chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient reports symptoms began on 9/14/21 with cough, shortness of breath, fatigue, and weakness. Also reports loss of taste and smell. Patient is receiving remdesivir and dexamethasone and is requiring O2 at 5 L/min via nasal cannula to maintain O2 sat >90%. Patient is admitted to the hospital.
5 year old male with DTaP administration in left arm.  Had immediate redness around inoculation site.
received 4 doses of Shingrix; patient received 4 doses of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 97PL2, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 17th April 2020, Batch number- 73E59, intramuscularly on an unknown arm) and Shingrix (received 1st dose on 13th November 2019, Batch number- 2CP9B, intramuscularly on an unknown arm).   On 4th January 2022, the patient received the 4th dose of Shingrix (intramuscular). On 5th January 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 5th January 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 4th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: This case was reported by the retails pharmacist. The patient received 4 doses of Shingrix on an unknown arm, which led to extra dose administered. All the doses were given at the same pharmacy. The reporter consented to follow up. This case is one of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002782:same reporter US-GLAXOSMITHKLINE-US2022002785:same reporter
pt recvd vax 16FEB95 & pt started having a t103, having periods of trembling in upper & lower extremities; 17FEB95 had an edematous fontanel upon awaking was taken to MD; 18FEB95 dx OM & tx w/Augmentin
SHINGRIX 50MCG      INJ: I ADMINISTERED THE VACCINE TO THE PT AND THE PT CALLED LATER TO REPORT A BUMP AT THE INJECTING SITE. I RECOMMEND THAT THEY SEEK MEDICAL ATTENTION AND THEY DID. A doctor office called later to investigate about the vaccine. Pt had the bump that occurred earlier burst and the doctor office are treating the patient.
Complained of bumps and swelling following the cervical spine area.  Seen by our psychiatrist and sent to urgent care.
This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB lot# reported as L029631 and expiration date: 14-AUG-2017, lot # M029233 with expiration date: 19-AUG-2018, lot #: M001578 with expiration date: 21-NOV-2018, lot# L045117 with expiration date: 06-OCT-2018 and lot # M022077 with expiration date: 10-AUG-2019 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Anxious, Pale, sweaty Seen by onsite EMTs. Discharged home with father on 5/13/2021 at 12:45 PM.
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a health care worker concerning a 2-month-old patient of unknown gender.  The patient's concurrent conditions, medical history, previous drug reactions, allergiesand concomitant therapies were not reported.  On 18-AUG-2022,, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one dose orally administered as prophylaxis (lot number W004504 which has been verified to be valid, expiration date reported and validated as 16-JUN-2023) and (lot number W002562 which has been verified to be valid, expiration date reported and validated as 12-OCT-2023) (strength and vaccination scheme were not reported). The reporter clarify that the patient received only one dose but did not specify which actual lot was administered. The administered dose of the vaccine was stored at a temperature of 11.3 degrees Celsius (C), during a time frame of 34 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
lethargy, inconsolable,  and fever up to 101 F for 2 days. Tenderness, redness, swelling at site for 1 week.
Child had MMR vac. on 1-26-04 at which time child twisted and turned to avoid the injection. Now upper arm is warm, swollen and inflammed.
Reported receipt of second dose > Day 35; Sore Throat; Can't Smell; Runny nose; Small migraine; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose), MIGRAINE (Small migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose) and MIGRAINE (Small migraine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), ANOSMIA (Can't Smell), RHINORRHOEA (Runny nose), MIGRAINE (Small migraine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Reported receipt of second dose > Day 35) outcome was unknown.            No treatment and concomitant medications were reported.
Had chest pain / hurt when breathing for several days.  Went to urgent care & ER on 4/23/21.  Everything was 'normal'.  No rash at that time.  Found a rash with blisters on my right breast on 4/27/21.  Went to PCP on 4/28/21.  Was diagnosed with shingles.  I have never had shingles in my life.
pt with c/o lightheadedness/dizziness approximately one minute after injection of Gardasil #1. Pt laid down and stated symptoms resolved after about 10 minutes. Pt also recieved TDAP that day. TDAP given first, then Gardasil. Symptoms occurred after Gardasil given.
Patient said he was fine after shot and he had no issues. He went home and decided to paint a room and used his left hand to reach in a corner to paint, He later became in pain that night and went to ER in the morning. Patient was given Flexeril and Norco to help with pain. Doctor did not see that the shot was related to his issue.
first dose in Jan-2021, not yet been given second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the Nurse assistant. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Muscles very sore. Headache. Sick to my stomach. Light headed. Chills
Pt started to develop a rash from head to toe Sat 5/22. Dr gave pt steroid shot and benadryl on mon 5/24, which helped very little. Rash continued to get worse so Dr. is referring pt to a specialist
Patient began to feel nauseous about 10 minutes after receiving her vaccine. She stated she was having pretty bad arm pain, and tingling  in fingers. Patient was brought back to obsservation and stated that she was feeling better, but arm pain persisted. Upon assessment , Patient was vaccinated very close to acromion process. Patient remained seated for monitoring and after having vitals reassessed she was released home with her parent.
Dizziness, feeling faint, sweating, nausea within 15 minutes of receiving vaccine. Pt lied on floor with feet elevated and cold wet cloth on forehead. Blood pressure was slightly lower than normal for pt 96/54 pulse 74 (normal for pt around 100/70).  Pt remained lying down for about 20 minutes. EMS was called to check pt vitals. On their arrival, about 30 minutes after symptoms began, pt was feeling much better with dizziness and nausea improved. Vitals were normal upon check by EMS and pt was advised to return home and rest.  Pt reported she had arrived home safely and was feeling better when called by pharmacy about 1 hour later.
breakthrough covid19 infection - onset of symptoms 7/31/2021 and admitted to hospital for fever/chills, diarrhea and renal failure on 8/4/2021
ulcers throughout my mouth; viral ulcer; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH ULCERATION (ulcers throughout my mouth) and VIRAL INFECTION (viral ulcer) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MOUTH ULCERATION (ulcers throughout my mouth) and VIRAL INFECTION (viral ulcer). The patient was treated with ACYCLOVIR [ACICLOVIR] for Mouth ulcer and Viral infection, at an unspecified dose and frequency and PREDNISONE for Mouth ulcer and Viral infection, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (ulcers throughout my mouth) and VIRAL INFECTION (viral ulcer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Other treatment medication included magic mouthwash.
Right arm swelled to 3x's normal size and knot at injection site getting bigger & bigger. Nausea, feet edematous, hives, itching. Started swelling on 10-18-03 and by 10-19-03 all the above signs were present. To ER at AMC on 10-19-03 gave Benadryal an steriod injection.
I get a headache this has lasted over a few days; I have completely lost my sense of taste and smell.; I have completely lost my sense of taste and smell.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in arm right on 01Mar2021 at 10:30 as 1st dose, single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (note: OCD- Obsessive-Compulsive disorder), post-traumatic stress disorder (note: PTSD: post-traumatic stress disorder) and food allergy (shellfish). The patient's concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 at 11:00, the patient experienced i get a headache this has lasted over a few days, i have completely lost my sense of taste and smell. No treatment was given for the events. The outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Within 1 minute of vaccine administration = immediate flush of heat, dizziness, weakness, blood pressure elevation.  Treatment = apple juice, water, monitoring blood pressure.  Better in 2 hours.
pt recv vax 22MAR98 & devel rash-armpits, w/in skin folds, armpits to naval;
approx 30-45 sec p/inj completed, pt slumped forward in mom's arms, eyes open but limp & unresponsive; lifted to table & had 30sec episode of rigid posturing, head arched back, fists clenched, arms flexed to chest; pt spontaneously relaxed
On 9/28, the pt developed diffuse varicella. She also developed clumsy gait, and extreme fussiness.
Aug 7 - vaccinations at hospital. Aug 14 - temp about 101 with nml activity. Aug 15- temp 103-104.7. Aug 16 - temp 102 103 - crying, limp, cheeks begin to speckle. Aug 17-19- rash head to toe decrease in temp.
Information has been received from the mother of an 18 month old female with no known allergies and no past medical history who on 4/12/01 was vaccinated with rubella virus vaccine live (second generation). There was no concomitant medication. On approx. 4/19/01, the pt developed a fever for 2 days. On 4/22/01, the pt developed a rash. The pt's rash persisted as of 4/26/01. Unspecified medical attention was sought. No further details were provided. Additional information has been requested.
Muscle aches, mild headache, fatigue, and dry mouth.  Symptoms started 5-6 hours after dose and subsided within 24 hours of starting. Muscle aches were more intense than with first two doses.  headache and fatigue was the same as first 2 doses.  Dry mouth only occurred with 3rd dose.
did not follow the recommended dosing schedule; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014A20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
20 minutes post shots mom noted hives (blotches welts) lasting 20 minutes;no troubles with throat no resp sx; sl. puffy eyes, no sequelae.
I experienced extreme inflammation in my hips, back, butt, arms, and legs (where it meets my Torso) which caused my skinny genes syndrome to  heightened. I had an appointment with my PCP who explained that the vaccine cause my Skinny Genes Syndrome to  flare up. My PCP did some blood work when I went in for an appointment. I am still currently experiencing the symptoms and cannot bend my leg back along with muscle pain and inflammation.
Myalgia; aches and pains all over; headache; arthralgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in April 2019 and experienced myalgia, general body pain, headache and arthralgia, refer linked case US2019130912).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced myalgia, general body pain, headache and arthralgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia, general body pain, headache and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, general body pain, headache and arthralgia to be related to Shingrix.  Additional information received were as follows: No lot number and expiry date was available. The patient experienced myalgia, headaches, and aches and pains all over. The events had not subsided. The reporter consented to follow up.
I received my booster on 10/29/2021 which was a Friday and after that I had flu like symptoms including a severe headache. By Sunday and Monday I was feeling fine, but I had noticed a sore on my right breast it looked like it was as if my skin had been scraped. I was concerned because I previously had breast cancer. I had a tele-visit on 11/03/2021 and they advised I need an in-office visit. On 11/04/2021 I had a doctor appointment and they ordered a sonogram. I was able to see my surgeon on 11/10/2021 he assured me it wasn't was cancer. I did have a visit with the dermatologist on 12/14/2021 and was diagnosed with pyoderma gangrenosum.
Woke up at 2am after injection at 4pm previous day.  C/O pain, swelling, reddness, hot to touch. Next morning at 6am continued with above and nausea, malise, felt like flu, ached all over.
Infant died on 12/17/2021 (3 days after vaccines given) of unknown cause. Infant was found unresponsive in crib at home.
"immense pain and burning across entire body" She described the pain as if her blood were on "fire".  She admits to having soreness and pain but it was improved by taking Naproxen OTC.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient were vaccinated with GARDASIL 9 (dose, lot #, expiration date and route not reported). The patients stated the injection sites were painful for an unspecified amount of time (onset date unknown). The outcome of the event was unknown. The causality between GARDASIL 9 and the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
On 6/5/2023, RN, administered expired Hep B vaccine with expiration date of 6/3/23 to a patient. Nurse failed to check expiration date on Hep B vaccine prior to administering to the patient. There was a tag on the Hep B vaccine box stating to watch expiration date. LPN, failed to put Hep B on the expiration date calendar for the month of June. The calendar is checked each morning by her and Nursing Supervisor.
Tight cough, chest pain 5 days after vaccination. Treated with albuterol inhaler, improving
The Pfizer covid vaccine cause breast pain and swollen lymph node in right armpit. Pain is constant as of the complaint I am filing.
About 7:00 am - fatigue and chills, muscle aches. Starting around noon, my fever was getting higher and higher - to 103. At 2:00 pm, I tried to sit up in my bed - I proceeded to throw up and faint. I contacted doctor to see if I should take anything. I took an ibuprofen and drank fluid - but didn't drink as much as normal because of nausea. I was nauseated all day. It stayed about 102 until about 8:00 pm. At about 10:00 pm that night, I started feeling a bit better. The next day fever was 99.7 and with more ibuprofen it normalized to 98.6. If I didn't take ibuprofen for awhile it went back up to 99. something so I had to keep taking ibuprofen for the rest of that third day. Fourth day - mild fatigue and muscle aches. Everything was normal other than that. Fatigue and muscle aches were gone about Friday morning.
DOSE 3 (BOOSTER), SINGLE/10Oct2021; Chills and passing out; Very nauseous; Chills and passing out; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:00 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE, dose 3 via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:00 (Batch/Lot Number: Ff2590) as DOSE 3 (BOOSTER), SINGLE at the age of 73-years-old for covid-19 immunisation.  Medical history included none. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation from 05Sep2021 to 05Sep2021; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported; olmesartan taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Feb2021 (lot number: Zn5318, Left arm) for covid-19 immunisation, erythromycin and experienced drug allergies.  Approximately 13 hours after 2nd and 3rd vaccine, patient experienced chills and passing out Very nauseous. Also dose 3 (booster), single/10oct2021 was reported. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.Outcome of chills and passing out, chills and passing out, very nauseous was recovered in Oct2021, of DOSE 3 (BOOSTER), SINGLE/10Oct2021 was unknown. Therapeutic measures were taken as a result of very nauseous.  No follow-up attempts are possible. No further information is expected