chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was age 67 when she received the immunization; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy (Splenectomy (spleen removal )) and distal pancreatectomy. Concomitant products included MENQUADFI and insulin aspart (Insulin Novolog).   On 14-AUG-2023, the patient received Bexsero. On 14-AUG-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: She was age 67 when she received the immunization). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-NOV-2023 The reporter was the patient. The reporter reported that she did not have the lot number of Bexsero. The reporter reported that Bexsero was approved for use in individuals aged 10 through 25 years and she was over the recommended age.  The reporter did not want to share her doctor of medicine (MD) contact information with GlaxoSmithKline. The patient received a dose of Bexsero above the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Patient woke up feeling feverish, headache and bilateral rib aching and upper abdominal pressure.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
pt exp inc temp x 3 days,up to 103 oral (102 mean) w/chills,vomiting x 2 days,body aches;given Ibuprofen,compazine supp;
Developed about 150 vesicles over a period of 24 hours; C/o itching; ST, fever
after he had the first dose, he had like a burst of energy/He came home and had tons of energy; little itchy on his stomach; the next day he just crashed/was tired/exhausted/Felt completely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Hypertension, Migraine, Hypokalemic periodic paralysis (it's a condition that causes extreme muscle weakness, he probably had it since a kid, sometimes they call it dead sleep,he has liquid potassium and liquid magnesium in his hand, and when he feels it coming, he can feel his muscles weak, and he would mix that with juice and then feel better, and then take it again after an hour) and Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for Asthma, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY XR) for Diabetes, LOSARTAN for Hypertension, ROSUVASTATIN CALCIUM (CRESTOR) for Lipids, ALPRAZOLAM, TADALAFIL (CIALIS), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR), DULAGLUTIDE (TRULICITY), OMEPRAZOLE, METOPROLOL TARTRATE, FINASTERIDE, ZOPICLONE and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted). At the time of the report, ENERGY INCREASED (after he had the first dose, he had like a burst of energy/He came home and had tons of energy), PRURITUS (little itchy on his stomach) and FATIGUE (the next day he just crashed/was tired/exhausted/Felt completely exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. Reporter provided concomitant Metoprolol tartrate  indication for Heart.  As the patient is suffering from hypokalemic periodic paralysis, he  states that  is the reason why he can't take certain medications anymore: azythromycin , prednisone triggers the condition   This case was linked to MOD-2021-356037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non-significant Follow-up
20 y/o AA male ADSM/Specialist is referred to FBVHC by SRC physician for smallpox vaccine inoculation site concerns.  R/O satellite lesions versus autoinoculation.  Symptoms:  Flu-like symptoms<96 hours, lesions, papule.
10/8/14 Progressive weakness and parethesias in her hands and feet". Unable to walk to the bathroom 10/9/14. 10/12/14 severe back pain, increased weakness, trouble swallowing. Intubated 10/14/14.
History of Present Illness 78 yo male who presented for SOB and fatigue and malaise x 4 days. he reports testing positive for COVID yesterday. He reports fully vaccinated. In the ED, patient had CXR which was unremarkable. Labwork unremarkable. Per ED notes, he was admitted due to exertional dyspnea.   Patient seen in the room this AM, he is on room air, NAD. He states he feels better as far as his fatigue and is mainly complaining to me of LLQ abdominal pain that is worse with coughing and states he needs to curl up in a ball in order to help with his pain when he coughs. Denies fever, chills, chest pain, shortness of breath, nausea, vomiting, urinary/bowel symptoms.
Patient presented to the ED on 4/28/2021, 5/9/2021 for Complex tear of medial meniscus of right knee. Patient presented to the ED on 5/11/2021 and 5/14/2021 for  Septic arthritis of knee and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Patient receive Flu vaccine and develop fever within 24hours. On 3-28-18 patient had cough and URI symptoms.
An expired dose of MMRV (Proquad) administered to patient.  Dose expired 4/6/23.    Contacted CDC and Merck for guidance.  Per CDC and Merck, no expectation of patient harm.   Dose potency potentially diminished.   Consider additional booster at least 4 weeks after administration date.  Log dose as invalid.  Administering medical professional attempting to contact patient parent to advise and schedule appointment  to reimmunize with additional booster of MMRV after 4 weeks.
Small red area developed 2 days after injection on my arm at the injection site. On day 5, I woke up with a sore throat. On days 6-9 I continued with a sore throat and developed runny nose and congestion. On day 6 after the injection I had a rapid covid test (non pcr) that came back negative. 9 days after the injection the red area on my arm at the injection site grew in size and continued to spread around my arm over the next 3-4 days. Spot was bright red and hot and itchy at times. Spot was tender if poked but otherwise not painful. On day 10 after the injection I woke up with a dizzy spell that lasted approx one hour. I was prescribed antibiotics on day 12 after the injection for concern of cellulitis. I never had fevers but I did have an episode of chills the night of  day 12 after one dose of keflex.  As I took the antibiotic, the spot decreased in redness and size within 48 hours. I took 500mg keflex two times a day for 7 days. I finished the antibiotic last night. The area is not as red, but looks more like a faded bruise. I read a story about ?covid arm? from USA today this morning about similar reactions and wanted to report my experience. I am a social worker in a primary care office that has been working remotely up until this point.
Patient reports having a high fever for approximately 48 hours and feeling ill. His wife believes he was having hallucinations - patient claims to have had spoke to his deceased sister during the time of the high fever. Patient reports feeling much better today when I spoke to him.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 13-JUN-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and Ramsay Hunt Syndrome, a neurological disorder caused secondary to zoster infections. The patient also reported hearing loss and nonpulsatile tinnitus since being vaccinated with ZOSTAVAX (exact onset dates unknown). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Ramsay Hunt Syndrome and hearing loss were determined to be medically significant. Additional information has been requested.
little pain where shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "she was ok". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little pain where shot was given".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 29JUN95 & w/in 1hr of vax pt devel a sl SOB & tongue felt sl enlarged as if burned from hot food;it was reported that these sensation started diminishing approx 3hr later;
The patient did not experience any symptoms; Improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions/allergies were not reported. On 20-DEC-2019, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of one dose (strength, route of administration and anatomical location were unknown) with lot # S005251 and expiration date 20-FEB-2021 for prophylaxis. The patient did not experience any symptoms. The vaccine underwent a temperature excursion of 47 degree Fahrenheit or 9 degree Celsius (55.44 degree Fahrenheit) for a time frame of 5 hours. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint associated with the case.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient's medical history included chicken pox. On 06-AUG-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number was reported as K000550 with expiry date of 24-JAN-2015. Concomitant therapies included ZYRTEC. On 06-AUG-2014, the patient developed red and raised area at the injection site that is approximately 25mm by 50mm in size. She felt nauseous, drowsy and had been vomiting. The patient sought medical attention. No treatment has been given for the event and no lab was performed. Nurse practitioner reported the patient mentioned she thinks she had chicken pox in the past and received (Oka/Merck) VARIVAX because she has negative titers. Nurse practitioner provided the lot number and expiry date for the sterile diluent that was used to reconstitute (Oka/Merck) VARIVAX as J005350/ expiry date January 2016. The outcome of drowsy, vomiting, nauseous and red and raised area and injection site was reported as not recovered/not resolved. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hemochromatosis" (unspecified if ongoing); "HBP(controlled and stable)" (unspecified if ongoing); "Known allergies: sulfite preservatives" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN; DULOXETINE; TELMISARTAN. Past drug history included: Known allergies: sulfites, reaction(s): "Known allergies: Sulfites". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks. COVID 19 Treatment with Paxlovid from 19Feb2023 to 21Feb2023, lot number: gf8462.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
little a soreness in the arm like when he gets the Flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Lot number: ER8732) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, reaction(s): "little a soreness in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little a soreness in the arm like when he gets the Flu shot".  Additional information: Patient stated that he had no reaction for the vaccine except for the event. He asked if there was a website where he can have searched for the expiration and manufacturing date of the vaccine.   No follow-up attempts are possible. No further information is expected.
Enlarged Thyroid on left side the same side as the shot. I will be having a test done on March 10 to extract fluid from nodules at hospital.
?Break through? bleeding (vaginal bleeding between periods). Patient has not experienced bleeding in between periods since starting oral contraceptives over 4 years ago
Broke out in severe hives, turned bright red over entire body.  Still experiencing symptoms.  Went to ER.  Treated with  Prednisone, and Antihistimines.  Came home with medpack (cortisteroid) and antihistimines.
pt recvd vax on 7DEC92 & was inconsolable all noc; had temp during noc; 8DEC t100.2, pt more comfortable resting; no treatment occurred;
Lost sense of taste; Lost sense of smell; Chest tightness; upper back pain; light congestion; tiredness; headache; muscle pain; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient reported himself). A male patient of an unspecified age received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL9261) via an unspecified route of administration on 22Jan2021 03:30 PM to left arm at single dose for covid-19 immunization. The patient's medical history and known allergies were reported none. Concomitant medication included diphtheria vaccine toxoid/tetanus vaccine toxoid (TD) on 09Jan2021 to his left arm (other vaccine in four weeks). No Covid prior and post vaccination. On 23Jan2021 06.00 PM, the patient experienced chest sightedness/upper back pain, light congestion, tiredness, headache, muscle pain, chills and feeling unwell; on 26Jan2021, lost sense of smell, and on 28Jan2021 lost sense of taste. The patient did not take any treatment in response to the events. Outcome of the events was recovering.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Injection site redness noted, rock hard, warm to the touch. That developed the evening after his D.V in AM. For injections on pt's (L) thigh only.
Headache; fatigue; fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in arm left on 17Feb2021 12:30 (at the age of 31-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Patient had no Known allergies. Patient did not have covid prior vaccination. Patient did not have other vaccine in four weeks. Patient was not tested for covid post vaccination. Concomitant medications included levonorgestrel (MIRENA); spironolactone (SPIRONOLACTONE) 25 mg tablet; escitalopram (ESCITALOPRAM) (Other medications in two weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 27Jan2021 12:30 (at the age of 31-year-old) at dose 1, single for covid-19 immunisation. On 18Feb2021 03:30 the patient experienced headache, fatigue, fever, chills, muscle aches, nausea. Patient did not receive treatment for the adverse events. Out-come of the events was resolved on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Fever, chills, body aches that started about 18 hours after the shot was administered. The symptoms lasted about 12 hours. I took Tylenol throughout the day to battle the fever, when the Tylenol wore off the fever spiked again. Fever was around 102 degrees Fahrenheit. Had soreness in the arm from the injection that lasted 2-3 days.
pt fell asleep noc p/shot & had salivia on side of mouth & woke up 10 mins later; no problems p/that;
The right arm pain is overwhelming and even worse; Could not even sleep last; Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse), MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist), ANXIETY (Anxiety) and INSOMNIA (Could not even sleep last) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Anticoagulant therapy since 1994. Concurrent medical conditions included Heart valve disorders since 1994. Concomitant products included WARFARIN SODIUM (JANTOVEN) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse) and INSOMNIA (Could not even sleep last). In April 2021, the patient experienced MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist) and ANXIETY (Anxiety). At the time of the report, PAIN IN EXTREMITY (The right arm pain is overwhelming and even worse) had not resolved and MUSCLE SPASTICITY (Cannot lift her right arm and cannot extend her right arm outward without using her other arm to assist), ANXIETY (Anxiety) and INSOMNIA (Could not even sleep last) outcome was unknown. Not Provided          Treatment for the events included acetaminopehen and a wet compress on her right arm. Patient reported that the band-aid placed after the second dose is quite high and more toward the back of the arm and wonders if the second dose may have been incorrectly administered into her shoulder. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD21-071731, MOD21-071816, US-MODERNATX, INC.-MOD-2021-071441 (E2B Linked Report).; Sender's Comments:  MOD21-071731:MOD-2021-071191  1st dose case MOD21-071816: US-MODERNATX, INC.-MOD-2021-071441:crosslinked
2 hours after vaccine - high fever, fever continues with vomiting. 7 hours after inconsolable, continues. Seen again 24 hours after vaccine, no treatment.
pt recv vax 4DEC95 & 6DEC95 devel an itchy allerg rxn on both upper & lower arms on the inside of wrists there was a red rash;7DEC95 eyelids & lips were swollen, red & itchy as was face;rash changed to hives;
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (Body aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.
Pt was given 2 Men B . Pt had some soreness and mild redness the day after. Pt was advised otc pain med if needed and cool compress.
Fully vaccinated with Covid19 Moderna EUA 04/29/21-05/27/21
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 8/5/2022,  3/17/2023,  2/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Child was in for flu vaccine 12-11/06 approximately 12 noon mother phoned clinic 12-13/-06 related child had a febrile seizure @ 0 PM 12-12-06. Child's last seizure was a year ago after last flu shot mother reported. Was told not to withhold flu vaccine as he underwent testing for his seizure and was found to be normal. This recent seizure was a grand mal lasting 10 minutes. 12/27/06-records received and reviewed. per parent experienced seizure. Temp not recorded. HX of seizure 1/17/2006 after MMR vaccine, temp in ED on 1/17/2006- 104 (R).