chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female with no drug reactions of allergies and with reportedly immunosuppression due to multiple sclerosis, who on 06-FEB-2007 was vaccinated into the right deltoid with a 0.5ml dose of Pneumovax (lot #655152/0889F). The patient was concomitantly vaccinated with Dtap into the left deltoid. Concomitant medications included medications for multiple sclerosis. It was reported that the patient presented to the office yesterday (07-NOV-2007) with high fever 101, redness at the injection site which was the right deltoid, swelling measured 5 by 4 centimeters. The patient experienced extreme pain at the injection site and limited movement of her right arm due to the pain. The patient sought unspecified medical attention and was treated with oral antibiotic. The patient had a follow up visit and the site was 7 by 6 centimeters of redness, but the swelling had gone down and her temperature was 99.8. The injection site was less tender and the patient had more movement of the right arm. The reporter determined the patients high fever 101, redness at the injection site, swelling measured 5 by 1 centimeters, extreme pain at the injection site and limited movement of right arm due to pain were considered to be disabling and other important medical events. Additional information has been requested.
This spontaneous report was received from a 60 year old female pharmacy technician reporting on herself. The patent was vaccinated with a dose of ZOSTAVAX in January 2012 (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist technician stated she developed a rash around her ankles 1 day after she was given the vaccine. She saw a physician who started her on prednisone (manufacturer unknown) and the rash went away, but the rash had returned. The rash began on both legs around her ankles and was itchy, tingles and was stinging. Furthermore the rash had bumps which when she itched, they would break open and create a hole in her leg. The outcome of the events was reported as not recovered. The relatedness for the reported events was not reported for ZOSTAVAX. Additional information has been requested.
Quarter size dark red, itchy spot at site of injection. Slowly itching decreased in intensity. Spot still quarter sized but now light pink as of 2/13/17 and no longer itching.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 01-FEB-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 24 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
headache; migraine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) in the left arm on 24Mar2021 at 10:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. On 24Mar2021 at 13:00, the patient experienced headache and migraine. The patient had been having continuous daily headaches and sometimes so bad as migraines ever since receiving the vaccine. The patient underwent lab tests and procedures which included rapid testing for COVID-19 on 15May2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with sumatriptan. The clinical outcome for the events continuous daily headaches and sometimes so bad as migraines were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot number cannot be obtained.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 62-year-old adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805003) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Soreness; Diarrhea on and off; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN (Soreness), DIARRHOEA (Diarrhea on and off), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.   Treatment medication information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated and declined further follow-up.
cough; felt miserable and grouchy; felt miserable and grouchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US254562.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset Nov2021, outcome "not recovered", described as "cough"; FEELING ABNORMAL (non-serious), IRRITABILITY (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "felt miserable and grouchy".  Additional information: Patient had cough, felt miserable and grouchy for the past 3 days since he got his 2nd COVID vaccine on 02Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, injection site pain, fatigue, back pain Narrative:
feeling faint; internal sensation jolt; increase blood pressure; pulse declined; face flush; fatigue; A spontaneous report was received from a consumer, concerning a 68-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue.   The patient's medical history includes allergic to codine drug. Concomitant product use was not provided by the reporter.  On 12-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 029L20A) via intramuscularly for prophylaxis of  COVID-19 infection.   On 12-feb-2021,he experienced internal sensation body jolt, feeling faint, increase blood pressure, pulse declined, face flush, fatigue. After 45 minutes following injection his blood pressure are as follows 145/90 mmhg,172/92 mmhg, Late 1 hr of injection blood pressure was decreased . No HCP consulted, advised him to consult HCP before receiving second vaccine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were unknown; Reporter's Comments: This case concerns a 68-year-old female who had a serious unexpected event of syncope along with nonserious unexpected myoclonus, blood pressure increased, heart rate decreased, flushing, and fatigue.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On the 8th day after first Moderns vaccine I developed severe reaction at the injection site upper left arm followed by three days of incapacitation from fatigue, connect tissue and joint paint, I was in bed and out of work for three days. It's day 15 and I still have a rash on my left shoulder, joint inflammation and headaches. I have photos.
I have detailed notes on this, if needed. Injection at about 1:45 pm. Reaction started at 2:00 pm. Tightness at the larynx. It felt like someone had put a rubber band around my neck, I did not initially experience it as swelling.  A feeling of swelling came a little later, at the level of my larynx, and then feeling heat in my throat, and then prickly feeling on my body, I  did nt see any hives. Also, my voice sounded a little strange. Unable to use the continuation sheet below, does not seem to let me in to it. I want to enter my allergies, and continue with this section 18, but it doesnt seem like I can.Milder reaction reaction to first covid vaccine 3 weeks prior, resolved with 2 50 mg doses of benydryl. Not this time: THIS TIME, I AM ON 5 days benedryl, ONLY SOMEWHAT IMPROVED. Unable to fill in a continuation page on the computer. Unable to save. Unable to continue in order to finish this. I WILL FAX THIS TO YOU. I DID TRY TO CALL EARLIER TODAY. NOTE: I DID DISCUSS WITH DR. BY PHONE AFTER FIRST DOSE, AND BEFORE 2ND DOSE - BUT I DID NOT GO TO THE HOSPITAL (PROBABLY SHOULD HAVE), ALSO SOME ANSWERS I FILLED IN LOOKED GRAY-ED OUT, SO I HAND WROTE. THIS IS THE MAR. 2021 FORM.
Patient received an expired dose of Pfizer vaccine. Pfizer vaccine administered 12/20/2021 expired on 12/17/2021, at 1800. Medication refrigerated per guidelines, however, dose was expired.
Received three doses of Pfizer (one from an outside facility and then two from another). System not checked prior to administering dose.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 29 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 027L20A), in left arm and on 11Feb2021 at 11:00 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "stress-related heart palpitations" (unspecified if ongoing), notes: stress-related heart palpitations; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 25May2022, stop date: 05Jun2022, also reported as other medication in 2 weeks. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Penicillin, reaction(s): "Known allergies:Penicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Continuing to test positive on Binax rapid at-home tests; (01Jun2022) Negative, notes: Tested negative on Wednesday and Thursday; (02Jun2022) Negative, notes: Tested negative on Wednesday and Thursday; (03Jun2022) Positive, notes: on Friday night and tested positive again; (Jun2022) Unknwon results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral treatment for COVID-19 with Paxlovid from 26May2022 to 31May2022. Clinical course was reported as, Patient had Rebound symptoms started on 03Jun2022 at 19:15. Tested negative on Wednesday and Thursday following course of 5-day Paxlovid treatment, then fever and sore throat returned on Friday night and tested positive again. Continuing to recover from symptoms now and isolating for another 5 days. Continuing to test positive on Binax rapid at-home tests. Patient was not recovered from symptoms and no treatment received for symptoms.
Two days after I received my first dose, from Friday morning to Sunday evening around five pm, I started to itch. I felt an itchy bump on my face, and my arms and face started to itch bad. It continued through the evening. When I went to bed that night it got to my hands, feet and legs on both sides. The itch was awful, it wouldn?t go away. I took one Benadryl, and it didn?t help so I took the second one and I finally fell asleep, but the itching woke me up again in a couple hours. The next morning I was still itching, seemed a little red on my hands. Went to work, and the itching started bad again, took one more Benadryl at noon, it didn?t help much. By the time I got off work at 4:30 pm the itching was severe, I was getting redder on my hands, and arms. In the span of a half hour or so I became covered with itchy red hives all over, even up into my hair. I went to urgent care at 6:30 pm. They didn?t seem surprised when I said I had my first vaccine dose, as they have seen multiple other patients with the same symptoms. They gave me 2 Benadryl and two prednisone tablets, and a prescription for both plus famotodine. 10 prednisone, two a day for The next five days, plus 2 Benadryl every six hours, and one famotodine Twice a day. It definitely helped calm down the hives. The doctor at urgent care recommended that I don?t get the second dose because I would most likely have a worse reaction. Presently, I feel some lingering fatigue that seems out of the normal. But that is it so far
Got the covid after having the booster in November; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got the covid after having the booster in November) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got the covid after having the booster in November). At the time of the report, COVID-19 (Got the covid after having the booster in November) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter  Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the doctor. The age at vaccination was not reported. The patient experienced a sore arm which had not resolved in 2 months since the injection.
Pt recv vax on 10/26/98; on same day pt exp throat swelling, itchy blotches of rash on body, puffy eyes & headache;dx=allergic rx; tx=steroids
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of pyrexia (fever), palpitation(s), fatigue, influenza-like illness (flu-like symptoms) and chills in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 02UA21A) for COVID-19 immunization. The occurrence of additional events detailed below. Co-suspect product included Tylenol (paracetamol) for an unknown indication. The patient's past medical history included no adverse event. On Mar 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form and Tylenol (paracetamol), unknown route; 1 dosage form. On Mar 26, 2021, patient experienced pyrexia (fever), palpitation(s), fatigue (feeling tired), influenza-like illness (flu-like symptoms) and chills. At the time of the report, pyrexia (fever), palpitation(s), fatigue (feeling tired), influenza-like illness (flu-like symptoms) and chills outcome: unknown/not provided. Reporter did not allow further contact.
Severe aches in muscles, joints, severe cold all nite, felt like I was coming down with cold, sore throat, etc. A little tired the next morning, but otherwise ok.
Guillain-Barre Syndrome weakness starting 1-2 weeks following 2nd dose of Pfizer vaccination for COVID-19.  Patient with worsening weakness over the summer then came to emergency room 9/17/21 with areflexia from the patellae down and significant weakness.
"Lesions all over body starting 3-3-04 fever for 12 hours few days ago" 75-100 red lesions with papules, pustules and scabs- torso, arms, legs.
Bruising not going away 3 weeks after the shot. Bruise is normal brown color with no pain. The bruise is going away and they will contact their doctor on Monday the 30th.
At the time of the vaccine (immediately after) the patient stated to her mom that her "brain felt like it was on fire". Since the time of the vaccine, she has had chronic headaches. Her mom stated she had never had frequent headaches before and that it is unlike her to complain about pain of any kind.
Patient asymptomatic on day of immunization. Afebrile before and after immunization. Patient found dead next day with face down on bed with lots of secretions.
vomiting x 1 8AM 12JUN92; lifeless; no appeitite; t104, fussy,tired;
Throat and chest tightness following vaccination- went to ER and received epinephrine, solu-medrol, benadryl, famotidine, and EKG due to tachycardia.
Patient reported to us on 3/30/16 that he had injection site severe pain on 3/29/16. Upon observation of the site, the pharamacist noticed a small rash and redness around the injection site. Patient was not in pain when he reported the event.
Prolonged crying began 1 hour after vaccines. Did not abate for 8 hours. Did not nurse for 10 hours. No fever (was on routine acetaminophen, first dose prior to vaccine).  Local care for left leg.  Treatment: Tylenol/ice
PER THE CUSTOMER EXPLANATION RASH STARTED  ON HER LEFT SHOULDER AN HOUR AFTER INJECTION AND THEN  RASH SPREAD TO BOTH LEGS NEXT MORNING.
Day 6 post vaccination - nausea/vomiting, low grade fever (100); lt neck-supraclavicular node-tender.   Day 8 post vacc - nausea; lt supraclavicular node enlarged; red; very tender; low grade fever.  Discussed with CDC CIL.
rash, fever, ear infection which led to immobility. Paralysis from neck down, consistent with Guillain Barre Syndrome. She was treated with IVIG and has slow but steady improvement - Loss ability to ambulate - Had silent aspiration requiring thickened feed, failed multiple swallow studies - Decrease use of upper extremities, needing assistance feeding herself - Needed inpatient rehab stay, now getting regular PT/OT/Speech therapy, continuing to still need this - Not back to normal self, not yet walking, still improving arm skills
Spoke to Pt who states worsening calf pain and recent redness of feet since Covid vaccine. Pt with h/o J&J vaccine in March. Pt scheduled for breast reconstruction surgery. Pt advised to go to ER for increased leg pain given h/o recent J&J vaccine.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
red non-tender, non-puritic, hot to touch; large arm, inject administered @ lower border of muscle insertion; no tx;
Onset of symptoms on 12 January, including weakness, fatigue, headache, muscle and joint stiffness.