chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache still present began day of vaccine; Chilled afternoon of vaccine; minor arm soreness at injection site; This is a spontaneous report received from a contactable consumer (patient reported herself). A 63-year-old non-pregnant female patient received first dose of (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 05Feb2021 09:30 AM at single dose to her left arm for Covid-19 immunization. The patient's medical history included hypertension controlled with medication. Covid was not tested prior or post vaccination. No known allergies. Concomitant medications included irbesartan, spironolactone, vitamin D NOS (VITAMIN D) and MULTIVITAMIN. On 05Feb2021 02:00 PM, the patient experienced headache still present began day of vaccine now day 5. Chilled afternoon of vaccine administration. Minor arm soreness at injection site for 24 hours. She did not receive any treatment in response to the events. Outcome of the events was not recovered.
This spontaneous report as received from a nurse in physician's office via a company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 11-AUG-2015, the patient was vaccinated with the first dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). On 30-OCT-2015, the patient was vaccinated with the second dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). On 06-JAN-2015, the patient was vaccinated with the third dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). The company representative was not aware if unidentified Merck human papillomavirus (HPV) vaccine was GARDASIL or GARDASIL 9. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
7.5x5 cm area - red and warm to touch. Non indurated swelling (L) arm around puncture site.
This spontaneous report as received from a health professional refers to unspecified number of unspecified patients. On an unspecified day in May 2015 (reported as 07-MAY-2015 or 08-MAY-2015), the patients were administered unspecified number of doses of improperly stored ROTATEQ, (lot# not reported, orally). No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse practitioner that refers to a patient of unknown gender and age. The patient had no pertinent medical history or drug reactions/allergies. In March 2012 approximately or April 2012, the patient was vaccinated with the first dose of VAQTA immunization regimen (dose, route, frequency and lot number were not provided). No other co-suspects were not reported. Concomitant medications were not reported. It was reported that on unknown date described as 4 months later. (In July 2012 approximately) the patient received the second dose of VAQTA. No adverse effect reported. Additional information has been requested.
I received the Moderna Dose 2 (was my booster) on 10/22/2021. I received Johnson and Johnson as my first vaccine.  On 11/13/2021- I was feeling symptoms of Mastitis on my left breast. I had pain on my left breast. It was visibly red and hot to the touch, painful, there was a lump and I was tired all day. The symptoms continued for a week. The pretty intense pain and redness and heat to the touch and became better within a week. The lump is still there and it is pretty pronounced but there is no pain or heat. I contacted my doctors since I am not breastfeeding.  We have been corresponding once a week over telehealth. She recommended a hot compress and to monitor it and contact her if it became worse.
She had body aches all day; she had nausea too/ nausea; Headache; She is feeling little clumsy; she had a mild like a low grade fever; she couldn't really walk very well, it's weird she was almost falling; she almost fell; She couldn't get out of bed; She was very clumsy like her equilibrium fall; This is a spontaneous report from a contactable consumer (daughter of the patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection and lot number: ER8733) via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE) for COVID-19 immunization. The patient got her second Pfizer shot yesterday on 31Mar2021 and on 01Apr2021 she was feeling little clumsy, she had a mild like a low grade fever. She woke up in the middle of the night and she couldn't really walk very well, it was weird she was almost falling and the reporter had to walk her out to the living room and get her in the recliner and she had body aches all day, low grade fever and headache all day, nausea, she had nausea too. It was also reported that she walked but she couldn't get out of bed. The reporter helped her up. She was very clumsy like her equilibrium fall. The patient she almost fell. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Daughter tested positive for covid on 2 separate tests.; fever 5 hrs later; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for his daughter. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. On an unknown date, the patient started therapy with Trumenba (MENINGOCOCCAL GROUP B RLP2086; Suspension for injection, Lot# and expiration date not reported) via unknown route of administration as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 (reported as 5 hr. later vaccination), the patient experienced fever. It was reported that the patient (daughter) tested positive for covid on 2 separate tests. Patient wanted to clarify whether she gets covid on Trumenba. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pressure in abdomen, went to er and found out my baby had no heartbeat.  Placenta Abruption.
Mom noted set redness, swelling at DTaP injection site approximately 48 hrs post injection. Recommended Motrin, Tylenol for discomfort.
pt presented w/h/a, rt shoulder pain, rt chest pain, rt neck pain & rt CN III & V difficulties;tx w/Ibuprofen & hot soaks to rt shoulder;also given DPH;c/o burning sensation in both legs;
died; This spontaneous report was received from a other health professional who refers to a female patient of unknown age who was his aunt. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she died. It was unknown if an autopsy was performed. The cause of death was reported as "unknown pneumococcal vaccine". The reporter considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).; Reported Cause(s) of Death: Unknown pneumococcal vaccine
developed fever within 48 hours. on and off low grade temp since then (11days). on 12/28 measles like rash started on torso and spread to all over the body.
Even with all his COVID vaccinations, he only had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (He believes he got the flu shot before the vaccinations, and they weren't even close together.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Even with all his COVID vaccinations, he only had a sore arm".  Additional information: NDC number and Expiry Date of Pfizer BioNTech COVID-19 vaccine was unknown. No Other Products were there. Lot Number / Expiry Date: EP7534 or ED7534, the caller (patient) stated the second letter could either be a P or D, it doesn't look clear/ Expiry date unknown. Route, Anatomical Location: Left arm (he remember since it was at the fairground, he rolled down his driver's side window, and didn't really have a choice for which arm; This was dose 1. No Investigation Assessment was there.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
102 FEVER,CHILLS, WIDESPREAD MUSCLE PAIN X 3 DAYS
chronic back pain due to a ruptured disc in his back.; chronic back pain due to a ruptured disc in his back.; This is a spontaneous report from a contactable consumer (patient himself) Pfizer-sponsored pro-gram. A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 07Jul2021 (age at vaccination: 62-years) as dose 1, single for covid-19 immunisation. Patient had his second Pfizer Covid 19 Vaccine scheduled for 42 days after first dose, on 18Aug2021. Concomitant medications included Oxycodone, which patient took for a medical condition, and if he does not take it, he suffers from pain. He read some information that a person was not supposed to take Tylenol, surrounding the time that the person is getting the vaccine. On an unspecified date, patient experienced chronic back pain due to a ruptured disc in his back. The outcome of event was unknown.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Blotch on Arm; Nose Rash/ Back Rash/ thigh rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th April 2019, 3 days after receiving Shingrix, the patient experienced rash. On 6th June 2019, the patient experienced blotchy rash. On 6th June 2019, the outcome of the blotchy rash was recovered/resolved. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash and blotchy rash to be related to Shingrix.  Additional details were provided as follows: The patient's husband called on her behalf to report the adverse events. Reporter stated that, approximately on 10th April 2019, they both received 1st dose of Shingrix vaccine and he was fine. However, approximately 3 days after vaccine, the patient broke out on her nose for about a month.  On 6th June 2019, at morning, the patient for the first time broke out with a large blotch on each arm. About 75 percent of her back was rashed out and she had a rash on her thighs.  The blotch and rashes resolved in approximately 1 hour. The reporter gave medical disclaimer and offered to contact health care professional and to the primary investigator (PI). Their 2nd dose of Shingrix was scheduled for 10th June 2019.
Period 1 week late; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0182) via an unspecified route of administration in the left arm on 11May2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24May2021, the patient experienced period 1 week late. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event period 1 week late was resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Today is dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Today is dizzy) 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 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced DIZZINESS (Today is dizzy). At the time of the report, DIZZINESS (Today is dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.   Reporter did not allow further contact
Burning feeling at injection site; Swelling; Burning Feeling at injection site; redness; warm to touch at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Antibiotic. No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a physician and refers to a 16 year old male patient. The patient has no pertinent medical history and no drug allergies. On 20-JUN-2014 the patient was vaccinated with two doses of GARDASIL due to staff error. This should have been dose three in series. Concomitant therapies reported included: typhoid vaccine (unspecified) for travel. On 20-JUN-2014 the patient was vaccinated with two doses of GARDASIL (indication reported: vaccination; lot number not reported): first dose (0.5ml) was injected intramuscularly in patient's left arm and second dose (0.5ml) was injected intramuscularly into patient's right arm. The physician stated that the patient complained of his arm hurting post vaccination. There was no treatment given for the event. Patient sought medical attention 'in the office'. There was no intervention to prevent serious criteria. There was no PQC involved. The outcome of the event (his arm hurting post vaccination) was reported as not recovered/not resolved. The relationship between the GARDASIL and the event (his arm hurting post vaccination) was unknown. Additional information has been requested.
both feet/toes are numbish.  (skin ) and now seems to be going up into the side of lower shin.
Erythematous lacey macular rash on ant. legs. Evanescent crying episode assoc. approximately 1 hr.
The vaccine was expired on 13-OCT-2021, placed in the refrigerator on 18-OCT-2021 and administered on 27-OCT-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vaccine was expired on 13-OCT-2021, placed in the refrigerator on 18-OCT-2021 and administered on 27-OCT-2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 13-OCT-2021, placed in the refrigerator on 18-OCT-2021 and administered on 27-OCT-2021). At the time of the report, PRODUCT STORAGE ERROR (The vaccine was expired on 13-OCT-2021, placed in the refrigerator on 18-OCT-2021 and administered on 27-OCT-2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vaccine was placed in refrigerator on 18-OCT-2021 and the vaccine did not undergo any temperature excursion. No other adverse events were reported for patient. No treatment information was reported.
Initial report received from a consumer on 16 September 2012. A male patient, whose age, medical history and concomitant medications were not reported, received dose of FLUZONE HIGH DOSE vaccine on an unspecified date (lot number, route of administration and site of administration were not reported). Patient's granddaughter reported that on an unspecified date that the patient had received Flu high dose vaccine and developed arm pain, a knot and itching. The corrective treatments and laboratory investigations were not reported. The outcome of the events was reported as unknown at the time of report. Documents held by sender: none.
No adverse effects; expired dose of GARDASIL 9 was administered to a patient; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.  On 04-FEB-2017, the patient was vaccinated with an expired dose of GARDASIL 9 for prophylaxis (expiry date  29-JAN-2017; dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
some mild soreness in his arm; This is a spontaneous report from a contactable consumer (patient). A male patient (age and unit not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via unspecified route administered on 16Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced some mild soreness in his arm. The outcome of the event was unknown. He has heard that the effects are much greater in the second dose. He wanted to know more information about that but disconnected before being offered to be transferred to the hospital. He read from an article that after first dose of the COVID-19 vaccine, you would have 52% efficacy. After waiting for all this time (long hold time), this was unhelpful.  Follow-up attempts are completed. No further information is expected.
Pain in my left arm and shoulder.  I cannot raise my arm above my head.  I have sharp pain in my arm, I cannot put any weight on that arm. I went to a shoulder specialist who prescribed Physical Therapy.
The day after vaccination patient couldn't lift her arm because of soreness in her arm.; soreness in her arm; slowness; injection site warm; strong headaches; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm) and HEADACHE (strong headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS for Nutritional supplement, IRON for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches). On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 02-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (The day after vaccination patient couldn't lift her arm because of soreness in her arm.), PAIN IN EXTREMITY (soreness in her arm), SLUGGISHNESS (slowness), VACCINATION SITE WARMTH (injection site warm), HEADACHE (strong headaches), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Patient presented to Hospital on 04/07/2022 with SOB.  Per EMS, patient was 78% on RA and placed on 3LNC.  Patient has a hx of asthma, lung cancer, liver cancer, and brain cancer, with home O2 use.  She was found to be Covid-19 positive.  D/t her underlying medical conditions, the only therapy available was oxygen  and dexamethasone.  Patient had a sustained run of V tach and required ACLS despite her automatic implantable cardioverter-defibrillator.  Patient was transferred to ICU.  She became more hypoxic and required intubation.  Her family chose to pursue hospice care and comfort care.  Patient was palliatively extubated.  Patient expired on 04/11/2022.
Redness, swollen at the site of injection. Pt took acetaminophen. Redness, swelling improved in 1-2 days then swelling again.