chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of crying in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-gsk). Concurrent vaccination included pneumococcal vaccines (non-gsk);Pfizer; unknown; unknown given on 2 May 2012. There were no concurrent medications. On 2 May 2012 at 10:30 the subject received 1st dose of PEDIARIX (unknown, left thigh), on 2 May 2012 the subject received 1st dose of haemophilus influenzae type b vaccine (Non-GSK) (unknown). On 2 May 2012, 30 minutes after vaccination with haemophilus influenzae type b vaccine (Non-GSK) and PEDIARIX, the subject experienced crying, irritability and pharmaceutical product complaint. The subject required medical attention at the doctor's office. At the time of reporting the crying and irritability were unresolved. The healthcare professional considered the events were probably related to vaccination with PEDIARIX and haemophilus influenzae type b vaccine (Non-GSK). The healthcare professional reported another case see A0976316A. Follow-up information was received on 23 May 2012 via healthcare professional who reported the events of crying and irritability resolved on 03 May 2012. The immunization series was not discontinued but it was noted that the subject will receive "Ped dt in the future". Quality Assurance (QA) results received on 05 June 2012. The nurse reported an undetermined quality concern with this box of PEDIARIX vaccines (lot AC21B323AA, expiration 31 October 2013) that resulted in two separate adverse events for two subjects, reported separately (see case A0976316A for details regarding other subject). The responsible physician would not allow the use of the remaining syringes and wished to have this investigated. Based on the fact that no precise technical problem was reported and the conforming test results, no technical investigation was performed. GlaxoSmithKline Biologicals considered the complaint as unsubstantiated.
Headache, Myalgia, Fever, Rash, UrticariaPruritus, Ear numbness/Tingling/Ringing at the left ear Narrative: Employee got the second dose covid vaccine 03/02/21, 15:02. Employee claimed that she developed hives/skin rash involving the neck, chest, abdomen Fever The is associated numbness /tingling sensation at the left ear, most of the symptoms resolved after the 48 hours But she has residual ringing in her left ear
Patient with no history of Diabetes reports to the hospital for not feeling well. She presents with a blood glucose of 561, acute kidney injury, and hypothyroidism.
Case fully vaccinated with Moderna vaccine. Tested positive for COVID on 9/8/2021. Admitted to Medical Center on 8/29/2021 and expired while still hospitalized on 9/19/2021.
Left knee became so swollen that I couldn't see my kneecap; over a period of a few weeks, symptoms became worse, to the point that I couldn't walk and could not lift my arms, developed low grade fever.  Pain continues to this day.
-Bleeding from vagina (I don?t start my period for another two weeks) -Nose bleeds -Heat flashes (feels like a fever) -Gets cold really easily (shivering and chattering teeth) -Large rash on arm -Unable to eat as much -Fainting  -Stomach ache -Headaches
sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a sore arm.  For tolerance after 2nd dose refer case US2020AMR044290. This is 1 of the 4 linked cases reported by the same reporter.
Day 1 sore injection site moved to shoulder and upper back, dizziness Day 2 exhaustion, dizziness, headache Day 3 exhaustion dizziness, headache Day 4 continuing headache, joint aches Day 5 back pain, pain in back of head, joint aches Day 6 back pain  more severe, pain in back of head, joint aches Day 7 lessening back pain, spasms,, joint aches
vaccination failure; Shingles; Second dose 7 months after the first dose; Shingrix vaccine was not available from GSK; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and 1 year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, drug dose administration interval too long and product supply issue. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, drug dose administration interval too long and product supply issue were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated, he had his 1st Shingrix vaccine dose about 1 and half year ago from the date of reporting. The patient stated, he could not get his 2nd dose of Shingrix vaccine because it was not available from GlaxoSmithKline.  The patient stated, he had his 2nd dose 7 months after the 1st dose which led to drug dose administration interval too long. The patient reported, he had his first symptoms of shingles a year after his 2nd vaccine dose.  The patient reported, he had shingles 3 times after his Shingrix vaccine series.  The patient stated, it did not work.  A lack of drug effect was reported as the patient experienced shingles after both injections of Shingrix. Till the time reporting, the patient stated his symptoms had resolved like a month ago. The patient reported, he had a total of 37 episodes of shingles including the 3 episodes after Shingrix vaccination.  The patient stated that if he did not take Acyclovir, he would have shingles again. All information was not available. The reporter was consented to follow up.
Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; Patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting; This is a spontaneous report from a contactable consumer.  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on 12Feb2021 14:00 at single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus and hypertension. The patient had no known drug allergies. The patient's concomitant medication included metformin. The patient previously took first dose of BNT162B2 on 23Jan2021 in the right arm at 07:00 PM. The patient had no COVID prior to vaccination and no COVID tested post vaccination. The patient experienced syncopal episode concomitant with neuralgia, nausea, vomiting on 14Feb2021 23:30. Patient was taken by POV to emergency department where he received fluids and anti-emetic. The outcome of the events were recovered on an unspecified date.  Information about lot/batch number has been requested.
Swelling and itching at injection site; Swelling and itching at injection site; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL1284) via an unspecified route of administration into the left arm on 03Jan2021 12:45 at a single dose for covid-19 immunisation. Medical history included hypothyroidism and hyper cholesterol. The patient's concomitant medications were not reported. The patient experienced swelling and itching at injection site on 11Jan2021 20:00. The patient did not receive treatment and was not pregnant. Outcome of events was not recovered.
Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, 5 microgram/0.5 ml injection, thimerosal free (TF), lot # L014418, expiration date 13-APR-2107 (dose and route of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) was 34 F for 40 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient called to say she was pregnant, did own test.  She figures conception was on 3-19-03.  Request patient to follow up with doctor.
she's experiencing a little bit of fever and muscle ache; she's experiencing a little bit of fever and muscle ache; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown, expiry date: unknown) via unspecified route of administration on 08Apr2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. The patient was asking what medicine she could take since she was experiencing a little bit of fever and muscle ache on an unspecified date. The patient also asked if it was okay to take Ibuprofen. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Our team did a COVID vaccine clinic at a nursing home in March.  We found an error when we were reviewing consents.  A resident?s consent was filled out by the DON prior to our arrival.  Based on the information provided on the consent, we looked up the resident in local database to confirm the doses that were printed on the consent form.  We were unable to locate him in either platform, so the DON said the dates were written in error.  We gave him a first dose of Pfizer on 3/10/23.  We returned to the facility on 3/28 and he was on our list to administer a 2nd dose of Pfizer.   When we were looking over the consents, we realized the birthdays on the 2 consents were different.  We verified the correct birthday with the DON and discovered the resident had already received his primary series in 2021 but because of the incorrect birthday on the 1st consent, we were unaware of this.   Therefore, he received 2 additional doses of Pfizer Monovalent on 3/10 and 3/28.  His initial vaccine dates that we were unaware of were: 4/25/21 and 5/16/21.
32 y.o pregnant female (8weeks) receive covid 19 vaccine in left deltoid at 6:45 pm. Around 7:10 pm patient developed tingling/pins/needles feeling and decreased motor coordination of left arm. Tingling/pins/needles sensation progressed to left eye lid, mouth, face, neck, throat, left lower leg and right hand. Pt was monitored in ER for an hour and sensation gradually dissipated
pt was found at home by family unresponsive and with facial cyanosis after an apparent fall; EMS called; no CPR done due to cyanosis and unresponsiveness; family states he had cough and congestion past 5 - 6 days; pronounced dead at home; COVID test was positive.
Information has been received from a health professional concerning an 18 year old female who on 03-AUG-2007 was vaccinated with first dose of Gardasil (lot# 09294). Concomitant therapy included several psychiatric medications [therapy unspecified]. On 03-AUG-2007 within minutes of receiving the vaccine the patient went into grandmal seizure. It was stated that the patient's mother has seizures all the time as well: Medical attention was sought. The patient was referred to a neurologist. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
pt rcvd vax; pt devel fever; erythema & warmth & swelling of deltoid; body & jt aches;
Day 8: in am reddened area at injection site. By evening larger, redder, itchy.  Day 9: In am less red but much larger area on upper arm.  Less itchy.  My doctor recommended I get checked so I got checked: no infection , was improving significantly by day 10/11.  Then went away completely.
Patient began having fevers of 101-102 degrees on the afternoon of 3/22 after having the vaccines on 3/21 in the morning. He had generalized malaise, headaches, body/joint aches, nausea, and notices some swollen glands in his left axilla. On 3/24 he developed some redness at the site of the injections on the left arm. He presented to Urgent Care on 3/25 and was diagnosed with cellulitis vs vaccine reaction. WBC was 12.6. Treated with Keflex 500 mg qid. Redness spread so seen in ER on 3/26, WBC 9.6 that day. Bactrim added to Keflex. Fevers resolved on 3/26. After starting Bactrim patient started to feel better, redness slowly improved over the week and had resolved by 4/3. He continued to have a small lump at the site of one of the injections in the left arm with some itchiness in that area.
Dizzy, very tired, fever x4 days, highest 24 hours after vaccine 101.5, painful sharp stomach cramping, diarrhea, chills, muscle spasms, muscle cramps.
Patient described "pulse like stinging" at injection site shortly after injection and continued through the 15 minute observation time.
Fever - next day for approximately 5 hours aches - next day onset for 36 hours diarrhea - next day 7 hours nausea - next day 24 hours vomiting - next day, 2 incidents blistering at injection site that hurts and itches - began approximately 48 hours after injection, came on suddenly and grew in size, is still occuring
Immediately felt warm sensation flow from upper body to lower.I said something is happening. Felt jittery,  flutter in chest and scared. Felt weak like I would pass out. Felt distant from Emt and nurse . Had difficulty getting words out. After about 7 minutes emt took me to his area ck bp it was 130/70. I know it would have been lower had he taken it sooner. I drank 3 waters stayed about an hour after injection.
When circulation is cut off and numb.; Hand turned cold; Arm began tingling/ my hand went tingly/ extremity falls asleep; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm right on 07Apr2021 at 09:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and birth control. Concomitant medications included sertraline 50 mg (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and norethisterone (NORLYDA) from an unknown date for birth control. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm right on 15Mar2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and cefaclor (CECLOR) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 09:35, about 20 minutes after, the patient experienced tingling in arm and then her hand went tingly like when an extremity falls asleep. Her hand then turned cold like when circulation is cut off and numb. This symptom remained for 4 hours after the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of arm began tingling, hand turned cold and numb were recovered with sequelae on 07Apr2021.   No follow-up attempts are needed. No further information is expected.
No adverse reaction; Improperly stored Proquad; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ).  On 11-APR-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent (DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored. The vaccine was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA000175: US-009507513-1905USA001299: US-009507513-1905USA001301: US-009507513-1905USA001305: US-009507513-1905USA001306:
When the CMA administered the 2nd dose COVID vaccine the needle malfunctioned and most of the vaccine leaked down the arm. There is no way to be able to tell how much the person received. We spoke to medical director and Pharmacist to consult on what we should do. It was advised to give the person another dose in the other arm. Patient was okay with getting another dose in the other arm.
No Adverse Event; patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was supposed to get themonovalent vaccine, but they received the bivalent booster as their first dose).    No concomitant medications were reported. Patient was supposed to get monovalent vaccine but received bivalent vaccine as the First dose. It was reported that patient had no known allergies or past medical conditions at the time of vaccination. Patient didn't receive other vaccine 1 month prior to Moderna COVID-19 vaccine. Patient was not taking other medications and patient's HCP was not aware of this incident. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. No treatment information was reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients received improperly stored doses of RECOMBIVAX HB (dose and lot number were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports becoming nauseous, dizzy and light sensitive approximately 15 minutes after receiving injection.  He received his vaccination at 9:30am and then laid down until approximately 11:45am.
This spontaneous report as received from a office manager refers to a patient (third patient) of unknown demographics. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dosing details and lot number were unspecified). No concomitant medications were reported. On an unknown date, the patient experienced injection site reaction. No treatment information was reported. The outcome of injection site reaction was unknown. This is one of several reports from the same source (MARSS#12010USA000130, MARSS#12010USA000140). Additional information has been requested.
Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.  This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD).   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment/concomitant medications were reported.  Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death
Local rxn leg red & hot to touch, cried off & on from 6PM; To bed @9PM up @ 11 placed in tub because of high fever (temp not measured), mom states also limp for short time;
Client tripped and fell while leaving the site of the POD. He hit his chin, head and wrist on the ground. He did not lose consciousness and had no bleeding. His vital signs were as follows: BP=118/72, Pulse=74bpm. On examination, client was conscious and alert X 3, and was talking coherently. He refused to go to the emergency room and stated that he did not want the EMT to be called. He was observed for 30 minutes and decided he felt well enough to leave. He was asked to call ?911? if he developed any symptoms including a headache or dizziness and he voiced understanding.