chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry cough/a neighbor had similar symptoms; body aches/a neighbor had similar symptoms; fatigue/a neighbor had similar symptoms; fever was 98.9/a neighbor had similar symptoms; chills/a neighbor had similar symptoms; arm soreness/a neighbor had similar symptoms; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, general body pain, fatigue, fever, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: This case was reported for the neighbor.  The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. It was also reported that a neighbor had similar symptoms that lasted 3 days. There was no other information available for that person. Consented to follow up. This case has been linked with case US2020159662 and US2020159668, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020159668:Same reporter
I am still very fatigue and tired.; I still have the headache.; I feel cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), single (Lot number: FM0173) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMSULOSIN; PREDNISONE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), FATIGUE (non-serious) all with onset 29Jun2022, outcome "unknown" and all described as "I am still very fatigue and tired."; NASOPHARYNGITIS (non-serious) with onset 29Jun2022, outcome "unknown", described as "I feel cold."; HEADACHE (non-serious) with onset 29Jun2022, outcome "unknown", described as "I still have the headache.". Therapeutic measures were taken as a result of fatigue, headache, nasopharyngitis, fatigue.  Additional information: The patient was receiving treatment with Tylenol.
11-22-08 Client states left upper arm wasosore & painful about 48 hrs after injection.  Afebrile.  Client applied ice initially.  Took TT TYLENOL.  10-23-08 client reports arm improved.  10-26-08 client feels fine.
Patient started with fever 10 days after MMR, felt hot. Also had congestion and cough.
This non-serious spontaneous case, initially received on 21-Feb-2018, was reported by other non-health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN flu vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date (reported as few years), after vaccination, the patient developed illness. The event lasted for a day or two (recovered). The outcome of the event was recovered.
Information has been received from a consumer concerning her daughter who in approximately September 2003, was vaccinated with a dose of Varivax. There was no concomitant medication. Subsequently the patient developed shingles on her left side. It was reported that there was no pain, itching or fever. The patient was seen in the physician's office and prescribed an anti-viral topical cream. There were no diagnostic or laboratory tests. At the time of the report, the patient had not recovered. Additional information has been requested.
blood clot; This is a spontaneous report received from a contactable pharmacist from a Pfizer-sponsored program. A 70-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist was asking if there have been any reports of blood clots associated with the COVID-19 vaccine as the patient developed blood clot 1.5 weeks after receiving his first Pfizer COVID vaccine on an unspecified date. The outcome of the event was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Blood clots cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent condition and medical history was not reported. On 10-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 2.5/0.5 (units unspecified) lot # L029631, Expiry date: 14-AUG-2017 (dose, route, therapy type not reported). No adverse effects were reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.
She experienced a slight redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She experienced a slight redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU, Penicillin and Cipro. Past adverse reactions to the above products included Adverse event with Cipro and Penicillin; and No adverse event with FLU. Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (She experienced a slight redness on her arm). At the time of the report, ERYTHEMA (She experienced a slight redness on her arm) outcome was unknown.            Patient mentioned that it was not the first time she experienced as she had adverse event with shingles, the cipro and penicillin but not with the flu shot. Patient believed she had a problem with the binder.  No concomitant medications were reported.  No treatment  medications were reported.   This case was linked to MOD-2022-533441, MOD-2022-533363 (Patient Link).
Client received Td in left deltoid on 11/19/2002. Soreness noted day following injection. Also some slight body achiness and some itching in injection area. On 11/23/2002 client noticed redness extending from deltoid area to interior side of arm covering area from axilla to six inches below. Recovering; client spoke with her MD. they advised to just watch.
Had MMR and Varivax 7/21/05. Rash started Fri. Getting worse overall. Varicella 2 hrs to Varivax.
inadvertent administration of Gardasil 9 to a pregnant patient instead of TDap vaccine; no additional adverse events reported; inadvertent administration of Gardasil 9 to a pregnant patient instead of TDap vaccine; This spontaneous prospective pregnancy report was received from a physician via a company representative referring to a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2021, the patient became pregnant. The last menstrual period (LMP) was on an unknown date in 2021; the estimated delivery date (EDD) was not known. The pregnancy outcome was pending.  On 09-DEC-2021, the patient was inadvertent vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, location, lot# and expiration date were not reported) for prophylaxis instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP). No additional adverse event details were reported. No product quality complaint was involved.
I seem to have covid arm. Redness, itchiness, stiffness, and sweelling. S
24 hours after receiving the booster shot the lymph node in my left armpit swelled up to the size of a lemon and my arm was extremely sore. This lasted for almost a week before the lymph node started to go down.
Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a 4-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 08-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jul-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medication was not provided.  Treatment information was not provided. Upon internal review on 04-Aug-2021, the age was corrected to 4 months.  Upon internal review on 03-Nov-2021, birth type captured as normal pregnancy outcome and fetal outcome captured delivered NOS.   This case was linked to MOD-2021-252946 (Parent-Child Link).   See case MOD-2021-252946 for details regarding the Parent case.
36 year old male presenting with chills, fever, and loss of taste and smell for 1 week, symptoms improving.  Had at home covid test 3 days ago, positive.  Brother has covid and whole family at Labor Day party sick with it now.  No prior covid infections.  Non smoker.  Covid vaccinated.  Hx allergies and HTN.  Treating with cold meds, has not taken in past 3 days.  Needs positive test officially for work.      Body mass index is 32.78 kg/m².   I wore mask, gloves, and eye protection for entire duration of visit.  Patient wore a mask entire duration of visit.
Heavy menses with large clots, irregular cylce, cycle twice as long, menstruated early.  Decreased exercise capacity.  Headaches.  Insomnia.
Lips began to tingle; Lips numb; Face itchy; Throat scratchy; Face became warm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Lips began to tingle) and HYPOAESTHESIA ORAL (Lips numb) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy (Allergy to Dilaudid). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PARAESTHESIA ORAL (Lips began to tingle) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion medically significant), PRURITUS (Face itchy), OROPHARYNGEAL DISCOMFORT (Throat scratchy) and FEELING HOT (Face became warm). On 05-Jan-2021, PARAESTHESIA ORAL (Lips began to tingle), HYPOAESTHESIA ORAL (Lips numb), PRURITUS (Face itchy), OROPHARYNGEAL DISCOMFORT (Throat scratchy) and FEELING HOT (Face became warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded.; 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.
ON 01/17/02, the child received her fifth injection of Infanrix. On 01/18/02, she experienced "severe" swelling at the injection site, which was also "very, very, red, hot  and painful". The child was seen by the physician, who made a diagnosis of cellulitis. The adverse events resolved without medical intervention on 01/20/02.
pt recvd vax on 15MAR93 1130AM & mom returned to clinia about 2PM stated pt was in bed following a bath was noted to turn pale, sweaty & weak; briefly, then vomited;
I started out with sore throat runny nose and achy. I also had diarrhea, I lost my smell, then I got a horrible cough that went on a few weeks so I went to doctor they diagnosed me with possible RSV. My smell has still not come back.
He was a little off the next day with a little bit of achiness; He was a little off the next day with a little bit of achiness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 024M201 and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness). At the time of the report, MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) outcome was unknown.            No concomitant medication was reported.  On 17-Feb-2021, the patient received second dose of Moderna COVID-19 Vaccine.  On 18-Feb-2021, the patient was a little off with a little bit of achiness.  On 26-Oct-2021, the patient received third dose of Moderna COVID-19 Vaccine.  On 27-Oct-2021, the patient was a little off with a little bit of achiness.  No treatment medication was reported.   This case was linked to MOD-2022-669169 (Patient Link).
Redness, swelling, 6" down arm, 3-4" wide, with heat.  No fever.  Pain in arm as well.  Diagnosis cellulitis secondary to injection.  Tx with AUGMENTIN 500 mg po BID x 10 days
?Pfizer-BioNTech COVID-19 Vaccine EUA No known effect on pregnancy. 31 weeks gestation, estimated delivery May 19, 2021.
Approximately 2 minutes after receiving the vaccine, patient stated that he felt nauseous. Patient was seated in observation area. Patient stated that he had no other pain or complaints. Pt appeared diaphoretic. Vital signs taken at 2:23pm were as follows. Pulse 44 regular and strong, BP 82/41, respiratory rate 14 and unlabored, oxygen saturation 95%. EMS was called. Patient was asked to lie down and his legs were elevated. Patient stated that he felt better and no longer felt nauseous. Vital signs at 2:28pm in Trendelenburg position were pulse 50, BP 109/56, O2 sat 98%, RR 14. Lung sounds were clear and equal bilaterally. Pt reported no difficulty breathing, no tightness or pain in chest, and no swelling in face. Vital signs at 2:30pm in trendelenberg position were pulse 56, BP 115/70, RR 14, O2 sat 99%. Patient was asked to sit up. He stated that he felt fine and returned to chair. Vital signs at 2:33 in chair were pulse 58, BP 109/66, O2 Sat 98%. EMS arrived and assessed the patient. Patient stated that he did not want to go to hospital. EMS released patient.
Extreme chills, nausea with dry heaving, extreme fatigue, persistent headache, numbness in feet, weakness in leg muscles with aching, slowed pupilary reflex response to light, slowed overall motor reflexes, aggravated bronchial congestion and sinus congestion
Patient's mother reports patient developed an area of approx. 4"x3" on right arm an injection site that was red, raised and warm. Use of BENADRYL and compresses 8/17/16. 8/19/16-area improving, no longer raised or warm, red fading.
Information has been received from a physician, concerning a 12 year old female patient, with drug hypersensitivity to CEFZIL, who on 12-JUL-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #657736/0389U). Concomitant vaccination therapy included BOOSTRIX. On 15-JUL-2007, three days following the vaccination, the patient experienced a headache and dizziness, that worsened during the day, and then began to resolve in the evening. The physician reported that on 16-JUL-2007, the patient was "fine," and confirmed that all symptoms had resolved. The patient sought unspecified medical attention. No further information is expected.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant medications were unknown. On an unknown date, the patients were vaccinated for prophylaxis with an improperly stored dose of Oka-Merck PROQUAD lot # N029878 and expiration date 22-APR-2019 for prophylaxis. Route of administration, number of previous doses and strength were not reported. The Oka-Merck PROQUAD vaccines were reconstituted with properly stored vials of sterile diluent. No adverse events were reported, however, Oka-Merck PROQUAD vaccines suffered from temperature excursion (stored at 15°F to 46°F) for a period of 49 minutes. Digital data logger was involved. There was no previous temperature excursion.
having an allergic reaction; Tongue and lips swelling; Tongue and lips swelling; covered in hives; itchy; trouble breathing; chest and back pains; chest and back pains; Stinging/stabbing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: FF8841), via an unspecified route of administration in left arm on 21Sep2021 at 13:15 (at the age of 28 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 22Sep2021 at 4:30 am she woke up around the morning after the shot having an allergic reaction. Tongue and lips swelling, covered in hives, itchy, trouble breathing. She used a primatene mist inhaler and chewed 50 mg of benedryl and began to get better shortly after. The next day she started having right side chest and back pains. Stinging/stabbing. Which have not subsided. Therapeutic measures were taken as a result of having an allergic reaction, tongue and lips swelling, covered in hives, itchy, trouble breathing, chest and back pains, stinging/stabbing. Treatment received at home from herself. No hospitalization required. Reporter considered events as non-serious. The chest and back pains, stinging/stabbing was not recovered, while with other events was recovering.  Follow-Up (30Sep2021): Follow-up attempts are completed. No further information is expected.
Severe skin rash and 'sunburn' with peeling on inner thighs. Later redness and small blisters on arms and hands.
my second dose given 39 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later). On 22-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my second dose given 39 days later) had resolved. Not Provided          Concomitant medication were not provided/unknown. Treatment medication were not provided/unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
This case was reported by a consumer and described the occurrence of tinnitus in a 26-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 19 June 2009, the subject received 1st dose of HAVRIX (unknown).  On 19 June 2009 or the next day, at an unspecified time after vaccination with HAVRIX, the subject experienced tinnitus.  At the time of reporting the event was unresolved.  The reporter was calling on behalf of his brother to report the symptoms and did not have the prescriber or office information available during the report.
pt recvd rubella vax 23JUN92 & on 1JUL92 devel lymphadenopathy on the side of the inject & presented to a MD for treatment; MD noted pt did have regional lymphadenopathy & a samll 2 cm enlarged lymph node on other arm;
Patient advised he had yet to received flu vaccine and asked if we could give him his vaccine. Gave patient flu vaccine quadrivalent. Discovered patient was given flu vaccine in September of 2022. Advised medical lead, who contacted (Medical/Program director) to advise. Medical Lead advised no additional observation time for patient and that patient was ok to go home. Wrote comment in Prep Mod explaining incident and action taken after.   Patient was advised of adverse event and informed that we would be writing a VAERS report.
Night of recieving shot, fever, extreme chills, extreme joint pain, extreme difficulty breathing. Since date of shot have been having intense chest pain several times a day every day since lasting aproxomately 20 seconds each.
Left facial cheek/lip twitching similar to Bells Palsy ? lasted 2 days