chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 83 yo M with COPD on 2-3L home O2, HFrEF (EF 35-40% Jan 2018), Atrial Fibrillation on apixaban presenting with increased O2 requirement and hypotension in the setting of COVID. He was diagnosed with COVID on 9/11 to another hospital in town despite being fully vaccinated with Pfizer's COVID vaccine on 2/5/2021 and 2/26/2021. He was not admitted at that time. Since then he had been staying with one of his daughters (daughter he lives with is also sick with COVID) and has decreased PO intake. He was slightly more SOB than is usual for him, remained on 2.5-3L O2. Used BiPap at night and continued since he has been sick. He received monoclonal antibody infusion 9/16/2021 and at that appointment he was noted to be bradycardic with HR in 40s and hypotensive to 70s/40s so came for further evaluation. He was admitted. Hypotension thought to be due to hypovolemia secondary to PO intake in setting of recent COVID infection. Improved with fluid resuscitation. He was discharged on 9/19/2021.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 28-MAY-2015 the patient was received improperly stored VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
little achiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little achiness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (little achiness at injection site). On 02-Mar-2021, VACCINATION SITE PAIN (little achiness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided. No concomitant medications were provided.   This case was linked to MOD21-066333 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-064999 (Patient Link).; Sender's Comments:  MOD21-066333:crosslinked case
skin broke out horribly / has serious skin issues / been suffering for years with skin issues; This shot altered his immune system; This case was reported by a consumer via interactive digital media and described the occurrence of skin breakdown in a male patient who received HBV (Engerix B) (batch number 5DE7C, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced skin breakdown (serious criteria other: Serious per reporter) and immune system disorder. On an unknown date, the outcome of the skin breakdown and immune system disorder were unknown.   It was unknown if the reporter considered the skin breakdown and immune system disorder to be related to Engerix B and hepatitis B vaccine pre-filled syringe device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Hepatitis B shot in 2016 and shot altered immune system. The reporter had another doctor wanting to make a test to see if this was the issue.  The patient skin broke out horribly and need a sample of this shot to provide to doctor.  The patient was saying that cannot get it but not giving up partnering as had serious skin issues.  The patient was suffering for years with skin issue.
Immediately after receiving the vaccine, pain at the vaccination site on left arm. Pain got worse overtime but did not do any treatment or take any medicine. Pain was worse when moving the arm or raising it. Sometime in August patient received shingles vaccine at same vaccination facility on the other arm. Patient went to pharmacist and let him know he could not use his arm and was encouraged to go to the doctor. In September patient went to doctor to get a physical and received a Flu shot also on the other arm. Upon examination of the left arm patient referred to physical therapy. Patient has had 5 sessions already and has not seen that much improvement. Patient went back to pharmacy last week and was encouraged to file a report. Pharmacist recommended  use of Asper cream but has not helped much.
tested positive 1/10/22, no taste or smell, moderna x2 no booster
This is an instance of  COVID-19 breakthrough disease after which death occurred.   The individual was vaccinated with the Pfizer product on 01/28/2021 and 02/18/2021. They became symptomatic for COVID-19 disease on 12/28/2021 and tested positive for COVID-19 via PCR test on 01/02/2022. They presented to emergency dept on 01/02/2022 and were admitted to hospital due to medical frailty. The individual had missed several dialysis sessions due to feeling poorly. They were put on mechanical ventilation on 01/13/2022. They were transitioned to palliative care and died on 01/24/2022.
Rash around eyes and on forehead; Looks like pimples; Has history of allergies and has had similar beforebut seemed to have gotten worse after second shot.; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Apr2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient had no known allergies to medications, food, or other products. Concomitant medications included cetirizine hydrochloride (ZYRTEC), ibuprofen (ADVIL) and alclometasone dipropionate cream 0.05% (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 17:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On 10Apr2021 the patient experienced rash around eyes and on forehead which looked like pimples. Patient had history of allergies and  had similar before but seemed to have gotten worse after second shot. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the event rash around eyes and on forehead which looked like pimples and had history of allergies and had similar allergy before but seemed to have gotten worse after second shot was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Muscle and joint aches, headache -- occurred initially (1-2 days), went away completely, then returned 2 weeks after the shot.  Still persisting and are unusual.  Headache was determined to be related to neck tension -- and has resolved but the strange muscle and joint aches are persisting.  Not at all typical in past.
REDNESS AT INJECTION SITE (1.5 INCH x 3 INCHES), WARMTH.
patient woke with Left leg swelling and pain, s/p Johnson/johnson vaccine. Pt referred to ER for R/O DVT
Fever (12 hours). Drooling (12 hours). Localized brusing. Localised raised, red margins (present). Treatment = BENADRYL.
Pt with a history of sulfa allergy received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 07/06/1999.  On 07/17/1999 she developed generalized joint pain, abdominal paid and pressure and diarrhea.  She recovered.
Patient called this office 7/21/21 and stated that on 5/3/21 he was found unconscious by his son just days after his second dose of Moderna and was taken by ambulance to the nearest hospital facility where he was stabilized and then transferred to another hospital system for higher level of care. He stated he spent 3 days in ICU and 3 days on a stepdown unit. Patient reports that since then he has felt weak and had to undergo rehab. Would not provide more information to this writer,
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 02-DEC-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
cornea keratitis, so unhappy; had two vaccinations, diagnosed with trigeminal herpes zoster; trigeminal herpes zoster; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, the patient received the 1st dose of Shingrix. On 26th November 2021, 403 days after receiving Shingrix and 542 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the patient experienced keratitis. On an unknown date, the outcome of the vaccination failure, herpes zoster and keratitis were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and keratitis to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccinations and diagnosed with trigeminal herpes zoster. A very severe case and the patient was devastating diagnosis.  The patient stated he/she also had cornea keratitis as a result. The patient was so unhappy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.
Fatigue, sore arm, generalized aches and pains x 3 days, (day 1-3 days post vaccine) chills, all day x1 day (on day 2 after vaccine), nausea/vomiting x1 day (day 2 after vaccine)
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Superficial blood clot in the leg/area is sore to touch; A spontaneous report was received from a consumer (patient), concerning a 82-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial blood clot in the leg/area is sore to touch (thrombosis).  No medical history was reported. No concomitant medications were reported.  On 19 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided),  on 15 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a superficial blood clot in her leg (medically significant). She also reported that the area was sore to touch. The doctor prescribed medication to treat her problem, but they said to wait a week to see if it solved on its own before taking it. She was also applying ice pack on the affected area. No further information as reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event of superficial blood clot in the leg/area is sore to touch (thrombosis) was unresolved.  The reporter did not provide assessment for the event of superficial blood clot in the leg/area is sore to touch (thrombosis).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccinator reported that one of three patients may have received injection that did not contain vaccine.  All three patients were informed and re-vaccinated in the opposite arm.  No adverse reactions reported by any of the patients.
3 or more hours after administration of vaccine, patient started having warmth in site of shot and pain, she had a lump form on the opposite side of her arm ( inner arm about five inches below the arm pit area ) the lump was  about 3 inches in diameter and hard, she applied cold and hot compresses alternatively with the ice compress mostly ! swelling  and lump gone down about 75% already, the pain went to her shoulder and to her upper chest area above the breast she also had nausea but no vomiting Today patient called her doctor and informed them, she also called the pharmacy. I spoke to her as I am the one who administered the vaccine yesterday collected the above info, she doesn't have any other symptoms she says the nausea has gotten much better and the lump is getting better I told her to watch for worsening of symptoms and if it happens to contact her doctor or 911 if severe but very likely she will continue getting better as the symptoms are getting better by time I advised her to use Tylenol for pain and swelling as needed  and I will follow up on her with a call later this evening .
Brain fog, dizzy, disoriented, off balance, fatigue, GI Issues, inflammation, racing heart, insomnia, limb weakness, limb pain, neuropathy, muscle pain, joint pain, anemia, splenomegaly, insomnia, difficulty falling asleep and staying asleep, sleeping long periods of time, tinnitus, hearing loss, internal vibrations, muscle twitching whole body, night sweats, hot flashes, poor exercise deterioration, chest tightness, high blood pressure, headache, leg paralysis, memory issues, noise sensitivity, tingling, numbness, hot spots on soles of feet and hands, menses issues, increased anxiety, increased depression, muscle and bone pain, all over body pain, malaise, neck pain, goose flesh, body feels bruised all over,
T-dap 2 days ago  (lt) arm developed itchy, swollen area has become more itchy and painful, very similar rxn lt arm 11/15 to flu shot. BENADRYL and 2.5% hydrocortisone should be seen by allergist referral sent.
L upper arm/shoulder redness/pain-swelling extending L elbow woke up 7/30/02 with 3/5-seen by MD 7/31/02.
I received the COVID-19 Bivalent vaccine on 9/21/22. I started symptoms on 9/28/22; tested positive on 9/29/22. Symptoms were as follows: runny nose, sneezing, coughing, sinus headache, low-grade fever. Felt like I had a bad head cold. My doctor advised me to use OTC treatments - Mucinex for head cold symptoms & Delsym for coughing. Symptoms continued for 5 days or so; felt back to normal about day 10.
Case number PHEH2012US011087 is an initial spontaneous report received from a pharmacist on 23 May 2012. This case refers to a patient of unspecified age and gender. On 22 May 2012, the patient was inadvertently vaccinated with MENVEO vaccine (batch number: unknown) that got expired in Apr 2012. The pharmacist stated that the physician was trying to determine whether another dose should be administered. No other information was available.
began to have difficulty breathing ONLY with activity; Elevated BP and HR accompanied; Elevated BP and HR accompanied; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 21Mar2021 at 12:30 hours as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) from an unknown date and unknown if ongoing and childhood asthma from an unknown date to unknown date. Concomitant medication(s) received within 2 weeks of vaccination included nabumetone, desogestrel, ethinylestradiol (Isibloom), mentha x piperita oil (Ibgard); D-mannose, vaccinium oxycoccos (Dmannosa) and cranberry (all taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination. On 22Mar2021, at 07:45 hours, following Monday, patient had difficulty breathing only with activity. Patient had asthma as a child, went away with adulthood. Elevated blood pressure (BP) and Heart rate (HR) was accompanied. Patient had doctor or other healthcare professional office/clinic visit for the events. On 24Mar2021, patient had been tested for the COVID-19 by nasal swab and result was negative. Therapeutic measures were taken as a result of all the events and treatment included albuterol inhaler. All the events were reported as non-serious by the patient. The outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Per pt, C/O chills, fever, body weakness, pain to the site and swollen. Warm to the touch after the Tdap shot. Scheduled pt to come back on the 4th and have it checked. Medications: Ibuprofen 600mg Tab, KEFLEX 500 mg Cap, Prednisone 20 mg tab and TYLENOL #3 300-30mg tab was given to pt for treatment. Try calling pt multiple times after office visit to check on pt, but pt didn't answer the phone calls.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant drug information was provided.  Reporter reported that a temperature excursion had occurred several days ago in the freezer.  Multiple patients had received vaccine from vaccine that underwent a temperature excursion in the freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable, 131 patients received doses of the vaccine. Patient did not reported any adverse event.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675735 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675735:same reporter
Nov. 23 within an hour I started getting a headache (around 2 PM) by 5-6 PM the headache had gotten worse, sensitive to light and noise and nausea, as of 12/2/09 still have a headache that worsens with bright lights and loud noise, causing nausea.
The pt developed nausea, and vomiting post vaccination with Hep a, b, and Jap E.