chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight cough; congestion; scratching in my throat; sore shoulder; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion), ARTHRALGIA (sore shoulder) and FATIGUE (fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PANTOPRAZOL [PANTOPRAZOLE] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced THROAT IRRITATION (scratching in my throat). On 01-Feb-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (congestion). On 25-Jan-2021, ARTHRALGIA (sore shoulder) had resolved. At the time of the report, THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
severe headache, muscle pain, shivering, irritability, periods of confusion, fear, unsteady gait,
A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician (patient's father) and a combat medic concerning a 28-year-old male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST bottle. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Narrative: 71yo male died at home hospice care from prostate cancer on 12/27/2021. PMH: Code Description Z51.5 Seen by palliative care medicine service I47.1 Supraventricular tachycardia K21.9 GERD - Esophageal Reflux Disease  E78.2 HLD - Hyperlipidemia  R97.21 Raised PSA C79.51 Secondary malignant neoplasm of bone  R91.1 Multiple pulmonary nodules  730.20 Osteomyelitis  681.11 Paronychia of toe (ICD-9-CM 681.11) I10. Essential hypertension C61. Carcinoma of prostate  E78.2 Mixed hyperlipidemia F17.210 Tobacco abuse  Pt had received covid vaccines on 1/7/21, 2/3/21, & 8/31/21. This death is not related to covid vaccines.
Post vaccination onset of tingling in left deltoid progressing to tingling of entire left arm, sensation resolving upon leaving work. Individual was seen by onsite paramedic, obtained vitals within normal range, determined to be local swelling. While at store around 4:00 PM tingling progressed to back of head, weak leg muscles and hearing in right ear for 2 minutes. Drove home arrived at 4:30 then went to phone store, while there she called urgent care at 4:49, nurse hotline at 4:52. Referred by nurse hotline to hospital. Went to the hospital, arrival at 6:18 PM with symptoms of shortness of breath, nausea, hives around mouth and left arm numbness. Release from Emergency room around 11:30 PM.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 01-SEP-2020 , the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Soreness; Pain in the body; shivering; nausea; Temperature was 101.4 slight low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 12-Mar-2021, the patient experienced PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering), NAUSEA (nausea) and PYREXIA (Temperature was 101.4 slight low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), MYALGIA (Pain in the body), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown and PYREXIA (Temperature was 101.4 slight low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 101.4 (High) 101.4. On an unknown date, Body temperature: 99.5 (High) 99.5 and 97.5 (High) 97.5.         The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Anxiousness, headache, aches, fatigue, and 100.5 fever for 24-48 hours after receiving vaccine. Generally more fatigued than normal for a week.
Shortly after receiving the vaccine, complaints headache, and sharp mid back pain, and  epigastric burning.  Anxious about getting shot.  Blood pressure 128/70, HR 90, Sat  89-91%.  Complaints of dizziness when standing up.  Oxygen 2 liters started and pulse ox at 92%.   First response team notified.  Transported to ER via wheelchair.  First response team given report on patient by this lead.
I got very sick and fainted.  I started feeling sick about 8 hours after and it lasted about 72 hours. I fainted about 18 hours after the vaccine. I did have covid back in November 2020
Patient reports "breaking out in hives" after receiving two immunizations on Friday July 8, 2016.
pt recvd vax & 2 days p/vax pt exp exacerbation of flu-like sx arthritis type sx, & lethargy; pt had flu-like sx when given the vax;
Progressive Rash/Hives onset about 48 hours progressing still at 72 hours; Angioedema of upper lip
Pt broke out in welts all over body. Pt took Benadryl & hives started to fade.
This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced swelling arm, chills, fatigue and headache. On an unknown date, the outcome of the swelling arm, chills, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the swelling arm, chills, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist in the office for herself. The age at vaccination was not reported, but it could be either 53 or 54 year of age. The patient experienced major arm swelling and intense chills, fatigue and severe headache symptoms which lasted for 24 hours. This case has been linked with US2018GSK132748, reported by same reporter.
covid after pfizer shot; covid after pfizer shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid after pfizer shot". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: swelling of optic discs, notes: Did an MRI which confirmed swelling of optic discs; SARS-CoV-2 test: positive, notes: she had COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium
Information has been received from a nurse concerning a female who when as a child was vaccinated with two doses of MMR II. It was protected against rubella until she recently (in approximately July 2010) became pregnant. The nurse stated that the patient now (in July 2010) had low rubella titers. No further information is available at this time of reporting. Follow-up information has been received from the nurse who stated that the patient was pregnant woman's spouse and no adverse experienced noted. Follow-up information has been received from the nurse who confirmed that the patient was the consumer's husband who possibly got an M-M-R II vaccination as a child while living in another country. He had a physical examination at an unknown physician's office and was found to have low rubella titers. On 27-JUL-2010 he presented to the clinic to receive the MMR II. No further information is available.
Narrative: Pt is a 73y.o. male who died on 02/14/2021 w/ h/o dementia, sickle cell trait, history of antineoplastic chemotherapy, history of radiation therapy, history of renal failure, depression, malignancy and the bladder, GERD, low back pain, hypertension, hepatitis C and PTSD. Pt received Moderna Covid-19 Vaccination 1/2 on 01/08/2021. Reviewing pt's chart (01/26/2021) saw pt was admitted to hospital yesterday w/ Covid. Pt was put on ventilator per daughter. Per his nurse, pt was extubated on 1/27/21 and is now on room air. He has been non-verbal throughout stay, refusing meds, on dialysis (having catheter placed tomorrow). Nurse stated family is looking at NHP. Pt died while inpatient at the hospital on 02/14/2021. Unlikely that Moderna Covid Vaccine caused/contributed to pt death.
This spontaneous report was received from a physician regarding an unspecified 15 year old patient. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in June 2015 (reported as about a week ago), the patient was inadvertently administered with a dose of PROQUAD (Merck) (dose/frequency, therapy route, lot #/ expiry date unspecified) (inappropriate schedule of drug administration). Concomitant medications were not reported. No adverse effect was reported. Additional information has ben requested.
not feeling well; experiencing a cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold). At the time of the report, MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold) had not resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
On 12-4 my arm swelled to double size was bright red, itchy and very hot. I called nurse holiness on 12-5 because it was getting worse. Took Tylenol, ibuprofen, and cold compresses. As of today 12-7 it is still the same. Lots of pain shooting down to my fingers also
Uncontrollable violent shaking that lasted for more than 24 hours that almost sent me to the emergency room at our local hospital
A patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to COCONUT).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   At the time of initial report, the pharmacist was not aware if the patient was experiencing symptoms or taking any prescription medications. The dose was administered more than 12 hours post puncture.  On 10-Nov-2021 the vial was stored in the refrigerator. Number of doses vials: 1 dose 1 vial, punctured 6 times prior On 11-nov-2021 at 10:00 am vial was first punctured and after that it was stored at room temperature and the vail doesn't  undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) 24 hours It was reported that patient was given 0.25 ml from a moderna bottle that had been punctured the day before and had sat on the counter for 24 hours.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up was received and updated the patient demographic details, added the medical history, and updated the booster dosage information and added the description of the events in the I-narrative
Child developed a rash on evening of 4/3/02. Mom describes rash as little red dots on back and stomach; rash did not spread to limbs and now is blotchy. Denies other symptoms. No fever.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Current conditions and other medical history were not reported. On an unspecified date in April 2014, the patient was vaccinated with the first dose of RECOMBIVAX HB (10 microgram/ml, intramuscular injection, dose 1; route, anatomical location, batch/lot and expiration date not reported). Later on, 22-OCT-2014 the patient was vaccinated with the second dose of RECOMBIVAX HB (1o microgram/ml, intramuscular injection, dose 2; route, anatomical location, batch/lot and expiration date not reported. Concomitant therapies were not reported. The reporter informed that the patient received the first dose of RECOMBIVAXHA in April 2014 and the second dose on 22-OCT-2014. No adverse effects were noted. Additional information is not expected as the reporter did not wish to be contacted for further follow up.
Had difficulty breathing and swelling of the back of her throat as well as a skin rash and itching on her chest.  She was given Epi, benadryl, and steroid inhaler by EMS.  In ED was started on an epi drip, when the was dced after a few hours patient's symptoms returned.  Epinephrine was  then restarted and patient was admitted to the hospital.
I don?t believe this is repeated by staff called and said i shld report it. I took Bactrim antibiotic for an ear piercing infection and had allergic reaction with full body hives. I have never had any problems with medications prior to this.  I was given a steroid and benedryl injection and prescribed 6 days of steroids as treatment, with continued oral antihistamines.
Pt woke at 3:00am with fever of 103.5.  Constant crying, giving motrin and tepid baths.  Mother noted twitching episodes at 6:30 and 9:30am.  Still fussy at 3:00pm has temp of 102.7.  Saw MD.  Dx with tonsillitis.
This spontaneous report as received from a pharmacy intern referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent (MERCK). On 25-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units, 1 dose, intramuscularly (incorrect route of drug administration), for prophylaxis (lot # and expiration date were not reported). No symptoms were reported.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  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: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208947.
Wednesday on September 15th, 2021 I started to cough a little bit after a walk. Thursday on September 16th I started feeling worse and coughing more. The morning of Friday on September 17th I woke up with a temperature preceding to be over 100 for the next 10 days. During that time my health has continued to go down. Tuesday on September 26th I went to the ER, and they did some testing. They kept me for awhile, and then sent me to another local hospital that same day and I was there until September 27th on Wednesday.
This case was reported by a nurse and described a 12 week old female pt who tested positive for hepatitis B surface antigen following receipt of Engerix-B. On 10/16/04, the pt received the 1st dose of Engerix-B. Approximately 4 days after administration of Engerix-B, on 10/20/04, the pt tested positive for hepatitis B surface antigen and negative for hepatitis B core antigen. The nurse considered the event to probably be related to vaccination with Engerix-B.
76 hours post-vaccination pt noticed "very itchy hives from the tops of my knees to below my bra. So my torso and thighs, front and back, welty-itchy hives". Pt took oral benadryl (2 tablets, 25 mg). Waited 5 hours, took 2 more oral Benadryl because pt was still itchy. Pt then went to sleep, woke up next morning and hives had disappeared, "it was as if no hives had ever been there".   Pt believed this was because of eating "traditional Japanese New Years treats, which were a brand new food for me" on 12/31/2020 at 2300. Pt became itchy on arms about 12 hours after eating new food, and noticed hives on body (in locations noted above) at 1800 on 1/1/2021. Pt did not contact WHS because believed that hives were from new food, and not from vaccine which she had received 76+ hours prior.
pt recvd 2 doses of Recombivax & 1 dose of Engerix-B & tested neg, no seroconversion on 14JUL92; recvd a booster dose of Engerix-B & will be retested in 8 wks;
I began experiencing itching at the injection site day 6 post vaccination, which I assumed was not unexpected. However, I subsequently began experiencing intense itching at night first on my left forearm and anterior left thigh and the next night on both anterior thighs, at which time  I also noted welts and redness over the surface as well. Both nights I took Benadryl to good effect and have not noticed itching or rash during the daytime.
On 1/18/21, exactly one week after injection, the injection site became swollen, red, and very itchy. I developed a rash across my upper chest and back. The rash was also itchy. The next day, on 1/29/21, a lymph node above my left collarbone swelled to the size of a walnut.
SEVERE HEADACHE, BODY ACHES, LOW GRADE TEMP (99-100) LASTED ABOUT 24 HRS. TOOK EXTRA STRENGTH TYLENOL Q 4 H
Red rash on arm that influenza vaccine about 8 cm in circumference. Received at school on 10/7/14.
12/4/11 had 1st outbreak out of school all week. Then developed a few more lesions 15-20 12/9 - still dx with CP. Had both vaccines #1 2/6/07 MMRV #1548F Merck.
Initial report received on 23 September 2009 from another manufacturer, who had received the original report from a health care professional via their Service Center (Document number 45225891). A female patient, whose medical history was not reported, had received a TETANUS TOXOID vaccination (manufacturer not reported) sometime in the past. At an unspecified amount of time later, the patient experienced an anaphylactic reaction. It was not reported whether any treatments were received, or if any diagnostic tests or laboratory data were performed. It was reported the patient did not die. Recovery status was not reported. Documents held by sender: None.
Tiredness; headache; muscle pain; fever; feeling unwell; nausea; joints pain; injection site swelling/redness; injection site swelling/redness; This is a spontaneous report from a contactable nurse.  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),Batch/lot number: EK9231, intramuscular in the right arm, from 07Jan2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jan2021 02:30, the patient experienced tiredness, headache, muscle pain, fever, feeling unwell, nausea, joints pain and injection site swelling/redness. The outcome of events was not recovered.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.