chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; She had some arm soreness at the injection site/injection area hurt; This is a follow-up spontaneous report from Pfizer-sponsored program, from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), intramuscular on 30Dec2020 at a single dose for COVID-19 vaccination. Medical history included pains in her arm (so any injection would hurt). There were no concomitant medications. Physician had muscle soreness after getting the 1st dose of the COVID 19 vaccine last 30Dec2020. Took ibuprofen (ADVIL) for pain management and wondering if this will affect the antibody response. Requesting for data regarding people that took pain medications during the clinical trials and asking for antibodies titer after taking pain medications. She will have the 2nd dose on 20Jan2021 and wants to know the options. On 14Jan2021, it was reported that right after the patient took the vaccine, she took some ADVIL because the injection area hurt. She is now seeing she was not supposed to take ADVIL, acetaminophen (TYLENOL), ibuprofen. She also wanted to know during the clinical trials, did they notice a decrease in antibodies after taking ADVIL or TYLENOL. Confirms she took ADVIL right after the injection. She already had pains in her arm so any injection would hurt. She was explaining she is now seeing on Medical (Social site name), a study in mice shows with COVID infections, NSAIDS were given, clarified as meloxicam, and it reduces the neutralizing antibody response. Now, all over Medical (Social site name), physicians are saying you shouldn't take ibuprofen, Naproxen, or Tylenol after receiving a dose. Wanted to know what was seen in the clinical trial data. Mice are mice. It's now all over Medical (Social site name). She has her second dose coming on Wednesday. She also wants to know what is she going to tell her patients? They are not going to want to know what happened in mice, they are going to want to know what happened in Phase 3 of Clinical trials. She had some arm soreness at the injection site. She confirms the arm soreness was gone in less than 48 hours, but she took ADVIL every 8 hours. Once the soreness was gone, she didn't take it. But now she is freaking out, wondering if she didn't get an antibody response? She received the standard dose, which she believes is 3mL of the solution, but she isn't sure. Therapeutic measures were taken as a result of muscle soreness and 'she had some arm soreness at the injection site'. The outcome of the event muscle soreness was unknown, while of 'She had some arm soreness at the injection site/injection area hurt' was recovered on Jan2021.  Information on the lot/batch number has been requested.
Received 1st dose of shinles vaccine, then 4 days later while at work, felt a "POP" in left shoulder, went to nurse, told me to take acetaminophen and ibuprofen til Friday June 4. Nurse and PT checked it and verified I had ruptured one of the bicep tendons - put on 6 week no lifting restriction. Aug 18  2021 received 2nd shingles vaccine in left shoulder. Then 6 days later had adverse reaction when I fell onto cement when assistant neglected to help me properly get out of van while confined. Fell onto my right shoulder, but caused rotator cuff damage in LEFT shoulder., and given three weeks off of work. Also had first COVID vaccine in left shoulder. Every night left shoulder goes numb down to my fingers while sleeping. Continuing PT now.
Significantly increase blood pressure following the J&J Covid19 vaccinations.  Not immediately notices as no necessity for medical diagnostics. Discovered during comprehensive physical at local Clinic
Myocarditis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient(teen) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization), outcome "unknown", described as "Myocarditis". Patient was hospitalized with myocarditis several days after vaccination. The reporter said that the booster shot could have killed the patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
severe pain in neck, back and legs. loss of feeling in both legs. hospitalized due to pain, neurological issues and elevated CRP, CK levels.  Advised suffered from neuralgia and acute kidney injury
lightheaded/dizzy; nauseous; fatigued; feels like hot flashes; feel lousy/don't feel well overall; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 57-year-old female patient who received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine) , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The consumer reported that "COVID19 vaccine:  Are these side effects and wondering about second dose?  I had gotten the Pfizer COVID vaccine on 06Jan2021. Yesterday (10Jan2021), I was lightheaded, dizzy, nauseous, really fatigued. Today (11Jan2021), the fatigue is gone but still lightheaded and nauseous. I don't have a fever. At times, it feels like hot flashes and I take my temperature and I am fine. I feel lousy and don't feel well overall. As far as having COVID19, are these symptoms (per REQ#: lightheaded, dizzy, nauseous, really fatigued) and should I get tested?" The outcome of the event fatigued was recovered. The outcome of the events feels like hot flashes and feel lousy/don't feel well overall was unknown. The outcome of the other events was not recovered.   Information about Batch/Lot number has been requested.
itchy eyes during the first 15 minutes post vaccine. took 50mg benadryl - didnt help. itchy face, hands, and throat to follow with closing of throat of shortness of breath
I had my vaccination on 06/13/2022. I started to experience symptoms to include sore throat headache bad cough on 10/05/2022 and difficulty swallowing. I tested COVID-19 positive on 10/07/2022. I was prescribed PAXLOVID on 10/09/2022. I am currently feeling better on 01/09/2023 but with residual fatigue.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 15-MAY-2017, the patient was vaccinated with an expired dose of ROTATEQ (Lot # reported as L035508; expiration date 12-MAY-2017) dose was unknown, orally for prophylaxis. No known adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Lot number L035508 is an invalid lot number for ROTATEQ. Additional information has been requested.
Shoulder and bicep red and inflamed, mild stiffness. Shoulder improved overnight, bicep became inflamed. Instructed patient to take anti-inflammatory and diphenhydramine and to seek treatment if symptoms worsen.
4" x 6" pink area, swollen, 3 small scabbed spots area of injection site - firm - size of dime.  Pain 1-2 days after injections.  Took Tylenol for pain.
Influenza shot given 10/12/2004 Patient on 10/14 had vomiting and on 10/15 had abdominal pain. 2 days later he had a fever and a itchy rash on the right side of his neck on 10/17/2004.
she had diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's daughter's-in-law mother) of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Feb2021 (Age at the time of vaccination was not provided) as DOSE 1, SINGLE for an unspecified indication. The medical history included irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter was asking how she can get an appointment for her daughter's-in-law mother. After the first dose yesterday, the patient had diarrhoea on 08Feb2021 but according to the caller this was normal because she had Irritable Bowel Syndrome even before she got the vaccine, and she ate bacon that night that might cause the diarrhoea. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected. Information on the lot/batch number has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: COVID infection following COVID vaccine series 02/24 Pfizer, dose #1 (non-facility) 03/18, Pfizer, dose #2 (non-facility) 11/22 COVID swab, result: detected 11/2 SARS-COV-2 Variant Sequencing 11/17pt cc: cough and fever exposure: unknown 11/26 clinically resolved
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The date of refrigeration of vial was on 07-May-2021.
Information has been received from a physician concerning a 23 year old female with egg allergy, who on approximately 24-SEP-2008, was vaccinated with her second 0.5 ml dose of GARDASIL, IM. Subsequently, "within days of the second vaccination", the patient experienced small papules on her body which the physician reported was an allergic reaction. The patient sought medial attention by seeing the physician. No further information is available. Additional information has been requested.
Pt became dizzy & pale after vaccination. BP 123/74; HR 71; RR 18. Recommended that pt lay down prior to getting 2nd dose. Stable & released from site
I had dizziness, head congestion, pressure particularly on the cheekbones, lightheadedness. stuffiness in my ears, and my temperature was very slightly elevated just enough to feel uncomfortable. I scheduled a health visit on 06/04/2021. They prescribed Augmentin. They said it was as sinus infection. I felt better after 72 hours.
This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a physician, via a company representative, concerning the physician's daughter, age 15 or 16 years, who on approximately 09-MAR-2007 ("about six weeks ago") was vaccinated, IM, with the third dose Gardasil. The physician reported that following the vaccination, his daughter experienced flu-like symptoms and nausea, that lasted for three days after the vaccine had been administered, approximately 12-MAR-2007. The physician confirmed that following the three days, his daughter was "fine." The patient's sister also experienced flu-like symptoms and nausea after vaccination with Gardasil (WAES#0704USA04661). Additional information has been requested. Initial and follow up information has been received from a physician, concerning his 14 year old daughter, who on 31-JUL-2006, was vaccinated with the first dose of GARDASIL, on 23-OCT-2006, with the second dose of GARDASIL, and on 06-APR-2007, was vaccinated, IM, with the third dose of GARDASIL. The physician reported that on 07-APR-2007, the day following the vaccination, his daughter experienced flu-like symptoms, was extremely nauseated, and had severe malaise that lasted for three to four days after the vaccine had been administered, and then recovered (approximately 11-MAR-2007). The patient's sister also experienced flu-like symptoms, nausea and malaise after vaccination with GARDASIL (WAES #0704USA04661). Additional information is not expected.
no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Pharmacist via Agency (Reference number- 00521572) and transmitted to Sanofi on 16-MAR-2021.  This case involves a patient (unknown age and gender) who was administered an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (lot U6214AA, expiry date: 14-Mar-2021) via unknown route in the unknown site for prophylactic vaccination on 16-Mar-2021(expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out 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.
Heart problem; Stabbing chest pain that went through to her back; Stabbing chest pain that went through to her back; Rash on breast; Pain under arm; Shingles; Arm swelled up really bad; Arm was very sore; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) and (batch number H2HM2, expiry date 29th August 2021) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 23rd August 2019, less than a day after receiving Shingrix, the patient experienced swelling arm. On 4th September 2019, the patient experienced pain in arm, chest pain, back pain, rash, axillary pain and shingles. On an unknown date, the patient experienced heart disorder. On an unknown date, the outcome of the swelling arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, chest pain, back pain, rash, axillary pain, shingles and heart disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient said her arm was swelled up really bad and was very sore for 3 or 4 days.  On 1st September 2019, the patient went to the emergency room with stabbing chest pain that went through to her back. The patient was checked for heart problems and released.  On 3rd September 2019, patient went to her family doctor with the same pain and a rash on her breast.  The pain also under her arm. The patient was diagnosed with Shingles. The reporter consented to follow up.
I have a very itchy, hot and red rash that comes and goes throughout my entire body and I am still dealing with this on a daily basis.
Time of onset is approximate. Generalized hives inflammation and pain at the injection site. Treated with oral Benadryl. Patient denied: dyspnea or difficulty swallowing.
Information has been received from a nurse practitioner concerning a 17 year old female with depression and allergies to iodine and IV contrast material who on 03-JAN-2008 was vaccinated with the first dose of Gardasil 0.5 mL IM (Lot #659055/1522U).  Concomitant therapy included MICROGESTIN, trazodone HCl and PROZAC.  On the way out of the office on 03-JAN-2008 the patient developed swelling and redness of her left hand.  She did not notify the office staff at that time.  The redness and swelling resolved (date not reported).  Over the next six days (approximately 04-JAN-2008) the patient experienced nausea and loss of appetite.  The nurse practitioner mentioned that the patient may have the flu.  She contacted the office by phone.  As of 09-JAN-2008, she was recovering.  Additional information has been requested.
joint and nerve pain became worse following dose; prevented her from being able to walk; Fever; Joint pain, prevented her from being able to walk; Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 years ago, prior to receiving her Shingrix dose), joint pain (prior to the vaccine) and nerve pain (prior to the vaccine).   On 7th September 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 7th September 2021, 4 hrs after receiving Shingrix, the patient experienced condition aggravated and walking difficulty. On 7th September 2021 15:00, the patient experienced fever, joint pain and nerve pain. On an unknown date, the outcome of the fever, joint pain and nerve pain were recovered/resolved and the outcome of the condition aggravated and walking difficulty were unknown.   It was unknown if the reporter considered the fever, joint pain, nerve pain, condition aggravated and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine into her right arm at approximately 11am at her pharmacy and at 3pm that day she experienced fever, joint and nerve pain that prevented her from being able to walk. Her fever broke after 48 hours and was resolved till the time of reporting. Her joint and nerve pain lasted for 2 weeks. The patient had a history of having shingles 2 years ago, prior to receiving her Shingrix dose.  The patient also reported that she had a prior history of joint and nerve pain prior to the vaccine, but that the pain became worse the day of and for 2 weeks following her Shingrix dose. The reporter did not provide the lot and expiration date of the vaccine given. The reporter consented to follow up.
This case was reported by a healthcare professional and described the occurrence of facial numbness in an adult female subject who was vaccinated with (BOOSTRIX, GlaxoSmithKline), and (TWINRIX). The subject stated that she felt "slightly unwell" before the vaccinations. On an unspecified date the subject received unspecified dose of BOOSTRIX (details unknown), unspecified dose of TWINRIX (details unknown). The next morning when she awoke, approximately 24 hours after vaccination with BOOSTRIX and TWINRIX, the subject experienced facial numbness. At the time of reporting the outcome of the event was unspecified. Follow-up received from reporting healthcare professional on 22 May 2009: The subject was 39-years-old. Past medical history included genital herpes. The subject does not drink or smoke. Concurrent medications included VALTREX. On 05 May 2009, the subject received a dose of BOOSTRIX (0.5 mL) and 1st dose of TWINRIX (1mL). Facial numbness occurred on 06 May 2009. The event resolved on 07 May 2009. The healthcare professional considered the event was possibly related to vaccination with BOOSTRIX and TWINRIX. The healthcare professional also considered the event could have been associated with medical history or a concurrent illness, an reported that the symptoms subsided when VALTREX was taken.
just the second of this new series. My husband also got the first one years ago; we're only itchy; Incomplete course of vaccination; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, pruritus and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and lady year got the shingles they were only 6 inches at his waist but were only itchy. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked with US2021AMR078485, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078485:same reporter
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.