chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 patients affected: Patients were administered Adacel (Tdap) vaccine between 2/3-2/10. on 2/10 it was discovered that the refrigerator had a temperature excursion starting at 22:35 on 2/2, reaching a max temp of 48.9 degrees for approx 130 hrs. Sanofi was contacted to check the viability of the vaccine. Sanofi advised that the vaccine was "most likely viable" but it was up to the physician to decide if revaccination is needed. Per provider he did not wish to revaccinate patients at this time.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for self that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller is due for a second dose of covid vaccine tomorrow. She has tested positive for covid before second dose. Outcome of events was unknown.   Information on Lot/Batch number has been requested.
Red rash at injection called covid arm i took potos everyday its lasted 4 days but getting better
LARGE AMOUNT OF SWELLING WITH FIRM MASS ON THE UNDERSIDE OF HER ARM,  STARTED 5 DAYS POST INJECTION , WENT  TO WALK IN AND WAS PRESCRIBED STEROIDS AND ANTIBIOTIC, NO IMPROVEMENT AS OF 2 DAYS LATER
Became fussy and took to doctor. He said it was a virus. Child became worse; went back to the doctor and he had a grand mal seizure and stopped breathing in the waiting room. He was taken to the hospital and almost died from seizures. MR showed cerebral palsy and cortical visual impairment. The 60 day follow-up states cerebral palsy.   Diagnosis from hospital: shaken baby syndrome with intracranial hemorrhage, retinal hemorrhage, Traumatic Stupor - Coma
Continuous mild aching all joints of right arm beginning six hours after vaccination in right arm. No other joints affected. No edema, redness, or warmth.
Patient said she felt like she was blacking out after. Had her lie down. She said she has fainted when getting blood drawn and hadn't eaten anything that day. Gave her some water and juice, felt better in about 5-10 minutes
Sore throat; Low grade fever; Runny nose; Cough; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 69-years-old) at 10:00 as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient known allergies including sulfa drugs. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN) for unknown indication since an unknown date. Prior to the 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 COVID-19 vaccine. On 17Mar2021 at 07:00, within 24 hours after the injection, patient experienced sore throat. Within the next couple of days in Mar2021, low-grade fever and developed a runny nose, cough. It has been over a week still patient experienced sore throat, cough and low-grade fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events sore throat, runny nose, cough and low-grade fever was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever, NauseaVomiting, Fatigue, stomach pains Narrative:
On Day 14 after receiving Vaccine #1, I had intense cancer pains return for 7 days.
Picked up from school 7/8 between 1730-1800. Noted to have hives most prominent on abdomen, right face, right arm, left arm. Rash was pruritic. Improved with diphenhydramine. Continued to wax and wane for 48 hours (time of report). Rash primarily located bilateral cheeks, abdomen, bilateral arms. No other symptoms. No known new exposure at school or detergents.
Fever of 103 degrees F with a febrile seizure within 6 hours of receiving Dtap #4, PCV 13 #4, Hib #4.
Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Previously administered products included for Infertility: LETROZOLE (5 day treatment) in March 2021. Concurrent medical conditions included Drug allergy (celcor) and Drug allergy (sulfa). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Feb-2021 and the estimated date of delivery was 05-Dec-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred  on 16-Mar-2021, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has a history of alcohol use prior which included 1 to 2 glasses of wine per night with dinner and reduced since 11-Mar-2021 and stopped on 02-Apr-2021. The date of positive pregnancy test was 02-Apr-2021 and estimated date of conception was 16-Mar-2021. The mother needed to conceive using clomid and used letrozole twice for this pregnancy. The patient had received prenatal care. Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074215, US-MODERNATX, INC.-MOD-2021-074215 (E2B Linked Report). This case was linked to MOD-2021-208955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Internal review on 20-JUL-2021 resulted in update in pregnancy details, medical history and the outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074215:MOD21-069043 US-MODERNATX, INC.-MOD-2021-074215:
pt recv vax 6AUG98 & a few hr later felt very tired & fell asleep;pt husband reported having difficulty awakening pt;next morning could not recall the event of the prev evening;
Diagnosed with OSA requiring CPAP, fibromyalgia, GERD, B12 deficiency, hyperthese, memory loss, eratic HTN.  Contact member to get copies of medical record.  Nurse follow up on 10/20/04 states: "Obstructive Sleep Apnea, exhaustion, diarrhea, and palpitations."
Pain at the injection site; redness at the injection site; knot in arm; Pain in arm; Arm redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 58160082311 ?, expiry date 16th May 2020) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced local swelling, pain in arm and erythema of extremities. On 17th May 2019, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the local swelling, pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, local swelling, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix on the left deltiod. The reporter stated that the patient experienced pain and redness at the injection site after injection which was resolved but states the pain, redness moved down to the left forearm and also had a knot which was unresolved. The reported batch number 58160082311 did not available in the sales date sheet so captured as 58160082311 ?
Bump at injection site, was seen by doctor for office visit and was told by that doctor to report it to the pharmacy, also advised patient to call.
After receiving MMR shot at age 1, patient lost her words.  About 1 month later, she started making eeee sounds.  At 18 mo, she had 2nd HEP A shot and flu shot, and began spinning and stimming.  8/28/09 PCP notes and vax rec rec'd.  Well baby and child checks until  speech delay noted 3/12/08.  Dx of PDD on 8/19/08.
8/5/09 upper outer arm red, warm 40 x 40 mm, slightly raised no pain, itching. 8/6/09 Area red, warm not raised slight itching 50 x 60 mm.
over exact location where he received his SQ Varicella vacc a cluster of clear fluid filled veiscles on a red base 3.5 cm round
Symptoms began morning after shot. Sore arm (left), headache, high fever, facial swelling, left axillary lymph node inflammation, general discomfort and pain. Lasted approximately 2-3 days.
12hrs after vaccination pt c/o reddness and warmth at vaccination site, @ 18hrs c/o swelling at site, @ 24hrs c/o temp 101, muscle aches, nasal congestion and cough.  Pt also c/o nodule developing at elbow.
The area surrounding the injection is swollen, itchy and hot to the touch as well as very red for several inches around the site.
Arm a little sore; Low grade fever (32C); Headache; Body aches (back and neck); Nausea; Can feel her glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 020B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands). At the time of the report, PAIN IN EXTREMITY (Arm a little sore), PYREXIA (Low grade fever (32C)), HEADACHE (Headache), MYALGIA (Body aches (back and neck)), NAUSEA (Nausea) and LYMPHADENOPATHY (Can feel her glands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 32 (High) 32C.         No concomitant medications were reported. No treatment information were reported.
One week following injection, itching, hardness, heat, swelling and redness at injection site.  Worsened overnight.  No improvement with diphenhydramine.  Some relief with topical hydrocortisone.  Some improvement at 48 hours:  no longer hot, still itchy and swollow, less red and hard
Approximately 12 hours after injection, I experienced hot flashes, chills, and a severe headache. The next morning I experienced a less severe headache but experienced noticeable shortness of breath especially on exertion. Tylenol P.O. helped my headache that morning, no known fever.  Approx 2 days after injection I also experienced a noticeable reduction in the ability to smell or taste. This Stayed for at least another day or so.
I had tingling and rash on my right face. It took two or three weeks to go away. I went to see my doctor about this. They told me that I had Shingles. They gave me an antivirus medicine.
Large local reaction with induration on right arm-Proquad, Large local reaction with induration on Right thigh-IPV
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added, narrative updated.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree celsius (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apt-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805489 was crossed linked to original cases 201804863 due to same reporter.
The next morning after you got to church all of sudden had major flu-like symptoms.  She went home immediately and noticed fever of 100.4, chills, body aches, nausea, headache.  She took Tylenol for this, which eased up some of the symptoms and reduced her fever.  She still had the chills without the fever, but just slept.  Yesterday around 5:00 PM, 3/8/21 the symptoms went away.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated
No adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and concurrent conditions were unknown. No drug reactions/allergies were reported.  On 04-JUN-2019, the patient was vaccinated with an incorrectly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002496 and expiration date 23-JUL-2020, for prophylaxis (dose, strength, frequency and route of administration were not reported.  The patient experienced no adverse events. It was reported that the  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) had a temperature excursion of (-9°C to 8°C) -3 C for a time frame of 3 hours 39 minutes. No previous temperature excursions were reported. Digital data logger was involved.; Sender's Comments:  US-009507513-1906USA008662:Case number: 1247169 US-009507513-1906USA008695:Case number: 1247112 US-009507513-1906USA008903:Case number: 1247164 US-009507513-1906USA008643:Case number: 1247165 US-009507513-1906USA008789:Case number: 1247163
10min p/vax pt got rashes all over body, started on face, was p/10min all over body;urticaria looking, all rashes gone p/2hr
Guillain Barre syndrome treated w/ 5 days IVIG, currently day 4.
Pain in shot area, Fatigue and exhaustion, headaches, physical bodily pains throughout entire body and today diarrhea and vomiting
Patient had FLUZONE immunization 10/21/2010. Onset of red patchy rash approximately 6 hours later on chest. Increasing in size & covering upper and lower extremity. Resolved with OTC BENADRYL.
Patient felt pain Wednesday evening, the day of the shot, around 9P.M. Thursday morning into Friday she couldn't move her arm and it was swollen. She called a nurse on Friday and they recommended she use a cold compress and take Tylenol. Her arm was better by Sunday.
Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown.        This case was linked to MOD-2021-080525 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-080525:caller's case
Patient developed zosteriform eruption in single thoracic dermatome 7 days after Zostavax.
Stomach was upset; Sore arm for about two days; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the 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. On an unknown date in Apr2021 the patient experienced sore arm for about two days. Stomach was upset for about an hour afterwards. No other affects. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events stomach was upset and sore arm was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Initial report received from a health care professional on 07 September 2011. A 63-year-old female patient received an intramuscular injection (route reported as unknown) of FLUZONE, sanofi pasteur Inc. lot number UT450AA, on 06 September 2011. The patient's medical history was unknown. The patient has had previous flu vaccine doses in the past. On 06 September 2011, the patient complained of headache, fever, chills, sore throat, myalgia and wheezing which persists today. The outcome was reported as not recovered. Documents held by sender: None.
local reddness, swelling, heat in area of inj lt deltoid;rx DPH & ice to area off & on;
This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sore throat, rash on the back, swollen lymph nodes in the right axilla, muscle aches, joint pain, slept for 12-14 hours the night post flu vaccination.
pt had red, raised whelps on both thighs 10-15min p/vax given;had one whelp (red, raised) on back;denied itching;gave DPH;