chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given the vaccination at approximately 5:25pm and around 5:27pm she  stated she felt as though she was going to pass out. I went out to the waiting area to encourage her to lie down. She slouched and lost consciousness within seconds of me approaching her. She was unresponsive for approximately 10 seconds. While unresponsive, Patient seemed to shake and her arms tensed up a bit. Once she gained consciousness, she immediately knew where she was and what she was here for. I gave her water and an ice pack because she stated she was hot. I monitored her blood pressure, which was elevated at first, but came down within 15 minutes of regaining consciousness. Patient did not want emergency services to be contacted because she stated she felt fine. She did report some nausea following the event. Patient was driven home by a family member around 6:00pm.
Pfizer-BioNTech Covid-19 vaccine EUA Rash patch on both sides of neck, both sides of upper chest (size of orange), inside of upper arms. Started 1/9/2021. Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on lower left side of back. Started 1/15/2021. Treatments tried-no relief -  Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-FEB-2016 the patient was vaccinated with an improperly stored dose of Gardasil 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and type of excursion (R/F) for the first excursion was 72, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 112, 30 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and type of excursion (R/F) for the third excursion was 208, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and type of excursion (R/F) for the forth excursion was 112, 32 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 16, 33 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the sixth excursion was 24, 34 and R. This is one of several reports received from the same source. Additional information has been requested.
Within 12 hours of second dose of vaccine participant woke up with shooting in hip, had a fever of 101, uncontrollable shaking, feeling of cold and hot. Participant had sweats and headache that lasted 5 day's and lymph node swelling in armpit. Symptoms resolved after about 12 day's. Participant cycle was longer.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were provided. Additional information was received on 12-May-2009: product complaint investigation results
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.  Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.  Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided.  This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 15-JAN-2014 in the morning. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient never called back and the were going to  consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source.  Additional information is not expected since all follow ups requested to complete the case were received.
FEVER; This spontaneous report received from a consumer via a company representative concerned a 59 year old male. 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: 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 patient experienced fever. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious. This case, from the same reporter is linked to 20210843017.
Sore arm; He experienced cold (Nasopharyngitis); Past 51 days and hasn't received second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) and INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 08-Feb-2021, the patient experienced NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) and INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (Past 51 days and hasn't received second vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and NASOPHARYNGITIS (He experienced cold (Nasopharyngitis)) had resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-034120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: Additional information received. Added second dose details, event, sore arm. Updated outcome of events experienced cold and past 51 days and hasn't received second vaccine from unknown to recovered/resolved. Updated action taken from temporarily withheld to not applicable. On 08-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of nasopharyngitis , a causal relationship cannot be excluded.  This report also refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 037K20A with no other associated AEs.
burning sensation on the left side of face, neck , eye and top of head that increasing at nigh; numbness sensation on the left side of face, neck , eye and top of head that increasing at night.; unable to sleep due to the pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness sensation on the left side of face, neck , eye and top of head that increasing at night.), BURNING SENSATION (burning sensation on the left side of face, neck , eye and top of head that increasing at nigh), and INSOMNIA (unable to sleep due to the pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (numbness sensation on the left side of face, neck , eye and top of head that increasing at night.), BURNING SENSATION (burning sensation on the left side of face, neck , eye and top of head that increasing at night) and INSOMNIA (unable to sleep due to the pain). The patient was treated with GABAPENTIN at an unspecified dose and frequency and a CT scan was performed. At the time of the report, HYPOAESTHESIA (numbness sensation on the left side of face, neck , eye and top of head that increasing at night.), BURNING SENSATION (burning sensation on the left side of face, neck , eye and top of head that increasing at nigh), and INSOMNIA (unable to sleep due to the pain) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
INJECTION SITE REACTION HOT TO THE TOUCH AND RED AREA. PATIENT WENT TO HER PRIMARY CARE DR. FOR ALLERGY SHOT AND THE NURSE DISCOVERED THE ADVERSE REACTION AND TOLD THE PATIENT TO COME BACK TO THE PHARMACY TO HAVE US REPORT THE ADVERSE EVENT. I ADVISED THE PATIENT TO KEEP AN EYE ON THE SITE AND THAT THIS HAPPENS ON OCCASION AND THAT THIS SHOULD IMPROVE. HOWEVER KEEP AND EYE ON IT AND IF IT DOES NOT IMPROVE TO GO TO YOUR DR. AND LET ME KNOW. I HAVE CONTACTED THE PATIENT FOR FOLLOW UP AND SHE IS FINE. SHE HAS NOT RECEIVED ANY OTHER VACCINE IN THE PREVIOUS MONTH.
Pt recvd 2 doses of Engerix-B on 18JUL91 & 16AUG91 & 24-36 hrs p/2nd vax (18AUG) pt devel rash generalized on trunk; The rash lasted 3-4 days & resolved w/o treatment;
11/18/21-In the last month, have you been in contact with someone who was confirmed or suspected to have Coronavirus / COVID-19?  Yes Have you had a COVID-19 viral test in the last 14 days?  Yes - Positive result Do you have any of the following new or worsening symptoms?  Runny nose;Cough;Loss of smell Have you traveled internationally or domestically in the last month?  No
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 at 19:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 56 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 15Dec2011. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 04Mar2023.
June 27th I developed Shingles, I am a healthy 44 yr old,  took valtrex po starting June 27th, July 2nd I ended up in ER with so much pain,  was admitted to  Medical center,  Varicella Zoster had gone to my spinal fluid.  I stayed 5 days in hospital getting Acyclovir IV every 8 hours, Sent home July 6th  continued with home health and continued to get Acyclovir IV every 8 hours until completed on July 12th at 2100
Patient presented to ED on 10/13/21 with complaint of intermittent chest pain x 3 days.  Patient has no past medical history.  Patient received COVID-19 vaccine about one week prior to start of chest pain.  CTA chest was negative for PE.  Initial troponin was elevated at 13.17, troponin peaked at 23.84.  Echo revealed LV ejection fraction of 68% with normal RV systolic function.  No tachy or brady arrhythmias noted during hospitalization.  Patient diagnosed with myopericarditis likely secondary to recent COVID-19 vaccine.
I contracted COVID 10/26/21 multiple people from bowling league that night tested positive.   Symptoms started 10/31/21 started isolation.  Fever 100.4 subsided overnight.  Body aches, fatigue, dry cough, runny nose, headaches all subsided in 3 days.  Lost taste and smell the 4th day regained it the 5th day.  Tested positive 11/2/21, as of 11/5/21 I have no symptoms feel 100% haven't napped in two days, remain in isolation until 11/10/21.  Went for 6 mile walk in woods today and have started working out again in isolation room.
little bit of fever lasted around 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little bit of fever lasted around 24 hours.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (little bit of fever lasted around 24 hours.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-May-2021, PYREXIA (little bit of fever lasted around 24 hours.) had resolved.            Concomitant drug included antidepressants.   This case was linked to MOD-2022-451556 (Patient Link).
Chills, fever, vomiting, diarrhea, muscle aches, fatigue, and an angry red rash that started on my left foot and gradually moved up underneath my knee. It was red, hot to the touch, swollen, and painful.
27 year old male with Down's Syndrome and no other past medical history received second COVID-19 vaccine on 4/27/2021. On 4/30/2021 began "feeling poorly" with nausea/vomiting and possible chest discomfort. Originally presented to ED on morning of 4/30 - EKG completed demonstrated diffused ST elevation. Patient was transferred to Medical Center for heart catheterization. Left heart catheterization demonstrated normal coronary arteries and LVEDP of 25. Stat ECHO demonstrated pericardial effusion and concern raised for myopericarditis. Patient subsequently transferred to a different Medical Center for higher level of care. Upon arrival to Medical Center plan was to intubate and take to cath lab for heart biopsy and PA catheter placement. However, upon intubation patient began to decompensate and subsequently developed cardiac arrest. During ACLS, VA ECMO was placed and therapeutic hypothermia was initiated. Following VA ECMO placement patient received IVIG, high dose methylprednisolone (1000 mg), anakinra 100 mg, and broad spectrum antibiotics (vancomycin and Zosyn). Despite these efforts the patient continued to have hemodynamic instability and was on high dose vasopressors (epinephrine, norepinephrine, dopamine, angiotensin II, vasopressin). Patient subsequently suffered another cardiac arrest, briefly regained pulse with high dose vasopressors, but subsequently lost pulse despite best efforts and died on 5/1/2021 at approximately 13:00.
Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 11:00 at a single dose for Covid-19 immunization.  The patient's medical history and concomitant medications were not reported. After dinner of 30Jan2021, the patient started having symptoms listed as headaches, chills, nauseated, and body aches. She described her chills as being so bad that she woke up last night shivering. She said the nausea and body aches come and go. She asked how long will her symptoms last. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
sore arm/arm pain; "felt the fire"/felt the burning of it going in; chills and heat/little chills; chills and heat/little heat; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 85, unit not provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine received on an unspecified date and the patient got really sick, got really sick with the flu, was like got the flu but in 2 hours. The patient received BNT162B2 vaccine and experienced sore arm on an unspecified date. He "felt the fire", experienced chills and heat on an unspecified date and then the next day he was fine. He stated that after the first shot, he had arm pain for a couple of days, felt the burning of it going in and a little heat and little chills but the next day he was on the way to being good. The patient recovered from the event sore arm/arm pain and was recovering from the events "felt the fire"/felt the burning of it going in, chills and heat/little chills and chills and heat/little heat. The reporter assessed the events as non-serious.
Shot was administered Wed, patient woke up Friday with soreness at injection site, bumps, itching, hot to the touch. It was swollen to about the size of a tennis ball. Patient used a cold compress and took BENADRYL. Swelling is going down now, 5-8-12.
nausea/ slightly nauseous; chills; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "chills"; NAUSEA (non-serious) with onset 15Mar2021, outcome "recovering", described as "nausea/ slightly nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called to report right arm pain after injection & continuing for last 2 weeks. Pain comes & goes.
vaccinated w/first hepatitis 31AUG89 on 5SEP89 developed flu-like symptoms, temp 104 required bedrest 3 days. Second dose 28SEP89 developed sore arm, arthralgia & was tired. NOV89 pt was fatigue, depressed and joint pain See WORM
she would have imbalances out of the blue; Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received palbociclib (IBRANCE) (ongoing) (Batch/Lot number: unknown) at 100 mg; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "Migraine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "she would have imbalances out of the blue". The action taken for palbociclib was unknown. Therapeutic measures were taken as a result of balance disorder. Additional information: Patient, reporting on Ibrance and who explains she was taking the product when she took at the second of the Covid shots and the second shot caused huge numbers. Patient clarifies that this means that the first 3 weeks after the Covid second shot did not ring well with the Ibrance and caused her to have multiple migraines. She was having a minimum of 3 each day and that went on for 6 weeks. It has slowly gone back to one a day at this point. The patient stated she wants to report his and is calling to renew her Ibrance refill. The patient explains she tore off the information she needed from the package and threw the box away. She confirms that the migraines started immediately after the second dose. Also, she got the second shot on the same day she started the Ibrance cycle. The patient does not know the exact date but this was several months ago. Patient doesn't have her vaccine card available and has no date, NDC, Lot, or Expiry to provide. It was confirmed the product was the Pfizer Covid vaccine. It was explained that they were continuing, the migraines. She doesn't have a problem with the migraine and the Ibrance normally but with the second shot she had the problem. The patient described them as electronic instead pain and they were also throwing her balance off; she would have imbalances out of the blue. She went to the neurologist and has recently started on a new medication for people that have a brain dysfunction as treatment for this, maybe that is helping. She has to build up with the product but it is scary to be on this type of medication. The product name is (name withheld), captured as spelled by the patient, 25mg tablets twice a day and that dose will increase next week. No NDC, Lot, or Expiry given by the patient when probed. When asking product information: The patient explains she tore off the information she needed from the package and threw the box away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Generalized body aches, swollen lymph nodes, especially on side vaccine administered ie L side.  Localized inj. site pain and swelling also.
Developed a lump in my throat soon after receiving the injection. Feel like I have to keep swallowing and clearing my throat. Some fullness in my ears that resemble having water in your ears when swimming. Some chest tightness, but mild. No shortness of breath. No rashes.  Reported this to the nursing staff at the Covid Pod site around 12:15pm. Ate lunch, drank water, and took Benadryl at 1230. Developed chills and fever of 100.1 at 2:30pm.