chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022; Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). 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 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, sigle (Lot number: EL3248), in right arm, on 22Mar2021 as dose 2, single (Lot number: EL3248), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 44 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Large 5 inch lesion at site. Started 1D after administration. Severe local reaction - no anaphylaxis.
Allergy from mosquito all over body; felt tired for 2 days; arm soreness; Arm Itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy), HYPERSENSITIVITY (Allergy from mosquito all over body) and FATIGUE (felt tired for 2 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (Patient experienced the same allergic reaction from vaccine that he experienced one month ago after a mosquito bite. He had an allergic reaction all over his body which lasted for a couple of days.).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy) and FATIGUE (felt tired for 2 days). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy from mosquito all over body). On 27-Apr-2021, FATIGUE (felt tired for 2 days) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), PRURITUS (Arm Itchy) and HYPERSENSITIVITY (Allergy from mosquito all over body) outcome was unknown.            No concomitant medications were provided. No Treatment medications were provided.   This case was linked to MOD-2021-279689 (Patient Link).
dose 2, 5 days before 6 months; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 7-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was unknown. The reporter was the patient's grandmother. The patient received 2nd dose of Havrix, 5 days before the 6 month period, which led to shortening of vaccination schedule. The reporter wanted to know if the series had to be started again. The patient was referred the healthcare professional. The reporter did not consent to follow-up.
- stomach upset and diarrhea the first night after being vaccinated  - general malaise for a few days after vaccinated  - developed petechial rash on top of hands
kicked my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (received 1st dose and it kicked his or her butt and refer case US2023AMR060423).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: kicked my butt). Rechallenge with Shingles vaccine was positive. The outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR060423   Additional Information: GSK receipt date: 23-Apr-2023 The case was received from the patient via interactive digital media. The patient got the jabs year ago and kicked his or her butt for a few days. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR060423:Same patient/same product
pt recv vax AUG96 & pt exp a very low platelet count;pt condition was improving @ the time of the report, but had not yet recovered;
Headache, fatigue, night chills, and injection site swelling and redness for approximately 3 days after injection beginning morning after.
Reaction to P from DTaP. Reaction versus viral illness. Reaction versus meningitis.  Nurse follow up on 07/20/04 states: "Complete."
Hot, swollen arm at injection site. Raised, red, round circle about 3" in diameter around injection site, and another raised, red, round circle about 2" in diameter below the injection site. Weeks later she complained of nightly headaches and stomach aches. We visited 4 doctors. One said constipation, one said allergies, another said anxiety. The 4th doctor actually tested her on 07/20/2018 and found her levels of aluminum to be the highest he had ever seen in an adult or child.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot# and expiration date were not reported). On an unknown date, within one week, the patient had "a short episode: of bloody stools. On an unknown date, the patient was vaccinated with the second dose of ROTATEQ orally (dose, lot# and expiration date were not reported). The physician mentioned the patient had the same experience of bloody stools. The patient was sent to the emergency room for evaluation on an unspecified date after the second dose. The patient sought medical attention via office visit. The outcome of the event was reported as recovered/resolved on an unknown date. The relatedness between he event and ROTATEQ was not reported. Additional information is not expected.
09/21/2005 - Had DTAP and Polio injections in left thigh.  09/22 complained of left thigh hurting.  Later that afternoon leg began to swell and felt very warm.  "Not herself".  09/23 Developed red blotches over area of swelling, less tender, slightly less edematous.  Edema from knee to 3 inches below groin.  Advised Motrin, warm compresses.  Fever of 101 degrees yesterday.
pt had screaming episode lasting 5 mins then had < 1 min jerking-?sz; pt observed in hosp over noc; had nl exam thru out;
Severe chills and shivering, violent abdominal cramping, and lethargy for 72 hours.
Left upper arm became red, swollen evening of day after vaccine. To use cold compresses tid.
Information has been received from a RN concerning a 12 month old Hispanic and Black female who was vaccinated on 15-JAN-2001 IM in the right leg with a third dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which stated that the child developed a lump and bruise at the site which was still present 12 days later. The lump was "the size of a pea". No intervention was needed and pt recovered.
Moderna, dose 2 administered fewer than 24 days after the first dose. Moderna dose 1, administered 02/26/2021
Janssen Covid 19 Vaccine clinic held at(Onsite Employer Services)Lot # 1808980  exp. 6/20/2021 As reported on Episode Note: Client returned to vaccination area c/o lightheadedness, dizzy, warm, chest discomfort. BP 114/74, HR 80 C/o centralized chest pain, pain level 5/10, sharp stabbing pain. "Feels like I swallowed water and it's stuck." Pain began when she walked down from the observation area.   1154- approximate time EMS called d/t continuing chest pain. 1156 BP 122/68, HR 84. continued dizziness, increasing fatigue.  Applied ice pace to nape of neck.  After ice pack applied, client c/o numbness/tingling of Right arm.  Ice pack removed. 1158 Patient requested RN call father. Father notified of client status per client request. 1207 Reports feeling chilled, continued chest pain and fatigue. EMS arrived. Vital and 12 lead EKG completed by EMS. Patient denied transportation to hospital.  1215 EMS left. Patient requested RN to notify father to pick her up from employers.  HR met with client to complete incident report. 1219 Father contacted to pick up patient.  Client voluntarily walked to main entrance of building with HR contact.
Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy.; Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9942) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy". The patient received treatment Paxlovid from 25Jul2022 to 29Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Redness, swelling, and tenderness increased from about 0.5inches  24 hours after injection to about 3 inches in diameter two days after injection.
2.5" - 3" dia. redness with swelling, tenderness, minor itching - all at inj. site. Headache, severe backache, body ache, sick to stomach with small amt. vomiting and diarrhea.
Chest pain 24hrs post COVID vaccine that progressed x 48hrs.  He received his second dose of the Pfizer COVID-19 vaccine 3 days ago. Since the vaccine he has been having low grade tactile fevers and headache that mom has been treating with Tylenol as needed. His chest pain is central and does not radiate. He denies syncope, shortness of breath or dizziness, and lower extremity edema. He does feel like his heart is racing at times and occasionally skips a beat. The pain is worse with exercise and with lying flat, he prefers to lean forward. Admitted for acute myocarditis post Covid vaccine.  Toradol q8hr. IVIG and 1 dose of solumedrol being given. Following serial troponins
Patient received 4 vaccinations on 02-18-09.  Later in that same day, patient complained of right arm pain.  Per Mom, the deltoid site was erythematous, warm to touch, and slightly edematous.  Mom called the NP and was told it was probably a localized reaction to vaccination, but the inflammation continued to increase, and patient was taken to the NP on 02-20-09 where she was diagnosed with cellulits. Patient was prescribed Cephalexin for 10 days.  Mom reported today that patient has completed the antibiotic and the infection and inflammation are resolved.
she developed an infection on her ankle; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on 15Mar2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller said that she received the first dose on Monday, 15Mar2021, but she developed an infection on her ankle and she needed to take antibiotics. Outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
107/71 82 20 96% @ 1530 95/61 64 20 98% @ 1540 Pt had a syncopal episode after injection. Pt has a history of same reaction to other injection
The patient had experienced a pain due to the needle stick, she felt the pain as soon as the needle got in touch with her skin she started complaining about it as the needle was introduced into the muscle, she started moving her hand, even though I tried to calm her down and confort her as this normal and she may feel a little sore due to the needle, but she continue to act uncomfortable, and the second I started to inject the medicine, she was hurt so bad and this was hapening the second I was injecting, she didn't stop moving that I decided to stop the administration of the vaccine giving the fact that the medicine may be the one giving her the pain, she received half of the dose of Prevnar 13.
Body aches/fatigue followed by hot red hard swollen area over injection site on right upper arm lasting until 3-24-15. On 3-25 her LEFT hand began to swell and body aches returned and she described the pain as 10 out of 10 on 3-26. She called her regular doctor today but could not be seen. They thought it could be a reaction to the Tdap given 3-20-15 and told her to call the health dept to report it.
Morning of 7JUL20, appx 0900, received injections in both left and right shoulder (see block 17).  Routine redness and tenderness associated from injections was present. Left shoulder was more tender than right shoulder throughout 7JUL20 (as expected with Anthrax).   Evening of 7JUL. left shoulder displayed swelling at injection site, redness, and warmth to touch.  Expected pain from injection did not self resolve.  Mooring of 8JUL20, left shoulder injection site displayed increase of swelling, redness, warmth and tenderness, but not to the point to cause concern. Afternoon and evening of 8JUL20, recorded temperature of 99.8, used Tylenol (2x 200mg) to address body aches and pain. Evening of 8JUL20, injection sight swelling, redness, and warmth continued to increase (area now encompassed most of the shoulder and some of the bicep). Evening of 8JUL20, tenderness transitioned to pain, causing some difficulty in routine arm use and sleeping. Morning of 9JUL20, area of swelling, redness and warmth grew  by estimated 20%, now encompassing 1/2 of the bicep and all of the shoulder.  Itching and burning sensation with pain/tenderness of the skin was present beginning morning of 9JUL.   Fever was not detected on morning of 9JUL20 as Tylenol was taken for pain before temperature was taken. Consulted doctor on the morning of 9JUL for suspected cellulitis associated with the injections on the left shoulder.
red spot; positive for COVID (swab); fever 100°F; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH MACULAR (red spot), COVID-19 (positive for COVID (swab)) and PYREXIA (fever 100°F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, FISH OIL (OMEGA 3 SELECT) and Vitamin.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 22-Jan-2021, the patient experienced COVID-19 (positive for COVID (swab)) and PYREXIA (fever 100°F). On 25-Jan-2021, the patient experienced RASH MACULAR (red spot). At the time of the report, RASH MACULAR (red spot), COVID-19 (positive for COVID (swab)) and PYREXIA (fever 100°F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment tylenol or aspirin
POOPY FEELING; HEADACHE; TIRED; BACK ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced back ache. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tired. On 23-MAR-2021, the subject experienced poopy feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, back ache, poopy feeling and tired was not reported. This report was non-serious.
Pt c/o swelling and tingling of tongue, dizziness, LE heaviness. Denies SOB, chest pain. BP 121/85, HR 70, RR 17, O2 100% RA. Benadryl 50mg IM given. No tongue angioedema, rash or puffy face noted.  Pt still c/o mild numbness on tongue and pt advised to go to ER and was accompanied by RN.
pt recv vax 26OCT98 & same day PM around 8PM had flushed, aching from mid chest up to head;noticed spontaneous hearing loss in lt ear & became dizzy & nauseated;
arm pain; neck pain/neck ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and NECK PAIN (neck pain/neck ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and NECK PAIN (neck pain/neck ache). At the time of the report, PAIN IN EXTREMITY (arm pain) and NECK PAIN (neck pain/neck ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment therapy was reported
Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line with a patient reporting substantial arm pain following the first dose.  The patient was on the fence about getting the second dose.  The reporter consented to follow up. No other details to provide at the time of report about site of injection, lot number and expiry date.
This spontaneous report was received from a nurse refers to a 6 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Listless -> weakness, not able to walk. No resp distress. Altered mental status (drowsy, slow to respond).
telephone call -itchy arm, neck, ED visit, RX benadryl, released after 1 hr, no resp/thrt, allergy consult; Incident rpt: -  I had received the vaccine around 4:45pm and was there for the 15 min of observation then went off to the floor I was floated to. Next around 6.40-6:45pm I started feeling chills and felt extremely itchy on my arm (the one I received the vaccine) my neck, and my eyes felt so itchy and puffed up. Then, the charge nurse sent me down to the ED because I was experiencing an allergic reaction; is advised to get second vaccine in allergist office
When injection was given and needle removed, the vaccine squirted out of the patient's arm.  Dose was received but unsure of quantity.
Felt bad after vaccine, had arm paint that went up my neck to my head, on 2nd day after shot I collapsed with a stroke.  Blood Pressure was sky high. I was taken by Ambulance to Hospital, as I was at work at the time of the stroke. I have perfect bmi, never  had high blood pressure, no  health problems at all.  No heart problems.