chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 17 year old female with asthma and allergies to naproxen and ibuprofen, who on 07-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # not reported). On 15-OCT-2007, the patient was vaccinated intramuscularly with her dose of GARDASIL (Lot # not reported). On 18-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LOESTRIN and albuterol inhaler. About 15 minutes after receiving the third vaccination, the patient developed hives and itching on both arms. The patient was treated with BENADRYL and SOLU-MEDROL. No additional information provided. Additional information has been requested.
I got really really dizzy and had positional vertigo. And then I went to the Dr. and they gave me exercises and medication.
pt recv vax & cried & w/in seconds eyes rolled back & shallow breathing, facial cyanosis, near LOC-stimulated then inc breathing & color;no CPR/meds required;given 02;observe x 1/2hr no problem;slept & only fussy the following day;
Numbness of left arm and leg. Flu shot given on Oct. 21, 2013. On Oct 22, 2013, she felt weak, nauseous and dizzy with anorexia. On Oct 23, 2013 -> developed numbness on left arm and leg. No focal weakness.
fever of 105 w/in 48 hrs of immun; seen @ ER;
Patient reported feeling numb, dizzy, and short of breath. Assessment revealed a thready pulse.  Patient complained of tightness in her throat.  Epi administered by observing nurse.
Within 24 hours of receiving flu vaccine, developed high fever and hot, painful, raised, red rash. Size of rash: 24cm x 20cm. Start injection site-left deltoid-and spread to elbow and shoulder.
STORAGE IN REFRIGERATOR (2C- 8C) UP TO 30 DAYS. (VACCINE USED AFTER 10/16/2021).
ANTHRAX #5 on 01 April 16 - on 14 April 16 broke out into rash. Treated with steroids and when steroids stopped, rash reoccurred. Another round of steroids has cleared rash. Dermatologist says rash due to ANTHRAX shot.
diffuse pruritic rash started neck-trunk-extremities & face; papular to confluent erythema on arms & back;
Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted overnight for suspected TIA. MRI subsequently confirmed acute to subacute right frontoparietal infarct
About 5 minutes after receiving the vaccination, the patient passed out rolling onto the floor from his chair and incurred some cuts to his nose/face. In addition to bleeding from his abrasions, he was vomiting/dry heaving repeatedly.  An ambulance was called, and care was taken over by paramedics. He was taken to local hospital to be examined and treated as needed.  He received the vaccine at 1;15 pm, passed out at 1:20 pm and was taken away by ambulance about 2:00 pm.
I felt a slight scratchy throat, but nothing that was worse than post nasal drip at approximately 2-4 hours post injection.  Then at 8 hours post injection I began to feel achy and had an elevated body temperature of 100F.  At 12:30 pm on 12/24, (22 hours post injection) temperature had risen to 102.5 F.  I took Ibuprofen 400 mg at that time.  No change.  At 6:30 pm on 12/24/20 temperature had risen to 103 F.  I took 800 mg of Ibuprofen, no change occurred in temperature.  At 10:30 pm on 12/24/20 temperature had risen to 104.5F. I took 1000mg of Tylenol at that time. Temperature reduced to 101.5 by 12:00 am 12/25/20.  Took additional dose of Ibuprofen at 2:30 am 12/25/20.  Temperature was holding at 102F.  I then took Tylenol at 4:30 am on 12/25/20 as temperature was at 102.5F.   Temperature held at 101.5F until additional dose of Tylenol was taken at 10:30 am on 12/25/20.  Fever then reduced to 100F.  Additional dose of Tylenol was taken at 4:30 pm on 12/25/20 and temperature was reduced to 98.0F.  At 10:30 pm temperature was back up to 101.0 F.  I took another dose of Tylenol 1000mg.  Fever reduced to 98.0.  Continued to take Tylenol for another 24 hours in 6 hour increments. Temperature would return to 101.5 as Tylenol dosage time frame would complete.  On 12/27/20  fever no longer present and discontinued use of Tylenol at 7 AM.
Stroke, Alteplase, double vision on left eye, ear pain and ringing, left arm mobility compromised, left leg mobility compromised.  In at jospital via ER, then ICU, discharged  4/9/2021, occupational and physical therapy. Being performed .
Rash on head and face. Continued to worsen for the next 5-6 days. Associated with fatigue and cough. Fatigue persisted for 10-12 days. Cough ongoing.
Myalgia, NauseaVomiting, skin sensitive Narrative: Pt experienced the following ADR post 2nd covid vaccine: Myalgia, nausea, & skin sensitive. Pt relieved with Tylenol 650mg oral.
Admit for COVID infection. Fully vaccinated. Steroids, remdesivir, O2, vit-c, nebs. Condition stable, pt discharged with home O2.01b701b701b701b701b701b701b701b701b7Acute respiratory failure with hypoxia secondary to COVID-19. Currently the patient is on 3 L nasal cannula. Continue dexamethasone, remdesivir.Remdesivir was completed on 08/25/2021.Continue vitamin-C and zinc supplementation. Continue the enhanced isolation protocol Pneumonia due to COVID-19. As above. Interstitial lung disease.No pulmonary follow-up for the last 2 years.Continue the DuoNebs and Pulmicort. Hypertension. Continue Norvasc. Blood pressure is stable. Patient may probably need to go home with home oxygen
The Patient received an expired dose of Typhim Vi vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Agency (Reference number- 00654049) and transmitted to Sanofi on 23-Jun-2021.  This case involves a patient with unknown demographics who received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] [once, lot number: R2A251M, expiry date: 11-May-2021] via an intramuscular route at the right deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).   Medical history, medical treatment, vaccination and family history were not reported.  At the time of report, list of concomitant medications reported as no other vaccines.  It was case of actual medication error due to expired vaccine used (Latency: on the same day).  At the time of report, reporter wanted to know if there is an extension to the expiration date and what course of action to take if they gave a patient an expired dose of TYPHIM.  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  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.
Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mass excision (Left breast).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches). At the time of the report, LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
FLUCELVAX administered at 10:40am. Pt stated she was feeling "funny" at 10:42. Observed swelling around eyes. Pharmacist administered EPIPEN at 10:43. Nurse practioner on site checked blood pressure and monitor pulse from 10:43 until EMS arrived to take over. Pt left on stretcher with EMS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had Paxlovid treatment for COVID-19 from 11Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
developed rash on both thighs; sore arm from injection site; This case was reported by a consumer via sales rep and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th February 2020, 4 days after receiving Shingrix, the patient experienced rash. In February 2020, the patient experienced pain in arm. On an unknown date, the outcome of the rash and pain in arm were unknown.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm from injection site and developed rash on both thighs. The reporter consented to follow up. The patient agreed to follow up.
Hello to all. Patient reported feeling dizzy right after sitting down for the 15 minute wait period. I asked her if she would like to lay down. I took her in the side room to lay on the hospital bed. Her bp was 177/115. She is a physician and so is her husband. He was with her. He suggested we had a bad cuff , and he wanted a manual one. Staff went to the ER to retrieve it.  Her husband took her BP and BP was elevated with the manual cuff as well. I provided juice and water for the patient and got her rags. Her blood pressure stayed elevated for the whole 30 minutes she was there. Her husband wanted to know what I had to give her. He wanted lisinopril 5mg. I explained that we only had benadryl and epipens for allergic reactions. He decided to take her home. He stated he would give her one of his blood pressure pills and that she would be fine. She was able to get up and walk out without assistance
First dose, no reaction except arm pain for about 2 days. Second dose (which I am reporting here because I think it is unusual) was followed one day afterwards resulted in fever and joint pain; 2 weeks later (Mar 6) I had sudden knee pain and then the palms of my hands broke into a red, lacy rash. I became nauseous. One day after that (Mar 7), the palms of my hands are bumpy, but the red, lacy rash is gone. My right knee has a red, prickly rash on it that resembles Fifth disease. I have not had any contact with people without an N95 mask following my second shot, except my husband, who is also isolated.
Information has been received from a physician concerning an 8 year old female who in approximately June 2001, was vaccinated with a dose of varicella virus vaccine live. On 6/7/04, the patient presented to the physician's office over 200 lesions and a fever. Acyclovir and acetaminophen were prescribed for the patient/ The patient was reported as recovering with sequelae. The final diagnosis was breakthrough/vaccine failure. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 6/4/04 in the PM the patient presented with a fever of 100.3 degrees and numerous papular lesions on her chest, groin, arms, and legs. A doctor visit was required. Additional information has been requested.
Had Covid Vaccine AM of 1.8.2021.  Woke up with Nausea, Vomiting X 4, Chills the following AM. Presented to ED.  Found to be hypotensive during ER.  Nausea Vomiting resolved.  Tx with fluid replacement and dismissed home instructed to monitor BP.  B/P dropped again at home returned and admitted to hospital.
Patient in the observation area reported feeling itchy in the body. The patient was taken to the treatment area where a cephalocaudal evaluation was preformed. Objective data: itchy foot, red area on the back, left side has hives or rash, area of the vaccine, no reaction is observed. No edema is observed in the mouth, throat, lungs are clear on auscultation. there is no stridor 99% SPO2, 75 pulse strong and regular. 16 breaths, 110/70mm B/P. A consultation with Doctor who indicates that he be given 50mg of BENADRYL PO and left under observation for and additional 15 minutes. After 15 minutes the patient is re-evaluated, there is no itching or edema.
Vaccines administered on 1/31/02. This morning, 2/1/02, mom called to report that the pt had a small localized, redness and rash around the Prevnar and Comvax IZ area, a low-grade temperature and no other symptoms.
Arm/shoulder area to elbow is red, swollen, hot, underarm hurts/shoulder blade area on back. Arm actually hurt from the very beginning of shot. No treatment. Lasted 4 days.
pt was exposed to child vaccinated w/varicella on 4MAY97;18MAY97 pt exp secondary transmission & devel chickenpox that consisted of 300-400 lesions;26APR96 pt varicella antibody titer was positive;
8OCT evening Friday Pm noted rash on abdo, buttocks & lt for arm; very itchy; c/o feeling flu like running temp of about 100-100.6;
Pfizer on 12/27/21, several hours later, got a severe headache, then patient does not recall what happened, tongue biting, not sure how long he was out, dizzy afterwards. Two days later same thing happened again
20 CM diameter area of blanching erythema on left thigh with 0.5cm blisters at injection site.
Patient had headache, fever of 102 degrees and localized redness and warmth 4x5 cm in the right upper arm at the injection site
Had menomune 05/28/02, states had severe headache on 05/29/02 and "weakness" started approx 8pm and went to bed after Tylenol extra strength x 2 and Aspirin x2. Feels okay today but did take x ASH approx 8am. Had PPD on same date 05/28/02.
Pain at injection site, abdominal pain and headache, fever of 99.4 to 100.2 continuing. Follow up with physician continues to worsen
Cerebellum Stroke 4/11/2021.  Presented in the Emergency Room of both hospitals with dizziness, nausea, unable to walk.  Treated 4/12-4/14 and then again 4/15-4/19.
migraine; sea sick like nausea; fever; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), VACCINATION SITE PAIN (sore arm), NAUSEA (sea sick like nausea) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Feb-2021, the patient experienced MIGRAINE (migraine), NAUSEA (sea sick like nausea) and PYREXIA (fever). On 27-Feb-2021, MIGRAINE (migraine), VACCINATION SITE PAIN (sore arm), NAUSEA (sea sick like nausea) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Covid arm; Started 8 days after shot. Redness, swelling, itching and tenderness. Using a cortisone cream, taking Benadryl and applying ice
mom called clinic pt had fever of 103; mom states pt fever went to 106 pt taken to hosp had blood work done to see if vax had caused rxn; WBC count nl; pt to have DT only in future
pt recv vax 6FEB96 & deceased 16FEB96;SIDS
patient inadvertently received 2 doses of Menacta 1 year apart from 2 different providers with no AE; Initial information was received on 14-Jan-2021 regarding an unsolicited non-valid non-serious case from a physician.  This case involves a 13 years old patient who inadvertently received 2 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 1 year apart on unknown dates from 2 different providers (extra dose administered) (lot number: unknown and expiry date: unknown] via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to extra dose administered (latency: unknown). Reporter wanted to know if there were any concerns after this error.  At the time of report, no adverse event was reported.  Disclaimer: 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 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.  There will be no information available regarding batch number in this case.
Severe flue like symptoms. Unable to work the next day. Severe muscle pain, headache, chills.  I was given no vaccine pamphlet or discussion of the severe effects.  CVS gives ample information on all prescription drugs. I got ample manufacturer information on the Pfizer Covid Vaccine (the symptoms were mild in comparison), and explained the side effects multiple times. I always get a vaccine disclosure and pamphlet with the flue shot. I never had such a sever reaction to a vaccine.
Pt. was given DTaP, MMRV, IPV vaccine.  After 20min had the following side effects, nausea and vomiting, hives and lethargy.  MD notified treated as needed.  7.5 ml PO BENADRYL and close observation.
Immediately following hep B inj. pt states felt "hardness" at inj site radiating to chest area. C/O breast pressure continues to complaint of chest muscle pain, and chest tenderness to touch. C/O palpitations on night following the injection. C/O axillary nodules. B/P 118/76 HR 82 regular.
Presented to medical support assistant stating he had right arm swelling however left for another appointment on Feb 9th, 2015. Returned same day and was evaluated by nurse as having redness and swelling above right elbow area below what he states is the injection site from his PNEUMOVAX that he received on 2/6/15. States that 2/6/15 PM his right arm was very painful and swollen. Denies respiratory concerns or shortness of breath, or swelling in throat. PCP and PharmD visualized area, localized reaction.
Patient presented to clinic with redness, swelling, and itching at the injection site. Patient was marked with a surgical marker and told to report to clinic if the redness spread outside of the marker and to take an antihistamine on 8 November. Patient reported to clinic on 14 November with less itching and swelling, but redness has spread outside of marker.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis and INFLUENZA VACCINE for prophylaxis.   On 19-SEP-2023, the patient received RSV vaccine, COVID 19 VACCINE and INFLUENZA VACCINE. On 19-SEP-2023, less than a day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 19-SEP-2023 The case was received from the patient via interactive digital media. On the day of reporting patient received 3 shots of RSV, Influenza flu and Covid-19 vaccine. The patients arm was little sore. It was unknown if the reporter considered the pain in arm to be related to Influenza flu and Covid-19 vaccine.  The follow-up could not be possible as no contact details were available.
REDNESS AND PAIN AT INJECTION SITE 24 HOURS AFTER RECIEVING INJECTION.
Around 2000 got very tired and chilled. At 2100 took temp and it was at 100.5. Took advil and went to sleep. Woke up at 0630 on the 16th to no fever but slight muscle weakness.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 16th January 2018, refer case US2018051224). Concurrent medical conditions included drug allergy (the patient was allergic to FLAGYL and MACRODANTIN). Concomitant products included levothyroxine. On 25th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced chills, tiredness, headache, fever, pain in arm and sleeplessness. On 27th March 2018, the patient experienced rash and tachycardia. On an unknown date, the outcome of the chills, tiredness and fever were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the sleeplessness, rash and tachycardia were unknown. The reporter considered the chills, tiredness, headache and pain in arm to be almost certainly related to SHINGRIX. The reporter considered the fever, rash and tachycardia to be possibly related to SHINGRIX. It was unknown if the reporter considered the sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The events arm soreness, chills, fever, tiredness and headache began approximately 6 hours after the injection. Less than a day after receiving vaccination, the patient also reported a sleepless night due to events. Two days after receiving vaccination, the patient developed a rash on her face on the left mandible area above the left nare and right maxilla and the patient also had a small eruption on her chest that resembles a pimple. The patient also had tachycardia and felt feverish. The patient had denied permission to contact their physician.