chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 03-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Immediately after injection, felt lightheaded, queasy, diaphoretic.  BP- 70/34, p-70,   repeat BP- 87/55, p-72 given juice, water, and laying down on gurney.  After 30 minutes,  reports feeling better, repeat BP- 96/60, p-73, O2sat- 98% Able to sit and stand without feeling dizzy or lightheaded.  Discharged home with mother and ER precautions
TRANSIENT CEREBRAL ISCHEMIA 11/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a nurse practitioner refers to 7 unspecified patients of unknown ages and genders. On unknown date in August-2017, the patients were vaccinated with VARIVAX (lot # reported as N014630, expiry date: 11-MAY-2019, lot #L044526 expiry date: 09-NOV-2019, lot #N012618, expiry date: 02-APR-2019 (route: subcutaneous). The vaccine was stored at a temperature of 32 F (foreign heat) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6 F to 14 F for total 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010196.
Throat felt tight - like something stuck in it/coughing without relief from water. Began vomiting during drive home (40 min commute). 1 episode explosive diarrhea by 4:30 pm then shaking, chills, hurting all over & weak. I took liquid BENADRYL & TYLENOL.
dry and reddened rash; the rash is so itchy and swollen; the rash is so itchy and swollen; This is a spontaneous report from a contactable Nurse.  A 54-years-old female patient received the second dose of  bnt162b2 (BNT162B2; Lot # EL9261) vaccine , via an unspecified route of administration in the left shoulder on 18Jan2021 at single dose  for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient received the first dose of BNT162B2 vaccine on 28Dec2020. The patient experienced dry and reddened rash in the anterior side of her neck  in the shape of her thyroid.  on 22Jan2021 with outcome of not recovered , the rash is so itchy and swollen on 22Jan2021 with outcome of not recovered.    The reported events were considered Important Medical Events. The patient  used her son's eczema cream, clarified as "Elcom" or "Elecom" but the events worsened.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events 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.
a little vaccine dripped on the patient's arm while it was being administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered). At the time of the report, UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Patient fainted immediately on giving the GARDASIL-9 vaccine. Unresponsive for only a few seconds. Had flushing and dizziness. Sat in chair for about 15 minutes and recovered.
Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking unspecified medications. Treatment information was not reported.
Information has been received from a physician concerning an 18 month old female pt  who in approx. Feb.2003, was vaccinated with a dose of varicella virus vaccine live. On 28Aug2003 the pt was brought into the office with a mild breakthrough of varicella. No further treatment was necessary, and it was indicated that it was a mild case. The number of lesions was not reported. It was noted that the pt recovered with sequelae. No product quality complaint was involved.
Information has been received from a registered nurse concerning a 6-year-old (also reported as 9.5 years old) male with no medical history or know allergies who on 22-APR-1999 was vaccinated subcutaneous in the left arm with his firs dose of varicella virus vaccine live (Oka/Merck) (lot # 628522/1843H). There were no illnesses at the time of vaccination. On 21-APR-2004 (at 09:20 hours) the patient developed 2 lesions on his neck and ankle suspicious of chickenpox. On an unspecified date, the patient had a serum varicella zoster virus antibody test and has varicella protection; additionally the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Initial report was received from a health care professional on 06 April 2012. The reporter also reported two other adverse events for two other patients which were captured in case numbers 2012-03758 and 2012-03760. A 44-year-old female patient, with a medical history of asthma, seasonal allergies and anxiety attacks, had received a dose one intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd. lot number C3940 (sanofi pasteur Inc. lot number U4046AA) on 04 April 2012 when she had an acute asthma attack. On 06 April 2012, the patient had a site reaction of redness and swelling that was treated with ice packs, TYLENOL and BENADRYL as needed (PRN). The patient was at the doctor's office for recurring asthma attack and not for the site reaction. The patient's concomitant medications included nebulizer, SINGULAIR and PROVENTIL. The patient's outcome was not reported. Documents held by sender: None.
sweating when sleeping to the point of being soaked; extreme muscle cramps in all my muscles was very painful; arm is red; has a huge bump the size of a tennis ball; Body aches; chills; 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 HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball) and MYALGIA (Body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweating when sleeping to the point of being soaked), MUSCLE SPASMS (extreme muscle cramps in all my muscles was very painful), ERYTHEMA (arm is red), SWELLING (has a huge bump the size of a tennis ball), MYALGIA (Body aches) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
nephropathy; shingles rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose either January or March 2020).   On 19th June 2020, the patient received the 2nd dose of Shingrix. On 5th July 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nephropathy. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the nephropathy was not recovered/not resolved.   It was unknown if the reporter considered the shingles and nephropathy to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and diagnosed with shingles. The shingles rash has resolved but the nephropathy has not. The reporter did not consent to follow up.
Soreness at injection site; fatigue; This is a spontaneous report from a contactable consumer received via Pfizer Sales Representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced soreness at injection site and fatigue on an unspecified. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient developed a fever of 105F six hours after the vaccination. The patient had a large area of induration over the deltoid with erythema in an area 15cm x 10cm.
Patient describes numbness and tingling in upper arm of injection site starting 9/28/19 and began to subside the morning of 10/2/19.  Soreness had not been present until the morning of 10/2/19.  During the early afternoon, patient describes the numbness and tingling "returned with a vengeance" and proceeded to call me as I instructed if the numbness and tingling returned.
A raised area 11 x 8 cm, with warmness and soreness after receiving Tdap vaccine.
Right thigh swollen after 24hours.  Large area with patchy, pink, hot, tender rash.  2 areas of blistering.  Fever within 1st 24 hours- Resolved  DTaP given right thigh.
PT recvd vax 22MAY92 & 2 days later devel t104 R x 2 days; pt given APAP & cool baths; fussy & unable to calm; did not see MD, did not call clinic;
No adverse effects. Patient came in to get the Moderna bivalent vaccine and was given Moderna monovalent.
Patient had dizziness and felt her arm get hot. Patient then felt cold, unsteady gait ,had patient lay down with feet elevated, given sips of water, symptoms  resolved within 15 minutes. pulse was 65, O2 97, BP cuff did not fit, pediatric size unavailable. Assumed vasovagal response
rapid breathing; Chills; Fever (102) lasting 36 hours; headache; muscle aches; malaise; nausea; Pain in injection site; arm pain; This is a spontaneous report from a contactable other HCP (patient). A 62-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0161), via an unspecified route of administration on 14May2021 at 10:00 (at the age of 62-years-old) in left arm as dose number unknown, single for covid-19 immunisation. Medical history included thyroid disorder, penicillin allergy both from an unknown date and unknown if ongoing, covid-19 in Dec2020 when she had 17 days of fever and severe cough. Concomitant medications received within 2 weeks of vaccination included l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. On 14May2021 at 20:00, the patient experienced chills, fever (102) lasting 36 hours, headache, muscle aches, rapid breathing, malaise, nausea, pain in injection site, and arm pain. Symptoms were similar to when she had contracted covid (positive test) in Dec2020 when she had 17 days of fever and severe cough. Patient had not been tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 14May2021, covid-19 test: positive in Dec2020. The outcome of the events chills and pyrexia was recovered on 16May2021 and for all other events was recovered on an unspecified date in May2021.  Follow-up attempts completed. No further information expected.
1/2 hr following HIBTITER vax pt devel swelling, fever, redness; t101.4 @ 24 hrs; had transient hypogammaglobinemia of infancy;
Chest pain, shortness of breath, dizziness, high blood pressure, pain in left arm and chest, forgetfulness, memory loss, migraines with aura, fatigue, increased anxiety and depression (to the point meds were required). 4 months and ongoing...
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 59267030402) at the age of 69 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: "Moderate cholesterol" (unspecified if ongoing), notes: Other medical history: Moderate cholesterol; "Glaucoma" (unspecified if ongoing), notes: Other medical history: Glaucoma. Concomitant medication(s) included: ATORVASTATIN, start date: 14Oct2022, stop date: 27Nov2022. Past drug history included: Percodan, reaction(s): "Known allergies: Percodan", notes: Known allergies: Percodan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
Headache, Myalgia, Arthralgia, Nausea Vomiting, Very Tired Narrative:
After receiving COVID and Menveo vaccines; the patient turned pale and passed out. The CMA and Mom guided her down to the floor. The patient did not hit her head. Patient came in and out of conciousness for several minutes.  Patient continued breathing normally and had a normal heart rate. CMA used a fan, juice, and snack to get the patient back to "normal" state.  Dr. came to examine the patient who fully recovered after 25 - 30 minutes. Patient was able to walk out of the office unassisted. Follow up was done via phone call at 24 hours post vaccination and 48 hours post vaccination with only reports of the patient being tired and no other symptoms. 48 hours post vaccination the patient is back to her normal routine.
This spontaneous report was received from a registered nurse and refers to a unknown number of patients of unknown age and gender. The patients' medical histories, concomitant medications and drug histories were all unknown. On 21-NOV-2016, temperature excursion connected with suspect vaccines occurred (duration was not reported) and on unknown dates in 2016, the patients were vaccinated with a doses of improperly stored ROTATEQ taken orally, lot # M019706, expiration date 24-OCT-2017 (dose and frequency was not reported). The reporting nurse stated that none of the patients reported adverse events or symptoms after receiving their vaccination. The patients' laboratory data was unknown. As of 28-DEC-2016, it was unknown if the patients would continue the therapy with ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014979: US-009507513-1612USA015005:
4 yo vaccines given on 11/14/19, DTaP/IPV and MMRV in R thigh. Over the next two days developed progressive localized pain, erythema, edema, pruritus in R thigh where vaccines were administered (R thigh). ED documentation reported "2 erythematous, tender, mildly edematous, circular lesions on the right anterior thigh. Diameter of smaller lesion is 1.5 cm. Diameter of larger lesion is 4 cm." No fevers. Seen at ED and prescribed 7 day course cephelexin for RLE cellulitis and benadryl PRN following vaccine administration. Completed 7 days of therapy. Mother states all above symptoms resolved.
Autism signs showing by 9 months old; suspect DPT/HIB. No obvious reactions; at 3 months old had tummy problems with 2/18/97 shot.
Coughing; light headedness; Injection site inflammation; Muscle pain; joint pain; Tiredness; shivering; Pain at the injection site; Redness at the injection site; Injection site swelling; Fever; This case was reported by a consumer via call center representative and described the occurrence of cough in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received the 1st dose of Shingrix (injection). On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and shivering. On 10th October 2020, the patient experienced cough, light headedness, injection site inflammation, muscle pain, joint pain and tiredness. In October 2020, the patient experienced fever. On an unknown date, the outcome of the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the cough, light headedness, injection site inflammation, injection site pain, injection site erythema, injection site swelling, muscle pain, joint pain, tiredness, shivering and fever to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that he received the Shingrix on his left arm on 9th October,2020 and experienced coughing and lightheadedness also stated he experienced inflammation, pain,redness and swelling at the injection site with that patient also experienced muscle pain, joint pain, tiredness, shivering, and a fever.  Patient stated that he no longer experiencing those problems. The patient wanted to know if coughing was listed as a side effect. The reporter did not consent to follow up.
1/13/21 pt came into clinic for vaccine.  Had difficulty remembering age.  Called me Mon. 1/18/21 stating she was sick.  When asked what her sx were, she stated fatigue.  She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun.  I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those.  I questioned her about eating and drinking and she said she ate and drank water.  She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911.  She agreed.  Two staff from clinic called her Mon. and Tues, (1/18 and 1/19).  On Tues. she may have had sl slurred speech.  She was found deceased on
red rash appeared around injection site 10 days after vaccination or 1/1/21.  In addition fatigue, body aches and headache were experienced in the two days following.  Rash progressed from upper deltoid to elbow. Only slightly pruritic.  Symptoms treated with acetaminophen (headache/body aches) and cetirizine (rash).  body and headache resolved 1/4/21
Lip swelling, blister on upper lip, wheezing developed at 2 after injection (flu shot). Patient took 50mg BENADRYL, symptoms resolved several hours later. Reported to center on 11/28/16.
Numbing in my left arm and hand; Ssensation of blood running down my arms; Dizzy; Tired; Brain fog; Can not think; This is a spontaneous report from a contactable consumer (Patient). A 72-years-old female patient reported herself that who received first dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 (at the age of 72-years-old) as SINGLE for covid-19 immunization and was administered in hospital. Medical history included chronic obstructive pulmonary disease (COPD) and asthma from an unknown date and unknown if ongoing. Also, the previously took Cipro, Penicillin and ongoing Crestor and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]) and meloxicam; both taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 14:00, the patient experienced numbing in her left arm and hand, sensation of blood running down my arms, dizzy, tired, brain fog can not think. Then went to urgent care and they found nothing. The patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 72-years-old) as SINGLE for covid-19 immunization. The patient underwent lab tests which included blood work, computerised tomogram (CT) scan of brain, electrocardiogram (EKG), urine analysis (UA), x-ray in Mar2021 for which they have found nothing in all tests. Therapeutic measures were taken as a result of all events. Adverse event result in healthcare professional office/clinic visit/ Emergency room/department or urgent care. The all events assessed as non-serious by the reporter. The outcome of all events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient was given moderna booster instead of the pfizer that she got as a first shot at a different location--- no reported side effects