chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports two days after Tetanus shot that left arm is tender along with hardening at injection site.  Patient also states rash noted on back of neck: describes rash as two lines with itching at local site around neck.  Patient denies any shortness of breath and was advised to monitor rash area and notify facility if symptoms and/or condition worsens.  Outcome: Patient reported on follow up call on 04/01/2021 that rash and tenderness had subsided, injection site hardening remains.
Milder form of weakness; Dizziness; Fever of 102 degrees; Horrible headache; Body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 21Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure, cholesterol, thyroid, use of sleeping pill (sleeping pill at night and drinks 2-3 oz of Vodka; falls asleep immediately), and alcoholic (doctor is convinced but patient denies; drinks 2-3 oz of Vodka every night). The patient's concomitant medications included hydrochlorothiazide/ lisinopril (LISINOPRIL HCT) for blood pressure, atorvastatin for cholesterol, liothyronine sodium for thyroid from 1970, and liothyronine sodium (CYTOMEL) for thyroid, all were ongoing; and a sleeping pill. The patient previously took the first dose of BNT162B2 (Lot Number: EL3247, Expiration Date: May2021) on 31Jan2021 at the age of 74 years for COVID-19 immunization (left arm) and experienced severe weakness, dizzy and lightheaded, felt like she was going to pass out, tightness in chest, heavy breathing, electrocardiogram (EKG) showed irregular with elongated T waves (09Feb2021), and liver enzymes (ALT and AST) jumped significantly (09Feb2021). On 21Feb2021, the patient had a fever of 102 degrees, a horrible headache, body aches, and chills. After the second dose (22Feb2021), the patient had a milder form of weakness and dizziness. All events resulted in physician office visit. The patient asked if the vaccine could throw a blood test off. The patient read in the newspaper that the vaccine could cause temporary irregularities in breast mammograms. The patient was recovering from "Milder form of weakness". The patient recovered from "Dizziness" on 25Feb2021 but with sequel. The patient recovered from the remaining events on 22Feb2021.
Within a week or two of receiving second dose of vaccine, I developed shingles. I had first gone to the ED at local health clinic when this started. This was diagnosed by Dr. and treated with Valtrex and prednisone PO. I then developed widespread lesions all over body. This was diagnosed as pityriasis rosea by Dr.. I have had this condition for the last 10 months.
she noticed 2 drops of the Pfizer BioNTech Covid-19 Vaccine during the administration of the 2nd dose.; I felt like symptoms with 10 min of chills; A major headache and body aches; A major headache and body aches; My period come over a week late; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program support.  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187), via intramuscular route of administration, administered in right arm on 20May2021 at 12:35 (at the age of 31-years-old) as dose 2, single dose for covid-19 immunisation. The patient family medical history relevant to adverse events was diabetes, high blood pressure and cancer run in her family. Concomitant medications were none. The patient had no prior vaccinations. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), via intramuscular route of admininstration, administered in right arm on 29Apr2021 at 12:50 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation and experienced minor with a light headache, flushed cheeks and tenderness near heart. It was reported that on 20May2021, patient noticed 2 small drops of PFIZER-BIONTECH COVID-19 vaccine during the administration of the 2nd dose and might have received less than the recommended dose. She was concerned that it may lessen the efficacy because she thought that the dose, she received may be lesser than the ideal dose. The healthcare professional who administered the vaccine mentioned that it was only because of the syringe being retractable. She noticed some tiny drops of fluid on the seat. She asked the pharmacist about the fluid, he told her fluid could left the syringe while being administered. She would like to ensure she still received the appropriate amount of the vaccine. Upon follow-up (22Jul2021), patient reported that, she had no life-threatening side effects from the Pfizer vaccine series, and after the second dose on 20May2021, patient felt like symptoms with 10 min of chills, a major headache and body aches and her period came over a week late. The events were non-serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (21Jun2021): This follow-up is being submitted to notify that the batch and lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up(22Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter sent which included that: Dates, route and anatomical site of administration and lot numbers of first and second doses of vaccination was added. family history (Diabetes, high blood pressure, cancer), events (chills, a major headache and body aches, and my period come over a week late).  Follow-up attempts are completed. No further information is expected.
This vaccine was stored at room temperature outside of 2 hours.  The vial was opened around 1235AM and the vaccine was administered around 3PM.  I did not realize this was incorrect until 11/5/21.  I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.
A medical assistant reported that a female pt received influenza virus vaccine injection and developed hives. Relevant medical history was not provided. The reporter indicated that the pt had no known allergies. Indication for influenza virus vaccine was immunization. Produce was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt developed hives "from flu shot." No additional info was available at the time of this report.
Respiratory problems, weak, tired, off balance all occurring within 2 weeks of getting vaccine, tooth & gum infection and then a tooth pulled, flu symptoms.
Client began oral typhoid 3/4/07.  At 9pm began feeling nauseated with abdominal pain, headache, denies fever.  Also dizzy and feeling weak.  Unable to go to work next day.  Called PMD who recommended increased fluids, rest, Benadryl prn and notication of Health Dept
Misadministration-VARIVAX given instead of ZOSTAVAX. Dr notified & discussed with patient. Pt is getting ZOSTAVAX in 4 wks.
Patient was given pfizer adult (12+) at 11 years old. No adverse reaction noted during observation time.
Booster dose given 2 months after the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given 2 months after the 2nd dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given 2 months after the 2nd dose). On 28-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given 2 months after the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided.
Thinking and thought process not normal, weakness in legs and arms, hypotension, head ache,  not my self, I normally swim daily, cook daily, I find it hard to do my normal task.
It was reported that a 40 year old female received Fluzone SV 98-99 USP vaccine on 10/27/1998. Reportedly within 4 hours the pt stated that she could not move her left arm, the pt also reportedly experienced pain and soreness. Pt not evaluated by a physician.
devel malaise 18hr p/vax no fever, h/a, severe myalgias w/in 20hr of recv vax;these signs cont for 7 days, fever was 102-104, along w/rhinorrhea, lt earache causing pt to miss a week of school;
03/31/2014: vaccination date; 04/08/2014: fever; 04/12/2014: atypical measles rash.
Swelling, redness, warmth right deltoid area. Discomfort, tenderness at site low-grade fever. Advised cold pack, Tylenol prn. Given 1000mg Tylenol po in office.
Heart rate of 140; Chills; Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20n) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS) and LOVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site). At the time of the report, HEART RATE INCREASED (Heart rate of 140), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details not reported.
Feeling like throat was closing up; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448), via an unspecified route of administration on 21Aug2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just had the vaccine and he/she have an allergic reaction. It was reported that the patient was sitting in front of the pharmacy right now (21Aug2021). The patient got the shot a little bit before 4 o' clock and he/she have been little bit stopped in the store and he/she just feeling like his/her throat was closing up. The pharmacist gave him/her a Benadryl as treatment. He/She have been so afraid to take this shot and now he/she have take the shot and this was what's happening. The outcome of the events was unknown.
Redness, warmth, and slight swelling to injection site approx 9 days after vaccine.  Seen at clinic, prescribed Keflex antibiotic by clinic MD.  Total visits 2.  Second visit 01/12/21 and discharged.
headache; soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, administration date 25Feb2021,, vaccine location: Left arm), administration date: 25Feb2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "soreness at injection site". Therapeutic measures were not taken as a result of headache, vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This was an unexpected therapeutic/reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 12May2021, outcome "unknown", described as "This was an unexpected therapeutic/reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information:This was an unexpected therapeutic effect.  (Name withheld), my brother, suffers from chronic Lyme Disease and reported to me on 17May2021 that he experienced a reduction in pain, better sleep, reduction in neuropathy, clearer cognition and better appetite after his first shot of the vaccine on 12May2021. He stated that there are others in his Lyme support group sharing similar stories after vaccination. Patient receive dany other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tiredness; muscle pain; nausea; not feeling well; Joint pain; slight headache; Slight pain in the injection site; On first day after, the patient had discomfort in arm; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-Sponsored program. A female patient of an unspecified age (Age: 94, no unit as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the next day after vaccination, the patient experienced slight pain in the injection site and had discomfort in arm and she took two paracetamol (TYLENOL) for it. On the second day, on 02Mar2021, the patient then experienced slight headache. Then on 03Mar2021, the patient experienced tiredness, muscle pain, nausea, was not feeling well and there was slight joint pain. The patient have had no fever and that's mostly what she had been experiencing. On 06Mar2021, the patient just stayed in bed almost the whole day and was just getting up to do some things. The patient further stated that when she was not moving around she does not have nausea or headache. The patient was wondering if it is normal to still experience the symptoms up until the time of report. The patient was concerned that these symptoms were lasting too long and wanted to know what to expect from the second dose. The patient also asked if she will develop more intense symptoms after receiving the second dose. Treatment was given in response to slight pain in the injection site and discomfort in arm which included paracetamol (TYLENOL). The patient recovered from pain in the injection site and discomfort in arm both on an unspecified date and the outcome for the rest of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician's business manager referring to a 2 patients of unknown age and gender. The patients drug reactions/allergies and pertinent medical history were not reported. On an unspecified dates, the patients were vaccinated with the dose of VARIVAX (Merck) (dose, frequency, route and lot# were not reported) which were improperly stored. No adverse events were reported. On 18-MAY-2015, a phone call was placed to the reporting physician. A voice mail message was left requesting that the physician return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up have been unsuccessful. Follow-up information has been received from a business manager on 20-MAY-2015. The reporter identified the two patients who received improperly stored VARIVAX (Merck). The second patient received dose on 12-MAR-2015. It was reported that improperly stored dose was lot# K002036, expiration date 26-FEB-2016. This is one of several reports from the same reporter. All scheduled correspondence was sent. Lot number K002036 is an invalid lot number for VARIVAX (Merck). Additional information has been requested. Analysis has been updated.
2nd anthrax shot. Burning in right arm, rash like burning itch on right arm. Right arm felt heavy. Flu like symptoms for 3 days, including diarrhea. Extreme pain in right arm kept PT from sleeping well. Funny taste in mouth, upper teeth felt numb. Above symptoms only lasted 3 days. However, PT has an arthritis feeling in his left shoulder and elbow that continues to bother him.
Fever Blisters; This case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she could still get fever blisters if he/she had got the Shingrix vaccine. The follow-up could not be possible as no contact details were available.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and malaise (didn't feel well) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030M20A) for COVID-19 immunization. No medical history reported. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm) and malaise (didn't feel well). At the time of the report, pain in extremity (sore arm) and malaise (didn't feel well): resolved. No concomitant medication or treatment information provided. Patient called in to inquire if she could take ibuprofen after the vaccine. This case linked to MOD-2021-017450 (patient link).
Migraine; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 20Jan2021at single dose for covid-19 immunization. Medical history included allergies: penicillin, iodine, shellfish; asthma. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications were not reported. Patient experienced migraine on 21Jan2021 07:00 AM with outcome of recovered. No treatment was received for the event.   No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 07 January 2014. This case is linked to case number 2014SA010023 (for 5 year old patient, same reporter and same vaccine). A 06-week-old patient had received a dose of PENTACEL instead of DTAP and IPOL vaccine on an unspecified date in August 2013. No adverse event was reported. Documents held by sender: none.
I contracted Covid-19 six months after my vaccine on 08/13/2021. I thought I was suffering from the current poor air currently. I started to have a lot of congestion and I needed to use my inhaler more. I was also very tired and needed to nap during the day. Five days later I still felt poorly. On 08/07/2021 I thought I was having a Cardiac event. I was sweaty and my blood pressure was very low. I called 911 and I was taken to the hospital. I was having chest pain for about two and a half hours. I was given a chest X-Ray and my Liver Enzymes were high. I had an abdominal Ultrasound, and all tests were negative. I was discharged and no Covid-19 test was performed. I saw a doctor three days later and my doctor did a Covid-19 test. The PCR test was positive, but I did not receive the results for a few days. My partner also tested positive. My current symptoms include some congestion and no sense of smell. I can't taste some things. My cough has improved, and I am not as tired.
Rash at the injection site red circular thing; Arm itching; Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm), VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in the arm) had resolved and VACCINATION SITE RASH (Rash at the injection site red circular thing) and VACCINATION SITE PRURITUS (Arm itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment details included Benadryl.
Pt faint, pale, sleepy, received O2 to improve color sent to the ER BP from 100/52 to 86/46.