chrisvoncsefalvay/vaers-outcomes huggingface dataset:
persistent high pitch cry and agitation for over 4 hours; irritable for 2 days
Nausea, fever, chills, headache ( major), chest pain, weakness and fatigue.
Body Aches, Fever, Chills, Muscle Pain, Joint Pain, Severe Headache, Severe Fatigue. redness and swelling t injection site Severe Nausea, Face feels like its on Fire.
Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.; Vaccine were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored on 08 Mar 2022 in refrigerator and vaccine administered on 16 May 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patient had not reported symptoms.   Treatment details was not reported by the reporter.  As per Moderna Lot analysis, Doses administered on 06May 2022,16 May 2022,20 May 2022,24May 2022,27May 2022,01June 2022:Moderna cannot guarantee patient received full protection against the COVID-19 Virus.
Patient presented to the ED on 12/13/21 with 2 weeks of dyspnea on exertion and productive cough with positive covid test. Patient is fully vaccinated. Patient was started on dexamethasone and remdesivir given underlying COPD and was discharged on 12/15/21.
Case number PHEH2014US017044 is an initial spontaneous report received from a pharmacist on 25 Aug 2014. This report refers to a 52 year old male patient. His past medical history included flushing in the past, the last episode in spring. On 23 Aug 2014, at 04:00 pm, he was vaccinated with FLUVIRIN (batch number: 145302) intramuscularly and at 08:00 PM, he took NIASPAN (other manufacturer, batch number: not reported). On the same day, at 11:00 PM, he experienced flushing which was so severe that he had to jump into a pool just to cool off. The patient completely recovered from flushing after 3-4 hours of onset. The seriousness and causality of the event were not reported.
Headache; stiff neck; dry mouth; moderate injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew01vz) via an unspecified route of administration in the right arm on 07Apr2021 at 10:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient previously took the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the left arm on 17Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included subacute small fiber sensory neuropathy and partial paralysis. Patient previously received penicillin for an unknown indication on an unknown date and experienced drug allergy. Concomitant medication included pregabalin (MANUFACTURER UNKNOWN) for an unknown indication from 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 vaccination. On 07Apr2021 at 10:45,  the patient had headache, stiff neck, dry mouth and moderate injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events of headache, stiff neck, dry mouth and moderate injection site pain was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt recv vax 6MAY96 935AM&pt called back 930AM 7MAY95&stated had painful swelling w/erythema encircling arm;pt instructed to apply ice&take APAP if fever occurred;
36 hours after taking 4th typhoid capsule, he had chills, abdominal pain, vomiting and diarrhea. He went to ER and received IV fluids and rest. After few hours rest at home he felt better and without symptoms. He had exercised vigorously 6 to 8 before the incident.
Burst blood eye vessel, my head felt hot for a few seconds. Felt light headed when I  stood up.
CALLED STATED HAS RASH ON ARMS FACE AND TRUNK OF BODY POSSIBLE HIVES STATES THAT IT ITCHES STARTED 12/16/07, CALL RECIEVED FROM CLT 12/19/07 RECOMMENDED THAT HE CALL PRIVAT MD AND BE SEEN TODAY FOR POSSIBLE IMMUNIZATION REACTION, TAKE IMMUNIZATION RECORD WITH HIM TO DR OFFICE.
Patient collapsed, almost lost consciousness, pulse was not detected/patient was turning blue, epipen was administered and pt regained consciousness slowly until emt arrived.
Intestinal bacterial infection; A spontaneous report was received from a consumer concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized for intestinal bacterial infection/gastrointestinal bacterial infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient was hospitalized for the event intestinal bacterial infection and was considered medically significant. Treatment for the event included antibiotics. The due date for second dose is on 08 MAR 2021 and the hospital physician  recommended to wait for "minimum 10 days."  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, hospitalized for intestinal bacterial infection, was considered to be resolved on 09 Mar 2021.  Consent granted for safety to follow up.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jun2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (24May2022) Negative, notes: tested negative on the sixth; (28May2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 19May2022 to 23May2022 (for five full days) and tested negative on the sixth day (i.e. 24May2022). Four days after that (i.e. 28May2022) patient started feeling poorly again and tested positive. The event was about rebound covid infection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states she feels generally sick, she cannot move her arm sometimes (the one that received the vaccine), her arm is sore sometimes, and she has a cough.
Given early dose of Pedvax Hib. System listed the vaccines under separate names and this was not noticed until after the vaccination was administered. Child received 3 doses of this when only 2 are indicated for their age.
SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (3 patients) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patients previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number and expiry dates were not reported) dose was not reported, administered on an unspecified dates for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patients received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients were sick (dose number in series 2). It was reported as "My entire fam has had 1,2,3x's, All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients had not recovered from sick, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221210446, 20221210961, 20221211116, 20221210980 and 20221212903.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L022259, expiry date 06-APR-2017 and lot # K010579, expiry date 12-FEB-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported.  There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Dec2021 at 12:00 as dose 2, single (Lot number: en5318), in left arm and as dose 3 (booster), single (Lot number: fd8448) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Caffeine" (unspecified if ongoing), notes: Known allergies: Caffeine. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included the patient did not receive any other medications within 2 weeks of vaccination. SUSPECTED COVID-19 was treated from 25Apr2022 to 30Apr2022. On 4May2022 the symptoms includes Runny nose, stuffy nose, chest tightness (like the flu, milder case), tired, - same symptoms as before he took Paxlovid, but milder. The patient was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had ileocolic intussusception on 8/31. Presented with vomiting, lethargy, and bloody stool.  Successfully reduced nonsurgically with air enema. Patient recovered well.
Within 3 hrs swelling c/o site and shoulder. Approximately 48 hrs later had hive-like rash to torso that resolved with one dose of Benadryl.
Patient was administered a vaccine that was kept in the freezer longer than the recommended time of two weeks.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Patient given 0.5mls of moderna vaccine as booster instead of 0.25mls of moderna vaccine as should have been given as booster for the patient is not immunocompromised.
I got vaccinated I had bad rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: RASH (non-serious), outcome "unknown", described as "I got vaccinated I had bad rash all over my body".  The lot number for bnt162b2 was not provided and will be requested during follow up.
About a week and a half after the vaccine, I came down with shingles and I'm so tired and have terrible brain fog and I can't function well.
This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's pertinent medical history included primary cholangitis. The patient did not have any drug reactions or allergies. No information regarding concomitant medications was provided. On 19-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105; expiry date 15-NOV-2017 (dose and route of administration were not provided). On an unknown date in December 2017 (reported as shortly after receiving the vaccination), the patient developed a cellulitis-like reaction. The patient sought medical attention by calling the office. No antibiotics or other treatment were given. No lab diagnostics or studies were performed. The outcome of the event was reported as recovered on an unknown date in December 2017 (reported as: "up to week after receiving the injection"). The causality assessment was not provided. The reporter requested a lot check for the PNEUMOVAX 23. Upon internal review, the event of the cellulitis-like reaction not under control was considered medically significant. Sender's Comments: US-009507513-1801USA000917: US-009507513-1801USA000916.
Severe allergic reaction presenting just how rash presented when had Covid in 8/2020.  Extremely itchy bumps all over the torso, abdomen, back, butt, and shoulders.  Skin tissue biopsy came back SEVERE ALLERGIC REACTION.  This lasted for over six months.  When patient had the rash from covid it lasted approximately 14 days.
Formation of Blood Clots in my Lungs - extreme pain in my chest, 3-4 days every few weeks Starting the end of October 2021.  Critical in Jan 2022, went to hospital and was diagnosed with Pulmonary Embolism. Edema around my heart. Diagnosed in Jan 2022 when I had a CT scan in the hospital.
Aching body, sore head, temperature, chills jabing feeling in my back, feeling very dizzy and and faint and sick. Irregular heart beats and being aware of my heart feeling uncomfortable
Sore arm, headache, fever, muscle aches, joint pain, nerve pain, brain fog, mild nausea beginning late evening/overnight on day of injection (Saturday) and continuing until early morning 2 days later (Monday). Sore arm continuing but beginning to reduce in severity. Treated with Tylenol every 4-6 hours.  After dose 1, I experienced a sore arm, as well as a rash at the injection site appearing 8 days after injection and resolving 1 week later.
Covid19 breakthrough.  1st vaccine received on 02/08/2021.  91 y/o with PMHx of AFIB, Dementia, Hypothyroid, HTN, Type 2 DM, UTI presents to ED from with AMS.  It was noted that pt less interactive than baseline, EMS called and found pt hypoxic with Room air sat of 80%.  Pt placed on 15L NRB, CT Chest with obstructed bronchus Left lower lobe, consolidation, atelectasis and Broncho PNA.  Pt started on IV ABX and steroids.
Initially face turned bright red and started burning.  Redness spread to neck and shoulders and started resembling hives.  Had some tingling in lips and tightness in chest, felt light-headed.  Paramedics observed and checked vitals.  Pulse ox was good, chest clear, BP high.  Gave me choice of getting IV or going to drugstore and purchasing benedryl to begin immediately.  Started oral benedryl.  Went home and took 2nd dose.  Redness is subsiding, BP reduced. Still mild light headedness.
Hospitalization for COVID-19 on dates  9/13/22-9/16/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of PROQUAD (Merck), (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Directly after the shot, i got an instant migraine. I took 200mg ibuprofen. Shortly after my nose felt numb and tingling/ burning in a way.  I had an interview at school and at around 5:45 my  whole right side of my face felt the same as my nose. It continued throughout the day.  Later that night at 3:30-3:35am i woke up and started shivering. After i stood up my whole body felt like i was sore especially my back. Not my arm i took the shot with because i worked it out throughout the day. I took a bath with epson salt , once i got out i noticed i had a nose bleed. The next day i wake up with a nose bleed. And a few hours go by until evenings and i have another nose bleed. ( i often do not get nose bleeds unless I?m in a very hot environment). That is everything that had happened to me so far.
This spontaneous report was received from the patient of unknown gender via GSK. The patient now was 67 years old. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     The patient took the older shingles shot of zoster vaccine live (ZOSTAVAX) at 62 years old, and took the newer shot of zoster vaccine live (ZOSTAVAX) around 65 years but only 1 injection (extra dose administered). Both doses: dose, route, lot# and expiration date were not reported for prophylaxis. The product also reported as varicella zoster vaccine rge (cho) (SHINGRIX) in GSK report (inconsistent information). The patient had shingles. Outcome of the event shingles was unknown. The causality between zoster vaccine live (ZOSTAVAX) and the event was not reported.
not feeling well; Fever; This is a spontaneous report received from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (lot number: ET7533) at single dose for COVID-19 immunization. Medical history included heart problems. Concomitant medications were not reported. The patient stated, "I got the Pfizer shot in Friday and I still am not feeling well (Apr2021). I have a fever (Apr2021) right now that I caught. Is that a side effect after 3 days?" Treatment received for the events included Ibuprofen. The outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contains no new information.
Confirmed Breakthrough Case  COVID-19 (Pfizer) 1 02/11/2021 Pfizer EM9810   COVID-19 (Pfizer) 2 03/04/2021 Pfizer EN6201   COVID-19 (Pfizer) 3 12/01/2021 Pfizer FH8028
chills, nausea. BP was higher than normal so was sent to ER for further evaluation
Breakthrough case admission after 3 vaccines Pfizer 2/13/21 Lot# EL9267;  Pfizer 3/6/21 Lot# EN6206;  MOderna 11/10/21 Lot# 034F21A
Pt. received DTaP #4 on 09/03/2002 as part of routine 2.5 yrs old P/E. on 09/04/2002 was noted by mom to have fever (101 degrees F) ass. with swelling and redness over left thigh where shot was given.