chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical receptionist concerning a 65 year old male with "sleeping issues" who on 26-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 656413/1477). Suspect therapy included lisinopril (manufacturer unknown), tablet (dose , duration and induration not reported). Other concomitant therapy Advair and Voltaren. There was no illness at the time of vaccination. The patient's wife reported that on the day of vaccination (after vaccination) the patient "didn't feel very good." On 11-MAR-2007 the patient reportedly passed out and stopped breathing. EMS was called and the patient was admitted to the hospital. It was also reported that the patient's heart rate dropped to 25. The patient did not have a detectable heart problem. On 15-MAR-2007 the patient was discharged from the hospital. On 22-MAR-2007 it was noted that the patient developed shingles on the left thigh and abdomen (the rash was described as both a shingles like rash and a varicella like rash but was diagnosed by the physician as shingles on 29-MAR-2007). Subsequently the patient was "recently" seen in the office and he was doing better but he still wasn't feeling great and still had some of the shingles rash. The patient was also still feeling "fluttering" in his neck and was sometimes lightheaded. The patient was still recovering from his hospitalization. On 01-MAY-2007 the patient passed out again and was hospitalized. The patient's status at that time was unknown. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Rash on chest and shoulders: went to MD. Patient tested positive for Strep. Diagnosed with Strep and reaction to vaccine (H1N1)
Initial information received on 20 December 2012 from the FDA under the Freedom of Information (FOI) Act. This information was initially request by a consumer and forwarded to the Company. The following information is verbatim from the listings provided by the health authority. Patient felt syncopal and nauseated. List of documents held by sender: None.
Received the vaccine around 9:15 pm PST. Arrived home and went to sleep. Around 11:15 PM PST, was awoken with extreme chest pains, nausea, and headache. Attempted to get up to get to the bathroom, and was unable to make it there prior to fainintng. Was able to come to cognitively but was unable to move or get up. Had an overwhelming feeling of extreme muscle weakness. Was getting muscles spasms in the legs and extreme fatigue. Husband was able to get her up and dressed and took her to ER for a full work up. Was there from 12-3am PST.
Participant was anxious, staff attempted to calm her, however, then she stated, "it feels like my throat is closing."  Epi Pen 0.3 mg. administered IM.  EMS called - upon arrival participant continued to complain of tightness in throat - transported to hospital
shivering; headache; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shivering in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, headache and fatigue. On an unknown date, the outcome of the shivering, headache and fatigue were unknown.   It was unknown if the reporter considered the shivering, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter did not consent to follow-up. The reporter did not wish to participate in a safety report, she just gave a general statement about her friend's experience with Shingrix.  There were no other details. For tolerance of 2nd dose, refer linked case US2019215483.
Fever; This is a spontaneous report from a contactable consumer, the parent. A 25-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. It was unknown, if the patient was pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever on 02Apr2021. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   The clinical outcome of the event fever was recovered .   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Case number PHEH2012US006719 is a spontaneous report initially received from a nurse on 21 Mar 2012 with a follow up information received on 06 Apr 2012 and 19 Apr 2012: This case refers to an 18-year-old female patient whose medical history included allergic rhinitis and asthma. She was vaccinated with MENVEO (batch number: 10130) intramuscularly into the left deltoid on 13 Mar 2012. On the same day she experienced edema and redness from shoulder to the elbow. It was described as a flushing redness. Although the site of vaccination was left deltoid she experienced this reaction to the entire arm. She also had edema of both the feet. She was treated with ORAPRED and diphenhydramine. The outcome of the event, flushing redness was reported as ongoing and that of edema was reported as complete recovery. The causality of edema was assessed as suspected to vaccination with MENVEO and that of other events were not reported. No other information was available. Follow up received on 06 Apr 2012: Patient demographics (height and weight) updated, medical history, treatment drugs and events edema and redness added. Follow-up received from the nurse on 19 Apr 2012: Updated event description, site of the vaccination and causality.
This spontaneous report as received from an unspecified reporter via field representative refers to a patient of unknown age. Field representative mentioned an unspecified adverse event with GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified) and the call was disconnected before questions could be asked. The outcome of adverse event was unknown. Additional information is not expected.
I received the vaccine (2nd shot) of the Moderna COVID-19 Vaccine EUA, on Wednesday, the 10th of March at 7 in the evening.  At about noon on Thursday, got chills and muscle aches; later that day/evening, discovered I had a fever of 100.4.  Next morning, felt fine, no fever.  All is good.
Arm muscle all the way to elbow became sore and unusable for 3 days. Neck shoulder and shoulder blade also very sore and painful when moved. Patient was sweaty. Heartbeat and breathing were rapid. Sleep was difficult. Nausea set in for three nights with vomiting on October 3. Stayed in bed mostly until Oct. 4. Arm still sore on Oct. 4 but improving.
7-8 slightly elevated papular rashes on chest, abdomen, armpits, groin. No other symptoms.
Fully vaccinated with moderna x2. Tested positive for Covid 02/04/2022. Admitted to Hospital on 02/04/2022. Expired on 02/09/2022 while still hospitalized.
Vertigo and continuous nausea since Thursday, April 1,  I have taken antivert 25 mg but it still persists impeding me from working and doing the daily routine
approx. week and a half later.  My Knees and feet got worse. Knees couldn't bend, walk up stairs, kneel. Feet had crushing pains, felt hot (internally) throbbing.  Ears ringing got louder then ever before. They are still in the same pain.   Also receiveed the gel shots for arthritis in my knees on 4/26, 5/3, 5,10.   Which has not made any difference in the pain.
Woke up in middle of the night with extreme chills and head, face. Hair completely soaked in sweat. Terrible headache. I thought I had a stroke or something. I was so out of it that I couldn't even figure out how to use my phone to call for help. Then I got the dry heaves for about a half hour. Was sick all day.
Information has been received from a physician concerning a 20 year old female with no past medical history who on 08-MAR-2007 was vaccinated SC with a 0.5 ml dose of Pneumovax 23 (lot # 655152/0889F).  Concomitant therapy included YAZ.  On 09-MAR-2007 the patient developed fever and vomiting.  Three days later the fever and vomiting were resolving.  Additional information has been requested.
Day 1-shot at 10:17am.  No immediate reaction in the 30 minutes waiting period.  14 hours after shot-fever onset just before bed Day 2-fever on/off between 99.9 and 102.4, sweating fever out overnight.  injection site is itchy at night Day 3- fever on and off all day, body is achy more than the usual amount.  feel weak when sitting or standing. fever breaks by early evening. Arm itches more, starts to swell. Day 4-Still feel a little weak, but the body aches are less.  Have shortness of breath.  Arm is itchy at night and swells. Day 5-Wake up with shortness of breath and arm more swollen.  Left knee hurting-inflammation is up. Day 6-Wake up with left arm tingly numb and it remains the whole day as such, shortness of breath continues.  Left knee continues inflamed.  Injection site still swelling more. Day 7-Inflammation is down, shortness of breath continues, injection site still swollen and bruising. Day 8 through Day 18-Fatigue, shortness of breath, swollen arm, but the lump in the arm goes down a little each day, like a timed release.
This spontaneous report was received from a pharmacist via a company representative regarding a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX in the arm (dosing regimen and lot number unspecified). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (dosing regimen and lot number unspecified). No concomitant medications were reported. On an unknown date the patient experienced cellulitis when ZOSTAVAX and flu vaccine were given on the same arm. On an unknown date, a medication error was reported as ZOSTAVAX and flu vaccine were given on the same arm. Patient sought medical attention and saw the physician. The outcome of the event cellulitis and medication error were unknown. Causality assessment of the event cellulitis with ZOSTAVAX was not provided. Additional information has been requested.
body itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "body itching". Therapeutic measures were taken as a result of pruritus.  Additional Information: Reported by Consumer. Description of Event is Approx 36 hours after receiving COVID vaccine had whole body itching, no rash, resolved a few hours and after 50 mg dose of diphenhydramine. Name of Product COVID vaccine. Country of Occurrence. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;swelling,pain,& rash on 6" area where TD given;feverish; also had pain into rt side of neck;had rash all over body until dph taken;also took cataflam for pain;
Throat was on fire; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat was on fire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Throat was on fire). At the time of the report, THROAT IRRITATION (Throat was on fire) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Patient recovered in 2-3 days.
No further AE.; RECOMBIVAX given during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 01-SEP-2023, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, one time, lot #W038227, expiration date reported as 23-MAY-2023, but upon internal validation established as 23-MAY-2025, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). It was reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was given during a temperature excursion. Temperature excursions were on 02-AUG-2023 and 04-AUG-2023. There were no adverse events reported (no adverse event).
Impotence for approximately 9 days after vaccination.   Normally it will happen occasionally, but this was consistent - despite using 100mg Viagra.  Our regular schedule for having intercourse is nightly.   After this 9 day period, able to perform as usual.  Husband will not permit me to use any identifying information due to the sensitive nature. Will report in this same manner after 2nd vaccination.
Patient reports injection-site reaction occurring approximately 6 hours after injection and lasting several days:  "softball-sized swelling that was red and hot to the touch."  Injection site was sore.  Additionally, patient reports general malaise and "cold chills" lasting 48 hours.  Patient reports she felt like she had influenza.  Patient recovered after 48 hours and reported all of this to pharmacy several days after occurring.
sore injection site, swollen shoulder; headache, myalgia, fogginess Narrative:  Other Relevant History:
Site erythema; swelling; redness ((L) delt) and fever 101. Body aches; cough.
It hit her very fast and hard with a horrendous sore throat; Could hardly talk; Sweating profusely; Could hardly move; Collapsed on the floor from the effort; Chilled; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move) and FALL (Collapsed on the floor from the effort) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Oil allergy (Palm oil - (breaking out, having digestive issues, feeling depressed, irritable, experiencing hair loss, and memory loss)).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued). On 24-Apr-2021, OROPHARYNGEAL PAIN (It hit her very fast and hard with a horrendous sore throat), SPEECH DISORDER (Could hardly talk), HYPERHIDROSIS (Sweating profusely), MOBILITY DECREASED (Could hardly move), FALL (Collapsed on the floor from the effort), CHILLS (Chilled) and FATIGUE (Fatigued) had resolved.            It was  reported that patient has been  experiencing the allergies for many years and believed it was sulfite or histamine allergy. She was on recurring allergic injections.  Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-297984 (Patient Link).
Patient called the pharmacy the day after the vaccine stating she had a large bruise around the injection site and there was a bump at the injection site shortly after given. I instructed her to apply ice to the area. I called her back the next day and she stated the bruise was a little darker, but her arm was not as sore anymore.
Chills; Body aches; Fevers; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 11Jan2021 (10:45) at a single dose for COVID-19 immunization at the hospital. Medical history included hypothyroidism and allergy to sulfa drugs. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported), intramuscularly on the left arm on 21Dec2020 (when the patient was 26 years old) for COVID-19 immunization. On 12Jan2021 (02:00), the patient had fevers, chills and body aches. The patient had received an unspecified over-the-counter (OTC) pain reliever and an unspecified ointment as treatment for the reported events. The outcome of the events, 'fevers', 'chills' and 'body aches', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Approximately 5 hours after vaccine, client reports slight itching of her face. Resolved by the time she woke up the next day.
This spontaneous report was received from an administrator via company representative concerning a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (strength, dose, lot# and expiration date were not provided) subcutaneously. There were no concomitant medications reported. On an unknown date, the patient experienced Bell's Palsy. The patient was to an unspecified hospital for which she was hospitalized and received treatment during an unknown length of time. Also, it was reported that an unspecified treatment was given to the patient for the event of facial paralysis. No product quality complain was involved. At the reporting time, the patient was fully recovered, since an unknown date, from the event of facial paralysis. The causality between ZOSTAVAX and the event of facial paralysis was not assessed. The reporter considered that the event of facial paralysis was not life threatening. However, upon internal review, the event of facial paralysis was considered to be medically significant. Additional information is not expected as the reporter did not consent for follow up attempts.
Patient was given COVID-19 Pfizer BioNTech vaccine instead of COVID-19 Pfizer BioNTech Bivalent Booster vaccine. No adverse reaction eported.
I have developed what was described as superficial blood clots on my left legs. The treatment is to continue to wear compression stocks (I always wear them because of my varicose veins) and a tropical cream to be applied (1% Voltarin). I don't know if this is attributed to the vaccine or not but it was suggested that I report this based on phone call I received today from a person working with control I believe.
Shoulder area of injection site became increasingly painful and very warm as the day went on. Around 4 pm, swelling occurred and got worse over the next several hours. I actually felt numbness in my left forearm which subsided after applying  an ice pack to the swelling on and off for 3 hours, the pain subsided as well over the same time. On a scale from 1 to 10,10 being extreme, I was at a 10. I still have discomfort in the entire shoulder area, I would say at a level of 6. The improvement was noted at 7am today 11/16.
localized at injection site, right thigh, erythematous papules, with induration total area approximately 6cm in diameter, with gradual improvement and resolution by day 4.  no treatment given
Patient received pneumococcal 23-valent polysaccharide vaccine on 9/2. After immunization patient had area of warmth, swelling, and redness.
Her symptoms started the night of the vaccine, but became severe the next morning. Severe flu like symptoms and severe exhaustion. She felt overwhelmingly sick for about 5 days. But on the 4th day she got sharp pains in her head. She says she had neck pain BEFORE the vaccine and the vaccine made it worse. The worst thing for her was sharp stabbing pains in her head. She went to doctor and had tests ran (MRI AND MRA) and the headaches have lasted the entire time since, but getting better. The extreme fatigue lasted about 3 months. The fatigue is starting to disappear.
pt recv vax 19MAY97 & 21MAY97 pt dx w/bronchitis;MD stated this was rxn to hep B;told pt not to have 3rd shot;pt missed 4 days of school;took ATB;pt recovered fully;
This spontaneous report as received from a physician via a company representative refers to a currently 67-year-old female patient. The patient's medical history, concomitant medications and drug allergies were not provided. In 2012, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not specified) for prophylaxis. On an unknown date, the patient developed shingles. The patient sought medical attention and contacted the doctor. The outcome of the event was unknown. The relatedness between ZOSTAVAX and the event was not provided. Sender's Comments: US-009507513-1710USA004915.
This spontaneous report as received from a physician via a company representative refers to a 60 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced myelitis transverse. No treatment was given for the adverse event. The patient sought unspecified medical attention. Action taken with ZOSTAVAX was not applicable however it was also reported as continued. The outcome of myelitis transverse was not specified. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of myelitis transverse was considered to be medically significant. Additional information has been requested.