chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 64 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ036AA, expiration date: 09-May-2019, route: intramuscular and site of administration: left deltoid) on 06-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (64 year old male, given a FLUZONE HD vaccine). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
The Pfizer vaccine triggered an early period and for the last 2 months my cycle has been very early and significantly heavier bleeding. This is problematic because I am a breast cancer patient and more frequent periods can lead to higher recurrence risk.
Red area on deltoid that is 2" width & extends down the lt arm 3 1/2 in;  sl. temp not taken, had sl diarrhea;
red raised rash that was itching; red raised rash that was itching; red raised rash that was itching; Information has been received from a patient's parent who is an employee, referring to a male patient of unknown age. The patient's concurrent condition, concomitant medication and historical condition were not provided.   On 29-OCT-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) dose 2 (route, dose, frequency, lot number and expiration date unknown) for prophylaxis.   On 31-OCT-2019, when the patient removed the Band-Aid, a red raised rash that was itching was observed. His brother received the same vaccination on the same day and had no symptoms. The patient would be taken back to the doctor if the rash did not go away in the next couple days. The outcome of a red raised rash that was itching was unknown. The reporter considered a red raised rash that was itching to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
She reported that she had a bad reaction to the flu shot she received in 2017, 18, and 19. She stated she was sick, with chills and felt as if her whole body was weak. Within 24 hrs she noticed a runny nose, fever 101, and body aches. Symptoms would persist for a 1-2 weeks and she would take time off from work. Never sought medical evaluation   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), OTH SPEC DISORD,NOSE&NAS SINES(J3489), PRURITUS, UNSPECIFIED(L299).
Began having chest pain with breathing.  Substernal pain that radiated into shoulders ipsilaterally.  Increasing each day, sob started and became increasingly worse.On March 1, 2021 admitted to the Hospital, with Pericarditis and left lower lobe infiltrate.  O2 sats 82.
I had high fever, shortness of breath, and flu like symptoms. Body aches, nasal discharge and phlegm cough. It was the most severe flu I had ever experienced. I was sick the whole month of January, I started to get better by the end of January but I was not completely fully recovered. I was tested positive for COVID. And as fast as it came on, it all just went away and I have been fine since.
Epilepsy; Abdominal pain; Breath holding; Developmental regression; Rash macular; Screaming; Information was obtained on a request by the company (Agency number AU-TGA-0000678685) via Public Case Detail referring to a 37-year-old male patient. Information regarding patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had no previous vaccine reactions.  On 17-JAN-1985, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine (manufacturer : unknown) for prophylaxis and diphtheria vaccine toxoid, hib vaccine, pertussis vaccine acellular, tetanus vaccine toxoid (DTPA HIB) (dose, frequency, route of administration, anatomical location, lot number and expiry date were not provided for both vacines).  On 17-JAN-1985, the patient experienced rash macular and screaming. On 03-OCT-1985, the patient experienced developmental regression. On an unknown date in 1986, the patient experienced epilepsy and was hospitalized for the event.  On an unknown date, the patient experienced abdominal pain. Within minutes Patient was covered in blotches, called the general practioner and advised to return, Mum was back within a couple of minutes and the blotches had all joined and he was red all over - 'looked sunburnt' - reviewed by another Doctor, 15 minutes later returned with antibiotic steroid cream to apply Sent home, started to scream, wouldn't stop screaming, wouldn't feed and then wouldn't sleep - only time he would was out of extreme exhaustion, high pitched screaming - went on - for weeks - diagnosis with colic on multiple representations, went on for months, seen only by local GP, no referral. Given combined diptheria tetanus sabin at one of the later review appointments no pertussis given. MMR 03-OCT-1985 Mum reports sleeping remained poor, diarrhoea, any advancements he had made he regressed post MMR vaccination - 'speech stopped everything'. Admitted to Hospital, vomiting, screamed, LP and other tests conducted - nil diagnosis provided 'mystery virus' On 17-DEC-1985, admitted again with similar symptoms - diagnosis again with another mystery virus Breath holding. Eye rolling episodes and abdominal wall sucking in when nappy changes attended, would scream post 1986 Requested review seen by doctor and admitted for 11 days, CAT (computed tomography scan), chromosomes, EEG (electroencephalogram), developmental age of 15month at 2 yrs, Diagnosis with epilepsy - commenced on medication. Noticed to have autistic tendencies - reviewed - did not meet all criteria at this stage, diagnosis at 5 having met all criteria (diagnosis 1989) Last vaccinated 03/07/1986 - combined diptheria & tetanus - nil since then. The outcome of the events were reported as unknown. (conflicting information end date for rash macular: 02-JAN-1986).  The reporter considered all the events to be related to suspected vaccines.
Development of cerebral amyloid angiopathy / full active case; Broken brain with a path of more micro-bleeds; broken brain; brain cerebral glucose deregulated; This case was reported by a consumer via interactive digital media and described the occurrence of cerebral amyloid angiopathy in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cerebral amyloid angiopathy (serious criteria GSK medically significant), cerebral microhemorrhage (serious criteria GSK medically significant), brain injury (serious criteria GSK medically significant) and glucose abnormal. On an unknown date, the outcome of the cerebral amyloid angiopathy, cerebral microhemorrhage, brain injury and glucose abnormal were unknown.   It was unknown if the reporter considered the cerebral amyloid angiopathy, cerebral microhemorrhage, brain injury and glucose abnormal to be related to Shingles vaccine.  Additional details were reported as follows: 56 years old patient went to hospital with high blood pressure.  The patient received unknown shingles vaccine.  The patient was at the time brain cerebral glucose deregulated with micro-bleeds to show (M.R.I.)  The development of cerebral amyloid angiopathy in play to encapsulate this Zoster pathogen gave to patient a further broken brain with a path of more micro-bleeds now in a full active case of cerebral amyloid angiopathy of someone 88 plus years old at only 56 plus. The patient stated that, this report was from his or her neurologist.  The patient was retired at 60. A struggle since 57 years old.  No fluff here just facts.
Five minutes after immunization given, pt appeared to have a vasovagal response, Patient stated he felt nausea and light headed, Nurse laid patient down, raised his legs, checked pulse and breathing P-60, RR-18, Ammonia inhalant given. 911 called.  Patient transported to hospital.  Patient reports that he stopped breathing and was given epinephrine, not sure if it occurred in the ambulance or hospital. d faint,
Within 12 hours of shot: fatigue, chills, intermittent headache, sore upper arm (no swelling or redness).  All lasted for 3 days after the shot. On 4th day, I was completely back to normal.
On 10/10/2001 the patient developed a low grade fever with inguinal nodes. On 10/11/2001 follow up by phone, the patient is doing better, the fever is down, but the patient still has inguinal nodes.
Developed general malaise and low grade fever by the evening time after my second dose at 2pm on a Monday. Took a NSAID prior to bedtime to address fever, experience night sweats due to fever throughout night. The whole next day, Tuesday, experience weakness, malaise and fever, enough so that took the day off from work. Took NSAID to help with fever. By the next day, Wednesday, all symptoms had subsided.
5SEP91 mom reported that for 2 days p/shots recd 1JUL91 PT slept a lot; 3JUL91 PT started to cry a lot-would not sleep >30 min; low-grade T; no vomit; diarrhea on 5JUL91 & 6JUL91; recovered by 6JUL91; MD said was DTP rxn & to only give DT;
Severe headache within 4 hours. Followed by fever, chills,body aches, brain fog and diarrhea lasted for 3-4 days. Also exhaustion lasted 2 weeks. Swelling and rash on left upper arm increased in size each day from first day. Rash and tenderness lasted for a week. My entire upper arm was red and swollen at one point. Then at 2 weeks post vaccination, I was diagnosed with shingles at an urgent care visit.
pain at the back of her neck that shoots to her head; neck was stiff at the right side; pain was sharp at times and kind of radiates to her ears; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METOPROLOL, IBUPROFEN, GABAPENTIN, MELATONIN, SERTRALINE, ATORVASTATIN, AMLODIPINE, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 19-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 NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears). At the time of the report, NECK PAIN (pain at the back of her neck that shoots to her head), MUSCULOSKELETAL STIFFNESS (neck was stiff at the right side) and EAR PAIN (pain was sharp at times and kind of radiates to her ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Vitamins are used as a Concomitant medication also. Ibuprofen used as a Treatment Medication.
Four to five hours after receiving influenza vaccine IM in left deltoid, developed scattered hives on left arm and left side of neck, had pruritis of scalp. She took a dose of BENADRYL and symptoms subsided.
Lymph Knot (Under Armpit); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph Knot (Under Armpit)) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph Knot (Under Armpit)). At the time of the report, LYMPHADENOPATHY (Lymph Knot (Under Armpit)) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  Patient gave his consent for safety to Follow-up.
Patient was given the PNEUMOVAX vaccination. Patient complained of unusual tenderness in her right arm where the vaccination was administered. Patient was in so much pain she was having difficult time even raising her arm. There was no visible swelling or redness noted at site. MOTRIN 800 mg was given and barely affecting the pain level. The lot number for the PNEUMOVAX was H010661.
felt cold; Fever at 100.2; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold) and PYREXIA (Fever at 100.2) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever at 100.2). On 12-Feb-2021, the patient experienced FEELING COLD (felt cold). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date for Fever, at a dose of 500 mg and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 12-Feb-2021, FEELING COLD (felt cold) had resolved. At the time of the report, PYREXIA (Fever at 100.2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 100 (High) 100 F and 100.2 (High) 100.2 at 7 PM. On 12-Feb-2021, Body temperature: 101.3 (High) 101.3 F.         No concomitant medication reported. On 11 Feb 2021, patient started with fever 100 F. Patient took two Advil and monitored her fever at 100.2 and took a Tylenol at 7 PM and 3 AM, during the night felt cold. Fever was 101.3 F and she took Tylenol 500 mg.   This case was linked to MOD-2021-087479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow up received on 12-FEB-2021 contains information about first dose and AE after first dose. On 21-May-2021: Follow up received on 21-MAY-2021 via TCT patient stated she was feeling fine now and has nothing else to report.
Case number PHEH2014US003596 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 09-year-old female child. On 26 NOV 2013, she was accidentally vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly. No adverse event was reported following the administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
STATED HE FELT "LOOPY" STARTING AT 30 MINUTES AFTER GETTING THE VACCINE, HAD DIFFICULTY FOCUSING AND REMEMBERING.  ALSO, FEELING COLD OFF AND ON, SKIN IS COLD.  NO RASH, ITCHING, OR DIFFICULTY BREATHING.  ADVERSE REACTION HAPPENED ONCE BEFORE AFTER A FLU SHOT WHEN HE WAS A CHILD.  HE HAD THE SEASONAL SHOT WITH NO REACTION.  MD ON DUTY TREATED ON SITE CLINIC AND RELEASED.
12 y/o received Varicella and MENACTRA, left office with Mom, 15 minutes later returned to clinic with SOB, wheezing, itching, chest tightness; given 0.3 mg epi, DUONEB and O2 via NC. Discharged after 2 hour observation. SOB, wheeze resolved. O2 sat 99% on RA.
Information has been received from a medical student concerning a 14 month old male who on 01/12/2005 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live subcutaneously.  There was no concomitant medication.  On 01/24/2005, the patient developed an erythematous, raised, urticarial rash on his body two weeks after vaccination.  The rash started on his back and spread to his abdomen, arms and legs.  Some of the lesions had a clear central head.  There was no rash on the palms of the hands or soles of the feet.  The patient was treated with diphenhydramine and the rash resolved the next day.  No product quality complaint involved.  No further information is expected.
Injection pain/soreness for a few weeks following. Woke up approx. 12 hours after injection with all muscle/joints aching causing unable to sleep/get comfortable. Also had mild nausea and temperature of 98', headache tiredness, aching lasting for another 12 hours. Site injection was red and felt hot and continued for some days/few weeks.
The dose the patient was supposed to receive is 0.25mL for the 3rd booster dose in the Moderna series. The dose she received was 0.15mL. Although the CDC recommends that this is considered a full dose because it is more than half of the intended dose, the patient prefers to get the 0.25mL dose again. She will receive this dose today 11/08/2021.
Left arm rash  Narrative:  Patient reports having "COVID arm" (red, hot, itchy at injection site) on 2/6/21 after vaccination on 1/22/21. Reports this has been going on for about 1  week and also involves itching on her head, neck, and shoulders. Reports the rash has not gotten smaller and is still itchy. PCP entered consult for allergist and  recommended Benadryl (unclear dosing) at night if needed for itching. Patient  reports rubbing "medicated lotion" on itches, but unclear what is being used.
how painfully it was but when I took the Pfizer shot it wasn't as bad as others; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: PAIN (non-serious), outcome "unknown", described as "how painfully it was but when I took the Pfizer shot it wasn't as bad as others".  Additional information: Patient have had many people talk about their shots and how painfully it was but when patient took the Pfizer shot it wasn't as bad as others. Age reported was 61.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified the patients of unkonwn age. No information about medical history, drug reactions and allergies was specified. On unspecified dates the patients were vaccinated with doses of VARIVAX (Merck) (lot#, dose, route not reported) that were exposed to a temperature excursion (temperatures of 6 Fahrenheit (F) for 20 minutes) on 15-JUL-2041, that was supported, have been administered to unspecified patients. No concomitant medications were reported. No adverse effects have been observed or reported. This is one of the two reports received from the same reporter (same reporter case 1408USA003916). Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, muscle pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved and the outcome of the muscle pain was unknown. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced substantial flu like symptoms for 24 hours, muscle aches, fever and chills. The reporter agreed to be followed up. This case is linked with US2018GSK173206, reported by the same reporter.
Blood Clot discovered in my leg my Wednesday April 27. Incredible amounts of pain. By May 5 pain caused by unknown bruise on foot on same leg.
small bruise; circular bump in the injection site; This is spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for female patient (reporter's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. on an unspecified date caller stated his mother got the 1st dose this afternoon 05Mar2021, and they want to confirm if his mother can take Tylenol. He stated that his mother had a circular bump in the injection site and a small bruise. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I evaluated patient, following her shot today. She had 2nd dose Moderna at about 11:40 AM. She was complaining of generalized itching, throat tightness, and shortness of breath following her shot.  She has a h/o multiple drug & environmental allergies. She has used an epipen many times before, last was about a year ago for a bee sting. She had her 1st dose Moderna last month and had pruritus and throat swelling, but this feels worse. Last time she took Benadryl here, and was monitored for about 2 hours. She refused an epipen that time or to go to the ED.  On exam, she is mildly anxious, constantly scratching at neck, chest, and lower back. Lungs remain clear, but somewhat diminished. Heart regular. No rash, except for redness from scratching/excoriation.  Patient had her atrovent inhaler and took two doses. She had taken Benadryl & Pepcid around 9 AM this morning.  By 12:20 PM the patient said she was feeling worse. She agreed to treatment with an epipen, which she self-administered. EMS was called, and arrived around 12:35 PM. She was taken quickly to the ambulance  and then to  ED.
Breakthrough case admission after three vaccines Pfizer 1/20/21 Lot# EL3248;  Pfizer 2/10/21 Lot# EL9265;  Pfizer 10/27/21 Lot# EW0186
slight fever, strong body ache for 1.5 days and strong headache for 2.5 days
Fatigue six hours after injection. Chills and fever started ten hours after injection, lasted for three hours. Pain, swelling, hardness and redness began next day near injection site (left arm) and lasted for a few days. Headache also began the day after vaccination and lasted for a few hours. Symptoms were treated with Tylenol.
5:30 am on 10/30 my (L) ear began ringing very loudly. When I got out of bed at 7 am, I could not hear out of my (L) ear at all.