chrisvoncsefalvay/vaers-outcomes huggingface dataset:
noticed inc hair loss breakage since DEC93 though this has since improved; perms hair every 3 months; last perm DEC93;
long COVID symptoms after they were vaccinated /neither had COVID before; long covid symptoms after they were vaccinated /neither had covid before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (Unknown).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "long COVID symptoms after they were vaccinated /neither had COVID before"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "long Covid symptoms after they were vaccinated /neither had covid before".  Additional Information: it was reported that it was not so much my interest as the feelings I got E the reasons for not being vaccinated are that reporter had 2 friends with long COVID symptoms after they were vaccinated. Neither had COVID before but now they are battling with long COVID symptoms to the point of being disabled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received first dose of Moderna vaccine at vaccine clinic. During 30 minute period after vaccine, patient reported swelling of face and rash/hives on face, neck and hands. Epinephrine 0.3 IM (12:25) and Benadryl 25mg given (12:17). Bangs called and patient sent to ER for follow up.
for a couple minutes it was like oh my gosh can't think; Wax in ear; pain in arm; pain in head/ head it just felt like a bowling ball, It's still heavy; slept for 12hours, didn't usually sleep that much; I am having trouble because I got wax in my ears, I am having trouble hearing you; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. The patient had some wax in ears anyways. The patient got the pain in arm and pain in head. when patient was done and got home, head it just felt like a bowling ball, It's still heavy. Patient 's received a call with questions. And for a couple minutes it was like patient can't think. But that's okay now, the only think was the patient slept for 12hours, didn't usually sleep that much. The patient stated, "I am having trouble because I got wax in my ears, I am having trouble hearing you but I'll do my best." Outcome of the events was unknown.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:53 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.18.  Concomitant products were not provided.  On 07-Jan-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 34; total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vial was moved to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a registered nurse referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In November 2016, the patients were vaccinated with improperly stored GARDASIL (also reported as GARDASIL 9) lot # M026306, expiration date 30-APR-2019; lot # M021407, expiration date 30-APR-2018; dose and route not reported) for prophylaxis. The doses of vaccine were improperly stored as follow (date, temperature, Duration of temperature excursion): lot # L017757, expiration date 08-APR-2018; lot # L017757, expiration date 08-APR-2018: 02-NOV-2016, 47 degree Fahrenheit (F), 25 min 02-NOV-2016, 48 F, 20 min 02-NOV-2016, 34 F, 91 min 03-NOV-2016, 34 F, 115 min 11-NOV-2916, 34 F, 1 min 13-NOV-2016, 34 F, 38 min 13-NOV-2016, 33 F, 35 min 14-NOV-2016, 34 F, 350 min 14-NOV-2016, 33 F, 240 min 15-NOV-2016, 33 F, 111 min 15-NOV-2016, 34 F, 307 min 14-NOV-2016, 33 F, 112 min 14-NOV-2016, 34 F, 212 min lot # M021407, expiration date 30-APR-2018: 01-NOV-2016, 32 F, 1 min 01-NOV-2016, 33 F, 37 min 01-NOV-2016, 34 F, 51 min 01-NOV-2016, 35 F, 148 min 02-NOV-2016, 34 F, 15 min 02-NOV-2016, 35 F, 110min 03-NOV-2016, 34 F, 4 min 03-NOV-2016, 35 F, 127 min 04-NOV-2016, 35 F, 96 min 04-NOV-2016, 34 F, 3 min 05-NOV-2016, 35 F, 105 min 04-NOV-2016, 35 F, 81 min Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007360: US-009507513-1703USA007361: US-009507513-1703USA007363: US-009507513-1703USA007364: US-009507513-1703USA007365: US-009507513-1703USA007063: US-009507513-1703USA000989:
Reddened area to site of VARIVAX injection. Started itching - no BENADRYL given and then reaction developed. After using Ibuprofen, Children's BENADRYL - reaction resolved.
COVID ARM - hardness, pain, itching, and redish/purpleish color surrounding the injection site
51 y/o female, walks in with c/o skin rash after H1N1 INFLUENZA vaccination. Pt received H1N1 vaccine alone on 19 Nov 09 and developed first pruritus and later, skin rash eruption within 24 hrs after receipt. Rash is still present but less pruritic since treatment at home with OTC hydrocortisone cream. Symptoms: Pruritus, rash, diffuse
Nine days after receiving dose one of Moderna, the patient developed a 1.8X0.8X1.5 palpable lymph node in the right axilla. This prompted a complete workup for breast cancer in this 45 year old woman, and severe emotional distress.  This also resulted in 2 visits to a healthcare provider, and two additional visits to a health care facility for radiographic procedures.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Neck pain and maxillofacial area necrotic lymphadenopathy, possible lymphadenitis
3/30/21 DAY AFTER SHOT HAD THE NUMBNESS IN LEFT SIDE OF FACE. 4/2/21 - 4 DAYS AFTER I GOT A RASH ON MY NECK AND CHEST. BOTH SIDES. I TOOK BENADRYL FOR 5 DAYS WENT TO CLINIC ON MONDAY (4/5/21) AND THEY SAID IT WAS A REACTION TO SHOT. RASH WAS GONE BY THURSDAY.
Left arm was sore for a couple weeks.  After that I have muscle ache in my left shoulder and if I have blood pressure taken in that arm much muscle pain for days afterward.  This was still happening over a month after the shot! Pain is severe enough that I've taken OTC pain meds for it.
Pt presented to the clinic "feeling well" to receive her 2nd Hep-B vaccine. She had received her 1st dose on 8/15/00 without complications. About 10 minutes, post 2nd dose of vaccine, she felt hot, sweaty, dizzy and fainted. Then, she complained of chest pain and while lying down, appeared to have tonic-clonic generalized seizure, lasting 2-3 minutes. She was admitted for observation without recurrence.
Moderna Vaccine lot #037C21A was affected due to out of temperature range. No adverse reactions from patients.  947 patient's affected.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 10-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number N025428 and expiry date 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA004452: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA008119: US-009507513-1811USA008123.
tested positive for Covid after getting the first dose of vaccine; tested positive for Covid after getting the first dose of vaccine; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of on 16Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient had previously received the first dose of shingles shot as immunization on an unknown date. It was stated that the patient tested positive for COVID after getting the first dose of vaccine in Jan2021.  The patient also mentioned that he was scheduled to have a second dose of PFIZER-BIONTECH COVID-19 VACCINE on 06Feb2021 and his second shot of shingles shot on 09Feb2021. Outcomes of the events were unknown.   Information on Lot/Batch number has been requested.
After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day my fever went up to 102 even after taking Advil every 6 hours. On the 3rd day my arm continued to be sore and my fever continued but was between 100.7 and 101.4. On day 4 my fever started going down to 99 for the day but my arm continued to be sore where the injection was and my armpit was sore as well like something was swollen. Day 5, today, my fever finally broke but my arm has a red circle and knot where the injection was given, its still very sore and also itches and warm to the touch. Every time I raise it up, I get shooting needles in the area of the shot. I have severe fatigue and sweats when I get up to walk anywhere and I feel exhausted. I called and spoke to the nurse who spoke to my Dr. listed on this form. She told me all of my symptoms were normal and said that if I started throwing up or my arm got worse to call back. I was not asked to come in to have anyone look at my arm or see if there is something else going on with the symptoms I am having.
3 min after being vaccinated with Moderna #2, pt felt nausea, dizzy & clamy. No LOC. Dry heaves. Alert & oriented x 3. Bp 110/80 P=64 & regular
On 1/14 felt tired and achy, but had had a good nights sleep.  On 1/15 felt more tired and achy.  On 1/16 more achy and tired than before.  On 1/17 felt worse and patient had a fever 101.  She took aspirin and then the fever rose.  She then took another dose of aspirin.  Did not feel better.  Still achy and feverish.  Fever broke during the night.  On 1/18 felt better in the morning, but felt sick again in the afternoon and starting having a sore throat.  Took Advil and Vitamin C.  Fever was 99.6.  Unable to sleep that night.  On 1/20 fever was 100.  Took more Vitamin C and Advil.  Not able to sleep well.  Fever subsided.  Still tired, but achy feeling is gone.  Now has upper respiratory symptoms "head cold" like and sore throat better.
Patient received his vaccination. Remained seated in the waiting area after receiving the vaccination for monitoring. Patient reportedly became light headed a few minutes later after receiving the vaccine and was helped to the ground to lay down. Patient remained conscious but reported feeling a little cold and light headed. EMS arrived and helped the patient up to his feet.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information was concurrent condition and historical medication. On 24-SEP-2016 the patient was vaccinated with improperly stored ZOSTAVAX 19400 PFU. Temperature was 6.7 F(Fahrenheit), temperature was 30 minutes and call was not because of the data logger. Previous temperature excursion was 12 F for 2 hours. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & was hospitalized from 17NOV95 to 19NOV95 for Guillain Barre Synd (dec reflexes, paralysis in lower extremities & arms & hands), vomiting & dizziness;these sxs were reversed in 36 hrs w/steroid therapy;
Her arm began to get very sore that night, then the next day it was swollen, she also had a horrible head ache for two days, the third day she slept most of the day in bed(highly unusual for her).  She has experienced fatigue every since the shot.  and she has had some digestion issues a couple of days; upset stomach and diarrhea.
Rash. Fine papular rash locally covering approx. 8 x 6 cm. The area is itchy and sore. The area is warm to touch. No redness. Papules are pale. TMTC. Symptoms x 4 days. Treated with ZYRTEC 10 mg and Hydrocortisone 2.5% cream one application with instruction to use Hydrocortisone 1% twice daily as needed and ZYRTEC daily as needed. Return to clinic if not improving.
Feeling like he has the flu; This spontaneous case was received on 06-Dec-2021 from other non-healthcare professional via Agency (reference number: SEQW21-05843) and concerned an adult male patient of an unknown age.   The patient's current condition includes alpha-gal allergy. The patient's  concomitant medications were not reported.  On unspecified date in Nov-2021, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated virus surface antigen (subunit), egg-derived, MF59; rout of administration, anatomical location: not reported and dose: 0.5 ml) for influenza prophylaxis. The batch number was not reported.  On unspecified date Nov-2021, after receiving Fluad Quadrivalent, the patient stated he felt like he had flu, also he did not have any adverse effect other than that. He stated his flu like feeling lasted only one day after receiving the vaccine.The patient was inquiring if the vaccine might raise the Alpha Gal antigen in his blood. He asked was there any canine component in this vaccine.   On unspecified date in Nov-2021, the patient had recovered from the event.   The reporter did not provide casuality assessment.  Company comment: The event of 'Flu like symptoms' was assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'Flu like symptoms' was assessed as related to Flucelvax Quadrivalent.
I was diagnosed with breast cancer. 12/01/2022 was the biopsy date. It was in my right breast. I had a bilateral mastectomy. It was invasive into the lymph nodes. I am at the start of 16 rounds of chemotherapy with 6 rounds of radiation afterwards.
NUMBNESS IN HAND; PAIN IN LEFT SIDE OF ABDOMEN; CHEST PAINS; LEFT LEG NUMBNESS; PAIN IN BACK; DIFFICULTY SLEEPING; NECK PAIN; LEFT LEG PAIN; STRONG PAIN IN ARM; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness in hand. On APR-2021, the subject experienced pain in left side of abdomen. On APR-2021, the subject experienced chest pains. On APR-2021, the subject experienced left leg numbness. On APR-2021, the subject experienced pain in back. On APR-2021, the subject experienced difficulty sleeping. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced left leg pain. On APR-2021, the subject experienced strong pain in arm. On APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strong pain in arm, pain in back, numbness in hand, headaches, pain in left side of abdomen, chest pains, left leg pain, left leg numbness, and difficulty sleeping, and the outcome of neck pain was not reported. This report was non-serious.
Developed a rash at approximately the date listed.  I did not pursue treatment for another week when I went to my physician and was diagnosed with Shingles.
body ache; Fever; headache; fatigue; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PYREXIA (Fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M201A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 CHILLS (chills) and FATIGUE (fatigue). On 03-Feb-2021, the patient experienced PAIN (body ache), PYREXIA (Fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (body ache), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.   Reporter did not allow further contact
Symptoms: nausea, fever, headaches, chills, sore arm; Pregnancy info: 28 weeks, due date 7/23/18, this is my second pregnancy. I had Tdap with first child and had similar reaction but not as bad as this time. First child is currently 2 years 9 months
My daughter was having difficulty seeing the board at school the week of 09/09/2013. On 09/17/2013 my daughter had an eye exam revealing a change in her eyes. The doctor mentioned seeing a specialist for Glaucoma. She saw a specialist, fitted for glasses. In the month of May 2014 my daughter could not see the board again at school. She was fitted with a new prescription for glasses again on 06/10/2014. On 07/07/2014 diagnosed at Hospital with Multiple Sclerosis.
Delirious, fever, sleeping all day, weak. Lost 10 lbs dehydrated. Emergency room after days - hydrated me - chest x-ray - blood work - urine test. Had low grade fever - released me. This lasted a good 2 wks. Then back pain and leg pain - then I couldn't walk.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included: allergy (unspecified). The patient had previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: unknown) dose was not reported, 1 total administered on 23-MAR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (does number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: unknown) dose was not reported, 1 total administered on 28-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported. On an unspecified date in 2023, the patient experienced covid-19 which was suspected covid-19 infection (dose number in series 2). The patient received non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin and route of admin were not reported, batch number: GG0067 expiry: unknown) dose and frequency were not reported from 08-APR-2023 to 13-APR-2023 for treatment of covid-19. On 17-APR-2023, the patient experienced covid rebound (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Headache, shivering, insomnia, dizziness, muscle pain, fatigue
It started out with a sore arm, then over the weekend low blood pressure and really bad oxygen saturation levels.  Monday after, mental status became very confused and drowsiness for about 3 days. Very tired as well and still drowsy and comprehension is slightly altered. No change in treatment.