chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized erythema 3 X 2 3/4" at injection site within 48 hours of immunization. left arm.  Cont. treatment with CLARITIN.
headaches; This is a spontaneous report based on information received by Pfizer from Novartis (mfr control no. NVSC2021US110715), report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headaches after her last COVID-19 Vaccine on an unspecified date. Outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
typical side effects with in the first 48 hours. then 8 days post injection began to have side effects again. Began with an itchy arm at injection site and thought nothing of it b/c there were not marks. by the end of that Sunday my arm was red and warm with round spots. I took some Cetirizine and used a topical cortisone. Monday morning I woke to two lumps, itchiness, heat, tenderness, sore muscles, headache. I took some APAP and IBU and applied some more cortisone, went about my day with a two hour car ride and a walk. i was stiff through the day so i completed stretches several times through the day. When i got home that night most of my major joints hurt enough that I could not sleep through the night even with Naproxen 440 mg , APAP 1000 mg, Cetirizine 10 mg on board. My arm began to be more swollen, my nervous system began to be off. I had no appetite, was dizzy, felt shaky but when I held my arm and hand out, I did not shake. I have continued on a with Naproxen an d APAP since Tuesday after read not to take PO IBU if had Moderna vaccine.  I have not been able to complete house hold chores, missed three days of work, and been able to be with family.  As of today, January 22nd 2021, thirteen days post injection I still have fatigue, intermittent dizziness, loss of appetite, joint pain, headache with no relief with OTC's. The redness, swelling, heat have dissipated in left arm at and near injection site.
During the evening of 22Mar91,developed a T 103 & as a result of the fever developed seizures.
headache which got worse in; injection site was quite red; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache and injection site erythema. In January 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix and experienced headache which got worse in the night, but subsided the next day of receiving vaccine. The patient's injection site was quite red, but was subsiding. The patient had no other issues. The patient wanted to know was the headache and red injection site considered an allergic reaction and should he/she avoid the 2nd dose or was it an expected side effect and safe to get the second dose.
She is feeling ill right now; I blow my nose I blinked my eyes; started to really hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43-year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Ear Infection" (unspecified if ongoing), notes: wants to know if she can take her antibiotic for chronic ear infection (Intent: Medical history). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 13Aug2021, outcome "unknown", described as "She is feeling ill right now"; PAIN (non-serious) with onset 13Aug2021, outcome "unknown", described as "I blow my nose I blinked my eyes; started to really hurt".  Additional information: Expiry date of COVID-19 Vaccine was unknown. She wanted to know if she could take her antibiotic for her chronic ear infection (Intent: Medical history) since she was feeling ill right now, feels like a normal infection as what she said earlier. She said that she felt it after getting the first dose. She had her first dose earlier today. She stated that she usually gets on 2 or 3 times a year and when she went and got her shot today. Her very first one it wasn't bothering but as the nights were on, she blows her nose, blinked her eyes. It started to really hurt, and she had antibiotics ('Erythromycin' (Further not clarified)) but was scared to take them because she did not want to mess up with vaccine. She further clarified that it is not a side effect of vaccine. She gets Chronic Ear infection and already have an antibiotic prescribed. She wanted to know if she could take it on top of the vaccine or if they are fine to wait. What if there a drug interaction that is what she was checking on. Reporter seriousness for events was unspecified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bumpy rash; rash was itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of papular rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 22-MAR-2023, 1 days after receiving Shingrix, the patient experienced papular rash (Verbatim: bumpy rash) and itchy rash (Verbatim: rash was itchy). The patient was treated with steroids nos (Steroid Pack (Nos)). The outcome of the papular rash and itchy rash were not resolved.   It was unknown if the reporter considered the papular rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the papular rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt date:27-Mar-2023 Patient stated the next morning when she woke up with a horrible itchy rash across her chest.  She stated that the rash spread to under her arms and to the back of her neck in the next couple of days after.  She stated that she went to an urgent care where she was given a metradose steroid pack to take for 5 days and she had 1 day left to take the steroid pack. She described the rash was itchy and bumpy. The reporter consent to follow up with her and healthcare professional.
Chills, extremely sore joints, entire spinal pain, extreme fatigue. Soreness lasted and fatigue lasted 24 jours
Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, phlebitis) 13 April; treated for dehydration and prescribed ASA.  Tachycardia on exam, resolved with resuscitation.  Asymptomatic 4 hours later, and expired overnight in his sleep.  Found unresponsive in the morning, time of death 09:57.
4 pts recvd 3 doses of Engerix-B vax & it was determined that they were non-responders; Reporter indicated that 2 pts were tested 16 or 17 months p/their last dose & one was tested p/only 2 doses;
This is a spontaneous report from a contactable other HCP (Pfizer colleague). This other HCP (patient) reported the following: A 35-years-old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration in left arm on 22Feb2021 at 03:30 PM as a single dose for COVID-19 immunization. The patient medical history allergies to bee/wasp and to medication including Naprosyn/Naproxen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient stated that on 22Feb2021, within 30 minutes after vaccination, she was aware of hives and within 1 hour after vaccination, her had epidermis had a burning sensation all over body. The patient reported that an hour after her COVID-19 injection, she began to experience itching all over her body from head to toe, hives, a burning sensation under her skin, nausea, and a tingling sensation in her extremities. Also, they became cold to the touch. Also, the pain at the injection site was more severe the 2nd day than the 1st. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events including Benadryl (antihistamine). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
16% loss of hearing; Fullness in ear on the injection side (left); This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 13Jan2021 at 11:30 at a single dose on left arm for COVID-19 immunisation. Medical history included breast cancer, lymphedema (right arm) and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR). The patient experienced 16% loss of hearing and fullness in ear on the injection side (left) on 14Jan2021 at 17:00. The patient underwent lab tests and procedures which included acoustic stimulation tests: 16 % (16% loss of hearing) on 14Jan2021. Therapeutic measures were taken as a result of 16% loss of hearing and fullness in ear on the injection side (left). The outcome of the events was not recovered.
Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches; Slight headache; arm discomfort; Getting dizzy off and on not sure if its from Zyrtec or vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine). At the time of the report, RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken. No treatment drug was taken.
patient received 1st dose 2/19 and 2nd dose 3/15. Admitted to hospital but unknown if COVID related. Still currently admitted as of 8/09/2021
Presented with weakness, confusion; + Covid, + UTI, CXR: no PNA; Tx: Rocephin, remained on 3 LPM NC during stay; back to baseline at d/c
Pt developed severe joint pain the evening he received his 3rd booster and developed a psoriatic type rash on his right elbow within  3-4 days after getting the vaccine. He has no personal history of psoriasis or family history of psoriasis.  He has used steroid cream with near resolution of the rash.
MMR given 10-8-09 subcutaneously in Lt. post arm.  Returned to clinic 11/2/09 with approx. 1 cm. "hard knot" at injection site; tender to touch.  Sl warmth & redness.
Metal taste; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 09:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation as other vaccine within four weeks prior to the COVID vaccine. On 29Apr2021 at 02:00, the patient experienced metal taste, dizziness & nausea. Since the vaccination, the patient had been tested for COVID-19. On 29Apr2021, the patient underwent lab test and procedure which included COVID-19 virus test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event metal taste, dizziness and nausea was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ACHE AND SORENESS; JOINT DISCOMFORT; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: non- smoker, and alcohol abstain from alcohol, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient do not had illness at time of vaccination. Patient do not had illicit drug usage. 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 18-AUG-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced ache and soreness. On 19-AUG-2021, the patient experienced joint discomfort. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 19-AUG-2021, was recovering from ache and soreness, and had not recovered from joint discomfort. This report was non-serious.
Vaccine was expired on 1Apr2022 and administered on 2Apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 1Apr2022 and administered on 2Apr2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 1Apr2022 and administered on 2Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 1Apr2022 and administered on 2Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, however the vaccine expired on 01-Apr-2022. Vial was initially stored in refrigerator on 04-Apr-2022. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.
Patient called today, 1/22/2021 stating he woke up this morning with abdominal cramps, nausea, and vomited 3 times.  Has improved since morning.  Instructed to drink  clear fluids sparingly to see if can tolerate  and to keep hydrated, rest and call if continues to persist or go to the ER.
She began bleeding rectally.  She was hospitalized and then dc for a day and then rehospitalized with extreme cramping and bleeding.  She was given a colonoscopy and was diagnosed with Ulcerative Colitis.  She had no symptoms before the vaccination.
Large red swollen area on left arm where shot given. Larger than a silver dollar. Pain X7 days.
Pt reports previously having COVID, and he experienced a change in taste/smell at that time. He experienced the same sx about 1 to 2 days after his first dose of Moderna, and he said this lasted about one day. He was unable to specifically describe the change, but he described it as a "minor alteration". He stated things just tasted "a little funny" or "a little off".
At approximately 01:00 am Saturday morning, patient's spouse woke him because he was violently shaking in his sleep. He very quickly thereafter became dizzy, unstable, and began heavily vomiting. His temperature at 01:30 am was around 104.0 degrees Fahrenheit. It fluctuated significantly for the next hour while he continued to vomit. He made it to bed around 03:00 am and was able to fall asleep, though he was still dizzy, shaking, and nauseous. Between 03:00 and 05:00 am, his spouse took his temperature and it had spiked up to 106.0 degrees Fahrenheit. He did not wake up until 8:00 pm Saturday evening. Saturday night and Sunday he was off balance and very weak. Today, 11/15/21, he is only a little fuzzy headed.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "Two days after the vaccination, I lost the effect of the steroid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, rash on left arm, swelling on the left arm. She also has a huge lump under the skin significantly bigger than  your general lump at the injection site.
Pt was admitted on 8/10/21 for severe hypoglycemia due to a medication prescribed as an outpatient.  She was tested for FluA and SARS CoV-2 AG on admission and was found to be positive for both.   She denied SOB, cough or fever at admission. She also denied headache, head congestion or sore throat. She reported dizziness with positional changes and diarrhea.  She was monitored for 2 days without any change in respiratory status.  She was discharged on 8/13.
p/vax sx started 10/28/99 swollen, reddened, lt upper arm, itching, discomfort;
Two weeks post-vax, developed pain in lower abdomen, pressure making me feel like I had to pee or poop. Vague nausea. Gas. A few days later, breast tenderness and vaginal discharge. I am four years past menopause, but the whole thing felt like a period about to arrive. No bleeding. Symptoms resolved after about a week and a half.
Approximately 5 minutes post vaccine, mom alerts the pharmacist that patient is experience some visual disturbances. The patient states that he felt dizzy/eyes were "going black" in and out. Heavier breathing than normal. States it feels harder to breath, but no reports of swelling or itching. Also states that ears were ringing. Pharmacist attempted to check blood pressure on patients left arm with an automatic cuff, but the machine errored twice. Then attempted to check BP with a manual cuff. Reading was varied due to patient moving his arm and hard to hear. Seemed to be around 90/50, but not precise. After 10 minutes, patient stated he was starting to feel better, just felt thirsty. Pharmacist rechecked BP on right arm with a different automatic cuff and reading was 104/62, with a pulse of 101. Patient continued to improve, stating that visual disturbances were gone and hearing had returned to normal. Was able to stand and walk around without feeling dizzy. No difficulty breathing reported at that time. Patient and mom waited another 5 minutes to ensure he had no symptoms and then were able to leave approximately 25 minutes post vaccine.
Fever of 101 degrees, severe headache, fatigue and bodyaches.  Chills and nausea.  Severe right arm pain.  Took tylenol and tramadol for pain and fever.
my heart rate went to 168 BPM; chest pains; numbness is face and arms; numbness is face and arms; shortness of breath; elevated blood pressure; Numbness and tingling in my arms and legs; Numbness and tingling in my arms and legs; At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported " I received my first Pfizer shot on06May2021. Immediately after the shot I began feeling symptoms, my heart rate went to 168 beats per minute (BPM), I had chest pains, numbness is face and arms, shortness of breath, elevated blood pressure. I was taken via Fire Rescue to the hospital where I was later admitted. Now that I am out of the hospital I am experiences a new set of symptoms. Numbness and tingling in my arms and legs. At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!".  The outcome of events was unknown.
TUESDAY 9/25/18 WITHIN HOURS OF RECEIVING THE 2ND DOSE OF THE SHINGRIX PATIENT FELT TIRED, SORE ALL OVER, NAUSEATED, AND SLEPT MOST OF THE DAY. HE TRIED TO EAT SOUP AND THREW IT UP. WEDNESDAY 9/26/18 PATIENT FELT THE SAME NO CHANGE. WIFE TOOK HIM TO DOCTOR AND WAS TOLD TO GO TO THE HOSPITAL AND HAVE BLOOD WORK AND CHEST XRAY DONE. PATIENT HAD ALL TESTS DONE AND CAME BACK NORMAL. THURSDAY 9/27/2018 PATIENT HAD A TEMP OF 101.6, HE WAS SWEATING, HE WAS COLD, HOT, COULD NOT GET AROUND GOOD. WIFE HAD TO HOLD ON TO HIM SO HE COULD GET AROUND AND WOULDN'T FALL. HE COULDN'T TALK. HE GOT IN A TUB OF TEPID WATER, ALSO TOOK TYLENOL. WENT TO BED ALSO SHIVERING. FRIDAY 09/28/2018 HE WAS SHAKING UNCONTROLLABLY. WIFE TOOK HIM BACK TO DOCTOR AND WAS TOLD TO TAKE HIM TO THE ER FOR A SPINAL TAP AND CT SCAN DONE. WAS ADMITTED TO HOSPITAL AND THE NEXT DAY HAD A MRI DONE ON HIS BRAIN. HE WAS ON 3 ANTIBIOTICS AND AN ANTIVIRAL. HE COULD NOT KEEP HIS BALANCE AND COULD NOT SPEAK CLEARLY, HE HAD TROUBLE REMEMBERING HIS AGE AND HIS FAMILY, AND DIDN'T KNOW WHAT YEAR IT WAS. MRI WAS NEGATIVE. HE CAME HOME AND IS VERY TIRED AND HAS NO APPETITE.
Sharp chest pain 30 minutes following administration of Moderna COVID-19 Vaccine DOSE 2
Sudden fever of 106', chills, rapid heartbeat, vomiting. Fever between 103-106' for 7 days. Treatment with Ibuprofen, fluids, rest.