chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & shortly p/exp problems w/co-ordination;pt could not walk;tx w/physical therapy;p/ 1 1/2 yr the problems partially resolved;pt still has some co-ordination problems;
Patient reports that she was diagnosed with COVID-19 this summer and since that time has been experiencing 'long haulers' with headache, fever, body aches and pain, coughing, nasal congestion, extreme fatigue and mental fogginess. These symptoms have been ongoing since patient had her COVID infection but did seem to be improving when she had her 2nd dose of the COVID-19 Pfizer vaccination after which the patient experienced an exacerbation of these symptoms. Pt developed fever to 102 degrees, chills, myalgias, nausea, severe low back pain, shakiness.  Was evaluated in the emergency department and discharged home
vaccines were given post excursion  with no adverse event; The excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees Fahrenheit with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and  gender patient who was vaccine given post excursion with no adverse event and the excursion lasted for 1 hour and 5 minutes. the minimum temperature of the refrigerator reached 27.5 degrees fahrenheit with no reported adverse event, while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) (lot C5843AD and  expiration date: 25-Oct-2023) at an unknown dose via unknown route in unknown administration site for immunization.  On 24-Jun-2022,  the reporter stated that temperature excursion due to leaving the door ajar for the refrigerator. The excursion lasted for 1 hour and 5 minutes. The minimum temperature of the refrigerator reached 27.5 degrees Fahrenheit (product storage error) (unknown latency) and the vaccines were administered post excursion  with no adverse event (poor quality product administered)(latency: same day) .  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for both events .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01180094:
Severe tinnitus in my left ear started one week after administration . This happened after the second dose as well and lasted for 7 months.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 52 years 7 months. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter.    This case was linked to MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  MOD-2022-542869:MCN number
Developed tightness in throat at approx. 1:30 pm, also cough.  At 3:00 pm, temperature was 104.  Took Benedryl adult dose.  Fever broke at 1:00 am 10/30/09.  No recurrance of symptoms.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  On December 6, 2021, vaccine vials of Lot 012H21B were placed in refrigerator.   This case was linked to MOD-2022-449524 (Patient Link).
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PEDVAXHIB with the following lot numbers and expiration dates: M034189/23-MAY-2019 and M046140/27-SEP-2019 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1708USA013008: US-009507513-1708USA013009: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-707USA005187: US-009507513-1708USA013005: US-009507513-1708USA013007.
2 min post injection developed tingling around site, and then urticaria on left upper arm. Then diffuse flushing diffusely and headache. HR=130's, normal BP. Difficulty swallowing during EMS transport. Received EPI sc, Pepcid IV, and Benadryl 50mg IV PTA. HR+140 on arrival post Epi  6 hour obs. NS 1L  D/c home with precautions, epilepsy pen rx, and allergist follow-up
Next morning, woke up and felt like out of balance and feverish.  Drank coffee and then slept for 22 hours.   When woke up, Fever continued, felt like hit over head, loss of appetite  and aching all over--felt dreadful.   Patient did not take any extra medicine than usual.   Symptoms lasted for 4 days.  A week later patient reported incident to the pharmacy.  Patient not sure if has received the Fluad vaccine before but has received Flu vaccine consistently in the past since she is a physician
Received Varicella vaccine 10/9/08 AM in MD's office. 10/10/08 - Arm very sore and tender. Mild redness and swelling at injection site. Had a headache and chills. 10/11/08 Noticed swelling more significant with tenderness and increased redness. 10/12 Seen in clinic and prescribed antibiotic.
pt recv vax 11JUL93 & 25JUL93 pt devel pain & swelling in knee & fingers;devel pain in lt knee & 3 days later devel pain & stiffness in the rt 4th & 5th fingers;1994 underwent tonsillectomy;SEP94 irregular menses;pain shoulder;lupus
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned eleven patients. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch numbers were 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 patients died due to unknown cause of death. Reporter stated that "All I know it when this first started I had 11 friends who died". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220100991.; Sender's Comments: V0: 20220100700-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
There is swelling of the injection site, 2nd Day after the injection. Up to day six the swelling is still there. The swelling feels hard.
Anxious, lightheaded, sweaty. Patient given water, cool cloth and sat for a few minutes. S/S resolved.
I am experiencing a loss of vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (I am experiencing a loss of vision) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (I am experiencing a loss of vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (I am experiencing a loss of vision) outcome was unknown.            No treatment information and no concomitant information was provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Very limited information regarding the event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-231563 (Patient Link).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Information has been received from a medical assistant concerning a 6 year old female patient who was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
I got a rash on my face , head, arms, chest and top part of back. I went to the er and dermatologist and received topical and oral medicine to use and take.  The rash appeared about a week and a half after the shot and I still have it.
PER EMPLOYEE, WOKE UP THE NIGHT OF THE 1ST WITH PAIN IN NECK AND LEFT SIDED FACIAL DROOPING WHICH HAS NOT YET RESOLVED. STATES DIAGNOSED AS BELL'S PALSY. IS BEING FOLLOWED BY PCP. WILL HAVE AN MRI DONE THIS WEEK.
Pt. states about 1 hour following vaccine administration her arm became very painful. States whole left arm down to palm hurt. No numbness, swelling or warmth. Pt. directed on 10/10/12 at 9:07 AM to take Ibuprofen 800mg. Pain resolved.
The patient states that her shoulder was sore following the vaccination.  The soreness increased and for months to come kept her from regular exercise.  It hurt doing her hair, lifting light weights, and lifting arm higher than 45 degrees. She visited a massage therapist, orthopedist and physical therapist.  After an x-ray she was diagnosed with a shoulder injury related to vaccine administration (SIRVA).  The orthopedist, told her the vaccine must have been administered incorrectly and that was why she was in pain. He recommended four weeks of  physical therapy, which provided no relief.  She returned to Orthopedist who suggested she give it more time and the pain would go away.  Six months later the pain has lessened but is still present.
Right upper arm with severe swelling, redness, pain, and tenderness from right shoulder to right elbow. Right upper arm increased in size by an estimate 50 percent.
24hrs post vaccination, pt reported pain at the injection site and that she is unable to lift her arm.  Pt instructed to take APAP or Ibuprofen for pain until symptoms resolved.  On 8/6 pt reported difficulty breathing/wheezing/SOB, a rapid HR the night before, dizziness, weakness, and abdominal cramping. Pt instructed to go to UC/ED given hx of Asthma and pt report of SOB.  Pt stated they were going to Hospital.  No information regarding that encounter is available to this writer.  Pt recovered and was given 2nd dose on 8/27.  Pt did not report prior reaction at that time.
to prevent throat and neck cancer; No further AE information; This spontaneous report was received from a pharmacist vis company representative and referred to a male patient of unknown age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date, This patient was requesting the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for throat and neck cancer (strength, lot #, expiry date, and route of administration were not provided) as it was recommended he receive it by his doctor since he was at high risk for smoke inhalation based on his occupation. It was unable to confirm with the pharmacist if the vaccine was given to the patient., and it could not be confirmed if the patient did or did not receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product use in unapproved indication). No further adverse event (AE) information.
Vaccine expired: 07/13/2023 Administered an expired vaccine to the patient on 7/31/23. No reactions at this time but was just given this morning. Will monitor the patient. Merck has data showing extended potency and does not recommend re-vaccinating the child.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication was taken in 2 weeks. Patient received Paxlovid for Treatment of COVID-19 from 26Jun2022 till 01Jul2022. Patient experienced COVID-19 rebound on 22Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2 .
Hospitalization: 1/30/2023 - 2/2/2023 (3 days) Presentation to the ED: BLE WEAKNESS COVID + date: 2/2/23. Treatment: NONE. PATIENT WAS DISCOVERED POSITIVE ON A TRANSFER SCREEN TO hospital.  Discharge to:   046A21A 3/31/2021 039B21A 4/28/2021 031H21A 11/20/2021
A few hours after the Thursday afternoon injection, my temp shot up and stayed right around 102, my heart rate was 135- just sitting, and my oxygen level was 93%. I shook uncontrollably the first 10-12 hours, and had chills. Tinnitus. Nothing inproved until the middle of Friday night- I sweated through sheets. Still had fever, high heart rate, and up and down oxygen for 18-20 days. My heart rate (I'm on 2 anti-arrhythmia drugs so my rate is rarely above 65) was still high but better by day 22. Fever is also better but not gone. Exhausted.
Received flu shot on 12/3/12; Increasing leg discomfort and trouble walking. No fever; Guillain-Barre syndrome
Swelling, pain, erythema, tenderness of left upper arm.  Swelling from bicep to mid forearm (distal to elbow).  Arm warm to touch.  Patient denies fever, sweats, urticaria.
Patient was under the approved age of 18 at the time of 1st dose. This error was caught when patient came back for 2nd dose.
Pt vaccinated developed back pain 2 wks after & progressive weakness & numbness about 3 wks later.
Four weeks after the first dose, I noticed blood in my stool.  There was no pain, but there was enough red blood to cause concern.  I got the second shot on the same day as the bleeding in the left arm.  I did not notice any more bleeding for a few weeks afterwards, but I did begin to have daily abdominal pain on the lower left side.  On August 23rd I used a home FIT test, which tested positive for blood (no visible blood).  On August 24th I again noticed visible blood in stool and saw my PCP on August 25th.  He recommended a colonoscopy to determine the cause.  I experienced bleeding several more times over the next two weeks, with the most bleeding September 13th and 14th.  I also had daily lower ab pain.  The ab pains have mostly subsided since the colonoscopy and I have not had any more bleeding but am still monitoring.  Could the vaccine have caused some immune response that caused colon spasms and bleeding - are there any cases of others with auto-immune diseases that have reported gi issues?
fever began, according to parents, on 4.28 after immunizations.  not measured with thermometer at home.  continued until visit to MD on 5.1, when rectal temperature was 103.4
pt recv vax & pt eyes rolled back in head & hit the floor;facial affect was blank w/fixed dilated pupils;sl jerking;pt came immed out of state w/ammonia inhalant;
Felt lightheaded and was given apple juice. BP 146/60, pulse 61, and O2 sat of 100%.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On 1st July 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (The patient did not know lot number, expiration date, or dose of SHINGRIX). The patient had a rash on her neck. The rash was described as itchy. The patient was treated with 1 percent hydrocortisone for rash. Since rash developed it had gotten larger. The patient advised pharmacy and her doctor about the rash. The patient could not provide full contact details for pharmacy and contact details for healthcare professional.
Patient experienced tachycardia and CNS stimulation immediately after vaccination. Patient did not inform healthcare provider of this effect until 20 hours after vaccination when she presented to the pharmacy complaining of arrhythmias that felt like "she got punched in the chest and that made her cough", light headedness, and nausea. She stated that her mother has a history of allergic reactions to vaccine in the past but that she herself has never had any reactions nor any cardiac concerns. 911 was called and pharmacist administered  324mg of chewable aspirin per 911 recommendations and patient was taken to the ER to be evaluated.
Joint pain; This is a spontaneous report from a contactable consumer via Pfizer. (The consumer, Grand mother who is also a patient reported for her grand son).  A male of an unspecified age, received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Reason for no lot number of Pfizer vaccine: Caller unwilling to complete the report. The patient medical history and concomitant medications were not Provided. Patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date for covid-19 immunisation. While the reporter was reporting on her own symptoms after the Pfizer COVID-19 vaccine, she mentioned that her grand kids had pain after the second shot as well, and had the Pfizer vaccine. The reporter confirmed that her grandson experienced joint pain. She just keeps telling her grandson(patient), that they got spoiled with the first one. Declined to complete report (Unspecified information), stated that she was sure he did it at his job. Reporter seriousness for the Joint pain was unspecified. Outcome of the event was unknown.  Information about lot/batch number is requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021690717 Same reporter/drug, different AE/ patient
one of them has a lump of medication that wouldn't dissolve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as 0.5ml (Lot number: FJ2602, Expiration Date: Jun2023) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one of them has a lump of medication that wouldn't dissolve".  Additional information: This was a product complaint issue. Practice manager calling on behalf of the facility from  Primary Care. She has called about Prevnar 20 and says they got a shipment in and one of them has a lump of medication that would not dissolve so they do not feel safe giving to a patient, so they would like to see if they can get a replacement or refund for this one. Caller says she needs to put her glasses on when retrieving product to provide NDC/LOT/EXP from it, but does not clarify this statement. She says that the Prevnar 20 has a white lump that she guesses is the powder, and they were shaking and shaking it and could not get it to dissolve, and it has been at room temp for a while now. She says all the other doses seem fine so far, it is just this one. Packaging sealed and intact was done.   No follow-up attempts are needed. No further information is expected.