chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spent two days in bed with everything - a headache and all the symptoms; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced spent two days in bed with everything - a headache and all the symptoms on an unspecified date. It was reported that the patient had the vaccine in April and she will be travelling to another county so the airlines wanted proof of her vaccination which has to be official and they have to be able to scan it, and they cannot use the card. The patient stated that she received the vaccine at the parking lot and that nurses gave the vaccine. She also stated that she had two vaccines and needed proof. The patient reported that on the first vaccine she had spent two days in bed with everything - a headache and all the symptoms. On the second vaccine, patient stated only one day in bed but still all the symptoms. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial and follow-up information has been received from a nurse concerning a 20 year old female who on 07-APR-2008 was vaccinated intramuscularly into the left gluteus with the first 0.5 ml dose of GARDASIL (lot no. 659655/1486U). On 29-May-2008, the patient had a colposcopy done which showed positive for human papilloma virus. The biopsy showed squamous mucosa and attached endocervical glandular mucosa with mild chronic inflammation and reactive changes. Focal changes suggestive of human papillomavirus-associated cytopathic effect. The patient stated that she had only one sexual partner (1st partner for each other). On 06-JUN-2008 the patient was vaccinated intramuscularly into the left deltoid with the second 0.5 ml dose of GARDASIL (lot no. 660387/1967U). At the time of this report, the patient was still positive for human papilloma virus. The patient sought unspecified medical attention. The reporter considered human papilloma viral infection to be other important medical event. Additional information is not expected. All medical records are available upon request.
Patient received a pneumovax and a flu shot in the same arm on Oct 13. Stated she started having some normal post immunization symptoms about an hour after she left the store. Flu like symptoms. Yesterday, she started having more symptoms. Today she went to urgent care with the following symptoms: red, swollen, hard, right arm all the way from neck to hand, body aches, blurred vision, chest fullness, pain in neck, headache, tingling in right hand and can't raise arm. Nurse practioner dx as cellulitis. Patient was given a 10 day course of bactrim.
Tested Positive for COVID-19 after full vaccination and booster dose. Completed 2 doses on April 8 2021 and Booster on 21 Nov 2021. Tested positive for COVID on 28 Nov 2021. Symptom-Lost sense of smell and taste
Appx. 100x150mm nodule with swelling and redness by day three after vaccine. Zone was warm and tender to the touch. No other reactions. On 8/09/02, pt presents with 15cm diam. firm, non tender subcutaneous nodule in right deltoid area and another 1cm nodule in right deltoid.
Fever, chills, headache, nausea, exhaustion. Treating with Tylenol and Motrin. Getting better but will likely not be back to normal w/in 24 hrs.
Very bad reactions; unsteady; Never been this sick from vaccines, Stay in bed all day; Disoriented; Fever 101°F for 8 hours; Nausea; Very bad headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented) and PYREXIA (Fever 101°F for 8 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B and 052E2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Anxiety and Breast cancer. Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Batch number: ER8733, Adverse reaction lasted 3 days.) on 02-Apr-2021, Pfizer (2nd dose and Batch number: EW0172) on 23-Apr-2021. Past adverse reactions to the above products included Fatigue with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included Allergy to antibiotic (Cipro), Allergy to antibiotic (Bactrim), Allergy to antibiotic (Azithromycin), Drug allergy (Zantac), Drug allergy (Nexium), Drug allergy (Omeprazole), Drug allergy (Protonix), Drug allergy (Tizanidine) and Drug allergy (Antihistamines). Concomitant products included CITALOPRAM, ZIPRASIDONE, LORAZEPAM, GABAPENTIN, LETROZOLE, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), PYREXIA (Fever 101°F for 8 hours), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 08-Apr-2022, VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, PYREXIA (Fever 101°F for 8 hours) had resolved.            She did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Other concomitant products include Bupropion SR and Multivitamins.
Agitated, aggressive, violent approx. 1 hr post injection. Didn't sleep through night first few days, waking crying, having tantrums, seems to be getting better each day. Would wake from naps crying. This lasted all week (injection was given on Tuesday). On Thursday morning pt was given a typical breakfast (whole wheat toast with jelly same brands for over a year) and instantly broke into hives on his face. His dad stopped feeding him-didn't medicate-and hives subsided. Went food shopping and while there pt ate a breakfast bar (same brand as always) and plain gold fish (cracker flavor). Went down for a nap at 11:30 woke at 1:15 face covered in hives (left eye nearly shut), medicated with Benadryl and phoned doctor-said to bring him in 1/2 later, by then hives subsided due to medication. Doctor said none of this could be from DTaP vaccine. Must be starting terrible two's and he must have eaten some things without our knowledge that caused the hives (impossible).
Information has been received from a nurse referring to a patient of unknown age and gender. On 04-NOV-2015 the patient was vaccinated with his/her respective second dose in the VARIVAX immunization series that was improperly stored, lot # L019130, expiration date: 27-MAY-2017 (dose, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
After receiving my second shot of the Pfizer vaccine on 03/27/2021, On  04/04/2021, my left arm started hurting and then  it started swelling.  The following 2 days, my ankles and legs got swollen.
Patient seemed slightly nervous but comfortable receiving her vaccine.  She moved to the observation area after.  It was observed her face was quite red.  She states she had a headache.  I sat to talk to her and checked her blood pressure.  Her blood pressure was 141/91 and pulse 127.  She said her blood pressure was usually normal.  She had drank coffee that morning.  We continued to monitor her pulse and blood pressure which were both high.  Her heart rate went to above 140.  She would occasionally shake and said she felt something electrical.  She stated her brain felt numb.  At that time paramedics were called. She declined to be taken to hospital.  She was observed a bit longer than a co-worker gave her a ride home where she said she did have a family member at home.
Pt. developed 2 episodes of tonic seizures following short syncope - immediately after administration of vaccines. Symptoms resolved in 5 min., was observed for 45 min - back to usual state of health. Hx of multiple fainting during vaccinations and blood drawing.
Papules on trunk and extremities, like chickenpox; This spontaneous case was received on 08-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03165) and concerned a 19-year-old, female patient.  The patient's current condition included asthma. The patient's concomitant medications were not reported.  On 29-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper left arm) for flu prevention. The batch number reported was P100247215, expiration date: 30-Jun-2021.   On 30-Sep-2020, reported as the next day, one day after vaccination with Afluria Quadrivalent, the patient developed papules on trunk and extremities, like chickenpox. It was reported that the patient did not have any treatment associated with event.  The outcome of the event 'papule' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Papule were associated with the use of the suspect product Afluria Quadrivalent. One day after vaccination with vaccine, the patient developed papules on trunk and extremities, described as 'like chickenpox'. The patient's current condition included asthma. Concomitant medications were not reported. With information presented, causality is assessed as possibly related due to plausible chronology.; Sender's Comments: Papule were associated with the use of the suspect product Afluria Quadrivalent. One day after vaccination with vaccine, the patient developed papules on trunk and extremities, described as 'like chickenpox'. The patient's current condition included asthma. Concomitant medications were not reported. With information presented, causality is assessed as possibly related due to plausible chronology.
Rectal abscess; This is spontaneous report from contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Apr2021 (lot number and expiry date: unknown) at the age of 60-years-old, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Apr2021 (3 days after the first jab), at 7:00 AM, the patient had rectal abscess. It peaked in 10 days, and without the surgery it disappeared in about 17-18 days. The event was considered serious, medically significant. The event resulted in healthcare professional office/clinic visit. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on unspecified date in Apr2021.  Information on lot/batch number has been requested.
Left sided numbness/tingling with left leg weakness Abdominal area numbness/decreased sensation
I had sore throat about several hours later after I got the flu shot. Then I got a cough and catch a cold. And It's more and more serious athough I had eat medicine every day.
Child refused to have immunizations in her arms. DtaP, Hib, Polio were given in the left thigh.  MMR was given in right thigh.  Mother noted swelling and fever in left leg.  TYLENOL given and soaks applied, phone private medical doctor for follow up.
stroke; This is a spontaneous report from a contactable consumer. An adult female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took dose 1 of bnt162b2 on unspecified date (batch/lot number was not reported) for covid-19 immunization. The reporter informed that it was unknown if patient received other vaccine in four weeks and other medications in two weeks. On an unspecified date, the patient experienced stroke. The reporter informed that the patient had a stroke months ago after getting the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
t103 last >24 hrs; fussy kept crying through noc, woke up every 15 mins & cried;
states she developed back pain unable to move, pain mid back shoulder blades and small headache intermittently; unable to sleep; feeling better at time of notification
Developed rash on right side on 07/23/2002. Child was seen in our office on 08/02/2002, Diagnosed with shingles and prescribed Zovirax.
6-10 days after 2nd vaccine rash started on arms, legs, feet.  Rash varies with raised dime sized welts to larger flat rashes.  Very itchy, esp. closer to joints.   Rash has increased with time and has not resolved
patient prematurely pulled away while receiving IPOL injection with no reported adverse event; Initial information received  on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old female patient prematurely pulled away while receiving injection with no reported adverse event ,while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the IPOL was given with 4 other vaccines, however he did not know which ones.    On 28-Jul-2022, the patient received a  dose of suspect IPV (VERO) lot number not reported via subcutaneous route in the arm nos for immunization.   On 28-Jul-2022 (latency: same day), the patient prematurely pulled away while receiving ipol injection with no reported adverse event  (incorrect dose administered) following the administration of IPV (VERO).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown   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.
Chills, fever of 100.4 (normal for me is 97.6). Continued off and on for 3 days. Site of injection still tender.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The pharmacist was unaware if the patient is taking any medications and if patient had any side effects.
Reported feeling light headed.  Was given juice and crackers.  At 10:40 stated it was worse. Alert and oriented x3. Skin pink warm and dry.  Respirations even and unlabored . Chatting with friends no sign or symptom of distress.  PSo2 99% heart rate 83.  1048 released to school nurse no signs of distress.  School nurse said she would call if any problems.  No report of problem at time of report 2:24pm.
Flushed sensation & rasp voice post injection while in observation area.  Patient sat for a total of 30 minutes.  She refused to seek any treatment & reported no worsening of her symptoms during her observation time.
I RECEIVED THE VACCINATION AT 11:00 AM.  BY 5:00 PM I WAS SO TIRED I COULD NOT STAY AWAKE.  I USED THE TOILET AND FELL ASLEEP ON THE TOILET.  THE NEXT MORNING I ATTEMPTED TO WORK (I WORK FROM HOME) AND I WAS SO TIRED I WOULD FALL ASLEEP DURING ZOOM CALLS.  ON SATURDAY MORNING I WOKE UP FEELING VERY MISERABLE.  ALL OF MY LARGE MUSCLES HURT, I FELT LIKE I HAD BEEN RUN OVER BY A TRUCK.  THIS GRADUALLY STARTED GETTING BETTER.  BY 3:00 PM THE MUSCLE ACHES AND SLEEPINESS WERE GONE.
Swollen lips, Nausea, Vomiting, Rash over arms and neck, Temp: 96.4. Benedryl started at 10:00am on 05/06/2022-25mg Q 6hrs. Still currently taking benedryl. Complaints of aches and a few very small flat red areas still present.
Hands were peeling really badly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 66 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN EXFOLIATION (non-serious), outcome "unknown", described as "Hands were peeling really badly". Additional information: due to getting the COVID Vaccine shot, her hands were peeling really badly, felt like a chemical peel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 15-JAN-2021, I experienced menstrual bleeding outside of my usual monthly cycle. My menstrual cycle has always been "like clockwork" - every 28 days, and I would bleed for exactly 7 days. I can describe in detail my bleeding pattern - the first day was always light brown blood and then the remaining 6 days of my cycle I would menstruate bright red blood with an occasional small blood clot. Since my first COVID-19 vaccine, my cycles have completely changed. I now have occasional "break-through" bleeding where I will bleed or spot on days I'm not due to menstruate. My periods are on average 8+ days now. The menstrual blood itself even looks different. My bleeding is now mainly brown in color - I only bleed "red" on 2 days out of the 8+ days that I menstruate. The consistency menstruation has changed as well. I can best describe my bleeding as viscous and very "stringy" - long, string like bleeding. My cramps have increased as well and my periods are much more painful. I have now received my Pfizer COVID-19 booster shot, and the period I am experiencing now is the worst yet.
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in right arm on 15Apr2021 (Lot number: ER8731, patient was 69-year-old at the time of vaccination) as single dose for COVID-19 immunisation/ because of the better protection for her. The patient's medical history included metastatic breast cancer. It was reported that patient also take ibrance (start date: Dec2020, dose: 100 mg daily for 3 weeks and one week off, Film-coated tablet) for metastatic breast cancer. There were no concomitant medications. Reported that she thinks that she caught COVID from someone. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 69-year-old at the time of vaccination), via an unspecified route of administration in right arm on 20Mar2021 as single dose for COVID-19 immunisation. On 02Jul2021, the patient experienced she has COVID/came back positive on 03Jul2021. On 02Jul2021, the patient underwent lab tests and procedures which included COVID nasal swab resulted as positive 03Jul2021 in the evening. Caller stated that her head is foggy on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information expected.
Severe abdominal pain (no nausea, no vomiting, no diarrhea, no gas, just CRAMPING not relieved by Tylenol or ibuprofen)
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and 0.55 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Deep pain in bones of arm now goes down to elbow and is experiencing a sharp pain in left hand
Received flu shot on 12-13-07.  On 12-14-07 developed a rash and/or whelps scattered over body.
I had received the vaccine in my arm. Sat down at the chair for my 15-min time period. During the first 10 minutes, I felt fine. I received my appt for my 2nd dose. After 10 minutes, heart rate went into a rapid beat. I had my pulse oximeter on me, which read my rate was 150 bpm. It stayed that way for almost 45 seconds before returning to a normal rhythm. This was a frightening symptom. And for the rest of the day at work, I was dizzy and unable to stay focused. I reported my symptoms to my coworkers. I had to take frequent rest breaks. So with these concerning symptoms, I choose against the 2nd dose, for fear of my reaction being worse than the first.