chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOUS HERPES OUTBREAK (ANAL DISCOMFORT, PAINFUL BLISTERS ON LABIA, DISCOLORATION/PUFFY/YELLOW APPEARANCE OF ANAL AREA THAT GOT ITCHY/BURNY AND PAINFUL, HAD ANAL BUMPS, FEVER); DISRUPTED SLEEP (PAIN FROM THE BLISTER WAS KEEPING PATIENT FROM SLEEPING); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included candida, and concurrent conditions included latex allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no history for drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced disrupted sleep (pain from the blister was keeping subject from sleeping). Treatment medications included: paracetamol. On 29-MAY-2021, the subject experienced vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever). On 01-JUN-2021, the subject experienced lower back pain. On 01-JUN-2021, the subject experienced kidney pain in the kidney area. On 01-JUN-2021, the subject experienced profuse sweating. On 01-JUN-2021, the subject experienced body aches. On 01-JUN-2021, the subject experienced freezing cold. On 02-JUN-2021, treatment medications included: fluconazole, and valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain, kidney pain in the kidney area, profuse sweating, and body aches on 04-JUN-2021, had not recovered from vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever), and the outcome of disrupted sleep (pain from the blister was keeping patient from sleeping) and freezing cold was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700.
Patient experienced a rapid heart rate measured at 100 BPM.  Recovered shortly with no issue.
This spontaneous report as received from a nurse practitioner via a field employee regarding a 12 year old female patient. On 18-NOV-2013 the patient was vaccinated with GARDASIL (Lot#J009098, Expiry: 04-DEC-2015) dose 1, intramuscularly. On 19-NOV-2013, the patient presented to the clinic with, black outs, black spots in her peripheral vision, nausea, and vomiting. The patient sought medical attention-office visits. It was unspecified if any treatment was rendered. The outcome of the events black outs, vomiting, nausea and black spots in her peripheral vision was unknown. Upon internal review the event black outs was considered to be medically significant. Additional information has been requested.
temperature excursion; Temperature= -13.9C to -14.7C; This spontaneous report as received from a nurse refers to a 5-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-NOV-2020, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S035110, expiration date: 03-MAY-2021; route of administration was not provided) 0.5 ml (product storage error temperature too high). The vaccine was stored in temperatures between -13.9 and -14.7 degrees Celsius (-14 to -10 degrees Celsius (-13.9 degrees Celsius) for 0 hours 30 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.2 degrees Celsius) for 0 hours 15 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.7 degrees Celsius) for 0 hours 20 minutes and 0 seconds; -14 to -10 degrees Celsius (-14.6 degrees Celsius) for 0 hours 5 minutes and 0 seconds). There was no previous temperature excursion. Digital data lodger was involved.; Sender's Comments:  US-009507513-2011USA001488: US-009507513-2011USA001736: US-009507513-2011USA001846: US-009507513-2011USA001953: US-009507513-2011USA001966: US-009507513-2011USA001975: US-009507513-2011USA002208: US-009507513-2011USA002225: US-009507513-2011USA002242: US-009507513-2011USA002568: US-009507513-2011USA002572: US-009507513-2011USA002578: US-009507513-2011USA002620: US-009507513-2011USA002622: US-009507513-2011USA002642:
32 yo female who felt well when she received AVA dose #1 in Aug 2005. The next day she developed headache, fever to 102.0 and chills. On post vaccine day (PVD) 2-3 fatigue and nausea began in addition to the initial symptoms. She was seen, told to consider herself allergic to AVA with permanent exemption and given 2 weeks in quarters. On PVD 3 the sensation of burning skin began, "like a sunburn", but without the redness of rash. It was over her entire body. She stayed in quarters for the two weeks when all of the symptoms had progressively resolved to where she felt well again. She deployed the following month. Upon return from deployment in Mar 2006 she began having ocular migraines where she had episodes of blindness lasting 15-20 minutes, occurring about once a month. She was diagnosed with ocular migraine and has learned behaviors that have decreased the frequency. In 2006 she also developed episodes of diplopia unrelated to the ocular migraines. It increased in severity until she could not see to drive. She has recently seen a neuro ophthalmologist who diagnosed optic neuritis and cataracts and suggested that AVA might have caused it. She was informed that optic neuritis can preceded autoimmune disease such as MS. Her rheumatology workup was negative. She is concerned though, because her grandmother developed MS at age 32, the same age as the patient. She suffered a head injury as well prior to onset of diplopia. Lasik surgery could treat her conditions, but the VA does not cover it.
Upper arm pink to deep pink, hot, pimply, itchy,  Ice packs, benadryl tablet, benadryl liquid spray to site, lasted about 5 days,   two weeks later, electric shocks from trigeminal  nerve radiating from lower left jaw upward to eyetooth are
Herpes infection; Jaw pain; Neck pain; Spike in fever that reached 102°F; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes infection), PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F) and VACCINATION SITE PAIN (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 29-Apr-2021, the patient experienced HERPES VIRUS INFECTION (Herpes infection). The patient was treated with FAMCICLOVIR (FAMCLOVIR) at a dose of 250 mg twice a day. On 24-Apr-2021, PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-102902 (Patient Link).
(R) thigh became swollen and pt had a lump complained of pain RT measured 28cm LT measured 24cm.
patient receiving additional doses of the Moderna COVID-19 vaccine.; patient received "not real vaccines"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health professional and describes the occurrence of OVERDOSE (patient receiving additional doses of the Moderna COVID-19 vaccine.) and PRODUCT SUBSTITUTION ERROR (patient received "not real vaccines") 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (patient receiving additional doses of the Moderna COVID-19 vaccine.) and PRODUCT SUBSTITUTION ERROR (patient received "not real vaccines"). At the time of the report, OVERDOSE (patient receiving additional doses of the Moderna COVID-19 vaccine.) and PRODUCT SUBSTITUTION ERROR (patient received "not real vaccines") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported
mom states pt has red, swollen, not area @ site of inj from vax; no inc temp is giving APAP q 4hrs; took to MD AM; told it was rxn to pertussis & doesn't want pt to get pertussis again;
injection site is red, warm to touch, itches, area is size of $1 piece.
I started getting fever, chills, joint pain and weakness. I started getting chest pains.  I went to Urgent Care they did an EKG, it was not right so they ambulance me to the hospital. I was in ER and they admitted me and kept me overnight.  They ran test with die, and it showed inflammation of my heart. They gave Lipitor and Colchicine and they had me take an Aspirin high dose twice daily.
Initially she felt flushed and "foggy-headed". Then developed a metallic taste in mouth and elevated blood pressure, required extended monitoring period with continued elevation in blood pressure.  Heart rate and respiratory rate stable, no respiratory distress noted.   Highest BP 195/93 ranging 180s/90s, however denied need to be seen in emergency department. Final BP 155/93, less foggy, no dizziness or lightheadedness; feeling flushed remains however, declines emergency treatment. Total monitoring time: 83 minutes, without significant distress.
piriformis muscle began to crap; pain from her hip down to her toes; squeezing on the sciatic nerve.; does not have any feeling in her toe,; nerve pain; gain some ability to walk again with the assistance of a cane; Hip Pain; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,) and NEURALGIA (nerve pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE), LOSARTAN, METOPROLOL, ESTRADIOL, IBUPROFEN, METFORMIN and MEDROXYPROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (Hip Pain). On an unknown date, the patient experienced MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain) and WALKING AID USER (gain some ability to walk again with the assistance of a cane). The patient was treated with GABAPENTIN (NEURONTIN) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL ARTHRITIS) ongoing since an unknown date at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) ongoing since an unknown date at an unspecified dose and frequency; CYCLOBENZAPRINE (oral) ongoing since an unknown date at a dose of 10 milligram; IBUPROFEN (oral) ongoing since an unknown date at a dose of 600 milligram; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain), WALKING AID USER (gain some ability to walk again with the assistance of a cane) and ARTHRALGIA (Hip Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had an MRI, the results of which were not stated.  Treatment medications also included Spinal injections and muscle relaxers.   This case was linked to MOD-2021-214904 (Patient Link).
fever; chills; This is a spontaneous report from a contactable Other Health Professional. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that he reports a fever that started Tuesday night, 26Jan2021, and persisted for the next day, along with chills. He reports he is feeling much better, today. He also went for a PCR rapid-Covid test, that was negative. To take the 2nd dose- it says 21 days. The place that we got the shot it says 17 to 21 days-CDC site says do not take before 21 days. The outcome of the events was reported as recovered on an unspecified date in Jan2021.  Information about Lot/Batch has been requested.
1 inch diameter red rash around injection site that was unresolved at time of second covid-19 vaccine administration The patient described the reaction as a purple area around injection site after first injection and then improved to the red rash that I observed at second injection.
Flu-like symptoms flushed, warm, body aches, headache, and a swollen mass on right ankle bone.  All symptoms resolved by 1PM the next day except the ankle mass.
This was a booster shot.  Normal sore arm next day.  At day three, my upper arm muscle became inflamed, causing severe pain and considerable loss of range of motion.  For example, when trying to lift my arm up to the side, I can go no further than slightly above waist level.  Raising it forward, it is at about 70 degrees.  I cannot reach across my body to wash my back or pull my seat belt across.  I cannot pull a T-shirt over my head to take it off. My GP gave me anti-inflammatory medication and ordered physical therapy.  It is going to be a long haul.  After more than a month of therapy, the muscle remains inflamed, swollen, and painful, my arm has not lost strength, but my range of motion is severely restricted, and pain at a low level is constant, with very severe, sharp pain if I  try to use the arm suddenly. or sleep on it wrong.
a child was administered Quadracel after they had turned 7 years of age with no reported adverse event; Initial information received on 23-Nov-2022 regarding an unsolicited valid  non-serious case received from  other health professional.  This case involves a 7 years old female patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] after they had turned 7 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine inact (Havrix) for Immunisation.  On 21-Nov-2022, the patient received 0.5 mL total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (formulation and strength not reported; lot U75268A and expiry date: 07-Sep-2024) via intramuscular route in unknown administration site for prophylactic immunization.  On 21-Nov-2022, the patient who was a child was administered quadracel after they had turned 7 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, a child was administered QUADRACEL after they had turned 7 years of age. This situation is reported as a medication error due to the patient not being in the age range of 4-6 years as stated on the label.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient tested positive for COVID-19 on 11/20/2021.  Patient was exposed to someone with COVID-19 on 11/13/2021. Patient had headache on 11/20/2021. At the time of this report, patient has been asymptomatic since 11/21/2021..
Patient hospitalized for C-section within 6 weeks of receiving COVID vaccination. She had an uncomplicated postoperative course.
At first I had gurgling in my stomach but after the 3rd day I had a blood flow for about a week. On 3/5 I set up an appointment and was set up for an Ultrasound on 3/19 and was diagnosed with Endometrial Hyperplasia. Biopsy suggested but with past complications with medical history opted to seek second opinion. Will be seeing my PCP in Jan for Gynecologist referral.
This spontaneous report as received from a registered nurse refer to patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II, lot # K000737, expiration date:16-JAN-2016 (strength, dosage, frequency and route unknown) which was temperature excursion. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient began to have itching all over starting 15 minutes after her vaccine.  She then complained about having throat tightness and feeling faint and nauseous. 911 was called at that time for further evaluation.
Severe generalized muscle and joint pain, migraine, weakness, exhaustion.  Symptoms gone within 24 hours of onset.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M019232, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. These vaccines were exposed to 28 degrees Fahrenheit for 14 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea; temperature; body ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache). At the time of the report, NAUSEA (Nausea), PYREXIA (temperature) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not provided.
Information has been received from a physician concerning a 13 year old female who in July 2008, was vaccinated with the first dose of GARDASIL.  Concomitant therapy included FLONASE and PROVENTIL.  After getting the first dose (onset date reported as January 2009), the patient experienced pain in hands, stomach ache and headache.  Magnetic resonance imaging (MRI) was performed but the result was unknown.  At the time of reporting, the patient's pain in hands and stomach ache and headache persisted.  The patient will not be taking the second and the third dose of GARDASIL.  Additional information has been requested.  5/27/09 Received vaccine & PCP medical records of 1/22-2/17/2009. Records reveal patient experienced tremor of both hands x 2 wks when seen on 1/22.  Neuro exam WNL.  Tx w/meds.  RTC 2/17 w/right wrist pain, tx w/splint & ice. No further records available.  5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. FINAL DIAGNOSIS: None Provided. Post vaccination intermittent shaking of hands. Headaches. 'Dry heaves' stomach pains.   6/1/09 Received Neuro consult records of 3/9/09. FINAL DX: accentuated physiologic tremor; cervical myofascial pain w/intermittent occipital neuralgia; muscle tension-contraction cephalgia w/vascular overlap.  Tx w/meds & referred back to PCP.
One day post vax, the pt developed a full body rash. She was treated with oral Benadryl and the rash subsided after one week. A similar rash reappeared two weeks later and persisted for another 1-2 weeks. During this time period, she was seen by a physician who had no definite dx. After her physician visit it was determined that an outbreak of "Fifth Disease" was happening at her school.
information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H022280, expiration date: 16-JUL-2014 (dosage and route unspecified). PNEUMOVAX23 had not been exposed to any temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT EXPERIENCING NORMAL VACCINE REACTION. FLU LIKE SYMPTOMS/FEVER/CHILLS FOR 2 NIGHTS. INABILITY TO CONCENTRATE
Patient came in for 3rd HPV on 9/30/14 and explained to nurse that one day after last shot he got a rash about 4 inches wide around injection site. The rash lasted for a few days and went away.