chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Other pains going on; Slept more than 8 hours; Muscle weakness; Unable to stand for long periods of time; Runny nose; Feeling weak; Cough; Tired/muscles are tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time) and RHINORRHOEA (Runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, the patient experienced PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was reported by the reporter.  It was reported that, the patient had symptoms listed under Covid-19.  Treatment included dirking liquids (orange and apple juice).
I got gallstones; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration administered on left arm on 12Feb2021 1:00 PM (at age of 34 years) as a dose 1, single for COVID-19 immunisation. Medical history included endometriosis. Patient did not take any vaccine in four weeks. No other medications taken in two weeks. Patient had no Covid prior vaccination. Patient was not tested for Covid post vaccination. The concomitant medications were not reported. The patient previously took cefprozil (CEFZILL) and experienced allergy. Patient reported that "I am not sure if this was caused by the vacccine or not but I got gallstones on 09Mar2021 01:00 PM and had gallbladder removal surgery after". The patient underwent Covid-19 test (nasal swab) on 18Mar2021 and it was negative. The outcome of the event was reported as resolved with sequel.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
She "felt high, like on THC-high"; After her first dose of vaccine, she suffered an injury to her knee; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via unspecified route of administration at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Past drug includes a cortisone shot in her shoulder 6 days before her first dose of the PFIZER BIONTECH COVID-19 VACCINE. After her first dose of vaccine, she suffered an injury to her knee and presented to the orthopedic doctor who declined to give her a cortisone shot in her knee because she was in the middle of the vaccine series. She also mentioned that after her first dose she felt high, like on THC-high and went home and baked chocolate chip cookies- which was out of character for her. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included SARS-CoV-2 infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID). At the time of the report, COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) outcome was unknown.        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.   No Concomitant medications were provided No Treatment information provided; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Injection site swelling traveling down her arm; Fingers numbness; Arm pain / throbbing hurts so much that she can't sleep; can't sleep; throbbing pain; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain. The patient was treated with paracetamol (Tylenol) and ibuprofen (Motrin). On an unknown date, the outcome of the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, numbness in fingers, pain in arm, insomnia and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine the patient developed right arm injection site swelling traveling down her arm and right two fingers numbness.  The patient also reported that right arm pain and throbbing hurts so much that she can't sleep. She has taken Tylenol and Motrin with no relief. The reporter did not consent to follow up.
Seven days post vax. this pt experienced redness, itching, and a hard nodule at the site of injection. *Follow-up report on 2/12/03: From add'l correspondence received on 7/30/99, add'l PT info. was provided. From follow-up #1 correspondence received on 5/7/01, it was reported that the PT cannot be identified. This case is closed. See reports U199900416 and U199900415, same reporter.
Patient expired.  ? Severe sepsis (HCC) 12/03/2021 Unknown   Resolved Hospital Problems No resolved problems to display.   There are no active non-hospital problems to display for this patient.     Date of Death: 12/6/21 Time of Death: 12:55 AM Preliminary Cause of Death: Acute hypoxemic respiratory failure due to COVID-19  Discharge Disposition: Deceased   a 87 year old man who presented to the hospital with chills, fever, and cough. He was found to be covid positive and was hypoxic requiring oxygen. He had and AKI. He was found to be bacteremic and was on IV antibiotics. He was having difficulty keeping his oxygen saturations on HFNC. Ultimately he desired to be made comfortable on 12/5/21. His wishes were honored and he was given Morphine to help with dyspnea and work of breathing. Unnecessary medication, testing and monitoring were discontinued. He passed away comfortably at 12:55 am 12/6/21 surrounded by his family.    Resident team was called to bedside by nursing at 12:50 on 12/06/2021 to pronounce patient death. Patient was unresponsive to voice, sternal rub, or nailbed pressure. No pulses were palpable and no chest rise was observed. Heart and breath sounds were absent to auscultation. Pupils were fixed, dilated and nonreactive to light.  No corneal reflex was present. Time of  death was 12:55 on 12/6/21. Attending physician as notified by resident team. PCP office to be contacted by nursing. Discussed with family and no needs communicated by them at this time.
On 12/25/2021 I experienced heavy congestion. I started sneezing first and then I developed a runny nose. Later that day, I developed a fever, fatigue, and my nose was running constantly. I also had body aches and ultimately developed a cough as well. I tested myself for COVID-19 that day and the following two days. All three tests were negative. I had a virtual appointment with my doctor who diagnosed sinusitis. He prescribed a round of steroids for the infection. Around a week and a half later, all of my symptoms were basically gone with the exception of some congestion and the cough which lasted around a month. On 11/16/2022, I began feeling the same way. I had all of the same symptoms as before. I called my physician who advised that I go to the local urgent care to be tested for COVID-19 and flu. Both of those came back negative. She did not see any infection so did not call it sinusitis. They prescribed acetaminophen, ASTELIN, and ZYRTEC. My symptoms continued to get worse though after that. I was so congested and went through probably 10 boxes of tissues. I was actually congested and coughing until around 12/01/2022.
diagnosed with shingles; rash on the back of the / head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2021, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and formulation unknown. The patient reported that 3 to 4 days after his injection, he was in a barber shop getting his haircut when the barber noted a rash on the back of the patient's head. The patient went to the emergency room for a few hours and was diagnosed with shingles. The shingles symptoms were improved. The patient did not consent to follow-up. Emergency room visit required.
Soreness in injection site; Soreness in armpit; Fatigue; Body aches; Headache; Pregnant at the time of vaccination?: Yes/ Gestation period: 10 weeks; This is a spontaneous report from a non-contactable consumer (patient). This consumer or other non hcp reported information for mother. This is a maternal report.   A 35-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:00 (35-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing and Known allergies: Sulfa medication. Concomitant medications included prenatal vitamin (manufacturer unknown) and loratadine (CLARITIN), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 09:15 (at the age of 35-years-old) as DOSE 2, SINGLE for covid-19 immunisation. 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 14Apr2021 09:00, the patient experienced pregnant at the time of vaccination?: yes/ gestation period: 10 weeks. On 14Apr2021 12:00, the patient experienced soreness in injection site, soreness in armpit, fatigue, body aches, headache. The mother reported she became pregnant while taking bnt162b2. The mother was 10 Weeks pregnant at the onset of the event. The outcome of event pregnant at the time of vaccination?: yes/ gestation period: 10 weeks was unknown. The clinical outcome of the events soreness in injection site, soreness in armpit, fatigue, body aches and headache were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
pt recv vax;devel swelling of both soles of feet,fingers,eye lids & lips;devel rash,redness & itching on thighs,arms,chest & back;to MD & tx w/ dph;
Swollen and tender lymph glands under left armpit. Foggy brain and tired.
Around 4/12/2021 I began I started realizing my left leg was throbbing, but I was linking it to my torn hip muscle, my doctor stated it could have been from my back.  The pain was unbearable so I went to the ER on 4/30/2021, they did an ultra sound and found that I had a blood clot in my leg which was causing the pain.  I was admitted over night at the Hospital and went home on 5/1/2021.  I went to my PCP for follow up and again  I went for a follow up ultra sound last week and it showed that I still  have the blood clot.  I was given Eliquis.  The pain that was in my leg is gone, but I continue to have swelling and a tingling sensation in my leg.
Hand injury; cellulitis; pharmacist told him to get his second Shingrix dose one month after the first dose; This case was reported by a consumer via call center representative and described the occurrence of hand injury in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hand injury (serious criteria hospitalization), cellulitis (serious criteria hospitalization and GSK medically significant) and intercepted product prescribing error. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hand injury and intercepted product prescribing error were unknown and the outcome of the cellulitis was recovered/resolved.   It was unknown if the reporter considered the hand injury to be related to Shingrix. The reporter considered the cellulitis to be unrelated to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter was the patient.  The patient received his first Shingrix dose about 1 month ago from reporting. The patient recently injured his hand and developed cellulitis.  The patient was hospitalized and treated with antibiotics. The patient mentioned that his pharmacist told him to get his second Shingrix dose one month after the first dose, but he had not yet received it and nothing else was reported. The reporter did not consent to follow up. Additional supportive information: Pharmacist told the patient to get his second Shingrix dose one month after the first dose, but he had not yet received it, which led to intercepted product prescribing error.
Patient received her covid vaccine booster dose 11-13-23. Pharmacist came to facility to administer vaccine to residents and staff. Patient noted with change in her mental sttaus 11-14-23 at the facility, EMS activated, 11-15-23 the facility staff received a call that patient expired at the hospital on 1-14-23
greater than 35 days since patient received first dose. Patient not yet received their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose) outcome was unknown.        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.   No concomitant information was reported. No treatment information was reported.
It started May 2nd. I woke up and realized I couldn't talk. My throat was sore, and I was coughing. It progressively got worse throughout the day, but I never had a fever. I had a headache and coughed repeatedly. I started to ache all over like the flu. These symptoms lasted about 2 weeks. I went to pharmacy and had a COVID-19 test which was positive. I took Tylenol and sore throat lozenges. It was like a cold, so I treated the pain and slept a lot. I got over it at the end of May. In August the cough caught up to me again. I have now been diagnosed with asthma because the cough has not gone. It slowed down until August but then started to kick back. I was taking prednisone to try to stop the cough. I ended up going to the emergency room on October 07, 2022. They put me back on Prednisone and Benzonatate 100mg. They helped at first but not so much now. I had to also had to take speech therapy to help with me coughing and talking.   I ended up going to a Pulmonologist in January.  I was prescribed an Arnuity Ellipta inhaler as well as Albuterol as needed. I also experienced burning at the roof of my mouth after all my Moderna vaccines. It usually lasted about to 5-7 days.
Vaccine administered was later determined to be past its beyond-use date of 11/16/2022 (though still within its manufacturing expiration date of 12/31/2023
Pt received dose of prevnar 13 before the age of 65 with no indications. Pt did not report any adverse events or side effects. It was discovered today 7/3/19.
PATIENT REPORTED, IMMDIATE PAIN IN LEFT SHOULDER POST INJECTION. MARBLE SIZE RED NODULE, SWELLING AND PAIN IN LEFT ARM TO ELBOW, AND INTO LEFT HAND LATER THAT NIGHT.  PAIN BECAME WORSE OVER NEXT WEEK, AND SAW MD. PATIENT STATED MD DX WAS BURSITIS & TENDONITIS.
1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event; 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event; Initial information was received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who received dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event after receiving influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] and influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; hepatitis a vaccine (HEPA [hepatitis a vaccine]) for Prophylactic vaccination; HIB VACCINE (HIB) for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 07-Sep-2023, the patient received a dose 1 of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8130BA, Expiry date : 30-Jun-2024, formulation, strength was unknown) via intramuscular route in right leg for Immunization and unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (expiry date, strength, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On 07-Sep-2023 the patient developed a non-serious event of 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event (wrong product administered and product administered to patient of inappropriate age) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported adverse event and was Unknown for the event 1 year old twins, a dose of fluzone high dose quadrivalent instead of regular fluzone quadrivalent with no reported 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 the 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.
made his wife mean; Hot flashes; burning in her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERSONALITY CHANGE (non-serious), outcome "unknown", described as "made his wife mean"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning in her face".  Additional Information: The caller thinks the covid vaccine made his wife mean and she has hot flashes after her vaccine. The patient got both doses. The patient is post-menopausal and it amplified what she already had. The patient had to turn down the air conditioning and there was burning in her face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.