chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 16:00 as dose number unknown, single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: Dec2020, stop date: 11Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was boosted with Moderna, but later found out that she qualified for the 3rd full dose d/t a health condition.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was boosted with Moderna, but later found out that the patient qualified for the 3rd full dose due to a health condition. The patient wanted to know if they could return for another half dose of the vaccine.  No treatment information was provided   Reporter did not allow further contact
PROFUSE SWEATING; This spontaneous report received from a patient via a company representative concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced profuse sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of profuse sweating was not reported. This report was non-serious. This case, from the same reporter is linked to 20210350172.
On 3/16/00, the child vomited twice, at that time her rectal temperature was 100.7. Within one hour, her rectal temperature increased to 104.9. The child than began having watery diarrhea. The reporter took her daughter to an ER. A dx of rotaviral gastroenteritis was made. The child was hospitalized and treated with IV fluids. She recovered and was discharged on 3/30/00. The child had been hospitalized from 3/23/00 to 3/25/00 for surgical repair of the reflux.
Mother brought in son for Pfizer vaccine. Told myself (the administering pharmacist) and the inputting technician that his date of birth was  making him 12 years old multiple times. Insurance rejected saying that his DOB was wrong but the mother was adamant that it was . We administered the vaccine then later got a hold of insurance and they have his DOB as  making him 11 years old. Cannot get a hold of mother to verify this information. Called her and left her messages but she has not returned calls and did not bring him in for his 2nd dose.
Constant mild left shoulder pain, with increased pain on abduction and rotation of the shoulder. Not treated. Persistent 3 weeks after vaccine administration.  I get this vaccine annually and it was placed very high this time, at the level of the joint.
Next morning there was a red dome size spot on injection site that gre to baseball size that lasted 17 days. Along with redness I had itchiness and swelling at the same spot and it was hot to the touch.bonbthe 14 the day I used ice for two days and took over the counter benadryl for two days. It didn't seem to help so I stopped taking the benadryl and using ice on the 14th day and around day 17 it went a way leaving a shadow of a spot of where the redness once was
mild tiredness after the third dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: she and her husband are immunocompromised; "I am asthmatic" (unspecified if ongoing), notes: I am asthmatic. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "mild tiredness after the third dose".  Follow-up (25Feb2022): This is a spontaneous follow-up report received from a contactable consumer. This female consumer (Patient) reported that: Updated information included: RMH. New Event of "My doctor was upset that I got the Covid vaccine. I am asthmatic and almost died and he asked me why I got a third vaccine".   Follow-up (10Mar2022): The initial and follow-up case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 10Mar2022, this case now contains all required information to be considered valid. This is a spontaneous follow-up report from a contactable consumer. This female consumer (patient) reported in response to Non-HCP letter sent via telephonic follow-up activity which included that: Updated Information Included: New event "Tiredness".  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Irritability and difficult to console for 48hrs after vaccines at 4 month well visit.
Guillain-Barre Syndrome. Sx: Pain on lower extremities, very tender to touch and weakness and difficulty walking. Pt was given an IVIG treatment. 12/3/09 DC summary received for date 1/7/09 to 1/11/09. DX: abnormality of gait, pain in limb, polyneuritis. SX: acute onset of limb pain, weakness, gait disturbance.Assessment: very early in course of acute onset of GBS/AIDP.  Hospital course received IVIG. Pt improved at dc. 12/7/09 Medical records received for dates 1/7/09 to 1/14/09. DX: GBS. Chief c/o leg pain. Pt parent states pt woke up w/ severe bilat leg pain and would not walk. Pt parent states unusual gait and weakness. Pt had febrile illness x2wks ago. Assessment: mild trunk weakness, proximal weakness. 1/14/09 DX: GBS f/u. Pt was admitted for GBS received IVIG. Pt was readmitted on 1/12/09 for HA, vomiting, abdominal pain. Pt stable on this day. Parent feels GBS related to seasonal flu vax on 11/8/08.
Patient called the morning after her second dose of the Moderna vaccine. She states that she started with a rash (no at the injection site) last night. The rash was down her arms, on her neck and scalp. Rash was red and itchy per patient. She took a Claritin and the rash resolved. Today she is feeling fine but states her skin almost feels "tingly" like the rash may come back. Advised to continue on her normal regimen of 1 Claritin a day (normally taken for treatment of her seasonal allergies) If any of her symptoms come back, worsen or new symptoms are to arise she is to call out office.
Pt. returned to clinic 5 hours after vaccination. Reporting nausea, headache, fatigue, rapid heart beat dizziness and weakness. Patient advised to go to emergency room and inform of receiving vaccine.
cannot sleep at night; really sick; fever; chills; headaches; constantly bad cough; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough). The patient was treated with DEXCHLORPHENIRAMINE MALEATE, HYOSCINE METHONITRATE, PSEUDOEPHEDRINE HYDROCHLORIDE (D-HIST D) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; VITAMIN D NOS at a dose of unknown and ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency. At the time of the report, INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough) outcome was unknown.
Rash on the L hand at 0826  Monitored  nausea at 0845
Developed fever and rash on 5/26 (6days following administration of vaccine) with Tmax of 102.  Fever and rash associated with increased irritability, poor appetite and poor sleep.  Was seen in the office on 5/28 (rash described as erythematous maculopapular) and was felt that this was reaction to vaccine.  Seen again today on 5/30 due to ongoing fever (however temperature curve improved with Tmax of only around 100 last 24 hours) and worsening of rash.  Today the rash reamins diffuse with classic target lesions and areas of post-inflammatory hyperpigmentation.  Otherwise child was well-appearing; smiling at times during exam.
Intense arm pain lingering for 72+ hours post injection.  24 hours post injection, 103 degree fever lasted above 101 for 22 hours.  Moderately severe headache lasting 72+ hours.
Infant died of apparent SIDS on 8/10/05, was co-sleeping with mother in the bed. Per F/U by FDA researcher who contacted the ME, the manner of death was undetermined and COD was unexplained infant death.
I have congestive every morning. I also having a hard cough every morning. I just don't feel the same. I am also have some headaches and fatigue.
Vesicular rash in S2 dermatome - R leg. Started a day after receiving varicella vaccine in left leg.
Day 1 in the evening I got a sore throat and ears starting hurting? Day 3 lost voice completely felt sick throat hurt and non emergent shortness of breath  Throat spray  Tylenol for body aches
Pain only at injection site mild tenderness. No redness. No warmth. No swelling.
Nausea; Spontaneous report received on 26DEC2019.  A caregiver (consumer's husband) reported that a female consumer had nausea (PT: Nausea) while being on oral Vivotif for typhoid fever prophylaxis. On 25DEC2019, the consumer took first dose of Vivotif and had nausea. On 25DEC2019, the consumer took second dose of Vivotif and had nausea again. Action taken with Vivotif with respect to the reported event was unknown. The consumer was not recovered from the reported event at the time of report.  Company Comment: A consumer experienced nausea each time after taking first and second Vivotif doses. Considering the potential of Vivotif to cause nausea and the case information, the causality of the event is assessed as possible with Vivotif.; Sender's Comments: A consumer experienced nausea each time after taking first and second Vivotif doses. Considering the potential of Vivotif to cause nausea and the case information, the causality of the event is assessed as possible with Vivotif.
Very fussy, increased temp 102, not able to be consoled for 3 days. Was given Tylenol and Motrin.
May 15, 2021 woke up with chest pain and pain in back between shoulder blades.  Sought medical care x 2 with Dr. Obtained EKG (normal) and diagnosed acid reflux and/or related to shoulder injury or RA. Prescribed Omeprazole which did not help. July 2021 was being physically active and noticed SOB, fatigue, chest pain, back pain, resting pulse of 140's. Mid July saw Dr. at local Healthcare as syptoms had increased. She did an EKG-normal, blood work with elevated Ddimer of 2400 and sent her to the ER. ER completed a CT scan to rule out a blood clot and found the pericarditis. Hospitalized overnight, echocardiogram was given the next day and found she could be released. Followed up w
patient received improperly stored VARIVAX; no adverse effect reported; Information has been received from a pharmacist referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 22-MAR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R023513; expiration date: 16-AUG-2020; strength, dose and route were not reported) for prophylaxis. No adverse effect reported. The temperature of storage was 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.9F), the time frame was 45 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of the events was unknown.
fainted; This spontaneous report has been received from a nurse via a company representative referring to a male patient of unknown age. Concomitant therapy included influenza virus vaccine (unspecified). The patient didn't have pertinent medical history, drug reactions or allergies.     On an unknown date, the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, batch/lot# and expiration date were unknown) intramuscularly for human papillomavirus (HPV) prevention.      On an unknown date (after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient fainted. No treatment was given for the event. No lab diagnostic/study was performed. The patient didn't seek medical attention. The outcome of the event was reported as recovered on an unknown date. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. No product quality complaint presented.    Upon internal review, the event of fainted was considered to be medically significant.
mom stated pt recv vax 1130AM taken home slept till 3PM;awakened in irritable mood;had high pitched cry consistently although took formula for 6 hrs;mom contacted MD;mom states pt felt warm-unable to take temp;high pitched persistent scream
Local erythema to Varivax. (+) temp 100.3 PO in office. Follow up call x 2 no answer 7-2-07, follow up call mom on vacation states area was fine.
abdominal pain Calculus of bile duct without cholangitis or cholecystitis without obstruction
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that the patient experienced an adverse event following administration of SHINGRIX, which was limited to the arm vaccinated. The healthcare professional refused to provide any details about the event.
Child developed Tic - a Blinking Tic. Tic was very frequent the day after the vaccines, then continued on and off the next several days, especially with fatigue. The Tic subsided about a week after the vaccines. The Tic has never been present before the vaccines.
About one hour after receiving the yellow fever vaccine pt developed paresthesias of her lips, facial and neck hives and difficulty breathing. She was at the local health department when this occurred and was then transferred via emergency squad to hospital. She was observed over night in their facility and received anti-histamines and steroids and made an excellent recovery.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
Pt was admitted to hospital 9/13, tested positive for covid 9/17, and died on 9/26.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: Gh9694) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies Macrobid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID". 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. Patient received nirmatrelvir, ritonavir (PAXLOVID) as COVID 19 treatment from 28Dec2022 to 02Jan2023.
Rash and upper arm swollen.  The rash was down to armpit, on to chest and back
Rash to (L) arm 8 cm in diameter. Warm to touch, red, tender.
Patient stayed in clinic for 20 minutes post injection. She noted feeling "hot" after 15 minutes, temp 98.7 and no other symptoms.  Left for work and by 9:40 was "itchy".  Took Hydroxyzine 12.5mg with no relief then took Medrol with good relief of itching. Also noted that arm of injection felt "heavy" for the day of the injection.
Pt seen in our office 7/20/17 due to fever 101.2. Ax and (R) arm swelling at KINRIX immune site 5x3 cm red hard erythema. Dx with cellulitis. Given cephalexin PO TID x7 days.
Consistent headache - Tylenol or Excedrine relieved Heavy period - began 4 days early. Excessive blood clots and amount of blood.  Left arm pain- unable to move arm without pain x 3 days. Tylenol relieved Fever- began 2 days after. Tylenol reduces fever.
Sweating, hard to breath, high blood pressure  reading 196/103. 911 came and took the patient via ambulance.
Information has been received from a physician concerning a female patient who in approximately 2006, about a year ago, was vaccinated IM with a first dose of Gardasil. In approximately 2006, about a year ago, the patient fainted in the office. No medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Information has been received through the Merck pregnancy registry from a Physician's Assistant concerning a female who is social alcohol drinker and smoker who on 11-MAY-2007 was vaccinated IM in the left arm with the first 0.5 mL dose of GARDASIL (Lot #655503/0012U). There was no concomitant medication. The patient received the second 0.5 mL dose via IM of GARDASIL (Lot #658554/0928U) on 22-JAN-2008. The patient reported that she became pregnant. Her LMP is December 2007. Follow up information was received. The patient a female had her last menstrual period on 01-DEC-2007. Her estimated delivery date was reported as 06-SEP-2008. The patient had no previous pregnancies. Follow-up information was received from the 18 year old mother who on 15-SEP-2008 delivered a full-term, health and normal girl, weighing 9LBS 7 OZ. She had an uncomplicated, spontaneous vaginal delivery. She said her pregnancy was fine-there were no complications. The baby was doing well, and was diagnosed at 3 month with "some eczema". The baby had gotten treatment (not specified) for the eczema and was ok with no problems. The mother stated that she was also well and had recovered from the pregnancy without any complications. No further information is available.