chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice and manager referring to a patient of unknown age and gender. On 25-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 72, 29 and R. The total cumulative (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 208, 31 and R. The total cumulative time (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 112, 30 and R. The total cumulative excursion time (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 16, 33 and R. The total cumulative excursion time (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 64, 32 and R. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case reported by an other healthcare professional, describes the occurrence of interchange of vaccine products (patient received Pfizer as first dose and Moderna as second dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included for COVID-19 vaccination: Pfizer. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced interchange of vaccine products (patient received Pfizer as first dose and Moderna as second dose). At the time of the report, interchange of vaccine products (patient received Pfizer as first dose and Moderna as second dose) outcome: unknown. No concomitant medication or treatment information provided.
SHORTNESS OF BREATH; HEART ISSUES; TROUBLE USING BATHROOM; MENTALLY NOT OK; HIVES (ITCH ALL THE TIME); SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On JUL-2021, the subject experienced shortness of breath. On JUL-2021, the subject experienced heart issues. On JUL-2021, the subject experienced trouble using bathroom. On JUL-2021, the subject experienced mentally not ok. On JUL-2021, the subject experienced hives (itch all the time). On JUL-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, hives (itch all the time), heart issues, trouble using bathroom, mentally not ok and severe headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Around 7:35 8/26/20 pt had a seizure, called 911, taken to ER. Had vitals taken, sent home. Saturday 8/29/20, pt had 2 minor seizures at home, and a third major seizure at the ER. He was hospitalized until 9/2/20. In addition to the 4 seizures, doctors say he had a stroke or "stroke-like event" sometime as well. As of 11/13/20, no one can tell us what may have caused the seizures or stroke, they have only ruled out a lot of things (except the vaccination which no one seems to want to talk about in the pediatric world). I'm not even sure exactly what vaccine he was given on 8/26/20 because the records were wrong that they gave me (records showed 2 shots (both cocktails) given in his arm and 2 oral vaccinations; my wife only saw him get one shot in his arm). They said they corrected his records and that all he had was the one shot in his arm that was just HepB, I'm not certain they even know what they gave him honestly.
just got over three week bout of flu; Initial information received on 01-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who just got over three week bout of flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of just got over three week bout of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (just got over three week bout of flu).  Outcome: Unknown
Fever and chills at 12 hours  Shingles on lower right back by 24 hours
BP before shots 106/59. After shots 87/47 - pt was transported to urgent care in a wheel chair where he was observed for about 30 min. After examination BP was nl. Patient self treated.
Awoke at approximately 1230 hours on 12/30/2021 with chills, elevated blood pressure, and temperature of 101F. Took Tylenol and nitroglycerin. Had seizure-like activity then went unresponsive. CPR attempted to no avail. Death pronounced at 0424 hours on 12/30/2021.
Patien't had small red spot, area warm to the touch, and small knot under the skin.
She had a seizure then turned blue and stopped breathing. Taken by ambulance to emergency rm. Follow up with pediatrician and neurologist.
swollen armpit lymph nodes on side of injection - two days after administration and continuing currently on third day
I started feeling muscle aches in my upper torso, shoulders, and upper arms. This started day after around 9:30 or so, but it was very mild. As the day progressed around noon it was pretty bad. 1-10 it was a 7. Finally I took an advil and that soothed it for that day. The following day the advil had worn off, but the pain was much less noticable. It was only if I wasn't moving that I felt it. By the next day it was gone.
Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain.
administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 28th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The medical assistant called to asked how to proceed with this patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Vaccine was administered but had reached its expiration/use by date on 1/31/23.
Patient did not receive 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The health care professional from physician's office reported that the patient never receive 2nd dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Arm pain; Tiredness; Arm pain sleepiness; This is a spontaneous report from a contactable consumer (patient herself). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 26Jul2021 14:30 (age at vaccination: 31 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient had covid prior to vaccination. On 27Jul2021 13:15, the patient experienced arm pain, tiredness and sleepiness. The patient did not receive any other vaccine in four weeks or any other medication in 2 weeks. No treatment was received for the adverse event. The patient was not tested for covid post vaccination. The outcome of all the events was recovering.
He had significant swelling of the left deltoid covering the entire upper arm and entire area was red.  Mom took a picture and showed to medical assistant at time of this report being done.  She did not call office to let anyone know.
Tightness in throat, pale appearing, near-syncope sensation then development of generalized rash. Also low grade fever and headache.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.    On unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M036056, as prophylaxis (Strength, dose, route and expiration date were not reported), which experienced a temperature excursion between 32 and 35 Fahrenheit degrees for 24 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA009947: US-009507513-1703USA007530:
Child mild fever & pain @ inject site; woke up crying; Limp & pale mom not certain if baby was breathing resuscitated poss SIDS;
Child got varicella vaccine 2 days in a row.  On 10/11/22 exposed to varicella at school.  On 10/12/22 vaccinated at school with Varivax with father's consent (name spelled different and 2nd last name omitted on consent) Interpreter present during education and consent completion.  On 10/13/2022 mother brings child to vaccine clinic and screening had occurred on 10//11/2022 . Mother consented through interpreter which indicated child needed varicella vaccination.  Error was not noted until entry after clinic.  Call to mother10/14/2022, child had mild fever treated with acetaminophen on 10/13/2022 and mother kept him home from school next day due to arm pain, but states child is eating and paying normally 24 hours after vaccination.
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that her priest received ZOSTAVAX vaccination and experienced a severe rash about three years later and was diagnosed with shingles (date unspecified), The patient was under physician's care for treatment. The patient sought unspecified medical attention. At the time of the report the outcome of shingles was unknown. The relatedness for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Red rash appeared in both arms from shoulders to almost the elbows.  No itching. Nurse gave Benadryl & Pepcid to slow symptoms.  Rash went away within half an hour. No other symptoms.
big lump on the lower side of my arm pit; Swollen lymph nodes (lymphadenopathy); This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a big lump on the lower side of his arm pit on an unspecified date. The patient wanted to know if this side effects was related to the vaccine and wanted to know if it was best to receive the second dose in the opposite arm or not since he has a big lump on one side of the arm. Response: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Outcome of the events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
aching in her joints of both her wrist and hands /Aching both hand joints /pain in hips; both shoulders ached; had to work extra hard to move around,like lethargy/trying to walk through molasses; lethargy; arm injection site became excruciating painful; did not sleep at all that Friday night; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and sleeplessness. On 8th February 2020, the patient experienced arthralgia, shoulder pain, mobility decreased and lethargy. On 9th February 2020, the outcome of the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sleeplessness, arthralgia, shoulder pain, mobility decreased and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and injection site became excruciating painful, she could not find a comfortable position even when she propped her left arm on a pillow.  She did not sleep at all night and her large joints and some of her small joints were aching, her hips and both shoulders ached the worse. She also experienced aching in her joints of both her wrist and hands but the left wrist and left hand were worse. She also had to work extra hard to move around, she compared it to like lethargy or trying to walk through molasses. She went to bed early on and when she got up all her symptoms had resolved.  The reporter did not consent to follow up. The NDC number reported as 58160082311.
A series of inflammatory events occurred which began with the first dose of the Pfizer vaccine. I initially developed a rash at the injection site of the first dose within hours of the injection. That was my only symptom after the first dose. The nurse at the vaccination site suggested that the second dose be administered in the other arm due to the rash which was still vivid. Within hours I also had a rash on the second arm as well. Over the next few days rashes appeared in the crook of my elbows and at my waistline. Shortly thereafter I developed "dry eye". My eyes were dry and sensitive to bright light. Then I started to have discomfort when I took a deep breath. On April 29, 2021 I had severe discomfort when breathing and was diagnosed by my doctor with pleurisy and possible pericarditis. I could not lie down for ten days and had to rest sitting up. Over time, and with the help of a great deal of ibuprofen I have improved. I no longer have discomfort when breathing and the rashes are 99% gone. The "dry eye" is slowly improving.
Information has been received from a pharmacist via a company representative, referring to a elderly female patient "in her 60's". The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in May 2017 (reported as "about 5 months ago"), the patient developed an injection site reaction after receiving ZOSTAVAX. It was reported that the patient's injection site "swollen 4 inches around and the area was very raw". The reporting pharmacist stated that the patient did not seek medical attention. The outcome of all the events was reported as recovered and the causality between the vaccination with ZOSTAVAX KEYTRUDA and the events was not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA003882: US-009507513-1711USA003883.
first in november of 2019, has not yet gotten second; left upper arm swelled up; left upper arm got hot; left upper arm got red; arm blisters; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient did not receive the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, feeling hot, erythema, blister and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, feeling hot, erythema and blister were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, feeling hot, erythema and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Aug-2022 Reporter's comments: The caller was the patient who stated that she got her 1st Shingrix vaccine in left arm and had not yet got her second vaccine, but plans on it. She also stated that after her 1st vaccine, her left upper arm swelled up, got hot and red, and was covered in little blisters. She said these reactions lasted for about 2 weeks. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix which led to Incomplete course of vaccination.
About 1 minute after injection, patient walked up to pharmacy desk and said she was having hard time breathing. We had the patient sit down and proceeded to give her 1 dose on EPI and called 911. After Epi injection, patient can breathe better. EMS came and said her throat is not swollen and she seems ok. Patient denies going with EMS to hospital for observance. Patient stayed in the pharmacy for about 10-15 minutes after EMS left and then left the store.
pt recvd vax; in eve had a low grade fever;apap given;next am, found dead in crib;no visible abnl; autopsy pending;
I received my first Moderna booster for COVID-19 on 8/16/2021. On 12/26/2021, I woke up with labored breathing. I used my pulse oximeter, and it was down to 93. I took a home COVID-19 test, which yielded a positive result. I had a low-grade fever of 100 and a headache. I was also confused and had body aches. However, I did not ever lose my senses of taste and smell. I called my doctor 15 minutes after waking up, and he directed me to go to the ER. When I got to the ER, I was given monoclonal antibodies. I also underwent a chest X-ray and full metabolic panel. They also wanted to do a urinalysis, but I was unable to give them a urine sample. I then went home and self-isolated for 2 weeks. During my isolation, my temperature dropped and my breathing improved. After a while, I used albuterol to help clear out the congestion in my lungs. I continued to improve, but after a week, I still tested positive for COVID-19. However, by that point, I no longer had any major symptoms. After 2 weeks, I tested negative. I then tried to resume my normal activities, but I felt very weak. My energy levels have gradually improved since then, but at the time of this writing, I still don't have the same energy levels I had before the breakthrough case.
patient experienced symptoms of "covid arm", redness, swelling, and itching at the injection site which ocurred 7 days after the injection
Pt developed an injection site reaction characterized by swelling, redness, warmth and a great big circle around the injection site. The pt reported that the physician related this event to TD injection and Enbrel (Etanercept), which she has been taking, both being proteins.