chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A pain and intense pressure in her chest/ Chest pain; Extreme itching to the palm of her hand; runny nose; Some blotches on right hand; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 57 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0179, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 as a first dose, single dose for covid-19 immunisation. Medical history included mini strokes (wherein patient felt weird and dizzy prior to vaccine) from an unknown date and unknown if ongoing. Patient have an ongoing hernia, confirmed as popped up before the vaccine, they said she would need to have surgery, maybe in a couple of months. Patient had a family history of aneurysms. Concomitant medication included clopidogrel bisulfate (PLAVIX) at 75mg once a day by mouth  taken for mini strokes, from Apr2021 (also reported as started two days before the Covid vaccine), as patient had mini strokes that showed up on the MRI in Oct2020, wherein patient felt weird and dizzy prior to vaccine. She did start Plavix 2 weeks prior to the vaccine, she was unsure if they knew that she was on Plavix when she got her vaccine. On 10May2021, patient experienced a pain and intense pressure in her chest/ chest pain and she went to the ED on Monday morning (May2021), they did testing on her, and had to be admitted from 10May2021 to 11May2021, everything was negative. Chest pain was completely gone by Monday night. On 12May2021, patient had extreme itching to the palm of her hand. She was looking for information about a side effect she was experiencing and she stated her hands were itching, that she got the vaccine on 30Apr2021, itching started yesterday 12May2021, and stated every time she thinks its getting better it starts up again and it was intense itching, that saw some blotches on right hand creeping up (2021), they did subside and the itching continued. She also noticed a runny nose, started Tuesday (11May2021), and seemed to be coinciding with the itchy hands states it was persisting. The patient recovered from chest pain on 10May2021 but had not recovered from runny nose and extreme itching to the palm of her hand. The outcome of the event some blotches on right hand was unknown.   No follow-up attempts are needed. No further information is expected.
I HAD HEADACHE FOR TWO WEEKS LIKE A SINUS HEADACHE, I HAD A WELP ON MY FOREHEAD, NOSE, AND A SORE IRRITATED AND BLOODSHOT EYE (LEFT). STILL RED AS OF TODAY.
Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). The physician reported that the patient was on GARDASIL regimen and experienced memory loss. The patient was working with their healthcare provider to address the situation. At the time of the report the patient's outcome was unknown. It has been determined that case #1203USA02733 is duplicate of case #1203USA02625. Therefore, case #1203USA02733 is being deleted from our files and the cases consolidated into case #1203USA02625. Additional information is not expected.
Currently, on 01112022, area has a rash, small bumps; Currently, on 01112022, area has a rash, small bumps; Itching and burning at injection site during second vaccination; Itching and burning at injection site during second vaccination; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Dec2021 (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: avocado, kiwi. Concomitant medications were not reported. Past drug history included: Ceftin, reaction: "Drug allergy", notes: Known allergies: Ceftin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 02Dec2021, when the patient was 41 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 23Dec2021, outcome "not recovered", and all described as "Itching and burning at injection site during second vaccination"; VACCINATION SITE RASH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 11Jan2022, outcome "not recovered", and all described as "Currently, on 01112022, area has a rash, small bumps". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash and vaccination site mass.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever, chills developed 10/23 AM, sought care in ER on 10/24 AM. Fever, earache, constipation developed 10/25, seen @ primary care clinic on 10/25 @ 1600. Mom reports sxs continued till 10/30 PM.
Side effects (pretty long term); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects (pretty long term)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects (pretty long term)). At the time of the report, VACCINATION COMPLICATION (Side effects (pretty long term)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Chills; Exhaustion; Stiff neck; Abdominal cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 27Feb2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and allergy to opioids. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN), valaciclovir (VALACYCLOVIR), vitamin d nos (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN) and ascorbic acid, copper, zinc, xantofyl, zeaxanthin, vitamin e nos (AREDS 2). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 14:30, the patient experienced chills, exhaustion, stiff neck, abdominal cramps, and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, exhaustion, stiff neck, abdominal cramps and diarrhea was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
severe headache; This is a spontaneous report from a contactable Consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021 patient stated that she started experiencing a severe headache on Saturday after receiving the vaccine and still had this severe headache. The headache was worse when she was standing up and feels a little better when she was lying down. She wants to know if this was a normal side effect after receiving the Pfizer COVID-19 vaccine and how long it was going to last. patient had not spoken with her HCP about these symptoms yet. She also states that her boyfriend received the first dose of the Pfizer COVID-19 vaccine on the same day and he has not had any adverse reactions after receiving his vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
This spontaneous prospective pregnancy report as received from a physician refers to a 13 year old female patient. No medical history or concurrent conditions were reported. The patient was vaccinated with GARDASIL (dosage, frequency and route of administration were not reported) on the following dates: 22-JUN-2011 (lot # and expiry date were not reported), 27-JUN-2012 (lot # and expiry date were not reported) and 03-DEC-2015 (lot # K008931 and expiry date of 04-MAR-2017) (inappropriate schedule of drug administration). On an unknown date, the patient became pregnant with a Last Menstrual Period (LMP) of 15-NOV-2015 and an Estimated Date of Delivery (EDD) of 21-AUG-2016. The pregnancy outcome was pending. On 03-DEC-2015, the patient denied sexual activity and hence a pregnancy test was not performed. The patient had not reported any adverse effects. Additional information has been requested.
Shivering, fever, body aches, pain in upper body, left elbow painful. I also had a more severe reoccurrence on Oct. 26, 2018, lasting about 6 hours. Second occurrence worse than first. I notified my Dr. of these side effects. I received this vaccination at Pharmacy. I do not know the lot number of the vaccination.
received four doses of dtap as an infant, but hasn't had anything since, with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 years old female patient who received four doses of dtap (diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]) as an infant, but hasn't had anything since, with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   It was reported, the patient received four doses (4 DF) of dtap (diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]) suspension for injection as an infant (batch/lot number, expiry date, strength, dose and route: not reported for all doses) in unknown administration site for immunization, but hasn't had anything since, with no reported adverse event (incomplete course of vaccination) (unknown latency).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Vaccine given 8/1/16. Parent reported 8/3/16 that on 8/2/16 child c/o arm hurting. Parent observed redness, warmth, swelling shoulder to elbow and 4 thin, watery blisters on shoulder.
Zoster conjunctivitis, rash, fever, swollen legs, neuritis, neuralgia, tenosynovitis, rotator tear, recurrent papules and sequential monthly eruptions with myalgia, joint pain, exhaustion, symptoms continue.
5/24/21- 5/27/21 - Tightness in chest, nausea, low grade fever, headache, fatigue 5/27/21-5/29/21 - fatigue but able to work 3-4 hour shifts at work 5/30/21-6/4/21 - heavy chest pressure, shortness of breath,  fatigue, heart palpitations periodically, ears buzzing loudly/knocking sensation in head 6/4/21 - Went to Dr and she sent me to lab for CT Scan/ Angiogram to check for blood clot told to go to ER if it worsened. 6/7/21 - Tighness of chest and shortness of breath, heart palpitations Went to ER.  Released me with nothing found wrong 6/8/21 - had appointment with Cardiologist Dr.  Prescribed Arythozmiasin, Steroids and anti anxiety meds.  told to go to ER if they symptoms return or worsen.  6/10/21 - Went to ER in AM  6/11/21 - sent home Current - periodic heart pressure, shortness of breath apon activity
Dizzy; Fatigue extreme/extremely tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever). At the time of the report, DIZZINESS (Dizzy), FATIGUE (Fatigue extreme/extremely tired) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Non-Significant live Follow Up Appended and no new information added.
SkinRash, ErythemaMultiform, Hematoma Narrative: Hematoma forms on left arm after injection
On June 23, 2022 I woke up about 6:00AM and had a restless sleep. I had a vague soreness in my throat and a mild headache. I had a slight sniffle. I already had the PAXLOVID prescription based on my wife's diagnosis and advice from my doctor. I never felt particularly sick at all and my symptoms went away within about 2 days. I did finish the 5 day round of PAXLOVID. Note about previous adverse event to vaccines. In 2014 or 2011 possible event related to Polio or Yellow Fever before trip.
Horrendous migraine; 10 plus body hurt pain; hands went into extreme shaking; weak; mind unable to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Osteo Arthritis" (unspecified if ongoing); "Dress Syndrome", start date: 26Jul2021 (unspecified if ongoing); "4-day coma", start date: 26Jul2021 (unspecified if ongoing); "loss of memory (just now getting some memory back)", start date: 26Jul2021 (unspecified if ongoing), notes: just now getting some memory back. The patient's concomitant medications were not reported. Past drug history included: Cymbalta, reaction(s): "known allergies: Cymbalta"; Pantoprazole, reaction(s): "known allergies: Pantoprazole"; Reclast, reaction(s): "known allergies: ReClast"; Voltaren, reaction(s): "known allergies: Voltaren"; Paxlovid, start date: 31Jan2021, stop date: 19Oct2022, for COVID-19 Vaccinations, notes: Brand: Pfizer. Vaccination history included: Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 2022, outcome "unknown", described as "mind unable to concentrate"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "weak"; TREMOR (non-serious) with onset 26Oct2022 at 19:00, outcome "recovered" (26Oct2022), described as "hands went into extreme shaking"; PAIN (non-serious) with onset 27Oct2022 at 12:01, outcome "recovered" (2022), described as "10 plus body hurt pain"; MIGRAINE (non-serious) with onset 27Oct2022 at 12:01, outcome "recovered" (2022), described as "Horrendous migraine". Therapeutic measures were not taken as a result of tremor. Therapeutic measures were taken as a result of migraine, pain.  Additional information: the patient's migraine and pain continued until it was treated with Fiorinal and Ultram but pain still lasted through the day. For six days, she was weak and her mind was unable to concentrate.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
dizziness within the 15 minute post injection time frame, about 6 hours later developed shortness of breath and chest pain
This is a spontaneous report from a contactable consumer (patient). A 77-years old female patient received first dose of bnt162b2(COMIRNATY, formulation: solution for injection, lot number: FA6780, Expiration Date: 30Sep2021) via an unspecified route of administration on 08Jul2021 at 11:00 (at the age of 77-year-old) in left arm as dose 1, single for COVID-19 immunisation. The patient medical history included fatigue from 1993 to ongoing, fibromyalgia from 1993 to ongoing , pneumonia bacterial from 1988 to an unknown date had severe bacterial pneumonia and was in the hospital for 2 weeks , blood cholesterol increased, it was genetic, blood cholesterol increased, it was genetic , drug hypersensitivity from 2020, allergies to Penicillin, Codeine, Latex Penicillin and Codeine she was allergic to this was years ago rubber sensitivity, seasonal allergy and she has some seasonal allergies. She stated that she never had a breathing problem or lung issue, she had no rash. The concomitant medications were not reported. The patient previously took Fluzone high dose and experienced illness, codeine and experienced drug hypersensitivity, Fluzone high dose and experienced fatigue and rhinorrhoea. On 09Jul2021, the patient experienced felt like bad case of the flu, felt very sick, tiredness/just exhaustion, headache, muscle pain, chills, joint, the injection site was a little tender, nausea, diarrhea, like her nose ran constantly, it was ongoing, it was like she kept getting a cold and she did not usually get colds. She confirmed that the symptoms began the next day after her firAst shot (09Jul2021). The patient underwent lab tests and procedures which included blood cholesterol increased: extremely high on 2020 sodium chloride was on the low side which she had that happen last year, full blood count: sodium chloride low on 26Jul2021 high cholesterol prior to receiving the COVID vaccine, laboratory test: unknown results on 26Jul2021. The patient not visited Emergency Room and Physician Office. The outcome of the events were not recovered (She was on the only one that still has ongoing symptoms). Follow-up attempts are completed. No further information was expected.
3 hrs. after flu shot, felt like lump in throat. Hard time breathing, S. O. B. Coughing.
maculopapular rash on arms, legs and trunk when evaluated on 5/11/21 and 5/14/21 Symptomatic treatment started 5/12/21 with benadryl and hydrocortisone  no improvement per patient when seen on 5/14/21, so was started on medrol dose pack and vistaril
SEVERE VERY DANGEROUS IMMUNE  RESPONSE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced severe, very dangerous immune response. On an unspecified date the patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe, very dangerous immune response. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210357960-Covid-19 vaccine ad26.cov2.s - severe, very dangerous immune response. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
1 day after vaccines given, developed cellulitis at injection site 5cm x 5 cm.  Encompassed both injection sites in right thigh.
Severe headache and right arm pain started 4 hours after vax. Lasted intermittently for 10 days, little relief with Tylenol, Advil, or Excedrin
Patients under the age of 18 were administered a COVID vaccine; A spontaneous report was received from a pharmacist concerning a 17 year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patients under the age of 18 were administered a COVID vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, a male patient, age 17 years old, was administered the COVID vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, patients under the age of 18 were administered a COVID vaccine, was considered resolved 29 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
I am currently breastfeeding. I received my first vaccination on Monday. On Friday (4 days later) my newborn (7 week old) broke out in major a rash all over her body. I watched the rash for 5 days and it did not go away. I consulted with the pediatrician who ruled out allergies and eczema. The doctor's best guess was that the rash was caused by a viral infection but remained unsure as she never had a fever to our knowledge. The mysterious rash persists.