chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster shot gave her/him covid/popped positive on every one of them/ coughing; booster shot gave her/him covid/popped positive on every one of them/ coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "booster shot gave her/him covid/popped positive on every one of them/ coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Positive. Clinical courses: The patient thought our booster shot gave her/him covid. The patient felt fine before the shot. The evening of and ever since she/he had been coughing terribly. The patient took two different at home covid tests, 3 times and popped positive on every one of them. The patient had never had covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
On June 29th Monday got PREVNAR 13 vacc. (pneumococcal 13) on Wednesday red blotches on my legs below knee, doctor referred me to my dermatologist (couldn't get in until 7/6/15 Mon.). The rash got large and swollen (I got prescription for cream, 2 day later steroid shot - from dermatologist).  Went away, in August the same blotches (rash) came back, give same cream, steroid shot, it just faded and I could feel it in me. My primary care Dr. then prescribed steroid pills and antibiotic (9-22-15). My endoscopy for Barrett's esophagus done 9-29-15 found yeast all through me. Dr. who did endoscopy took scrapings for lab (waiting for results) don't feel good. (Prescribed, nystatin 100,000 units Aug 29 continue rest of antibiotic). June 29th - vacc shot primary doctor. July 1st - primary care. July 6th - dermatologist. Aug 3 - primary care. Aug 4 - Derm. Sept 23 - primary. 9-28 - primary.  9-29 - endoscopy.
Patient is a92y.o. year old female from adult foster care with acute mental status changes and fall. It is not clear if Fall 1 week ago preceded the MS changes. Covid testing on arrival 9/26 positive. Patient was fully vaccinated with Pfizer 1/27-2/17/21. Patient is requiring supplemental O2 3L /NC. She is confused and not able to provide any history. D dimer >10,000  Heparin per IM Decadron/REmdesivir  procal 0.46  Cannot r/o possible superimposed bacterial pneumonia. CXR with multifocal pneumonia consistent with COVID  Urinary antigens for Legionella and Strep pneumo negative U/A with pyuria cannot r/o associated bacterial infection, await culture data  Continue Rocephin
Difficulty breathing, treated for pneumonia, did not get better. Is currently in hospital with blood clots in lungs and legs. Difficulty breathing started not long after second dosage of vaccine.
mom states child started w/ a fever on 29OCT97;mom states given APAP suspension to control fever;30OCT97 broke out in a heavy pronounced red rash that covered the abd, back & face;fever up to 102;3NOV97 mom took pt to MD for eval;
Pt recv vax on 8/28/98; on 8/29/98 pt exp swelling & pain at vax site causing a limp; dx=cellulitis; tx=Keflex; pt imp 3 day
Patient nl exam received Tdap around noon on 8/7/08. Early am of 8/8/08 woke up from sleep feeling dizzy, had 1 episode diarrhea and then fainted. Altered consciousness for about 1 hour and then resolved; No sequelae or further episodes
expired Menquadfi Vaccine administered with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics who received expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection expiry date: 24-sep-2023 Lot u7449ab via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 28-SEP-2023 the patient received expired menquadfi vaccine administered with no reported adverse event (expired product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired menquadfi vaccine administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable consumer or other non HCP (the patient, reported for self).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3246, Expiration date: UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.   Patient stated, on Sunday, the 31st, like in the evening she started getting a little sore throat and then on Monday she had a nasal congestion and watery eyes which was sort of subsiding this morning, the nasal congestion but she was just wondering if that is a side effects or what. Patient confirmed it was the Covid19 vaccine of Pfizer. When paraphrased, patient stated, Initially it was a sore throat and then that subsided on Monday and then basically it was nasal congestion. Consumer was unwilling to complete the report. Hence, limited information available. The reported events were non-serious. The outcome was unknown for event sore throat and recovering for events, Nasal congestion and Watery eyes.  Follow-up attempts are completed. No further information is expected.
Rec'd. 12 mo. shots in office on 7/14/16. Per Mom on 7/30/16 at return visit, pt with developed rash (patch) to (RT) shoulder (resolved within 30 min) on 7/20/16. Pink macular rash began 7/30/16 - AM - rash to scalp, trunk and extremities. Afebrile. (Went to fair with animals 7/29/16 - pm). No vesicles; No pruritus.
DKA New onset juvenile diabetes.  Vaccine given 8/8/08 pt developed symptoms consistent with diabetes over the next few months. Presented with DKA 12/2/08  1/30/09 Received PCP medical records which included hospital medical records of 12/2-12/5/2008. FINAL DX: DKA; new onset DMI Records reveal patient experienced emesis, polydypsia, polyuria, fatigue, difficulty breathing & altered mental status.  Seen in outside ER, found to be hyperglycemic, acidotic w/(+)urine ketones. Transferred to higher level of care & admitted PICU.  Endocrine consult done.  Tx w/IVF, insulin.  Improved & d/c to home on continued insulin & Endo clinic f/u.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M032636 with expiry date 06-APR-2018, orally (exact dose was not reported). The doses were exposed to the temperature higher than 8 degrees Celsius but lower than 25 degrees Celsius for a time frame of 1 hour 7 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Fever, vomiting. Came to ER; reassured patients and recommended to give Tylenol.
Burning rash from the top of my shoulders all the way to my finger tips; Blisters; Burning rash from the top of my shoulders all the way to my finger tips; Wanted to scratch the skin off of my body so much; Fever of 102; Terrible allergies; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's sister got Shingles and was sick for weeks). Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation, blister, rash, scratch, fever and allergy. On an unknown date, the outcome of the burning sensation, blister, rash, scratch and allergy were unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the burning sensation, blister, rash, scratch, fever and allergy to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported.                           The age group was not reported but was captured as an adult as per vaccine indication.                                      The patient's mother and sister got Shingles and were sick for weeks. The patient was okay with the first shot but felt that the second shot was a nightmare. The patient had a burning rash from the top of the shoulders all the way to the finger tips. The patient had never wanted to scratch the skin off of the body so badly, then the rash became blisters. The patient also had fever of 102 degree Fahrenheit which subsided later. The patient also had terrible allergies. The patient was not sorry that they had the vaccine, however was worried about the Covid vaccine which they were going to get. The patient was questioning if one should take the chances or not but unfortunately did not have the answer for that but the patient stated that they would still get the vaccine.
Severe Muscle pain to the extent of having diffucult time using all muscles in body needed help getting out of bed or chair because muscles were weak and in so much pain.  Severe pounding headache and mild fever.  Took Ibuprofen and it helped somewhat but did not relieve it completely.  This started 20 hours after shot and continued for 54 hours after the shot with each day muscle pain and headache becoming milder.
09/05/21 The patient presents with AMS. Pt reports to have been at church when he began to feel delirious. Per family, pt was at church when he became combative. Family states pt began yelling and walked out of church. EMS services were called and at arrival they noted pt to be hypoglycemic with a BGL of 49 and given oral glucose. At ED bedside, pt reports to feel better but notes to have been experiencing chills lately. Pt s/p kidney transplant prescribed with prednisone and glimepiride, states to have not administered with Prednisone for the past 3 weeks. Pt denies abdominal pain, nausea, vomiting, fevers, chest pain, shortness of breath, and all other symptoms.
Patient vomiting+diarrhea at time of visit; Patient vomiting+diarrhea at time of visit; Feeling sick, not eating; Feeling sick, not eating; An incorrect administration of an unnecessary vaccine Vaxelis; This non-serious spontaneous safety report with Agency reference #02102374 and interaction #02102370 was received by a partner on 03-Feb-2022 from a Nurse, and forwarded to Agency on 04-Feb-2022.  The reporter did not assess the causal relationship between Vaxelis and the events 'Feeling sick' and 'Not eating'. It was unknown if the events were due to the vaccine administration since the patient already had similar symptoms prior to vaccine administration. Furthermore, the causality between Vaxelis and the reported event  'An incorrect administration of an unnecessary vaccine Vaxelis' was not applicable, due to the nature of the event.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 09-Feb-2022 from a nurse, and forwarded to Agency on 10-Feb-2022.  No medical history was reported.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events: Patient vomiting and diarrhea at time of visit. An intercurrent gastrointestinal infection needs to be taken into consideration.  Further information is expected.
skin reaction; rash; Tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 033B21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness). The patient was treated with HYDROGEN PEROXIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN REACTION (skin reaction), RASH (rash) and FATIGUE (Tiredness) 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.   Concomitant medications was not reported. Treatment information was not reported.
SWELLING, REDNESS AND ITCHING AT SITE OF SHOT.  ICE PACK, IBUPROFEN.
By 3/28 this patient developed redness at the site of his injection, 7 x 12 cm, flat, not tender. No axillary nodes.
This spontaneous report was received from a consumer (Patient's mother) refers to her daughter who is 4 year old. Patient's mother stated that her daughter, at the age of 12 months received an unspecified vaccination of measles and varicella. On 16-JUL-2015 at the age of 4 years, patient was vaccinated with PROQUAD (Merck). On 21-AUG-2015 the patient was vaccinated with second dose of PROQUAD (Merck) (strength not reported) 0.5 ml subcutaneous injection with a lot # L009210 (expiry date not provided). Concomitant therapies included DTAP-IPV, Hepatitis A vaccine, Hepatitis B vaccine and Hib Conj vaccine (unspecified carrier). No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Patient received a 3rd dose of Moderna. 1st dose on 1/4/21, 2nd dose on 2/1/21, and 3rd dose on 6/10/21.
Expired vaccine used Expired drug administered) A non-serious spontaneous report of administration of expired product s received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 21-Dec-2008, three on 02-Jan-2009,  six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of sibling who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccine were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse events associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marking commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Pt came back on 8/4/01 with 50mm induration, erythema, tender and warmth at site of varivax vaccination on right anterior thigh. No fever noted.
Patient complains of shortness of breath, dizziness and feeling weak and lethargic but easily aroused.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 06-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Apr 10: Sudden onset of severe vertigo at bedtime. Apr 12: Due to continued vertigo and dizziness, received  by phone and completed prescriptions for Azithromycin 250 mg dose pack and methylprednisone 4 mg dose pack for suspected ear infection. Meclizine 25 mg 2x daily as needed for vertigo; discontinued after 4-5 days due to accelerated heart rate (90-95 bpm). May-June: Vertigo subsided to mild infrequent occurrences. Dizziness continued upon changing body position. Now plateaued at mild level of discomfort. Patient believed antibiotic should have cured any ear infection and then connected symptoms potential to COVID vaccine after effects after reading articles in the press. No history ever of these symptoms.
Vomiting, diarrhea, sore throat, fatigue, headache, sore arm, edema in legs, redness in feet
Myalgia & Fever Narrative: dose 1: day 1-pain; diarrhea; day 2 fatigue day 3 nausea dose 2: day 1 pain and weakness; day 2 bodyache; day 2 fever 101 day 4 chills
Redness and swelling at the injection site; Redness and swelling at the injection site; Given in her lower arm in her tricep area and possibly given subcutaneously; A spontaneous report was received from a nurse who was a 27-year old, female patient who received the Moderna COVID-19 vaccine and experienced given in her lower arm in her tricep area and possibly given subcutaneously and redness and swelling at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) subcutaneously in her lower arm tricep area for prophylaxis of COVID-19 infection.  On 29 Dec 2020, during vaccine administration, the patient noticed the vaccine was not being administered in her deltoid, but instead possibly subcutaneously in her lower arm, in the tricep area. She was unsure of the needle size as she did not see if at the time of vaccination. She reported experiencing injection site redness and swelling, which she typically experiences when getting the flu vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, given in her lower arm in her tricep area and possibly given subcutaneously, was considered resolved on 29 Dec 2020. The outcome of the events, redness and swelling at the injection site, was not reported.   The reported assessed the events, redness and swelling at the injection site, as related to study drug.; Reporter's Comments: This case concerns a 27-year old, female subject, who experienced a non-serious event of injection site redness, injection site swelling, and wrong route of administration. The event of injection site redness, injection site swelling was expected, and wrong route of administration was unexpected. The events occurred one day after first dose of mRNA-1273, lot # 026L20a. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Almost exactly 24 hours after my second vaccination I experienced chills, muscle aches, and extreme tiredness so I went to bed and was fine the next morning.  I assume this was my immune system reacting and understand this is a good thing.
8/29/22-fever started @ night 102 8/30/22 1245pm pt was in moms arms starting up at ceiling, unresponsive to get his attn. Body was limp. Lasted over a minute. EMS called, pt was better when EMS arrived. Patient checked out. Parents drove child to ER for evaluation.
At 11:07am second dose of Covid vaccine administered  11:30am post monitoring complete 12:30pm- manual blood pressure recorded at 180/110                     Woshing sound/ sensation in the right carotid                     Blurred vision in the right eye                     Heart beat irregular  1pm- Dr notified  1:30pm- Follow up phone call with Dr                      Manual BP 170/110                     Prescription for Clonidine called to pharmacy  2pm- Clonidine 0.1mg taken 3:13pm- Manual BP 140/100 3:30pm-6pm- Napped 6pm- Manual BP 140/90              Clonidine 0.1mg taken
Patient presented with red circular rash on deltoid muscle around injection site. Also reported moderate pain in arm.