chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the morning after the 2nd dose had Fever 104.2 F; heart rate 126; vomiting; fatigue; mottled/bluish fingers and lips; mottled/bluish fingers and lips; This is a spontaneous report from a contactable consumer (patient). A 12-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via an unspecified route of administration, administered in Right arm on 04Jun2021 13:15 at the age of 12-years-old as dose 2, single for covid-19 immunisation. Medical history included Von Willebrand Disease from an unknown date. The patient had no known allergies. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in Right arm on 14May2021 13:00 at the age of 12-years-old as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 05Jun2021 at 06:00, in the morning the patient experienced after the 2nd dose had Fever 104.2 F, heart rate 126, vomiting, fatigue and mottled/bluish fingers and lips. Adverse events resulted in Emergency room/department or urgent care. The patient received treatment for adverse events with IV fluids. The patient underwent lab tests and procedures which included heart rate: 126 on 05Jun2021, fever (Body temperature): 104.2 fahrenheit fever on 05Jun2021, Applied biosystems 7500 real-time PCR (Nasal Swab) (sars-cov-2 test): negative on 03Jun2021. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
After the first dose, she just had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the first dose, she just had a sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Clotting disorder.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, 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 experienced PAIN IN EXTREMITY (After the first dose, she just had a sore arm). At the time of the report, PAIN IN EXTREMITY (After the first dose, she just had a sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-073670 (Patient Link).
ALLERGIC REACTION SEVERE RESPIRATORY SYMDROME ,ERYTHEMATOUS DESQUAMINATING LESIONS FACE, NECK, SOME PAPULES ON FOREARMS.
administered an expired TENIVAC to a patient with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 76 years old and unknown gender patient who was administered an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jul-2023, the patient received 0.5 mL dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (batch number: U7092AA; Expiry date: 24-Jun-2023) via unknown route in unknown administration site for Immunization, with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired tenivac to a patient with no reported 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 in the 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.; Sender's Comments:  US-SA-2023SA228200:
I received my injection from my car and in my left arm at 9:35am. At 9:41, I noted that my lips began to feel tingly. About a minute later, at 9:36am, my teeth and the tip of my tongue felt like they were tingling. Around 9:50, the larynx area of my throat was mildly numb/tingly. At 9:58am, my ears felt a little plugged and I was feeling slightly lightheaded. At 10:04am, I noted my toes were feeling 'pins and needles'.   Sore throat mid afternoon, lasted a couple hours.  Pain in jaw and behind ears late afternoon. Headache. Still persisting as of 3/18/21 10:23am
Information has been received from the authors as stated above in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficency or recurrent infections in all three cases. This case refers to a male patient of unknown age. The patient had no history of immunodeficency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2013, the patient was vaccinated with sixth dose of MMR II (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in May 2014, MMR titers were measured with the results showed positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on an unspecified date in June 2014. Vaccination failure was reported. On an unspecified date his serum CD3/CD4/CD8/B & T cell counts were normal. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR II (manufacturer unknown). This report is linked to MARRS # 1603USA003154 and #1604USA004010 (same literature link). A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Body aches, lethargy, fever, headache. Treated with Tylenol. Symptoms preset for 24 hours.
Level 5 pain immediately after the first shot which subsided to level 3 in 2 weeks. The level 3 pain persisted for several months. I consulted a doctor and she prescribed a steroid treatment that was ineffective. Further examination revealed a severe deltoid muscle seizure. I'm currently in PT to try to resolve the problem. It has caused a lot of pain over the months and restricted my ability to work.
Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL on an unspecified date. The patient fainted after receiving a dose of GARDASIL. The patient had sought unknown medical attention. At the time of report the patient's status was recovered. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 3rd dose of TWINRIX (unknown). The subject had received TWINRIX according to the accelerated schedule. At an unspecified time after completing the 3 dose series of TWINRIX, the subject was found to have not seroconverted. No additional information was provided. It was reported that this event occurred in two students. There were no patient identifiers.
raised area approximately 5 inches in diameter; Large red area at injection site 5 inches in diameter; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: raised area approximately 5 inches in diameter) and injection site erythema (Verbatim: Large red area at injection site 5 inches in diameter). The outcome of the extensive swelling of vaccinated limb and injection site erythema were resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.   It was unknown if the company considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter asked if she should get her 2nd Shingrix dose. She reported that following her first dose in March 2023 she had a red, raised area approximately 5 inches in diameter that lasted 2 to 3 weeks. The patient did not have the doctor's contact information.  The reporter tried a quick internet search but found nothing. The reporter consented to follow up.
Numbness in both legs escalating upwards to her waist and hands; Tingling in both legs escalating upwards to her waist and hands; driving crazy; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands), PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands) and FEELING ABNORMAL (driving crazy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy -Hives). Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands) and PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands). In December 2021, the patient experienced FEELING ABNORMAL (driving crazy). At the time of the report, HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands), PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands) and FEELING ABNORMAL (driving crazy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2022, Blood test: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller stated approximately 20 or 30 minutes after receiving the Moderna injection, patients started to experience events.  Patient reported she did not receive the second Moderna COVID-19 dose due to the numbness and tingling. Patient went to see her primary care physician. patient went to see a neurologist on 17-Feb-2022 and reported that the neurologist tested for nerve damage, and the results were normal. patient had a flu vaccine every year and never had any problems with the flu vaccine. patient mentioned the numbness and tingling was ongoing and constant each day. The symptoms worsened. No treatment medications reported.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks 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 case was reported by the patient's neighbor. The age at vaccination was not reported. The patient received Shingles vaccine last year from the date of reporting. For the tolerance of other Shingles vaccine booster dose, refer linked case US2021AMR186113.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186113:same patient/ same reporter
Rash on my legs, right arm where put the vaccine and it itches and it does not want to go away; Rash on my legs; Rash on right arm where put the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Reported stated "I had received vaccine (unspecified vaccine) of yours (Pfizer) back on 21Mar2021 and for the past week I had not the first week but the following week in 2021, I have been having a rash on my legs, my right arm where put the vaccine and it itches and it does not want to go away and I have been calling you people, my doctor said to call Pfizer, find may be about sort of side effect or maybe you have to hold on for the second shot and my second shot is next week, so what can you tell me, what can you do for me Is this going on for week and half this rash on my arm" The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On April 3 I received my first dose of Janssen vaccine and the vaccinator showed me the amount she was going to inject into me, it was very little, just two lines on the cylinder of the syringe. The next morning I woke up at 0400 and felt fine.  I went to the bathroom and returned to bed and fell asleep until 0800 when I woke up and felt sick.  By 1000 I was feeling better so I continued on with my daily affairs.  On October 29 I received my Janssen Booster.  The vaccinator did not show me how much he was giving me but he told me he was giving me the same dose as I received the last time.  But when he injected it I could tell he gave me A LOT more, the muscle in my arm where he injected it "blew up" from all of the fluid hi injected, and it was a different type of syringe, that made a loud clicking noise.   I know I got a much higher dose from the booster than the original.  I was sitting in bay number 5  when this happenned. Call me for the rest I'm about to timeout.  Stupid computer system.
I received the J&J COVID-19 vaccine, within minutes, I passed out. While unconscious, I hit my head on the pavement, resulting in a laceration across my right eye-brow requiring 10 stitches.
Caller says both she and her daughter were tired and had arm pain after getting the Pfizer COVID-19 vaccine; Caller says both she and her daughter were tired and had arm pain after getting the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable consumer (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller said both she and her daughter were tired and had arm pain after getting the Pfizer COVID-19 vaccine, it was funny. She said it was just a thought like was this a side effect. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Information has been received from a physician concerning a male between 12 and 15 years of age with obesity and another male (WAES#0804USA03682) who in 2008 was vaccinated SC with his second dose of VARIVAX (Merck). Suspect vaccinations administered within the same visit included a dose of MENACTRA and a dose of DTAP. In 2008, within the last couple of months, the patient developed severe swelling at the injection site and rash cleared on its own and the patient recovered. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
nausea; slight dizziness; muscle pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received 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 05Mar2021 as single for covid-19 immunisation. The patient's medical history and concomitant medication were was not reported. After receiving the first dose, after 21 hours he experienced nausea, slight dizziness and muscle pain on an unspecified date on Mar2021. The patient wanted to know if he can get the 2nd dose of the vaccine due to these symptoms The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Around 3pm, had notable arm soreness.  Around 9pm, started having very mild myalgias and mild chills.    Overnight, I was awake with sweats and chills, max oral thermometer temperature 101.0.  Had moderate myalgias, polyarticular arthralgia (left knee,  left ankle), holocranial headache, and pulsatile tinnitus.  Got very little sleep. Pertinent negatives: no nausea/vomiting/diarrhea Alleviators:  acetaminophen x 2 tabs -- > defervesced, some improvement in myalgias and headache  On 1/26, had ongoing myalgias, polyarthritis, headache, fatigue, anorexia.  Took the day off from work.  Noticed symptoms improving ~2pm.  All symptoms aside from arm soreness had almost entirely resolved by ~5:15pm.
This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received BOOSTRIX (unknown) on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included incorrect storage of drug. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included incorrect storage of drug (unknown). The pregnancy was ongoing. Additional information received on 05 December 2014: The vaccine may have been improperly stored. The due date, the gestational exposure and the last menstrual period were not reported. This is one of the 3 cases reported by the same reporter for the same vaccine.
a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19; A spontaneous report was received from a consumer who was a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19 (vaccine complication).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of symptoms, the patient received her first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient reported that she had a series of adverse reactions "that have already been reported to the CDC."  She stated that many of these symptoms overlapped with symptoms of COVID-19. She did not specify the symptoms she had.  The patient was "fairly confident" that her symptoms were related to the vaccine.  She had been testing negative on days when she came into the office.    No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Wrong age range, dose of Infanrix was given outside of the recommended range; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa (Infanrix) (batch number 5RM39) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age range, dose of Infanrix was given outside of the recommended range). The outcome of the inappropriate age at vaccine administration 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: 30-MAY-2023 An anonymous healthcare professional called in to request information about the lot number of a vaccine. The reporter declined to give any information and briefly mentioned that a dose of Infanrix was given outside of the recommended range, but they hung up before anything else could be said. The patient received a dose of vaccine than the recommended age, which lead to Inappropriate age at vaccine administration.
Client came to clinic for dose #2 and during  screening mentioned she had been diagnosed with Bell's Palsy on /22/21.  Client reports on 1/22/21 she had paralysis on R side of face, R eye would not open or close, pain and swelling on R side of face. Client also reported taste was altered on R side of mouth.  All symptoms resolved 2/1/21.  Per consultation with Medical Director, dose #2 was not given.
Developed abscess @ site of injection about 1 week post vaccine (she was the first of  2 recent patients who had infection @ site of injection. Our policies and personnel have not changed and we never had this happen in the past.)