chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 8am feeling slightly nauseous. By noon, I was in bed with severe body aches, headache, and absolutely no energy and no appetite. I could not keep my eyes open. I slept for 8 hours and then awoke feeling a little better. After a full night's sleep, I felt back to normal. Three days after getting the shot, my arm started itching at the injection site, and I developed an itchy circular bump about 3 inches in diameter at the injection site. The rashy bump slowly got smaller and became less itchy over the next 3 days.
Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted at least 1 hour).   Eventually went away.  Then two days later, Tinitus and lethargy similar to past MS symptoms, felt "off".
Homebound patient scheduled to receive 2nd dose of Pfizer vaccine.  Was given Pfizer bivalent vaccine instead of Pfizer monovalent vaccine.
I received my second dose of the COVID19 Moderna on 4/2/21 @7:40  through my employer, where I've worked over 11 years. By that evening, I had the normal fatigue, headache, and sore arm at my injection site that evening which even became swollen, red, and rashy by that next morning with some joint pain but attributed to normal side effects and dismissed it. But I woke up early Sunday morning, 04:30, very sick, with a fever, chills, diarrhea, cramping and aching abdomen and joints and also developed a rash and hives on my arm, up my neck, into my hair and down my chest left chest with some swelling as well. I took some Benadryl, it went down some but continued but I called the Tele service line to be evaluated as my symptoms were getting worse, not better. I continued experiencing these side effects as they increased intensity, especially the watery diarrhea that occured almost immediately everytime I drank and the rash and hives and ache in joints. I lost all appetite and even got so nauseas it woke me from a 10 minute nap vomitingI had an appointment w/MD 04/06/2021where she prescribed Zofran and told me to take Imodium, which I did not think I could since I was told nothing but Tylenol after the vaccine.She told me to follow -up with my primary or ER if I wasn't better by Thursday, today, but didn't think my diarrhea and stomach had anything to do with my vaccine.My fever, chills, rash, hives and itchiness came back and continued throughout yesterday as soon as I tried to stop taking Benadryl and Tylenol for a day as my stomach was so upset, cramping and sore. I went online to request an appointment with my PMD for follow-up and further evaluation as I am still nauseous too, and as I discovered after trying to eat toast and rice again, my taste is off.I received no response to my requests online so I called my doctors office today and they made a special appointment by telephone @08:30pm with Dr. so I do not have to come into the Clinic and get others sick.I've had to submit a LOA claim as well from missing now what will be 5 days of work. I hoping to be better soon.
Swollen lymph node in neck, same side as injection site, lasted 2/14/21-2/18/21.
09/01/21 (PM evening of taking vaccine) - Experienced the routine and anticipated chills, achiness and tiredness from the vaccine. 09/03/2021 (AM) - Dull pain in right eye socket begins. Never experience such pain in past.  09/04/21 - In addition to the dull pain, swelling and redness below right eye begins in upper Maxillary Sinus area.  Swelling is soft but not painful to touch. Swelling is defined to a 1.5' long and .5" high area.  When eyes are closed tightly, the pain in right eye socket is very noticeable.  09/12/21 - Swelling in upper right cheek appears to be slightly less, but general discomfort in right eye socket remains unchanged.  09/13/21 - When jaw is clinched, there is mild pain in upper right back teeth and mild sensation (like nerve pain) when right cheek is touched. It's a unique sensation in the cheek when rubbing fingers over the right cheek.   By the end of Sept 2021, the swelling and pain is essentially gone. Conducted a video call in Sept. 2021 with my doctor, Dr. We concluded that I would keep him informed if symptoms got worse.  The symptoms did not get worse.  I declined my 2nd Shingrix vaccine out of concern of experiencing another reaction.
redness on arms and legs; received second dose after 5 weeks; red blotch at her injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on arms and legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose after 5 weeks) and VACCINATION SITE RASH (red blotch at her injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (red blotch at her injection site). On an unknown date, the patient experienced ERYTHEMA (redness on arms and legs) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose after 5 weeks). At the time of the report, ERYTHEMA (redness on arms and legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose after 5 weeks) and VACCINATION SITE RASH (red blotch at her injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment medication cortizone cream were reported   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: added event, dosage form
Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 16:30 as dose 2 (maroon cap), single (Batch/Lot number: unknown) at the age of 3 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1 (MAROON CAP), SINGLE, Anatomical location: Right leg), for Covid-19 Immunisation. The following information was reported: PYREXIA (non-serious) with onset 22Jul2023 at 12:00, outcome "recovering", described as "Fever". The event "fever" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient received Children's Tylenol as treatment for fever. Patient did not have covid prior vaccination or tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Suspected vaccination failure; She's had it three more times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (it was excrutiating).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: She's had it three more times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter mom got shingles and it was excruciating so she got the shot. since then, she's had it three more times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
LOSS OF BACK MUSCLE CONTROL; Fatigue; Started shaking violently for 2 - 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (LOSS OF BACK MUSCLE CONTROL), TREMOR (Started shaking violently for 2 - 3 hours) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2VA and OBM2OA) for COVID-19 vaccination.     NO MEDICAL HISTORY WAS GIVEN.  Concurrent medical conditions included Blood pressure high (No medical history reported) since 04-Nov-2012, Diabetes since 01-Apr-2016, Chronic bronchitis since 01-Oct-2011 and Reflux gastritis since 01-Jul-2014. Concomitant products included METOPROLOL TARTRATE from 01-Nov-2012 to an unknown date and LISINOPRIL from 01-Nov-2012 to an unknown date for Blood pressure, CETIRIZINE HCL from 01-Oct-2011 to an unknown date for Chronic bronchitis, EMPAGLIFLOZIN from 01-Apr-2016 to an unknown date for Diabetes, OMEPRAZOLE from 01-Jul-2014 to an unknown date for Reflux gastritis.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced TREMOR (Started shaking violently for 2 - 3 hours). On 10-Mar-2021, the patient experienced MUSCLE DISORDER (LOSS OF BACK MUSCLE CONTROL) and FATIGUE (Fatigue). On 10-Mar-2021, TREMOR (Started shaking violently for 2 - 3 hours) had resolved. On 11-Mar-2021, MUSCLE DISORDER (LOSS OF BACK MUSCLE CONTROL) had resolved. On 12-Mar-2021, FATIGUE (Fatigue) had resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: New events, and events outcome were updated. Concomitant products were added. Lot number was added.
Itching at the injection site on day 8, and redness of skin covering about 4 inches.
I received the second Moderna shot at 2:20 pm and that night around 10 PM I was shaking uncontrollably  I was freezing but had a very high temperature I took two ibuprofen and the entire next day had bodyaches a terrible migraine headache and fever over 102  and very dizzy I stayed in bed the entire  day.   I?ve never gotten the flu shot and never gotten the flu. I did not want to get this shot but it was forced upon me.
PT contacted the center after experience adverse events following her first anthrax immunization on 1/26/03. 2 hrs post vax, she experienced dizziness, nausea and blurred vision. She also had a sharp headache behind both eyes. All of these symptoms resolved in a few hrs. About 2200 hrs she began having stiffness and soreness in her back. About 0200 the next morning she was awakened from sleep with severe back pain, severe enough to go to the local ER for treatment. There she was given an injection for pain and was sent home with muscle relaxants and ibuprofen. On 1/28/03 she contacted the Vaccine Healthcare Center because her pain continued. We recommended that she continue the treatment that was prescribed and follow-up with the Vaccine Healthcare Center by phone the following week. On 2/3/03 PT informed us that her symptoms had resolved on 1/29/03, 3 days post anthrax #1.
32 YOM AOX2 on wheelchair with history of unknown mental condition as per caregiver next to him at all times, pt 10 minutes after vaccination started to have seizure. pt seizure lasted for about 2 minutes, as per care giver it was a mild seizure and was completely normal for pt. pt history of seizures and unknown mental condition. Pt care giver was given the option to use EMS services but pt care giver verbally declined, pt care giver gave pt lorazepam from pt own medication. pt care was given back to care giver and was told that if another seizure accrued to please call EMS services for higher level of care.
Suspected vaccination failure; Shingles on eye; Shingles on ear; shingles on her head, right side of her face; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (dose received on December 2014), Flu vaccine (dose received on an unknown date) and COVID vaccine (dose received on an unknown date).   In FEB-2019, the patient received the 2nd dose of Shingrix. In SEP-2018, the patient received the 1st dose of Shingrix. In JAN-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles on eye) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles on ear) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on her head, right side of her face).  The outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient received Shingrix vaccine and experienced on her head, right side of her face, eye and ear. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740 and 2018SA279743 (same suspect). This case involves a 31 years old female patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV, lot QFAA1829; expiry date; 30-Jun-2019 via intramuscular route in the left deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was not provided any information confirming whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Left upper arm became hot and swollen 12 hours following administration of immunization. Over next 24 hours, reaction became more localized. Now central clearing around injection with reddened, swollen area approximately 3" in diameter. BENADRYL 1/2 tsp qid prescribed.
Encounter for laboratory testing for COVID-19 virus Lab test negative for COVID-19 virus Generalized abdominal pain
Sxs started 2 days after receiving vaccine. Sxs improved 6 days later.
Headache ,Sore throat, body aches, congestion, chills, lightheaded
Initial report received from a healthcare professional on 08 October 2012. A 21-year-old female patient received MENACTRA (batch number: U4395AA) intramuscularly in the left deltoid on 27 September 2012. Medical history was none and concomitant medications were not reported. The patient received previous dose of MENACTRA vaccine in 2008. On 28 September 2012, the patient presented with headache, dizziness, nasal congestion, sore throat, nausea and back pain. It was reported that the patient was evaluated by physician at student HC. The patient was advised to take Ibuprofen for headache and back pain. On unspecified date lab work was done and neuro exam was normal. On 04 October 2012, the symptoms were not resolved. At the time of this report, the outcome was unknown. Documents held by sender: none.
anemia; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 23Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional. A 67-year-old female patient received the first and second doses of the bnt162b2 (BNT162B2), via unspecified routes of administration in Feb2021  at single doses for covid-19 immunisation. Medical history included rheumatoid arthritis from 12Feb2021 to an unknown date and anaemia from an unknown date and unknown if ongoing in her 20s. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 02Dec2020 to Feb2021; ascorbic acid, ferrous gluconate (IRON & VITAMIN C) taken for an unspecified indication, start and stop date were not reported. The patient experienced anemia on an unspecified date. The event was further described as: the patient had been off tofacitinib citrate since Feb2021. Per MD, tofacitinib citrate did not cause her anemia since she had been off the therapy for a while. The MD continued to hold the therapy due to anemia. The patient underwent lab tests and procedures which included cholesterol: great on an unknown date and blood test: showed anemia (low iron) and too much water in her body on 10Mar2021. Blood work showed improvement in Apr2021. However, MD was not comfortable for the patient to resume the therapy. Per patient, MD did not determine that the therapy caused "anemia" as she also received and completed her two doses of bnt162b2. The clinical outcome of the event, anemia, was unknown.    No follow up attempts are needed. Information on the lot/Batch number cannot be obtained.
Itching right thigh at site of 11-year-old hip replacement at 1st vaccine. At 2nd vaccine, within 2 days, large open wound about 3 inches in diameter in middle of otherwise linear scar . Wound was/is open, it is red/purple, oozing and draining constantly a sticky yellow liquid. Pain and inflammation
MENACTRA to a patient but only injected about 0.4mL instead of 0.5mL full dose. The 0.1mL was expelled out from the needle with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00768862) and transmitted to Sanofi on 14-Sep-2021.  This case involves an unknown age and gender patient who vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot and expiry date not reported) but only injected about 0.4ml instead of 0.5ml full dose and 0.1ml was expelled out from the needle via unknown route at an unknown administration site on an unknown date for prophylactic vaccination (incorrect dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to incomplete dose administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Dark red 6 1/2 mm long 3 1/2 mm (center circle) light pink 7.5 mm long 6.5 mm center layer/red circular bump on location site. Slightly warm.
Vasovagal response; pale and limp, post vax. Tactile stimulation and ice to baby's feet and has responded to stimulation.
9/22/11 Received Influenza vaccine in (R) arm, some soreness that day, yesterday, after school mom noted red, raised bumps. Rx with BENADRYL. Today, red area is larger on upper arm with some itching, intermittently afebrile.
Sore arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (mild fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient with 3 COVID vaccinations who admitted with COVID detected test. Provider d/c note: "90 YO female w/ history of CKD III, hypertension, Diabetes mellitus 2, Alzheimer's dementia, COPD presented with worsening dyspnea. She was noted to be hypoxic on arrival. She was admitted for management of acute hypoxic respiratory failure with concern for COPD exacerbation. During her stay, she was retested for Covid (2 days post admission) as there was a history of recent attendance to a Youth fair. She tested positive for COVID on 08/22. She was also started on steroids. She received supplemental oxygenation that later slowly weaned to 1L on exertion only. She was evaluated by PHYSICAL THERAPY who recommended either going home with therapy or nursing facility. Patient's insurance did not approve nursing facility placement due to her level of mobility close to her baseline. After much discussion with her son (sole caretaker), she was discharged home in stable condition. Home Oxygen was prescribed and home care were ordered".
chills; Fever; couldn't sleep at night; headache; backache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever), INSOMNIA (couldn't sleep at night), HEADACHE (headache) and BACK PAIN (backache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (Fever), INSOMNIA (couldn't sleep at night), HEADACHE (headache) and BACK PAIN (backache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (Fever), INSOMNIA (couldn't sleep at night), HEADACHE (headache) and BACK PAIN (backache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No medical history information was reported.