chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient asked for the 2 nd  dose of moderna in the primary series and was given the bivalen
Diarrhea, runny nose, fever not noted greater than 100.6 degrees F.  Mother noticed fussiness 4-6 hours after the vaccinations.  She states the fever broke 48 hours after shots.  She thought the vaccine symptoms may have coincided with teething.
Information has been received from a registered nurse concerning an 11 year old female who on 06-APR-2000 was vaccinated SC with a first dose of Varivax (lot 632369/1461J). Concomitant vaccinations administered that day included an IM fifth dose of DTaP, a SC fourth dose of poliovirus vaccine and a SC second dose of MMR II (lot # 654043/1716J). On 20-MAR-2006 that patient developed chickenpox. The child was seen by a physician and diagnosed with varicella. She had less than 50 lesions mainly covering the neck and stomach. She did not have a fever. NO treatment was ordered and no labs were done. There were no other symptoms. At the time of the report the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Fever, sores around mouth, couldn't sleep, poor appetite. Abscess? Impetigo/varicella.
Approx <24 hrs after vaccines, developed redness, warmth, itching at both injection sites. Worsened with spreading redness at 48 hours. No fever. Right vastus lateralis- Tdap with 7x7cm erythema.  Left vastus lateralis- Menactra with 9x10cm erythema
Received first covid vaccine on 7/22/21. Required admission to hospital for covid pneumonia on 8/12/21
No other AE reported; Expired vaccine used; This spontaneous report, as received from a pharmacist, refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications, drug allergies, or reactions was not provided.     On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular for prophylaxis(lot # S026366, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 17-SET-2020) (expired product administered). No other adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA006884:
I contracted COVID-19. I had body aches, chills, and fever. It lasted, I was too sick to do daily activities for about 8 days.
Red, raised indurated area developed around 2 injection sites on the left thigh. Pt. was prescribed Bactrim & Keflex in urgent care; symptoms started 9 days after injections. Redness, warmth, swelling decr. after 2 days abx.
1 week after injection itchy, hot, inflamed, red rash began at site of injection. It has persisted for over a week.
Left side of face is swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Left side of face is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Facial swelling in 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SWELLING FACE (Left side of face is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Left side of face is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that, patient was taking medical history and was on medications.,  Treatment for the event included diphenhydramine HCl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The pt experienced a fever which began 4 hours post fav and lasting for 4 days. This was accompanied by lethargy and required an ER visit.
expired dose of Rotarix; second dose /administrated late for the recommended schedule; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX LYOPHILIZED FORMULATION).   On 29th October 2021, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated an expired dose of Rotarix, which led to expired vaccine used. The expired dose was meant to be a second dose which was also administrated late for the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not have the exact expiration date of the vaccine because the health care professional was not at the faccility, but was informed by the colleagues that it was in fact expired. No further events were reported. The reporter consened to follow up.
had severe onset diarrhea with bright red blood shortly after taking Vicks sinus medication - have taken that medication with no effects prior to having had the vaccine. ischemic colitis seemed like what I was experiencing  with sever cramping
Patient fainted after receiving vaccines. Patient was calm and and did very well during process. After receiving vaccines, patient went limp in chair. RN held patient up and fanned patient and applied cold washcloth to patient's neck. Patient came to quickly and felt nauseous and hot. Patient did not vomit and improved with water and cooling down. Mother at side. Patient had never passed out and was surprised he did as he was not scared of needles and had tattoos. RN monitored patient for 15 minutes without adverse events or reactions. Mother was driving.
This spontaneous report was received from a healthcare worker referring to a patient of unkown age and gender. The reproter reported that improperly stored GARDASIL (Lot# unspecified) (1 dose) was administered to the patient on unknown date (route and frequency unspecified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
My arm was sore for a few days. Then, it was itchy for a few days. I had diarrhea the day after the vaccination. I also had chills, but I did not have a fever.
Persistent headache for many weeks; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced persistent headache for many weeks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event persistent headache for many weeks was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN and a mother concerning her 8 yr old daughter who was vaccinated with a dose of varicella virus vaccine live. On 08Jun05 the pt was seen at the health dept with approx 50 pinpoint red papules at differing stages scattered throughout her body. It was also noted that the girl had not been feeling well on 07Jun05. The mother was advised that the rash could represent varicella disease but other etiologies could not be ruled out, therefore, the child should be considered contagious for at least 4-5 days until all of the areas are scabbed over. The nurse also reported adverse experience of three siblings who had previously received a dose of varicella virus vaccine live (WAES0507USA01715, 0507USA03557, and 0507USA03558). Additional information has been requested.
got 101.7 fever; headaches; bodyaches; Joint pain; stomachache; sick; have not felt well since; This is a spontaneous report from a contactable consumer. This 60-year-old Female consumer (Patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9267, Expiry date: Unknown) (age at vaccination: 60years-old) via an unspecified route of administration, administered in Arm Left on 17Feb2021 07:20 as dose 2, single for COVID-19 immunisation. Patient medical history included Gamma globulin anaemia and do infusion once a week 9 grams of Hizentra subq, Autoimmune disease and Connective tissue disease from 01Mar2013. Patient already had COVID and hospitalized in July2020 got out, went back 14 days later left lung collapsed. Patient previously took dose 1 BNT162B2(Lot number: EL9263) on 25Jan2021 for COVID-19 immunisation. The patient concomitant medications were not reported. On 17Feb2021 20:00 the patient experienced got 101.7 fever, bodyaches, joint pain, stomachache, sick and have not felt well since. The patient underwent lab tests and procedures which included body temperature: 101.7 on 17Feb2021. The outcome of the event fever was recovered on 19Feb2021, have not felt well since was unknown and all other events were recovered on 21Feb2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021132518 Same patient/ drug and different dose/event.
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 11 YEARS OLD AND PFIZER 0.3ML DOSE IS INDICATED FOR 12 YEARS AND OVER. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN QUALITY ASSURANCE AUDIT.
6/10/03 Pt received Adult Td booster to left deltoid and on 6/11 noticed itching, swelling and red area around injection site. Today 6/13/03 pt examined and has local area of erythema and warmth to site. No fever or facial swelling.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 03-APR-2015 was vaccinated with an unknown dose of ROTATEQ (lot # K011663) (route identified as oral) that was 12 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
rash, hives. popping up every day since 2 days after shot. Its been 8 days and i'm still getting these hives popping up and itching each day.
This spontaneous report as received from a Medical Assistant refers to a 15 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-MAY-2016, one day before the patient turned 16 years old, the patient accidently received a dose of VAQTA (dose, route, lot# and expiration date were not reported) instead of GARDASIL. The reporter stated that the dose of VAQTA the patient received was an extra dose of Hepatitis A vaccine because the patient completed the series as a child. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been requested.
Perceived loss of hearing 12/16 Documented loss of hearing 500HZ on right ear Right ear looked normal to inspection
14 hrs following vaccines felt lethargic, hot, nauseous. Headache, malaise , chills, pins & needles in arms and legs,  nausea severe enough to keep me in bed for 2 days. Gradual letup of symptoms  except prolonged nausea , diarrhea & fatigue still continuing 8 days later. Can?t get back to normal routine still.
Swollen, painful, erythematous arm for 3-4 weeks with ongoing localized pain, normal function.
Pt stated she had swelling and pain at injection site.  Fever of >100.  Redness at site.  No SOB.  Area at injection site noted to have be warm to touch and hard.
Every day at random times a week after I got the vaccine, I've been experiencing heart pains in a random manner throughout the week. Sometimes it feels like my heart is going to sink when I sleep.
None. Pt received flu vaccine 9/8/2022 and 10/13/2022
PATIENT DEVELOPED HOTNESS ALL OVER AND A HEADACHE AND AN INCHREASE  IN BP. PATIENT DID NOT WANT EMS CALLED AND HAD HER HUSBAND DRIVE HER HOME I ADVIZED HER HUSBAND TO KEEP AN EYE ON HER AND IF HER SYMPTOMS CONTINUED TO CONTACT HER PRIMARY DOCTOR OR AND IF THEY GET WORSE TO CALL EMS.
No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 12-JUL-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) albumin status rHA (second dose, 0.5 mL, lot #W036940, expiration date was reported as 15-APR-2024, but upon internal review was established as 19-MAY-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).   On unknown day, the suspect vaccine experienced a temperature excursion of -8.6 degrees Celsius (C) for 51 minutes. There was previous temperature excursion of -11.5 C for 1 hour and 16 minutes. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No further details given.  This is one of several reports from the same reporter.
Client's guardian reported wrong date of birth on two separate occasions, 6/17 and 7/15.
Pt exp inject site rxn & local hives w/in 2 minutes p/immun; There were 5 linear streaks of hives 6cm x 1, area of inject site rxn was 4 x 5 cm wheal & flares; tx Susphrine; Resolved w/in 4-6 hrs;
Patient was given the shot in the (L) deltoid. He immediately felt numb and weak on the entire (L) arm. He regained over 30min strength in the (L) hand but was only able to flex the elbow to 100 degrees. He felt less sensation in the upper arm on the left side.
Patient who has gotten the 2nd dose early; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a pharmacist and reported that they believe one of their patients was given second dose of vaccine early. No detail of patient demography, vaccinated date, anatomical location, Lot number, Date of expiration or any symptom after administration was provided.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
On 04/01/2000, post vaccination, the patient developed a 1cm by 2 cm red dermal nodule that was fairly soft superficially, but indurated deeper in the dermis of the vaccination site. The nodule was present for 5 months and resolved to a flat scar, still indurated like a "dermato fibroma" within 1 month of treatment with Topicort Cream. Additional information is not expected. Per F/U 6/17/02: Information has been received from a physician concerning a 12 month old white male, with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination on 3/31/00 with a 1st dose of varicella (lot 631475/1003J) in the thigh. Concomitant vaccination the same day, included the 1st dose of MMRII (lot 632236/0937J) in the thigh. In 6/00, a course of cephalexin was tried and failed. In 9/00-10/00, the pt was referred to a dermatologist who treated the red nodule with Topicort Cream. It was reported that the pt (WAES00101513) had a similar experience following exposure to MMRII. Additional info is not expected.
fever, runny nose, fatigue, cough, shortness of breath, no appetite, loss of smell
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 30-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715: US-009507513-2207USA004234:
This spontaneous report as received from a physician refers to 2 patients of unknown age and gender. On 01-JUL-2013 the patients were vaccinated with a dose of MMR II (Lot # H018181, exp date 05-OCT-2014) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patients received MMR II that was exposed to 70F for 16 hours. No adverse effect reported. Additional information has been requested.
Pain inside the left bicep muscle; Pain in the joints near of the elbow; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old patient (unspecified gender) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included tendinosis in the wrist, arthritis, herniated disc (stenosis), COVID-19. The patient had no known allergies. Concomitant medications included cyclobenzaprine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), vitamin d nos (VIT D) and MULTIV all from an unknown date and for unknown indication. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced pain inside the left bicep muscle and in the joints near of the elbow. The patient reported that one month after the second dose and the pain continued. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events pain inside the left bicep muscle and in the joints near of the elbow was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.