prescribed Meclizine 25 mg, but it did not help. On 11/18 I went to PMD. He ordered an MRI , neurology apt and begin Vestibular therapy. MRI done 11/12/22. No issues found. Vestibular therapy began 11/15/22, twice a week. Epley maneuver done multiple times. I will continue therapy twice a week as I am ver unbalanced in my gait.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored doses of ROTATEQ orally (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F or 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt broke out in red rash on right side of body with fluid filled vesicle. Rash on right arm, leg, abdomen and pubic area. Rx cephalexin, BACTROBAN. Dx impetigo, vaccine induced varicella.
started w/fever on 13AUG t103, rash started same day on face spreading to chest, trunk, extremities; no vomiting, diarrhea;
Initial report received from healthcare professional on 11 December 2013. On an unknown date, FLUZONE exposure to OC for 3 weeks and advised to discard. If patients were vaccinated with unstable vaccine, the CDC states, Damage to the immunogenicity of a vaccine exposed to temperature outside of the recommended range might not be apparent visually. As a general rule, vaccines that have been administered guidance is available from the state health department or CDC. Vaccine exposed to inappropriate temperatures that is inadvertently administered should generally be repeated. Clinicians should consult with state or local health departments in these situations. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Patient was given dose that was expired around 20 hours after it had been punctured - the vaccine itself before puncture was within time frame
Patient appeared to have 45-60 second seizure following first dose of Pfizer COVID-19 vaccine. Appeared to experience a tonic/clonic seizure. He was sitting in a chair, scheduling an appointment to receive his second COVID-19 vaccine and became unresponsive and stiff. Staff responded, patient was lowered to the floor for safety. Patient was turned on his side to maintain airway. O2 was take 97-99% on RA. Once rigidity had resolved, O2 was applies at 3L NC as a precaution once stiffness resolved. BP was taken, 83/59 and pulse 105 side laying. 5 min later, BP 109/73, pulse 106 supine. EMS was called, patient transferred to ambulance.  Patient was alert and oriented.
As per mother, patient experienced chest and heart pain, shortness of breathe, and heart palpitations 3 hours after vaccination. Symptoms occurred immediately in conjunction to soccer practice.
Information has been received from a consumer concerning his 8 year old son with no previous medical history or drug allergies who on 03-DEC-2007 was vaccinated SC with his second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 23-DEC-2007, the patient was diagnosed with diabetes 20 days after vaccination. Unspecified medical attention was sought. A blood test was performed. The patient was not recovered at the time of this report. There was no product quality complaint. No further information is available.
pt says she started itching and developed hives all her body.  This includes her skin, eyes, ears, throat.  Pt took Benadryl which seemed to help relieve her symptoms.  The hives were gone the next day.
0931 Client felt hot at back of neck; States she has a hx of panic attacks for which she takes Ativan PRN; States this feels the same;  BP 140/95 P90 R 15; SpO2 99%; Resp unlabored; Lungs clear - no wheeze or stridor; Skin warm pink and clammy; LOC A&O x 3 0932 EMS notified; ice pack provided for back of neck for comfort 0935 P 75 SpO2  99% ; Client states she is feeling a little better 0940 BP 118/86  P 84  R 12 SpO2 99%; Resps continue unlabored; LOC A&O x 3; juice provided  0945 EMS arrived; BP 138/96   P 90  SpO2 99%; Client is feeling nervous again b/c EMS is on scene; Hand off report given to EMS.  0951  EMS retrieved Ativan from client's vehicle and allowed client to take usual dose; client feeling better; EMS departed without the client 1000 Client states feeling well enough to leave; Resps unlabored; A&O x 3
An immunocompromised 44 year old patient received Zostavax intramuscularly; An immunocompromised 44 year old patient received Zostavax intramuscularly; An immunocompromised patient received Zostavax concomitantly with Moderna COVID-19 vaccine; The patient reported a rash on neck and arms; This spontaneous report was received from an immunocompromised 44 year old female nurse prescriber via company representative reporting on herself. Patient's drug reactions or allergies and pertinent medical history were not reported.  On 09-MAR-2021, the patient was vaccinated with a dose of  zoster vaccine live(ZOSTAVAX), 1 injection, intramuscularly (lot # and expiration date were not reported) for shingles prophylaxis.    Concomitant therapies included sars-cov-2 spike protein mrna vaccine(MRNA-1273) ( Moderna COVID-19 vaccine) administered in January and February 2021. On unknown date in March 2021, the patient experienced rash on neck and arms. No further adverse symptoms reported.   At the time of the report, the patient was recovering from rash.   The relationship between rash and zoster vaccine live(ZOSTAVAX) was not reported.
25NOV93 devel body rash, followed by swelling of hands, feet, fingers; react declined on 29NOV93; exp itching; joints hurt; face burning, blotching on torso;
Vomiting began 10-11-18, headache started 10-10-18. Decreased energy. 10/11/18 exam: Strawberry tongue, erythematous posterior pharynx. Throat culture: negative for Strep. Ibuprofen.
This spontaneous report as received from a pharmacist refers to a 25 year old patient. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On 22-APR-2019 the patient experienced inappropriate schedule of product administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of product administration and no adverse event is unknown. The reporter considered inappropriate schedule of product administration and no adverse event to be not assessed to GARDASIL 9.
started crying & fussing around 430PM; excessively temp of 105.2 R @ 111PM; pt seen by MD; pt also had vomiting & shaking & screamed uncontrollably @ 5AM;
Severe rash to both legs, with emphasis to feet and ankles. Rash was swollen, red (almost large mosquito bite looking bumps) and would itch severely to the degree that medication was required. I would wake up in the middle of the night with severe itching requiring additional meds and wash treatments. Rash started seven days after first vaccine of Moderna was given and got worse for another seven days before improving. During '"improvement" the rash seemed to turn into bruises as it healed. And most of the rash was gone by the time I was due for my second shot of Moderna on 1/30/2021. I did not get the rash back after the second vaccine but I did continue to have itchy feet and legs and have difficulty working.
Expired vaccine given. 04/12/2022 was expiration date for vaccine but was administered on 4/15/2022
Blood sugar went up; This is a spontaneous report from a contactable consumer (patient) via medical information team and a Pfizer-sponsored program . A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown) via an unspecified route of administration on 11Feb2021 at single dose to prevent COVID-19 virus. Medical history included that he was legally blind and he did not drive; his oncologist told him to take the Pfizer COVID-19 Vaccine because he has Leukemia, to prevent the COVID-19 virus that has been going around; this consumer was a type II diabetic and he took his blood sugar every morning. The patient's concomitant medications were not reported.  He had an injection of BNT16B2 on 11Feb2021 afternoon and his blood sugar spike up on 12Feb2021. The outcome of event was unknown.  Information on batch number has been requested.
Information has been received from a registered nurse concerning a 5 year old male with a seizure disorder, mild developmental delay, and a cow's milk allergy who on 29OCT1998 was vaccinated with a first dose of varicella virus vaccine live in the right thigh. There was no illness at the time of vaccination . On 29AUG2003 the patient developed a fever. On 30AUG2003 the patient developed a rash of 40 vesicles on the arms and face. The doctor in the emergency room confirmed chickenpox, also reported as breakthrough chickenpox. The rash did not require any medical attention. The patient recovered. It was also reported that the patient's sister also developed chickenpox "on about the same day." No further information is expected.
Symptoms of R arm and hand weakness, tingling noticed by patient approx 24 hours after receiving 2nd covid vaccine in right arm. Presented to care on June 11 2021 and found to have weakness of tricep, eval'd by physical therapist the next day who localized weakness to radial nerve distrubtion, NCV/EMG was ordered and referral placed to physical therapy. Study was completed, he has not yet completed therapy, continues to have symptoms.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Headache; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. Patient inquired if he was allowed to take paracetamol (TYLENOL) after his second COVID shot because he has a headache. The outcome of event was unknown.   No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further Information is expected.
Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness at the injection site. The patient consented to follow up. This case has been linked with case US2019142240, reported by the same reporter.