chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluttering skipping heart; can't catch breath; Numb tingling left arm, both calves numb; dizzy spells; bad temple pain; nausea; swollen; numb lips; blurred vision in left eye; This is a spontaneous report from a contactable consumer. A non- pregnant female patient 48 years old received (Age group 18-64 Years) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 17:00 (age at vaccination 47 years) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Fish (Known allergies: Fish, sensitive to Valium). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took valium and experienced drug hypersensitivity, Synthroid (take Synthroid daily). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited Doctor or other healthcare professional office/clinic visit. On 22Apr2021 17:30 the patient experienced fluttering skipping heart, can't catch breath, numb tingling left arm, both calves numb, dizzy spells, bad temple pain, nausea, swollen, numb lips, blurred vision in left eye. Patient did not receive any treatment for reported events. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Guillain-Barre syndrome, hospitalized as a result; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The reporter was patient husband. The reporter stated that the patient received the first dose of the vaccine and then developed Guillain-Barre syndrome. The patient had been hospitalized as a result and had received two complete rounds of intravenous immunoglobulin infusions. The reporter give consent to follow up.
Patient is a 59 y.o. male transferred, presents with right foot pain.  He states this has been going on for about a month, but acutely worsened last night.  He has still been able to walk on it.  He has chronic neuropathy in his bilateral feet, but the increase in numbness in his right foot is new.  He has also noticed it being cold to the touch.  He has never had this happen to him before.  He is chronically on warfarin, but was off of it for about 3 days due to difficulty getting it filled to his pharmacy.  His last dose was this morning however.  He is on insulin for his diabetes, and states his sugars run approximately 150.   Round to be COVID positivie incidentially.
Patient is complaining of a large red lump on her arm.  She says it is itchy and warm to the touch. She says her arm is swollen and red with a few small pimples.  Patient was instructed in the afternoon to take a Claritin to help with the itchiness by the pharmacist who had given her the shot. She called back later in the evening stating that it did not help so I instructed her to contact her doctor. After that she said that it wasn't that bad that she should bother the doctor tonight so she will call the doctor in the morning.
4 hrs p/vax administered pt devel cyanosis of LE which spread up to body over 4 hr period; pt then pale & diaphoretic x 5 mins; no wheezing, no vomiting, no LOC;
Localized skin reaction. No s/sx of systemic reaction. Occurrence on 07/01/2020
I have developed an approximately 2 in area of swelling with hard marble type lump underneath skin.  The area seems to be getting larger, is painful to touch, and bruising is extending from edges.  My under arm is also tender with touch and movement.
SAB/Miscarriage at 9 weeks gestation on 3/2/2021. Was 3 weeks pregnant on date of vaccine 1/20/2021, was unknown to be pregnant at the time. Had spontaneous miscarriage 6 weeks later.  Have had prior uncomplicated pregnancy and delivery in 2018. No history of pregnancy loss/infertility.
Patient reported getting her menstrual cycle the morning after receiving the vaccine.  She reported she has not menstruated since February of 2020.
Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches.  Chills subsided in 4 hours, muscle aches in 6 hours.
Patient's wife called to stated pt. had "bad reaction right arm is swollen red & hot w/a red ring on the whole arm."
4 inch elongated rash just below injection site; rash is warm, itchy, and bumpy
Temp > 103 24 hours post vaccine chills, leg pains and weakness; skin painful, mild HA. Ruled local reaction. Rx TYLENOL. Sms persisted 24 hrs.
Itching,  red  painful lump at injection site . Warm to the touch.  At midnight after receiving vaccine
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 16-OCT-2012 09:48, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant, for the Pregnancy Registry for VARIVAX (Merck), concerning a 27 year old female who on 01-AUG-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot number, injection site and route not reported). Subsequently the patient had a positive pregnancy test. Unspecified medical attention was sought. Follow-up information has been received from the medical assistant who indicated that the patient had a miscarriage at 14 + 5/7 weeks gestation, and ultimately needed a dilation and curettage (D&C) afterwards. Upon internal review, miscarriage was considered an other important medical event. Additional information is not expected.
has had primary Janssen plus Janssen booster developed sx cough, runny nose, congestion, temp 100.7F  tested positive for covid on abbott id now molecular
Within 2 minutes of vaccine, my heart rate was very high. I could feel a radiating feeling down my arm. For the next several hours, my heart rate was very high and I could feel my heart thumping. The next day and a half my heart has hurt if I took a deep breath in.
FELL ASLEEP; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced fell asleep. On 14-MAY-2021, the subject experienced very tired.  Laboratory data included: Body temperature (NR: not provided) 100 degree. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, very tired and fell asleep was not reported. This report was non-serious.
No adverse reactions or symptoms following administration of either dose of the vaccine. However, approximately 1 month after the second vaccination, I had my biannual teeth cleaning, where it was noted that I bled excessively with the cleaning and following the cleaning for approximately one half hour. The bleeding then stopped. I have good dental health and do not take any blood thinners or birth control. I have had no issues since then and have not had a second cleaning done yet as it is not due.
Little bit headache; Muscle pain; Little bit tired; This is a spontaneous report from a contactable (patient). A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 21May2021 (at the age of 33-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0169) via an unspecified route of administration, administered in Arm Left on 30Apr2021 (at the age of 33-years-old) as single dose for covid-19 immunisation. On an unspecified date in May2021, after second shot, patient experienced feeling like little bit headache and muscle pain. Reported that was not heavy, but just like little bit tired. Patient inquired that he could take pills for the pain, Tylenol or Advil. Patient was not treated for the events. The outcome for the events was unknown.
Round red circular rash on left upper forearm about 1.5 inches from injection site.  Pruritic.  Responded to Zyrtec and Hydrocortisone cream X 2 days.  Symptoms lessened, but continues to be present.  Rash is much more diffuse in color and less itchy.  Currently taking no medication for these symptoms.
breakthrough case; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough case) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (breakthrough case) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough case) outcome was unknown.            The concomitant history was not reported. The treatment history was not provided. Patient had taken a booster shot.  Company Comment: Very limited information regarding these events has been provided at this time. Further information is not to be expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is not to be expected.
Fever, body aches and chills began Tuesday, 1/26/21 @ 1:10am. Took Tylenol, but fever and chills did not go away completely. Right arm continues to be extremely sore even after taking Tylenol
Upper and lower lip swelling (Angioedema). Upper lip tingling. Took benadryl, gradually resolved on Monday (10/30/2023), resolved completely w/ prednisone. Has residual upper lip tingling, gradually getting better.
I received the Janssen vaccine on 4/8/21 at 12:00 pm.  By 5:00 pm that day I began having flu-like symptoms (fatigue, body aches, nausea).  These symptoms carried through to the next day (4/9/21).  When I woke up at 6:00 am on 4/10/21 I had a rash on the backs of my upper arms and the front of my thighs.  As the day went on, the rash progressed to cover my entire body.  I went to the ER around 2 pm where I received a steroid injection and was prescribed oral steroids.  I was fatigued for the next two days, but was able to return to work on 4/12/21.  The rash began subsiding, but overall lasted 2-3 weeks.    I completed my seven day prescription of oral steroids on 4/17/21.  On 4/18/21 I was very fatigued.  On 4/19/21 and 4/20/21 I was extremely fatigued and unable to get out of bed, sit up, or stand up.  On 4/23/21 I woke up at 7:00 am with a swollen face, throat, tongue and lips.  I returned to the ER where they prescribed me another round of steroids, but a lower dose and a longer duration.  I experienced fatigue for 6 weeks after receiving the vaccine.
Three days after receiving my booster, I was feeling lethargic and had mucous everywhere. I had sinus issues and a sore throat. Around midday I couldn't stop coughing. The lethargy lasted about 5 days. On Monday, 12/27, I saw my physician and was prescribed high dose steroids for 15 days. Since I was coughing up clear/yellow mucous, I was not prescribed antibiotics. I have had two COVID tests, which were mandatory from my employer, and both tests were negative.
Few hours after the administration pt developed dizziness headache and vomiting. ? day after she developed papulaoerythematous rash on face and upper chest. Pt given Benadryl and medrol dose pak.
Pt describes swelling at injection site at 40 hours after injection, redness and fever, pain in elbow of injection arm, approximately 60 hours post injection, swelling of half the face, opposite the injection arm. Slight temperature, and redness and warmth of half of face.
Pt received DTAP, IPV, HIB, Prevnar and Hep-B on 4/29/02. On 5/1/02, was noted to have jerky movement of body and eyes rolled up.
This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Resident is weak and unable to get out of bed and resident is up everyday by 0800. Her R arm is sore and warm to touch at the injection site in comparison to the rest of her arm.
c/o generalized itching and tingling in throat. EMS notified and handed off to EMS
vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine administered after beeing in the fridge for 40 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine administered after beeing in the fridge for 40 days). At the time of the report, PRODUCT STORAGE ERROR (vaccine administered after beeing in the fridge for 40 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Administered 0.5cc of Prevnar, RT, IM and 0.5cc of Hib, LT, IM per doctor's orders. Per F/U 4/15/02: Group A Streptococcal Sepsis, tracheitis and bronchitis (chronic); cerebral edema with herniation of brain, temperal lobe; thymic petechiae; S/P attempted resuscitation; Blunt force injury of abdomen-laceration of the gastro-splenic ligament, avulsive, recent; retroperitoneal and perinephric hematoma, left (10ml), recent; hemoperitoneum (35ml); blunt force injury of right leg with contusion of thigh, small, organizing; child's abdominal injury is inconsistent with resuscitative efforts. The child was reportedly found unresponsive in his crib by his mother on 3/1/01 AM. She and the child's grandmother are reported to have initiated CPR and called for EMS. EMS found the decedent "unresponsive and cyanotic" at the scene and transported him to the ER. The child's body temperature (R) was measured at 107.9F at the ER.
Chills, body aches, skin sensitivity (clothing and blankets felt scratchy and painful), restlessness (could not get comfortable), nausea, vomiting, insomnia. Side effects began 7 hours after vaccine and lasted for 12-18 hours.  Side effects had subsided 24 hours after vaccination.
first dose of Shingrix more than 2 years ago on 17Feb2019 / not received the second dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 17th February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The 1st dose was received more than 2 years ago from reporting date. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient had received 1st dose of Shingrix at primary reporter's facility. No vaccine data was reported. The reporter consented to follow up.
chills so bad; Muscle pain; felt so bad; headaches really bad; fatigued; Dry cough; This is a spontaneous report from a contactable consumer (patient) (phlebotomist). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (at the age of 51-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Medical history included one kidney and high blood pressure. Concomitant medications included losartan (50mg once a day) taken for one kidney and high blood pressure; clobetasol (0.6mg tablet by mouth daily) taken for high blood pressure; furosemide (LASIX [FUROSEMIDE] (40 mg once a day) taken for high blood pressure all from an unspecified start date from last 4 to 5 years or maybe longer and was ongoing. No prior vaccinations within 4 weeks of COVID vaccine. No additional vaccines were administered on same date of the Pfizer suspect. On the 22Mar2021, the patient started getting sick. The patient had so bad chills and muscle pain, felt so bad, had really bad headaches, fatigued and dry cough. On 26Mar2021, the muscle pain, headache and chills were better. She was still having the fatigue and cough. It was reported that 26Mar2021 was the first day out of bed since 22Mar2021. The patient called her physician because she was really concerned. Her physician said that it was from the vaccine and to take Tylenol and rest. The outcome of chills, muscle pain, headaches and fatigued was recovering; the outcome of felt so bad was unknown while the outcome of dry cough was not recovered.   No follow up attempts are possible. No further information is expected.
R scalp tenderness/burning sensations onset early july 2021?persistent but not continuous?starting mid august had additional symptoms of same description involving R upper ear, R upper/lateral eye orbit, also intermittent R sided upper and lower lip tingling, and sporadic sharp stabbing pain (1 second duration) in R inner ear?symptoms have been persistent but not continuous and not severe but ?annoying?
Patient given adult dose of Covid 19 vaccine - patient was monitored for the required 15 minutes, no reactions
Fever 102 degrees for 12 or more hours. All over body pain, crippling skin pain all over body that restricted movement. Headache for several days, extreme lethargy, pain at injection site still at 6 days post injection.
Information has been received from a nurse concerning a 4 year old child who, over the past month, in approximately July 2006, was vaccinated with MMR. Concomitant therapy included PEDIARIX. Unspecified medical attention was sought. About 2 days after injection, in approximately July 2006, the patient experienced cellulitis at the injection site. About five days after injection, in approximately July 2006, the patient recovered. The reporting physician also reported the experiences of 4 other patients with MMR (WAES # 0609USA00641, 0609USA00642, 0607USA05076, 0609USA00644). Additional information has been requested.
Patient called clinic the following day to report that she felt extreme pain while getting the vaccine, pain located in front of her upper arm, but not in the location of the injection. When lifting arm, it is difficult and causes pain to lift. unable to lay on that arm and had difficulty sleeping. No bruising or swelling.
Fever, knot on left arm from injection site (left deltoid) to elbow, unable to move without pain.
an expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was had an expired dose of tenivac was administered to a patient with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength, dose, route and administration site not reported; lot U6669AA, expiry date: 15-May-2022) for prophylactic immunization.  On an unknown date, the patient developed a non-serious event of an expired dose of tenivac was administered to a patient with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported, "an expired dose of TENIVAC was administered to a patient. The TENIVAC had expired on 15MAY2022".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Fever (100.4) for about 12 hours; body aches; bad headache (24+ hours); swelling and pain at injection site.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000434, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, NauseaVomiting, Syncope, Injection site pain Narrative: