chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned to clinic with a circular raised erythemous area of 3.5cm, a dark erythemous area at 5cm, and a mild erythemous at 8.5cm circular pattern. The area was hot and tender to touch. Denies SOB, nausea, vomiting, wheezing or cough. Pt was seen today by provider. TX: cool compress, Ibuprofen 800mg 3 times a day, Gatifloxacin 400mg 1 tab q day x7 days. RTC in 4 days for reevaluation, or sooner if symptoms worsen.
Temp= 100 F, nausea and chills. Temp at 1:00PM=100
After first dose MODERNA  shot I feel my left pain . Doctor recommend  take over counter ibuprofen  but  not help my chest go way yet .After 2 week still pain in my chest .
called to c/o small, raised, painful erythematous rash scattered over shoulders, sides & back; itchy; seen by MD 16NOV92 was told shingles result of Hep B shot;
syncope; POTS; orthostatic intolerance; autonomic dysfunction; fatigue; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 22-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Soft-ball sized redness, swelling and severe pain at tricep injection site, onset about 48 hours after receiving vaccine.  Fever of 102.
Fncarging Local Redness after in DSMD of Bending; Seasonal Hours after N jection - Become better By 48h.
pt recv vax;exp n,abd cramps,sweating & hot flashes which lasted for approx 1 wk;md felt sx possibly due to menopause & not vax;
Within one hour my arm became very red and swollen in the next 4 hours my whole body ached. By 9pm i had a fever and chills and by the next morning i was struggling to breathe.  I needed to take several doses on Benadryl and use a nebulizer to be able to breathe without struggling.  It is now 4/11 and i am on antibiotics because the vaccination site is still extremely red, hot, and swollen.
shingrix vaccine, broke out with shingles; broke out with shingles, still suffering; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The reporter was patient's relative reported via interactive digital media The reporter's sister had the shingrix vaccine and thought she was protected.  The patient had three weeks after getting Covid booster she broke out with shingles and still suffering with it.  The reporter's daughter also got shingles after getting Covid shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Red macular rash over entire body and face. No vesicles, no papules. Had pruritus and also a low-grade fever and URI symptoms, rhinorrhea. Had 1 day of fever and rash, then better. Treated with Benadryl.
I got an immediate headache in my temple from the shot. That evening I developed fatigue, chills, sore throat, swollen (throat) glands. Woke up the next day feeling all of those plus coughing and sinus congestion/draining. Went to urgent care the following day and tested negative for Covid and flu. Returned to urgent care on Saturday for a chest xray and was diagnosed with pneumonia.
Narrative: 78 yo male with COPD, hx lung ca s/p lobectomy & on oxygen at home died at home on 6/26/21. Pt had received covid vaccines on 2/14/21 & 3/14/2021. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
patient developed shingles/symptoms are still on going; patient developed/fever/symptoms are still on going/the fever has been present for more than a week; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date unknown) for prophylaxis.   In June 2021, the patient received Shingrix (intramuscular). In June 2021, 1 week after receiving Shingrix, the patient experienced shingles and fever. On an unknown date, the outcome of the shingles and fever were not recovered/not resolved.   It was unknown if the reporter considered the shingles and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, the dose of Shingrix was received on 9th June 2021 or 10th June 2021. The patient received dose of Shingrix in an unknown arm. The reporter does not know if the vaccine was administered in left or right arm. A week later, after administration, the patient developed shingles and fever. The symptoms were still on going and the reporter mentioned that the fever had been present for more than a week. The reporter was informed about the adverse event on 18th June 2021 around 2:00 pm. The reporter does not know if the patient had given a consent to follow-up with healthcare professional.
Some vesicular/ others erythematous papular pruritic lesions started shoulder/face and spread over body with exposure to friend few weeks prior who had Varicella. Also had strep during illness-put on Amoxicilin.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills and fever. On an unknown date, the outcome of the pain in arm, general body pain, chills and fever were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX injection at a pharmacy and complained of chills, fever, general achiness, and a sore arm. No other details were available for the patient. The reporter did not wish to provide her demographics. She hung up the call when she got her answer despite of asking her  if some questions might be asked. This case is linked to case US2018GSK094752 (husband's case), reported by the same reporter.
Initial unsolicited report received from a pharmacist on 28-Nov-2016. This case involves a 68-year old female patient who was vaccinated with FLUZONE HD via intramuscular route (Batch number: UI691AA, expiry date: 30-Apr-2016; dose and dose in series were not reported) in left deltoid on 28-Sep-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as no known allergies. It was also reported that patient had no illness at the time of vaccination. Concomitant medications was not reported. On 27-Nov-2016, 10-week after the vaccination, patient experienced sore left arm and was also unable to raise arm and symptoms just began. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K0011004 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
After completion of vaccinations, pt left room and went into lobby at 03:40PM. Pt's mother went to restroom. Pt states "she felt nauseous and light-headed" and then staff was notified by other individuals in lobby that pt had passed out 03:45. Pt awoke within 10 seconds with 2 nurses to help assess. Pt was pale in color and cool to touch. Pt was alert to place, time, and situation.  Witness to pt's fall states pt hit head. Pt complained of head and arm pain but unable to give pain level. Pt states head pain diminished within a few minutes. Pt vitals were taken by RN, BP 112/66 HR 85 and O2 98%. Pt given cool rack and willing to try snack. Pt feeling better without nausea or dizziness and pain in head and arm diminished at 04:00PM. Pt able to ambulate to car to go home with mother.
She received flu shot and Pneumovax in different arms on 11/11/08 . Later that day she developed L arm soreness with fevers to 102 degrees F. Also chills, aches, headache, back pain, Emesis x1. She had an indurated red rash on left deltoid with significant tenderness. I treated her with prednisone, Benadryl and T#3. Labs showed increased WBC, elevated CRP, elevated SED, elevated LFT Urine was. Slowly improving will recheck labs in 1 week.
nausea; hard time trying to eat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 103L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm). At the time of the report, NAUSEA (nausea), DYSPHAGIA (hard time trying to eat) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient with headache 5/10, fever up to 102.5, rash to injection site, chills but felt warm, neck stiffness but movable.
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information not provided.
Immunization given on Wednesday evening. On Friday evening, developed pain and rash near groin. Thought it was reactivation of HSV-1. However, it has been diagnosed as shingles.
Acute onset of repeated emesis, up to 15 times.  Pulse was 160, and patient was moderately dehydrated at the doctor's office.
pt recvd vax & 15 mins following vax pt devel severe flushing, pounding h/a, dizziness & nausea; pt was seen in ER when exp occurred; ER md was unclear whether pt exp a vasovogal response to vax;
neck pain; Chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (neck pain), CHILLS (Chills) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NECK PAIN (neck pain), CHILLS (Chills) and HEADACHE (headache). At the time of the report, NECK PAIN (neck pain), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, chills Narrative:
pt recvd vax; lt arm red & swollen from elbow to deltoid; tender to touch; still swollen x 72 hrs but dec;
A nurse reported that pt received pneumococcal (manufacturer unk) and 1993-94 formula influenza (manufacturer unk) vaccines in 1993 and subsequently developed an injection site reaction characterized by redness and soreness. She recovered.
This spontaneous report as received form a medical assistant refers to a three unspecified patients of unknown gender and age. In September 2014 (reported as since the temperature event), the patients were vaccinated with a doses of GARDASIL (dose, dose number, route, lot/batch number, expiration date were not reported) that were improperly stored on 08-SEP-2014. No adverse effects were reported. No product quality complaint (PQC) involved. Follow-up information has been received from the reporting medical assistant, who provided patients' identifiers (age and gender), dates of vaccinations and lot numbers. This reports concerns a 70 years old male patient. No information on his medical history, concurrent conditions or concomitant drugs was provided. It was reported that the PNEUMOVAX23 underwent the temperature excursion on 08-AUG-2014. On 21-AUG-2014, the patient received a dose of PNEUMOVAX23 which underwent temperature excursion (dose, site and route of administration unknown; lot# J008799, expiration date 16-APR-2014). This is one of several reports from the same reporter. Additional information has been requested.
Erythematous papular, slightly pruritus rash area (L) anterior thigh.
No adverse event; On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series ), PFIZER BIONTECH COVID-19 VACCINE (Booster dose) and PFIZER BIONTECH COVID-19 VACCINE (Primary series ). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 25-Mar-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (On Saturday March 25, 2023 the patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    Concomitant medication was not provided.   Treatment information was not provided.
No adverse event; accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     Patient had no relevant medical history,allergy, concomitant diseases and risk factor. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 04-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border).    No concomitant information was reported. It was stated that no adverse events were reported. No treatment information was provided.
Redness, swelling, itching, pain, spontansously resolving over the course of 5 days subsequently.
Hives and rash lasting 5 hours, Foot and Hand swelling lasting 2 hours - Benadryl 50 mg po x1 alleviated all symptoms.
rash on the arm of the injection, which never went away completely; Fever which resolved shortly afterwards; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm of the injection, which never went away completely) and PYREXIA (Fever which resolved shortly afterwards) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on the arm of the injection, which never went away completely) and PYREXIA (Fever which resolved shortly afterwards). At the time of the report, RASH (rash on the arm of the injection, which never went away completely) had not resolved and PYREXIA (Fever which resolved shortly afterwards) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications were not provided.  treatment medication was not given.   This case was linked to MOD-2021-100827 (Patient Link).
4-5 days post vax devel rt upper arm muscle soreness which has persisted for about 2 1/2 wk;no localized redness, no fever, chills, numbness or tingling;had nl achiness fro the shot pain;no bruising;
trouble scheduling a second dose/she waited too long already and today 22Mar2021 would put her at day 49; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (trouble scheduling a second dose/she waited too long already and today 22Mar2021 would put her at day 49) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MA20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (trouble scheduling a second dose/she waited too long already and today 22Mar2021 would put her at day 49). At the time of the report, PRODUCT DOSE OMISSION ISSUE (trouble scheduling a second dose/she waited too long already and today 22Mar2021 would put her at day 49) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided.
temp chills; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar event for 2 patients. This is 1st of 2 reports. This consumer reported for himself.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced temp chills on an unspecified. Patient stated that, yesterday (name) and got shot number 2 of the Pfizer COVID-19 injection. We have had a temp chills etc. Not getting COVID-19 is worth it. The outcome of the event unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225707 same drug/reporter/AE, different patient
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL. MMR II and PNEUMOVAX 23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored MMR II and PNEUMOVAX 23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sore arm. Red blotchy, hot rash  about 6 inches by 3 inches running toward bicep from injection site