chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 year old patient was vaccinated with Pfizer COVID-19 booster vaccine. At 10.35am he felt dizzy and was pale. Code white was activated and 911 was called. In every step of the process, we inform his mom the action we were taking, and what and for what was everything given to the patient. We brought him an alcohol pad to inhale and elevated his legs. Patient didn't respond and at 10:37am we gave him a glucose tablet but he can't chew it, so we proceed to give him a glucose shot at 10:39am. Patient wasn't responding and I noticed a red patch at his right hand. We proceeded to inject him Epipen at 10:41am. Patient was the same so at 10:43am we measure his blood pressure and it was at 75/46mmHg, pulse 50bpm. With his mom authorization, at 10:44am we gave him salt sublingually. In seconds, he began to respond and opened his eyes. At 10:47 his blood pressure was at /107/71mmHg, pulse 66bpm. At 10:53am his blood pressure was at 116/71mmHg, pulse 77bpm. Paramedics arrived at 10:55am and performed him a dextrose test where he had 140mg/dL. Paramedics transferred patient to the hospital.
"Hot, Blotchy"  given Benadryl 25mg liquid, po x1 dose. Resolved
Redness 24 hours after injection site, Nickel sized. 48 hours later, Signifigantly swollen, redan and hard in the middle.
devel redness, sl swelling, soreness 3" below inj site day p/inj given;
Severe itching at random parts of the body starting two days after the second dose. Hives and rash appear as a result of scratching on the affected zone. It appears that it is an allergic reaction. Have been taking Benadryl to manage the itching.
Fever 101.2 am, irritability night before, decreased appetite, alert and active, tremors of left leg on and off since birth. RX Tylenol/Motrin, increase fluids.
Fingers (peringual) warts resolved; HPV vaccine for fingers (peringual) warts;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 35 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans and curettage). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for fingers (peringual) warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient's fingers (peringual) warts resolved (drug effective for unapproved indication).   The patient's immune status was reported as none. The patient was followed up for treatment for 7 months.  The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 03-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: L003855 and Expiry: 05-FEB-2017) (route unspecified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
10cm long rash, hot, redness after 24 hours  rash lasted for 3 days, at first injection site very hard
Menstrual cycle is late; sharp shooting pains in stomach - feels like birth contractions; nausea; extreme fatigue; dizziness; jitters; headache; skin feels like it's sunburned- mostly on arms and back; sharp pains in left leg and foot.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 17:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "Menstrual cycle is late"; PAIN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp shooting pains in stomach - feels like birth contractions"; NAUSEA (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "extreme fatigue"; DIZZINESS (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "dizziness"; FEELING JITTERY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "jitters"; HEADACHE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "headache"; SUNBURN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "skin feels like it's sunburned- mostly on arms and back"; PAIN IN EXTREMITY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp pains in left leg and foot.". Therapeutic measures were not taken as a result of menstruation delayed, pain, nausea, fatigue, dizziness, feeling jittery, headache, sunburn, pain in extremity.  Additional information: The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to 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. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Dose 1 given  12/28/2020 Lot # Unknown  Patient was hospitalized with Covid 19 and PE, discharged to home
loss of taste; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number not reported dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loss of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient left at exactly 30 minutes post-vaccination. Less than 2 minutes later, he returned to the office reporting of itchiness and throat tightness. BP 102/64, 75 HR, 97% SpO2. Hives on back of the neck. Patient seated and given 50 mg Benadryl PO. 20 minutes later patient reports feeling much better. Kept for 30 minutes post Benadryl administration. Patient reports feeling much better, hives and itchiness has resolved, reports no issue with throat. BP 106/70, HR 72 SpO2 98%. Patient left after 40 minutes and reporting to feel back to his normal.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX Lot number L017145 with expiration date of 13-MAY-2017, L019124 with expiration date of 20-MAY-2017 and reported lot # L044055 with expiration date of 02-MAY-2017 (dose and route were not reported), which were stored at 7.9 F for 12 hours, 10.6 F for 12 hours, 6.8 F for 12 hours and 6.8 F for 12 hours, the worse case scenario was 48 hours cumulatively. The vaccine did not have previous temperature excursion. No adverse effects reported. Lot number L044055 is an invalid lot number for (Oka/Merck) VARIVAX but was valid for (Oka-Merck) PROQUAD. This is one of several reports received from the same source. Additional information has been requested.
CMA gave a 5-11 yrs Pfizer COVID vaccine to a 61 years old vs the Pfizer COVID vaccine 12+ yrs
Dose patient received had been out of the time frame from when reconstituted. Dose was prepared on 04/15/21 at 7pm and was left out in the immunization room overnight. Next morning 04/16/21 dose was administered to the patient at 9:15am. Store clinical team was contacted along with Pfizer as soon as this was discovered.
Anxiety attack; A spontaneous report was received from a consumer (patient's husband), concerning a female patient (age unspecified), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Anxiety attack.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 09-JAN-2021, the patient experienced Anxiety attack. Treatment for the events was not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event Anxiety attack was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
HEADACHE; FEVER; This spontaneous report received from a vaccine facility concerned a 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested  for this case. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 07-APR-2021 07:00, Laboratory data included: Body temperature (NR: not provided) 99.4 F. On an unspecified date, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
GM states baby became ill 1/24/11 with vom., diarrhea, lethargy, etc. Took to ER then transferred to another hospital. Admitted. Underwent bowel surgery for intussusception.
Patient reported swelling, itching and redness in left arm starting 2 days after vaccination. Patient was referred to her physician for evaluation and treatment. Unknown whether patient will be asked to make an appointment for evaluation or to watch and wait.
This case was reported by a nurse and described the occurrence of hives in a 34-year-old male subject who was vaccinated with TWINRIX for prophylaxis. Concurrent medical conditions included penicillin allergy. There were no concurrent medications. The subject had no adverse events following previous vaccinations. On 14 Marhc 2006 the subject received the 2nd dose of TWINRIX (1 ml, right arm). On an unspecified date in March 2006, at an unspecified time after vaccination with TWINRIX the subject experienced hives. The subject presented to the emergency room two weeks after the 2nd dose of TWINRIX was given. There was no streaking or redness at the injection site. On an unspecified date in March 2006 the event was resolved.
Patient was in waiting area after vaccine. He started feeling faint and nausea. He sat down on floor and motioned for help.  Ran to help. he was hot and clammy.  applied cold hand to back of neck till able to get cold cloth, gave him bag in case of vomit,  gave him a water. started feeling better , gave him several Hershey kisses. He sat for 10 minutes then felt normal and left
Became dizzy when she bent over to tie her shoe.  Came to lie down for dizziness to pass.  Reported a headache and being hungry.  Juice and trail mix given.  Later went to the restroom and vomited a small amount per client.  Rested further, reported her headache improved and wanted to go home.  Was informed we would like for her to get a ride home. She did not want to and declined to stay for further observation.  b/p 138/76 pulse 72. Informed to seek medical help for further problems.
fever; swollen arm; fatigue; NAUSEA; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times before starting the vaccine). Concurrent medical conditions included immunocompromised.   On 5th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced fever, swelling arm, fatigue and nausea. On an unknown date, the outcome of the fever, swelling arm, fatigue and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, swelling arm, fatigue and nausea to be related to Shingrix.  Additional information was provided as follows: The patient experienced fever, swollen arm, fatigue and nausea after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
pruritus; Broke out in a rash on the top of both hands; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Feb2021 09:45 (Batch/Lot Number: EL3302) (at age 29-years-old) as dose 2, single for covid-19 immunisation. Patient received the first dose on 18Jan2021 09:4 (lot number: EL3246) (at age 29-years-old) on the left arm. Medical history included gallbladder removal. There were no concomitant medications. Patient broke out in a rash on the top of both hands on 09Mar2021. The left side has recovered a lot a better than the right (it left these hard raised bumps and dry skin from scratching), but patient still get bouts of pruritus that affects her right hand more often on 09Mar2021. It can also extend to areas of her face but she does not feel the urge to scratch those areas. She was not prescribed treatment was use Aquaphor for the events. Outcome of the events was recovered with sequel. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
he had a painful and swollen lump in his lower back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYST (he had a painful and swollen lump in his lower back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CYST (he had a painful and swollen lump in his lower back). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, CYST (he had a painful and swollen lump in his lower back) outcome was unknown.            No concomitant medications were provided
pt recv vax 7OCT96 & the next day 8OCT pt exp fever (unspecified) & a 4x4 area of redness, erythema & induration;
Janssen COVID-19 Vaccine Symptom: vaginal ulcers appeared approximately two days after dosage. Chills one day after vaccine.
- Three red spots on arm - all different in size ranging from 1/2 inch to 1 1/4 inch - very warm to the touch and itchy - went and saw doctor and was put on Famotidine for 5 days - Spots went away after a couple days and came back again a couple days later as a red line formed around the three spots previously - very warm to the touch and itchy as before - Went away after a day or so and got what seemed to be hives in a couple different spots (back of right leg, right side of back, right hand, small area on left wrist) - very itchy and went away after a few hours  - Lasted about a week from onset of initial symptoms
This is a spontaneous report from a contactable Nurse Practitioner via a Pfizer sales representative. This nurse reported the same event for 2 patients. This is the 1st of two reports. A patient of an unspecified age, gender and race received TRUMENBA for Immunisation at 0.5ml single dose on unknown date via intramuscular route. No concomitant medications, other medical conditions, or testing/investigations known at this time. Within an hour of receiving the first dose of vaccine, on unknown date, the patient experienced arm pain, severe headache, vomiting  and dizziness. The patient went to the Emergency Room. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017465773 Same reporter/drug/event, different patients.
Pain in heart.  Subsided at night after taking ibuprophen.  It happened with both Covid shots.  Felt like bad heartburn and heartburn medicine did not help when taken.  I informed the person prior to my second shot.  I wasn?t sure about the time of day I had shots
After receiving the Janssen Covid 19 vaccine, I proceeded to the waiting area and was instructed to wait 15 minutes before leaving the facility. Approximately 5 minutes after receiving the injection, I started to feel faint, lightheaded, nausea, and clammy. I informed a member of the staff and several medical personnel came to assist. They laid me down on a cot and checked my vitals. I started to feel better after laying down. The staff took my blood pressure and heart rate readings, which were relatively normal. But after sitting me up and taking my vitals again, my blood pressure and heart rate spiked. I was taken to Hospital in an ambulance; however, after waiting in the ER waiting room for about 2.5 hours, I left without seeing a doctor. During those 2.5 hours my original symptoms did not return, so I elected to leave.
Subsequent to receiving one dose of Lymerix, the pt was achy all over. The outcome is ongoing. Subsequent to receiving the second dose of Lymerix, the pt continued to feel achy all over. No treatment was given. The physician plans to administer the third Lymerix dose in November, 2000. The physician stated that he was not sure if the adverse event is related to Lymerix, due to the pts complaint of achiness prior to the first Lymerix dose given. As of 11/02/2000, the outcome of the event is ongoing.
On 08/07/2000, the patient developed a "varicella lesion on soft palate, erythema, vesicles, papules and pustules on her face, scalp, trunk, and extremities. Additional information has been requested.
Pt relates flu-like symptoms with stiffness for 2 days that resolved except for tiredness. Tiredness and stiffness increased after 3rd shot. Pt stated he is sleepy all the time.
Pain and swelling at the injection site and at the axillary lymph nodes.  Fever, chills and a headache.  Swollen maxillary lymph nodes and pain of the extremities.  Fatigue  Treatment: acetaminophen every 4 hours
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
As soon as I received the shot and stood up, I immediately felt itchy all over, my body got warmer and then my tongue started to swell
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Dose number series was 1. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain Barre syndrome 8 days after the vaccine. The patient also enquired "This cytokine storm, when read about it, appears to be a rush of super inflammation. For people already having inflammatory or autoimmune disorders, that was very dangerous". The patient also questioned if there was "any connection between guillain barre syndrome and rheumatoid arthritis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211161448- COVID-19 VACCINE AD26.COV2.S- Guillain-Barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
palpitations about 2- 2 1/2 weeks after receiving 2nd dose of Covid Vaccine.  Patient did not provide vaccine information
Headache and fatigue - the following day after receiving the vaccine (all day) Muscle ache in neck - beginning 36 hours after receiving the vaccine. Got worse throughout the day. Lasted 2 days. Was worst about 48 hours after receiving the vaccine.