chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; Neck and shoulder are stiff; His body "rejects vaccine"; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain, neck and shoulder are stiff and his body "rejects vaccine" on an unspecified date. The patient confirmed he was scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow. He asked what is the efficacy of the vaccine after a single dose. He then explained his body "rejects vaccine" and stated he was still experiencing muscle pain from the first shot. He added his neck and shoulder are stiff.  He expressed he was trying to determine if he should get the second dose of the vaccine. The patient stated he was due to take the second shot for Covid. He did not know if he needed it. He asked if he was protected with the first shot. The patient said his body tended to reject shots. He is scheduled for second shot tomorrow. Outcome of the event (his body "rejects vaccine", neck and shoulder are stiff) was unknown and muscle pain was not recovered.  Information on batch/lot number has been requested.
Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care  on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.
Pt reported that after the shot she was bleeding quite a bit and had a bruise where she received the shot. 11/5 she called to report that she still has a small bruise where the injection was given and pain in the arm when she touches it or lays on it. She does not have any problem moving her arm up or down or behind her back its only tender when touched.
Extensive rash; Soreness; Completed series in 2020, has shingles now/suspected vaccination failure; Shingles, diagnosed by HCP; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 18th January 2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash and pain. On an unknown date, the outcome of the vaccination failure, rash and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 25-Jan-2023 Reporter's comment: The patient's wife reported that the patient completed his Shingrix series in 2020 and now had shingles, diagnosed by his health care professional. The reporter stated that the patient had quite an extensive rash with soreness but no nerve pain. The reporter did not consent to follow-up. The case was linked with case US2023AMR010171 reported by same reporter for herself. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Regarding the outcome date clarification request was raised and meanwhile the outcome was captured based upon the reported information.; Sender's Comments:  US-GSK-US2023AMR010171:Same reporter
After about 12 hours from injection, started to feel headache, body aches, and nausea, by the morning 7 am, the headache was so intense that I could barely move.  (I have migraines, but this pain was on the left side of my head, not my right like usual, and was even more intense than usual.)  I had chills and sweats, and body aches.  I checked several times and had no fever.  By the next morning (Saturday, March 13 at 7 am) I was feeling fine.
Vaccine given at doctor's office. Later that day started to cry - crying for > 3hr, not consolable. Mom called Dr at  that they told to give TYLENOL. She wasn't seen by a Dr. after till today with me.
Received MMR 12/4/19. Minimum intervals between live vaccines not met. Varicella to be repeated at appropriate interval.
It sucks/feel like been punched; This 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.   On 25th July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot on the day before the date of reporting.  The patient stated that it sucked and it felt like he/she had been punched but it was better than having all the nerves on fire. Follow up was not possible as no contact details were available.
pt recv vax; 24 hr later, exp fever to 103, vomiting, flu like sx, stiff neck and charlie horse in both legs;
adult dose of Havrix to a pediatric patient (4 years, 7 months); adult dose of Havrix to a pediatric patient (4 years, 7 months); This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows:  The nurses in clinic inadvertently gave an adult dose of Havrix to the pediatric patient, which led to overdose and adult product administered to child. This was received as a webform, so these are the only details provided email and clinic address available for follow up.
Headache, Myalgia, Arthralgia, Fever,  chills,fatigue, Narrative:
Low-grade fever, chills, headache, redness, swelling  & warmth at the injection site approx 24 hours after injection (9/20/21) Took ibuprofen at 3 pm and 10 pm. Fever resolved by the morning of 9/21/22, area of redness, swelling & warmth slightly increased to approx 1x2 inches. By 72 hours post-injection (9/22/21) area of swelling, redness & warmth increased to approx 2x3 inches and starting to itch and not quite as tender.
This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose number, exact dose, route of administration were not provided; lot # N014371 with the expiration date of 09-MAY-2019), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered doses of vaccines experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 40 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported.
Had shingles shot still got them / Suspected vaccination failure; got them mild case below left shoulder; discomfort; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles shot still got them / Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: got them mild case below left shoulder) and discomfort (Verbatim: discomfort). The patient was treated with trolamine salicylate (Aspercream). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was recovered/resolved and the outcome of the discomfort was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, herpes zoster and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the Shingles shot, but still got them (shingles). It was a very mild case though below his/her left shoulder. That was 3 years ago from reporting.  The reporter stated that the day anyone thought they had it, they should call their physician. He or she could give them something to lessen the affect it might had on them. After the worse was over, he/she still had a slight discomfort. His/her physician said to put Aspercream on that area and it really helped. Follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a medical assistant concerning a 63-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JAN-2016, the patient was vaccinated with improperly stored of ZOSTAVAX lot # L029484, expiration date 06-NOV-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Persistent ear ringing, first in one ear then both. Has continued and actually increased as I progressed through second shot and booster.
0100 pt recv vax;0230PM pt felt nauseated;315PM inc nausea & vomited x 2;330PM cont nausea,went home ill;10:00 nausea resolved;
pt recv vax 4MAY95 & 13MAY95 pt devel redness & swelling @ inj site; pt was evaluated by the MD & felt to have a localized rxn w/sl induration; pt did not have a fever, malaise or a rash; pt recovered 15MAY95
Client had received 2 doses of Pfizer. Client is on immunosuppresive therapy. Privary Care physiciaian recommened getting a dose of a different type of Covid-19 vaccination, recommended Janssen.  client was over the 28 days recommended between types of vaccines for Covid.   No adverse reactions occured at either the time of vaccination or after vaccination
This spontnaeous rpeort as received from a nurse refers to a 29 year old patient. On 21-DEC-2013 the patient was accidentally administered with a dose of ZOSTAVAX, (0.65 ml, subcutaneous, (lot #, expiration date and indication not reported) instead of VARIVAX (Merck). No adverse effect reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 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 was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011.
feels very ache this morning; sneezing; chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), PAIN (feels very ache this morning), MYALGIA (sore arm) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (sore arm). On 03-Apr-2021, the patient experienced SNEEZING (sneezing) and CHILLS (chills). On 05-Apr-2021, the patient experienced PAIN (feels very ache this morning). On 05-Apr-2021, MYALGIA (sore arm) outcome was unknown. At the time of the report, SNEEZING (sneezing), PAIN (feels very ache this morning) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Thyroid medication. No treatment information was provided.
Patient returned to pharmacy w/fluid filled blister, redness, inflamed rash around injection site. Patient stated the site itching terribly. Patient was instructed to apply cold compresses, and to notify MD. 7/14 - Itching, redness, alcohol applied. (7/15) Sm. blister. (7/16) Blister enlarged, more irritation.
2 days p/2nd HIB vax devel hypersensitivity, paresthesias, soreness & burning in supraclavicular area; hypersensitivity, paresthesias, soreness & burning in supraclavicular, pain, neuritis secondary to Hep b vax;
Narrative: Fully vaccinated, COVID positive on admission for hyperglycemia. Patient was asymptomatic.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FENTANYL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            Treatment information is not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-016430 (Patient Link).
Initially, from the first dosage - I developed COVID-19 arm and later, not too long after that I developed migraines. Two months after the vaccine, I developed a migraine. September 23, I developed a migraine and it hasn't gone away. I went to my primary care doctor and he said it had been too long for me to be tested for COVID-19 and they wanted me to see a Neurologist even though I had an MRI done in June for a totally different reason. I was diagnosed with Chronic Migraines but there doesn't seem to be a cause. They put me on four different types of medications - Trocandy - daily - two different milligrams of that; in the moment medication: Ubrelvy (can take when I have a breakthrough but can only take it 8 times in a month); nose spray - Sprix - to use (NSAID) in case I can't take Ubrelvy - for migraines)   and five different types of supplements  ( to try to help on daily basis): CoQ10; B12; Alpha Lipoic Acid; B2; and made sure I was taking Vitamin D and Magnesium; since the appt on the beginning of October I've been on these.  I do still have breakthrough migraines but they are not as severe. I am also going to check vision in case that has something to do with it. I don't think it is but this started before my glasses were an issue. The pain from migraine affects my memory. I have another appt with a Neurologist in about a week and a half.  It's definitely better but it's still there.
to ED c/o weakness, multiple falls, cough, diarrhea; + pneumonia, no hypoxia; TX: ceftriaxone, azithromycin, maxipime, remdesivir, singulair, solumedrol, lovenox, zinc; d/c'd home on room air--to go to SNF on Monday
started w/fever of 100.3 ax 2MAY96 APAP given;parent called MD 3:00 on 3MAY for t102.6R;pt also irritable & red, swollen lt eye;saw MD 3MAY96 3PM ear infect inflamed;cry high pitched
Pt given Tdap at age 76 years instead of Td.  There were no adverse reactions.
Patient stated that on 10/2/18 at 1900 he came down with a fever of 103 and then by 2200 his temp came down to 101 and by 00 his temp was below 100. On 10/3 he noticed swelling at the site of injection on his left arm where the PPSV23 and flu vaccines were given and area was hot to the touch and on 10/4 his arm became painful. 10/5 he called into the medical office and reported his symptoms and stated that he had been taking Ibuprofen and Tylenol and that the swelling had gone down but that it was still red and he could feel a lump. An appointment was made for him to be seen. (at time of this report appointment had not yet taken place).
Tdap administered on 8/10/11 to left deltoid. Employee states developed hives around injection site on 8/16/11. By 8/17/11 hives converged into one large erythematous indurated area approx 7.5cm in diameter.
Fatigue, weakness, nausea, vomiting, pain in arm.  As a part of hospital protocol, was tested for COVID.
1. Tinnitus- loud metal banging and hollow echo sounds ( like being inside a tin can) in both ears. Began almost exactly 12 hours after my vaccine at the same time other ?typical? side effects that I have experienced with previous vaccine doses such as fever and muscle aches began. While other regular side effects resolved after 36 hours the tinnitus continues 4 days later although the severity and frequency seems to be getting reduced.   2. GERD, Stomach pains and diarrhea- I have GERD normally controlled by medication but the vaccine always exacerbates it and beginning 12 hours after my vaccine for 24 hours my GERD was extremely bad and the medication was not even touching it. I also had some nausea during that time period which I have not had with the COVID vaccines previously. Then on day 4 post vax I suffered from stomach pains and diarrhea for about 12 hours. I have been eating a bland diet since the vaccine trying to calm down my GERD so nothing in the food I have eaten explains the diarrhea or it?s relatively sudden onset and resolution within 12 hours.   3. Fever- began 12 hours after vaccine. Peaked at 101.8 about 14 hours after vaccine, and remained there until 24 hours after vaccine at which point it dropped to about 100.4 for another 12 hours before returning to normal at about 36 hours post vax. I have had a fever with all both dose #1 but this was one of the higher fevers, similar to fever experienced with dose #2 of primary series. U
This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed systemic lupus erythematosus. Serious criteria included GSK medically significant. The outcome of systemic lupus erythematosus was unknown. It was unknown if the investigator considered the systemic lupus erythematosus to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled post-licensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. In this study, the risk window was 1-85 days: time period in which it was hypothesized that the risk of events might be affected by vaccination-following index vaccination (first dose of vaccination. Comparison window was defined as the period from the end of the risk period (1-84 days) up to 1 year after vaccination or to disenrollment, whichever came first.) No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, an unknown period post index vaccination, the patient was identified from automated algorithm with acute glomerulonephritis. Later, the patient was confirmed for systemic lupus erythematosus. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of systemic lupus erythematosus and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50,000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
On 2/1/18 the patient reported she was still having pain from her FLUZONE HD flu vaccine on 9/7/17. She said right after she had pain and bruising, now the pain continues from her shoulder to her elbow. She said it feels like she is still being "injected" with the needle.
Swelling of arm. Acetaminophen/Hydrocodone one tab PRN.
Redness and swelling at injection site; warm to touch; patient states reaction started immediately upon arrival home.