chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When the needle was retracted, blood came out then a clear stream of fluid; When the needle was retracted, blood came out then a clear stream of fluid / concerned he did not get the full dose; When the needle was retracted, blood came out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out then a clear stream of fluid"; UNDERDOSE (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out then a clear stream of fluid / concerned he did not get the full dose"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out". Additional information: The reporter wanted to know what to do and was querying if there was any harm in getting a third dose of the vaccine. Reporter was also querying if there was any protection with only getting one dose if you don't get a second injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received an expired dose of Menactra, with no reported adverse event; 64 years old patient received a Menactra Vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00647494) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 64-year-old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered,Product administered to patient of inappropriate age].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 15-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6594AA and expiry: 21-May2021] via an intramuscular route in the left deltoid for prophylactic vaccination.   It was a case of actual medication error due to expired product administered and product administered to patient of inappropriate age [Latency: on the same day].  No laboratory test was reported.  At the time of report no adverse event was reported.  It was not reported if the patient received any corrective treatment for the events.  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.
rash, got worse after the second shot, on his upper torso, chest, arms, and back, on his lats; it started out as "hives" but it is now"blown out."; has left scarring from where he had itched (scratched); rash got worse and it is that red!; rash got worse and It feels like "a poison ivy and mosquito bite itching; This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (1st dose received on 20th June 2021 refer case US2021210530).   On 27th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash aggravated, hives, scar, rash erythematous aggravated and itchy rash. On an unknown date, the outcome of the rash aggravated, hives, scar, rash erythematous aggravated and itchy rash were not recovered/not resolved.   The reporter considered the rash aggravated, hives, scar, rash erythematous aggravated and itchy rash to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself. The patient received a dose of Shingrix in left arm and experienced a terrible rash that he has had for 3 months and it progressively got worse after the second shot. he thought that it may be related to Shingrix. The patient stated that the best way to describe the rash is that his arms and chest look like he felt slept on the beach with no sunscreen. it was that red as it felt like a combination of poison ivy and mosquito bite itching along with the worst sunburn it ever had. The patient had seen a general practitioner and an allergist and was wondering if he should see an infectious disease specialist. he indicated that in the beginning it started out as hives but was now blown out. he said that initially it was on his legs then it dissipated from his legs and has left scarring from where he had itched (scratched). at the time of reporting, the rash was more concentrated on his upper torso, chest, arms, and on his back were his lats are. rash was not resolved. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210530:same reporter and patient
Fever 103.8(R) on 21FEB91 1wk p/shot to ER dx ear infect & congestion;
Patient begin to slouch in her chair immediately after the shot, I reached over and grabbed her so that she would not fall, she began to straighten up on her own and sat back into the chair comfortably. She did not seem to fully black out but I took precautions in case she did.  She was given water by her dad, and her blood pressure and pulse were measured at (84/55) and (87) respectively.  We waited about 30 minutes and made sure she did not have a reaction before clearing them to leave the pharmacy.
pt presented w/in 2 days of shots w/warm, red rash of upper arm surrounding inject; tx'd w/Keflex for ? cellulitis, cont to expand-Keflex inc & eventually by 8-10 days resolved; no known fever during illness;uncertain cellulitis or erythema
pt recvd vax 11JAN93 & 12JAN93 devel a fever & cough; 14JAN93 pt devel a pruritic rash w/red spots & papules 1 to 5 cm in size; also exp swelling in ankles; pt presented to MD & was dx as having erythema multiforme;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history or concomitants medications were reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot# 008353, expiration date: 11-SEP-2016; lot# L003221, expiration date: 30-JUL-2016)(dosage schedule was not reported). No adverse event was reported. This is one of several reports received fro, the same reporter. Additional information has been requested.
DIARRHEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Dizzy BP=117/77                  115/81                  119/63 HR=101                           100                          100 O2=97%                            97%                         98% Pt. discharged at 14:17 Recorded by RN
Itchy throat, eyelid edema, burning sensation on the tongue, headache (10/10), neck pain (10/10).
Before given vaccine, patient stated he has passed out from vaccines before.  He received the dose, stated that I provided good technique but would stay with his wife for the 15 minute period afterwards just in case.  He started to feel lightheaded/dizzy and voluntarily laid down on the floor.  We provided him water, and he was sitting up, standing up, and able to leave within the next ten minutes.
This spontaneous report was received from a consumer (patient mother) refers to a female patient of unknown age. On an unknown date in July 2013, the patient was vaccinated with GARDASIL (dose, route and frequency were not reported). It was reported that the patient had not received any further doses. No adverse effect reported. No further information was provided. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received bnt162b2 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 11Mar2021 at 12:00 PM (at the age of 37 years old) as single dose for covid-19 immunization. Medical history included chronic allergies. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Concomitant medications in two weeks included omeprazole magnesium (PRILOSEC), amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). The patient received other vaccine on same date 11Mar2021. The patient had no other vaccine in four weeks. The patient experienced delayed skin rash on arm on 14Mar2021 01:00 AM. No treatment for event. The outcome of event was nor recovered.   No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.
Outbreak of herpes simplex; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex type i (the patient had a history of herpes simplex type 1).   On 23rd June 2022, the patient received the 1st dose of Shingrix. In June 2022, several hours after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-Jun-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, a few hours after receiving a Shingrix, she experienced outbreak of herpes simplex. The reporter did not consent to follow up.
3hrs post vax pt vomited x 3; eyes rolled bac part way & pt started turning blue; no shaking of extremities; mom kept calling baby & pt focused on mom p/30 seconds; mom does not know if pt stop breathing;
This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
07/04/2021 at approx. 3:00 AM  I woke up with severe chills .  At approx. 6:00 AM I experienced abdominal pain and diarrhea.   The diarrhea persisted for approx.  2 hours.  I was very weak  for the rest of the day .   At approx. 7:00pm diarrhea persisted.  07/05/2021  approx. 8:00 PM abdominal pain and  diarrhea started again.
Shoulder pain and inability to move shoulder within 2 hours of receiving vaccine. Decreased range of motion, still having pain at 2 month mark. MRI of joint done approx. 1 month after vaccination and MRI was clear. No other advice from physician assistant other than to wait it out for 6 months.
EXPERIENCED ITCHING ,SHORTNESS OF BREATH, HEAVINESS IN CHEST DIFFICULTY BREATHING,  RASH ,REDDNESS SWELLING ALSO HAD FEVER CHILLS OVERALL WEAKNESS WITH NUMBNESS AND TINGLING IN ARMS AND FACE.
Erythematous rash both upper, lower extremities and trunk tachycardia.
Started with intense tingling up both right and left fingers, hands, and arms, followed by intensifying (migraine) headache, fever, chills, allover body aches, dehydration, and skin breakouts. After approx. 18 hours, fever & migraine went away and was replaced by ongoing headaches, fatigue, body aches, leg cramps, a sore throat, and dry cough. Dr. recommended covid test, which was completed on Friday, April 16th, and was negative.
Patient under 65 received Fluad QIV; Soreness; Left arm with numb fingers; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04803) and concerned a 52-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced severe soreness, left arm with number fingers and headache. The patient was treated with Tylenol (paracetamol) and Aleve (naproxen).   The outcome of events was not reported.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 52-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain, headache and hypoaesthesia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, lot #, expiration date and route were unknown) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004183: US-009507513-1708USA003696: US-009507513-1708USA004182:
Neck pain; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and HEADACHE (headache) in a patient of an unknown age and gender 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 NECK PAIN (Neck pain) and HEADACHE (headache). At the time of the report, NECK PAIN (Neck pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: On 25-may-2021, No new information was added(Non significant follow-up)
ABOUT 2:30 A.M.WOKE UP WITH A ON AND OFF AGAIN HEADACHE THAT STARTED ABOVE MY RIGHT EYE AND TRAVELED TO MY RIGHT EAR. I GOT UP AND HAD SOME WATER BUT THE HEADACHE KEPT GETTING WORSE. GOT UP AGAIN ABOUT 3:30 AND TOOK TWO ASPIRIN, ABOUT 4:00 A.M. GOT UP AND HAD DIARRHEA, WENT BACK TO BED ABOUT 4:30 GOT BACK UP AND VOMITED ALL THE WATER AND ASPIRIN UP.  THE HEADACHE GOT A LITTLE BETTER BUT ALL DAY IT WAS THERE AND I FELT DEHYDRATED AND JUST SICK.  COULDN`T DRINK ANYTHING OR EAT. I SLEPT ALL DAY, ABOUT 6;00 P.M. I STARTED TO FEEL A LITTLE BETTER. I DON`T THINK I`LL GET ANOTHER FLU SHOT NEXT YEAR, I HAVE NEVER HAD A HEADACHE LIKE THAT BEFORE
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Headache, Myalgia, mild soreess at site, heache, myalgia, fatgue, chills x days 2-5 of dose Narrative:
Immediate hardened bump at injection site. 15 minutes later, purplish bruising. 2nd day post vaccination bruising noticed but diminished.
Patient left the site at 1354 after 15 minutes wait. Returned to entrance area reporting "feeling weird" and difficulty swallowing.  Benadryl 50 mgm given PO. After 30 minutes the patient stated felling throat had lessened  and felt okay to leave. Patient left with spouse. Patient stable upon exit.
muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included covid-19 (both she and her husband suffered with Covid 19 this year.).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not applicable for this report. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness without any kind of other reaction. On 13th September 2020, the patient had Fluarix Quadrivalent 2020-2021 and experienced itch on her chest near her left shoulder and it went body wide including her scalp, legs, feet, and back. The reporter consented to follow up. This case has been linked with US2020186260 reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186260:same patient
Fever 99.6, max, sore arm, fatigue, dizziness (probably from the fever) this has lasted two days, so far.
Case number PHEH2015US016660, is an initial spontaneous report from a pharmacist received on 21 August 2015. This report refers to an adult middle aged female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received MENVEO, (batch number: not reported) on an unknown date in late Feb 2015. On an unknown date subsequent to the vaccination the patient was losing hair. Final outcome, seriousness and causality was not reported.
patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.
Administered Lot#047B21A, but lot#008C21A was logged. Both lots expired on 5/13/2021.
Maculopapular rash on abdomen, chest, sides and back, underside of arms. Noticed rash a few hours after vaccination. Next morning rash was worse. Went to the doctor. He said take antihistamine. And call next day if rash is worse. I called today because rash is worse.
pt recvd vax;exp redness,soreness & edema around inject site;persisted x 3 days;rash also devel on trunk;exp also sore muscles/joints for almost 5 days;pt recovered fully as of 20oct94;