chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized for pneumonia.; Rash/severe rash that itches; She was running a fever; This is a spontaneous report from a contactable other health care professional. An 80-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 11:00 (at the age of 79-years-old) (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included raynaud's phenomenon Takes Procardia for this. Left arm goes ice cold, right is warm. If takes Procardia this not happen, blood pressure high, Heart disorder, Gastric reflux, Congestive heart failure, Extra fluid, Leg jumps, Restless leg syndrome. The patient received first dose of BNT162B2 for COVID-19 immunization on 04Mar2021 at the age of 79-years (Dose :1st, Lot/Expiry Date: EN6199/ UNKNOWN at 10:45 am Administered in her left arm). Concomitant medications included losartan potassium (COZAAR) taken for Blood pressure high; metoprolol tartrate (LOPRESSOR) taken for Blood pressure high; nifedipine (PROCARDIA [NIFEDIPINE]) taken for Heart and raynaud's phenomenon; apixaban (ELIQUIS) taken for blood thinner; omeprazole (PRILOSEC [OMEPRAZOLE]) taken for Gastric reflux; bumetanide (BUMEX) taken for congestive heart failure and To get rid of extra fluid; potassium (POTASSIUM); magnesium (MAGNESIUM) taken for leg jumps, restless leg syndrome. Caller reporting on the covid vaccine. She had a severe rash. It was in the groin, in rectum, inside of her legs, shoulders, upper arms, and stomach. It started Apr2021. She flew to to see her sister and she knew when she went there she had already had the rash for a month before that. She had kept trying different ointments on it. Commented it gets irritable and irritating when the rash gets to itching. It is very disturbing. The doctors have tried everything. She has had 4 doses of Solu-Medrol, Prednisone, Benadryl, and it does not seem to be letting up. She confirmed she has no details to provide lot/exp/NDC. Once the packet is empty she throws it away. She also went to the Emergency Room due to this and was given Benadryl, Pepcid, and Cortisone. She has been given Cortisone pack four times now. The patient was hospitalized on 01Jul2021 to 04Jul2021, but was hospitalized for pneumonia. She was running a fever. She had covid test and they were all negative. She also mentioned she has had other hospitalizations, but no details provided. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, full blood count: unknown results on 01Jul2021 She had a CBC to determine if there was an infection , sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of the events rash pruritic. The outcome of the event Rash/severe rash that itches was not recovered, while unknown for the other events.
This baby had to be woken up, glazed eyes, high pitched inconsolable screaming, sleepy, no appetite.
Lethargic; Swollen left eye; Both temples were swollen; Redness on both temples if tired; Tired; Cannot get enough sleep; Sleepiness; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW013) via an unspecified route of administration in the right arm on 10Apr2021 at 11:00 (at the age of 55-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on an unknown date in May2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B. The patient had no known allergies to medications, food or other products. The patient received unspecified medications 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 17May2021, two weeks after second dose of vaccination, the patient experienced lethargy, swollen left eye, both temples were swollen, redness on both temples, was tired and she couldn't get enough sleep, also experienced sleepiness and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargy, swollen left eye, both temples were swollen, redness on both temples, tired and couldn't get enough sleep, sleepiness and itchy were not resolved at the time of this report.
2-3 days after receiving shot, patient reported itching and swelling at site of injection. I observed a nickel-sized area on right upper deltoid upon patient's presentation two weeks after presentation. Patient stated it was no longer causing pain, but that it had been itchy for at least a week and the patient's itching had caused the area to bleed and scab over.
SORE; LOSS OF APPETITE; FEELING TERRIBLE; ACHING JOINTS; INCREDIBLE FEVER; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, once a total administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sore. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling terrible. On MAR-2021, the subject experienced aching joints. On MAR-2021, the subject experienced incredible fever. On MAR-2021, the subject experienced tired. Laboratory data included: Lab test (NR: not provided) 8/10 recommended (units unspecified). The action taken with covid-19 vaccine was not applicable. The outcome of the tired, loss of appetite, incredible fever, aching joints, feeling terrible and sore was not reported. This report was non-serious.
Around five hours after receiving vaccines patient became distraught, and unconsolable.  He presented a low grade fever and cried, whimpered and screamed for about three and a half hours. Later that night I saw two eczema spots on his chest, which had already been there, but they were bright red and more noticeably raised than before.  He also on both of his arms from about slightly above his elbows to about middle of his forearms round, red, rings, which looked eczema like presented. They are still present no longer red, but still there when he never had them before.
I became very cold and achy approximately 9-1/4 hours after the second dose of vaccine. I took Aleve and experienced some relief, but the ache became more joint-acute than muscular. The chills subsided about 11am Saturday morning (the 24th), but the aches and joint pain lasted until about 7pm.
On the day that I had the 3rd dose of the vaccine, I was not able to function or go about my daily chores. I experienced aches, pains and exhaustion which lasted only 24 hours. I started having a sore throat recently with no fever. The 2nd day I had sneezing runny nose, aches, pains and tiredness. Today I developed a light cough. I used a home testing kit and I tested positive. I reached out to the doctor who recommended that I take Tylenol, rest and have fluids. As well as self isolating for 5 days. I woke up feeling miserable but a bit better now. I am still on the mend but not completely recovered.
Three days after the vaccine I had severe  tinnitus.  I am still struggling with it two weeks later.
chills; arm used for injection was very sore; body aches; felt nauseous.; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 13:15 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies Tree fruit" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Lot number : unknown , Left arm , DOSE 1, SINGLE, administration time: 01:30 PM), administration date: 23Feb2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 19:00, outcome "recovering", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 16Mar2021 19:00, outcome "recovering", described as "arm used for injection was very sore"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "body aches"; NAUSEA (non-serious) with onset Mar2021, outcome "recovering", described as "felt nauseous."; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of chills, vaccination site pain, nausea. Therapeutic measures were taken as a result of pain, headache.  Additional information: The patient did not receive any other vaccine within four 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 felt better by Friday morning on 19Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. Therapeutic measures included treatment with Ibuprofen (ADVIL) which helped with body aches and headaches however they returned over time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna 2/12/21, 3/12/21, 11/29/21. Positive on 2/6/23 (pos. on SNF)
Two days after this second Moderna vaccination I noticed a large, red, oval-shaped area about 3 1/2 inches by 3 1/2 inches about 3 inches below the vaccination needle site.  It was quite red and hot to the touch.  It increased a bit over the next two days but is starting to fade a little bit.  I have had no itching or pain except for the usual pain from an injection in an arm. (I researched the symptom and find it is called Covid Arm)  I do have some photos of the arm if those would be helpful. I have had no other symptoms other than being more tired for a day after the vaccination.  No fever.
No additional AE; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # W011622, expiration date: 06-APR-2024, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (product storage error).  No adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 1.6 degrees Celsius for 2 hours 10 minutes.
Pt recvd 3 doses of Engerix-B vax 23NOV90, 27DEC90, & 24MAY91 & 9OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
flu-like symptoms; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included seizure disorder, depression, anxiety, mild hyperthyroidism and allergies to penicillin. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR) and omeprazole. The patient previously received the first dose of BNT162B2 on 17Dec2020 (Age at vaccination: 41 years) for COVID-19 immunisation and experienced flu-like symptoms, headache, aches, chills, night sweats and more fatigue than normal. The patient experienced flu-like symptoms on an unspecified date. It was reported that with the second shot, the patient took ibuprofen shortly after receiving it and mainly had a headache and fatigue. Just for 24 hours after the shot did the patient have symptoms. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
COVID 19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am
given expired doses; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 6th October 2021, the patient received Havrix. On 6th October 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 6th October 2021, the patient received a dose of a Havrix which was already expired on 16th September 2021. The reporter consented to follow up via email. This case was linked with the case US2021208270 (Twin's case with same initials), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208270:same reporter
Left clinic after vaccine. Returned within 20 mins with complaints of facial flushing and fleeting dizziness.
Patient received an expired dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-Jan-2000 and GERD since 01-Jan-2000. Concomitant products included OMEPRAZOLE from 01-Jul-2020 to an unknown date for GERD, LEVOTHYROXINE SODIUM (SYNTHROID) from 07-May-2020 to an unknown date for Hypothyroidism.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received. Patient demographics were updated. Patient medical history was added. Patient route of administration, anatomical location, and concomitant medications were added.
I had a long cold cough that has not gone away. It went away towards the end of the year, but then returned back in January. I've had a cough so bad that it broke a vertebra in my back back in July.
Information has been received from a physician concerning an 84 year old female with hypertension, hyperlipidaemia, hypothyroidism, bundle branch block right and a drug hypersensitivity to (LIPITOR) who on 26-APR-2008 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck) (lot # 656861/0329U). Concomitant therapy included (SYNTHROID), calcium (unspecified) and aspirin. On 08-JUN-2008 the patient experienced
Later that night arm was sore and soreness did not go away. Patient did not take any medication or called the doctor. In late October, soreness continued and mentioned to doctor during an scheduled visit; no treatment recommended. Overtime, soreness has worsen to the point that patient can't lift arm over head without holding it with other hand. Soreness is centered at injection site and can't sleep on the right side at all. Patient has not been to the doctor or done anything at home to take care of it.  Patient reports she has received Flu shots in the past with no problem and nothing else has been done to the arm except for the vaccine.
Sore Arm; Itching; Redness; Hot area; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 31st July 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, pruritus, erythema and skin warm. The patient was treated with non-drug therapy (Warm Compress) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, pruritus, erythema and skin warm were recovered/resolved.   It was unknown if the reporter considered the pain in arm, pruritus, erythema and skin warm to be related to Shingrix.  Additional details were provide as follows: The patient received dose of Shingrix in the left arm. After vaccination with dose of Shingrix, experienced sore arm, which lasted for 5 to 7 days. The patient also experienced redness, itching and hot area starting from the site of injection site to above the elbow for about 5 to 7 days. No further details were provided. The patient did not consent to follow up.
I started out exhausted, I was at a nursing convention. I could barely hold my eyes open. Saturday night my throat started to hurt, I felt congested, and I could not quench my thirst. I had crazy migraines. I was burning up. I took 2 rapid tests the came back negative. Later that day I started sweating and my bones were hurting, and I tested again, and I was positive for Covid 19. The doctor prescribed me PAXLOVID.
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
Was administered the flu shot in the OR at around 1000, noticed a small welt and redness. Then by 1100 it was larger and warm to touch.
Information has been received from a licensed practical nurse concerning a female in her "late 30's or early 40"s" who was vaccinated with a dose of GARDASIL vaccine. The nurse reported that the patient "may have Guillain-Barre syndrome." The patient contacted the office by phone. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review possible Guillain-Barre syndrome was considered to be an other important medical event. Additional information has been requested. 12/19/08-records received-C/O weakness of muscles on 5/16/08 after Gardasil vaccine. 2/28/08 C/O increase in urge and frequency of urination for 24 hours. Suprapubic pain. DX UTI.  8/13/07 C/O foot pain/blisters after walking Gardasil vaccine adminsitered 11/15/07 lot #0955F left deltoid., 1/7/08 2nd Gardasil lot#0955F left deltoild and 3rd on 5/5/08 lot#1446U left deltoid.
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently", in 2006, the patient experienced breakthrough chickenpox. It was reported that the child was being boostered. It was also noted that the child was in an a unspecified stage of breaking out with lesions. It was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
May 13: left arm swelling, jagged edges around an approximate 12 cm patch.   May 15: stiffness in back radiating out from muscle on left side of spine up to base of head
no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681675, US-MODERNATX, INC.-MOD-2022-681659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681675: US-MODERNATX, INC.-MOD-2022-681659:Same reporter
Patient complained of flu like symptoms and fever >99 degrees for approximately 24 hours following her 2nd dose of Shingrix on 9/13/18. She has been taking Acetaminophen (dose unknown) OTC since the reaction began yesterday and fever has subsided as of today 9/15/18.
Pt states extreme muscle pain, Tylenol and ice not helping, pain in entire arm, no redness, no swelling.
When the pharmacist injected my arm with the vaccine, I felt a sharp pain.  With the other 3 covid vaccinations, I felt a sore upper arm for 3 days after the vaccination was given.  This was immediate sharp pain, totally different.  My upper left arm was very sore from the start.  It is now 4 weeks later and there is no improvement.  The pain comes from any movement, especially raising my left arm - to get dressed, shower, carry things, etc.
Hives (neck) - itching/hot. Sore (hot) injection site - (Right upper arm) headache.
Red, tender area on L upper arm, approximately 4.5 cm L and 6 cm wide. Small "hardended" area at injection site. Pt. reports it was only a small red area but worse this AM.
Swollen glands in armpit, cervical area, neck. Low grade fever using ibuprofen.
The first time I contracted COVID was May, about a month after my vaccine. I called my doctor and was given Paxlovid and by the 2nd day I was feeling better. Originally I had a sore throat which caused me to take a COVID test which came back positive. I also had cold symptoms, which were a light cough, runny nose, and had fatigue which caused me to sleep the whole day.
sore arm, then redness about 2 inches in diameter around the injection site.  lasting about 5 days, before it cleared.