chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT STATES THERE WAS INITIAL SORENESS AT THE TIME OF ADMINISTRATION. PT STATES THAT BRUISING DEVELOPED AROUND THE ADMINISTRATION SITE. FOLLOWING DAY THERE WAS REDNESS AND ELEVATED BUMPS BELOW THE BRUISING AND THERE WAS SOME WARMTH FELT AROUND THE AREA.
Dizziness; Difficulty swallowing; Headache; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 18:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and food allergy (almonds). The patient did not receive any concomitant medication within two weeks of vaccination. 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 an unknown date in 2021, the patient experienced dizziness, difficulty swallowing and headache. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events dizziness, difficulty swallowing and headache were unknown.   No follow-up attempts are needed. No further information is expected.
Patient received 2 varicella vaccines (2/23/05, 1/28/08). Patient presented to the office on 1/14/09 with scattered pox-lke lesions.  Varicella titer obtained on that date.  Results were IgG 2.49, IgM <0.91.
pt arrived to hosp via EMS; EMS called due to increasing SOB; O2 sats 60s; placed on CPAP; cyanotic and no improvement; pt gave consent to be intubated in the field; pt was positive for COVID 1 wk before arriving at the hosp, completed remdesivir and steroids; PMH:  chronic respiratory failure, on 10-12 L O2 via NC and astral device at home; in ED pt was severely hypotensive with septic/cardiogenic shock; pt was made a DNR; he arrested in the ED and died
started to get  pain in his back, two months after his second dose, and eventually became incapacitated,; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) (seriousness criterion medically significant). At the time of the report, BACK PAIN (started to get  pain in his back, two months after his second dose, and eventually became incapacitated,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient experienced pain still there, but he has gotten a lot better. Treatment information was not provided. Company comment: This spontaneous case concerns a 51-year-old male patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of Back pain, approximately 2 months after the second dose of mRNA-1273 vaccine. Patient had previously received the first of mRNA-1273 vaccine, and both were administered in an appropriate schedule of vaccination. As per source document, he eventually became incapacitated, but he has gotten a lot better. No further details on clinical course, test results or treatment were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old male patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of Back pain, approximately 2 months after the second dose of mRNA-1273 vaccine. Patient had previously received the first of mRNA-1273 vaccine, and both were administered in an appropriate schedule of vaccination. As per source document, he eventually became incapacitated, but he has gotten a lot better. No further details on clinical course, test results or treatment were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
shortness of breath/ having trouble breathing; he was extremely ill and sick in bed for 3.5 weeks; chest pressure; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient himself) reported that a 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient was extremely ill and sick in bed for 3 and a half weeks within a week of getting the second shot. He was having trouble breathing, chest pressure, and had shortness of breath. He went to the emergency room (ER) for his symptoms. He didn't feel any better after that so he also went to urgent care. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Anaphylaxis requiring 2 doses of epinephrine, Benadryl and ER transport.
Vaccine left  Health District at 10:45 AM and was mixed and given to patient at 1:30 PM.  This was 45 minutes outside of two hour window.
I started to cramp and my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; and my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; my cycle was VERY heavy and lasted for 1 day. It usually last 3 days and is very light. I am still cramping even after my cycle is over; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown) via an unspecified route of administration on 09Jul2021 at 01:00 PM (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. The patient medical history, allergies and concomitant medications were not available. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient wasn't COVID-19 positive prior to vaccination and was not tested for COVID-19 post vaccination. On 31Jul2021 at 08:00 AM, patient experienced that after two weeks of vaccination, she started to cramp, and her cycle was very heavy and lasted for 1 day. It usually last 3 days and was very light. She still cramping even after her cycle was over. No treatment was received in response to events. Outcome of the event Cramps menstrual was not recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A large rash of approx. for inches wide by 6 inches long at arm injection site. Skin hot to touch. Extreme itching. Fever. Cold chills.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of ZOSTAVAX with lot number M001747 and expiration date of 07-APR-2017 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at more than -15 Celsius degrees (°C) but less than -10 °C (more than 5 Fahrenheit degrees (°F) but less than 14°F) for 69 minutes. There was a previous temperature excursion of more than -10°C but less than 8°C (more than 14°F but less than 46°F) for 185 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012283:
Fever body pain freezing even when room temp 80 & dressed & heating blanket. 99.9 when just in pjs.  Did layers after temp.  Nauseous none
Pt with severe right lower quadrant pain - 48 hours after vaccine and required ER evaluation, labs, CT scan.  There was mild diverticulitis on the left side, did not explain her pain on the right side.  Placed on antibiotics which caused side effect of diarrhea. Required follow up telephone visit and follow up office visit.
pain (see below) Narrative: As reported by Employee on 6/25/2021: ********************************************* "After the second shot, it felt like I had nerve damage. I still get random pains from my left shoulder to the palm of my hand. It is excruciating pain when it occurs. What were the symptoms? (DETALED): none"
breaking out in hives on  both arms, chest, then eventually on  face; didn't sleep well; itch goes away but the rash does not go away; Bumps under skin; itch; Tired, fatigue for several days; Tightness/ throat contractions in throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightness/ throat contractions in throat), MASS (Bumps under skin), URTICARIA (breaking out in hives on  both arms, chest, then eventually on  face), SLEEP DISORDER (didn't sleep well) and PRURITUS (itch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 Year.   On 12-Feb-2021, the patient experienced THROAT TIGHTNESS (Tightness/ throat contractions in throat) and FATIGUE (Tired, fatigue for several days).   On 16-Feb-2021, the patient experienced MASS (Bumps under skin) and PRURITUS (itch).   On 19-Feb-2021, the patient experienced URTICARIA (breaking out in hives on  both arms, chest, then eventually on  face), SLEEP DISORDER (didn't sleep well) and RASH (itch goes away but the rash does not go away). The patient was treated with CHLORPHENIRAMINE MALEATE for Allergy, at a dose of 4 milligram.   At the time of the report, THROAT TIGHTNESS (Tightness/ throat contractions in throat) and PRURITUS (itch) had resolved, MASS (Bumps under skin), URTICARIA (breaking out in hives on  both arms, chest, then eventually on  face), FATIGUE (Tired, fatigue for several days) and RASH (itch goes away but the rash does not go away) had not resolved and SLEEP DISORDER (didn't sleep well) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She felt a little sore at the injection site; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received unknown dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on an unspecified date as a single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient felt a little sore at the injection site and just wanted to know if she can take Tylenol to feel better. The clinical outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Information has been received from a health care professional concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine lot # 659083/1418U. Subsequently, the patient experienced a reaction around the injection site extended to forearm. The outcome was unknown. The health care worker has requested a lot check. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory, the lot met the requirements of the center for biologics Evaluation and Research and was release. Follow up telephone message received from the pharmacist. She reported that they were initially concerned about the lot as they saw a few reactions. However, they had since decided there was nothing wrong with the lot and were no longer interested in a lot check. Additional information has been requested.
Headache; fever; chills; shaking; underarm swelling; arm pain; muscles pain; fatigue; lighheadness; This is a spontaneous report from a non-contactable Other Health Professional (patient).  A 25-year-old female patient (not pregnant at the time of vaccineation) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1283), via an unspecified route of administration at left arm on 07Jan2021 12:00 at single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 08Jan2021 01:00, the patient experienced headache, fever, "chills/shaking", underarm swelling, arm pain, muscles pain, fatigue, and "lighheadness". The above mentioned events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering. The reporter considered the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Just come down with Covid/has 2 shots & no booster; Just come down with Covid/has 2 shots & no booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing), notes: he is overweight. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Just come down with Covid/has 2 shots & no booster".  Clinical course: It was reported that, his doctor said, Paxlovid is not yet commercially available. Since time is of the essence (he is overweight and told me that if the symptoms did not subside in a day or two, he may need hospitalization. Is there any way I can get the medicine to him while he Ts still ambulatory?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Text message from patient : 2.37 pm Saturday 02/20/2021 had the vaccine , waiting for 15 minutes & 2nd dose due 3/18/2021 Test message 9.44 am Sunday :feeling little sick with stomach ach  No answer to phone calls on Cell/ Landline on Sunday No answer to phone call/ or  text message  No further communication.
Patient received Moderna booster immunization but was under the age of 14. Moderna is indicated for those 18 and up.
At 36 hours post shot, extreme vomiting and diarrhea began.  This continued for approximately 12 hours.  At that point a few of 102 began and continued for another 24 hours even with Tylenol.  Extreme body aches were involved throughout the ordeal.
Enlarged red mark and swelling at injection site. Lump in armpit on the same arm
After waiting 15 minutes, I was released to head home. About 5 minutes into the drive home I suddenly couldn't swallow. I was able to breathe without any feeling of my airway closing. The inability to swallow lasted about 3-5 minutes. I stopped at a store and picked up Benadryl and took 2 tablets. I turned around and went back to the vaccination clinic. They checked my vitals and watched me for another 20 minutes. At the end of the 20 minutes the doctor checked with me and determined that I could leave. It was recommended that I speak to my general practitioner about the reaction and whether or not I should get the second dose.
COVID vaccine breakthrough case  all Moderna dose 1  2/15/21  031L20A dose 2  3/15/21  030A21A dose 3  11/18/21  069F21A dose 4  7/8/22  017B22A
Noticed swelling in my neck on 5th day after 2nd dose of vaccine, Tuesday April 20th.   Was seen in urgent care on  Wednesday evening April 22, diagnosed with parotitis  and prescribed Augmentin.    Continued to worsen, was treated on Friday April 23.   I received IV antibiotics while in ER.  Am continuing to take clindamycin and metronidazole.   Condition is improving.
4 cm diameter erythematous circular rash- started 1 day after DTaP vaccine. Started on KEFLEX in case cellulitis although seems more due local reaction.
Dose #1 - experienced vertigo symptoms for approximately 2 hours and then brain fog which resolved in 24 hours Dose #2 - The following day after second dose of COVID vaccine, experienced chills, body aches, and severe migraine (sensitive to light and sound).  Six days after vaccine, began to experience moderate dizziness without nausea.  Sought medical attention on day #7.  No explainable reason for dizzy symptoms.  Prescribed meclizine for dizziness.  Now, two weeks after 2nd dose of vaccine, still experiencing  dizziness on a daily basis.
Flu imm. given on 10-21-08 with FLUVIRIN. Age group to be 4+ years. Child was only 3 years when given. No apparent problems
Syringe malfunctioned while administering second dose of Pfizer Covid vaccine. Began injection into left deltoid and when I depressed the plunger on the syringe, the needle retracted almost immediately before the full dose was administered. I estimate the patient only received 0.05ml of the 0.3ml dose they were supposed to.
SORENESS ON THE INJECTION SITE; This spontaneous report received from a consumer concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included persistent back ache. The patient was previously treated with paracetamol for back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness on the injection site. This report was non-serious.
shingles; other zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 81-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 01-JAN-2011, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was unknown.   The reporter considered the events of shingles and other zoster-related conditions (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
80 small itchy bumps occurred 2 days after shot at injection site. Patient put steroid cream on site with no relief. Bumps were "hive-like" but not red.
AE: patient felt dizzy and lightheaded 20 minutes post vaccine administration. Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.