chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uncontrollable vomiting/Threw up; Gestation period when reaction/event was observed in the fetus: 15 weeks; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 27Jan2021 (at age of 29 years old) as single dose for COVID-19 immunization. Medical history included Asthma, Known Allergy: sulfa medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was prenatal vitamins. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot No: EJ1686) on 08Jan2021 (at age of 29 years old) at arm left as single dose for COVID-19 immunization. Gestation period when reaction/event was observed in the fetus was 15 weeks. Patient last menstrual period date was 12Oct2020. Pregnancy Due Date was 18Jul2021. About 16hrs after second vaccine, on 28Jan2021, patient had uncontrollable vomiting. Couldn't keep down food or water. Threw up 7 times before going to the ER. Date of start of reaction/event was 28Jan2021. No Hospitalization Prolonged. The adverse event result in: Emergency room/department or urgent care. Treatment received for the adverse event (IV Zofran, fluids, bloodwork). The outcome of the event was recovered in 2021.; Sender's Comments: Based on the current available information and the close drug event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event vomiting cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Generalized rash began four days ago. Redness at site <5mm, frontal sinus HA after getting shots. Rash progressively getting worse-diffuse scartina form rash.
When getting the shot, the vaccine or fluid in the syringe was dripping on the arm; When getting the shot, the vaccine or fluid in the syringe was dripping on the arm; Tiny bity pain tenderness and soreness on the injection site at her left arm; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm), UNDERDOSE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm) and VACCINATION SITE PAIN (Tiny bity pain tenderness and soreness on the injection site at her left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Allergy to antibiotic.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm), UNDERDOSE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm) and VACCINATION SITE PAIN (Tiny bity pain tenderness and soreness on the injection site at her left arm). On 05-Apr-2021, DEVICE CONNECTION ISSUE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm) and UNDERDOSE (When getting the shot, the vaccine or fluid in the syringe was dripping on the arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Tiny bity pain tenderness and soreness on the injection site at her left arm) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-178629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26 May 2021 had new information regarding reporter, patient, allergies and information regarding second dose.
After 1st shot-24 hrs later. pain in L elbow with weakness and seemed to have limited ROM. No reddness or swelling but some warmth at site 2nd shot-within 10 same symptoms with elevated pain and decreased weakness
incorrect mixing covid shot Pfizer brand administered as second dose, patient originally received moderna brand as first dose
Patient inadvertently received a dose of ActHIb reconstituted with an MMR diluent (sterile water)/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (reference number- 00626689) and transmitted to Sanofi on 03-Jun-2021.  This case involves a 6-months-old female patient to whom healthcare professional (HCP) administered the dose of 0.5 mL ACT-HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, batch number: UJ405AAB and expiry date: 08 Oct 2021via intramuscular route at left thigh administration site) after diluting with MMR diluent (sterile water) (product preparation error) on 26 May 2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  Reporter requested guidance on how to proceed.  At the time of reporting, no adverse event was reported.  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.
mom called clinic 28SEP92 to report this ? reaction; 25SEP92 mom stated pt had inc swelling of rt leg & face, t104; MD told mom to given pt DPH; 27SEP92 inc crying ? high pitch sound-hosp ER t101;
Had the chills, body aches, headache, nausea, muscle pain and fever all happen at once about 8 hours after receiving the vaccine and continued throughout the night. Took 2 Tylenol to help with symptoms. Still feeling very weak and achey this morning but no chills, nausea or fever currently
Went to ER 6/17/09 0200 for chills, fever, bodyaches, chest pain, dizziness, nausea. Asthma type s/s starting <12 hrs after Tdap. -No rash-. Reports given shot, steroids, PO at ER. Told they couldn't say for sure it was an allergic reaction to Tdap. No problems now. Site of shot normal.
Tinnitus began intensely 4/29/2021.  Was prominently in one ear for the duration of the day.  Lessened by next day, but present and constant in both ears now.  Continues in both ears despite completed round of prednisone prescribed by physician and use of Flonase.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, lot number, expiration date were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Symptoms: shortness of breath Diagnosis: acute shortness of breath Treatment: Epipen 0.3mg dose was given at 1:20pm to left outer thigh. Second dose of Epipen 0.3mg  given at 1:43pm to right outer thigh. Patient was then transported to Medical Center through EMS.
8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot and had speeding and heavy heartbeat while body temperature exceeded 100 degree fahrenheit. Dizziness and fever persisted for over 24 hours until taking Tylenol and a night of sleep.
Noted significant decrease in eye contact, smiling, and vocalizations for 4 days following vaccine. Increased Moro response with difficulty calming child. Movement patterns became ataxic. Child had an excema flare on right knee, stomach, and behind ears for several days.
Lymph node on affected arm was swollen just below the clavicle. It was the arm where he received the TD and Hep-B.
PATIENT CAME TO MY PHARMACY ON SATURDAY THE 7TH ABOUT 5.30PM, AND COMPLAINED THAT I GAVE HIS VACCINATION TO HIGH UP IN HIS RIGHT ARM, AND SIGNALING THAT A NERVE WAS DAMAGED AND THAT HE DID GO TO HIS DR TO COMPLAIN AND HE WAS SENT TO THE THERAPIST. HE SAID IT WAS A LITTLE BETTER WHEN HE CAME IN ON SATURDAY, AND HE WANTED SOMEONE TO KNOW WHAT HAPPENED.
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm and on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31May2022, outcome "unknown", COVID-19 (medically significant) with onset 31May2022, outcome "recovering" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical Information: Facility type vaccine: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. If covid prior vaccination: No, If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination: Nasal Swab, Covid test name post vaccination: BinaxNow, Covid test date: 31May2022, Covid test result: Positive. Known allergies: No. Other medical history: None. No treatment received for adverse events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
PATIENT RECEIVED VACCINE ON 02/01/2019. ON THE MORNING OF 02/02/2019, PATIENT'S UPPER ARM WAS SWOLLEN AND RED. THE FOLLOWING DAY PATIENT'S ARM WAS "PINK AND SLIGHTLY SWOLLEN". PATIENT DENIED ANY RASH/FEVER, BUT DID CONFIRM THERE WAS SOME MILD ITCHING AT THE SITE. ON THE THIRD DAY POST VACCINE, PATIENT REPORTS ADR WAS RESOLVED: NO MORE ITCHING, REDNESS, OR SWELLING.
stiff neck; painful neck; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had outbreak 35 years ago), neck pain (during outbreak) and stiff neck (during outbreak).   On 10th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st June 2021, 11 days after receiving Shingrix, the patient experienced stiff neck and neck pain. On 21st June 2021, the outcome of the stiff neck and neck pain were recovered/resolved.   It was unknown if the reporter considered the stiff neck and neck pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received dose of Shingrix and approximately 11 days after receiving the Shingrix dose he had the same stiff and painful neck, which resolved on the same day. The patient consented to follow up with his physician.
Bottom lip doubled in size; Bottom lip cracked in the middle; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain). At the time of the report, LIP SWELLING (Bottom lip doubled in size), LIP DRY (Bottom lip cracked in the middle) and PAIN IN JAW (Jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Severe headache, migraine strength. Started as a neck ache about 4 hours after receiving the vaccine then progressed into debilitating pain. It hurt to move, breathe, etc. The worst of the pain started at 11 pm and lasted for 4 hours. I need to stress that this may have been a result of volunteering and dehydration, not the vaccine itself.
DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9291), via an unspecified route of administration in left deltoid on 24Dec2020 10:00 at first single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Caller was calling to report a possible adverse reaction to the Pfizer Covid-19 vaccine. The patient was currently at hospital, she was admitted for deep vein thrombosis (DVT) of left iliac vein, the patient had no past history as to why this would happen, that she is only 28 years old. Received the vaccine on 24Dec2020, the following day she did have pain in same site where DVT was. Took ibuprofen for the pain. The patient was admitted yesterday 04Jan2020 for the DVT, they were currently treating her with Lovenox injections and prescribing dose for discharge is Eliquis. CT scans and three shots of Lovenox for it, doing a doppler of bilateral legs and echocardiogram (echo) of her heart to make sure there is nothing else. The AEs require a visit to emergency room. The patient was asking if she can still get the 2nd dose based off the adverse event she experienced. Outcome of DVT was not recovered, of pain was unknown.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/23/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/23/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
pt recv vax 7JUL95 & exp sudden onset of h/a w/in 5mins of receiving the vax;h/a's returned 3 to 4 times a day & lasted mins to an hr;lab testing & EEG were unremarkable;optometry showed the pt was sl nearsighted;
Red swelling of entire arm. Pain over the entire arm. Red rash and swelling on the upper back. Itchiness.
Confusion and disorientation onset in morning of 4/29/2021. Did not know where I lived and various other things. Confusion and disorientation again on 5/13/21. Was assigned to neurologist and consultation 5/24/2021. Ordered a 72 hour EEG.  EEG report determined that I had partial seizures in my temporal lobes. Three discrete seizure events during the 72 hours analysis. These affect the left anterior temporal region of the brain. This corrolates to forgetting events and locations.
This spontaneous report as received from a pharmacist refers to an unknown age and gender patient. Pertinent medical history, drug reaction or allergies were not reported. On 07-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. On 07-NOV-2013, the patient experienced an immediate allergic reaction to ZOSTAVAX. The nature of the allergic reaction was not specified. It was reported that the patient sought medical attention in the pharmacy. The outcome of the patient experiencing an immediate allergic reaction to ZOSTAVAX was not reported. Causality was not reported. Additional information is not expected.
Pain, redness, rash, fever of 103.8, shivering, feeling tired, muscle pain, joint pain, sweating. Duration of approximately 20 hours.
Patient DOB 1/22/1985 was vaccinated on 4/1/2021 with 1st dose Pfizer, lot EW0150 expiration date 7/2021. Patient informed RN-BSN student that 4 hours after receiving the 1st dose, she felt weak and tired. Her symptoms progressed to pain and cramping. At 3 days post-injection, she developed nausea, vomiting, shortness of breath, and severe headache. She lost consciousness for an unknown amount of time, waking up in the morning after vomiting. Symptoms resolved at 6 dyas post-injection. Patient denied allergies or medications. Medical conditions include thyroid nodule, and prediabetes. Patient reported she did not go to the ER but did follow up with provider who approved 2nd dose of Pfizer.
Admission date 1/13/2006 AIDP- Acute Inflammatory Demyelinating polyneuropathy. Information received from discharge summary states GBS, urinary incontience, fecal incontinence, decreased reflexes, asthenia, paresthesis. msv
Dizziness; Foggy brain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had no known allergies. 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 08Apr2021 at 12:15 the patient experienced dizziness, foggy brain. 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 of the events dizziness, foggy brain was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 19FEB96 & 20FEB96 felt achy & exp joint pain all over;
11/19/03: 3.30p flu shot doctors office. sxs by 5pm. Bright red face and body, rash/hives.  Treatment Benadryl and advised to go to ER if conditions gets worse. 11/24/03: trunk of body, arms, legs, face, neck covered with sores/rash, felt sick, achy and tired. Shot of dexamechazone. Prescribed Allegra pills. 11/26/04: body covered with weepy sores, blisters which broke spontaneously oozing clear fluid. Entire skin on body felt burned; inside mouth and lips sore and swollen, trouble swallowing; nausea and muscle aches. Referred to dermatologist. 1/12/04: Annual visit. Rash appears to be fading, some rash remains on face and back, lips/ inside mouth still sore and swollen. Throat tender, hard to swallow and eat, little taste. Mouth dry, lack of saliva. Fatigue.
Anthrax vaccine-currently left arm swollen, tender, and itchy with fever and chills
no adverse event; administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours) and NO ADVERSE EVENT (no adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2022 at 9:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours) 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 EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours).    No concomitant medication information was provided.  The reporter reported that a patient was administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours. She would like to know the validity of this dose that was administered to this patient.  The vial size was 2.5 mL.  The vial was initially stored in the refrigerator on 08-Oct-2022.  The vial was first punctured on 08-Oct-2022 at 2:30 P.M.  The vial was stored in the fridge post its puncture.  The vial did not undergo any temperature excursions.  The vial was exposed to room temperature range for a period less than or equal to 24 hours.  The patient had not reported any adverse reactions at that time.  No treatment information was provided.
Patient presented to the pharmacy for their 2nd dose of the Covid 19 Pfizer vaccine. Stated she was hesitant to get the 2nd dose as she experienced adverse events with the first dose. Patient reported that almost immediately after receiving the 1st dose of the vaccine, their left arm (same arm that patient received vaccine in) went immediately numb and had a tingling feeling  from the top of the shoulder to the bottom of the fingertips as well as the left side of the patient's face went numb and had a tingling sensation as well. Patient reported the feeling in both places continued until lunchtime of the following day (approximately 24 hours after receiving the first dose of the vaccine). Patient stated that the numbing and tingling sensation went away on its own. Patient also reported chest pains and palpitations that started approximately one hour after receiving the vaccine. Patient reports the pains and palpitations being sporadic in nature. Patient reports that the chest pains felt dull and achy. Patient reports that the chest pain and palpitations stopped on their own approximately 30 hours after receiving the first dose of the vaccine.