chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
big red itchy circle about 2 inches; big red itchy circle about 2 inches; arm is still swollen; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Flu vaccine (she gets big red itchy circle from flu vaccine).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen). At the time of the report, PRURITUS (big red itchy circle about 2 inches), ERYTHEMA (big red itchy circle about 2 inches) and PERIPHERAL SWELLING (arm is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
This case was reported by a lawyer and described the occurrence of mercury poisoning in a 5 year old male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerosal component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 01/01/2001. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of his injuries. The attorney also alleged that the patient suffered significant impairments in his ability to enjoy life, faces significant obstacles to performing the tasks and activities of every day living, and suffers ongoing physical and mental distress. The case was assessed as medically serious (OMIC).
Patient stated she had SHINGRIX injection on 6/28/2018, and C/O fatigue, local redness, feel warm and painful on the right deltoid, feel hot (did not take temp). Patient stated she took one TYLENOL 500 mg and used ice pack to relieve pain at the night of 6/28/20118, but symptoms stay the same.
Information hs been received from a consumer concerning a 10 year old female who was vaccinated with GARDASIL. Then the patient started to feel very sick and was "a completely different person". No further information is available.
On 3/28/2022 the Department of Health identified this individual as a recipient of an expired dose of Pfizer Covid vaccine. The expiration date had been found to be miscalculated. The individual has/will be notified by telephone as well as by letter of the event and offered an additional dose of Pfizer Covid vaccine to ensure effectiveness. This additional dose of Pfizer Covid vaccine has not yet been administered to the individual.
Immediately after vaccination I could feel that my arm was more sore than the first time, My arm hurt like crazy. I had the same arm pain as the first time around. About a week later My glands in my armpit were extremely swollen. It was hard to raise my arm and was extremely painful. I tried icing and all over the counter medications. I went to see the doctor when I got to where I could not dress myself any longer. I was diagnosed with rotator cuff impingement and possible torn bicep. I was given Steroids' and stated physical therapy.
1st dose 5Dec2022, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 31st January 2022, the patient received the 2nd dose of Shingrix. On 31st January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: Medical assistant (MA) reported the potential administration of Shingrix less than 2 months following the initial dose in an immunocompetent patient.  The patient was administered 1st dose of Shingrix on 5th December 2022 and was in office on the day of reporting for 2nd dose, which was 5 days prior to dose being due.  It was unknown if dose would be administered or not at time of call. The reporter did not consent to follow-up. HCP disconnected phone call prior to collecting patient demographics.  2nd dose of Shingrix had not been administered at time of the call.  It was unknown whether Shingrix was administered at the patient's visit.
Fussy, inconsolability, brief period of going limp. No color changes . Evaluated in ED immediately
Cold; Weak; Feeling really tired; Chills; Little bit nauseated, feels very queezy; Fever of 100.4; Arm is sore; Bright red at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site) and FATIGUE (Feeling really tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VERAPAMIL, AMITRIPTYLINE and VITAMINS NOS 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 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and VACCINATION SITE ERYTHEMA (Bright red at the injection site). On 03-Feb-2021, the patient experienced FEELING COLD (Cold), ASTHENIA (Weak), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4). At the time of the report, FEELING COLD (Cold), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm is sore), VACCINATION SITE ERYTHEMA (Bright red at the injection site), FATIGUE (Feeling really tired), CHILLS (Chills), NAUSEA (Little bit nauseated, feels very queezy) and PYREXIA (Fever of 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100.4 (Inconclusive) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Constant pressure headache in front of head, tinnitus and anxiety that still has not resolved 4+ weeks after first shot. Anxiety is similar to GAD/Panic Disorder, which was previously controlled with Zoloft (since discontinued). Vaccine caused resurgence of anxiety/panic. Headache does not respond to any of the following: aspirin, Tylenol, Advil, Aleve or any combination thereof.  Neurologist prescribed gabapentin and fioricet. Acupuncture for temporary symptom relief.
could not sleep; headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired) in a 60-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.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired). At the time of the report, INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient came in for his 2nd dose of a covid vaccine. Asked the patient what vaccine will he be taking today, he responded that he will be taking his 2nd dose of Pfizer. After administering the vaccine, his ticket reported that he was suppose to get Moderna as his second. After confirming his first vaccine in the system, it was confirmed that his first dose was Moderna. Patient was monitor for thirty plus minutes for any signs and symptoms. None was noticed and none was reported by the patient when ask how he was feeling. Patient was educated about the signs and symptoms that were considered to be normal and those and were considered to be an emergency. Patient will be follow up by one of the nurses and educated the patient  to call the clinic back if he experience any of the adverse reaction. The event occur at 7/25/21 around 11:55 AM.
This spontaneous report as received from a nurse refers to a 62 year old male patient (her husband). On 13-DEC-2012 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and lot # were not provided). On 15-DEC-2012 ("about 2 days after"), the patient experienced a shingles-like rash on his leg the ZOSTAVAX administration. Nurse reported that her husband was treated with acyclovir and prednisone (unspecified dose, frequency, duration) and the rash went away "almost immediately". The lab did not perform. The patient sought medical attention and visit to physician office. The outcome of event was reported as recovered/resolved on unspecified date. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed an injections site reaction following administration of PNEUMOVAX23. The injections site reaction was described as a doubling of the arm at the site the PNEUMOVAX23 was administered. The outcome of injections site reaction was unknown.
Multiple arthralgias in both wrists and knees. Actually began after the 2nd vaccination but did not make connection. Much worse 8 weeks, after 3rd vaccination.
The patient received an undiluted orange cap pediatric pfizer does (0.3ml) instead of the appropriate 0.3ml dose of the gray cap 12+ pfizer shot
Lasting about 3 days: swelling and pain at the injection site, fatigue, achiness, migraine headache  (these were controlled with ibuprofen and did not limit much of my day to day life. LASTING 10 DAYS OR MORE: notable depression symptoms that are normally controlled with daily medication - inability to think clearly, irritability, unexplained sadness, frustration, difficulty making decisions (I have tried to control these symptoms with tactics I have learned through behavioral therapy as well as reducing stress to the extent that I'm able. This has not been completely successful and I am considering requesting an increase in my depression medication for the week following the second dose of the vaccine.)
He hives that were very mild; The hives were on his chest ,neck and behind his ear.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He hives that were very mild) and URTICARIA (The hives were on his chest ,neck and behind his ear.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (He hives that were very mild) and URTICARIA (The hives were on his chest ,neck and behind his ear.). At the time of the report, URTICARIA (He hives that were very mild) and URTICARIA (The hives were on his chest ,neck and behind his ear.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Right deltoid, lower injection site 4"x 2 3/4" reaction raised and red area. Earlier that day the pt had her allergy shots.
VACCINE REMAINED IN FREEZER BEYOND MANUFACTURER RECOMMENDATION. AFTER CONSULTATION WITH PFIZER REVACCINATION WAS RECOMMENDED  TO ENSURE PROPER EFFECTIVENESS.
evening of vax pt devel gen body edema & gen rash;seen by MD on 8JAN97;total body rash which was red, raised & pruritic;cracked, peeling skin;pt seen by MD 31JAN97 w/reduction of edema;dx serum sickness,dx pityriasis rubra pilaris;
ASTHMA, DIVERTICALITIS,  FATIGUE BODY ACHE, HEADACHE, KIDNEY STONES
Large local redness / warmth after Anthrax #2. Vaccine administered to right arm. Member seen by physician and prescribed Keflex, Zyrtec and Motrin.
Fever, lethargy, rash, complaining of pain all over, screaming out at night and whenever wakes up.
Side effects after they got the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after they got the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after they got the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects after they got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Treatment information was not provided.
I was 33 weeks pregnant at the time of shot. Not pain or numbness at the time of shot. Starting at 10 am in the 7th I had chills and a headache. Took a nap and temp started to rise from 99.5 to 101.7 at 5 pm. Took 2 500 mg tabs of acetaminophen  help with fever and finally broke at 3 am on the 8th. Weak all day in the 8th with headache and felt back to normal on the 9th.
Within 24 hours I develop chest pains nausea dizziness eyesight has become increasingly worse chest pain is becoming increasingly worse checked in with the health department they basically said it wasn't their problem because I do not have the money to have a regular doctor I do not know who to go to and cannot afford a hospital visit I am normally a very healthy person now almost three weeks later it's got increasingly worse and I don't leave the house unless it's absolutely mandatory migraine headaches have become so bad that I don't drive at times I'm afraid I'm having a heart attack
Patient experienced red, hot, indurated, tender and painful left arm of injection site.  Patient also experienced itcing for 3 days.
This spontaneous report was received from a medical assistant and refers to a 53 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported. On 24-APR-2018, the patient was inadvertently vaccinated with a dose of Oka-Merck) PROQUAD lot # M044020, expiry date 01-MAY-2018, intramuscularly for prophylaxis, instead of (wistar ra 27-3) M-M-R II (lot# and expiry date were not reported). Concomitant therapies included sterile diluent (lot# and expiry date were not reported). No adverse effects were reported.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 09-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of appetite.  Treated w/ bed rest, water, and ibuprofen. Lasted three days after shot. Fourth day, no fever, no swollen glands, and appetite returning.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        Treatment medication were not provided. Action taken with mRNA-1273 in response to the event was not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
immed pain, swelling & lump @ inj site w/progressive inc of size of lump & swelling progressive to involve most of arm;exam showes 3" x 2" hard mass in triceps @ inj site w/ hot, red overlying sking & moderate sweling arm;t100; 2 1cm nodes
Pt received vaccine at outside pharmacy so I do not have lot numbers etc. With dose #1, he had no issues. After dose #2, he developed erythema at the injection site, now progressed over several days to much of his upper R arm. I am electing to treat him for cellulitis.
9OCT91 pt recvd DTP/OPV/HIB TITER for 1st time & on 13OCT91 started w/generalized hives seen on 14OCT91 prescribed DPH; gradual recovery; rechecked 16OCT91;
vaccinated patient fainted at exit. Customer alerted pharmacist. Epipen was adminstered and blood pressure checked seem below normal. 911 called and ambulance came to administer to patient. Store Director supervised when ambulance arrived. Patient got water to drink, said he left to go lie down in the car. He did not alert pharmacy staff before leaving if unwell as was advised.
No adverse effect, standard administration procedure followed including using alcohol swab on area before administration.  After injection, noticed area on arm with black spot looking like a spot of dirt.  Inspection of arm and during alcohol cleaning nothing noted.  Vaccine and needle inspected as normal and no abnormalities in these.  Unable to determine if spot was in exact injection site or not so unknown if risk of any contamination. Patient was supposed to wait after administration but left area before able to go over with him and inspect arm before leaving.  Standard band aid was attached to injection site area after administration.  Will follow up with patient.
tender to the touch; Sore arm at site of injection; feeling tired and rundown; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown) in a 43-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea. Previously administered products included for Product used for unknown indication: Flu shot on 04-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 05-Oct-2023, the patient experienced TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown). At the time of the report, TENDERNESS (tender to the touch), VACCINATION SITE PAIN (Sore arm at site of injection) and FATIGUE (feeling tired and rundown) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Symptoms developed within 16 hours of vaccination. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment information was reported.
Hospitalized with COVID pneumonia and hypoxia. Acute right sided DVT.Rocephin and Azithromycin;