chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRUISE; CALF PAIN; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 12-APR-2021, the subject experienced bruise. On 12-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from calf pain, and bruise. This report was non-serious.
HARD TO MOVE; LIMP LIKE; VERY WEAK; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced hard to move. On 14-MAR-2021, the subject experienced limp like. On 14-MAR-2021, the subject experienced very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hard to move, limp like, and very weak on 16-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Mumps vaccine administered 4/1/08 (for titer 0.81 3/27/08).  Unilateral parotitis began 4/20/08.  Improved but continues as of 4/28/08.  Started Ceftin & Benadryl 4/23/08.
pt recvd vax 17OCT95 & on 20OCT95 noted rt arm was bruised & devel welts on back & neck all on rt side;believes the welts are secondary to pneumovac's; has had flu shot tiwce a/ w/o problem
Client reports having "every thing he can think of." Specifically reports SOB, rash from waist up and itching. He has not seen a doctor for this condition. This writer encouraged client to call and make an appointment with his doctor. He agrees. In the last few weeks, client had severe pain in his right hip. He saw a orthopedic physician that did an x-ray and determined it was arthritis.
Heart rate in low 90s; Chills; Temp to 100.7; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the arm left on 15May2021 at 16:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to sulpha drugs, allergic to raw onions and patient reported she was healthy. Prior to the vaccination, the patient was not diagnosed with 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 24Apr2021 at 16:00 (age at vaccination: unknown), as a single dose for COVID-19 immunisation. The patient previously had allergy to high doses of erythromycin (MANUFACTURER UNKNOWN). On 16May2021 at 10:00, 18 hours after second dose of vaccination, the patient experienced heart rate in low 90s, chills and temp to 100.7. On 16May2021 at 10:00, the patient underwent body temperature test and the result was found to be 100.7 (unspecified units) and heart rate was found to be low 90s (unspecified units). 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 heart rate in low 90s, chills and temp to 100.7 were recovered on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
All over her abdomen, chest and the front of her torso; Rash on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest) and RASH (All over her abdomen, chest and the front of her torso) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (Rash on chest). On 02-Apr-2021, the patient experienced RASH (All over her abdomen, chest and the front of her torso). At the time of the report, RASH (Rash on chest) and RASH (All over her abdomen, chest and the front of her torso) was resolving.            Patient was taking other medications but no concomitant medications provided. No treatment information were reported.
COVID has got her really foggy; COVID has got her really foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID has got her really foggy". The patient underwent the following laboratory tests and procedures: Weight: 110 lbs, notes: Caller was 110 pounds; 107 lbs, notes: is now 107 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (1 Nirmatrelvir and 1 Ritonavir tablets) together by mouth twice a day for 5 days from 09Sep2022 (no stop date provided).  No follow-up attempts are possible. No further information is expected.
chills; started night of started 09Apr2021 fatigue started 09Apr2021 muscle aches started 09Apr2021 anal bleeding when going to restroom - quite a lot and did not stop right away - started 11Apr2021 migraine starting 09Apr2021
Patient is complaining of numbness in the arm where the shot was given. She also says the shot was unusual feeling and painful when given.
Jan 13 first dose received...Jan 30th collapsed at night by herself.  Was able to get up and go back to bed.  Next day was taken to urgent care and sent by emergency to hospital.  Suffered large blood clot in the leg that broke off and traveled to the lungs.  Acute saddle pulmonary embolism with acute cor polmonale.  Was put on blood thinners and released from hospital on 2/2.  As soon as we got home from the hospital she suffered from a massive gastrointestinal intestinal bleed and had to be rushed back to the hospital.  Two days later while still in the hospital she suffered a mild heart attack and had a stent inserted.
Information has been received from a Post-Marketing evaluation program for Rotateq concerning a 5 month old male who was vaccinated PO with her first dose of Rotateq.  Subsequently 36 days post dose, the patient was admitted to the hospital with a 3 day history of intractable vomiting and no diarrhea and remained hospitalized for 6 days.  Films were performed which showed a positive result for currant jelly stool and intussusception requiring resection.  The patient recovered and was discharged on day 6.  Intussusception was also considered to be an other important medical event by the reporter.  Additional information has been requested.
Contracted covid; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-APR-2023, the patient received the 2nd dose of Shingrix. On 04-MAY-2023, 22 days after receiving Shingrix, the patient experienced covid-19 (Verbatim: Contracted covid). The patient was treated with nirmatrelvir + ritonavir (Paxlovid). The outcome of the covid-19 was not resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter was the patient. The patient was contracted covid. The patient stated that she was started on Paxlovid by her healthcare professional for treatment. The reporter did not consent to follow up.
Pt recvd vax around 130-2PM t102, fussy, lethargic, got more fussy & irritable 6PM t104, would lay still & then get fussy; vomited 2AM; not eating or drinking; ER x 3 visits; 18MAR93 dehydrated;
Experienced COVID symptoms: first nasal drip (two days), second sore throat (two days), third chills (one day) and body aches( three days), fifth phlegmy cough (four days), sixth  headache (on and off over seven days.
- Significant arm pain  - Small Hematoma in the arm of the vaccine  - Joint pain - Fatigue  - Body Ache  - Sleepiness  - Fever (100 F)  - Weakness - Pain lower chest
The vial was moved from the freezer to place in the refrigerator the day before it was used; No adverse event; Second booster dose of expired Moderna Covid-19 vaccine (Monovalent) administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second booster dose of expired Moderna Covid-19 vaccine (Monovalent) administered to patient), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2022 at 4:26 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2022 at 4:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second booster dose of expired Moderna Covid-19 vaccine (Monovalent) administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Second booster dose of expired Moderna Covid-19 vaccine (Monovalent) administered to patient), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Second booster dose of expired Moderna Covid-19 vaccine (Monovalent) administered to patient) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used).    No concomitant medications were reported.  Reported that patient received 2 COVID dose and 2 booster dose. The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022, vial was removed from the freezer and placed into the refrigerator on 29-Aug-2022. The size of the vial was reported as 5.5ml. The vial did not undergo any temperature excursion.    No treatment medications were reported.
Lymph node under your arm 2-3days, my armpit hurts. It turned black and blue after a couple of days, fever, joint pain, headaches, dizziness, body aches.
swelling of the mouth and face and around left eye treated with otc benedryl 50 mg and claritin 10 mg by mouth
Patient came in for his 2nd dose COVID vaccine. The chart was preloaded and had the wrong Lot Number in it. I read the lot number and grabbed the corresponding vaccine and administered it. Patient tolerated fine, no adverse effects. CDC has been notified.
A patchy rash formed that covered nearly all of my right hand and some of my left, and chronic headaches almost every day
01/11/2022 Tested positive for COVID-19. I was having terrible reflux issues two days prior. It began with tightness in my chest and almost went to the ER. My throat hurt and I began to get a really bad headache that none of my meds were helping. The day after my test, I took dexamethasone that helped considerably. However, I continued to have fatigue and I was having terrible reflux issues continued. I was prescribed a stronger antacid that helped out as well. A week after COVID-19, I had a terrible menstrual cycle for about two months. Ultrasound done that showed no issues as well.  My cycle is still having issues to this day. No more reflux, or headaches, or fatigue.
VOICE SOUNDED LITTLE FUNNY; BODY NOT MOVING (BARELY ABLE TO  STAND-UP); WHOLE BODY PAIN, BODY HURTING; DIZZINESS; DOUBLE VISION; COUGH; FELLING HORRIBLE; FEVER (100.7F); BAD HEADACHE; NAUSEA-FELT LIKE VOMITING; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and acute infectious colitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included for acute infectious colitis. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced double vision. On 28-MAR-2021, the subject experienced cough. On 28-MAR-2021, the subject experienced felling horrible. On 28-MAR-2021, the subject experienced fever (100.7f). On 28-MAR-2021, the subject experienced bad headache. On 28-MAR-2021, the subject experienced nausea-felt like vomiting. On 28-MAR-2021 04:00, the subject experienced body not moving (barely able to stand-up). On 28-MAR-2021 04:00, the subject experienced whole body pain, body hurting. On 29-MAR-2021, the subject experienced voice sounded little funny. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from whole body pain, body hurting, body not moving (barely able to stand-up), fever (100.7f), dizziness, bad headache, double vision, nausea-felt like vomiting, cough, and felling horrible, and had not recovered from voice sounded little funny. This report was non-serious.
A little over an hour after receiving my second dose I experienced a severe seizure that resulted in a trip to the ER.
pt c/o joint pain in his shoulders, kness, neck and hands starting one week after receiving the pfizer vaccine, first dose.
flare up of her Lyme disease/Possibly flared up her Lyme disease; flare up of her Lyme disease/Possibly flared up her Lyme disease; Back pain; Headache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 19Jul2021 (Batch/lot number not reported), at age 28 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history included Lyme disease from an unknown date and ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) received on an unspecified date, as dose 1, single for COVID-19 immunsation with no reaction reported. On 19Jul2021 (Monday), the patient received her second dose of the Pfizer COVID-19 vaccine. The patient was fine during the first couple of days. On 22Jul2021 (Thursday), the patient had a bad headache, dizziness, fatigue and back pain. She stated that she was trying to call her doctor in case the vaccine flared up her Lyme disease to see if the doctor wanted to do a round of antibiotics. Her doctor advised her to call Pfizer to see if there is any information about the vaccine causing a flare up of her Lyme disease. She stated that the doctor will not do anything until he knows if it flared up her Lyme disease. She stated that she had Lyme disease before she started getting the shot. She wanted to know if the vaccine flared up her Lyme disease. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored GARDASIL 9 lot # L020015 expiration date: 18-AUG-2017 (dose, route and site of administration were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A1A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.). On 18-Mar-2021, VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided.
No adverse event from Prevnar 13, only delay in getting PPSV 23 which is appropriate for asthma.
Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021.  On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells.  Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with  no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.
Patient received ZOSTAVAX on 4/15/15. On 4/19/15-pt reported a raised rash near injection site. Went to emergency room on 4/20/15 for treatment-rash began to blister.
Hep-B dose 1 in 2020, dose 2 not received; Received third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date) and Hepatitis B vaccine (1st dose received on 2020).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine and received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Shingrix, the patient experienced incomplete course of vaccination and extra dose administered. On an unknown date, the outcome of the incomplete course of vaccination and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received 1st dose of Hepatitis B series of unknown brand in 2020 and then never received 2nd dose. The reporter stated that the patient also inadvertently received 3rd dose of Shingrix vaccine. No further details were provided on the call. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The patient received extra dose of Shingrix vaccine inadvertently, which led to extra dose administered.
Injection site swelling, pain, pruritus, erythema. Loratadine 10 mg every day, diphenhydramine 25 mg once.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager, referring to a 13-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 04-OCT-2022, the patient was vaccinated one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot numbers and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, administered for prophylaxis (administration sites, and routes of administration were not provided)  The doses of vaccines experienced 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 min. Total time: 25 mins. Temperatures were reported as 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: