chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022; administered 3 vaccines beyond the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to MOD-2022-566621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Follow-up received contains no new information.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Information has been received from a pharmacist via a company representative concerning to a 69 years old patient of unknown gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, and lot number were not provided); the route of administration was reported as injection. The pharmacist reported that on an unknown date in approximately July 2016, reported as "last week", the patient developed shingles after receiving the dose of ZOSTAVAX. Also the pharmacist reported that the patient was being treated by a doctor. At the time of reporting, the outcome of shingles was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with PEDVAX HIB (does and route not provided). The reporter stated an unspecified number of patients may have received doses of PEDVAX HIB (does in series unspecified) that were exposed to 25F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time  . No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex, who on 26-JUN-2012, was vaccinated with a dose of VARIVAX (Merck) (dose, route and frequency were not reported) (lot #: 1434AA; Expiration date: 13-SEP-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:49 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219, at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of rotavirus G1 P1 vaccine live (89-12) (ROTARIX) oral route and lot # Y5CN5, diphtheria toxoid, hepatitis B virus vaccine rHBsAg (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (PEDIARIX) at a dose of 0.5 mL intramuscularly (IM) on the Right tight (RT) lot # YS4Z5 and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the Right tight (RT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2003USA002275:
pt recv vax & 1hr post vax pt exp swelling in arm (inj site) & radiating pain in arm (inj site);arm doubled in size w/in 2 hr;tx ice, motrin, & DPH;sx resolved p/5 days;
SHORTNESS OF BREATH FEVER UTI (urinary tract infection) Systemic inflammatory response syndrome (SIRS) without organ dysfunction (CMS/HCC sepsis
shortly after getting the covid vaccine, I developed intermittent shortness of breath with chest pain. I had a cardiac workup that was negative. But I have just gotten diagnosed with antiphospholipid syndrome with DVT and bilateral, multiple PEs. The pain that I had with the PEs is the same pain that I have been having intermittently with activity, but the previous pains were not as serious as this recent PE which required ICU admission and Heparin infusion and now daily Warfarin.
pt recvd 3 doses of Engerix-B & had nonresponse;
diarrhea from constipation relieving tea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea from constipation relieving tea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Constipation. Concomitant products included DOCUSATE SODIUM (STOOL SOFTENER), NAPROXEN, LEVOTHYROXINE, LOSARTAN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID (VIT C) and MECLIZINE [MECLOZINE] for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIARRHOEA (diarrhea from constipation relieving tea). At the time of the report, DIARRHOEA (diarrhea from constipation relieving tea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
3 days after the second dose, I had blocked partial vision in my right eye. From there I went to the Eye Center and they diagnosed it and they sent me to the hospital for testing. Nothing else was found. They called it a stroke in my eye, there was a blood clot in my eye. I had to go to the ER to have the work up done. They looked for other clots but they did not find any. There is no treatment for it, I just have to wait for it to dissolve and see if I can get my vision back. Also, after the second shot, gradually, I developed tendonitis in my left arm. I have been going to the chiropractor for that. It helps some but I do think it has to do with the way they gave me the injection.
Felt cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a 82-year-old 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, an unknown time after receiving Shingles vaccine, the patient experienced feeling cold (Verbatim: Felt cold).  The outcome of the feeling cold was recovered/resolved.   It was unknown if the reporter considered the feeling cold to be related to Shingles vaccine.     It was unknown if the company considered the feeling cold to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and felt cold for few hours. The patient stated that feeling effect was a good sign the vaccine was working and at 82 years of age there was not much to lose. The patient was nothing experienced after received second dose of shingles vaccine. Follow-up would not possible as no contact details were available.
for 12 hours I vomited at least 10 times, I couldn't keep anything down. If I drank anything or sipped it, I would immediately throw it back up. I had to call my dr to prescribe me Zofran which helped me stop vomiting. Then, 1 week after the vaccine, I had a low grade fever 101 and a headache.
I experienced a low CBC and called my Hematologist and ordered some labs of a CBC with a white blood cell differential on 08/23/2021and 08/24/2021. I'm scheduled to have another CBC done on 08/26/2021 to find out if my palette count went back to normal.
HOT/COLD SWEATS; SEVERE DIARRHEA; AURA MIGRANE; HEAD PRESSURE/HEAVY HEAD; FATIGUE; HIT LOWER COLON; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bowel resection, iga, ana, radioactive iodine treatment, graves syndromes, and autoimmune issues, and concurrent conditions included crohns disease, celiac disease, ms, lesions, and stenosis, and other pre-existing medical conditions included patient has no problems with bowel or bladder control. patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included siponimod fumarate for ms. The batch number was not reported and has been requested On 2011, Laboratory data included: Radioactive iodine therapy (NR: not provided) not reported. On 2021, the subject experienced hit lower colon. On 21-JUN-2021, the subject experienced head pressure/heavy head. On 21-JUN-2021, the subject experienced fatigue. On 21-JUN-2021, the subject experienced aura migraine. On 22-JUN-2021, the subject experienced hot/cold sweats. On 22-JUN-2021, the subject experienced severe diarrhea. Laboratory data (dates unspecified) included: ANA (NR: not provided) Abnormal, and IgA (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head pressure/heavy head, hot/cold sweats, fatigue, severe diarrhea, and aura migraine, and the outcome of hit lower colon was not reported. This report was non-seriousc
Information has been received from a registered pharmacist concerning a 63 year old male who on 29-OCT-2007 was vaccinated with a dose varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The pharmacist stated that the patient was not vaccinated at the pharmacy. No other information. There was no product quality complaint. Additional information has been requested.
shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported patient himself/herself. The age at vaccination was not reported. The patient received the shingles shot and 3 days later had the shingles. The reporter therefore decided no more vaccinations for him/her. The follow up would not be possible as no contact details were available.
Day after vaccine became super tired and lightheaded, then on March 9 noticed difficulty walking because feeling of numbness in left leg.  I called clinic and they told me to call 911.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 015M20A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up information received on 12-NOV-2021 contain No New Information.
PT was given a concentrated dose of the Pfizer COVID 6mos-<5yrs maroon cap vaccine.  The vaccine was diluted with only 0.2ml of solution and not the full 2.2mls.  PT was given the correct 0.2ml amount but just of a very concentrated dose.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; patients where vaccinated with expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients where vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. It was confirmed that the vial didn't undergo temperature excursion issue. Vaccine was stored in the refrigerator on 4-Apr-2022. No treatment drug information was provided.
Around 7pm I noticed I was very red and in pain with a swollen muscle at my injection site. The following morning I still had that pain and my body felt like the day after working out after a while. This morning I had cold sweats. My body movements at the time doesn?t warrant a sweat  It?s a cold sweat. As Im typing these symptoms I?m sitting on my couch sweating
No additional AE; temperature excursion on VARlVAX.; This spontaneous report was received from a medical assistant referring to a 14 month old patient of unknown gender. The patient's concomitant medication, pertinent medical history, and drug reactions/allergies were not provided.   On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not provided; lot# was T021826 and expiration date was 25-JUN-2022) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event (AE) was reported.   The administered dose experienced temperature excursions from - 58 degree Fahrenheit to + 5 degree Fahrenheit for 6 hours 0 minutes 30 seconds and - 58 degree Fahrenheit to + 5 degree Fahrenheit for 0 hours 7 minutes 30 seconds. There was previous temperature excursion. It was detected by a data logger.; Sender's Comments:  US-009507513-2104USA008022: US-009507513-2104USA008081: US-009507513-2104USA008255: US-009507513-2104USA008342:
1/25/2016 - patient received DTaP on left thigh. 1/26/2016 - patient developed swelling, redness and rash at injection site and rash on abdomen. 1/27/2016 - visit with PCP - instructed to give TYLENOL, ice compression, recheck 1 day. 1/28/2016 - mother reported local reaction is resolving.
Information has been received from a physician who received a letter on 11-JUN-2010 from an Ob/Gyn who concerning an 18 year old female with no pertinent medical history or no drug reactions or allergies who on 13-MAY-2009 was vaccinated IM with the first standard dose of GARDASIL. The second dose was vaccinated on 02-JUL-2009 and the third dose on 14-APR-2010. There was no concomitant medication. Subsequently the patient tested positive in the Pap smear even though the patient received 3 series doses of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Submassive pulmonary embolism with elevated troponins and an enlarged PA trunk on CT. Imaging reveals several bilateral and proximal pulmonary emboli within all segmental arteries (with the exception of the right lower lobe segmental pulmonary artery). PESI score 110 suggestive of high risk (mostly driven by the patient's age). Treated with heparin drip as an inpatient then transitioned to a direct oral anticoagulant on discharge.
Administered ZOSTAVAX and PREVNAR vaccines after pre-screening pt for appropriateness and if any contraindication present. Pt developed rash consisting of blisters, redness, weeping lesions on legs first, then arms, then trunk. Pt presented to MD office Thurs 5/14 and was prescribed prednisone, Amoxil, and clobetasol cream. As of 5/14 7pm rash is resolving per pt.
A report was received from a health care professional on 12/11/03 concerning approximately six children aged between 1 and 3.5 years and of unspecified sex who inadvertently received Fluvirin from an unspecified date in October 2003 until 12/9/03. Approximately six children inadvertently received Fluvirin from an unspecified date in October 2003 until 12/9/03. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: Follow up information received from a health care professional indicated that a 1.5 year old male vaccinee inadvertently received Fluvirin on 12/7/03. No adverse events have been reported to date. No follow up pending.
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 24-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
24y/o 100lb f who was given a h1n1 nasal attenuated vaccine 6 days after she was given the seasonal flu shot ..about 1 1/2 months ago .......pt says she developed  sxs 2 days after h1n1...pt says she has migraine headaches , back pain , neck pain , double  vision , and general malaise ...she has gone to her PCP and got a ct scan and was neg ..pt also said other labs were also neg.