chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and medical records concerning a 4 month old male infant whose medical history and concurrent conditions included the following visits to the physician: on 14-MAR-2008 had normal 1 week exam. His weight was 9lbs 3 ozs and length was 21 inches. On 20-MAR-2008 the physician reported that the baby had several different issues. He was doing some vomiting up of fluid and basically the fluid that he was coughing up was probably from overfeeding, because the mother admitted to feeding him more than 4 oz. if he was hungry. His umbilical cord was healing well, dried blood was scraped off. He had a temperature of 97.1 degrees. The baby was put on glycerin suppositories to use for constipation. On 27-MAR-2008, the baby was seen and the physician reported that he had "lots of matter in the left eye". He had conjunctivitis of the left eye which was treated with SODIUM SULAMYD 10% eye drops to each eye. On 7-APR-2008 the physician reported that the baby had cough with congestion and couldn't catch breath "lots of day". His temperature was 98 degrees and his weight was 11 lbs 13 ozs. The physician reported that the baby had issues with GERD and was having a lot of problems with vomiting up small amounts after he ate. The baby was put on ZANTZC 2 mg per kg per day, divided doses and he was getting 1/4 ml TID every eight hours. On 18-APR-2008 the baby was seen by the physician who reported that the exam was normal except that there was concern that the GERD problem was not getting any better. His ZANTAC was increased to 1/2 CC BID at 15 per CC as his weight had changed. His weight was 11 lbs 10 ozs and length of 23 inches. The baby was to be seen in 2 months. On 15-MAY-2008 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (lot # 660425/0278X). On 10-JUL-2008 the baby was vaccinate with a second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (lot # 66425/0278X). Concomitant therapy included ACTHIB (lot # UF573AB) on 10-JUL-2008, PEDIARIX (lot # AC21B1330A/AC21B156EA) on 15-MAY-2008 and 10-JUL-2008 respectively, and PREVNAR (lot # C547UZ and C65048) on 15-MAY-2008 and 10-JUL-2008 respectively. Physician's exam shower that the baby weight of 12 lbs 12 ozs and length 24 1/2 inches. Current concerns were diarrhea for awhile. On 10-JUL-2008 the baby was seen by the physician who reported a weight of 14 lbs 12 ozs, a length of 25 inches and head circumference of 17 inches. The physician's concern was that the baby "was still spitting up". On 31-JUL-2008, the baby had a follow up with the physician who reported that ZANTAC was increased to 3/4 tsp BID as the baby had grown to the point where the medication was not working as good as it was prior. On 10-JUL-2008 the baby was seen by the physician and was still spitting up. The next visit was to be scheduled as needed (PRN). Additional information has been requested.
Swelling in both legs below the knee (all the way). Lumps under the skin of both legs below the knee in calves and below. Skin discoloration (like bruises) in places where the lumps are as well as other areas. Compression socks and elevating the feet helped. These symptoms lasted for 4 weeks- up until the day before the 2nd dose.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old female. Initial information was processed along with additional information on 18-NOV-2022. The patient's weight was 175 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. Concomitant medications included hydrochlorothiazide, and lisinopril.  The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  The patient had COVID-19 infection, symptoms included congestion and sneezing throughout and on 13-OCT-2022, patient had tested positive for covid-19 (confirmed covid-19 infection) (dose number in series 2) which resulted to confirmed clinical vaccination failure (dose number in series 1) for which patient received non-company suspect Paxlovid ((pf-07321332), ritonavir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, first dose administered on 13-OCT-2022 for covid-19 treatment. Date of last dose of administration was 18-OCT-2022. On 23-OCT-2022, Laboratory data included: COVID-19 virus test Negative (5 days after last dose of paxlovid). On 25-OCT-2022, patient experienced rebound covid-19. Laboratory data included: COVID-19 virus test Positive (7 days after last dose of paxlovid).  On 31-OCT-2022, Patient tested positive for covid-19.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000259921.; Sender's Comments: V0: 20221140777-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
vaccinated on 12/09/2019 with first dose / didn´t receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th December 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the 1st dose was administered in another facility (did not have information) and because the patient was not present, he did not want to share demographic information. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
This spontaneous report as received from a registered pharmacist refers to a 68 year old male patient. On 14-APR-2014, the patient was vaccinated with a 0.5 ml expired dose of PNEUMOVAX 23 (Lot # H016295, expiration date 02-NOV-2013) intramuscularly. No adverse effects were reported. Additional information is not expected.
Pt did pre treat with 50mg of benadryl . Pain and feeling of swelling in injected arm that moved to other arm as well within minutes of injection.  Pt had us call pcp which prescribed Medrol dosepak and tylenol . Patient waited for an hour then left.
sick at home; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; headache; Fatigue; This is a spontaneous report from a contactable consumer reported for a patient. A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Apr2021 (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in May2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jul2021, the patient experienced headache, fatigue, fever, sore throat, cough. It was reported that on 31Jul2021-01Aug2021, the patient stated experiencing headache, fatigue, fever, sore throat, cough. On 02Aug2021, the patient tested positive for COVID. The patient underwent lab test which included Sars-cov-2 test: positive on 02Aug2021. As of 03Aug2021, he was sick at home, no hospitalization. The event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After vaccine was administered, patient was sitting down and became dizzy, which he mentioned is "normal" after getting vaccine. However, after about 10 minutes he was yellow and dripping sweat, and drifted out of consciousness briefly (eyes rolled back). I immediately caught him and lowered him to his back on the ground and raised his legs on chairs. He regained consciousness right away. I received his verbal consent to give him 50mg diphenhydramine.
After vaccination, next morning patient noticed the vaccine arm ( right upper arm) swollen and red. No itching  or pain on the site. Patient came to the clinic to show the arm after two days, vaccine site no swelling, redness or any signs of infection. But swelling and redness noticed around the right elbow and patient reports the swelling is much better and the whole arm was swollen before
This case involves a patient (age and gender unspecified) who got sick while he/she received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and suspect PNEUMOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient who got sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. Other relevant laboratory data was not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, event outcome was not reported for illness. There will be no information available on the batch number for this case.
Approx. 3-4 hours after vax, patient cried constantly for 3 hrs. then off and on for 1 more hr. No tx. Family only notified us today when shown for next set of shots.
Vaccine administered 06/19/02. 06/21/02 he reported that two hours post hot given he felt dizzy and "not right" until he went to bed. He awoke the next day "feeling fine." Reported incident ot Doctor who ordered to see PMD for problems and not to repeat hep B shots if risk.
This spontaneous report as received from a Community Nursing Service refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route not reported) lot # J003727, expiry date 07-NOV-2015. Outcome of the event was not reported. Additional information has been requested.
Swollen lymph node under arm near injection site, 7 days after shot. Followed by fever 3.5 degrees above baseline, muscle aches in arm,  fatigue, swelling in entire arm, and neck/chest are near injection site. Large injection site rash developed on day 8. Rash began to diminish on day 9, with other symptoms abating and fever gone.
Very ill,dizzy, shivers, fever, nausea, extreme fatigue one week ongoing after injection
Second moderna dose, body aches, joint pain, stiff neck, fever 100.6, shaking, chills, headaches, loss of appetite, pain 6:10 vaccine location
Pt was given the varicella vaccination on 11/23/11 & on 11/29/11 pt was seen for the dx of chicken pox.
Received shot on Friday and on Sunday felt and noticed small pocket of swelling in left armpit.
This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 43-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject is not a diabetic and receives unspecified thyroid medication concurrently. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject started to feel bad and experienced hypoglycemia (drop in blood sugar to 17 per serum test) and sleepiness. Fatigue was also documented. This case was assessed as medically serious by GSK. Product complaint was reported. The subject was given orange juice and peanut butter crackers and about 30 minutes later, her blood sugar was 49. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave 20 doses of FLULAVAL in the morning and three subjects reported hypoglycemia.
Moderna COVID-19 Vaccine EUA  I received the Moderna vaccine at about 11:00 am, and waited the 30 minutes before leaving. On the way home (so probably after about 35 minutes), my lips, tongue and mouth starting feeling numb and swollen. I also felt a little dizzy.  I feel occasionally like my heart is beating fast.  My lips still feel swollen after 5 1/2 hours, but the other symptoms are better. I have emailed with my doctor about symptoms and treatments.
accidentally gave Moderna Covid-19 vaccine to the wrong patient; accidentally gave the wrong medication to the wrong patient; vaccine was given subcutaneously; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Jun-2021, the patient experienced WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously). On 02-Jun-2021, WRONG PRODUCT ADMINISTERED (accidentally gave Moderna Covid-19 vaccine to the wrong patient), WRONG PATIENT RECEIVED PRODUCT (accidentally gave the wrong medication to the wrong patient) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was given subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No treatment information provided by the reporter; Sender's Comments: This report refers to a case of Wrong product administrated, wrong patient received product and Incorrect route of drug administered  for mRNA-1273, lot # 033B21A with no associated AEs.
9/18/21: Patient arrived to ER due to complaints of generalized weakness since 4 days prior.  Upon initial EMS evaluation, patient was found with a SpO2 of 77% and was placed on a non-rebreather mask at 15 L per minute. He was then placed on heated high-flow nasal cannula with only mild improvement in oxygenation and was therefore upgraded to BiPAP.  He underwent CT Angiography evaluation of the chest with incidental findings of a type B dissection with a small intimal flap involving the proximal descending thoracic aorta and intramural hemorrhage/hematoma.  There is also mild fusiform aneurysmal dilatation of the ascending thoracic aorta without dissection.
Developing rash on the trunk, fussiness, temperature up to 100.9 degrees Ferenheit.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Tight chest, headache. Started as I was leaving the store. Not enough to need my inhaler but enough to notice.
pt recvd vax 5NOV92 & exp a severe migraine headache;pt took no medication & went to bed;2nd dose administered in one half doses w/no problems & 3rd dose as a full dose w/no problem;No further details were provided;
Sore throat; Throat got tighter and hoarsed; Throat got tighter and hoarsed; Chest started to get a little tight; Headache; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN 6202), via an unspecified route of administration, administered in left arm on 03Mar2021 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included multiple sclerosis, rheumatoid arthritis, breast cancer female from 2014 to an unknown date breast cancer 2014 and 2021, food allergy, seasonal allergy. Concomitant medication and in two weeks included gabapentin (NEURONTIN), lamotrigine (LAMICTAL), levothyroxine sodium (SYNTHROID) and prednisone. The patient had allergies with Rituxan, seafood, pineapple, watermelon, seasonal allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 16:05, the patient experienced headache with 5 minutes, at 16:15 started out as sore throat but the throat got tighter and hoarsed, chest started to get a little tight. She ended up taking Tylenol about 1/2 hour later and took Benadryl about an hour later. The patient received treatment. Outcome of the event was recovered.   No follow-up attempts are possible. No further information was expected.
Hepatits B was ordered and Hepatitis A was intended order. Hepatitis B was given.
Patient reported delayed reaction to the Moderna vaccine. Patient initially experienced normal vaccine reaction but 7 days after administering vaccine she experienced red and slightly raised batch in her left arm
On the day of my first shot, immediately after shot my arm had a burning feeling.  2 days later it was just saw with buring feeling gone.  A week later I woke up with my arm feeling like a bug bit it and it was itcing in the shot site.  Later that night it felt like a small bump and swelling.  The following  morning I woke up having to itch and then it started burning really intensly.  I looked in mirror and my left arm around the shot site was bruised and small bumps appeared.  By that afternoon, there was tingling sensation down the entire are to the fingers. I called the pharmacy and spoke to the person that administered the shot and was told  he was not sure why (1st person reporting this to them)  that a week later I would have these symptoms, but try cortizone cream and over the counter pain medication .  I rubbed Cortzone cream and took benadryl.  the burning remained and the itching was less. Seeing doctor in 4 days
30 minutes after the shot, the roof of my mouth and back of mu throat went numb. Only lasted 15-20 minutes. Extreme fatigue and headache. Fever and epistaxis
pt recvd vax & devel fever, a red mouth & red eyes; lab tests revealed inc GGT, SGOT & SGPT & an elevated serum bilirubin of 1.7;
Patient states that his arm burned and stung when he received the injection.  He called back the next day and states that he is still having some burning in his arm and his arm is very sore.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.