chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very bad fatigue; Joint soreness; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and sertraline (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 12:00, the patient experienced very bad fatigue, joint soreness and muscle soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad fatigue, joint soreness and muscle soreness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Intense headache began around 2:00 pm in the afternoon after receiving the vaccination that morning.  A high level headache has continued now for  (6) days.  Today (4/24/21) the headache has escalated again to pretty severe.  Tylenol was taken for two days but did not feel any reverse side effects from the pain.
3 Pfizer : no reactions 1 Moderna:  continuous vomiting, fever of 102, headache, muscle weakness.
no adverse effect; patient received an improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to an approximately 4-year-old patient of unknown gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.       The vaccine underwent two temperature excursion of -14 degree Celsius to -10 degree Celsius (also reported as "-11.91 C, multiple") for 8 hours, one on 12-AUG-2019, and one on 13-AUG-2019. There was no previous temperature excursion. Data logger was involved. On 21-AUG-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R026722, expiration date 17-MAR-2020 or lot # R023499, expiration date 13-FEB-2020) (dose, route of administration were not reported) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effect was reported. No product quality complains involved.
11/8/03 Went to ER 9:15 AM with fever, bulging fontanel, vomiting came  after Tylenol and/or Motrin. Admitted for 1 day. 11/13/03 In doctors office; states swelling to head had gone down but now swollen face and temperature of 99.5. 11/13/03 To ER (temperature 105), fever and otitis media. 11/14/03 Saw doctor and admitted to hospital; fever 105 for 3 days (positive influenza A on 11/14/03). The discharge summary received on 12/24/03 states influenza A.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 34 months old patient who was inadvertently administered with a 0.5ml single dose of FLUZONE QUADRIVALENT lot UT6375MA via intramuscular route in the right deltoid on 15-Nov-2018 (reported as last night also). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was not reported whether the patient experienced any adverse events. 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. Documents held by sender: none.
COVID arm; large red circle near injection site developed three days post injection; itching, appears worse as day goes on; itching, appears worse as day goes on; Site pain and knot; Site pain and knot; booster; This is a spontaneous report from a contactable other hcp (patient herself). A 42-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: 301458A, Expiration date: Unknown), via an unspecified route of administration in right arm on 04Oct2021 10:30 as dose 3 (booster), single (at the age of 42-year-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. Patient was not vaccinated with other vaccine in four weeks. Patient was on other medications in two weeks. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EN6207, Expiration date: Unknown), via an unspecified route of administration in right arm on 12Mar2021 11:00 AM as dose 2, single (at the age of 41-year-old) for COVID-19 immunization. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9267, Expiration date: Unknown), via an unspecified route of administration in right arm on 18Feb2021 03:00 PM as dose 1, single (at the age of 41-year-old) for COVID-19 immunization. On 04Oct2021 10:30, the patient experienced booster. On 05Oct2021 01:00, the patient experienced COVID arm, large red circle near injection site developed three days post injection, itching, appears worse as day goes on, Site pain and knot lessening since it began day two. Therapeutic measures were not taken as a result of events. The outcome of the events booster was unknown. The outcome of other events was not recovered.    Follow-up attempts are completed. No further information is expected.
Patient had anxiety prior to Hep A vaccine. Had history of LOC once before due to frightening event associated with blood. The child lost consciousness after receiving vaccine and she hit her head. At approximately 2:30 pm the mother called urgently to the room where the patient was waking up, disoriented and pale on the floor. She was observed (O2 saturation 97%) and discharged after 1 hour. She continued to be disoriented and ill appearing until 12/29/04, at which time she was reevaluated. There were no abnormal findings.
PATIENT REPORTS TACHYCARDIA AFTER THE VACCINE ADMINISTRATION. ELECTROCARDIOGRAM COMPLETED WITH NORMAL LIMITS. PATIENT WAS PLACED IN MONITOR FOR A SPACE OF 1HRS. AT NO TIME UNDER OBSERVATION, DID PRESENT TACHYCARDIA.
pt had change in sleep pattern slept >4hr x/for feeding;no fever-fine p/24hr;
Tested positive for COVID on 9/20/2022 experienced minor symptoms. Mild headache, sore throat and arm, and light chest congestion. I took MUCINEX and it resolved quickly.
CHILLS; FEVER; NOT FEELING GOOD; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 62 year old male white Not Hispanic/Latino ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: 5 stents in the heart and drug allergy (bactrim).  The patient was previously received with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on unspecified day for prophylactic vaccination (Dose number in series 1). No adverse events were reported for dose series 1.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 29-NOV-2021 on right arm for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 29-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced nausea and severe headache (dose series 2). The reporter stated that in the early morning, the patient was complaining of a major headache (also reported as  severe headache) with a  pain level of 10/10. The patient took 2 Tylenol (paracetamol) tablets without any relief. Laboratory data included: Pain scale (NR: not provided) 10/10. On 30-NOV-2021, the patient experienced not feeling good, fever, chills, nausea and severe headache (dose series 2). The reporter stated the patient's temperature reached as high as 102.2 and stated he felt freezing and required additional clothing. Laboratory data included: Body temperature (NR: not provided) 102.2 F measured via ear. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. At the time of this report, the  patient had not recovered chills, severe headache, fever, nausea, and not feeling good.  This report was non-serious.
Pain, swelling, itching at injection site 4 hours after administration; mild chills and mild increased heart beat, fatigue, mild body aches. 325 mg TYLENOL taken at onset of side effects. 2 extra strength EXCEDRIN caplets taken 8 hours after onset of side effects which significantly reduced pain and fatigue. Most pain and swelling reduced 16 hours after injection, but mild side effects continued throughout the following day. It should be noted that FLUZONE high-dose 2018-09 0.5ml SYR was administered concurrently at the pharmacy when PNEUMOVAX was administered.
This spontaneous report as received from a consumer refers to her twin sister of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date unknown). On an unknown date the patient experienced swelling larger than a golf ball at the injection site after she received her ZOSTAVAX vaccination. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
After 10 days, I developed itching and several large red welts on my right arm at injection sight. Took Benedryl pills & used cream for 3 days until it cleared up. After my second vaccination on 2/2/2021  developed redness & itching again on my left arm at site. Still using Benedryl now.
1 d after vaccines - on 1/16/09, low grade temp. suddenly became limp & unresponsive. Vomited & then responsive. 911 brought to ER then he became more like normal & by time in ER fine. Thought febrile Sz, had no h/o tonic-clonic action. Did have fever. Please see ER record 1/16/09; 2/1/09
A report was received from a health care professional on 11/07/03, concerning a 33 month old female vaccinee who advertently received Fluvirin on 11/7/03. On 11/7/03 the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting the vaccinee did not exhibit any adverse symptoms. There was insufficient information to determine the reporters causality assessment. Update 1, 01/24/04: A follow up report was received from a health care professional indicating that no adverse reactions were reported, at the time of reporting. No follow up pending, all information received.
Patient received vaccine on 1/23/2021 and death occurred on 1/30/2021.
hives, itching; seen in ED given po Benadryl,,  Pepcid with relief discharged on po Benadryl,   Rx Decadron if needed Improved and back to work in 2 hours;   will follow up with health clinic.
On the day of the shot my left arm was a little sore so I thought that's normal. After 3 to 4 days Pain persisted and right now I can't rotate my left arm, it aches, wakes me up at night and can only lift & turn my left arm to go back half way.
I had an e-visit on 1/6/2022 and again on 1/13/2022 for laryngitis and a sinus infection.
whole back gave out; muscle spasm; Little headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BACK PAIN (whole back gave out), MUSCLE SPASMS (muscle spasm) and HEADACHE (Little headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 011A21A and 015M21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Little headache). On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (whole back gave out) and MUSCLE SPASMS (muscle spasm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. In December 2021, HEADACHE (Little headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), BACK PAIN (whole back gave out) and MUSCLE SPASMS (muscle spasm) outcome was unknown.
Moderna COVID-19 Vaccine EUA  An all over headache started around 8 pm on 1/19/2021, then every single joint in my body started to hurt and ache, low grade fever of 100 degrees, fatigue, and ear ache in the left ear and continued until 1/21/2021.  Headache and fatigue is on going today 1/22/2021.
Upon physical assessment on 4-27-11, the pt had approximately 3" above knee on (R)-leg a 1 1/2" wide and 1 1/4" in length a swollen area with a purple/bruise in the center of the raised area.
Huge rash around injection site as well as hard lump underneath and around. Itchy as well. Spot went away and then came back 2 days later.
Information has been received from a consumer concerning her son with reaction to all vaccines and medications he has received that contain gelatin who on 07-MAY-2001 was vaccinated with the first dose of MMR II (lot # 636662/0019L). On 19-MAY-2005 the patient was vaccinated with the second dose of MMR II (lot # 648478/0634P). The patient experienced vomiting after vaccination. Subsequently, the patient recovered from the events. The patient also experienced an adverse event on VARIVAX (Merck) (WAES#0902USA00178). Additional information has been requested.
His oxygen dropped too low to 76; Pneumonia; something with toxins; he couldn't eat or swallow; he couldn't eat or swallow; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports.   This consumer (wife) reported for a 75-year-old male patient that received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 31Jan2021 (at the age of 75-years-old) for COVID-19 immunization. Medical history included dialysis for approximately 2.5 years, a lung problem, blood pressure. Concomitant medications included carvedilol and warfarin and other unspecified medications.  The patient experienced pneumonia and died on 11Feb2021 03:00 AM. An autopsy was not performed. The cause of death was reported to be  pneumonia. Clinical course was the follows the next day on 01Feb2021 at 9:30AM the patient was dressed and ready to go to dialysis. His oxygen dropped too low to 76. He wanted an ambulance called. He went into the hospital. The patient was confused, and he was not normally confused. In the hospital the physicians said he had pneumonia, but it wasn't that bad. The doctors were baffled. He also was in the hospital for something with toxins. He had a lung problem for a long time. If he didn't go to the bathroom the toxins were hitting the liver and then the toxins were going to the brain. When he was in the hospital he couldn't eat or swallow. The first day he did eat a bit, but he had dialysis in the hospital, and it knocks him out. They were giving him antibiotics IV. He couldn't swallow any of his pills. He was in there for 11 days and had not eaten. He couldn't swallow any pills. He started going to sleep and they started giving him Morphine drip at the end. They couldn't get any medicine in him because he couldn't swallow. The patient died of pneumonia, the outcome of the other adverse events was unknown.   Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247875 Same report, different patient/event; Reported Cause(s) of Death: Pneumonia
6/13/07 child seen at clinic-red papular rash 3-4 areas confluent mark of 7-10 cm. 6/14/07 OU Pediatric Clinic eval-rash spreading to face 6/18/07-TC mom reports rash resolving. 6/25/07 child again has similar rash after strawberry jelly-Resolved with Benadryl El.
First shot make me tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (First shot make me tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Stent insertion NOS (3 Heart Stents). Concurrent medical conditions included Emphysema pulmonary (prior vaccination), Cholesterol and Breathing difficult. Concomitant products included THEOPHYLLINE for Breathing difficult, ATORVASTATIN for High cholesterol, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (First shot make me tired). At the time of the report, FATIGUE (First shot make me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not register any change on her illness status post vaccination. Patient did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's. Patient did not register any change on her illness status post vaccination. Patient confirm that received all the vaccines in her left deltoid and did not seek for medical care post vaccination. The patient did not experienced a similar event on the past. No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533310, MOD-2022-533315, MOD-2022-533316 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 04-MAR-2013 the patient received an expired dose of M-M-R II (Lot# 1644Z, expired on 24-NOV-2012), dose and route not reported. No adverse effect was reported. It was not known if the patient sought medical attention. Additional information has been requested.
Augmented sense of smell to certain substances such as coffee, baking soda toothpaste, gasoline, many cooking odors. For example, I cannot distinguish salt marsh from skunk spray and neither smell as they would tradishionally.
Headache, Neck pain Narrative: Employee had MRI-negative. Lab work within normal limits.
Severe flu like symptoms, chills, headache, nausea, vomiting,  severe body aches
Sore throat , chest tightness , cough , runny nose , sneezing , headache , dizzy
This spontaneous case, initially received on 30-Nov-2017, reported by a pharmacist and concerns a 29-year-old, adult, female patient. Patient's medical history and concomitant medications were not reported. On 15-Nov-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 170104P, expiry date: 31-May-2018). However, not all of it went in, but tiny bit of vaccine leaked out of administration site and onto patient's arm during administration. It was reported that, no adverse effect was noted in the patient. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 30-Nov-2017: The expiry date of the suspect product was corrected from May-2018 to 31-May-2018. The narrative was amended accordingly. Case correction received with IRD 30-Nov-2017: Added new event as "exposure via skin contact" in the event tab. The narrative was amended accordingly.
03/02/2021- the day of the vaccine-07:28pm arm was sore, minimal headache, 07:34pm weird taste in my mouth, Later in the evening migrating joint pains. 03/03 headaches, occipital headache. 03/04 occipital headache and nasal nasopharynx felt swollen, fatigue. 03/05 nasopharynx still felt weird and clear drainage, more than usual. 03/06 the headaches spread to the front of my head. 03/07 sudden abdominal discomfort, diarrhea, it was just a one time episode and then I was fine. 03/10 headaches on and off all day, seemed worse, and bloating 03/11. Headaches and nausea. 03/16 first day without headaches since the vaccine. I probably got 2 weeks of headaches after that shot. 03/19 weird pressure in the back of my head when I bend forward. After that I stopped getting headaches.
Vomited immediately after eating lunch on Monday, November 22nd at around 12:15PM.  Awoke at 2AM on November 26th and vomited three times. Was fatigued, low energy, no appetite the next 2 days. Became constipated.
Muscles in the back of my legs and thighs have been giving her issues; Pain from when trying to move her legs and walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A22A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk). At the time of the report, MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication information was provided The patients treatment products information included Tylenol.