chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of myalgia in a 48 year old female patient who received hepatitis A vaccine inactivated (Havrix).  On 08/18/2004, the patient received the first dose of Havrix in the right leg.  On 08/18/2004, the patient also received an injection of typhoid vaccine.  Approximately 2 days after the administration of Havrix, on 08/20/2004, the patient experienced myalgia.  On 08/24/2004, the patient experienced a fever greater than 101 degrees Fahrenheit, nausea and vomited twice.  On 08/26/2004, the fever and vomiting resolved.  On 08/27/2004, the myalgias got worse.  The patient was seen in the emergency room.  A complete blood count revealed a white blood count of 4.6 and lymphocyte count of 51%.  The patient was told in the emergency room that the events were probably due to a viral infection.  ON 08/29/2004, the patient experienced dizziness.  She was seen by a neurologist.  A CAT scan was normal.  At the time of initial reporting, the myalgia had worsened, and the dizziness and nausea were ongoing.  The reporting pharmacist considered the events to not be related to vaccination Havrix.
Developed rash on belly, diaper area, upper thighs.  Dime sized, confluent, red, slightly raised.  Spread to face, eyes, arms, between fingers and toes.  Not itchy. Rx: Zyrtec.
The member was in on 9/16/22 to receive her bivalent booster.  Her CDC card was stamped appropriately; however, the nurse documented that she administered a flu vaccine in error.  The patient continued to receive notification that she was due for a booster and booked another appointment for today.  Because the first booster was documented as a flu vaccine on 9/16/22, when the nurse checked the record, it appeared the member was indeed due for her bivalent booster, so she administered it erroneously.
pt recv vax & devel adipose necrosis 1x1cm <less;dimpling of thigh  which is a result of necrosis of fatty tissue;
EXTRA DOSE IN THE VIAL GIVEN TO THE PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced extra dose in the vial given to the subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extra dose in the vial given to the patient was not reported. This report was non-serious.
Headache, Sedation, Myalgia, Fever, Diarrhea, STUFFY NOSE, CHILLS Narrative:
Complaints of itching/tightness shortly after receiving vaccination. There was diffuse, broad edema and mild erythema around injection site over left upper arm. Given Zyrtec 10mg, ice.
8 days post injection I started to have swelling and redness at my injection site. I noticed this while in the shower in the morning. The redness and swelling continued to grow and site became warm to touch.
Left arm and shoulder pain day after inoculation. Resting pain subsided approximately 30 days ago: now painful with lifting and range of motion.
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010325: US-009507513-1906USA010324: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010331: US-009507513-1906USA010330: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Devel 10 cm erythema, swollen area around vax site on lt deltoid; no joints problems;
Initial report was received on 08 March 2012 from a consumer, who is also the patient's parent. A 5-year-old male patient received an injection of dose one of IPOL, sanofi pasteur SA (lot number unknown, route and site not reported) and an injection of dose four or five of DAPTACEL, sanofi pasteur Ltd. (lot number unknown, route and site not reported) on 08 March 2012 at 11:30AM. The patient's past medical history was not reported; however, the patient had allergies to "Termeric" (Turmeric) and dairy protein. The patient had no illness at the time of vaccination, took no concomitant medications and had not received any vaccinations four weeks prior to date of vaccination. On 08 March 2012 at 8:00PM, eight and one half hours after vaccination, the patient experienced a "stomach reaction", throat constriction, coughing, and temperature of 99.2 degrees Fahrenheit, puffy eyes and redness at injection site. The patient's parent stated he gave his son BENADRYL and called the healthcare professional and would seek treatment as needed. The patient's outcome was not recovered. Documents held by sender: None.
Severe shivers for approximately one hour.  Overall body aches for 1 1/2 - 2 days
71 yo R handed female PMHx of obesity, anxiety, depression, HTN, afib, and COVID infection who presented to ED on 5/15/2021 with stroke like symptoms. She presented with right sided weakness, facial droop and slurred speech. LKWT 5/15/2021 at 0430. Patient reported going to bed around 2300 the night before and woke up at 0400 that morning with right sided weakness. Her daughter noticed slurred speech and right sided facial droop. Denied chest pain, HA, dizziness, no vision changes and no history of CVA. Stroke protocol was called. Teleneuro consulted and recommended a MRI. CT head was unremarkable. She takes ASA at home and received Plavix per neuro recommendations. Of note, patient tested positive for COVID but denied any respiratory symptoms and she has received her first COVID vaccination. Patient was admitted to the hospital for further treatment and evaluation for suspected CVA. Neurology consulted. Continued ASA, Plavix and Statin. Allowed for permissive HTN. Patient with history of Atrial fibrillation, currently normal sinus rhythm on telemetry. CHADS2VASC 3-would benefit from AC if no contraindication. Unsure why she has not been placed on AC and patient stated he only had one episode of Afib. Chest XR showed No acute cardiac pulmonary findings. Patient refused to have MRI brain due to anxiety. She stated that she attempted to have a MRI before and even with medication for anxiety she was not able to. Echo showed normal EF, mild MR, AR, TR, no PFO noted.CTA head and neck showed right vertebral artery ends in PICA, no acute abnormalities.  Labs noted B12 4,268 cholesterol 231 total, HDL 52, LDL 152, TAG 134, HbA1c 6.2, TSH WNL. Patient was out of the window for tPA. She was given a large dose of IV Ativan for anxiety. She continued to have elevated blood pressures with nausea that required IV labetalol to maintain blood pressure. HTN could likely be due to her significant anxiety. Cardiology planned to follow patient after discharge to discuss AC medication. Patient initially tested positive for COVID on 2/2/2021 and was able to take patient out of isolation.  Dx: CVA
Administered vaccine to patient and monitored per protocol. While monitoring, patients body became stiff and he was unable to move. Within a minute patient was able to regain control of body. Per patient, he did not remember what happened, he said it was a lapse of consciousness/black out. I continued monitoring patient for 15 minutes, and provided water.   I asked the patient and cargiver if we can administer an epi-pen and call an ambulance, they denied both.
Decreasing mobility of right arm. Sore throat. Milky discharge from right breast possible lymph node swelling on the right side breast. I noticed the discharge from the right breastOccurred that evening around 5 PM March 15, 2021. Headaches occurred to a.m. March 16, 2021.
On 4-25-08 noticed somw swelling at sight of injection. Doring afternoon of 4-26-08 right shoulder became sour and difficult to use. Things were better in the mornings the net few days bur worse in afternoon and evening; unable to sleep. On 4-29-08 right shoulder began throbing constantly and pain became worse, arm doesn't move without great pain. I ave tred: heating pad, ice, Darvocet-N 100 mg, Motrin 800 mg, Baclofen 10 mg, Valium 10 mg on different days and times. Nothing helps the pain!
swollen lymph node is groin when woke up Saturday morning; increased in size and pain over the weekend--red and warm; other body aches where I have arthritis were worse as well;  went to doctor on Tues. Was infected; started antibiotic (clindamycin) Tuesday evening; started draining Wednesday. feel better and seems to be healing and reducing in size.  Will go back to doctor next week for follow-up.
PAIN, SWELLING, FEVER, LETHARGIC, GUARDING ARM, UNABLE TO MOVE ARM.
Lip swelled, throat tightened. Given Benedryl and Epriniphin
Small bumpy rash at injection site the evening after vaccine. Small bumps were not red, did not itch.  However the bumps expanded up and down his arm the next day.  Still not red and not itchy.
Patient stated left eye lid swelling for about 12 hours. Stated swelling and warmth of the upper arm of injection site for a little over 2 weeks .
fever / temperature of 104 F; This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and fever onset rising to a temperature which lasted for 36 hours.  The patient went to Emergency room to get tested for COVID but was negative for COVID and sent home.
Pt stated she began getting whelps on her face, neck, mouth, throat, eyes on either 03/20 or 03/21/21. She also had some difficulty breathing. She took benedryl, but did not seek medical attention. She stated she does not have a PCP.  She stated she is now beginning to feel somewhat better, but still has some whelps. She was advised to seek medical treatment.
Headaches, fever, body aches, declined covid test, and states it is reaction to the vaccine.
Developed the hives the night of the vaccination on the right side of the face and throat, both forearms.  Over the following 10 days, hives changed and moved daily.  Got steroid shot May 10th.
I was extremely tired, I had a low-grade fever, felt nauseous. I took a home COVID-19 test, it came back negative. I woke up feeling horrible, I called my doctor and explained to him that my stomach wasn't feeling good, I felt like something was brewing. He sent me to the lab to get test, my doctor wrote me a prescription for the Paxlovid. When I got home the dam burst wide open. I slept on and off twenty-four hours straight, only waking up to go to the bathroom or get something to drink. I did lose my sense of taste, I had nausea, it took four days before I could eat anything. My strength still has not returned to me one hundred percent, my energy is not back either.
daze; chills; could not sleep; eyeballs did not work; Initial information received on 21-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 56 years old male patient who was having daze, chills, could not sleep and eyeballs did not work while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious events daze (feeling abnormal), chills the patient went to bed early but could not sleep (sleep disorder) eyeballs did not work (eye disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (daze, chills, could not sleep, eyeballs did not work).  At time of reporting, the outcome was Unknown for all.
Shortness of breath, drop in O2 saturation, excesive secretions through mouth, agitation
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient tested positive for Covid-19 twice (confirmed covid-19 infection, confirmed clinical vaccination failure) and only symptom he had was a running nose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000202803.; Sender's Comments: V0 20211139699-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
sore arm; fever 100.3 less than 24 hours later; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later) in a 52-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 milliliter. On 05-Oct-2023, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever 100.3 less than 24 hours later) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2023, Body temperature: 100.3 less than 24 hours later.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Patient found on floor pale, diaphoretic, unconscious approximately 3 minutes after receiving vaccine.   patient became suddenly alert on first attempt to rouse.  Noted 5 cm reddened area on forehead which was assumedto be a result of hitting her head on the nearby plastic trash bin.  Pt Ox3 upon awakening.  She was aware that she had lost conscousness during a syncopal episode.  She denied smilar reactions in the past.  Rapid Response called.  Ice applies, 11:35 BP 104/66, HR 79, SpO2 99%.  Assisted to a sitting position.  11:40am BP 108/70, HR 72, SpO2 99% RR arrived.  Pt assisted to WC then to cot.  Denied Further dizziness.  To ED via security vehicle, accompanied by security officer and MA from clinic.
Dose administered after allowed time after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information received and contains No new information On 29-Sep-2021: Followup document received on 29-SEP-2021,Patient demographics, concomitant medicines were reported and the event were added
About a month after the vaccination, I started feeling heavy in my chest. I had difficulty breathing after walking short distances. That went on until about January. In January, I started feeling more pressure in my chest. I thought it was a heart attack, so I took some Aspirin and went to bed. I didn?t go to the hospital. It went away, and I was fine.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 21-MAY-2017, the patient was vaccinated with ZOSTAVAX (lot # M042849 with expiration date: 18-JAN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F for 2 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Increased blood pressure, increased pulse rate, shakiness, dizziness, feeling of uneasiness for about 20 minutes.
Pt was given Dose 1 of SHINGRIX. An unclear number of days after the vaccine, pt experienced injection site reactions, itching, irritation, warmness. Pt was advised to have a physician look at area to determine if any intervention in needed. Pending a status update.
A migraine that lasted for over 3 days.  This migraine did not resolve with any of my standard migraine protocols.
Vaccine was administered at 4PM on a Friday afternoon.  The next day, Saturday night, I woke up with my heart in A-fib.  180 bpm.  I awoke frightened with tight chest, and thought I was having a heart attack.  Very scary.  I went to the E.R. and they gave me an IV drug to slow my heart down.  It took several hours and they said if it didn't slow with the drug, they'd have to "shock" my heart back to a normal pace.   I was terrified of that possibility.  Luckily, it did slow eventually and they sent me home.  I WILL NOT be taking the second shot.
Had 2nd dose 3-19-21 Pfizer Lot#EN6204 3rd dose 10-28-21 Pfizer Lot #FF2593  Experienced numbness in leg and could not walk and confusion 7-2022. Fell at hospital 8-19-2022 due to brain hemorrhage. Patient died 8-30-2022.
She states that she had COVID in May2022; She states that she had COVID in May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-026672 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She states that she had COVID in May2022".  Clinical course: Product Complaint: There is no product complaint associated with this case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient has not had an adverse event; however he received 1.0ml instead of the 0.5ml dosage.