chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 06-MAY-2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided).  On or about 02-AUG-2016, the patient was treated by a physician at a family practice for vestibular neuronitis The patient was diagnosed with vestibular neuronitis and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Myalgia, Fever, Diarrhea, NauseaVomiting, fatigue, legs swelling;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates between 07-JUN-2016 and 08-DEC-2016, the patients were orally administered the improperly stored doses of ROTATEQ (lot # L039638 with expiry date on 23-AUG-2017, lot # L037574 with expiry date on 01-JUL-2017 and lot # L039297 with expiry date on 19-JUN-2017; dose was not reported) for prophylaxis. On 07-JUN-2016, doses of ROTATEQ underwent a temperature excursion of minimum 25 degrees Fahrenheit for 12 hours prior to being administered. There were no known adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004642: US-009507513-1612USA010753: US-009507513-1612USA010751.
I received the vaccine ar 1:30 Pm and i felt Nausea in 1 hour that persisted for several hours , resulting in vomiting at 9 PM   I was nauseated the enitre next day without vomiting
At 4:30pm on day of vaccine (Saturday 3/3), patient began to feel mild flu like symptoms. By later in the same evening she has having shaking chills. Next day (sunday) she was feeling somewhat better symptoms "ebbing and flowing". By Monday she was having severe spasms in her back and significant aches in her knees and hips. Today (Tuesday) she still not feeling well. She called her doctor who asked her to report to us the pharmacy and have us report to you. MD is following up with temp checks and according to pt, her doctor does not feel this is the flu.
Fever, chills arm red and swollen (left) itchy. Size of silver dollar Prednisone prescribed.
Pt complained of nausea and vomiting on the day following the immunization.  No other symptoms.
shortly p/MMR given 1x1 cms wollen area noted 1" below site of inject; ice pack applied; mom states swelling resolve shorelty p/ w/1-2 hrs;
patient received the varivax vaccine in february 2009 while pregnant with her daughter in her first trimester; Varivax was administered via intramuscular route; patient received varivax vaccine while pregnant; This spontaneous retrospective pregnancy report was received from a currently 31-year-old adult female patient regarding herself.  The patient did not have any pertinent medical history, drug reactions or allergies, and there were no concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date, sometime in February 2009 (during first trimester of her pregnancy) the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), one shot intramuscularly in the arm for chickenpox (prophylaxis) (dose, lot # and expiry date were not reported) (maternal exposure during pregnancy, Incorrect route of product administration, Product use issue). The patient delivered a female baby. The pregnancy outcome was live birth. The product quality complaint was not involved.  This case is linked to the case 1906USA003555 (child case) (parent-child link).
A report was received from a health professional on April 09, 2001 concerning several patients of unknown demography who experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain after receiving the Fluvirin vaccine on unknown dates. On unknown dates several patients experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain.  At the time of the report it was unknown if the patients had recovered. There was insufficient information to determine the causality assessment of the reporter.  Cross Reference with PJP2001-00267 and PJP-2001-00270.
around 7:30 pm started having muscle cramps in both legs and body aches and feeling light headed like had the flu. both arms had muscle cramps like charlie horses.  has to use a muscle cramp foam for cramps (therarx) every 2 days this lasted for abut 2 days still cramping after 2 days but not as bad.  headache very intense no noise or light "out of this world" woke me up out of sleep took advil at 3:00am  becuase woke up from side effects.  Headache remains to this day but not as intense but will be more severe in the morning when she wakes up. went to primary care dr on 02/04/2022 was covid negative and flu negative.   Primary care dr recommends to go to  eye exam  went for eye exam on 02/09/2022 and  eye dr noticed unknown fluid or blood behind right eye and recommends specialist.  She has contacted specialist and is waiting for appointment.  She thinks eye dr. wants to rule out fluid
Anaphylaxis.  Face started turning red and swelling up, throat swelled up and couldn't breath, hands were swollen and red too.
chills, body sore, fever - took Tylenol around 6 hours after start of side effects, kicked in around an hour later
Pounding headache started around 4 pm body aches started around 4:30 pm. Headache  went away today which is the next morning. I took Advil 3 times to stop the pain. Today which is the next day I?m just tired my body is fatigue I just been sleeping because I feel horrible.
Patient states that the same day she noticed a nickel size bruise immediately after the injection.  On 2/4/21 she began having arm pain and on 2/5/21 she went to see her PCP.  She was diagnosed with cellulitis and put on doxycycline.
Syncope with convulsions. While making a salad for dinner, I began to feel weak and light headed. I sat at the dining room table and soon passed out. My husband revived me, and I passed out again. He revived me again, and I stayed alert. Both times my body convulsed, and he thought I was having a seizure. He called 911, and paramedics came and took me to the emergency department at the nearest hospital approximately 20 minutes after I passed out for the first time.  I was treated with IV fluids, rest and food and was released at 11:22 p.m.
c/o sharp pain in throat; pulse 102; 12:25--wheezing,bronchospasms-right greater than left;  12:35--Temp 101.2 F.; 1240  increased wheezing, bilateral, posterior; 1250--taken by ambulance to Dorchester General Hospital;  received nebulizer treatment  1430--discharged from hospital ED--diagnosis of bronchial irritation
This spontaneous report as received from a pharmacist refers to a 14 years old female patient. Pharmacist stated patient picked up GARDASIL (lot# was unknown) on 14-AUG-2012 and did not store it properly. Patient left the GARDASIL out at room temperature of 70F for more than 2 months. The patient was vaccinated with GARDASIL on 17-OCT-2012. That was the patient's first dose of GARDASIL. No adverse effects reported. Additional information is not expected.
NO adverse events- Patient tolerated vaccine well (No events till today). Reporting purely due to inadvertent vaccination of a 15 year old with co-morbidities. We do not yet know if we will provide the second dose (due 3/30/21)- more than likely NOT- unless CDC gives us the go ahead.
COVID vaccine booster; fever; Arm pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID vaccine booster"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient complained itch bumps on torso and extremities that appeared on Tuesday and called pharmacy on Thursday night at 08:50pm. patient was advised to take Benadryl  for itchiness and advised not to drive or operate any machineries.
Did not have an adverse reaction but incorrect vaccine was administered. Should have received a Bivalent booster but received a Non-bivalent booster in error.
Pt complained that arm was swollen, painful, fever at night and vomiting. Pt was given prescription for clindamycin 150 mg every 8 hrs x 10 days and TYLENOL with codeine 1 Tsp by mouth every 4-6 hours as needed. ROCEPHIN intravenously in clinic for 2 days. Patient required hospitalization for 3 days due to fever elevated 104 degrees, cellulitis and erythema. Pt was given vancomycin inpatient as well as ROCEPHIN intravenously.
shingles left chest   painful   maculopapular     labs with elevated igg and igm vzv    still painful   lesions still present  no crusting or weeping   no past hx of shingles vaccine
Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and  heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days.  Finally feel somewhat normal on 9th day although tongue still heavily coated with white.
horrible side effect from the vaccine; has visited the hospital several times and only got worse; armpit is black and hurts; rash expanded, down the arm till  wrist and to the chest and breast,the rash affecting their scull and other body parts, it is all over body.; It started as a rash in the armpit of the left arm where, they got the injection; armpit is black and hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (horrible side effect from the vaccine), CONDITION AGGRAVATED (has visited the hospital several times and only got worse), SKIN DISCOLOURATION (armpit is black and hurts), RASH (rash expanded, down the arm till  wrist and to the chest and breast,the rash affecting their scull and other body parts, it is all over body.) and VACCINATION SITE RASH (It started as a rash in the armpit of the left arm where, they got the injection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 038A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN and INSULIN for Diabetes.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (horrible side effect from the vaccine), CONDITION AGGRAVATED (has visited the hospital several times and only got worse), SKIN DISCOLOURATION (armpit is black and hurts), RASH (rash expanded, down the arm till  wrist and to the chest and breast,the rash affecting their scull and other body parts, it is all over body.), VACCINATION SITE RASH (It started as a rash in the armpit of the left arm where, they got the injection) and AXILLARY PAIN (armpit is black and hurts). The patient was treated with CORTISONE (oral) for Adverse event, at an unspecified dose and frequency; CALAMINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (horrible side effect from the vaccine), CONDITION AGGRAVATED (has visited the hospital several times and only got worse), SKIN DISCOLOURATION (armpit is black and hurts), RASH (rash expanded, down the arm till  wrist and to the chest and breast,the rash affecting their scull and other body parts, it is all over body.), VACCINATION SITE RASH (It started as a rash in the armpit of the left arm where, they got the injection) and AXILLARY PAIN (armpit is black and hurts) had not resolved.            Patient visited the hospital several times and only got worse. Patient visited 2 hospitals for this but was not admitted in any of them..
A few hours after receiving the vaccine, my son developed what looked like red and brown freckles all around his eyes and eye lids. He didnt complain of any pain or discomfort. The spots have lightened overnight but still remain 24 hrs later.
This spontaneous case reported by a consumer, describes the occurrence of insomnia (sleeplessness), discomfort and pain in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. March 2021, patient experienced insomnia (sleeplessness), discomfort and pain. At the time of the report, insomnia (sleeplessness), discomfort and pain resolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment medication provided.
Dizziness, fever, nausea and generalized aches all with 24hrs of receiving MENACTRA vaccine
This spontaneous report was received from a registered nurse refers to a 3 year old patient (gender unknown). The nurse reported that the patient received a dose of PROQUAD (merck) on 27-MAR-2014 in error instead of a dose included M-M-R II. The nurse reported that the patient had two previous doses of M-M-R II. The first dose of M-M-R II was given on 23-APR-2002 and the second dose was administered on 28-SEP-2004, but the second dose of M-M-R II was unverified in a vaccination database and a decision was made to administer another dose of M-M-R II. The nurse reported that the patient had received two previous doses of VARIVAX (merck), the first dose on 23-APR-2002 and the second dose of VARIVAX (merck) was on 16-NOV-2004. No adverse effect reported with the dose of PROQUAD. No product confusion discovered, just medication error. This is one of several reports received from the same reporter. Additional information is not expected.
vaccines from vials that had been thawed more than 30 days ago were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) had resolved.        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 medication was provided by the reporter. No treatment information were provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received included no new significant information. Awaiting translation.
patient stated she had a red rash from her neck down her chest and a little on her stomach like what happens when she takes Keflex. She said it lasted 2 days.  No treatment that I am aware.
1 of 2 pts who were vaxed during wk of 12AUG91 w/in 24 hrs pt reported swelling & redness @ inject site, generalized aches & fever; tx w/ASA & DPH; pts improved; sx not completely resolved; pt vaxed from same vial;
Information has been received from a registered nurse concerning a 4 month old male who was vaccinated with an oral 2 mL first dose of rotavirus vaccine (human-bovine). Concomitant vaccination included "standard 4 month old vaccines". While the patient was being vaccinated he bit down on the vial. The patient cut his lip or mouth "a little" while receiving the vaccine and started to bleed a little due to "the hard plastic nature of the vaccine vial". The nurse reported that the patient "could very well have been teething" and the reason for the reason why he bit down on the vial. No lot number was provided. It was reported that the patient "was fine now". A product quality complaint was resolved. Additional information has been requested.
Area is red, swollen. Above is bruised (she had 2 shots- where the Prevnar 13 was given. She indicated it was not where the Tdap was given). Recommend that she mention it to her primary care (also indicated it was itching a little now- 2/1/16.  Shot was given on Thursday 1/28/16 and she said it started on the next day). Told her to keep me inform.
Information has been received from a registered nurse concerning a 7 year old white male who on 07-JUL-1999 was vaccinated SC with a first dose of Varivax. Concomitant vaccination on the same day included a SC first dose of MMR II (lot # 631056/0532J), an IM fourth dose of Tripedia (lot # P0897AA) and an IM fourth dose of ACTHIB (lot # 7172AA). On 07-JUL-2005, the patient developed varicella disease. The patient recovered on 17-JUL-2005. Additional information is not expected.
Information was received on 30-JUN-2017 from a registered nurse who was reporting on an unspecified patient (no age or gender reported). No medical history or concomitant medications were reported. The nurse reported that on 25-JUN-2017, one unspecified patient was administered a dose of improperly stored PROQUAD (lot M041507, expires  09-APR-2018) that was reconstituted with properly stored DILUENT (lot M019892, expires 18-OCT-2018). No adverse effects reported. The vaccine was under a temperature excursion of 6 degrees F. to 14 degrees F. for 230 minutes. There was no previous temperature excursion and this was as a result of data logger. No other information was provided. Additional information has been requested.
My symptoms of interstitial cystitis were largely under control prior to obtaining the second dose of the Pfizer vaccine.  I have an IUD, and I also had no pain from the IUD.  The day after I got the vaccine, my interstitial cystitis symptoms became extremely flared, and my IUD felt painful and like it was going to fall out.  I was at the end of the menstrual cycle at the time.  The flare went away (and the pain from the IUD), but it repeated itself with my next menstrual cycle.   My symptoms of interstitial cystitis have never been this bad, and my IUD has never been this painful.
tender arm after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender arm after the first dose) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia (mild mid-stage).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (tender arm after the first dose). At the time of the report, VACCINATION SITE PAIN (tender arm after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not take any concomitant medications.  Patient did not take any treatment medication for the symptom.   This case was linked to MOD-2021-037288 (Patient Link).
tingling; numbness; pain in the feet/pain in her feet and ankles; pain in her feet and ankles; arthritis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 11:30 (Lot number: FJ5683) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "tingling"; HYPOAESTHESIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "numbness"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2022, outcome "unknown", described as "pain in the feet/pain in her feet and ankles"; ARTHRALGIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "pain in her feet and ankles"; ARTHRITIS (non-serious) with onset 13Jan2022, outcome "unknown", described as "arthritis".  Additional Context: Caller was a pharmacist at # that was calling about a patient who received her 1st adult gray cap Pfizer BioNTech Covid-19 vaccine this morning at around 11:30 AM. Caller stated the patient called her later today and states she was experiencing tingling, numbness and pain in the feet. Caller stated the patient was treated for arthritis already and this seems coincidental.   No follow-up attempts are possible. No further information is expected.
Patient is >12 years old, received the dose for 5-11 years old (under dosed for 1st dose)
The adverse event was a sore throat that hurt when swallowing, I got swabbed for covid and bacterial infection so my PCD thought it was a viral infection but wasn't sure what. it lasted for about five days and that was it. I took ibuprofen and then it just went away after a few days on it's own. I had went to the doctor on June 18, 2021.
Sore right arm, chills and shaking, body joint aches, headache, woozy stomach
Information has been received from a nurse practitioner, via a company representative, concerning a female patient (age not specified) who in September 2007, was vaccinated with a dose of GARDASIL (lot # not reported), and has since not had her period. Diagnostic laboratory testing was performed (test and results not specified). Additional information has been requested.