chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 20Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Connective tissue disease (unknown autoimmune issue)" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 01Jun2021; LUNESTA, start date: 02May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative after taking full course of Paxlovid; Positive, notes: Tested negative after taking full course of Paxlovid. Symptoms and positive test returned after 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included paxlovid Treatment start date:14Jul2022 and stop date: 18Jul2022. COVID symptoms rebound after taking Paxlovid. Tested negative after taking full course of Paxlovid. Symptoms and positive test returned after 5 days. The patient received other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
inappropriate route of vaccination; Swelling at the injection site; Warmth at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 11th June 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2019, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The Shingrix vaccine was administered to the patient subcutaneously under the skin, this led to inappropriate route of administration.  The patient was experiencing redness, warmth and swelling at the site of injection which was 3 and half inches in diameter.  The patient was recommended to take Benadryl. The patient consented to follow up and provided her physician's details but she did not feel comfortable to provide her address. No further details were provided.
Fever of 102.5 severe migraine sweating body aches Nausea blurred vision
pt recvd vax 24JUN92 @ 1200; arrived ER 0325 25JUN92 febrile-104 R, 3 tonic clonic vs coarse tremor episodes; prior to arrival in ER; pt sent home w/instructins & APAP suppositories-further sz activity noted;
Had big bowl of chili. Got very tired. The kind of tiredness where she had to just lie down and go to sleep. Went to bed. The next morning, she was fine.
I am experiencing a rash on my face that has concentrated on my forehead. I always have redness that appears on my cheeks on and off from rosacea, but this is a new area of redness. In the last month I began experiencing itching, and flakiness on the rash in addition to the redness. I have been using hydrocortisone, cocoa butter, and NIVEA lotions with no resolution to my symptoms. The rash has continued to slowly worsen. I have an appointment with my PCP on 01/04/23 for my rash. I have not recovered from this adverse event.
Skin reaction, sweling, pain and itching at the injection site. Shoulder and left arm pain Appeared exactly 14 days after receiving the first dose now experiencing only pain
Elevated temperature (103.5) approximately 14 hours after immunizations.  Tylenol per ER, diarrhea/vomiting started a few hours after that.  (2-6ok) checked on pt, decreased temperature down, baby doing better.
On 12/07/2022, I started to notice I was getting a sore throat. I tested on 12/09/2022, and the test came back positive. I couldn't get in to see my doctor until 12/12/2022 and that was too late to take Paxlovid. I was prescribed some cough medicine for the dry cough that came about as well. I tested 12/20/2022 and received a negative result.
pt returned on 8APR93 p/recvd vax 5APR93; inject site had devel cellulitis, t96.4, diffuse erythema rt buttock w/lymphangitis to inguinal area; no adenopathy; treated w/Amoxicillin;
SHIVERS, SHAKES, hot forehead, cold sweats, dizzyness, unbalance, mussel weakness, joint weakness, flu-like symptoms, bed-ridden, for 2 days,
No additional AE reported.; a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a "other" reporter described as "HBP" and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W002601, expiration date 24-JAN-2024 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was improperly stored for 30 minutes at a temperature of 5.7 Fahrenheit (F) degrees. The vaccine was also previously improperly stored at a temperature of 6 F degrees up to 14 F for 1 hour 6 minutes and at a temperature of 6 F degrees up to 14 F for 1 hour 8 minutes. No adverse events reported.
Information regarding Flumist nasal solution was received from a 49 year old female consumer who experienced scratchy throat and runny nose. At 49 years of age, the patient received a dose on 12/11/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose (IN). Concomitant therapy included Celebrex, Wellbutrin, and Evista. On 12/14/03, 3 days post-immunization, the patient experienced a scratchy throat and runny nose. On 12/15/03, her symptoms were worse. No additional information was available at the time of this report. Follow up informatiion received from the physician revealed that the patient did not report the adverse event to the physician.
This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 08-MAY-2001, the patient was vaccinated with first dose of VARIVAX (0.5 ml, intramuscularly) (lot #, exp date: unknown). On an unknown date, the patient missed her second dose of VARIVAX because of a defective vial. No adverse effects were reported. Additional information is not expected.
Patient developed sores on the outside and inside of mouth and throat. She was refusing to eat or drink. Patient also had fevers 102-103 x 2 days. PCP x 2 visits, both visits PCP diagnosed chicken pox from vaccine. Now has pox on both legs. still has sores.
After the vaccination my son had hours of crying, fussiness and irritability. Then he started punching his head with his fists and crying saying his head hurt. He also started banging his head on the headboard of the bed. In the days after the shot he continued to bang his head on the floor, headboard and punch himself in the head. He had a very similar reaction to the vaccine shots in 2016 and the doctor told me that it was normal behavior for his age and that he was have temper tantrums. My son has had issues ever since then with meltdowns, crying fits and other things. This is only some of the reactions and symptoms he has had.
Moder a COVID-19 vaccine EUA Develop Hives 5 hours after immunization
Swelling, red, hot to touch on LD site. 04/04/2003  2:30pm 14 x 14cm. Non tender.
Vomiting, low grade fever for 3 days, trembling, twitching while sleeping
Patient getting physical at health department. After physical immunizations were given to update for kindergarten and flu. Asked family to wait in lobby for safety. About 10-15 minutes later they reported child beginning to break out in a rash. Slight rash on face & forearms. BP 80/48, R 18, P 84, rash present. Administered 7.5 ml liquid BENADRYL po x 1 at 2 pm. At 230 pm adm 5ml po x 1.
Was scheduled for his 2nd vaccine and did not receive it; Tested positive for Covid-19; A spontaneous report, was received from a consumer (patient's wife), concerning husband, a male patient of an unspecified age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and tested positive for COVID-19 (COVID-19 virus test positive) and was scheduled for his 2nd vaccine and did not receive it (Product dose omission).  The patient's medical history was not provided. No concomitant product use was reported.  On 20 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient was tested positive for COVID-19. The patient was scheduled for his second dose of vaccine on 17 Feb 2021 and did not receive it. The patient wanted to know when he could receive the second dose of vaccine. Treatment information was unknown.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events tested positive for COVID-19 and was scheduled for his 2nd vaccine and did not receive it were not reported.; Reporter's Comments: This report refers to a case of Product dose omission for mRNA-1273, with the event of COVID-19 virus test positive.
chest pain on right side immediately after vaccine administered.  nausea, headache, right side neck stiffness
Patient completed COVID vaccine series on 2/14. On 4/3 patient came to the emergency department with shortness of breath and cough. Patient tested positive for COVID-19 at emergency department.
about an hour after receiving vaccinations, patient called back and reported a headache 10/10.  She took ibuprofen and reported the headache was down to a 6/10- about 30 minutes later patient called back with vomiting, nausea, body shakes.  She was directed to go the Emergency Department where she presented tachycardic and hypotensive.  She received Zofran and Tylenol for supportive measures and an IV was initiated and she was given a normal saline bolus as well as IV Benadryl in the Emergency Department.  After these interventions she felt markedly improved and tolerated oral intake.  She no longer had headache, body aches or chills.  Her nausea and vomiting had resolved.  Her vital signs normalized and she was discharged home in stable condition.
This vaccine expired on 6/14/2021 and was given on 6/18/2021. Mom was notified that day of the discrepancy and was given the recommendation to get the vaccine repeated ASAP. Mom opted at this time to just continue with the course and get the second dose when indicated instead of repeating the first.
use by date was 1/18/23 admin date was 1/20/23. no adverse event reported
Student had gotten a flu vaccine on 11/03/20. He came to the campus flu clinic on 1/27/21 and received another flu vaccine, his first dose being unbeknownst to the flu clinic staff.
A legal complaint was received from an attorney alleged that a male child received Orimune on 7/20/99, as well as a series of Tripedia, ActHIB, IPOL, Hepatitis B vaccine, Recombivax-HB, MMR, and Varivax from 7/3/98 through 10/4/99. According to the legal complaint, as a result of the mercury in the thimersol-containing vaccinations, the child suffers, from the toxic neurological effects of mercury poisoning. No further information was available at the date of this report.
Worsened Headaches, Worsened Body Aches, Worsened Fatigue Takes Tylenol and will see his Dr. on 7/19/21 and if worsens will go to urgent care.
patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not reported.
After the 2nd COVID shot he had hot and cold flashes. He also had horrible joint pain and headaches. 24 Hours later all the symptoms got worse.
Fever; extreme body aches/pain; headache; Severe cough; chest pain; exhausted; dizziness; blurred, slow response vision; sweats; chills; swollen gland; shortness of breath; sore arm; unable to work at 100%.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 12:30 (Lot number: 30145BA, Expiration Date: 30Nov2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LARIN 24 FE taken for contraception, start date: 1997 (ongoing); IBUPROFEN taken for adverse reaction. The following information was reported: PYREXIA (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "extreme body aches/pain"; HEADACHE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 12Oct2021 13:30, outcome "recovered" (2021), described as "Severe cough"; CHEST PAIN (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "chest pain"; FATIGUE (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "exhausted"; DIZZINESS (non-serious) with onset 12Oct2021 13:30, outcome "recovering", described as "dizziness"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "blurred, slow response vision"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "sweats"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen gland"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "unable to work at 100%.". Therapeutic measures were not taken as a result of pyrexia, pain, headache, cough, chest pain, fatigue, dizziness.  Additional information: Patient had no known allergies. Patient had adverse reaction (unspecified) to ibuprofen. Patient did not have any long term medical history. 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.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M037669, expiry date 09-MAY-2016 (dose, route and site of administration were not reported). On an unknown date, 1 day after receiving the vaccine, the patient experienced redness, swelling and warmth at the injection site. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not provided. The reporter requested lot check due to another patient having the same adverse reactions after receiving PNEUMOVAX 23 with same lot #. This is one of two cases received from the same reporter. Additional information has been requested.
Lymphedema right axilla with tenderness, no erythema, no warmth to touch
J96.00 ACUTE RESPIRATORY FAILURE 11/27/2021 PNEUMONIA R09.02 HYPOXIA 12/6/2021 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 11/27/2021 PNEUMONIA R09.02 HYPOXIA 12/6/2021 PNEUMONIA
Patient developed petechial rash on neck around 6pm after receiving the vaccines. Patient had a lab draw and mom will  continue to monitor.
Been sick a total of 4 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Cold" (unspecified if ongoing), notes: Verbatim: Cold once every 2 or 3 years; "Flu" (unspecified if ongoing), notes: Verbatim: Serious flu once every 5 or so years. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 02Feb2022, outcome "unknown", described as "Been sick a total of 4 times". Additional information: Patient was  stated that I am a healthy 43 year old male. My whole life I would get a cold once every 2 or 3 years. I would get a serious flu once every 5 or so years. Since my recent Covid-19 vaccine Nov2021 I have been sick a total of 4 times. Just recently starting on 02Feb2022.   Follow-up attempts are completed. No further information is expected.
Pt recvd 2nd dose of Hep B vax & devel fever which later resolved;
Client given booster half dose of Moderna while 17. This was a clinic error, although the client did sign up for Moderna booster.
Rash on front and back of torso that migrated down buttocks and legs and up to neck Achy all over Left hand where I sometimes have minor arthritis it was painful. This also happened with the first dose.
On 2/3/21 received 2 separate doses of Moderna Covid vaccine. 2 different arms at a Vaccine Clinic by 2 different staff
*Migraine *Numbing, tingly and achy leg on same side as injection followed by body pain and aches in muscles And limbs overcoming the whole body after several hours. *feelings of being very cold while sweating * feeling of being really hot with goose bumps  cold fingers *cold feeling and pain in nipples  Lower left abdomin/ and lower left back  area  shooting pains *extreme increase of pain in previous injury (lumbar spine) Dizzy, nausea, lightheadedness, very tired, moving slowly, stiff, achy, runny nose Pain in feet toes and fingers, fever, hot/cold flashes, sleepy,  occasional spasm of face muscles around mouth causing numbness of lips and causing lips to not shut for short periods, palpitations, chest pain that comes and goes, sore throat, chest tightness
This spontaneous report as received from a healthcare worker refers to an unspecified patient. On an unknown date the patient may have been vaccinated with improperly stored VARIVAX (Merck) (dose, route and indication not reported). The healthcare worker reported that an improperly stored VARIVAX (Merck) that was exposed to 4.2C for 192 hours may have been administered. Due to the healthcare worker being unsure if the VARIVAX (Merck) had been administered, patient and physician details were not available. The healthcare worker did not have the lot# or expiration date available at the time of the call. No adverse effect reported. Additional information has been requested.
Patient hypoxic and currently requiring 3-4 LPM oxygen via nasal cannula to maintain saturations above 90%. Denies any pain. Per daughter, patient with some chronic confusion (forgets the date) at home but confusion appears worse than baseline currently as patient does not know date or place. No focal neurologic deficits. Patient very HOH which makes assessment difficult. BNP elevated at over 12000 but no signs of volume overload on exam or on xray.  - COVID-19 special precautions, continuous pulse-ox - Oxygen: continue current support with nasal cannula; titrate to keep SpO2 between 90-96% - Labs: Daily COVID labs ordered x4 days (CBC, BMP, D-dimer, CRP).  Continue to trend after 4 days as needed.  - Imaging: no additional imaging needed at this time - Breathing treatments: no inhalers needed; avoid nebulizers in favor of MDIs  - IV fluids: not indicated at this time - Antibiotics: not indicated  - COVID-Focused Medications: Dexamethasone x 10 days or until hospital discharge, started on 1/13 and Remdesivir x 5 days or until hospital discharge, started on 1/13 - DVT Prophylaxis: at high risk of thrombotic complications due to COVID-19 (DDimer = 0.80 ug/mL FEU (Ref range: 0.00 - 0.50 ug/mL FEU) ).
Approximately 45 minutes later on my drive home my face on the left side started to feel numb. It started on my cheek and gradually ran up to right under my left eye and down to under my chin. It lasted for about an hour then gradually started to disappear.  I got a little nervous but checked all signs that I was not having a stroke..  I ate dinner and calmed down.  I also took a Tylenol 500 mg and drank a lot of water It?s gone now. It?s now 8:29 pm.  Just feeling tired now.
Injection site became red, swollen, painful, and itchy.  Was within two hours of injection.  Have put hot compresses on site and taken Tylenol.  (Can send picture if needed.  Give me an e-mail address to send it to.)