chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Fatigue, Tingling & Numbness, Tightness in upper chest  11:20am-4pm
3 days after taking the vaccine she had  fatigue and chills. She felt out of body. She had confusion, weakness, lightheaded and  loss of consciousness.
Pt began seizing 45 minutes post administration. Did not stop breathing and retained a steady pulse. EMS called and taken to hopsital. Pt is stable self reported dx as vasovagal response. stable.
On 5/10/99, the pt experienced soreness at the site of injection and bumps which were itchy and spread to her chest. By 5/11/99, the rash had spread to her back, arms, and legs. The pt sought treatment in ER. The pt was treated with IV Benadryl and Solu-Medrol.
This is a spontaneous report from a contactable other HCP (patient). A 37-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), at the age of 37, via an unspecified route of administration, in left arm, on Mar 15, 2021, at 13:30, single dose, for COVID-19 immunization. The medical history and concomitant medications not reported. The patient has no history of allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), at the age of 37, via an unspecified route of administration, in left arm, on Feb 22, 2021, at 15:00, single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested with COVID-19. On Mar 16, 2021, at 11:00, patient experienced fever, tiredness and chills. The patient received no treatment for the events. The outcome of the events recovered on an unspecified date in Mar 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
9/23/13 PM - Pt noticed itching. 9/24/13 PM - Area itching-removed band aid noticed area red and swollen. Took Benadryl 50mg P.O. at bedtime. 9/25/13 Observed. Reddened, feverish, raised area on R upper arm-60 mm x 50 mm (Applied cool compress. Advised to continue cool compress-PRN-may apply cortisone cream to R upper arm.
No additional AE details provided; Temperature BELOW 2°C (1.3C) for 0 hours 25 minutes and 0 seconds/One dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUN-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot # 1775808, expiration date: 20-AUG-2023, administered for prophylaxis (strength, anatomical location, and route of administration were not provided). The vaccine experienced a temperature excursion of 1.3 degrees Celsius for 25 minutes (product storage error). There was no previous temperature excursion. No additional adverse event details provided (no adverse event).
Employee started feeling nauseous and light headed. States she drank water and symptoms resolved within 20 minutes,
on/off mild headache; extreme fatigue; swollen, very tender pea size lymph node by collarbone nearest to the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm left), on 18Dec2020 at 10:45, at a single dose, for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included attention deficit hyperactivity disorder (ADHD), anxiety, chronic back pain, and allergies to penicillin. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), baclofen, oxymetazoline hydrochloride (CLARITIN ALLERGIC), and sertraline hydrochloride (ZOLOFT). On 19Dec2020, 24hrs post vaccination, the patient had a swollen, very tender pea size lymph node by collarbone nearest to the injection site, and an on/off mild headache. 48hrs post vaccination, patient had extreme fatigue and on/off headache, still had swollen lymph nodes. The patient did not receive treatment for the events. Outcome of the event swollen lymph nodes was not recovered, while for the other events was unknown. Since the vaccination, has the patient has not been tested for COVID-19.
I had it at night time when I was in bed, My bed were hurting so bad that I had to roll out the couch and it was like that for 20 minutes, all the pain was on both of my legs. I called my doctor and he prescribed me some muscle pain relaxer. I was in a car accident back on July 31, 2021 so I needed a refill and I ended up getting a refill. The pain finally ended a week ago 12/02/2021.
headache; my arm felt like someone punched me; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN (my arm felt like someone punched me) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and NICOTINIC ACID, SIMVASTATIN (SIMCOR [NICOTINIC ACID;SIMVASTATIN]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (my arm felt like someone punched me). On 14-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, PAIN (my arm felt like someone punched me) outcome was unknown. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
That my back starting hurting feeling very uncomfortable and itchy. The next day my back was broke out and I knew by looking at it that I had shingles. I went to the doctor to confirm that what I suspected was correct. Doctor prescribed acyclovir 800mg to clear the shingles and a shot for the itching (I cannot remember the name of this).
Lower Back Ache; Fever; Head Ache; Injection site arm sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BACK PAIN (Lower Back Ache), VACCINATION SITE PAIN (Injection site arm sore), PYREXIA (Fever) and HEADACHE (Head Ache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site arm sore). On 16-Apr-2021, the patient experienced BACK PAIN (Lower Back Ache), PYREXIA (Fever) and HEADACHE (Head Ache). On 15-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, BACK PAIN (Lower Back Ache), VACCINATION SITE PAIN (Injection site arm sore), PYREXIA (Fever) and HEADACHE (Head Ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.
No adverse events. Client received FLUVIRIN at a health fair on 10-13-13. Also received another FLUVIRIN at Health Department on 10-21-13. Client was pregnant when she received both vaccines.
Vaccine was administered after being stored between 3.4°C and 6.9°C for 76 days. Tens day in the refrigerator was up on 5/26/2022. Parent was contacted and reported no adverse event.
The pt experienced an apparent apneic episode after feeding, some pallor, perioral cyanosis, hypotonia, hypo-responsive noted. The pt experienced a spontaneous full return to normal color, tone, mental status within 5-10 minutes. Was transferred to the hospital for tests and observation.
COVID 19 Treatment/Got COVID; COVID 19 Treatment/Got COVID; Moderna_ dose 4 and Pfizer BioNTech_dose 5 - 19Sep2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Mantle cell lymphoma" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other medication in 2weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Moderna_ dose 4 and Pfizer BioNTech_dose 5 - 19Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "recovered" (13Jan2023) and all described as "COVID 19 Treatment/Got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had a COVID 19 Treatment of Paxlovid, started on 28Dec2022, stopped on 03Jan2023. Reportedly non-serious report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse referring to a patient of unknown age. Medical history and concurrent condition of the patient was not reported. On 24-FEB-2015 the patient was vaccinated with a dose of GARDASIL (lot # H010123, expiry date: 16-JAN-2015, 0.5 ml, intramuscularly). Other suspect and concomitant therapies were not reported. No symptoms reported. No product quality complaint (PQC) involved. Additional information has been requested.
Extreme chills, maybe fever, slight nausea,aches and pains. Went to bed with many covers and had fitful night's sleep. Woke up with aches and pains but no other symptoms. Felt normal less than 24 hours from vaccination
Nearly immediately after vaccination, patient began to feel light-headed and to sweat profusely. In three minutes, the symptoms evolved to include trouble breathing and tingling in left and right arms.  Patient had his rescue albuterol inhaler on-hand, and took one dose by inhalation. One minute following dose, the difficulty to breathe improved. He remained in store for further observation for 15 additional minutes. Prior to departure, he confirmed that he was able and willing to leave the premises and declined emergency care.
approx 21 days p/vax pt had a petit mal seizure also had a upper respiratory infect
approx 5min p/vax given APAP;pt became pale & unresponsive-almost like fainting spell;3min later pt responding;crying & became pink;pulse ox 99 transferred to hosp;P120min;
3 bouts of vomiting 99.8 degree fever Chills  Headache All symptoms subsided around 8pm on Saturday
This spontaneous report was received from a physician refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L032396, expiry date 26-AUG-2016, 1 dose subcutaneously. No adverse effect was reported. Therapy with VARIVAX was continued. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose #2 on 4/24/2021.  Patient was found down on 4/25/2021 for an unknown amount of time and EMS was called. Patient noted to be seizing on EMS arrival. Blood glucose was noted to be 32 and an amp of D50 was administered. Patient arrested, received CPR (approximately 1 round) and was intubated in the field. His second glucose reading was undetectable and he received a second amp of D50. Patient also received sodium bicarb, calcium, and epinephrine and transported to ED. Patient subsequently transferred to Medical Center. He was treated for septic shock. His mentation remained very poor after pressors weaned off and sedation stopped. He likely had severe brain injury from hypoglycemia and anoxia - poor brainstem reflexed but did have spontaneous breathing - very poor prognosis - patient was extubated for comfort measures and all interventions stopped after family discussion and per their plan.
Injection site redness, swelling, tenderness also nodes, aches, N/V x 3 d, symptoms improved 3rd after immunization. treatment: Motrin, PRN warm compresses to injection site, increase fluids. Pt will f/u in 1 1/2 weeks.
Approximately 3-5 minutes after receiving the influenza vaccine patient fainted. She recovered quickly. She did not need to go to the Emergency Dept. She required no treatment.
Got a period; it was weird several days ago thought she was ovulating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 11:00 (Lot number: EW0153) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Vaccination Time: 11:00, NDC number: Unknown, Expiry Date: Jul2021, Anatomical Location: Right arm), administration date: 19Mar2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: OVULATION DISORDER (non-serious) with onset 2021, outcome "unknown", described as "it was weird several days ago thought she was ovulating"; MENSTRUAL DISORDER (non-serious) with onset 12May2021, outcome "unknown", described as "Got a period".  Additional information: The patient reported that she was 55 years old and thought she was done with getting a period. The patient had not had a period since the beginning of jul2020. It was weird several days ago the patient thought she was ovulating. The patient got a period yesterday, 12May2021. The patient wanted to report this event. Got a period: it had been 10 months and the patient thought she was done with menopause and got a period. The patient stated the lot was not very clear, looks like EP7534. Patient stated she was unsure if it was a p or an o. The patient clarifies the lot for the first dose was the letter p. Patient sees the similarities in the person's handwriting on the vaccination card where the person wrote the letter p for Pfizer. The patient confirms she was certain the lot for the first dose is EP7534. The patient did not require emergency room visit for AEs. The patient had no prior vaccinations. No relevant tests.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nursing director at a facility concerning a patient who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine. The director reported that there had been a viral thing at the facility that had affected approximately 33% of the residents. The director reported that one of the patient's who had experienced the viral thing had been vaccinated with pneumococcal 23v polysaccharide vaccine, however, she was unaware if the patient had received the vaccination before or after the onset of the illness. The patient experienced symptoms of an elevated temperature (laboratory value not provided) and respiratory distress. On an unspecified date, the patient developed aspiration pneumonia and was hospitalized. At the time of this report, the outcome of the event was unknown. Additional information is expected.
Pt c/o difficulty breating, fast heart rate, dizziness, BP 100/60, RR 36, pulse 120, unable to hear lung expiration.  Bp prior to immunization 130/66.  Called 911, took pt to Hospital.
Caller is a nurse reporting a temperature excursion, requesting stability data (Temp. Excursion 01765539).; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 19-OCT-2020, the patient received 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021). The vaccine administered experienced a temperature excursion of -6.6 degrees Celsius, for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010518: US-009507513-2010USA010508: US-009507513-2010USA010598: US-009507513-2010USA010384: US-009507513-2010USA010735: US-009507513-2010USA010577: US-009507513-2010USA010526: US-009507513-2010USA010709:
bullous pemphigoid; Information has been received regarding a case in litigation from a lawyer referring to an elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: bullous pemphigoid. The outcome of the event bullous pemphigoid was unknown.  Upon internal review, bullous pemphigoid was determined to be medically significant.
Bloody nose 6 hours after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the arm right on 10Jun2021 at 10:15(at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety from unknown date and unknown if ongoing. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0185) via an unspecified route of administration in the right arm on 20May2021 at 20:00 (at the age of 12-years-old) as a single dose for Covid-19 immunisation. 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 10Jun2021 at 16:00, 6 hours after receiving vaccination, the patient experienced bloody nose. 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 reported event. The clinical outcome of the event Bloody nose was recovered on 10Jun2021.   No follow-up attempts are needed. No further information is expected.
fever - 102F max, began 11 hours post injection, duration 28 hours; chills - began 12 hours post injection, duration 12 hours; skin sensitivity - began 12 hours post injection, duration 12 hours; abdominal pain - began 11 hours post injection, duration 4 hours; joint pain - began 12 hours post injection, duration 48 hours; earache - began 24 hours post injection, duration 4 hours; fatigue - began 11 hours post injection, duration 48 hours; nausea - began 54 hours post injection, duration 8 hours; pain at site of injection - began 6 hours post injection, duration 72 hours;
This spontaneous report was received from a consumer regarding his son, a 6-months-old male patient. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided. In July of 2021, the patient received the first dose of Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), on 11-OCT-2021, the patient received the second dose a little late because he was sick so it was held off (inappropriate schedule of vaccine administered) and, on 17-NOV-2021, the patient went to the doctors, however, the doctors did not have in their system that the patient had already received the second dose of the vaccine so it was administered again at 6 months old (Extra dose administered) (dosage, route of administration, lot number and expiration date were not provided) vaccine was administered to prevent HIB. At the time of the report, the patient was irritable, crying and wouldn't put pressure on the leg that had the shot, had leg soreness. No treatment or laboratory test had been performed. At the time of the report the patient had not recovered from irritability, crying and pain in extremity. The causal relationship between Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and the events was not reported.
no adverse effect; Administered an improperly stored dose of Varivax; This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dosage information, route of administration, anatomical location was unknown) of lot # S006021 and expiration date of 27-FEB-2021 for prophylaxis (Product storage error). The concomitant medication included sterile diluent (lot# R019504 and expiration date 04-NOV-2020) which was reported to be stored properly. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of -14 degree Celsius (C) to -10 degree Celsius (-10.5 C) for a time frame of 58 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender, whose age was reported as less than 50 years. Drug reactions, allergies or medical history were not reported. On 24-FEB-2014 the patient received ZOSTAVAX (dos, route and lot # were not reported) instead of VARIVAX (Merck). No adverse symptoms reported. Additional information has been requested.