chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to 15 patients of unknown age. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ lot # N000172, oral for prophylaxis. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to ROTATEQ. The reporter considered no adverse event to be not related to ROTATEQ. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005788:
Initial unsolicited report received from physician via other company (Pfizer, under the reference number 2016268466) on 26 May 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID ADSORBED (batch number, expiry date, route and site of administration was not reported), on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING, HIVES AND NAUSEA  -  TAKEN TO ER FOR OBSERVATION AND ADMINISTERED DIPHENEHYDRAMINE - RECOVERED AND DISCHARGED
Arm soreness started evening on 1/20/21. At 1:30AM 1/21/2021 I woke with a fever, chills, muscle pain, joint pain, muscle cramps, headache, nausea and fatigue. Highest fever 102.3, fever holding at 100.5 with Tylenol. Drinking fluids.
The night after receiving the vaccine experienced fatigue, dizziness, nausea, vomiting, chills, sweats, and muscle aches. The next day symptoms had improved but hadn't gone away completely.
To clinic 4/7/03 for 2 month check and immunizations. Doing well, only complaints stuffy nose. On 4/12/03 to ER, not breathing and ER was not able to revive her.  Preliminary autopsy reports listed as SIDS as cause of death.
Pt recv vax on 2/10/99; 2 hr post vax pt exp nausea, diarrhea, uneasiness; 10-12 hr post vax pt exp itchiness, agitation, shortness of breath, wheezing, throat closed, syncope; tx=Benadryl, Epinephrine; pt imp 3 days
Employee reported reaction of hives approx 2 hours and 12 minutes after getting the covid vaccine. She was administered epipen and was sent to the ED. The ED observed her and then discharged her.
On 11/3/2021 it was discovered the vaccine administered that day had been stored in the freezer longer than the recommended 14 days. Patient did not have an adverse event.
POSSIBLE PARTIAL DOSE ADMINISTERED; BLEEDING AT INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced possible partial dose administered. On 18-MAR-2021, the subject experienced bleeding at injection site. On 18-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding at injection site, and the outcome of pain at injection site and possible partial dose administered was not reported. This report was non-serious.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 16-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 19-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Client experienced nausea and slight dizziness while walking  to be seen by EMT 4 minutes after vaccine was administered.  Client's symptoms stopped while with EMT.  EMT checked cleared client with no issues.  Client confirmed she was okay to go home.  No medications were administered.
The morning after the vaccination, the patient states, "she has trouble raising her arm above her head, and there are severe pains radiating from her shoulder. It takes some time before the pain resides."
Beginning in the afternoon of receiving immunization, I started itching on my arms, chest and neck areas. Took 12.5mg of Benadryl and itching subsided. Later that evening, I started feeling symptoms similar to those of the flu. Chills, shivering, slight fever, felt tired and sleepy. Slept for about 12 hours, not my usual 8. Felt better next morning, back to usual routine about noon.
Pt is at the clinic to get J&J covid vaccination today. @1620 Rapid response was called. Pt shook for less than a minute after receiving vaccine and lost consciousness. Dr. and rapid response team on scene. Dr. assessed pt. Pt AOx4 breathing even and unlabored, was not in distress. Estimated time less than 2 minutes of losing consciousness. Pt is coherent, color is back to of skin patients regular skin color after regaining consciousness, temp: warm/WNL, R and L eyes PERL. Pt denies the following: pain, CP, palpitation, and c/o nausea. See vitals: WNL, Pt's glucose today 100 mg/dl. Per Dr. observation for 30 minutes. Pt taken to ER per Dr. via boyfriend.
Swelling, warmth, pain radiating down left arm; took Tylenol to treat - no relief of symptoms.
Dizziness 4:08 pm On8/12/22 Running nose on and off plus Sleepiness 5:30. On 8/12/22. Arm soreness  and sneezing around 6pm. On 8/12/22 Fatigue and clammy sweat around 7pm. 10 am on 8/13/22 diarrhea with nausea. Arm pain and swelling increased even though otc Tylenol.  On and off from 8/14/22 diarrhea on and off.  Clammy and occasional shortness of breath on and off 8/15/22 plus continued fatigue.
NOSE BLEED; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia vera.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered IN MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 5 mg, 2 times every 1 total, from JUL-2020 for polycythemia vera. No concomitant medications were reported.  In MAR-2021, the patient experienced nose bleed for 1 day and stopped. Then a week later, she had a nose bleed that lasted for 5 straight days. For the past 2 weeks before reporting, patient had only 1 nose bleed. Patient reported her nose bleed to physician, who suggested her to keep a watch on nose bleed. The patient had not experienced nose bleed until recently and wondered if receiving the vaccine and having nose bleed were related. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The outcome of nose bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210629648-covid-19 vaccine ad26.cov2.s -Nose bleeding. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Starting at 7 pm nauseous headache exhaustion and pain at injection site, next morning- same symptoms with chills low grade fever (100.1) continued until 3/6/21 at 8:30am; pain at injection site continues ((3/9/21 9:51 pm)
Information regarding PREVNAR 13 was received from a nurse regarding a patient who experienced high fever. The patient received a dose in 2010. The patient experienced high fever on an unknown date in 2010. Outcome is unknown. No additional information was available at the time of this report.
Patient reported (seen visually) redness and swollen right arm from injection site to elbow. I reported to patient's provider. Provider ordered methylprednisolone dosepack and cephalexin.
pt recv vax & devel an inj site rxn characterized by redness, swelling, itching & pain;pt was instructed, via phone to take DPH & apply ice or heat to inj site;
This spontaneous report as received from a physician refers to a female patient currently 11 years of age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2007 (reported as 12 days before she turned one year old), the patient was vaccinated with an unspecified dose of VAQTA (dose, frequency, route, lot # and expiry date were not reported) at an unspecified location for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Chills, fever, swollen arm, swollen lymph node in right armpit, swollen glands on right side of neck under the jaw, sore right hip , fatigue. The reaction lasted one week with no long term after effects.  Notified my PCP.
Transverse Myelitis - 6 days after second dose.   MRI T spine showed enhancing lesion.  MRI Brain, C,L normal CSF,AQP4, MOG all normal
This spontaneous report as received from clinical medical assistant via company representative refers to a male patient of unknown age concerning her son. On an unknown date the patient was vaccinated with GARDASIL, first dose (dose unit, lot# and expiry date unknown). On an unknown date the patient experienced headache after receiving the first dose of GARDASIL. No information was available on the severity or duration of the headache. Patient did not continue the GARDASIL series as a result of the headache. On an unknown date headache was recovered. Therapy with GARDASIL was discontinued. The outcome of headache was reported as recovered/resolved. No further information reported. Additional information is not expected.
Patient presented as an acute walk-in for involuntary body shaking with cold sweats. Vitals WNL Immediately administered BENADRYL 25mg tab po #2 at 1500 as a precaution. Vitals WNL. Administered LR 1L R AC. Pt tolerated procedure well. At approximately 1622 1L of LR has been infused, and patient's shaking has stopped
Numbness and tingling in arm where injection given, dizziness, lightheadedness.
Confluent, itchy erythematous area around site of injection ((L) deltoid).
Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM and difficulty grasping items by end of day.  Day #3 Fingers improving. Day 4 Knees swollen and difficulty bending or climbing stairs, resolved by Day 5. Dose #2, Day 1- 12 hrs after injection started with joint stiffness in hands. Day #2 Finger joint swelling/pain. Day #3 finger,hand,shoulder,hip,knee and metatarsal pain/swelling/limited ROM. Day #4 (same as Day 3), DAY 5,6,7 symptoms improving: able to complete 12 hr shift at work.  Day 8 finger/hand joint swelling/pain/stiffness
Case number PHEH2014US003768, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 JAN 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
By the evening of the shot (Thursday) my arm became sore. The following day, Friday, I had muscle aches and shivers; by the time I got home from work, about 5:30 p.m., I had a fever of 100, along with fatigue, muscle aches, and now the whole of my upper arm where the shot had been injected was extremely sore. By the third day after the shot, Saturday, I still had great fatigue, sore arm and by evening I felt feverish again. By Sunday I still had fatigue and my arm was sore, but less so. By Monday I was mostly feeling well. I self-treated with ibuprofen.
Pain in (L) shoulder, ROM of (L) arm. The injection site is a little red, but not very warm. There is edema. There are macular lesions down the length of the arm and up the neck.
About a couple weeks after the vaccination, I began having severe joint pain in my wrists, then it spread to knees, elbows, shoulders, and ankles. I continue to have them to this day, several months after the vaccination.
red rash; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), HEADACHE (Headache) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), HEADACHE (Headache) and FATIGUE (Fatigue). On 11-Mar-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Had generalized itching start the day after his first oral typhoid pill. It progressivly became worse after each pill he took. Still has the itching, at it's worst today, four days after completing his last pill. No hives, SOB, etc.
12 year old male here with chest pain following his second COVID-19 vaccine. At around noon on 6/29 he received his second Pfizer COVID-19 vaccine. The following day he was tired, had a headache, and stomach ache. Thursday at 2 am he felt "wheezy" and had a subjective fever. He woke up this morning just after midnight with central chest pain, and  pressure that was 7/10. He was given ibuprofen and it improved to 5/10. His mother then took him to ED where labs were done and notable for an elevated troponin to 7.09. He was then sent here for further care. He was given a dose of Toradol and his pain resolved. Troponins were trended and stayed below 10, so he was not given IVIG or steroids. He remained asymptomatic and labs improved so he was discharged the day after admission.
pt stated that he wasn't feeling good.  asked couple questions but pt was not responding to my question.  called 911 right away.  asked pt if he was having difficulty breathing and he responded by shake his had side to side.  as we were making phone calls he did stated he was feeling better.  I had manager watch pt until paramedic came.  paramedic took pt.  pt came back after about 20 minutes and stated that paramedic released him since his vitals were normal.
This case is associated with case 2013SA100252. Initial report received from a pharmacist on 03-Oct-2013. Two patient (age and gender unknown) had received an intramuscular dose of FLUZONE (batch number: UH898AA, dose number and site of administration not reported) on September 2013. The patient's medical history was unknown. Concomitant medication was unknown. On September 2013, 2 patients reported having a heavy feeling to their arm. No laboratory tests were performed and corrective treatments were not reported. Outcome of event was recovered. List of documents held by sender: None.
2-3 weeks after started having numbness and tingling to left side of body - face tingling and left eye dropping and twitching had started in June and has gotten more intense with headaches to left side of head.
Went in for routine cardiology check up and was diagnosed with low heart rate and complete atrioventricular block also known as heart rate disorder. Subsequently a pacemaker was placed to correct the heart rate. I was diagnosed with heart failure prior to vaccine (2007) but am unsure if this new development is related to vaccine or not.
After 4 month immunizations (03/14/01) and 6 month immunizations (04/25/01), the infant developed 5 - 6 days of fevers from 102 to 104. The fevers started the day of the immunizations. The infant had URI symptoms on 03/14/01 and a mild ear infection on 04/30/01.
Pfizer; BUD Date 04/07/2022 administered on 04/11/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended re-vaccination
WEIRD SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced weird symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird symptoms was not reported. This report was non-serious.
pt recvd vax;24 hrs later, dizziness; saw MD; felt dizziness related to vax;
-ER visit. 9/23/9. Diagnosis: cellulitis @ injection site. Prescribed BACTRIM with KEFLEX.
INCORRECT STORAGE OF VACCINE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and incorrect storage of vaccine was not reported. This report was non-serious.
Patient experienced swelling in left arm following Moderna booster and flu shot in that arm. Patient consulted with PCP who is monitoring this reaction. Patient will follow-up with PCP.
This spontaneous report was received from a patient (who is also a field representative) of unknown age concerning herself. On an unknown date in June 2013 the patient was first vaccinated with RECOMBIVAX HB, intramuscular in the left arm (dose and lot # unspecified). On 17-SEP-2015 (reported as "today") the patient was vaccinated with second dose of RECOMBIVAX HB, intramuscular in the left arm (dose and lot# unspecified) (Inappropriate schedule of vaccine administered). No adverse effects reported. No further details provided. There was no PQC involved. Additional information has been requested.
Muscle and Joint Pain especially in my upper body.  Worse pain in my hands and fingers.   Usually worse in the Morning.  Tightness in my finger joints is constant though.  When making a fist it feels really tight.  Also have upper bicep pain that comes and goes..
Grand Mal seizure lasting approximately 5-7 mins. Posticatal state for 4 mins, then an alert, incoherent psychosis like state for approx. 30 mins.  No PMH for Epilepsy
Area of induration and macular rash in upper right muscle of 9cm x 7cm.
My injection site arm encased in red rash. I have leukemia so I went to my doc for assistance. First time ever I had an adverse reaction to flu shot.
12/16 vaccine 24 hours later, experienced diarrhea, chills, myalgia, HA, swollen/sore injections site.  Felt 'out of it'. Bedridden for 24 hours.  *noticed the 2nd dose was the same batch, same lot #; 1/6/2021 2nd vaccination; zero side effects
Patient is a 38 year old male with PMH of MS who presents to the ED for c/o chest tightness. As per patient, he had c/o fever and sweating on 1/9/22 and took a home covid test which was positive. Patient reports daily nightly fevers of 102 since the positive test. Patient states that he would take Advil which would relieve fever by morning. Patient has had c/o cough and developed pleurtic chest pains with deep inspiration. Patient was sent for a CXR done yesterday which showed bilateral ground glass opacities. Patient denies shortness of breath, nausea, vomiting and diarrhea. Patient is double vaccinated w/ Pfizer.  In the ED, O2 saturation on RA 90%. Na 130, CRP 4.48, ferritin 356, trop <0.03, D Dimer 343. CTA of the chest reveals no evidence of PE, patchy bilateral ground glass opacities which are relatively symmetric, imaging features may be seen in Covid 19 PNA. Patient received dexamethasone.
Uncontrollable vomiting 11:00 pm-04:00 am wheezing horrible muscle & body aches, (unable to move body by self by 3:00am (non paralyzed) current still experiencing (04:33) PM sore throat, low fever.
Moderate hearing loss in left ear two days after vaccination.  Symptoms include intermittent fullness in middle ear, inability to equalize pressure (pop  ear as on airplane), left nasal passage blockage.
This spontaneous report as received from a physician refers to a 62 year old female patient with no known allergies. On 18-OCT-2013 (ten days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006153, expiration date 30-AUG-2014) intramuscular opposed to the subcutaneous route in the arm (dose unknown). Concomitant therapies included WELLBUTRIN. The physician stated that the patient was experiencing severe pain in the unspecified arm and neck in which the vaccine was administered in October 2013. There was no redness or swelling just pain, "like nerve/muscle ache". The patient visited the physician and was treated for the event with unspecified anti-inflammatory on an unknown date. The patient was not recovered at the time of reporting. Additional information has been requested.
47 year old female (DOB: 05/01/1973) received the first dose of the Pfizer COVID-19 vaccine on 04/07/2021 @ 16:15. Pt started experiencing a headache which started 04/07/2021 @ 16:45 resolved by 04/10/2021 evening, nausea started 04/07/2021 @ 17:15 resolved by 04/09/2021 evening, low grade fever 99.9F, body aches, and fatigue started 04/07/2021 @ 19:15 resolved by 04/14/2021. Pt denies allergies. Pt takes Daysy birth control and Zyrtec. Pt asked if taking medication before the 2nd dose was warranted. Pt was advised to not take medication as a prophylaxis measure to the vaccine and to call back if pt experiences any symptoms as per Q525.
1 week after injection, left deltoid site began having  redness, swelling, pain, and itching