chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient wants to know if she should take the second dose of the Pfizer COVID-19 vaccine after the side effects that she developed, she received the first dose of the Pfizer COVID-19 vaccine on March 26th and was supposed to get the second dose on April 16th but she chose not to get it as she developed vertigo 6 days after the first dose and the side effect is continuous since the past couple of weeks, she mentioned that she has allergies towards some medications and she tends to develop dizziness as an allergy symptom and she does not want to develop a reaction that she might not be able to handle, this concerns her moving forward with the second dose of the vaccine. On 06 April 2021 she received response saying, Nausea is reported as a side effect of the medication, no reports of vertigo, dizziness is described as part of a possible severe allergic reaction to the vaccine. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. According to information of the CDC these reactions could be normal signs that your body is building protection and should go away in a few days. Patient wants to know the efficacy of the Pfizer COVID-19 vaccine after a single dose and also wants to know if a booster for the other COVID-19 variants (i.e a third dose) will be needed in 6 months. Responded as there is limited data of the efficacy of the vaccine after a single dose, efficacy data started to get collected 7 days after the second dose with a 95% efficacy rate. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. Patient wants to know what is the longest time that she could wait to receive the second dose of the COVID-19 vaccine. Responded as a second dose 6 weeks or 42 days after the first dose is still considered valid. The recommendation is to take the second dose as close as possible to the 3week time period. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered VARIVAX (Merck) (dose, route, lot number and expiration date were not reported) and TD had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Wrong dose of Moderna COVID Bivalent vaccine was given on 10/14/2022 at 0.25mL instead of the 0.5mL (As146B). Another 0.25mL was given today 10/27/2022 (061F22A)
2/25 - loss of taste 2/26 - dizziness/woozy, severe flu like symptoms all day (no energy, ache) 2/27 - continuing dizziness, minimal energy 2/28 - continuing dizziness, wheezing/trouble catching breath (needed oxygen to calm)
Left side body stiffness; (joint pain) all over the left side of his body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Enlarged prostate. Concomitant products included TAMSULOSIN for Enlarged prostate.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Left side body stiffness) and ARTHRALGIA ((joint pain) all over the left side of his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Eczematous rash on hands/feet 2 days after vaccine - no previous similar rash - Treated w/hydrocortisone 1% cream BID -> resolved.
VIOLENTLY ILL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, administered for prophylactic vaccination. No adverse events were reported (dose number in series 1). The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that the effects of the booster (dose number in series 2) were more than the primary vaccination (dose number in series 1). On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient was violently ill (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill was unknown. This report was non-serious. This case, from the same reporter is linked to 20211233585.
DId not find details on packaging or our toolkit indicating that this was for booster doses only, until after administered
This spontaneous report as received from an office manager for a physician vaccine practice via company representative refers to an unknown number of male patients. No concurrent conditions or medical history were reported. On unspecified dates between September 2015 and March 2016, an unspecified number of male patients all under the age of 18 years were inadvertently administered with subcutaneous doses of improperly stored VARIVAX lot# K011182; exp. date: 08-AUG-2016 or K011184; exp date: 16-AUG-2016 (dose not provided). Concomitant therapy was not reported. Office manager could not specify how many patients received vaccine from each lot. No adverse effects or PQC were reported. This is one of two cases from the same reporter (MARRS# 1607USA009540). Additional information is not expected because there is no consent to contact the physician.
Three days after receving the Moderna Bivalent vaccine, I developed severe tinnitus in my right ear.
Diarrhea; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Slight headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Slight headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Within 10 hours of receiving the first vaccine I had a robust reaction with a high fever that resolved within 24 hours.  On 3/12 /21 I got symptoms of Shingles.  It was at the same site as a previous bout in 2019.  It did not develop beyond pain and high fever and lasted 3-5 days.  I  got but one shingles blister at the site.  I still have a very slight pain at the shingles site rated at 1/10 on pain scale.   I suspect that the shingles reaction  was triggered by the Covid shot.  I am aware that if one searches the internet hard enough one will find the answer one seeks.  Sure enough I found a newspaper article written by a dermatologist in LA that wondered if there is a link between Covid vaccine and shingles.  He had treated 2 patients in a timeframe that suggested this link.  There is no research available on this.  I am a little concerned about getting the second Covid vaccine as it typically provokes a stronger immune system response than the first one.  I believe that I had Covid-19 in July with typical symptoms but I tested negative.  They say that the first Covid vaccine can cause a greater reaction if one has already had the Covid virus. I am hoping that this is the case and my second vaccine will provoke a milder reaction.
This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included COVID-19, and concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient otherwise healthy. The patient had no known allergies.The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 16-JUN-2021, the subject experienced strong chills. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong chills on 16-JUN-2021. This report was non-serious.
Patient face became flushed, lips got tingly and numb, then tongue felt tingly and numb. Patient has been able to eat drink and swallow. She also reports feeling nauseous
A non-serious spontaneous report of administered a dose of H1N1 within three days to one week was received from a physician concerning four children, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for these patients. The patients received the vaccine on an unspecified dates in year 2009 for immunization. There was no adverse event associated with this medication error; therefore, treatment and report causality assessments are not applicable and the event is considered resolved.
Severe "Open Wound" like feeling on full right side of body above knees with very strong "sore" like feeling near collar bone. Severe Chills and shaking with that, fever that reached 102.  General unable to work or do much without multiple med routine of Advil Tylenol.   I had just started a pill of 2.5 mg of Crestor same day, take 112 mg of Synthroid, Zyrtec, and two baby aspirin daily.  Generally healthy professional.   Not overweight.
On an unknown date, 1 day post vax, the child developed conjunctivitis with discharge, cracked lips, a swollen face, friable skin on face and diaper area that was detached when couched. The child was hospitalized. Eyelid culture was positive for branhamella catarrhalis, staphylococcus aureus and streptococcus pneumoniae after onset of rash. Acetaminophen was given after the onset of the rash. This case was classified by the authors as a probable Stevens-Johnson syndrome toxic epidermal necrolysis.  A follow up report received 9/5/2002 adds: The authors made the following comments: "For the one definite and five probable case, 2 features support a causal relationship between vaccination and SJS/TEN. First the pts did not have evidence of an acute illness and were not taking other medications at the time of vaccination, reducing the chance the rash was caused by another etiology. Second the timing of the onset of symptoms and the diagnosis of SJS/TEN after vaccination is consistent with the published literature on SJS and TEN after medication and infection." Nevertheless, they mentioned that a causal link between SJS/TEN and vaccination could not be established by this study for different reasons (see article for more info).
MUSCLE ACHES, CHILLS, NAUSEA, PAIN IN ARM - RADIATING TO NECK AND SHOULDER AREAS. RESULTED IN SICK LEAVE FROM WORK AND A PHONE CONSULT WITH PHYSICIAN'S OFFICE. PATIENT TO REPORT TO CLINIC OR HOSPITAL IF SYMPTOMS WORSEN OR RASH DEVELOPS.
Information has been received from a healthcare worker concerning a 58 year old female with allergy to VICODIN and MINOCIN who on 21-JAN-2009 was vaccinated IM with the first dose of PNEUMOVAX 23, 0.5ML (lot# 659922/1667U). Concomitant therapy included influenza virus vaccine (manufacturer unspecified), ZANTAC, VENTOLIN, SYMBICORT, RESTORIL, PREMARIN, NASONEX, CENTRUM, and ACIDOPHILUS. On 21-Jan-2009 the patient developed arm pain, swelling and redness at the injection site. Subsequently, the patient recovered from arm pain, swelling at the injection site and redness at the injection site. The patient sought medical attention in the office. The reporter considered arm pain, swelling and redness at the injection site to be disabling. This is one of several reports from the same source. Additional information has been requested.
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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 21Feb2021 as dose 2, single (Lot number: EME201), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.
Diarrhea; Vomiting; Not feeling well; Headache; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nauseas) and VOMITING (Vomiting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well), HEADACHE (Headache) and NAUSEA (Nauseas). On 17-Apr-2021, the patient experienced VOMITING (Vomiting). On 19-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 19-Apr-2021, VOMITING (Vomiting) had resolved. At the time of the report, MALAISE (Not feeling well), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included medication for arthritis and fibromyalgia.  Treatment medication included Imodium and Pepto Bismol.
Pt recv vax on 10/28/98; 2 hr post vax pt exp red, warm vax site; pt imp 11/2/98
rash on back, trunk & couple of lesions on arm;has h/a, temp 100.2 on 16MAY rash started 15MAY97;8-10 lesions on body;crusted over returned to work 28MAY97;
Immediately had soreness in arm making it very difficult to drive home, and then symptoms worsened over the next 30 hours, or so.  Overall, the symptoms included exhaustion, muscle weakness, loss of appetite, severe dizziness, jolting pain in shoulders, neck, and , head, nasal congestion, and drastic temperature fluctuations (sweating to freezing, back and forth).  I was drinking lots of fluids, eating healthy foods (fruits and vegetables, soup, etc.), and eventually took some ibuprofen (about 26hrs after the injection) that significantly helped with the pain and dizziness.  I had fully recovered (aside from some minor lingering pain around the injection site for a few more days) by the next morning (~38hrs after the injection).
Myalgia; joint pain shoulder pain, hip pain; pain, warmth, redness at injection site.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 27-NOV-2015 at time- 21:45, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.1 and 1.9 (units unspecified). There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
The patient came to the pharmacy with local irritation, redness and swelling on her left arm.
Offender given 2nd dose 8 days after 1st dose.  Offender denies adverse reactions.
I was positive for COVID-19, I started feeling the symptom on 19JAN2023 I took a test and came back negative than on 23JAN2023. I was feeling lethargic, muscle ache, cough, headache and a mild fever. Contacted my doctor, and I didn't take the PAXLOVID. I was cleared on 31JAN2023, I feel pretty good now.
1 patient (P-8) having prolonged hospitalization but ultimately recovered; breakthrough SARS-CoV-2 infection; This is a literature report for the following literature source(s):  A 52-year-old male patient received BNT162b2 (BNT162B2), 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: "MDS" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Seasonal influenza vaccination, for immunization. The following information was reported: DRUG INEFFECTIVE (prolonged hospitalization, medically significant), outcome "recovered", described as "1 patient having prolonged hospitalization but ultimately recovered"; BREAKTHROUGH COVID-19 (prolonged hospitalization, medically significant), outcome "recovered", described as "breakthrough SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: IPSS-R/ELN/DIPSS: 2.5, notes: low; Unknown results; Karyotype analysis: normal; SARS-CoV-2 antibody test: Unknown results. Clinical details: The patient had documented breakthrough SARS-CoV-2 infection after 2 vaccine doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200798599 same article/drug and different patient/event
Information has been received from a physician concerning a male over the age of 65 who on Sept 20 2004 was vaccinates with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). On Sept 20 2004 the patient developed an injection site reaction. The reaction was described as a red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination had been at least 5 years previously and there had Been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation into the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649692/0371P) (WAES0409USA02427). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 648139/0009F) (WAES0409USA00219, WAES0409USA00780). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt. received SHINGRIX dose #1 on 5/11/18. On 5/12/18 noticed pain, redness, and saw PCP 5/16/18 for previously scheduled appt. Also examined by pt's daughter, an ER physician. Spoke to pt 5/21/18, still with some swelling/pain/itching at site, but resolving.
The patient received their first dose of Moderna COVID-19 vaccine on 04/01/2021; The patient returned Public Health's drive through vaccination clinic on 04/29/2021 to receive their second dose of the COVID-19 vaccine.  The nurse administering the vaccine to the patient asked the patient what vaccine they had received first and the patient informed the nurse they had Pfizer COVID-19 vaccine, the nurse then administered Pfizer COVID-19 vaccine to the patient  as that was the vaccine Public Health was providing that day for second doses.  The patient was inadvertently given the Pfizer COVID-19 vaccine instead of the Moderna COVID-19 vaccine for their second dose.  Therefore there was no adverse reaction to the COVID-19 vaccine, the patient was inadvertently given Pfizer COVID-19 vaccine instead of second dose being Moderna COVID-19 vaccine.
Some congestion in the back of the throat. No fever. Lasted about one week. I knew I was exposed. Took self test which was positive. Never went to doctor. Very mild symptoms.