chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed fever that evening that broke by morning, full body aches. Then Started feeling inflammation in my chest/sternum area frequently throughout next month or so. I also experienced random bouts of racing heart rate. I wore a fitbit at the time and my resting was high 60s on average, was randomly spiking to low 100s. Symptoms have subsided but still feel bouts of racing heart rate that I never dealt with prior. I switched my diet up to be more anti-inflammatory and that has helped a lot. I also have been exercising regularly which also seemed to help.
Rash, Swollen arm, fever, dizziness. loss of movement in fingers, numbing and tingling sensation in arm, loss of grip in left hand, no strength
Patient received the vaccine and was asked to take a sit for 15 minutes.  Approximately 10 mins later his girlfriend approached us stating he felt dizzy.  When I got to him, he was becoming pale.  I called 911, and returned to the patient who was in and count of consciousness.  Myself and a second pharmacist assisted him to the floor and checked is blood pressure and awaited EMT's to arrive.  The fire department and EMT's assessed the patient who was now feeling better and he refused to be transported to the hospital.. He left the pharmacy with his girlfriend.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose VARIVAX, dose route and frequency unknown. On 24-JUN-2009, the patient was vaccinated with improperly stored dose of VARIVAX lot # 663710/0219Y. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Initial report received from a health care professional in the USA on 23 April 2008. A 5 year old, female patient (with a history of allergy to peanuts and eczema) complained of swelling of the left deltoid, 2 days after she received a fifth dose of DAPTACEL (lot number C2933AB) intramuscularly in the left deltoid, a fifth dose of IPOL (lot number A0298) intramuscularly in the left deltoid and a first dose of TUBERSOL (lot number C2678AA) intradermally in the left forearm on 25 March 2008.(Needle length - 5/8" 25 gauge). The swelling of the left deltoid was described as 8 x 12 cm around the injection site. The arm was described as red, hot to touch. No complaints of range of movement change. She did not have any illness prior to the vaccinations and was on topical creams. She was treated with MOTRIN and cold compress for the adverse events. She did not have any diagnostic or laboratory tests done. The symptoms resolved and the patient recovered.
This spontaneous report was received from a consumer refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported). On an unknown date, date the patient experienced adverse event. The outcome of adverse event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Moderna  COVID-19 Second vaccine: Brain fog, muscle aches, very tired, sore injection arm, loss of appetite. No symptoms other than sore arm for first injection of vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-DEC-2015 at 07:48, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 and 7.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
allergic reaction; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer (Case ID: GI-2021-2524). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reaction. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 4:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 4:14 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 65.73  and 65.80.  Concomitant products were not provided.  On 03-Mar-2021, excursion time was 09 AM, 10 AM and 01 PM, and temperature was 51, 34, and 35 respectively, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vial was moved to clinic on 03-Mar-2021. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36, 4 PM: 46 and 5 PM : 36.  On 30-Mar-2021, excursion time was 09 AM, and temperature was 33 respectively, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 23-Mar-2021. 03 vial was moved to clinic on 30-Mar-2021. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
stroke; Flashers in her eyes that continue; Woke up in the middle of the night several times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, LEVOTHYROXINE, CHLORTHALIDONE, SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ACETYLSALICYLIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE (CORICIDIN [ACETYLSALICYLIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine and Headache, at a dose of 1 dosage form four times per day. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (stroke) to be not related. No further causality assessments were provided for PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times).    Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded.  Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow received and the initial diagnosis of ocular migraine was wrong and is confirmed to be a stroke.  Reporter causality was updated to unrelated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded.  Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.
Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The reporter had reported for his/her brother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "Patient is a 74 YO female with a history of hypertension, CVA, and depression who presented with altered mental status and weakness and was found to be febrile and hypotensive.  Patient tested positive for COVID-19."
no adverse event; Physician calling in to request a vaccine temperature excursion evaluation for GARDASIL 9 (see TE case number 02215650 for details) that had been administered to a patient.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 29-JUL-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection dose 0.5 ml, lot #U028825, expiration date: 02-NOV-2023, administered intramuscularly (strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature excursion information: on 25-JUL-2022 46.5 degree Fahrenheit for 15 min and on 29-JUL-2022 48.2 degree Fahrenheit for 15 minutes. There was no additional adverse event reported (no adverse event).  This was one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2208USA000140:
REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME LEFT FACIAL MUSCLE WEAKNESS
Patient scheduled her Shingrix vaccine over the phone and spoke to RPh the morning of on 1/24/23 to confirm her 12:20pm appointment same day. After administering Shingrix, patient stated this was her second dose in the series. Rph asked when she received her first dose and patient replied a year ago. Rph asked where she received the vaccine and she replied here at Pharmacy.  After the patient left, Rph was looking in her file and upon further inspection (search initially did not show records past 2022) showed the patient received both Shingrix doses on 3/17/2021 and 5/25/2021.
Rash, small bumps first on my R hand 9/25/10 rash started on R arm, then on 9/26/10 R leg, then L leg. It was worse the evening of 9/27/10 and seems to be going away today 9/28/10. I had stiffness in my arm, neck, and shoulder on side of injection and swelling of the neck near my jaw on the R side the first two days after the injection.
all muscles & joints on both lower extremities were extremely sore & was nable to walk, sit, or bend;the pains were so excrutiating htat pt had to take narcotics;
This spontaneous report as received from a medical assistant refers to a 15 month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5ml, intramuscular (lot # J006695, expiry 30-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14, 2021 in my right arm.  Almost immediately, I felt a pain go down to my wrist and across my chest. We pulled into the waiting area and around five minutes after the injection the right side of my face went numb., the pain had left my arm and chest by the time.  The nurse reacted by calling the emergency room and sending me there.
a patient missed her second dose of IMOVAX RABIES, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 46-years-old female patient who received first dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date not reported) via an unknown route and administration site on 04-Aug-2020 she missed her second dose in the series for post exposure immunization and received it on 11-Aug-2020 dose: 1 mL (batch number: R1C711M, expiry date: 30-Apr-2021) via an intramuscular route in the left deltoid for post exposure immunization.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. No concomitant medication were given.   It was an actual medication error due to missed dose.  At the time of reporting, no adverse event were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
101 degree fever; Chills; Vomiting; Nausea; Headache; Aches; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 21Apr2021 at 13:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included algae oil pills (MANUFACTURER UNKNOWN) and turmeric (MANUFACTURER UNKNOWN) from unknown dates and unknown if ongoing for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8489) via an unspecified route of administration in the arm left on 31Mar2021 at 14:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 08:30, the patient experienced 101 degree fever, aches, and chills after 12 hours for 24 hours duration followed by nausea, vomiting and headache for an additional 48 hours. On 22Apr2021 at 08:30, the patient underwent body temperature test and the result was 101 degree with unspecified unites. The event did not result in doctor or other healthcare professional office/clinic visit, and 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 101-degree fever, chills and aches were recovered on 23Apr2021. The clinical outcome of the events vomiting, nausea and headache were recovered on 25Apr2021.   No follow-up attempts are needed. No further information is expected.
She got her vaccine, had taken a Tylenol prior to getting the vaccine based on what she read on the internet.  She was fine, she did 3 other errands, went home and was absolutely fine and felt nothing.  Around 4:00 she felt achy, and took another Tylenol.  By 8:00 PM that night she was feeling really lousy and before bed she took a Tylenol PM, and during the night she was so cold and achy that she got up, got extra blankets on her bed, turned the heat up more.  She hurt so much all over that during the night she woke up and could not roll over.  She got out of the bed to change her position.  She was awake probably 10 times that night even with the Tylenol PM.  She ached all over, felt like something was going through her system.  She felt like poison was going through her system, she could fell something going through her body.  Her skin felt like she had sunburn, where the shot was given was a normal reaction, but all over had the sunburn sensitivity all over her skin.  She had muscle pain and joint pain to the point that when she woke up in the morning she could hardly get to the bathroom.  That's when she decided that she needed help.   She took her dog out, took some more Tylenol.  She was dizzy, very exhausted and anything she had to do was a major effort.  She felt heaviness in her chest, pain in the kidney area in her back.  She went back and laid on the sofa, fell asleep again and woke up feeling a little bit better, enough that she was able to eat some cereal.  She just was totally exhausted.  As the day went on after she ate, and napped again and got up and had some lunch, and had soup.  She started to feel a little bit better.  By the afternoon she was improving, and by dinnertime she actually made herself a dinner and felt better.  That night everything was better, very lethargic, felt like she had the flu.  Everything was fine, took another Tylenol before bed, and woke up yesterday and was much better.  She was still exhausted, and felt like her body was sore, but she could function again.  She also had a headache deep inside, and she never gets headache.  Not a sickly person, does not take any other medicines, and that bothered her.  It was alarming that every once in a while she would get a sharp pain in her head.    Today she is fine, still feels after effects, feels stiff.   She was truly shocked and went on the internet the next day to see if any of the symptoms were alarming, and states that she will not take another one of these vaccines.  She feels that there has to be better warnings, as she was not given any pamphlet with any of the side effects, given absolutely nothing.  He explained that the second vaccine was 2-6 months and that was it.   She had Pfizer COVID vaccines, and the third one she had a bad reaction to, her lymph nodes swelled up and it bothered her as long ago she had breast cancer, this was last spring.  She talked to her doctor about it, and had a Moderna vaccine in October.
I received my first dose of the  Moderna vaccine  at 0830 am and my symptoms began at 1900 for about 36 hours.  Fever, chills and body aches.
Patient became faint, assisted from sitting position to lying RL on floor. Brief syncope but responded spontaneously wet wash clothes applied to forehead and neck - after 5 - 10 minutes assisted back to chair in good condition.
Normal temperature; very hot to touch; very sleepy for 1 1/2 days. Treated with children's Motrin.
Patient is a 16 year old female here with mother, complaining of right deltoid pain since MCV4 and Men B vaccination on 07/20. Injection pain up to her neck, later radiating down to wrist. No medication yet.
Patient received 3 doses of vaccine due to overdraw from vial.  Patient monitored for 30 min after injection.  Experienced some aching at site of injection comparable to expected side effects.  No other adverse effect of overdose noted in the 30 minute observation period.
Tested positive for COVID-19 on 10/10/2022. I  lost my sense of smell and taste ;developed a cough, and had fatigue for 2 days.