chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain is substernal, pressure-like, 3/10, radiates to the jaw and associated with a jaw pain that is 6/10. Pain lasted from around 9.30 pm until he fell asleep around midnight. Patient woke up pain free. However, after his breakfast at 11 am, the same pain came back. . His pain is worse with deep breathing.
PATIENT'S WIFE CALLED US ON 11/2/22 AND REPORTED THAT AFTER 3 DAYS OF HIM RECEIVING THE VACCINE HE HAD A STROKE ON 9/15/22.  I CALLED HER BACK AND SPOKE TO HER FOR AWHILE.  THEY DON'T KNOW IF THE STROKE IS RELATED TO THE PFIZER BIVALENT VACCINE OR NOT, BUT I WANTED TO REPORT IT.    HE HAD DROOPY MOUTH AND 911 WAS CALLED.  HE SPENT A WEEK IN THE HOSPITAL THEN REHAB FOR ONE WEEK AND ANOTHER WEEK IN REHAB.  NO OTHER SYMPTOMS REPORTED CURRENTLY, SEEMS LIKE FULL RECOVERY.    PER HIS VISIT TO NEUROLOGY TODAY, HE IS ABLE TO DRIVE, AND DOCTOR INSTRUCTED HIM TO  STOP LIPITOR DUE TO LOW LDL AND CONTINUE ON ASPIRIN.   HE WAS WEAK ON LEFT SIDE, BUT TOTALLY RECOVERED.    DOCTOR DOESN'T SEEM CONCERNED IT IS VACCINE RELATED, BUT FELT OBLIGED TO REPORT.
raised rash at the injection site; injection site was hot; injection site was painful; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced injection site rash, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix in her right upper arm and experienced a raised rash at the injection site, and the injection site was hot and painful. The patient inquired how long it would take for symptoms to subside and if she could take Benedryl. Additional supportive information:  The patient disconnected the call and agent was unable to obtain further adverse event information.
Patient was mistakenly given the pediatric formulation of this vaccine instead of the intended adult formulation.  No adverse effects or issues; reporting this on the basis of a vaccine error specifically involving the COVID-19 vaccine.
I was awakened in the middle of the night as if an explosion happened in my body. I experienced SEVERE INVOLUNTARY MUSCLE TWITCHING AND JERKING THROUGHOUT MY BODY.  THIS WAS CONSTANT. I ALSO HAD ROLLING WAVES OF SEVERE ANXIETY AND FEELINGS OF DOOM. I COULD NOT EAT AND LOST 11 lbs in 15 days. I COULD NOT SLEEP DUE TO THE CONSTANT TWITCHING AND JERKING. I STOPPED taking the Hydroxychloroquine immediately. Gradually over time the anxiety got better, it took about 1 month for severe anxiety to stop. Then very slowly the constant, systemic involuntary  twitching and jerking got better however the twitching and jerking DID NOT completely stop until September 2021. I do now sometimes get small muscle ripples here and there in my body and also faint "buzzing" feeling in my legs.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
rash all over chest, stomach, arm pit, shoulder arms etc. Itchy sensation for the past more than 24 hours (2/24/2021 11am to now 2/25/2021 4pm)
Patient developed nausea and vomiting 45 minutes after receiving H1N1 vaccine. Given Phenergan and APAP with resolution of sx.
unable to make his second appointment within  the window; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to make his second appointment within  the window) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to make his second appointment within  the window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unable to make his second appointment within  the window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.
COVID Infection about 6 months after 2nd shot; Breastfeeding when received the second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID Infection about 6 months after 2nd shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (She delivered a healthy (9 months) baby on 18APR2021) on 18-Apr-2021.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot). In December 2021, the patient experienced COVID-19 (COVID Infection about 6 months after 2nd shot). In May 2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding when received the second shot) had resolved. At the time of the report, COVID-19 (COVID Infection about 6 months after 2nd shot) outcome was unknown.            No concomitant medication reported. No treatment medication reported.  It was reported that the patient was not hospitalized because of infection.  COMPANY COMMENT : This maternal exposure during pregnancy case reported by the spontaneous concerns a 39-year-old female patient, with medical history of Pregnancy (She delivered a healthy 9 months baby) on 18APR2021, who experienced the unexpected non serious event of covid- 19, which occurred 6 months after second dose of mRNA-1273 vaccine. Maternal exposure during breast feeding also reported.was not added as no proper start date of 1st dose was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-508309, MOD-2022-508349 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This maternal exposure during pregnancy case reported by the spontaneous concerns a 39-year-old female patient, with medical history of Pregnancy (She delivered a healthy 9 months baby) on 18APR2021, who experienced the unexpected non serious  event of covid- 19, which occurred 6 months after second dose of mRNA-1273 vaccine. Maternal exposure during breast feeding also reported. was not added as no proper start date of 1st dose was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient was back in the office with sibling and was noted to have a 3.5" x 3" red area on right deltoid area at vaccine site. Patient stated it was itchy but no other complaints.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose #1 03/26, Pfizer, dose #2 08/27 pt cc: chills, cough, fatigue, headache, exposure: unknown 08/31 COVID swab, result: detected 08/31 SARS-COV-2 LINEAGE AY .25 08/31 SARS-COV-2 CLADE 21I DELTA
Red and itchy rash at injection site; vacciantion site pruritis; Vaccination site urticaria; A spontaneous report was received from a consumer concerning a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (vaccination site joint erythema, vaccination site pruritus, vaccination site urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.  on 03FEB2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left upper arm deltoid for prophylaxis of COVID-19 infection.  Laboratory details are not provided.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.
After injection, area was sore to touch and did have some swelling.  All of that was gone by 1/5/2021. Started to itch morning on 1/7/21 and swell again, with the central area of the swelling being hot to the touch.  Still an ongoing issue at time of this report.
Client was dizzy, and loss consciousness for couple of seconds.  Lowered to ground , legs elevated,  water provided, ice pack applied, vitals found within normal limits . Client left site with steady gait.
Patient was developing normally, and was babbling and had formed some basic word sounds. After 1 yr shots he went completely silent within a day or two. A few days after his 18 month shots he had a huge personality shift, stared into space for minutes, laughed as though drunk, lost all balence and coordination, started chasing and biting parents.  Please see VAERS case # 276280 for continuation.  04/24/2007 MR received from PCP.  OV 4/27/04 for rash DX: Heat rash. OV 5/21/04 for c/o walking with feet in. DX: Normal gait variation. OV 6/14/04 for developmental concerns-stopped babbling, stopped talking. DX: hearing loss vs. speech delay.   Neuro eval 7/1/04 for developmental concerns. Impression: Mild delay of language acquisition with normal gross  and  fine motor dev.  Suspected Seizures manifested by staring and altered responsiveness.  DX: Absence epilepsy.  OV 9/16/04 with concerns re: off balance/clumsy walking, food preferences, waking at night screaming, gasping, hand flapping. Impression: probable sleep disorder. possible behavioral eating disorder, possible dev delay. Neuro consult 10/5/04 with dx:  Developmental apraxia of speech.  Mild ataxia. Case continues with VAERS 276280.  1/01/10 follow up - serious regression after vaccinations. now diagnosed with autism.
rash, pruritus, swelling at injection site on R arm. Started today around 9pm
My face has rash then my arm; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My right face was numb; I had arm sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin allergy (allergy to Penicillin) and allergic to ants and cockroach; all from an unknown date and unknown if ongoing. There was no prior vaccination (within 4 weeks). The patient's concomitant medications were not reported. It was reported that "On 04Aug2021, I just had the Pfizer Covid Vaccine first dose and then the first day I had arm sore and on 06Aug2021 my ear start to swell and coming to bother, my right face was numb and on 07Aug2021 I went to the Emergency Room and while my right ear can't hear anything and now today my other ear start to swell." The patient also stated, "I got vaccine, before I told them about my allergy to Penicillin and allergic to ants and cockroach, still they gave me the shot (vaccine). I don't know why my right ear can't hear anything and my right face is numb." For the treatment the patient stated "No, I didn't." It was added, "I don't know what should I do for my ear, I was going in Emergency Room to see ENT Doctor, I don't know if they can fix my problem or not. My face has rash then my arm, my right ear is swelled and now my left ear start to swell." And, "Can you get me call back or something like that how to resolve my problem of my ears swelling." The outcome of the events was unknown.
Patient stated she had cottons in her ears.  Patient was sweating and pale after administration of 3 vaccines.  Patient was placed in her back with knees bent.  Patient stated she feels much better after 5 minutes.
sore arm; headache; tired; achy; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 13:30 (Lot number: EL 6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "FLU LIKE", start date: 12Feb2020 (unspecified if ongoing), notes: Other medical history: "Flu like" on 12Feb2020; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL 9264, Administration time: 08.30, Vaccine location: Right arm), administration date: 01Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; HEADACHE (non-serious), outcome "recovered", described as "headache"; FATIGUE (non-serious), outcome "recovered", described as "tired"; PAIN (non-serious), outcome "recovered", described as "achy". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue, pain.  No follow-up attempts are possible. No further information is expected.
PATIENT STATED LEFT JAW SWELLING STARTED TODAY, 02/15/2021.
Rash began 24 to 48 hours after immunization. Neck rash spread (body wide) over 8 day period. Cleared approximately 2 weeks after vaccination.
Patient reported similar reaction with last dose as experienced with first. She described injection site as discolored, bruised with a round knot about 4 inches in diameter beneath the skin. Also, itching noted with last dose only.
The patient has had severe itching since soon after the vaccinations.  Patient is being treated with first triancinolone 0.1% ointment starting on 12-10-2021 then fluocinonide 0.05% ointment starting on 1-28-2022 with no relief yet.
10-02 101.0 temp, felt bad from 9-26-07. Broke out in a measles like rash 9-28-07. Told to go to her doctor and call us back to tell us what he said but this occurrs1 out of 900 MMR's. MD said was 3 day measles.
C/O (L) arm pain & swelling from inj. site down to elbow. Also c/o "flu like" symptoms. States (L) arm so painful patient was unable to move or use it and could not sleep on arm. C/O feeling "hot" 9/29/11 but was afebrile. Please see attached noted for further info.
Received vaccine 10.20.09 at 12:00. At 20:30 on 10.20.09 had swollen lips and fingers, a migraine, severe abdominal cramps, and diarrhea. Took an antihistamine and symptoms went away. No medical treatment.
Fever for 3 days. Mild rash on back, neck and face, arms.....red spots.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details: product=COVID 19 Treatment, Treatment start date 25Jun2022, Treatment stop date 30Jun2022, Indication treatment of COVID-19, Reported Event was Covid Rebound, Adverse event start date was 04Jul2022, If patient not recovered, If treatment ae was No. Known allergies was no. Device Date was 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 48-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0175, Expiry date: Unknown) via an unspecified route of administration on 07May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. Patient tested positive post vaccination. The patient previously received bnt162b2 (lot number: EW0162) as dose 1 on 16Apr2021 for COVID-19 immunisation. The patient was not pregnant. On 23Aug2021, the patient tested positive for covid today aka breakthrough case, headache, fever, loss of smell, and body aches. The adverse event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. It was unknown if therapeutic measures were taken for the events. The outcome of the events was recovering.
This case was reported by a pharmacist via call center representative and described the occurrence of sleeplessness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling. On an unknown date, the outcome of the sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the sleeplessness, injection site rash, general body pain, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient after receiving the 1st dose of the SHINGRIX vaccine, she was unable to sleep, and she had body aches. She also described pain, swelling and a rash at the injection site. The reporter thought that the patient might still be experiencing the symptoms but could not confirm. Unable to obtain additional information from the reporter. The reporter did not consent to follow up.
Patient falsified DOB when registering for vaccination, stating the minor's DOB was 12/03/2001. Guardian did not consent to the vaccinations.  Department of Health verified with statistical records that the patients actual DOB is 12/03/2003 which made the vaccine a contraindication.  1Moderna vacciantion given: 01/29/2021 2nd Moderna vaccination given: 02/28/2021  No known adverse reactions noted.
Patient described itching and tightness on forehead, and one or two red, broad-based, slightly raised bumps on back, inner thigh, without fever or other signs/symptoms. Treated with antihistamines.  Forehead rash gone by Wed. 3/19; inner thigh and back rash gone by Fri., 3/21.  No loss of work.  Take at site of vaccination.
onset of respiratory failure on 05/14/2021 to be eventually diagnosed with pulmonary embolism.  hospitalized at facility .
Erythema, pain & pruritis beginning on 10/08/02; Tx; Benadryl 25 p.o tid; Sx lasted 3 days only
Erythema, warmth, swelling, tenderness, and induration at injection site. Left arm.
Symptoms: Nausea + facial flushing.  Client assessed and treated by onsite Paramedics. Client cleared for home at 1:34 pm.  Per Paramedics all symptoms resolved, no further evaluation needed.
Hospitalization 12/13/21  First dose 2/3/21 as noted above 2nd dose 2/24/21, Pfizer COVID vaccine, LOT EN6202, IM L arm 3rd dose 9/9/21, Pfizer COVID vaccine, LOT EW0172, IM R ARM
Muscle fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue) and CHILLS (Chills) in an 86-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included Heart disorder and Defibrillator/pacemaker insertion since an unknown date.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (Muscle fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (Muscle fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.