chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration error: RN administered Adult dose Havrix Hep A to patient who was 16y11mo of age. Pt tolerated vaccine well. Error recognized next day by clinic staff. RN reached pt by phone to let her know about error and assess for any adverse effects. Pt reported that her arm was sore after injection but soreness was tapering off. Pt verbalized understanding of error and denied further questions/concerns.
pt was sitting on exam table for vax; recvd vax & as needle was withdrawn, pt lost consciousness, fell off exam table to lt side, fell to floor & hit head on edge of wall desk; 1cm laceration; dizzy;
Dizzyness; Body Ache; Fatigue; Chills; Head ache; Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Head ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101.5 (High) 101.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Fever, chills, fatigue and headache are consistent with the product known safety profile.
8/3/2021- Patients roommate tested positive.  8/6/2021- Patient presented to clinic for COVID-19 test. Pt hat the following symptoms: cough, nasal congestion, diarrhea. Patient tested positive .
VACCINE EXPOSURE DURING PREGNANCY; LOST WEIGHT; This spontaneous pregnancy report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy, and lost weight. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost weight and vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20220114730 and 20220137233.
Far more pain and burning than any previous flu shot. Injection was made too high and not in my muscle I believe. Shot given only 1 inch below top of shoulder. Burning and stinging are continuous. Hard lump where vaccine has not been incorporated into the muscle. Arm mobility is painful and limited. Injection location made above deltoid muscle near shoulder bone.
Rash on arm 3 days after vaccine; Vomiting; Could not get out of bed; Body aches; Worst migraine I've ever had; Insomnia; Extreme nausea; Felt so sick; Fever of 102; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), MIGRAINE (Worst migraine I've ever had), INSOMNIA (Insomnia), NAUSEA (Extreme nausea) and MALAISE (Felt so sick) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Peanut allergy, Food allergy (Treenuts) and Fruit allergy (Fresh fruit).   On 12-Mar-2021 at 5:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 5:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021 at 7:00 PM, the patient experienced PAIN (Body aches), MIGRAINE (Worst migraine I've ever had), INSOMNIA (Insomnia), NAUSEA (Extreme nausea), MALAISE (Felt so sick), PYREXIA (Fever of 102), VOMITING (Vomiting) and FATIGUE (Could not get out of bed). On 12-Apr-2021, the patient experienced INJECTION SITE RASH (Rash on arm 3 days after vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form(2 days). On 11-Apr-2021, FATIGUE (Could not get out of bed) had resolved. On 17-Apr-2021, INJECTION SITE RASH (Rash on arm 3 days after vaccine) had resolved. On 25-Apr-2021, PAIN (Body aches), MIGRAINE (Worst migraine I've ever had), INSOMNIA (Insomnia), NAUSEA (Extreme nausea), MALAISE (Felt so sick), PYREXIA (Fever of 102) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102 (High) 102.         Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054591 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054591:First dose case
broke my hip; fell; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Apr2021, the patient stated that he couldn't make the 2nd dose scheduled on 20Apr2021 because he just got released from the hospital because of hip replacement surgery and needed to rest for a bit. The patient planned to reschedule the 2nd dose on 26Apr2021 if possible. On 18May2021, the patient stated that the week before his 2nd shot appointment in Apr2021, he fell and broke his hip and had to delay the 2nd shot by one week. The patient had no issues with the shot. The outcome of the event was unknown. The patient reported that there was no relationship to shot.  Information on the lot/batch number has been requested. Further information is expected.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events fell and broke his hip are not related to BNT162B2, but an accident.
From 12/10/22-12/17/22, I had fever 99-101 and extreme fatigue -- this was certainly side effect from vaccine.  From 1/8/23-1/30/23, I had vertigo and fatigue--my doctor and I are not 100% certain it was the result of the vaccine.
Severe shortness of breath. Unable to walk or talk. Had to go to "ER"  via ambulance and was in hospital for 4 days.
Exactly 6 weeks after receiving the vaccine, I woke up that morning and every joint, shoulder to ankles were achy. I was given meloxicam for the pain. The medicine given helped with the joint pain. The pain lasted for about three days.
blisters, reddish/purple on front and back of hands; feet; and around and in mouth. RX steriods by PCP
Extreme fussiness, almost inconsolable at times, excessive sleeping (i.e. having to wake her up after 3 hour naps).  The above symptoms started by afternoon on 9/28 and have continued throughout today.
Temperature excursion occurred due to the vials not being pulled out of the freezer on 10/19/21 according to storage guidelines vials were not pulled out until November 2, 2021 @ 0800.
Mixed with wrong diluent making the vaccine invalid pt is rescheduled to receive valid dose.
Patient has a swollen left shoulder that is tender to touch. There is a 1 cm area of induration with erythema. She reports it is hard to move the arm above her shoulder.
presented at 1340 "not feeling well, itchy, hot, dizzy"  received covid vaccine 3 hrs prior, no new foods or environmental triggers  syncopal episode at 1344 -> 120/91, 73 bpm, 100%, 131 blood glucose  heart & lung sounds wnl  facial swelling, erythematous raised rash to neck / semi-conscious for approx 2 min  50 mg diphenhydramine administered @ 1346  regained consciousness and transported to bed for ekg, which showed nsr  lucid but still altered and unable to sit up without feeling dizzy  8 mg of dexamethasone administered at @ 1356 -> 111/76, 64 bpm, 100 %  pt was then deemed stable and elected to go home  son called for transportation  strict er precautions given
First shot reactions: I woke up I was in so much pain over my whole body. I was sobbing. I was told I could take ibuprofen, so I did , it helped relieve some of the  body aches. But the headache on the left side continued for 4 days. I stayed in bed for 4 days. The second shot, I got a horrible headache within the fifteen minutes,  I told the staff I had a horrible headache but they said to go home anyway. This was March 10th.  I went home and was in bed for 2 days. Since then I have a sick headache on left side, and blurred vision, the fatigue is terrible and I am dizzy, I don?t feel like I have my balance. I?ve been to 4 specialists since then with numerous tests, but no one has an answer.
rash started on 27FEB98 & went in to welts, hands red, eyes swollen;
shingles twice, Got the two shots/Suspected vaccination failure; shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments: The case was reported by the patient via interactive digital media. The patient got the two shots. The patient had shingles twice.  The patient said please get them. Much better than the alternative. Additional Supportive Information: This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
severe cramps in both legs & feet;unable to drive car;As of 1APR96 only has soreness in one calf muscle in leg;did not seek med attention;
Patient is under 65 years old and was given  FLUAD which is the 65 and older vaccine. This was done at an off site clinic at a senior living center. Patients nurse and doctor were on site and notified and will monitor patient, didnt think any harm was done to patient.
pt c/o arm discomfort early in evening on day recv vax;had sl temp elevation 100 which mom stated lasted about 24hr;child w/n/v x 3 that noc which resolved Friday 4/16/99;redness, puffiness;
The evening of the vaccination patient started to have aches all over his body and run a fever. The fever of around 104 degrees ran for approximately 2 days.
Patient reports itchiness to opposite forearm (right).  Redness to right forearm 2x1 in. size.  Pt. states no pain in area.  Redness subsided.  SOB.   No signs of discomfort or anaphylaxis.  Pt. left facility in stable condition.
Notified by police department that patient was found dead at his home on 3/12/21.  Per the officer, the family reports patient reported diarrhea on 3/11/21 and fatigue on 3/12/21.  The family found him in his home deceased later in the day on 3/12/21
8OCT97 noticed sore upon wakening, no elevation in temp;9OCT97 aroused 11AM body appeared to be sunburned;temp @ 12:30 100.7;took APAP;T102.2;T102;joints hurting behind knee, wrist lip & eye swollen;all body deeper red;dx micro-hives;
Blurred vision + eye irritation started the day after second Covid shot and continues to present.    Started Maxitrol Rx on 9/2/21
This spontaneous report was received from a pharmacist refers to a patient of unknown age.  On 08-JUL-2017 the patient was vaccinated with one dose of improperly stored ZOSTAVAX 19400 PFU, lot # N009777, expiration date: 04-MAR-2017) (route and dose# unspecified) for prophylaxis. Temperature and time frame: 6°F to l4°F for 5 Hours 15 Minutes respectively. There was previous temperature excursion. The call was because of a data logger. Concomitant therapies included sterile diluent (DILUENT MRK INJ). The sterile diluent (DILUENT MRK INJ) did not undergo a temperature excursion. No adverse effects reported. No additional information provided.
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022.; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On an unknown date in 2022, the patient was vaccinated with the a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, once (lot number W016358, expiration date 16-NOV-2023) (route of administration and anatomical location were not provided) as prophylaxis. According to the temperature stability evaluation of vaccines, the vaccine administered had been suffered a temperature excursion since 14-JUL-2022, no exact dates provided (Product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004086: US-009507513-2208USA004135: US-009507513-2208USA004105: US-009507513-2208USA004255: US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004060:
A report was received from a health care professional on 10/24/2002, concerning a 12 month old male vaccinee who inadvertently received 0.25 ml Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced a medication error following inadvertent administration of 0.25 ml Fluvirin intramuscularly. No adverse event was reported. There was insufficient information to determine the reporter's causality assessment. Update 1 12/09/2002: A follow up report was received from a health care professional on 12/09/2002. It was reported that the vaccinee received 0.5 ml Fluvirin subcutaneously on 10/23/2002. No adverse reaction was reported.
This spontaneous report was received from a registered nurse refers to a 44 year old male patient. On 10-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck), (lot number, expiry date and route was not reported) instead of MMR II. Concomitant medications were not reported. No adverse symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Caller is reporting that an improperly stored vaccine was administered on 25JAN202 l.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally , lot # 1688504, expiration date: 19-NOV-2021 (exact dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 13.4 degrees Celsius for 2 hours and 9 minutes. Data logger was involved. There were no previous temperature excursions reported.
Excessive hair loss.  Her hair had become very brittle and would break or fall out when washing.  This was 2nd Gardasil shot. She developed pneumonia after 1st shot.
About 15 yrs ago, I had a herniated vertebra disc - L 3-4.  I have had to be careful with lifting etc, but had had minimal problems over the years.  I had no problems or exertion just prior to the vaccine.  24 hrs after I got the shot, that nerve in my right leg intermittently burned like fury - off & on X 48 hrs.  Gradually decreasing in intensity & frequency.  That was 9/8.  All symptoms are gone.  No treatment.
I received the injection and experienced minor soreness immediately. At 11:30 PM I woke up with severe pain in my shoulder and back. My left arm, shoulder, chest and back were swollen. I had 104.5 fever and I had severe pain in my arm and a sharp pain in my upper back.  I was also suffering chills and extreme fatigue. I took Tylenol and it did nothing, so I took my prescription for Oxycodone and that reduced the fever and the pain.  The swelling had decreased to just the injection sight by morning (1/4/22) and my fever broke.  I continued to have fever (101) the rest of the day and through the night.  On the afternoon of 1/5/22 I still have slight swelling and soreness in my left arm at the injection sight.  I still am running a low grade fever.  During this time I saw my Pain Management Doctor and told them what happened and they advised me not to get any more Covid vaccines.
That evening I found him unresponsive and not breathing in his crib. I gave resuscitation breaths to get him responsive. The following day he was irritable, cried constantly, vomited and had diarrhea. This continued for 2 months. From the night of his vaccinations, when I gave resuscitation breaths, he has had Apnea.
This spontaneous report as received from a consumer via Clinic refers to a currently 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAY-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Vial of vaccine was diluted incorrectly with 0.8ml of sterile diluent instead of 1.8ml.
Patient did not experience any adverse effects from intramuscular injection. No additional AE; HCP reporting that PROQUAD was given intramuscularly instead of subcutaneously.; This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered intramuscularly instead of subcutaneously (dose, dose number, anatomical location, lot # and expiration date were not provided) for prophylaxis (incorrect route of product administration). The patient did not experience any adverse effects from intramuscular injection, no additional adverse event was reported (no adverse event).
This spontaneous report was received from a nurse and refers to a 4 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 22-JUN-2017 at 09:32, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DTAP) and poliovirus vaccine inactivated (unspecified) (IPV). The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  Patient received second booster dose.  It was reported that the dates of administration were 3MAY2022, 4MAY2022, 9MAY2022, 11MAY2022, 17MAY2022, and 20MAY2022  No treatment medications were provided by the reporter.
Patient came to the pharmacy and had a large red area/rash on the arm the vaccines were given. The red area was about 1-2 inches by 3-4 inches. She reported it was itchy, hurting, and swollen. She stated that on the day of the vaccine and for 2 days after she was unable to move her arm due to swelling and pain but starting on the 4th day that symptom improved. She also reported having a fever and body aches for 3 days after receiving the immunizations.