chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of respiratory syncytial viral infection in a 6 month old male subject who was vaccinated with Pediarix for prophylaxis. On 4/7/05, the subject received a dose of Pediarix (dose and lot number not provider). On 4/7/05, the subject also received injections of Prevnar and ActHib. In the "early morning" of 4/09/05, 2 days after vaccination with Pediarix, "after receiving 3 doses of Tylenol", the subject experienced a fever of 102.5F. The mother of the pt "called the pediatric emergency overnight service and was told to keep an eye on him and if the fever reached 105F, to bring him to the hospital". On "the evening" of 4/10/05, the subject experienced a fever of 103.5F (rectally) and was seen in an ER. In the ER, "the fever came down to 101.9F". It was noted also that, "the injection site of the ActHib was still raised and red". Exam in the ER also revealed that, "the child had a raspy cough". The ER physician dx'd the subject with respiratory syncytial viral infection and an ear infection. The subject was prescribed Xopenex and amoxicillin. All events resolved on 4/28/05. In the physician's opinion, the events were not related to vaccination with Pediarix.
As per EMS, pt C/O dizziness and a "noticeably forced wheeze." Pt was transported to ER for possible allergic response to Pfizer COVID Vaccine. Pt given Ibuprofen and Benadryl with good results and spontaneous resolution of symptoms.
TIRED; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and headache was not reported. This report was non-serious.
maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL246 and expiry date: unknown), via an unspecified route of administration, left arm on 11Jan2021 09:45 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 10:30 (lot number: EJ1685) on the left arm. Medical history included mild asthma GERD (gastrooesophageal reflux disease, and allergies to certain antibiotics causing a rash. Patient was not pregnant. Concomitant medication included montelukast sodium, omeprazole, and colecalciferol (VITAMIN D). The adverse events began as maculopapular rash on abdomen now redness covering trunk and extremities, sparing head, hands, and feet on 12Jan2021. Outcome of the events was not recovered. No treatment for the events was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
My left hand started itching so much that it woke me repeatedly during the night. It continued to itch throughout the day after the vaccination. In addition to itching, there was a burning sensation and sometimes a tingling.  The itching has subsided, but tingly sensation persists a little.
THREW UP THE THIRD DOSE; STOMACH UPSET; TOOK TWO DOSES ON THE SAME DAY; This spontaneous case report was received from another healthcare professional (PVX2019-695) on 21-Mar-2019. It described a 34-year-old male consumer who threw up the third dose and experienced stomach upset following the intake of Vivotif capsule for an unknown indication. The consumer also "took two doses on the same day".  The consumer's medical history included Gastrooesophageal reflux disease (GERD).   The consumer's concomitant medications included Adderall (dextroamphetamine and amphetamine; 20 mg), Protonix (40 mg), Phenergan (promethazine; 25 mg), testosterone injection (200 mg/ ml) and Peridex (chlorhexidine; 0.12% solution) for an unknown indication.   It was reported that the consumer took the first two doses of Vivotif after which he was fine but when he took the third dose on 20-Mar-2019, he experienced stomach upset and threw up. He saw the whole capsule in the vomit, so he took the fourth dose on the same day.   He did not take any treatment medication for the events.  The action taken with Vivotif with respect to the events threw up the third dose and stomach upset was dosage maintained while with respect to the event "took two doses on the same day" was not applicable.  The clinical outcome of the events threw up the third dose and stomach upset was resolved while with respect to the event "took two doses on the same day" was unknown.  Company's Comment: In this case, it was reported that a 34-year-old male consumer "threw up the third dose and experienced stomach upset" following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. However, the intake of first two doses of Vivotif vaccine were uneventful. Also, the events threw up the third dose and experienced stomach upset can be explained by patient's past medical history of GERD (Gastrooesophageal reflux disease) and multiple concomitant medications like Adderall (dextroamphetamine and amphetamine; 20 mg), Protonix (40 mg), Phenergan (promethazine; 25 mg), testosterone injection (200 mg/ ml) and Peridex which provides a plausible explanation for the reported events.The causality of the event "took two doses on the same day" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a 34-year-old male consumer "threw up the third dose and experienced stomach upset" following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. However, the intake of first two doses of Vivotif vaccine were uneventful. Also, the events threw up the third dose and experienced stomach upset can be explained by patient's past medical history of GERD (Gastrooesophageal reflux disease) and multiple concomitant medications like Adderall (dextroamphetamine and amphetamine; 20 mg), Protonix (40 mg), Phenergan (promethazine; 25 mg), testosterone injection (200 mg/ ml) and Peridex which provides a plausible explanation for the reported events..The causality of the event "took two doses on the same day" was considered as not applicable.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers 01 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
crying for 4-5 hrs w/o stopping; turned red all over-carried to ER seen by ER MD states to never given pt pertussis again;
tongue and lip tingling then swelling sweaty palms nausea bladder and fecal incontinence black out/ loss of vision vision coughing labored breathing complete throat swelling burning all over  resulted in epi pen usage then admitted to the emergency room
Initial unsolicited report received from a pharmacist on 15 September 2016. This case involves a 77-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number: UI634AA, expiration date: 22 March 2017, dose not reported) intramuscularly in the left deltoid on 08 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination were reported as none. Concomitant medications were not provided. It was reported that, the patient was not on blood thinners or blood pressure medicines. On 08 Sep 2016, same day following the vaccination, the patient experienced bleeding at the injection site (from the time of the vaccine administration until the next morning). Also reported that, next day in the morning patient had a blood stain on his shirt at the injection site. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event. List of documents held by sender: none.
Following the injection (early morning of the next day), pain at site. This was followed by fever (up to 102 degrees) for one day, lower fever for several days afterwards, in concert with fatigue. There was also a slight rash along the arm. Of ongoing concern is pain at injection site more than three months after the vaccination.
injected arm became weak and very sore within minutes of the injection with first shot, had not recovered yet when 2nd shot was administered and the intense weakness has continued long past second shot.  Debilitating headache with intense  nausea has continued as well. Other symptoms seem to have mostly subsided.
pt thigh was swollen & erythematous for 3wks; now there is an indentation @ site w/SQ sclerotic nodule palpable
Patient passed out and was shaking. She regained consciousness. The paramedics were called and monitored her. She was able to leave on her own.
patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient had only one of the 1st 3 doses of the Covid-19 vaccines which was given "quite a few months ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant information provided. No treatment information provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose  2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jun1995, stop date: 04Feb2023; SINGULAIR, start date: 01Jun1995, stop date: 04Feb2023. Other concomitant therapy included unspecified oral birth control.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient started Paxlovid as treatment from 25Jan2023 to 30Jan2023. 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.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient with no pertinent medical history or any drug reactions/allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number 0071AE, expiration date 03-APR-2013) on 27-AUG-2012. No other co-suspects were reported. Concomitant medications included simvastatin, XALANTAN and FOSAMAX. On 29-AUG-2012 the patient experienced warm, pink area around the injection site after receiving ZOSTAVAX. The patient had contacted pharmacist for medical attention. No treatment or any laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
COUGH, TINGLING THROAT AND TONGUE WITH SLIGHT SWELLING OF THROAT AND TONGUE
swelling on right lateral thigh at site of injection of DTaP / IPV vaccine with pain and redness, resolved after 2 days of ice
Chills, Cough..body ache...fever at present day four. I did return to the clinic next day. The clinic then took me too hospital, and was given benzonotate cough capsules. No report was made, and I've been taking extra strength tylenol every four hours too keep the fever down.
At 5:30 AM on 1/21/20 while on toilet started shaking, started to shower felt lightheaded in tub. Mom witnessed him uncontrolably shaking x 1 hour. NO LOC, taken to bed continued to shake, fell asleep (no fever) woke to come in for office visit. C/O (L) arm pain from injections Able to walk out from office today.
General body aches; Chills; Headaches; Fever; General itching; Itching on the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills) and HEADACHE (Headaches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site arm). On 17-Feb-2021 at 2:00 PM, the patient experienced PRURITUS (General itching), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever). In February 2021, PRURITUS (General itching), VACCINATION SITE PRURITUS (Itching on the injection site arm), MYALGIA (General body aches), CHILLS (Chills), HEADACHE (Headaches) and PYREXIA (Fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient received injection at the hospital and the hospital kept her there for an hour after second Moderna Covid-19 vaccine because of the itching.  Patient went to bed at 6pm on 17 Feb 2021 at when she woke up it was all over. No side effects.   This case was linked to MOD-2022-455172, MOD-2022-455193 (Patient Link).
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
NIECE REPORTS ROUTINE VISIT TO CARDIOLOGIST 01/13/16 WITHOUT S/S.  LATER 01/13/16 BEGAN FEELING WEAK, BAD, NO APPETITE.  BY MONDAY NEXT WEEK DEVELOPED ULCERS IN MOUTH, LOW BP, DEHYDRATED.  ADMITTED TO HOSPITAL STAYED 5 DAYS. REQUIRED NURSING HOME PLACEMENT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported as adverse event treated with Paxlovid and received Positive COVID test after two negative tests. Rebound COVID adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Leg pain, evening after vaccination given, a limp secondary to hip inflammation and decrease ROM. Not yet recovered, will be following.
Upon documentation post vaccine, I realized an error occurred. I didn't realize the vaccine expired 10 days prior, on 1/31/20. Told my supervisor immediately and was told to call patient's parent and explain what happened, and to have patient return for repeat vaccine. Patient mom understanding and she returned.
Bump on top of the butt; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bump on top of the butt) in a female 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 SWELLING (Bump on top of the butt). At the time of the report, SWELLING (Bump on top of the butt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Broke out in red rash on neck, chest and arms. Lips itchy and tinging.
PATIENT FELT DIZZY AND SAID HE LOST CONSCIOUS FOR FEW MINUTES AND THEN WOKE UP . WHEN I SAW THE PATIENT HE WAS AWAKE BUT FELT LIGHT HEADED. I LAID HIM ON THE FLOOR AND ELEVEATED HIS LEGS ON A CHAIR. I CHECKED HIS BLOOD PRESSURE 4 TIMES WITH 2 DIFFERENT MONITORS AND IT WAS BETWEEN  130/90 . I GOT HIM WATER AND HE DRANK HALF OF A BOTTLE ,. HE STAYED ON THE FLOOR FOR 10 MINUTES AND THEN WAS ABLE TO GET UP AND WENT HOM WITH HIS MOTHER. I CALLED AND CHECKED ON HIM AFTE 1 AND THEN 3 HOURS AND HE SAID HE WAS FEELING NORMAL . PATIENT ALSO SAID HE LOST CONTROL OF HIS BLADDER WHEN HE WAS SITTING ON THE CHAIR.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-DEC-2018, the patient was vaccinated with improperly stored M-M-R II (lot # N024698, expiration date 08-SEP-2019) and VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). The sterile diluent used to reconstitute M-M-R II was properly stored. No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Narrative:  Vaccinated, not boosted pt admitted for COVID PNA requiring intubation ultimately palliatively extubated and deceased
I started my minstrel cycle the same day I for the shot. I had it for 8 days stopped for 8 days and started again for 2 days
Pain, tenderness, swelling, hard area on right upper arm after vaccination on 1/6/03. Still sore on day 4.
did it ever hurt / Never ever had a shot that hurt until today; yelped out loud; This case was reported by a consumer via  interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st September 2021, the patient received the 2nd dose of Shingles vaccine. On 1st September 2021, immediately after receiving Shingles vaccine, the patient experienced injection site pain and screaming. On an unknown date, the outcome of the injection site pain and screaming were unknown.   It was unknown if the reporter considered the injection site pain and screaming to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second shot on the day of reporting and stated that never ever had a shot like this, which hurt until today. The patient yelped out loud in the doctors office.
Case number PHEH2013US014921 is an initial spontaneous report received from a pharmacist on 10 Jul 2013: This report refers to an 18-year-old female patient. She was given only the MenCYW135 component of MENVEO (batch number: X11077) intramuscularly, without being constituted with MenA component, on 10 Jul 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
Began vomiting approx 1 1/2 hrs p/immun acted drowsy; Developed fussiness x 2d;