chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received full vaccine series and is now hospitalized.  Per H&P   Patient:  Age: 61 Years     Sex: Female     DOB:    Chief Complaint   rash x 4 days  History of Present Illness        Patient is a 61 yo wf with pmh DMII on insulin, HTN, CAD, anxiety/depression who presented to ED on 1/2/22 with painful rash across the torso x 3 days.  She states that for the past 7 days she has nonproductive cough, intermittent fevers, nausea with intermittent NBNB emesis, and 3-4 loose stools per day.  3 days ago patient developed small red bumps across her torso that has since coalesced to large red regions across the torso and back and down into the proximal thighs.  She states the rash is very painful.  She denies any involvement of the vagina or mouth.  Over the past day while in the emergency room, rash has spread to the face and neck.  Again she is not having any difficulty with breathing does not have any sloughing of the skin of the face, mouth or torso.  3 months ago she began given taking gabapentin and 2 weeks ago she was started on Wellbutrin.  She called her PCP 2 days ago and was taken off the Wellbutrin.  She has never taken this medication prior.  Over the past day her diarrhea has improved and she has had one episode of loose stools.  She denies any abdominal pain.  She was tested for Covid about a week ago and was negative.   Unknown vaccine manufacturer, date, or location received.
Child developed urticaria after Flu Mist. Treatment: Diphenhydramine Elixir.
Patient fainted shortly after receiving vaccinations. Woke up quickly but felt hot and nauseated. Called 911. EMS evaluated blood pressure, heart rate, and did an EKG. Blood pressure and Heart rate were both originally low, EKG normal. EMS continued to monitor and BP and HR returned to normal. Patient drank some water and was able to go home.
Shortness of Breath  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat
28MAR91 2 day hx sl cough, fever for 24 hrs, t103.4 AX, sz-5min duration, observed by medics in ER; t104.9 R, became more alert p/1 hr, walking, exploring surroundings; LP refused by mom;
Muscular soreness in the shoulder, loss of movement without pain, muscle weakness & loss of strength, frozen shoulder
BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT.  I DID NOT SEE A DOCTOR .
Pt developed fever of 103 with 1 episode of vomiting, lightheadedness No syncopal episode
J12.82 - Pneumonia due to coronavirus disease 2019 U07.1 - COVID-19
Low grade fever for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2023, outcome "recovered" (Sep2023), described as "Low grade fever for 24 hours". Therapeutic measures were not taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The lymph nodes on the left side of my neck are extremely sore.  It feels tight and painful to move or sleep.
Anxiety, nausea, headache, racing heart 12:00pm-10:00pm day after vaccine
vesicles on trunk, extremities, face, scalp. Onset 04/11/05/ Home care measures given. Itching. Was examined by MD
While in observation, patient felt faint/sweating. Patient did not fall. Patient alert and oriented. Given snack and water.
Terrible body aches, extremely painful headache, chills, nausea, tiredness. Could not get out of bed for 24 hours. Couldn?t eat more than a bite of a cracker drink fluids. Could not sleep because of headache. Started to feel better after approximately 24 hours, but still weak and tired and not feeling normal for several days after second vaccine.
fainting, recovered in pharmacy after about 15 minutes, was given one dose of ammonia inhalant.
redness at the injection site; heat at the injection site; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2022, the patient received the 2nd dose of Shingrix. On 19th August 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The consumer was the reporter and the patient. Consumer stated she received her 2nd Shingrix vaccination in the arm and experienced redness, heat, and swelling at the injection site. The reporter stated that all symptoms was not resolved as of 23th August 2022.  Consumer Inquiring if this was an expected side effect and should she notify her rheumatologist. Spoke from content and package insert. The reporter was provided HCP referral.
Intermittent, indescribable cool feeling in chest,was feeling odd; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6206 and expiration date was not reported) via unknown route of administration on left arm on 08Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for two weeks. Past drug medication included Codeine and experienced Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 patient had intermittent, indescribable cool feeling in chest and was feeling odd. As a result, patient had doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The outcome of the events was unknown.
Information has been received from a nurse concerning a 5 year old male with dextromethorphan hypersensitivity who on 08-OCT-1996 was vaccinated with VARIVAX (Oka/Merck) (617313/0769D) S.Q. Concomitant therapy included HIB (manufacturer unspecified) and DTP (unspecified). Four years after the patient's first and only dose of VARIVAX, in approximately 2000 the patient developed shingles. Subsequently, the patient recovered from shingles. Additional information has been requested.
Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient, height: 66.22 cm & weight: 175 kg, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 17:00 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in the clinical trial. Medical history included LASIK eye surgery. Concomitant medication(s) included prednisolone acetate (manufacturer unknown) and moxifloxacin (manufacturer unknown) both were taken after LASIK eye surgery. On 19Apr2021 12:30, the patient experienced Bell's palsy. The clinical course was described as follows: On 19Apr2021 at 12:30, the patient was eating lunch and he noticed the left side of his face was a little numb. The patient states he thought originally that he might be having an allergic reaction, but he was eating the same food that he always eats so it couldn't have been that and sort of ignored it. About 21:30, 22:00 at night (19Apr2021), he realized in the shower that he could not open his right eye, right eyelid, then his face was numb and he couldn't form his mouth to make a whistle, and he still can't, and he thought he was having a stroke because his face was all messed up. So that's when he went to the emergency room and they did a CAT scan that determined it was not a stroke, it is Bell's Palsy. The patient stated they prescribed him medications to take, and he was not hospitalized and discharged home. The patient stated his eyelids, they don't blink at the same rate and his left eye doesn't close all the way, he had to force it closed and it's very annoying. The patient verified that all his symptoms began on 19Apr2021 at 12:30 and all symptoms have worsened. The patient stated that he is perfectly healthy, not overweight and he's never had it before, and it came right out of the blue. The clinical outcome of the Bell's palsy was not resolved.
nausea, vomiting fever, diarrhea starting 24hr p/vax
little rash on my arm/rash on left arm; unable to sleep because of the itching; unable to sleep because of the itching; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer (patient). An 89-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 89-year-old) as DOSE 2, SINGLE, for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication(s) included atenolol (MANUFACTURER UNKNOWN) taken 50 mg daily and hydrochlorothiazide (MANUFACTURER UNKNOWN) 25 mg daily; both taking for 10-15 years and taken for unsure water or blood pressure from an unspecified start date and ongoing. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 24Feb2021 (at the age of 89-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. On an unspecified date in Mar2021, patient developed a rash after a week of getting it and it has returned. Patient was trying to find out what was happening. He was unable to figure out why or what it was. It didn't do any damage. He was unable to sleep because of the itching. The events did not result in emergency room or physician office. The seriousness of the events was reported as non-serious. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient fainted twice after second vaccine administered. Patient's Mom stated after the fact that the patient has fainted after vaccines in the past but did not disclose that information prior to because she thought her daughter had "grown out of it".
Swollen Lymph nodes, headache, fatigue, muscle weakness, brain fog, diarrhea, skin sensation in shin area.
Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; This is a spontaneous report from a contactable Other HCP (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, on 08Jan2021 15:30 at single dose on left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient has no other vaccine in four weeks. The patient had no Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. The patient had Swelling in left arm on injection site had now become hard and itchy on 09Jan2021. No treatment was received for all events. The outcome of the events was not resolved.
Severe headache, fatigue, chills, night sweats.  Started within the first week.  Headache is an 8-9 out of 10 for pain.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 48 year-old non-pregnant female patient received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG198) via an unspecified route of administration in left arm on 26Feb2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin.  The patient  did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in the left arm on 01Feb2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced shingles which was diagnosed on 19Mar2021. Therapeutic measure for shingles included treatment with valacyclovir and prednisone. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Some diarrhea and abd pain-almost to nausea stage but have taken some Zofan
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L026405, expiration date 15-JUL-2017 (dose, route of administration and anatomical location were not provided). The vaccines were frozen and exposed to the following temperatures and time frames out of range: -3 Celsius degrees for 261 hours between 17-JUN-2016 and 24-JUN-2016, -6 Celsius degrees for 50 hours between 28-JUN-2016 and 30-JUN-2016, -1 Celsius degree for 191.5 hours between 30-JUN-2016 and 07-JUL-2016, -3 Celsius degrees for 336 hours between 08-JUL-2016 and 19-JUL-2016, -3 Celsius degrees for 166.5 hours between 19-JUL-2016 and 27-JUL-2016, 0 Celsius degrees for 84 hours between 29-JUL-2016 and 01-AUG-2016, -1 Celsius degree for 36 hours between 01-AUG-2016 and 03-AUG-2016, 1 Celsius degree for 193 hours between 03-AUG-2016 and 10-AUG-2016, -1 Celsius degree for 344.25 hours between 11-AUG-2016 and 25-AUG-2016, 0 Celsius degrees for 161.25 hours between 26-AUG-2016 and 31-AUG-2016, -3 Celsius degrees for 21 hours between 01-SEP-2016 and 02-SEP-2016, -2 Celsius degrees for 131 hours between 02-SEP-2016 and 07-SEP-2016, -2 Celsius degrees for 46.5 hours between 07-SEP-2016 and 09-SEP-2016, 0 Celsius degrees for 143.75 hours between 09-SEP-2016 and 15-SEP-2016, -1 Celsius degree for 110.25 hours between 15-SEP-2016 and 20-SEP-2016, -3 Celsius degrees for 57 hours between 20-SEP-2016 and 22-SEP-2016, 0 Celsius degrees for 136 hours between 22-SEP-2016 and 28-SEP-2016, 0 Celsius degrees for 71.5 hours between 27-SEP-2016 and 30-SEP-2016, and -2 Celsius degrees for 94 hours between 03-OCT-2016 and 05-OCT-2016 (summary time of excursions 2634.5 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
His heart is racing and feels like it will jump out of his chest; His blood pressure is not consistent. It goes way up and comes way down.; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4176, expiration date unspecified), via an unspecified route of administration on 16Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included back surgery and patient used to weigh 218 but lost weight due to a back surgery. This was prior to getting the vaccine. There were no concomitant medications.  On 16Jan2021, the patient experienced his heart was racing and felt like it will jump out of his chest and his blood pressure was not consistent and it goes way up and comes way down. He was told by the individual who gave him the vaccine to call and report this. There was no treatment received. Patient was scheduled for the second dose on 06Feb2021. Outcome of events was not recovered.
Initial report received from healthcare professional on 15 November 2013: A 73-year-old female patient had received a first intramuscular dose of FLUZONE right arm (batch number: UH900AA, previous dose: 0) on 15 November 2013. Patient had vaccine at 9:30 am and came back to the doctor's office later in the day with ocular hyperemia and facial flushing. The subject had medical history of MICARDIS, Simvastatin, omeprazole, fish oil, ASA, codeine allergy. Any other vaccinations within 4 weeks of vaccinations was not reported. The subject's illness at the time of vaccination was not reported. The subject was not recovered from the events. Lab investigation was not reported. Documents held by sender: none.
Pruritis and rash injection site and same on the right arm.  Systemic reaction.  Arthralgia in both knees, but left knee stopped my activities.  Arthritis suddenly developed in the left knee.  The right knee was not x-rayed.  Almost a year later and the left knee is still stopping my activities.  Now paraesthesia started in my right foot.    I had occasional GERD.  Now gastroesophageal reflux disease is daily.  I never had headaches.  Now occasional headaches.  My eyes are slow to adjust.  My left knee was already a problem, but never this bad.
Developed a headache in the afternoon following my vaccination that continued through the night. It was the worst in the middle of the night and early morning hours - similar to a migraine - and nothing seemed to help. I took multiple doses of Tylenol to try to take the edge off, but it just got progressively worse and interfered with my sleep until around 3 a.m. when I was finally able to fall asleep. By the time I woke up around 7 a.m., the pain was less intense.
Pt had swelling, tenderness, chills, nausea, diarrhea, sharp shooting pain, fever, and area spreading.  Pt started noticing area Tuesday at 1600.  Pt was given 50mg of a Benadryl type medication that she takes q 6 hrs.
Arm Pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  The patient had received their second of two planned doses of mRNA-1273 on 02-FEB2-021, in the left upper arm.
I had a virus and went to my family doctor who did a blood panel for a regular physical and she called me to request that I have a 2nd blood panel completed because they saw something abnormal with my liver and I am losing a large amount of blood from an unknown area of my body. I was running a fever and had really bad chills. I was not able to get out of the tub. My husband had to physically remove me from the tub. He brought me some electrolytes and I drank that and went to bed. The next morning I was feeling fine. I was referred to a gastroenterologist. I am still very tired and I do not have the strength I did.
Rash on arm, erythema, itching, tenderness with 24 hours of injection and lasted for 4-5 days. Denies dizziness, shortness of breath, headache, nausea or vomiting.
11/21/2022 I tested positive for COVID-19 I had a massive headache, sinus pain and fever. I called my Physician and was prescribed Paxlovid. I was feeling alot better after 2 days. 03/02/2023 I started getting heart palpitations and it was hard to sleep or rest. I  went to clinic and had an EKG  it was noted that I was in  PAC . Physician suggested that I may have autonomic neuropathy which he has seen post vaccine. I have a follow up with a Cardiologist for a Holter Monitor in August.
sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Information has been received from a physician concerning a 12-month-old "otherwise healthy" female with an ear infection who on 08-AUG-2003 was vaccinated with a dose of varicella virus vaccine live (Lot # 646137/0474N). Concomitant therapy included cefdinir (OMNICEF) for an ear infection. On 13-AUG-2003, one week post vaccination, the patient developed a fever of 101.5 degrees Fahrenheit and an unusual rash. The rash was described as pink and raised with papular marks  (rather than vesicular) 1/4 to 1/4 inches in size. The physician noted that the patient presented to the office on 15-AUG-2003, two days after the rash appeared. The patient was also noted to have a low grade fever (approximately 101.5 degrees Fahrenheit). Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.