chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ABDOMINAL PAIN; LEG PAIN; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. 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 APR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, abdominal pain and leg pain was not reported. This report was non-serious.
I had sore throat, fatigue and coughing. I tested positive for COVID-19.  I talked to my doctor and they prescribed to me Paxlovid.A couple of weeks went on and I felt like I wasn't improving so I called them again and they told me to take Mucinex which helped a lot.
WEEKNESS IN LEGS AND FEET, TINGLING IN FEET, FALL, GETTING WORSE
This spontaneous case reported by a nurse, describes the occurrence of accidental overdose (received a full dose of the COVID-19 for his first booster dose) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 056A22A) for COVID-19 immunization. No medical history reported. In 2021, patient received the first and second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On an unknown date, patient experienced accidental overdose (received a full dose of the COVID-19 for his first booster dose). At the time of the report, accidental overdose (received a full dose of the COVID-19 for his first booster dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient received primary series in spring of 2021. Patient took 1st booster dose. Patient did not experience any adverse event.
Daughter was given the flu shot without parent consent. Daughter, who is 4 months old, was to be given the PREVNAR shot but the nurse administered the flu shot instead. According to the office manager, the nurse opened the wrong patient file; the patient after my daughter was to get the flu shot.
Red 2.54 cm raised welt and hot to touch; burned on receiving; itchy within 1 hr. Welt was gone 3 days later.
Report 20010185421 described skin turning red (hands and arms) in a female pt of unspecified age who received Lymerix. In 1999 and 2000 the pt received the first, second and third doses of Lymerix. Subsequent to receiving the third dose, the pt felt that her hands and arms were getting redder. Th pt thought that this adverse event was possibly related to Lymerix. As of July 30,2001, the outcome of the event was unknown.
Pt has complained of dizziness and lightheadedness after vaccinated with the first dose of pediatric Pfizer
An hour after the shot he reported having a "funky" feeling. next day on 3/4 he had a fever of 101.4 F and had lethargy . felt normal again on two days later on 3/5
This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. Since 02-OCT-2014 patients were vaccinated with oral, ROTATEQ (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
12/11 vaccination  2AM started to feel really bad; heart fluttering, anxious, jittery; lasted about 24 hours.  BP was very high165/114 at its highest. Lasted in 150's for the rest of the week. I drove the the ER but it was full of patients and I figured it was full of COVID patients, so I left before entering. 12/15 telehealth w/ kidney doctor. Called me in a new BP medication, Monitor for a week and reevaluate then. I suspect this was caused by the vaccine. I just know that I felt fine until shortly after I had the vaccine. I have been on BP meds since 2016 and numbers  stay around130/90's.
Developed foot, painful shin, and hand numbness from about day 3 to 8 post vaccination.  Leg muscle fasiculations around day 5-6 for 2 days. Livedo Reticularis rash around day 8 that still comes when she is hot.
Had healthy daughter 02/01/1997. Started Anthrax series 11/20/1998. Wife has had 2 miscarriages 03/14/99 and 03/14/2000 at 12 and 8 week gestation. Father has had 4  doses of vax.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; feeling that her left eye was swollen underneath the eyelid and a little red on the inside corner of the eye; The syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye; This spontaneous report was received from an unspecified person referring to a 26-year-old female patient (nurse). The patient's concurrent conditions, medical history, drug allergies/ reaction and concomitant medications were not reported. On 25-NOV-2019, the patient was getting ready to draw up measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, formulation, dose/frequency, route were not reported) lot # S012944, expiry date:28-APR-2019 for prophylaxis into the syringe. When the nurse began reconstituting the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with the sterile diluent the syringe blew apart and the solution sprayed everywhere, including in the nurse's left eye (occupational exposure to product, exposure via eye contact and accidental exposure to product ). She washed the affected eye for about two minutes. On the same day, patient reported that her left eye was swollen underneath the eyelid and a little red on the inside of the eye (ocular hyperaemia and swelling of eyelid). The patient flushed her eye with water and sought medical attention from physician. The outcome of the events ocular hyperaemia, exposure via eye contact, accidental exposure to product, occupational exposure to product and swelling of eyelid was unknown. The causality of the events ocular hyperaemia and swelling of eyelid was unknown with respect to suspect therapy Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Pt had some mild intermittent stomach aches 2 weeks prior to WCC. Had WCC & 1st HPV, then 6 days later seen for vomiting & diarrhea and abdominal pain. Pt diagnosed with acute appendicitis and received surgery.
Ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EJ1686) via unspecified route of administration on 21Jan2021 at (at the age of 64-years-old) as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via unspecified route of administration on 11Feb2021 at (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were reported as no. There were no known allergies reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. The patient had not received any other vaccines within four weeks prior to the vaccination. On 23Jan2021, the patient experienced ringing in ears. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the events. The clinical outcome of the event ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swollen lymph node on left side of mouth; This is a spontaneous report from a non-contactable healthcare professional. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the right arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node on left side of mouth on an unspecified date. No treatment was given for the event. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
woke up with her bottom lip swollen; now both lips are swollen; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (woke up with her bottom lip swollen), LIP SWELLING (now both lips are swollen), CHILLS (chills) and PYREXIA (fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 22-Apr-2021, the patient experienced LIP SWELLING (woke up with her bottom lip swollen) and LIP SWELLING (now both lips are swollen). At the time of the report, LIP SWELLING (woke up with her bottom lip swollen), LIP SWELLING (now both lips are swollen), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
With first vax - bloody noses. 2nd vax- nausea, vomiting, headaches.
Sore at injection site; Fatigue; Chills; Waking up in the middle of the night feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish). On 06-Feb-2021, VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish) had resolved.            Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-123 is not applicable.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 52-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX .5 ml, BOOSTRIX and PREVNAR 13. On 8th August 2018, less than a day after receiving SHINGRIX and BOOSTRIX, the patient experienced fever, headache, myalgia, dry cough and chest heaviness. On an unknown date, the outcome of the fever, headache, myalgia, dry cough and chest heaviness were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, dry cough and chest heaviness to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: After receiving SHINGRIX, BOOSTRIX and PREVNAR 13, the patient experienced symptoms on the same day he received the vaccine. On 8th August 2018, the patient had a fever with a high of 101 degree F. On the date of reporting the patient's fever went down to 98.8 degree F. It was unknown if the reporter considered the fever, headache, myalgia, dry cough and chest heaviness to be related to PREVNAR 13 as well. It transferred to medical information for questions.
Narrative:  Patient received one dose Janssen COVID 19 Vaccine in May 2021. The patient tested positive for COVID 19 on 11 February 2022. The patient presented to the ED with shortness of breath, hypoxic, and upper respiratory symptoms. The patient was admitted on 12 Feb 2022 with COVID 19 pneumonia. The patient was treated with dexamethasone and remdesivir. The patient was discharged in stable condition on 14 February 2022. Reported per EUA.
Client reports  right arm was achy for 2 days post vaccination. Client reports deep pain in upper arm and shoulder worsening on 10-24-04. Also less strength in arm and difficulty sleeping due to pain. Applied heat to arm and took Tylenol with little relief. Sought chiropractic care 10-25-04. Still has no relief. Will call MD today to make appointment
4/7 - Anxiety, sense of dread, tickling of spine 4/12 - Anxiety, sense of dread, ticking of spine, heavy eyes 4/13 - Anxiety, sense of dread, ticking of spine, coldness of hands/ feet, heavy eyes, itchy skin, mild sweating 4/15 - Tickling of spine, coldness of hands/ feet, numbness of hands/ feet, mild arthritis
Information has been received from a licensed practical nurse concerning a 15 year old female with ZITHROMAX and with no other pertinent medical history who on 03-JUL-2008 was vaccinated with a dose of GARDASIL 0.5 ml IM. Other suspect therapy included a dose of VARIVAX (MSD). In January 2009, the patient experienced hair loss six months after receiving GARDASIL. No labs were performed. The patient mentioned this at a recent office visit unrelated to this. Additional information has been requested.
Delayed ovulation; unplanned pregnancy; Is pregnant: No; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 (Lot number: ER8729) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "gluten sensitivity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EP6955 , administration time: 04:00 PM, vaccine location: Right arm), administration date: 09Mar2021, when the patient was 38 years old, for Covid-19 immunisation. The following information was reported: OVULATION DELAYED (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Delayed ovulation"; UNINTENDED PREGNANCY (non-serious) with onset 08Apr2021, outcome "not recovered", described as "unplanned pregnancy"; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 06Apr2021, outcome "unknown", described as "Is pregnant: No". Therapeutic measures were not taken as a result of ovulation delayed, unintended pregnancy, maternal exposure before pregnancy.  Additional Information: The patient has no known allergies. The vaccine was administered to patient in a Pharmacy or Drug Store. The patient had no covid prior vaccination and not tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no other medications received in 2 weeks of vaccination. The patient reported to have spoken to so many women about effects on menstrual cycle and delayed periods and was asking why this information was not disclosed. She had  heard of so many women where this was happening, and estrogen levels were so high. She will not give any of these vaccines to her kids after her experience and hearing from others as she did not want to mess with their hormones. She instructed the company to figure out what was going on and disclose it to the public because the company will risk losing credibility for the world on these shots. She further stated that she used to make fun of people who said it messed with fertility as a conspiracy theorist, and she felt like she got played.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patient was vaccinated with 2 doses of M-M-R II (exact dose, frequency, site and route of administration, lot#, expiration date and albumin status were not reported) outside the recommended dosing schedule. No adverse effects were reported.
The patient received the 3rd dose of pfizer COVID-19 on 10-22-21 at 4:51 pm. The patient was feeling ok and was in the store waiting the allotted 15 minutes. After about 10 minutes, she returned to the immunization room saying she did not feel ok. She started to faint and had a what appeared to be a small seizure.  911 was called, an Epi-pen was administered and her vitals were monitored. She began to respond immediately to the epi-pen and was directed to go to the emergency room by EMS and staff. The patient's mom picked her up and took her to the ER.
Upper right arm extremely sore after flu shot. Soreness lasted for two days and interfered with my ability to lift items, perform tasks with right arm.
A report has been received from a consumer concerning a 6 years 6 months old female patient. Patient's concurrent diseases and relevant history was not provided. In Oct-2015, the patient received nasal FLUMIST QUADRIVALENT (intranasal) for in lieu of flu shot and in Apr-2016, patient had received unknown Penicillin for unknown indication. In Apr-2016, it was reported that reaction to penicillin broke out in hives (preferred term: urticaria) when the patient took Penicillin in Apr-2016 and that she experienced runny nose (preferred term: rhinorrhoea). Action taken with the suspect drug of Penicillin was unknown. At the time of reporting, the patient recovered from broke out in hives and the outcome of the runny nose was not recovered. Company physician assessed runny nose and broke out in hives to be non-serious.
Patient was given booster on 8/8/2022 with vaccine that had been in the fridge for 10 weeks on 7/30/2022.  CDC was contacted and recommended revaccination.  Tried to notify patient, but neither phone number we have is in service.  Will continue to try to contact.
More sore with second vaccine, within a handswidth of injection site; Intermittent runny nose/sneezing; Intermittent runny nose/sneezing; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Feb2021 16:30 as SINGLE DOSE for covid-19 immunization. Medical history included osteoporosis, stroke at 35 yrs old, lactose intolerance, significant lactose intolerance and gastrointestinal (GI) issues and allergic to caine family of drugs from an unknown date and unknown if ongoing. Concomitant medications included evolocumab (REPATHA SURECLICK) and lorazepam; both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 12:00 PM as SINGLE DOSE for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 at 12:00 AM, the patient developed more sore with second vaccine, within a handswidth of injection site. Intermittent runny nose/sneezing. It was unclear if related to vaccine. I was asked by Pfizer to report, since I am on a bi-monthly dose of injectable Repatha. The patient did not received any treatment. The outcome of the events was recovered in Feb2021.  Follow-up attempts have been completed. No further information was expected.