chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 20-month-old male patient who received FLUARIX QUADRIVALENT (batch number J97D2, expiry date 17th June 2017). In October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2016, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The healthcare professional inadvertently administered FLUARIX to a 20 months old patient, which led to an inappropriate age at vaccine administration. Follow up information received from nurse on 28th November 2016: The reporter's contact details were updated. The patient's demographic details were updated. On 14th October 2016, the patient had had 15 month old well child. Billixy flagged, on 17th October 2016, the patient received 2nd dose of Flu vaccine intramuscularly at nurse visit. DTaP Flu shot deferred due to recent illness. On 17th October 2016, nurse visit the patient was given DTaP and FLUARIX (3+) instead of FLUZONE. In October 2016, less than week after receiving FLUARIX, the patient experienced injection site pain and injection site redness and cranky. On 1st December 2016, the patient had 1 flu shot but never had the follow up dose. It was a medication error without harm. He was scheduled to get FLUZONE (6-35 month old) on 28th November 2016 to complete the primary 2 doses. The VAERS information was updated.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 09/22/2004. Guardian, consented to the vaccination.  Department of Health verified with statistical records that the patients actual DOB is 09/22/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
Quarter will stick to injection area/a magnetic pull at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site). At the time of the report, VACCINATION COMPLICATION (Quarter will stick to injection area/a magnetic pull at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Heart racing; Fluttering; Stress; Anxiety; Dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0170) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; ATRIAL FLUTTER (non-serious), outcome "unknown", described as "Fluttering"; STRESS (non-serious), outcome "unknown"; ANXIETY (non-serious), outcome "unknown"; DEHYDRATION (non-serious), outcome "unknown".  Clinical course: The caller states her 19-year-old daughter got the Pfizer BioNTech COVID-19 vaccine in May2021 and had some heart racing and fluttering issues that were not immediate after the administration of the vaccine. These symptoms, that happened when the caller's daughter was 17-year-old, were attributed by the cardiologist to stress, anxiety and dehydration however, caller states that upon checking the VAERS reports, the lot numbers that her daughter was administered (EW0170 and FK9729) counted more that 3000 reports of side effects while her mother-in-law three lot numbers had only 124 reports. She now has learned to manage the anxiety a lot better, she's drinking the water she should, and she is still having these problems. Caller also states, "Your fact sheet should be more factual." After providing Pfizer MI and Customer Service do not have information on the production number for each lot of the vaccine: I've called multiple people from Pfizer, nobody has been able to give me this information. Patient was thinking something was a little shady. So, this study says that one month after dose 2 none of the people had contracted or tested positive for COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046062 same patient/vaccine/event, different doses;
no symptoms to report. Adverse event was administering 3rd dose of J&J when not supposed to
sugar dropped; was a little dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (1st dose), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "sugar dropped"; DIZZINESS (non-serious), outcome "unknown", described as "was a little dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother was asking if these are normal side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vax w/ MMR/Prohibit 1W p/MMR seizures, fever 104 x 2 lasting 10 min each  DX OM in ER. F/U 19MAR91:  HAS HAD SZ SINCE, D/T VIRAL ILLNESS, NOT VAX RELATED.  PRESENTLY OK & DOING WELL.
Received dose from vials beyond 30-day use by date; Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Date of refrigeration was 7 May 2021.
On 4/15/06 Present in office 4/15/06 with local vaccine reaction. Top of left leg was red and indurated. Comvax and MMRV had both been injected in left leg on 4/3/06.
Administration error: Patient received his Moderna Booster, on November 14, 2021 when according to the established guidelines his booster is to be administered on December 14, 2021 six months after the second and third dose.
Few days after vaccine noted significant night sweats--soaking the bed. 13 days after vaccine (1/10) I noted supraclavicular lymphadenopathy (L sided). 14 days later (1/11) I had onset of exertional tachycardia. Heart rate would increase to 120-130 with simple activities like cooking dinner or taking a shower. This was sometimes prolonged with standing and associated with shortness of breath.  The night sweats continued for the next 6 weeks until time of submission. The lymphadenopathy was also noted L axilla and R supraclavicular and has also persisted. 2nd covid moderna vaccine received 1/30/21 with only mild headache.
SWEATING, MILD NAUSEA, COLD HANDS AND FEET, DIARRHEA, PAIN AT THE INJECTION SITE, SORE ARM NEXT DAY
Shots didn't work for me. On my fifth year. Pain everyday/ suspected vaccination failure; Shots didn't work for me. On my fifth year. Pain everyday; Pain every day.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said shots did not work for him/her. On patient's fifth year, the patient had pain every day. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Received both Moderna vaccines at the medical facility (01/16/2021 and 02/12/2021).   Fully vaccinated covid death.
patient was given pediatric dose without diluting 0.3ml, spoke to md and they are fine.
received their First dose of the pfizer covid vaccine on 3/24/21; a week and half later they were tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program COVAX support reported by a contactable nurse (Reporter Subtype: Pharmacist). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was tested positive for covid a week and half later after vaccination. The reporter reported that there was no PQC. The reporter needed the information about the second dose, when the patient should get it. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021432741 Same reporter/drug/AE, different patient
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent. A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "cant walk straight".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain in my left side and pain in my left arm. It was very hard to breath.
Vesicles few scattered on head, extremities; enduration on (R) thigh muscle with  dermal erythema and dermal edema.
Patient began reporting dizziness approximately 5 minutes after vaccine given- patient's vitals monitored  over an hourwhich were stable; B/P 140/80's; juice and crackers provided.
Moderna COVID-19 Vaccine EUA. After about 12 hours of injection, extreme chills unrelieved by heat application started which extended to about 30 hours after injection. Chest pain (sometimes sharp, sometimes a fluttering/tickling feeling) with heart rate up to low 100's, weakness, full body aches, coughing, and general side effects for approximately 36 hours. Symptoms able to be resolved on own after 36 hours of injection. Altered sense of smell only remaining symptom at time of this entry.
eyes burn; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burn) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information was provided.     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 EYE IRRITATION (eyes burn). At the time of the report, EYE IRRITATION (eyes burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies or food and none daily medications were reported. Positive or negative COVID-19 within last month of vaccination was not applicable.  Concurrent medical conditions included Hyperlipidemia and Bipolar disorder (Bipolar).    On 06-Apr-2022 at 9:25 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.  Patient received a vaccine past the 30-day storage on the refrigerator. The Moderna vaccine in question had been put aside and was not currently being used until further notice.  The vaccine was refrigerated on 25-Feb-2022, but it got expired on 25-Mar-2022 and later was administered on 06-Apr-2022 (administered after 30-day Use By Date). Vial did not undergo any temperature excursions.  The patient was not experiencing any side effects yet.
Information has been received from a health professional concerning a 30 year old female dialysis patient with SLE and Sjogren's syndrome who is on the transplant list and no known allergies who on 8/25/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647029/0460P). Concomitant therapy included her regular medicines and epoetin alfa. Other concomitant therapy included a second dose of hepatitis B virus vaccine (lot # 644857/0370P). The first dose of hepatitis B virus vaccine (lot # 644857/0370P) was given on 7/30/04. On 9/21/04 the patient had a grand mal seizure at home. She went to the ER and had another seizure while in the ER. She was hospitalized and her sodium was low at 122. The sodium was replaced, but the patient had another seizure while hospitalized. All labs, including a CT scan and head MRI were completely normal. It was noted that the patient had a low hemoglobin recently due to a heavy vaginal bleeding, but that had been corrected. The patient has been released from the hospital and recovered with no sequelae. At this time, no one knows what caused the seizures. The patient has been placed on seizure precautions, medications and prednisone. She has also been removed from the transplant list. No product quality complaint was involved. No further information was provided. Additional information is not expected.
Vertigo/Booster was about 20 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical location: Arm Left), administration date: 14Apr2021, for Covid-19 immunisation, reaction(s): "vertigo"; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0173, Anatomical location: Arm Left), administration date: 07May2021, for Covid-19 immunisation, reaction(s): "Vertigo". The following information was reported: VERTIGO (non-serious) with onset 2022, outcome "recovered", described as "Vertigo/Booster was about 20 days later". The event "vertigo/booster was about 20 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient experienced vertigo with all the three doses and afraid to get second booster. The patient did not have any other vaccines in four weeks. The patient had no covid-19 prior to vaccination. The patient was tested negative for Covid-19 post vaccination. The patient had no known allergies and other medical history. Other medications in two weeks included Multi vitamins.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201157238 Same patient/Vaccine/event, different dose;US-PFIZER INC-202201157337 Same patient/Vaccine/event, different dose;
Left side body numbness, including tongue, face, and arm. immediately and on going Extreme nauseanes  immediately has gotten better Body aches immediately and on going tiredness immediately and on going chest tightness/ soreness immediately and on going Brain fog  not able to focus having problems keeping thoughts going immediately and on going
Mild tenderness after shot.  Nurse pinched arm to inject which I thought was unusual. I had some itchiness.  I think it was seven days later that I noticed redness about the size of a silver dollar around the site.  It had been itching.  Today is day ten and the redness is still there.  I have very slight pain at site but was concerned that it was still "red" -  more pink and after ten days.  Just wanted to report it to see if it's normal.  My next vaccine is scheduled for March 1, 2021.   Thank you
Received vaccine at 1700, at 1715 started to feel a lump in her throat, itchy eyes, throat swelling, constantly clearing her throat. Epi-pen given, oral Benadryl sent to Urgent Care. In Urgent care given Pepcid and fluids. At 2030 patient felt throat was scratchy and tight, felt the need to clear throat and throat tightness. Second epi=pen given and transferred to Emergency Department via EMS
This spontaneous report as received from a nurse via company representative refers to a 3 year old patient. No information on patient's medical history or concurrent conditions was provided. On an unknown date in 2012, the patient was vaccinated with the dose of PEDVAXHIB, MMR II, VARIVAX and RECOMBIVAX HB (doses, lot number and expiration date were not reported). No information on patient's concomitant medication was provided. On approximately 25-SEP-2015 (reported as "was just administered") (also reported as date unspecified), the patient was administered the "catch up" dose of PEDVAXHIB, MMR II, VARIVAX and RECOMBIVAX HB (doses, lot number and expiration dates were not reported). No adverse effects reported. Additional information has been requested.
Patient called to inform us that one hour after vaccination she developed hives on her right arm that spread to her neck and chin. She states she took an over the counter antihistamine (unsure of name). She states the hives went away shortly after and have not returned. Denies facial edema or shortness of breath.
5 minutes after receiving covid vaccine shot felt itchiness on injection site, left arm. 5 minutes later felt itchiness on right shoulder and arm. Monitored  VS. Pt's mother &  doctor at the bedside. 25 mg PO Benadryl given. pt discharged home per MD's order.
pt recvd 1st Hep B vax on 8JAN92 & w/in 15 mins of vax devel a knot @ inject site; w/severe itching; the itching lasted for 2 days; it required no treatment & resolved;
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Pt developed bluish discoloration and 1 cm lump at injection site. Stable - not changing since vaccination. No limitation to activity. No pain.
pt was observed for 15 minutes after receiving moderna covid-19 vaccination and was discharged home. Pt states as she was driving home she noticed hives devloping over face and chest and returned to clinic i8mmediately after (about 25 min total after receiving vaccine)
I only had a sore arm after my first. After my second dose, I had chills starting 11 hours after. They were so bad that I was shaking and couldn?t sleep. They lasted about an hour, and then a fever started. It lasted all night and until around 9 AM the next morning. I also had severe low back pain that kept me up all night and has lasted off and on throughout the day today as well. I still have a lingering headache too.