chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to a 12 year old female patient. The patient's concurrent condition, medical history and concomitant medication were not provided. On 29-NOV-2016 (also reported as about 18 months ago in January), the patient was vaccinated with the first dose of GARDASIL 9, 0.5 milliliter, intramuscularly (lot # and expiry date not reported) for human papilloma virus (HPV) prevention without any side effects after the first dose. The physician stated that on 19-DEC-2016, the patient was seen for viral upper respiratory infection with nasal congestion, cough. On 25-DEC-2016, the patient experienced diarrhoea and vomiting, but was not examined. The physician stated that on 07-JAN-2017, the patient was seen for persistent congestion, headache and temporomandibular joint symptoms. The reporter stated that on 12-JAN-2017 (also reported as about 7-8 months after receiving the vaccine), the patient was seen with muscle aches in lower extremities but had a "normal exam". At that time, blood work was taken and results included "negative Lyme and Epstein Barr Virus (EBV) titers". On 14-JAN-2017, patient went to unknown emergency room (ER) with "objective muscle weakness, decreased Achilles reflexes." At that time, neurology was consulted (clinician not specified) and patient was admitted to unspecified hospital on 20-JAN-2017. The final diagnosis was muscle weakness with "mild" case of Guillain Barre Syndrome. It was reported that neurologic symptoms developed in August or September 2017. The patient was treated with gamma globulin and discharged on 26-JAN-2017. It was also reported that last year mother of the patient refused the second dose of HPV-9 vaccine. The outcome of the events was unknown. The relatedness between the events and suspected vaccine was not provided. Upon internal review, the event of Guillain Barre Syndrome was considered to be medically significant.
I began having random muscle twitches first in my legs, and then over my torso and arms and face.  Like insects crawling under my skin.  I ignored these at first, thinking this was from my spinal stenosis.  Saw my neurologist and an EMG was done .  NO Change from one done a year earlier to diagnose my spinal stenosis.  Symptoms then were weakness in extremities and numb feelings in my feet.  And tinglings in my arms and legs.  These improved with Physical Therapy.
The patient developed a rash all over his body with a fever of greater than 102.5F. The rash looked like chicken pox without the blisters. The rash was gone within 24 hours.
Pt lost consciousness for 15-20 seconds approx. 1 min after injection.
Arm soar directly under injection site and red/swollen for a day too. Now 6 weeks later arm still hurts and seems to spread slightly. Currently not warm to touch or red. When press spot hurts and on fingers tingling. Not debilitating and relieved by APAP.
COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included antibodies infusion in last week of APR-2021. On an unspecified date in APR-2021, about a month and a half later of vaccination the patient got covid-19 (Dose number in series 1).  The patient also received two doses of non-company suspect vaccine comirnaty (tozinameran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on 2021 (after 90 days from APR-2021) for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date on JUL-2022, the patient had covid-19 (Dose number in series 2). As per the doctor the antibodies are high.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the covid-19 and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
7JAn99 1210 c/o tenderness & soreness to lt upper arm;c/o gen rash to entire body w/itching;has quarter sized sl reddened area to lt deltoid;
Redness at injection site. Fatigue & lightheaded. Symptoms of chest cold.
Severe shoulder pain has lasted 7+ weeks since injection, no prior pain before injection.  Xray, ultra sound and MRI show tear of Supraspinatus tendon.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EWV183), in right arm for covid-19 immunisation. The patient's relevant medical history included: "CSF Leak from left nostril (repaired)" (not ongoing); "Known allergies: some foods" (unspecified if ongoing); "headaches" (unspecified if ongoing); "high pressure in head (mostly controlled)" (unspecified if ongoing), notes: mostly controlled; "high blood pressure (controlled)" (unspecified if ongoing), notes: controlled; "high cholesterol (controlled)" (unspecified if ongoing), notes: controlled; "obesity" (unspecified if ongoing), notes: controlled; "depression/anxiety (controlled)" (unspecified if ongoing), notes: controlled; "depression/anxiety (controlled)" (unspecified if ongoing). Concomitant medication(s) included: ALLERGY MEDICINE, start date: 05Jan2019, stop date: 22Nov2022; LAMOTRIGINE, start date: 01Mar2021, stop date: 22Nov2022; AMLODIPINE BESYLATE, start date: 13Jul2020; ROSUVASTATIN CALCIUM, start date: 24Jan2022; ASPIRIN EC, start date: 24Jan2022; ACETAZOLAMIDE, start date: 07Jul2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
stroke; heart attack; he has a lot of heart problems; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced stroke, heart attack, he has a lot of heart problems. Clinical course was reported as patient was 69-year-old patients who wants to know when he and his wife will get their booster shot. He has a lot of heart problems. he had a stroke and a couple of heart attack. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
A little bit of nausea, disturbance.; back pain; neck pain; Fever of 103.5.; Headache; A little bit of nausea, disturbance.; Chill; I started having abdominal muscle pain; Dry cough; I have kind of like a virus on my lip, kind of Herpes Zoster.; This is a spontaneous report from contactable consumer (patient). This female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got the side effect or symptoms few months after getting both vaccines. She had started having abdominal muscle pain and back pain and neck pain, then she got fever of 103.5. She was experiencing all of that. She had headache and chill, a little bit of nausea, disturbance, dry cough and she had kind of like a virus on her lip kind of herpes zoster on the time of reporting this report. The patient underwent lab tests and procedure of body temperature and resulted as fever 103.5. The outcome of events was not recovered.  Information about lot/batch number had been requested.
This spontaneous report as received from an office manager refers to an 18 year old patient (gender not specified). No information regarding the patient medical history was provided. On 06-MAR-2012 the patient was vaccinated with GARDASIL injection dose 1. Route not specified. On 08-MAY-2012 the patient received the second dose and on 18-NOV-2013 the patient was in the office to receive the third dose. No concomitant medication was reported. No adverse effect was reported. Additional information has been requested.
Since the administration she states she has pain and tingling down her left arm being followed by her private medical physician
The patient fainted and was unconscious for about 30 seconds before waking up.  He rested for a few minutes and then felt better and left with his father.
10/10/2021 - Positive Covid Test Tested positive both at home test, as well as at testing site.  Breakthrough Covid Case. 3 days heavy flu like symptoms body aches, headache, sore throat, loss of smell, lost of taste, tired severe headaches for week and a half.  continuing on and off for 3+weeks afterwards cough developed after a week or so - lingered for 1+ month (light) tested negative again on 11/23
Within 15 min, pt experienced dizziness, pulse 78, BP 148/79. Advised pt to remain seated. Her BP normally not above 120 on top. No nausea. Gave her Coke. Said helped some. No SOB. Called husband to pick her up. Called Dr. to see if ER.
patient was feeling flushed and teary, she also said she was very nervous and felt like maybe her feelings were anxiety about getting the vaccine.  we gave her 25mg of bendryl and talked to her for a while.  over the course of about 45 minutes she felt much better.
"Weak, Wants to pass out, needle phobia, feel weird in chest" Narrative:
This spontaneous report was received from a nurse refers to an unspecified patient of unknown age. On an unknown date, the patient was vaccinated with a dose of unspecified PNEUMOVAX23 in November, December and in July. On an unknown date, the patient experienced unspecified adverse reaction. The outcome of unspecified adverse reaction was unknown. Additional information is not expected.
Fever, red, hot raised area 13cm x 9cm lasting 5 days.
Lower than recommended dose at 0.4 ml for 2nd vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .4 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273 with no associated AEs.
Local erythema/tenderness two days after vaccination. Diagnosis-local reaction vs cellultiis of the thigh. Given antibiotic/Tylenol.
Chills, joint pain, whole body aches, nausea, vomiting, diarrhea.
pt recvd vax & c/o goose egg lt arm site of inject; also facial swelling lt cheek; sl raised red area;
Patient was given the Jannsen vaccine on March 26, 2021 by mistake.  He received the Pfizer vaccine in December 2020 and January 2021.  He stated he did not have any adverse reactions after he was given this vaccine.
pt administered DPT/OPV/HIB/Hep on 15JUN92 11AM; mom called later that day stated pt was ?grunting for 1-2 hrs p/shots; also reportedly very pale & crying;
Information has been received from a physician concerning a female who was born on 09-Jun-1988 was vaccinated the first dose of GARDASIL (Merck) (LOT # 0210U), 0.5ml, on 23-MAY-2007. On 07-AUG-2007 she got the second dose of GARDASIL (LOT # 655620/0171U). There were no concomitant medications. Subsequently the patient experienced lymphomatoid papulosis after getting the first dose and second dose of GARDASIL. After that the patient sought medical attention. The patient never received the third dose. At the time of the report, the outcome was unknown. A medical assistant reported the patient's mother advised that the patient was undergoing treatment (no further information given) and would not be receiving the third dose. Additional information has been requested.  6/25/09 Medical records received DOS 12/28/07 to 12/24/08. Assessment: Lymphoid papulosis and iron deficiency.  Patient presented with hives on upper extremities. Acne on face. Cellulitis L thigh, lymphadenopathy in groin. Lymphoid papulosis lesions on face, eyelid, legs buttocks. Shotty adenopathy neck. Infection R thigh. Oral contraceptives. Vaccine record: HPV-1 Merck 0210U RA 22.Nov.09  6/29/09 Medical records received 12/28/07 to 12/24/08. Additional information abstracted: Patient presented to oncology center with sweats at night, weight loss, rash and itching. Multiple open weeping papules yellowish in nature, others erythematous and reddish/brown, some are papulopustular. Present on eyelids, neck, arms, back, and posterior portion of legs.  8/24/09 Dermatology consult received. FINAL DX: lymphomatoid papulosis, type C, leaving scars. Records reveal patient experienced widespread & painful nodular lesions, ulcer on left hand, intermittent mouth sores, fatigue, nausea.  Tx w/methotrexate starting 6/08, clobetasol propionate cream & folic acid.  Developed MTX-induced pneumonitis.  MTX d/c'd.  Punch biopsy done when developed scaly patches c/w eczematous dermatitis.  Tx w/PUVA & Oxsoralen starting 12/08 w/good results.
booster dose flu-like sx; fever, fatigue, myalgias, urticarial type rash primarily on trunk & proximal arms;
pt recvd vax; pt reported pain, redness, swelling & fever in arm & generalized fever lasting to present time (6 days later); also reporting shortness of breath;
pt recv vax 14AUG95 & same day exp severe pain up back of neck, neck stiffness, severe h/a, gen malaise & a funny feeling in throat;pt did not exp resp distress;presented to MD office; VS nl;
Fever, body aches, chills, nausea, headache, pain at injection site.
COVID 19 Treatment; COVID 19 Treatment; 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), on 06Oct2021 as dose 3 (booster), single (Lot number: FC3184) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was given anti-viral Paxlovid 25Aug2022 to 28Aug2022 for treatment of COVID-19 (Lot numbe GE0257). No known allergies.
Pt recvd complete series of Hep B vax in 1986; Over the following yrs pt exp EBS w/sx of fatigue & inc ESR; pt was able to work;
Hallucinations, delirium, hysteria, loss of speech. I was counting the amount of letters and syllables in words instead of the letters that structured them.
I started to have a fever, cold chills, body ache, hot and cold flashes and sweats, it was like I was going through the flu. Went to the ER, they said let it run its course. At the end of 72 hours, it was over.
Patient received an expired dose of ACTHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (GMI) (Reference number- 00718295) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 12-month-old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for immunization.  On 10-Aug-2021, the patient received a third 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ357AAA and expiry date: 26-Jul-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported that "Caller states her son went in for 12 month checkup and immunizations and they gave him expired ACTHIB. Patient received "4 sticks" in total."  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Day after vaccine 1, mild fatigue/dizziness/chills (no fever). Nine days later on 2/14, two asthma episodes (I don't have asthma), short of breath all day, severe chills (no fever), very dizzy. Took two tylenol and a Benadryl, went to bed early, felt fine next day.
Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced shingles. It was a light case but the doctor recommended to patient that he/she get the better shingles shot. The patient hoped people will get the shot. The shingles was terrible and the patient hoped they never get them. The follow-up would not possible as no contact details were available.
Systemic: Hypertension-Mild, Additional Details: Pt reported feeling "weird, almost like drunk" within 15 min after immunization (pt had both flu shot and moderna booster). Measured BP and HR twice with a ~10 min-interval and HR was normal but BP reading was in the 170s/100s range both times. Pt felt good enough to go to car with family to see MD. Called pt after a couple of hours to check up on her. Pt went to see MD and was released to home. BP was ~140/90 in the office and was going down. Pt stated that she felt fine now. Pt will follow up.
Patient called on 10/3/2017 stating that her left arm is still hurting after flu shot given on 9/23/2017 at flu clinic. Patient states she is a nurse and says pharmacy student intern administering the flu shot (in her opinion) was too high on the shoulder, causing bursitis. Patient feels this is due to incorrect technique, rather than adverse reaction. Patient was given claim number to get expenses covered to see a physician. Patient did not call back about further pain.
This spontaneous report as received from a healthcare worker via a company representative refers to a 9 month old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported. On 20-APR-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # L014418, expiration date 13-APR-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
2 weeks later arm still painful and stiff. Radiating to armpit and elbow. 1st day thumb spasms. Tx-heat and ROM exercises.
Case number PHEH2016US028846, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse. No additional information was provided.