chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DRUG EXPOSURE DURING PREGNANCY; MULTIPLE VACCINE DOSES; OFF LABEL USE; SKIN DARKENING; BURNING NOSE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.The batch number was not reported and has been requested.  On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. On an unspecified date, the subject experienced drug exposure during pregnancy, multiple vaccine doses, off label use, skin darkening, and burning nose. The date of the subject's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin darkening, and burning nose, and the outcome of multiple vaccine doses, off label use and drug exposure during pregnancy was not reported. This report was non-serious.
Patient woke up freezing under her covers and was shaking, she tried to get warmer and realized she must have a fever because she couldn't get warmer. She felt her face with her hands and it was burning up so she knew she had a fever. She got up to take TYLENOL for the fever. When getting out of bed, she was shaking violently from the chills more than she had before and could hardly walk. She got to the TYLENOL and dropped some and after she had taken 2, she headed back to the bed, still wobbly from the chills and eventually went back to sleep. The next morning she woke up with a headache and felt awful and took 2 more doses of TYLENOL and felt okay by the next evening.
Information has been received from a physician concerning a 35 year old female pt who in "spring" of 2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast).  Just after the second dose, the pt began to develop a rash on her arms and legs that appears about 2 hours each day then resolves.  No product quality complaint was involved.  Unspecified medical attention was sought.  Additional information has been requested.
Patient was in observation post vaccine and pharmacist saw patient looking different and began to call out SIr Sir as pharmacist was making way to chair when patient fell forward onto floor and hit his head on a display of cold medicines.  Pharmacist and another associate helped patient up who was conscious. He asked what happened and if he were standing.  He shared that everything went pitch black.  He was placed on chair; pharmacist asked if he wouldl like to lie down and he declined. He stated he had felt nervous and scared about imz before his appointment. Patient did cut his lip in fall and was given napkins for bleeding and a cold compress for face and neck. Patient waited with us for 2 hours. His BP was 154-74 and pulse of 54 ; patient stated he was a runner with low pulse. Patient arranged for a ride from family member since he lived far and was not sure about driving. I recommend that he place a call in with his provider.
Information was received on 05-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 18-FEB-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain condition of herpes zoster and post herpetic neuralgia. On or about 31-MAY-2016, the patient was treated by a physician's assistant and a physician, for a blistering vesicular outbreak and stabbing pain in her ears which was then diagnosed as severe herpes zoster, or shingles. On or about 08-JUN-2016, the patient has worsening and uncontrolled symptoms, and called her medical team for treatment of severe pain. On or about 15-JUN-2016, the patient was treated by a physician for new and worsening symptoms of shingles, accompanied by facial drooping and difficulty talking and swallowing. The patient was then diagnosed with Bell's Palsy, secondary to zoster infections. On or about 29-JUN-2016, the patient was treated by another physician for worsening neurological symptoms of herpes zoster and Bell's Palsy. On or about 08-AUG-2016, the patient received subsequent treatment from a physician for continued complications of facial paralysis. On or about 28-OCT-2016, the patient was treated by a physician, who then diagnosed her with post-herpetic neuralgia, a chronic condition of nerve pain and permanent damage secondary to shingles outbreaks. The patient continues to seek treatment from a neurology team for treatment of her worsening Bell's Palsy condition. For management of her outbreaks and complications, the patient has been prescribed VALTREX, gabapentin (manufacturer unknown), prednisone (manufacturer unknown), pramoxine (manufacturer unknown), tretinoin (manufacturer unknown), ciclopirox (manufacturer unknown), PRAMOSONE, ZONALONE, doxepin (manufacturer unknown), HYTONE 2.5% and TEMOVATE, at increased dosages, in attempts to curb her painful symptoms. 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, Bell's Palsy was considered medically significant. Additional information has been requested.
myocarditis with chest pain, 12 lead ekg abnormal for peaked t waves, cardiology consulted and patient to take NSAIDs to treat.
Left upper arm tenderness after receiving injection & then over course of 2-3 hrs she noted warmth, erythema & swelling with hives on left upper arm radiating to her neck & right arm. Denied respiratory symptoms. Treated in ED with po BENADRYL & steroid taper.
Information has been received from a medical assistant referring to a 14 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 17-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019)  (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776: US-009507513-1709USA012774:
Highest temp measured 104 R, local rxn @ inject site, screaming episode lasting greater than 3 hrs; tx 3MAR91 for BOM;
Patient complained she had soreness and was painful and unable to move her arm. Patient was advised to apply ice to the affected area and to take a pain reliever.
pt recvd flu vax & 1 month later pt was treated for an abscess; pt was given Keflex & has been advised to receive physical therapy
Respiratory swelling: asthma attack was stopped by albuterol inhaler. It lasted about 12 hours.
Extreme pain.  Within a few hours I was unable to lift my arm.  That evening I tried ice - did not help.  Entire bicep area felt bruised and swollen for 3 days.
Roughly 24-30 hours after booster shot was administered, I developed a sharp pain in the underarm below the site of injection, my right arm. Having had this pain before, I knew it was most like a case of swollen lymph nodes, and internet research lists that swollen lymph nodes by the site of injection is a possible side effect.
Pt developed quarter-sized hard lump on lt leg 4JUN91; Seen in ER; tx Duracef;
Numbness in lips; Numbness in lips and extremities; The patient received third/booster dose; The patient received third/booster dose; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included unspecified blood pressure medicines from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced numbness in lips and extremities that lasted 4 days post third dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness in lips and extremities was resolved on 11Oct2021, after the duration of 4 days. The events numbness in lips and extremities occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Moderna COVID-19 Vaccine EUA - I started having irritation at the injection site more than a week after the injection. Immediately following the injection, the site was slightly sore, but that went away in about 36 hours. Then, more than a week later, the injection site became itchy, blotchy, and slightly warm to the touch.
Pt reported on phone 6 inch streaking and Red line From inj site (3 in both Directions) plus heat, warmth, pain, Flu like symptoms. Advised patient to go to walk in clinic or urgent care and to F/U w/PCP. Also to use Ibuprofen and cool pack, possibly Benadryl if worsening allergic reaction
Cough, fever and decreased appetite since vaccine was given. Treatment required hospitalization for respiratory distress per dr. Likely one night. Pt received nebulizer with albuterol treatment.
Pain and swelling Right arm with redness and warmth along with knot size of an apple.
HCP reported pregnant patient received VARIVAX and experienced a rash. Patient received vaccination on 09/19/2023 and noticed rash that appeared the evening of vaccination. No additional details provided. Reported patient also received MENQUADFI vacc; HCP reported pregnant patient received VARIVAX; This spontaneous report was received from Other Health Professional and refers to a 31-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI).   On 19-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X007373, expiration date: 12-MAR-2025 (strength, route of administration, and indication were not provided).  On 19-SEP-2023, HCP reported pregnant patient received VARIVAX and experienced a rash. Patient noticed rash that appeared the evening of vaccination. No additional details provided. Reported patient also received MENQUADFI vaccination on the same day in the same arm. See case 02477021. VZVIP information packet was emailed to HCP. No additional AE/no PQC. At the time of reporting, the patient had not recovered from the event rash. The action taken with VARIVAX regarding rash was reported as Not Applicable.   The causal relationship between rash and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Severe chest pain; Severe back pain between shoulder blades; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 11Apr2021 at 14:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 21Mar2021 at 13:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:30, the patient experienced severe chest pain and severe back pain between shoulder blades. The patient did not receive any treatment for the events. The clinical outcome of the events severe chest pain and severe back pain between shoulder blades were unknown.   No follow-up attempts are needed. No further information is expected.
Headache A severe feeling of burning on my facial skin and a flushing of the skin   My forehead felt as though I had a severe sunburn    A slightly elevated temperature: normal is 97.3  elevated 98.6 All day 02/01, Partial day 02/02,  Redness gone and feeling of burning less severe 02/03 and 02/04.    02/05 a couple of  episodes  of sensation of facial burning  and slightly elevated temp
Warmth, discharge, fever, red streak from left side, redness, swollen area around site on left thigh - cellulitis. Treated with Augmentin 2 times a day for 10 days.
Pt recvd 1 dose of Engerix-B the adverse event includes the sx that eye can't close; tx Pred; pt referred to neurologist;
positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER2613), on 16Apr2021 as dose 2, single (Lot number: EW0151), on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Jun2022 as dose 4 (booster), single (Lot number: FN7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Allergy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2023, outcome "recovered" (25Oct2023) and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive; (25Oct2023) Negative. Therapeutic measures (Paxlovid therapy start date: 19Oct2023, Stop date 24Oct2023) were taken as a result of vaccination failure, covid-19. Clinical course: Patient was initially positive for Covid on 17Oct2023. Tested negative on 25Oct2023 felt pretty good except tired until 27Oct the late afternoon when she started feeling sick again and then tested positive at night.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350940 same patient, different drug and AE;
pt recvd vax; pt broke put in rash on chest,back, face; md felt that rash could be chicken pox;
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- HYPOTENSION 3/31/2023 GI HEMORRHAGE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/31/2023 GI HEMORRHAGE HYPOXIA 4/21/2023 GI HEMORRHAGE
Employee stated she began to have hives on her lower torso & legs approximately 24 hours after injection. Stated she was treated by her HCP for unrelated infection also.
On Feb 1 2021 I started losing my facial beard in patches. On Feb 19 2021 facial beard was almost completely gone. On Feb 22 2021 I received my 2nd covid 19 Moderna vaccine. In Mar 2021 through June 2021, my facial and head hair continued to disappear. By July 5 2021 there was NO hair left on my face or head. I continued to lose hair on my body and as of Aug 11 2021 there was NO bodily hair anywhere. Feb 8 2022 my hair does not appear to be coming back in. There are no stubbles of hair anywhere on my body.  Beginning Feb 1 2021 pictures were periodically taken on the hair lose. There have never been any signs or symptoms of having had COVID19 before or after the vaccines.
Headache, Myalgia & Arthralgia Narrative: Took Tylenol and Thera-flu for symptoms.
Pt. reports fever, severe headaches, eyes sore, draining ears, SOB, back pain, "knots" under skin.  States she had CAT scan of head due to severe headaches to r/o tumor - no tumor.  Had biopsy of "knot" on side of head that was Dx as keratosis.  States she has remained dizzy and still has severe headaches.
This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-OCT-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) (VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY 8/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
102-103 F fever, severe headache, chills  a day after receiving the second dose of the Moderna Covid 19 vaccine. Fever broke overnight and no headache or chills returned.
Clients guardian called on 8/3/16 reporting (R) leg was swollen had a temp of 101.0 and was vomiting. 8/4/16 temp 99.5 (R) leg near inj. site red, swelling had gone down then increased. After phone call came to office measured about 7 in diameter reddened area, reported on 8/3/16 had vomited 3 times.
This spontaneous report as received from an office manager refers to a patient of unknown age. On an unknown date over one year ago the patient was vaccinated with GARDASIL (lot#, expiration date, dose, route, indication not reported). The patient might have received the 2nd dose of GARDASIL late. No adverse effects reported. Additional information has been requested.
Hives, itching, nausea, weakness & epigastric burning; treated in ER w/DPH & steroids & given script for same; Resolved;
He can't walk on his own and he can't do anything on his own; my healthy father walked in to get the vaccine and has not walked out yet; This is a spontaneous report from a contactable consumer reporting for their father (patient). A 73-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 73-years-old, via an unspecified route of administration on 02Feb2021 (Batch/Lot number and expiry date were not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported) on an unspecified date for covid-19 immunisation. The patient experienced he can't walk on his own and he can't do anything on his own; healthy patient walked in to get the vaccine and has not walked out yet on 02Feb2021. The patient was hospitalized for the event from 02Feb2021 to an unknown date. The patient underwent lab tests and procedures which included laboratory test: unknown results on an unspecified date. The outcome of the event was unknown.  Information about Batch/Lot number has been requested.
I had no side effects with the first dose on 3/17/2021.  A Severe rash from head to toe, benedryl, topical cream, vinegar wash - no changes in rash  Went to the Doctors office, didn't seem to know except it was an allergic reaction, suggest to see Dermatologist.
Elevated fever with hallucinations and episode of increased topical reaction (swelling, erythema); pt unable to move arm (left arm). On 11/2/01, improved.
Patient reported experiencing high fever of 104F, achy joints, sweats and chills, about 6 hours after administration of high-dose FLUZONE.
No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 21-APR-2022, improperly stored, varicella virus vaccine live (oka/merck) (VARIVAX) 0,5 milliliter, lot #U019906, expiration date: 24-JUN-2023, subcutaneously was administered for prophylaxis. The vaccine experienced a temperature excursion of 6.8 degree Fahrenheit for 1 hour and 36 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.