chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/11/2021: Fever range 99-102.4+, body aches, chills, headache  4/12/2021: fever range 99-100, body aches, headache
Moderna COVID-19 Vaccine EUA: hospitalized for COVID-19 infection with weakness and decreased oral intake. Received oxygen, IV fluids, and physical therapy. Discharged to home medically stable.
fever; sweating; chills; dizziness; body weakness; extreme fatigue; lymph node swollen and tender; This is a spontaneous report from a contactable consumer. This 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIOTECH COVID-19, Solution for injection), via an unspecified route of administration on 19Feb2021 12:00 PM (at the age of 33-year-old) on left arm as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 (PFIZER-BIOTECH COVID-19) on 28Jan2021 at 06:45 PM (at the age of 33-year-old) at right arm, dose 1 for COVID-19 immunisation. The patient had not received any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested positive with covid post vaccination. In Feb2021 at 11:00AM, the patient experienced fever, sweating, chills, dizziness, body weakness, extreme fatigue after 19 hours of vaccination and after 36 hours, lymph node swollen and tender on an unknown date in Feb2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Moderna Booster dose was given instead of Moderna Bivalent Booster. No reactions noted.
Initial unsolicited report received from a consumer on 05 July 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (Manufacturer: unknown, batch number, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced tenderness, referring to the injection site. Laboratory investigations and corrective treatment were not reported. The patient outcome was reported as unknown. List of documents held by sender: none.
Presented to the ED with stroke like symptoms, admitted to the hospital for inpatient treatment and further testing.
Pt had 1 "bad" sx on 24FEB91 followed by 2 "light" sz; Rushed to Hosp by ambulance; Fever was 104.9; Unable to r/o rxn to immun; Dx w/intestinal tract infect
swollen place where the shot was; Redness where the shot was; pain where the shot was up her arm and neck; pain where the shot was up her arm and neck; feels hot where the shot was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 06Mar2021, outcome "not recovered", described as "swollen place where the shot was"; VACCINATION SITE ERYTHEMA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Redness where the shot was"; PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious) all with onset 05Mar2021, outcome "not recovered" and all described as "pain where the shot was up her arm and neck"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "not recovered", described as "feels hot where the shot was".  Additional Information: The patient had not received any vaccine within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received  6 doses of Moderna COVID-19 vaccine in one shot; Headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (very tired) and ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A or 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (Headache), FATIGUE (very tired) and ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot). On 20-Sep-2021, ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (very tired) was resolving.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter reported, on vaccination card, in the lot number, the 3 is crossed and 7 was written on it (first vaccine).  As of 22-Sep-2021, the patient felt a little better.
DID NOT EAT MUCH; SLEPT A LOT; TIRED AND FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPHAGIA (DID NOT EAT MUCH), HYPERSOMNIA (SLEPT A LOT) and FATIGUE (TIRED AND FATIGUE) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 15-Oct-2018, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced FATIGUE (TIRED AND FATIGUE). On an unknown date, the patient experienced HYPOPHAGIA (DID NOT EAT MUCH) and HYPERSOMNIA (SLEPT A LOT). On 30-Dec-2021, FATIGUE (TIRED AND FATIGUE) had resolved. At the time of the report, HYPOPHAGIA (DID NOT EAT MUCH) and HYPERSOMNIA (SLEPT A LOT) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 74-years-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and non-serious events of Fatigue and Hypophagia.The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The co-suspect UPADACITINIB (RINVOQ)  remains a confounder.The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 74-years-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and non-serious events of Fatigue and Hypophagia. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The co-suspect UPADACITINIB (RINVOQ)  remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
lt leg pain inc end of Dec & JAN;spastic both legs 1st of FEB;9FEB96 PCP;11FEB96 ER;12FEB96 neurologist,adm to hosp x 2 days on Baclofen
Freezing (no chills) literally woke up freezing and shaking bad trying to get warm, fever, bad muscle and joint pain and bad fatigue
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of PROQUAD (lot # L051101 and expiration date 17-JUL-2017, albumin status therapy type, dose and route of administration were not reported) that was improperly stored. The temperature of excursion was 6 Celsius degrees and the time frame of excursion was 52 hours. There was no previous excursion and the call was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
The patient received the vaccine after the 6 hours expiration mark. Patient was called and explained what happened and give the vaccine according to the  health department
Information has been received form a physician through the pregnancy registry for varicella virus vaccine live concerning a 30 yr old Caucasian female pt with a penicillin allergy (which caused a rash) who on 28-JAN-1999 was vaccinated with one dose of varicella vaccine live (site unknown). The pt learned that she was pregnant. The pt had no illnesses at the time of vaccination or during her pregnancy. Medical records indicated that during the pt's pregnancy she experienced a low lying placenta at 18 weeks. a repeat ultrasound was done and the pt's experience resolved. On 18-MAR-2000 the pt delivered a normal, healthy baby girl whose weight was 8 lbs. Moderate shoulder dystocia was noted during delivery however the pt's total labor time was 7 hrs and 6 minutes No further information is expected
About 2 hours after injection arm started hurting really bad, about 1 hour later throat started itching, coughing, tightness in chest, hoarseness & felt SOB. These lasted about 5 hours. I went to bed. All next day still had hoarseness & some tightness in chest.
Pt presented 1100 for Pfizer Covid #1. Form filled out online. RPh reviewed form online (all answers no) before orally confirming in booth prior to injection. Injection given at 1110 am, discussed possible side effects, etc with patient for couple of minutes, pt was seated in waiting area  for 15 minutes prescribed period , and was visually checked by RPh every couple of minutes. At 1131 another customer waved and informed us  patient had  fainted in chair (no fall). 2 pharmacists responded with rescue kit and bp monitor as pt was awakening. bp was taken, pupils,  skin temp, peripheral blood flow, etc. Patient reported he felt a bit nausea and dizzy but very relaxed. Was surprised but not upset. One pharmacist stayed with patient the required extra 15 minutes +  and provided pt with water while repeatedly checking vitals.  At 1147am pt was past the 15 minutes and felt he was ready to go. Rph verified patient stability and reflex before pt left.
Fatigue, extreme aches in joints, nausea, severe headaches, tingling in toes, heart racing, light headedness.
I woke up the following day with fever, headache, and severe epigastric pain not relieved by calcium carbonate or OTC famotidine. Epigastric pain continued to progress to the point that I had to present to Emergency Room.
little pink points around the site and down upper arm, like multiple injections; 5 days after shot she had extremely itchy at the injection site; the injection site little red; some soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (5 days after shot she had extremely itchy at the injection site), VACCINATION SITE RASH (little pink points around the site and down upper arm, like multiple injections), VACCINATION SITE PAIN (some soreness at the injection site) and VACCINATION SITE ERYTHEMA (the injection site little red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included big complexfor hair growth for Abnormal hair growth, LEVOTHYROXINE SODIUM (THYROXINE), METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), CORTISONE and VITAMINS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (some soreness at the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (5 days after shot she had extremely itchy at the injection site) and VACCINATION SITE ERYTHEMA (the injection site little red). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (little pink points around the site and down upper arm, like multiple injections). At the time of the report, VACCINATION SITE PRURITUS (5 days after shot she had extremely itchy at the injection site), VACCINATION SITE RASH (little pink points around the site and down upper arm, like multiple injections), VACCINATION SITE PAIN (some soreness at the injection site) and VACCINATION SITE ERYTHEMA (the injection site little red) 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 treatment information was provided.
Diarrhea.  Patient stated it started 2 days after vaccination and has been lasting everyday since then.  Reported to me on 2/6/2021.
A case was received from a health professional in the United States on 20 June 2007. An 11-year-old male patient experienced weakness, pain at the injection site, lethargy, tiredness, and fever following left arm intramuscular injection of Adacel (lot number C2689AA), right arm intramuscular injection of Menactra (lot number U2233CA), left arm intramuscular injection of Hepatitis A (lot number 0018U), and subcutaneous right arm injection of Varivax (lot number 0456U). All vaccinations were given on 06 June 2007, and within 12 hours the patient experienced weakness in both legs, pain at the injection site in both arms, lethargy, tiredness, and fever (101 degrees Fahrenheit). he was seen in the physician's office and then sent to the emergency room, where he was given Motrin. The patient has no known medical history, no concomitant medications, and was not ill at the time of vaccination. The events resolved.
This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-AUG-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K023534, expiration date: 22-MAY-2016, orally. No adverse effects were reported. Additional information has been requested.
Pt experienced fatigue, weakness, headache, weight loss of 8 lbs, sensation of warmth, light headed, poor appetite, vertigo, neck pain, shoulder pain, stiffness, insomnia, bron spasms, palpitations and muscle weakness. Pt saw his MD on 1/17/2002. Pt will have blood work on 1/21/2002.
L arm a week after vaccine sharp shooting pain from L shoulder to L arm. Then pt put arm in sling pain eased away. Pt can now move arm but when tries to lift above shoulder sharp pain remains.
A non-serious spontaneous report of flu like symptoms manifested with headache and fever, stomach ache and loss of appetite has been received from a health professional concerning a five-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Oct-2011. On 07-Oct-2011, the patient experienced flu like symptoms and rapid test came positive for flu. The patient also experienced headache, fever, stomach ache and loss of appetite. The outcome of flu like symptoms, stomach ache and loss of appetite was not resolved.
The day following each vax, BOTH arms felt like they had been punched..  it subsided after first vax.   However now 3 weeks after 2nd vax I have continued  to have this ache/ pain in both arms frequently and sometimes alternating knees off and on.  Both arms are currently throbbing, possibly  aggravated by a/c.
About 12 hours following DTaP, IPV, HIB and Prevnar, patient with 100.5 fever and rag doll like state for less than 3 hours.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 12/29/2020 and 01/29/2021. They presented to Emergency Department on 03/04/2022 with generalized weakness, increased confusion, recent increase in falls, and altered mental status with hallucinations. They were admitted to hospital on 03/04/2022. They were transitioned to comfort care only on 03/10/2022. They were going to be discharged back to skilled nursing facility for end-of-life care but they died prior to discharge, on 03/10/2022.
CLIENT C/O TINGLING IN HER THROAT AND SAID SHE WAS HOARSE. STATES FEEL JUST A LITTLE SOB. APN GIVE BENYDRYL 50MG IM IN L. DELTOID. VITAL SIGNS STABLE WITH O2 SAT AT 98% ROOM AIR. CLIENT C/O WORSENING OF SYMPTOMS. APN GIVE 0.5MG OF EPI IM IN L. DELTOID. EMS ARRIVED AND TRANSPORTED CLIENT VIA AMBULANCE TO EMERGENCY ROOM.  ON 01/29/2021 NURSING SUPERVISOR CALLED CLIENT. STATES SHE WAS DOING MUCH BETTER AT THAT TIME.
Joint pain started in their right shoulder and moved into their left shoulder; Fatigued / tired; Feeling wobbly on their feet; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Feeling wobbly on their feet), ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.). Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced BALANCE DISORDER (Feeling wobbly on their feet). On an unknown date, the patient experienced ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired). On 08-Feb-2021, BALANCE DISORDER (Feeling wobbly on their feet) had resolved. At the time of the report, ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
This spontaneous consumer report (initial report 12-Dec-2011) concerns a female patient, who had a medical history of allergy to codeine, TALWIN, ALEVE and MOTRIN. She has no pertinent medical history. On 01-Nov-2005 the patient received one dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. In the evening of 01-Nov-2005 the patient experienced a 'white welt' at the injection site with redness and swelling in her upper arm from the shoulder to the elbow. She also developed 'flu-like' symptoms, aches and sweating on the same day. The patient saw the physician and the physician thought that the swelling and redness was 'cellulitis'. The patient was treated with a 7-day course of KEFLEX. On 04-Nov-2005 these symptoms were resolving. The symptoms completely resolved on an unspecified date. On 16-Nov-2007 the patient received a second dose of PNEUMOVAX 23 injection. Flu vaccine was reported as concomitant medication. Within a few minutes of receiving PNEUMOVAX 23 the patient developed severe redness and swelling at the injection site. The redness and swelling were so severe that the physician at the office tried to give her 'something to immediately stop the reaction'. She was prescribed prednisolone and XYZAL to treat the swelling. The redness and swelling did eventually resolve on an unspecified date.
Area of redness around injection site approx. 7.5cm x 5.5cm with 3cm superficial induration
INJECTION SITE SORE ARM; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the subject experienced injection site sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site sore arm. This report was non-serious.
Little sore all over; Had first shot and after that I had a bit of headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Little sore all over) and HEADACHE (Had first shot and after that I had a bit of headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 047A21A) 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) (unknown route) 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. In February 2021, the patient experienced PAIN (Little sore all over) and HEADACHE (Had first shot and after that I had a bit of headache). At the time of the report, PAIN (Little sore all over) and HEADACHE (Had first shot and after that I had a bit of headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information include nitroglycerin two times. 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.   This case was linked to MOD-2021-072814 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unkown age or demographics. On an unspecified date (assumed to be in 2009 based on: the patient was re-vaccinated about 5 years ago) the patient was vaccinated with PNEUMOVAX 23 dose 2. Date of first dose of PNEUMOVAX 23 was unspecified, date of re-vaccination with PNEUMOVAX 23 was unspecified. No information was provided on batch/lot number or vaccination site. No adverse event reported. No other information was provided. The outcome of the patient had been revaccinated with PNEUMOVAX 23 and no adverse event is unknown. Additional information is not expected (no consent to contact reporter).
Rash and itching on both arms, both legs, both feet, stomach area. Worse on right arm. Dermatologist prescribed topical steroid oint, sarna anti-itch cream, and aquinil to wash in shower instead of soap. Rash has improved everywhere but on feet. Itch has improved everywhere but not completely gone