chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (strength, dose, frequency and route were unknown; lot number L046900 with expiration date 23-FEB-2017). Temperature for vaccine was 22 F with duration of 8 hours. The call was not because of a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of the two reports that received from the same source. Additional information has been requested.
The patient presented to me on 8/17/2018 stating that her injections gave her a feeling of unease. She said her face got puffy, but no other symptoms or sign of allergy. When she was speaking with me, she appeared normal and said the symptoms she had been feeling were gone. She had no site reaction on either arm.
body ache; muscle ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills). On 10-Apr-2021, PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills) had resolved.            2 days after the symptom patient drank two cans of Beers. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Night sweats second night after injection; Injection site pain; Extreme tiredness; Muscle pain; Skin pain under clothing; Joint pain; Feeling unwell; fuzzy head; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 21Mar2021 at 13:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included pre diabetes and the patient was having normal body mass index (BMI) for his age. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), fosinopril (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: ep7534) via an unspecified route of administration on the left arm on 25FebMar2021 at 17:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Past drug history also included ELAVIL and CIALIS for which patient developed allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 04:00, the patient experienced injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head. On 23Mar2021, the patient experienced night sweats. The patient was not treated for the reported events. The clinical outcome of the events injection site pain, extreme tiredness, muscle pain, skin pain under clothing, joint pain, feeling unwell and fuzzy head was resolved on 23Mar2021, while that of night sweats was resolved on 24Mar2021.   No follow up attempts are needed. No further information is expected.
COVID booster and Influenza administered at same time, same arm. Pain began 12/14/2021 in back and spread to arm and fingers. Muscle spasms, pain, and weakness in arm and  back . Loss of feeling in thumb, index and middle finger began 12/26/2021. Was prescribed gabapentin and predisone. Seen by dr again on 1/7/22. Prescribed Amitriptyline and told to continue gabapentin and NSAIDs. Referral given for neurologist.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-DEC-2015 at 21:26, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.4 and 6.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Rash on both ankles and wrists; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both ankles and wrists) and PRURITUS (Itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 022C21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash on both ankles and wrists) and PRURITUS (Itchy). At the time of the report, RASH (Rash on both ankles and wrists) and PRURITUS (Itchy) outcome was unknown.            A few days after the first vaccination, the patient got a rash in a band like pattern about 2-3 inches wide on both ankles and wrists. It is itchy, but there were no other symptoms. The rash did not dissipate, and it continued even after she got her second vaccination.  Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.
dizziness; difficulty of breathing; fast heart rate 80bpm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm). At the time of the report, DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (Inconclusive) 80bpm and (Inconclusive) 50bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Experienced dizziness, difficulty of breathing and fast heart rate:80bpm. According to the patient his resting heart rate is only 50bpm.
Cellulitis R arm. Evaluated at ER and treated with KEFLEX with resolution.
Bleeding from private area, went to walk-in clinic vitals were bad. Sent to Hospital, was kept for 7 hours. Was prescribed antibiotics. Vomiting, nauseous.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 11:10. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient did not respond to attempts to contact. No adverse side effects or event as result of dose reported.
Information has been received from a 59 years old female patient concerning herself. The patient had no pertinent medical history. In December 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were not reported) in the left arm. She got the first episode of shingles in March 2013, and started getting another episode of the shingles on Saturday, 16-JAN-2016. She had read an article that sometimes a booster of the ZOSTAVAX was recommended. She sought medical attention via talking to her doctor about the 2 outbreaks she had had after getting the vaccine. She had only been given acyclovir (800mg, 5 times a day) to help with the symptoms of the shingles. The outcome of these events was unknown. Causality was not reported. Additional information is not expected because the physician would not like to be contacted.
My period doesn?t go away and if it does I still spot bleed and my period lasts for a month and a few days now.
Got 1st on 28th Sep 2022, never got the 2nd; After hepatitis b vaccine, did titer and no antibodies were found; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Engerix-B (received first dose on 28-Sep-2022 with lot no. 9255P and expiry date 15-Feb-2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Hepatitis B vaccine. On an unknown date, an unknown time after receiving Engerix B and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: Got 1st on 28th Sep 2022, never got the 2nd) and therapy non-responder (Verbatim: After hepatitis b vaccine, did titer and no antibodies were found). The outcome of the incomplete course of vaccination and therapy non-responder were unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The reporter reported that patient received hepatitis B vaccine (unknown when he was little) and then pulled titer on him did not have anything so they were making him do it again, so patient got first dose of Engerix-B on 28-Sep-2022 but never got the 2nd dose.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Fever began about 10:00 PM 3/23/2021 and ended about 5:00 PM 3/24/2021. Treated with tylenol and ibuprofen.  Intense muscle aches all over body began about 8:00 PM 3/23/2021 and ended morning of 3/25/2021.  Treated with tylenol and ibuprofen.  Glands until arm of injection site were very tender beginning about 10:00 PM 3/23/2021 and improved daily until gone on 3/27/2021.  Generalized fatigue experienced on 3/24/2021, ending by morning of 3/25/2021.
1st HepB vx 2017, 2nd dose Engerix-B 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Hepatitis-B vaccine (received first dose of unknown hepatitis B vaccine at 9 years of age).   On 19-SEP-2022, the patient received the 2nd dose of Engerix B pediatric. On 19-SEP-2022, an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: 1st HepB vx 2017, 2nd dose Engerix-B 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 16-Mar-2023 The reporter told that the patient received series of unknown hepatitis B vaccine when they were younger. The reporter did no consent to follow-up. The patient received the second dose of Engerix-B pediatric later than the recommended interval, which led to lengthening of vaccine schedule.
mom reported pt exp high pitched cry since 10MAY98 & today is 13MAY98;mom did not check temp;pt has lumps to bilat legs from vax;mom has been putting cold wash cloths on both legs to reduce lumps;advised to see MD:pt still cranky;
Constant headache, foggy brain , forgetting things, salty taste from foods, slaughtering  while talking.
devel a swollen area @ inj site of 5 1/2cm, area hard, too c/o pain @ site 23OCT to 12cm, less red, not warm, very sensitive;
pt recv vax;became red,pruritic & hard few hrs p/ inject & remains red & painful;to md tx w/ triamcinolone cream to area;instructed not to have Td again;
Right arm swelling, redness, pain consistent with cellulitis vs allergic reaction after anthrax shot. Started 2 days after shot. Placed on antibiotics, antihistamine, NSAIDs.
my Lichen planus condition has aggravated with nodules appearing in several other parts of my body; nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area; have rash on his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 12:00 (Lot number: ER8732) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lichen planus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 07Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious) with onset Mar2021, outcome "not recovered", described as "my Lichen planus condition has aggravated with nodules appearing in several other parts of my body"; NODULE (non-serious) with onset Mar2021, outcome "not recovered", described as "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area"; RASH (non-serious) with onset 2021, outcome "unknown", described as "have rash on his body". The events "my lichen planus condition has aggravated with nodules appearing in several other parts of my body" and "nodules/nodules on his back/nodules on his scalp/nodules on his hands/nodules on his legs/nodules on his groin area" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lichen planus, nodule.  Additional information: No seriousness criteria were reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. It was reported that patient did not see the nodules before where they appear after vaccination with second dose. Patient applied Clobetasol Propionate Ointment, USP 0.05% to the affected areas twice a day but the growing number of spots and slow recovery this might not be as effective the manage the condition. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies reported. It was reported that patient had an adverse event for Covid vaccine after the second shot and began to have rash on his body. It was reported that patient had lichen planus condition for many years, which was a chronic condition that affects his legs and hands sometimes. Stated that he was treated with Betamethasone twice a day. Stated that he has them on his back, scalp, hands, legs and groin area.   Follow-up attempts are completed. No further information is expected.
Patient is a healthcare worker who received COVID-19 vaccine through her employee health vaccination program. 2 days later, patient developed subconjunctival hemorrhages, then fever, headache, and blisters on trunk. Over the next several days the blisters developed into pruritic pustules including extremities, palms, and soles and patient had increasing joint pain and stiffness in extremities. Patient was seen by rheumatology who thought this may be flare of her psoriatic arthritis or a viral etiology. They deferred treatment with steroids since she was due to receive her 2nd dose of the COVID-19 vaccine soon. Patient received 2nd dose of COVID-19 vaccine and called employee health 2 days later with fever, headache, nausea, swollen lymph nodes, rash spreading to head, and congestion. COVID-19 swab neg. She was seen at an urgent care and diagnosed with pneumonia and was started on doxycycline. Three days later, she presented to the emergency department and was admitted with fever, cough, sob, continued rash (macular and pustular), reported worst headache of life and continued worst arthritis flare of life. Patient was seen multiple times by a variety of clinicians throughout her illness including dermatology, rheumatology, emergency medicine, and internal medicine. Patient had an extensive work-up to identify causes including negative blood cultures, RPR, varicella PCR, respiratory pathogen panel, gonorrhea/chlamydia PCR, HIV, and lumbar puncture with bacterial, viral, and fungal testing. The most common themes of provider assessments were that patient had a psoriatic arthritis flare (worst of life per patient report) which may have been related to the first dose of the COVID-19 vaccine. After 2nd dose of vaccine, patient was diagnosed with guttate psoriasis which was thought to be either related to COVID-19 vaccine or Humira as TNFi has been linked to guttate psoriasis, although Humira was not a new med, and this had not happened in the past.
On 2/5 the right deltoid felt warm to the touch. By 2/6 the area was noted to be warm and red and also extended from the right deltoid to the right elbow. Client brought into ER with his mother. Was prescribed Cephalexin 500mg three times a day. Follow up with PCP on 2/9 in AM. Mother has not looked at site since.
ADVERSE EVENT: MYOPERICARDITIS Patient received 2nd dose of Pfizer Covid-19 vaccine on 10/19/21. On 10/21/21 at 8pm, patient experienced chest pain 7/10 that did not resolve with famotidine. He presented to the ED and was found to have ST changes in V2-V6 and elevated troponins. Patient was taken for an emergency diagnostic cath. The cath did not show any severe stenosis in major cardiac vessels, findings were consistent with probable myopericarditis. Patient was monitored in the ICU for monitoring post cath. He will be medically managed with aspirin and colchicine. Patient is hospitalized at the time of reporting this event.
Patient fainted about 2 minutes after vaccination.  Was awake and alert within 2 seconds after fait and falling from observation chair.
All issues are still present to this day: Fatigue, lethargic,  Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-MAR-2019, the patient was vaccinated with M-M-R II therapy type rHA, intramuscularly, lot # R024906 with expiration date 30-AUG-2020 (dose and frequency) which was reconstituted with sterile diluent (manufacturer unknown) intramuscularly (dose, frequency, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
injection given in right arm, given too low for IM, more probably subq. Knot in arm for 4 days, plus red, hot to touch, continues to have area which is darker in color than normal. Additionally, two days after injection had fever, chills and fatigue.
first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. Other Case identifier(s): MOD-2023-714901 (Moderna).  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Small intestine carcinoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 14Jan2023 patient woke up with the usual big body aches, Fatigue, nausea and vomiting and watery diarrhea, near migraine headache. Non painful Blood coming from rectum for two days that soaked through clothing. Stopped abruptly the 3rd day. Still having significant headaches/migraines, nausea, vomiting and watery diarrhea fatigue. Patient had lost close to 20 lbs in this time frame. Miss-ing work at times. Mostly forging through. Poor quality of life. Patient had viral syndrome. Patient had history of carcinoma of Small bowel. Patient was told patient was one of 3% of people who had these kind of symptoms. Patient was only wanting to know if there was anything to help feel better. Patient was only on medication for hypothyroidism. Stopped supplements other than multivitamin and apple cider vinegar capsules to help tummy. Patient had yearly CT for carcinoma and that was completely clear. Patient never had COVID. Patients first 3 vaccines were Pfizer- first one took me months to recoup from but symptoms were not nearly as bad as the symptoms from this vaccine. This last vaccine was Moderna. Due to the way patient was right now- patient was strongly thinking that patient will not vaccinate again for COVID. At the very least not with Moderna.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax 23JUN95 & 28JUN or 29JUN95 pt devel 3 canker sores clustered in mouth;pt recovered;No further details were provided;