chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Dehydrated; Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 09:15 (Lot number: EW017) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung nodules (scars)" (unspecified if ongoing); "Alcohol" (ongoing), notes: It has happened every time she drank alcohol. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Time: 02:15AM, Anatomical location: Right arm, lot number: EW0164), administration date: 14Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Headache"; DEHYDRATION (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Dehydrated"; PALPITATIONS (non-serious) with onset 15May2021 04:30, outcome "recovered with sequelae" (2021), described as "Heart palpitations". Therapeutic measures were not taken as a result of headache, dehydration, palpitations.  Additional information: It was reported that when patient drank alcohol she woked up between 4-5 AM next morning with headache, dehydrated and heart palpitations. It had happened every time when she drank alcohol. 1 glass of white wine (15May2021 & 22May2021),1 gin tonic (01Jun2021). The facility where the most recent COVID-19 vaccine was administered was other. The patient had not been received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Bexsero administered instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received Men B NVS (Bexsero) (batch number 94BS5, expiry date 31-MAR-2024) for prophylaxis.   On 09-MAR-2023, the patient received Bexsero. On 09-MAR-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero administered instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAR-2023 The reporter reported that the patient was supposed to receive a dose of Menveo but received Bexsero vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The reporter reported that, they were intending to administer Menveo and inadvertently administered Bexsero instead of Menveo, which led to wrong vaccine administered.
Initial report was received from a healthcare professional on 11 November 2011. A currently 12-month-old male patient had received at 2-months-old an Intramuscular (IM) injection of PENTACEL (lot number C3640BA invalid) in left thigh, PREVNAR in right thigh and ROTATEQ oral on 09 December 2010. On the same day of the injection, the patient experienced screaming for two hours, abdominal distention, rigidity day, temperature "102" and fussiness for several days. The patient had no bowel obstruction; however he had a minor cold symptom at the time of vaccination. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Follow-up information was received from a health care professional on 12 March 2012. It was the patient's first dose of PENTACEL, PREVNAR and ROTATEQ. The patient recovered on 10 December 2010. No additional information was available at the time of the report. Documents held by sender: None.
Sore throat; Stuffy nose; Low grade fever; Headache; Tiredness; This spontaneous case was received on 29-Sep-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-02815) and concerned a 25-year-old, male patient.   The patient's medical history and concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced low grade fever, headache, sore throat, stuffy nose, and tiredness.   The outcome of all events was unknown.  The reporter assessed the events to be related to Flucelvax Quadrivalent vaccine. As reported, the patient experienced adverse reactions after receiving Flucelvax Quadrivalent vaccine.  Company comment: A 25-year-old male patient was vaccinated with Flucelvax Quadrivalent. After unknown amount of time, the patient experienced oropharyngeal pain, nasal congestion, pyrexia, headache and fatigue. Patient's medical history, concomitant medication and relevant diagnostic findings were not provided. Considering limited information provided, lack of information regarding vaccination date, events onset dates, and unclear temporal relationship, causality of the suspect vaccine is unassessable.; Reporter's Comments: The reporter assessed the events to be related to Flucelvax Quadrivalent vaccine. As reported, the patient experienced adverse reactions after receiving Flucelvax Quadrivalent vaccine.; Sender's Comments: A 25-year-old male patient was vaccinated with Flucelvax Quadrivalent. After unknown amount of time, the patient experienced oropharyngeal pain, nasal congestion, pyrexia, headache and fatigue. Patient's medical history, concomitant medication and relevant diagnostic findings were not provided. Considering limited information provided, lack of information regarding vaccination date, events onset dates, and unclear temporal relationship, causality of the suspect vaccine is unassessable.
This case was reported by a consumer and described the occurrence of fussy in a 4-month-old female subject who was vaccinated with Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent vaccination included Haemophilius influenzae type b vaccine; Aventis given on 3 May 2007 and 24 July 2007; pneumococcal vaccine, unspecified; given on 3 May 2007 and 24 July 2007.  On 3 May 2007 and 24 July 2007 the subject received 1st dose and 2nd dose of Pediarix (.5 ml, unknown).  Less than one day after vaccination with Pediarix, the subject experienced fussy and not being oneself.  The events resolved at an unspecified time.  Following vaccination with Pediarix on 24 Aug 2007, the six-month old subject also experienced not being oneself, screaming without control, excessive sleep and fever.  At the time of reporting the events were improved.
On Tuesday, 12/19/00, pt suddenly felt weak, cold, sweaty, myalgias, arthralgias and shortness of breath with deep inspiration. Also light-headed. Pt saw NP on Thursday, 12/22/00 and started ibuprofen and ice for her swelling and red, sub-deltoid of right arm which was 9cm X 9cm in redness. In the process of recovering.
had a mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tozinameran (Covid 19 Vaccine Pfizer) for covid-19 prophylaxis.   Concomitant products included tozinameran (Covid 19 Vaccine Pfizer).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, the patient started Covid 19 Vaccine Pfizer at an unknown dose and frequency. On 1st April 2021, between 4 and 5 months after receiving Shingrix, the patient experienced shingles. The action taken with Covid 19 Vaccine Pfizer was unknown. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 72 or 73 years. The patient got both Pfizer COVID-19 shots in March 2021. It was unknown if the reporter considered the shingles to be related to Covid 19 Vaccine Pfizer. The patient experienced mild case of Shingles after Shingrix vaccination. The patient recovered from above event. The patient did not receive the second Shingrix shot but was still within timeframe for second shot. The patient did not consent to follow up.
Began about 6PM cried; Sight of DTP inject became red & hard, was swollen, couldn't touch & wouldn't eat; T103 & APAP was given; slept fitfully, cry was normal; Called MD advised to watch carefully & give APAP;
Patient given their vaccinations. Pt left exam room and when reached front of clinic, felt faint, no LOC, no vomiting. Vital signs initially HR 64, pulse ox 100%, BP 100/62. Pt seated, given blow by O2 and status improved.
Information has been received from a pharmacy student concerning a 22 year old female patient who on an unspecified date was vaccinated with her first dose of GARDASIL (lot number unknown) and subsequently tested positive for HPV. The patient sought unspecified medical attention. At the time of report, the patient had no recovered. No further information is available.
mom states approx 1 hr p/vax started a high pitched cry which cont until 630PM; @ that time pt was taken to PMD to be ck'd; MD stated it was a rxn to DTP & gave prescription for DT for further;
This spontaneous report was received from a registered nurse and refers to a 24-year-old female patient.  The patient had none pertinent medical history, none drug reactions or allergies. The patient's concomitant therapies included levothyroxine sodium(manufacturer unknown). On 28-AUG-2017, the patient was vaccinated with the first dose of VAQTA 50/1.0 U/ml strength, intramuscularly, lot number N005796 with expiration date 26-MAY-2018, (dose and anatomical location were not reported) for Hepatits A Vaccination. On the same date, the patient was vaccinated with a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine, intramuscularly, lot number U5110AA (dose, anatomical location and expiration date were not reported) for prophylaxis. The illness at the time of the vaccination was reported as flu and unspecified thyroid disorder. On 28-SEP-2017 (also reported as October 2017), the patient experienced abdominal pain and loose stools for 3 weeks (diarrhoea).  The patient was seen by the doctor and was diagnosed with Hepatitis A on unspecified date in 2017. Health department traced exposure to hepatitis A at the end of August 2017. On 07-NOV-2017, an Hepatitis A antibody  IgM was performed which result was positive (hepatitis a antibody positive). No treatment was given for the events. At the time of the report, the patient was recovering from the abdominal pain and diarrhea. The outcome of the hepatitis a antibody positive and hepatitis a was unknown. The relatedness between the events and therapy with VAQTA  and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine was not reported.
Approximately 1/2 inch lump above left collarbone and is sore to the touch
Patient passed out after vaccination. Blacked out for a moment and very sweaty then came back to consciousness. They had stated that they have passed out before when donating blood and that they had not eaten anything for breakfast today before hand.
Received partial dose as the vaccinator accidentally withdrew the syringe before injecting the vaccine, and some dripped out before the vaccinator reinserted the same  needle/syringe and injected the rest of the contents.  Next day patient reported weakness in that arm--difficulty moving without assistance from other arm.
Pt admitted for left hip pain and dyspnea.  Pt was tested for COVID prior to admission to rehab facility and tested positive.
neck/shoulder pain; Extreme pain in left arm for over 3 months now; neck/shoulder pain; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program and medical information team. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number En6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history included coronary artery disease and COVID. Concomitant medications included metoprolol tartrate; metoprolol tartrate (LOPRESSOR); acetylsalicylic acid (ASPIRIN) and niacin taken in two weeks prior vaccination. It was unknown if patient received any other vaccine in four weeks. The patient was not tested COVID post vaccination On 01Mar2021, patient experienced neck/shoulder pain, extreme pain in left arm for over 3 months now. The patient went to Physician Office due to the events. No treatment was given for the events. The outcome for the events was not recovered.
scheduled to be delivered on 5/31/19. Caller stated they didnt get the vaccine until 6/4/19. Caller stated when they; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 20 patient with (with unknown demographic) who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. it was reported that Menactra was scheduled to be delivered on 5/31/19. Caller stated they didnt get the vaccine until 6/4/19. Caller stated when they opened ice packs were in the container but it was not frozen.  At the time of reporting, no adverse reaction was reported.  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 in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.   Information on the batch number was requested.  List of documents held by sender: none.
About 10 minutes after receiving first dose started feeling short, quick pulses of pain coursing through my arm down to my wrist. Later same night I felt same pains throbbing through left leg. I took a baby aspirin in fear it was blood clot related and symptom calmed down a little but still feel occasionally in same places next day less than 24 hours after receiving first dose. Mentioned to Pharmacist who referred me to this website.
was only injected the adjuvant component of Shingrix; was only injected the adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, patient was only injected the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patient's identifiers provided. No lot number and expiration date provided. No adverse event was reported. The reporter did not consent to follow up. This case was linked with case US2019086074, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019086074:Same reporter
fever, body aches, muscle cramping, left arm and hand numbness, shaking, loss of bladder control multiple times
Light spotting (bleeding), which was unusual for me because I have an IUD and have not had periods since it was inserted in 2017, which is consistent from when I previous use of an IUD from 2014-2015(16?). Both instances have been Mirena.  Spotting continues as I am completing this form. I am not seeking medical attention or reporting this to a physician at this time (unless severe adverse conditions present).
55m x 110mm redness, swelling, heat @ site of inject; shot administered on 30JUN excessive swelling & soreness upon rising today;
Symptoms starting roughly 10 hours after vaccine, and lasting for 18-24 hours: High fever, chills, intense body ache, joint pain (to the point of not being able to move), fatigue, headache, vomiting,  diarrhea, abdominal pain, weakness/fainting
MORE SWELLING; PAIN IN ALL JOINTS SPECIALLY IN HANDS AND THE LEFT SIDE UNDER SCAPULA (LOTS OF PAIN THAT COMES AND GOES); PAIN IN HANDS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bee stings allergy, arthritis, egg yoke allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the patient experienced more swelling. On 25-JUL-2021, the patient experienced pain in all joints specially in hands and the left side under scapula (lots of pain that comes and goes). On 25-JUL-2021, the patient experienced pain in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in all joints specially in hands and the left side under scapula (lots of pain that comes and goes), more swelling, and pain in hands. This report was non-serious.
Had inflammation around his heart; Had bad nerve pain from head to toes; Felt terrible from head to toes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Had inflammation around his heart) in a male patient of an unknown age 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 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 PERICARDITIS (Had inflammation around his heart) (seriousness criterion medically significant), NEURALGIA (Had bad nerve pain from head to toes) and FEELING ABNORMAL (Felt terrible from head to toes). At the time of the report, PERICARDITIS (Had inflammation around his heart), NEURALGIA (Had bad nerve pain from head to toes) and FEELING ABNORMAL (Felt terrible from head to toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.  It was reported that the patient was a pharmacist and experienced side effects that were really bad. Treatment information was not provided.  Company Comment This case concerns a patient of an unknown age with no previous relevant medical history reported. The event occurred on an unknown date after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Very limited information regarding this event has been provided at this time. Clinical course with diagnostic workup and treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age with no previous relevant medical history reported. The event occurred on an unknown date after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Very limited information regarding this event has been provided at this time. Clinical course with diagnostic workup and treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Fatigue Painful arm- both to touch and w/ mobility Unable to lift arm w/o extreme pain Swelling- localized at inj site Warmth- at inj site Numbness (minimal) in L hand Hand- slight redness
21 yo female with fever 100.8, vomiting and diarrhea about 4-5 hours after administration of first HPV (Gardasil) shot. Patient recovered within 24 hours.
About 40 mins after the first dose, I started itching all over my chest up my neck to my nose. Both cheeks of my face were very red and warm-to-touch. Severe fatigue immediately hit me. By the morning when I woke up, I had throat swelling with bumps all over the back of my tongue that almost looked like raised blisters. Throat felt irritated like it was swollen.
I began to have several very severe nose bleeds starting Saturday and into Sunday night.  It was nothing I had ever experienced.  It took 30 minutes to an hour to get them to stop.  Then it would randomly start again.  Just sitting quietly and it would start again.  I am hoping they do not continue into today.  I have had one real nose bleed in my life and it was a broken nose.  These were as bad if not worse than the broken nose.  During the time when I was trying to stop them, huge clots would form but they would just fill the gap and the blood would drain out the other side or down my throat and into my mouth.  Soon the clots would get a little smaller and finally After getting the clots all out it would finally subside.
Redness and swelling at the injection site, extending to a 3 inch diameter and is itchy and warm to the touch. Self care, applying cold compresses and topical analgesic Benadryl (Diphenhydramine HCl 2%, zinc acetate 0.1%) Continues to be itchy. This occurred with my prior Moderna vaccine booster on 6/8/2022 and lasted about 8-10 days. I expect a similar experience this time.
I had an extreme reaction with sever Flu like symptoms - light/sound sensitive, front headach, total body achs sore - high Fever, chills, sweating on 2nd day.
Allergic reaction at the  left deltoid injection site one week after receiving the Shingrix vaccination. Shingrix lot #9EY93, 0.5 ml volume.
NOTE - Paresthesia started before vaccine, weakness started after vaccine. Feet numbness started on 10Feb10, and spread to ankles and fingertips. Evaluated 11Feb10 by health care provider, was given influenza vaccine at this visit of 11 Feb 10. Developed trouble walking on 12 Feb 10 and had hand weakness on 2/12/10. Admitted for treatment of GUILLAIN BARRE syndrome on 2-14-2010.