chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It looks like an allergic reaction; Bumpy injection site; Itches like crazy injection site; Red injection site; Rashes at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021: Outcome of the events has been updated to recovered /resolved.
Lost of taste; This is a spontaneous report from a contactable consumer (patient's mother).A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on an unknown date as dose number unknown, single for covid-19 immunization.The patient medical history and concomitant medications were not reported.In Jun2021, the patient experienced loss of taste. The mother reported that, her daughter got the vaccine, and she experienced a loss of taste, it's been about 4 days or so. She was wondering if that was one of the side effects of the shot or maybe she has it or what to do. She called her doctor but they did not know what to tell her. Outcome of event was unknown.   Information on the lot/batch number has been requested.
1st dose of Moderna was inadvertently given to an adolescent age 15. Client did not have and noted adverse reactions during time spent immediately after vaccination and within the post-vaccination observation period.
mother has not gotten the second shot yet; Headache, as CC reported; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) and HEADACHE (Headache, as CC reported) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) and HEADACHE (Headache, as CC reported). At the time of the report, PRODUCT DOSE OMISSION ISSUE (mother has not gotten the second shot yet) had resolved and HEADACHE (Headache, as CC reported) outcome was unknown. Not Provided          The concomitant medications information was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received on 1-jun-2021, new events information was updated.
On 12/29/11 pt. reported fever (not measured), nausea and muscle cramps starting on 12/18/11 which resolved in 25 hrs. Pt. received dose #3 on 1/5/12 under observation of Physician x 1 hr. sans problems. 1/9/12 Pt. states sore arm only after dose #3 of RABAVERT on 1/5/12.
Arthralgia BODY ACHES, FATIGUE. Narrative:  Other Relevant History:
At approximately 2:35 to 2:40 after receiving the Moderna Vaccine, patient developed hives on arms. Injection site had no such reaction. Patient reported no other symptoms other than the skin change. Patient declined benadryl injection. Her hives began improving at 2:50 but were still visible. She left the clinic at 3 pm.
The patient got vaccinated on her left arm. Next day, she developed flu like symptoms with body aches, fever (101 F) for 2 days. On 3rd day, her left arm became red, swollen, hot, painful from shoulder to elbows and lasted for 2 days. Pt recovered after 5 days of reaction. Patient did report to her MD. No medication taken. The reactions were resolved by itself.
In November I started have mild acid reflux at night while laying down or after eating. It's started to get worse as I have regurgitated food, the reflux is making me very uncomfortable, and it's been hard to sleep due to the discomfort. I have an appointment with my primary care physician to find out what can be done. I am currently taking a 14 day course NEXIUM.
Bell's palsy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy from COVID 19 vaccine on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mother took child to the ER on 5/22/03 - entire left arm swollen. No treatment in ER - child sent home.
Tachycardia and POTS since 1 hour after vaccination. Heart rate ranging 111-203 constantly up and down no lower for at leat 73 hours after injection. Fatigue.
Developed a papular rash- some spots filled with fluid and others have drained. Rash is mostly on the face, only couple spots on trunk.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 10-MAR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N027002 (expiration date 28-SEP-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
pt recvd vax & 10 days post vax devel strep pneumonia;
Shot really felt like it went into the bone & it has hurt ever since & I can't move my left arm very far towards my head.
Headache; Ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8727) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Tuberculosis (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all"; Influenza (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all"; Shingrix (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all". The following information was reported: TINNITUS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The events "ringing in ears" and "headache" were evaluated at the physician office visit.  Additional information: The patient was taking a multivitamin. The patient later received bnt162b2 (BNT162B2), administered 19Apr2021, in upper muscle at 10:15 to 11:00. No additional vaccines were administered on same date of the pfizer suspect. At one point doctor prescribed Prednisone, a 7 day step down course, but it didn't really help. Doctor looked in his ear and advised caller to go to an ear, nose, and throat doctor. Prior vaccinations (within 4 weeks) were none.  Follow-up attempts are completed. No further information is expected.
Pt. called our office 2pm c/o chills this am; followed by bodyaches and hypersensitive to touch. pt also tightness lower rib area last 1 hr. Denies SOB. pain with respiration no skin redness, rash or fever. Took motrin 400mg @ 10am today. seen in office 3:30 pm 10/9/20: Seen in office; no obvious distress VS stable temp 99.1 p - 72 resp 18 BP 170/72 No obvious rash or flushing alert oriented. Injection site free of rash or redness. Instructed pt in signs and symptoms to be seen in ER if develop.
Patient felt faint/lightheaded. Blood pressure decreased to 96/60. It quickly rebounded and she returned to baseline within 15 minutes.
Achy body; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy body) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced MYALGIA (Achy body) and CHILLS (Chills). At the time of the report, MYALGIA (Achy body) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Heart rate: 114 (High) Abnormally high heart rate (up to 114 beats per minute).         No treatment information was provided. No concomitant product was reported. Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. The 3 patients were vaccinated intramuscularly with PNEUMOVAX 23 on 16-OCT-2012. Lot # (670187/0895AA). No other co-suspects were reported. No concomitant medications were reported. Later the same day (16-OCT-2012) the three patients reported the nurse a sore arm with swelling and warmth at the injection site. The nurse did not have any specific information for the patients. No treatment information was reported. The outcome of sore arm, warmth at the injection site and swelling at the injection site was unknown. The relatedness for sore arm, warmth at the injection site and swelling at the injection site was unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Immunized 7/31/03   Woke up next morning with stiff neck.  No other symptoms.  Stiffness as of 8/5/03
BCR-ABL test jumped very high; This is a spontaneous report received from a contactable consumer (patient) via medical information and via Pfizer-sponsored program. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 80 years old via an unspecified route of administration, administered in arm left on 26Jan2021 (Batch/Lot Number: CN5318) as 2nd dose, single for COVID-19 immunization and bosutinib (BOSULIF), oral from an unspecified date (Batch/Lot Number: unknown) to an unspecified date at 300 mg, 1x/day for chronic myeloid leukemia. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 05Jan2021 (Batch/Lot Number: EK4176) as 1st dose, single. Medical history included chronic myeloid leukemia. The patient's concomitant medications were not reported. Patient experienced: BCR-ABL (Philadelphia chromosome) test jumped very high on 12Apr2021 (her results went from 1.9 to 11.8). The event was considered related to the medicinal products. Seriousness criteria reported as serious. Outcome of the event was unknown. She has not had any testing since. Action taken in response to the event for bosutinib was dose not changed.
Itchiness at the injection site; Redness that is increasing at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is increasing at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Vaseline.
Information has been received from a physician concerning a (approx) 20 year old female, with no known drug reactions/allergies or concomitant medication usage who in approximately November 2007 (exact date not reported), was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot # not reported).  Subsequently the following day, post vaccination, the patient developed a rash on her chest.  The patient reported the rash to the physician's office but no treatment was prescribed and no diagnostic labs were performed.  The patient recovered from the rash in an unspecified time period.  Additional information has been requested.
pt recvd vax;shortly thereafter, exp memory loss; saw MD who dx dementia & alzheimer's disease;
Started coughing with each breath and felt a lump in throat and foaming in bronchial. Went to Urgent Care. Heart rate at 145 and BP @ 185/98. Not sure of oxygen saturation but was put on oxygen before receiving a shot of Benadryl and prednisone. Was transported to ER by ambulance and given a Benadryl drip in transport. Was in ER for five hours and had an xray of soft tissue in throat. BP was still elevated @ 165/89 when released from hospital with prescription for 5 day course of prednisone and Pepcid.
Information regarding Flumist nasal solution was received from the father of an 11 year old female who experienced stuffy nose and sore throat. At 11 years of age, the child received a dose on 12/15/03. The child had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). The child was not taking concomitant therapy. The child experienced stuffy nose and sore throat on 12/16/03. No additional information was available at the time of this report.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
I have severe joint pain in hands andankles; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 08Jan2021 (at the age of 47-year-old) as DOSE 2, SINGLE for covid-19 immunization in hospital. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID) and omeprazole. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EK5730, expiration date: not reported), via intramuscular, on Left arm, on 18Dec2021 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunization in Hospital.  The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 17Jan2021, after second dose, the patient had severe joint pain in hands and ankles to the point where patient can't open a jar without pain and cannot exercise because of ankle. The patient further reported that she never had joint pain as she was only 47 yrs. old. It was reported that events result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The outcome of the event was not recovered at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
in May of 2021, 5 days after she got her second covid shot, she woke up and her entire head hurt, her blood pressure was high, and she had blurry/pixelated vision. She went to the hospital and was told she had COVID. They also found a mass on her lung which had to be surgically removed. It was found to be benign. She stated that she could hardly eat or drink anything for ~3 months and is still having trouble walking and moving around. Her quality of life has significantly decreased.
Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low blood pressure on Jan. 27,2021
two after shot, patient had joint stiffness and pain all over body and rash all over the body. Patient mentioned top layer of the rash (patient said it was like dead skin) would peel off. It is still going on and patient mention its hard to walk. Patient saw PCP on 4/9/21 and got a shot of steroid and also oral steroid to take. Patient was informed to come back next Friday for follow up and blood work.
PATIENT HAD PFIZER VACCINE ON Dose 1 date: 12/29/2020,   Dose 2 date: 01/19/2021, AND TESTED POSITIVE TO COVID.
Monday morning I started sneezing like crazy and all day I was blowing and my nose. Tuesday was the worse, continued a bit on Wednesday but was resolving.  I did contact my employee health, they sent me in for a Covid test which came back negative.
WHEN ASKED, PTS FATHER SAID PT WAS 12 YEARS OLD. ON CONSENT FORM, LISTED AS 12 YEARS OLD. UPON TYPING, NOTICED SHE WAS 11 YEARS AND 11 MONTHS OLD
pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache, and was nauseated.   She took medicine for nausea but then she felt even more sick and then vomited.  Pt stated she is still nauseated and will contact her PCP if she doesnt get to feeling any better.
Diarrhoea; This is a spontaneous report from a non-contactable consumer, the patient.   A 43-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7534) via unspecified route of administration as a single dose in the left arm on 19Mar2021 at 12:45 (at an age of 43-year-old) for COVID-19 immunisation. Medical history was not reported. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 17:30, the patient experienced diarrhoea. The patient was not treated with any medication for the events. The clinical outcome of diarrhoea was unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Update the leading sentence as- This is a spontaneous report from a non-contactable consumer.
Pt recv vax in 2/98; 30-60 min later pt exp nausea, headache, dizziness, flushing & muscle cramps in arm; tx=Medrol
Undiluted Pfizer 5-11 y/o Covid vaccine administered to pt.
On 11/27/2022, I started to experience a cough that didn't feel like a normal cough and a lot of head congestion. Then, for about 36 hours, I experienced a fever. The highest it went was 101.1. Other than the coughing, head congestion and fever, I felt fine. I did not have any breathing problems whatsoever. I tested at home for COVID-19 and tested positive. I contacted my oncologist and they put me on PAXLOVID right away. I feel that PAXLOVID helped me tremendously and tested negative on the fifth day and felt great. Five days after finishing PAXLOVID, I experienced rebound COVID-19. I contacted my doctor right away because I tested positive again. It seemed to last about 24 hours and after that, I felt perfectly fine. I tested again five days later, and the test was negative.
Left deltoid-swelling area was red, hot and hard. Had reaction DTaP #4-red swollen leg. 04/20/02, seen by MD dx. wit cellulitis, given Rocephin IM and Amoxicillin PO.
Patient received vaccines on 4/8 in AM. On 4/8 in PM patient had fever to 101, body stiffening episodes, and increased sleepiness. Patient taken to ED for evaluation.
Swollen lymph node in armpit of left arm, tingly feeling in left arm, headache
Irregular scheduling event gave Hep A 30Jan, found minutes afterwards record of receiving same injection of Hep A on 24 Jan 2007. No reactions noted while in the clinic.