chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting roughly 9 hours after injection started to feel fatigued. When I woke up the next day I had a fever of 101.4. I got up for a few hours and then went back to bed from about 11am to 4pm. I took two Tylenol 8Hr caplets in the morning, two more about 5pm and one more about 9. I felt fatigued and had the chills most of that day. The next day I woke without a fever and didn't take Tylenol. About 1pm I started feeling fatigued and sweaty. I laid down and checked my temp which was around 99.6. I slept for a few hours and also took two Tylenol. The third day I woke feeling pretty good. No fever. However was tired in the afternoon and laid down for a few hours. Fourth day was fine all around
p/vax pt broke out w/chickenpox w/approx 20 to 30 spots that looked like typical chickenpox;pt also exp some irritability & some itching;
Info has been received from an LPN via a company representative concerning a male in his "twenties" with a possible history of seasonal allergies and a history of vaccination with a dose of MMRII (lot unknown). Subsequently, "one of the men went on a trip to another country and developed mumps when he got back home to the US". It was also reported that "subsequent to his arrival home, he infected his roommate, who in turn infected a sibling". No additional info was available. The recovery status of the roommate's sibling is unknown. There was no product quality complaint involved. Additional info has been requested.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-DEC-2015, the patient's healthcare provider at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In January 2016, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
6 days of Mild headache that has gradually and steadily progressed to constant severe headache, hurts to move eyes, +photophobia, +phonophobia, but not her typical migraine.  Also anxiety.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 25-OCT-2012, the patient received a dose of intramuscular VARIVAX (Merck) (lot#, dose and frequency not provided) instead of ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
second dose >35 days after first dose; fatigue; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 25-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose). On 25-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) had resolved. At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Patient's concomitant medication include- thyroid tablet.  No any treatment medications were reported.   Reporter did not allow further contact
On the sixth day after the vaccination at the site of the vaccination  on the left upper arm I experienced slight swelling, redness, and itching.
18 hours in - nausea. Lasted 3 days after. 24 hours in - woke up in middle of night with racing heart. 3 days in - arm pain at site. Still going on 6 days in - full body aches. Still going on.
FINGERS ARE VERY STIFF AND SORE; THE ARM IN WHICH THE VACCINE WAS INJECTED WAS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced the arm in which the vaccine was injected was sore. On 24-MAR-2021, the subject experienced fingers are very stiff and sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the arm in which the vaccine was injected was sore and fingers are very stiff and sore was not reported. This report was non-serious.
10 days post immunizations, pt had a pin point rash on his body resembling a heat rash (and he had been outside).  Now 12 days after, pt has large, red spots all over his whole body.  He is afebrile, but not sleeping as well, more fussy and clingy, drinking fluids, but not eating as many solid foods.  He is not actively itching his skin anywhere.
Admitted for altered mental status and dyspnea.  NSTEMI, elevated trops., COPD exacerbation
This spontaneous report as received from a health professional refers to a 12 month old patient. On 16-JUN-2014 the patient was vaccinated with a MMR II (lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Acute episode of delirium with diagnosis of encephalitis, specifically, Immune mediated encephalitis. Patient had acute confusion beginning 10 days after his second Pfizer Covid Vaccine dose. Extensive work for metabolic encephalopathy was negative. CSF studies showed autoimmune encephalitis. He was treated with Plasmapharesis for 4 days, High dose steroids, 1000mg three day Sina row and then weekly, IVIG and Ritiuxan without any resolve. Patient remains in delirium state.  He was initially in hospital in (HOME CITY)  then a specialist clinic.
Extreme fatigue, foggy mind, for 48 hs starting six days after vaccination.
It is now almost 2 weeks since my vaccine. I didn't have any adverse affects until this morning.  When I woke up my arm was sore at the sight where I got my shot.  Several hours later there is a red spot like a big hive around where I got the shot.  It doesn't itch. Its now not as sore as this morning.  Its not major but I thought you should know since the symptom tracking is only for 7 days following the shot.
Swelling, redness, hot to touch, arm pain. Treatment: Depo-Medrol 80 mg - injection - one time. Clindamycin 300 mg 1 tab - 3 times a day.
Moderate pain right deltoid x24h beginning several hours after shot.  Low back pain beginning 9 days after shot continuing for at least 4 days (to present) unrelated to any activity.
PAIN, SWELLING IMMEDIATELY AFTER INJECTION. APPLIED ICE PACK AFTER 1 HOUR FOR A FEW MINUTES. BRUISE DEVELOPED AT INJECTIOIN SITE APPROX 3 X 4 INCHES IN SIZE THE NEXT DAY.
A day or two after symptoms started sore muscle at injection site, chronic stuffiness in nose similar to seasonal allergy. Patient complains of being achy and groggy. Continued through today 11/15/16.
Headache, Myalgia, NauseaVomiting, abdominal pain, congestion
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse.  This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and Expiry date not reported) via intramuscular route in the left deltoid on an unknown date which was outside of the recommended temp range. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patient's were given vaccines that were outside of the recommended temp range). No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Felt chilly after the second dose; Lost of taste; This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiry date: unknown) via an unspecified route of administration, in right arm on 08May2021 12:30 PM (at age of 47 years old) as dose 2, single for Covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733, Expiry date: unknown) via an unspecified route of administration, in left arm on 17Apr2021 12:00 PM as dose 1, single for Covid-19 immunization. Patients concomitant medication included Fenofibrate taken for an unspecified indication at 145 mg received within 2 weeks of vaccination. patient had no known allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and patient been not tested for COVID-19 since the vaccination. The patient felt chilly after the second dose on the second day, 09May2021 of the shot and recovered on the third day, 10May2021. He also experienced lost of taste on 09May2021, but not recovered yet. Patient did not take any treatment for the events. Outcome of the events chills was recovered on 10May2021, and loss of taste was not recovered. No follow-up attempts are possible. No further information is expected
This case was reported by a physician via call center representative and described the occurrence of myalgia in a female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Previously administered products included allergy medication (receiving allergy shot compounded with extract and glycerin, once monthly for over 20 years without issue). On 19th March 2018, the patient received SHINGRIX .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, headache, shivering, fatigue and inability to work. On an unknown date, the outcome of the myalgia, headache, shivering, fatigue and inability to work were unknown. It was unknown if the reporter considered the myalgia, headache, shivering, fatigue and inability to work to be related to SHINGRIX. Additional details were provided as follows: The case was transferred by the GSK Vaccine Service Center. The reporter did not have an exact date of birth to provide during the call but said that this patient was past 60 years old. The reporter could not recall during the call which arm she had administered the SHINGRIX vaccine, but said it was the upper arm deltoid muscle. The symptoms started not immediately but at some unknown time before the next morning on Tuesday. The patient called the doctor the next morning after the day the vaccine was administered to report the symptoms. The patient did not report any pain or redness at the site of injection. The doctor did not know if the reported shivering indicated any fever. The patient had not been able to go into work since receiving the vaccine. The symptoms were not resolved by yesterday when the doctor last spoke with the consumer. The status of symptoms was unknown at this time. The patient received an allergy shot subcutaneously in each of the patient's lower arms the same day as the SHINGRIX. The patient had been receiving allergy shot compounded with extract and glycerin by the reporter once monthly for over 20 years without issue. The patient granted permission to be contacted by Regulatory Authority. A nonrelated QA follow up for an entirely different case UV20180076 in which no product was administered to any consumer was submitted during the call. The lot number was the same for that case as for this one. The reporter said the patient had no quality concern with the product which was administered to this consumer. The lot number and expiration date was provided from the product box, as the product was already discarded. The call was transferred to the GSK MI team regarding the inquiry of whether or not the patient should have a second dose of SHINGRIX in the series.
Shortly after vaccinated: broke out of cold sores in places on the face where 2 had before had a cold sore. Have had 3 outbreaks in nostrils (nose).
Initial and follow-up information has been received from a pharmacist concerning a 61 year old female patient with a history of sores which lasted for about 6 months, then resolved and later reappeared, who on 17-SEP-2008 was vaccinated with a first dose of ZOSTAVAX (Merck).  On 18-SEP-2008, on the next day, the dentist noticed a white sore in her mouth.  Neither the dentist nor the pharmacist felt this related to the vaccine.  The dentist ordered VALTREX.  This pharmacist stated that the sore in his mouth was prior to receiving ZOSTAVAX (Merck).  The patient had not taken the VALTREX yet.  Additional information is not expected.
Severely swollen supraclavicular & axillary lymph nodes on the left side; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 27Feb2021, the patient experienced severely swollen supraclavicular and axillary lymph nodes on the left side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severely swollen supraclavicular and axillary lymph nodes on the left side was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Narrative: COVID infection after COVID vaccine series 04/05 COVID vaccine dose #1 04/26 COVID vaccine dose #2 12/07 pt. presents to ED C/o body aches, dry cough, dizziness/light headiness, fever, " body felt sick" exposed to positive case at party, tested for COVID, treated with ketorolac and IV Fluids, COVID positive 12/10 pt. administered Casirivimab/imdevimab in ED, discharged to home.
Information has been received from a nurse practitioner concerning a 25 year old female who on 21-JAN-2008 was vaccinated with her first dose of GARDASIL intramuscularly in the right deltoid. Concomitant medication included MIRCETTE. The patient waited for 20 minutes but when she attempted to leave she became dizzy and sweaty. The patient sat down and proceeded to lean to the side and hit her head on the side of the table. No injury was sustained. The patient was placed on the bed and after 10 minutes the patient was ready to sit up and left after 20 minutes. The patient's blood pressure and heart rate were within normal limits. The patient recovered. Additional information has been requested.
SINCE COVID SHOT. RIGHT HAND HAS BECOME VERY PAINFUL., MORE NUMB AND TINGLEY.  I HAVE Neuropathy AND IT HAS MADE MY Neuropathy MORE PAINFUL. .  LEFT HAND WAS THE SAME AS RIGHT HAND BUT THAT HAS STAYED THE SAME.
myalgia after injection beginning 1 day later. Given symptomatic treatment. Lortab 57500 QID till better
TUNNEL VISION; CHEST PAIN/PRESSURE; WEIRD TASTE IN MOUTH; DRUNK FEELLING; CRAZY DREAMS; DIZZINESS; NAUSEA; SHOOTING INJECTION SITE PAIN; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient 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, and batch number: 041A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient immediately felt dizzy and nausea. Later, she developed tunnel vision, chest pain/pressure, shooting  pain in arm of injection up into jaw (left side) and weird taste in mouth for 6-7 hours. She felt drunk and developed muscle aches. She had crazy dreams and headache. She took Tylenol (paracetamol) about  3-4 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pressure, chemical taste in mouth, and shooting injection site pain on 07-APR-2021, tunnel vision, drunk feeling, nausea, and muscle ache on 08-APR-2021, and headache, was recovering from dizziness, and had not recovered from crazy dreams. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416274-Covid-19 vaccine ad26.cov2.s-TUNNEL VISION . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Injection site got swollen, big bump, red, hot to touch, painful to touch, headache, lower back pain, muscle aches, face warm to touch no fever at time temp 99 oral.
After flu shot flu symptoms and strange weakness starting on 10/11/2010.  Flu symptoms except for nausea and weakness went away within 3-4 days.  Nausea eventually went away.  Weakness pronounced on 110/14/2010.  Went to the Dr. and then to the emergency room on 10/15/2010.  Diagnosed and treated for Guillain Barre.
Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore throat, nausea, vomiting, diarrhea, altered taste Also complaint of intermittent acute shortness of breath and cough
Abnormal bone marrow function: Drop in WBC which has persisted since the vaccination. Also, had abnormal drop in RBC following standard blood donation that persisted for two weeks.  Associated with four bouts of diverticulitis 11/21-1/22. The last time I had this condition was well over 10 years ago. This pattern was completely atypical for me.
Chills, low grade fever 32 hours post vaccine. This lasted 4-5 hours. Sore muscles, flu like feeling.
Retinal tears/detachment; Retinal tears/detachment; Severe swelling of knee; This is a spontaneous report from a contactable consumer (patient).   A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 26Feb2021 08:45 (Batch/Lot Number: EN6203) at a single dose for covid-19 immunization.  The patient's medical history concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine neither received any other medications within 2 weeks of vaccination. He was also not diagnosed with COVID-19 prior vaccination and has not been tested since the vaccination.  The patient experienced retinal tears/detachment and severe swelling of knee on 27Feb2021 07:30 am; all with outcome of recovered with sequelae (recovered with lasting effects).  Therapeutic measures were taken as a result of retinal tears/detachment and severe swelling of knee. Patient received multiple laser treatments. The events were assessed serious- disabling/Incapacitating.
PT called clinic on 8-14-2020 reporting redness, tingling, swelling @ injection site extending on lateral surface -> elbow. Injection given on 8-12-2020, sx started 8-13-2020 and progressed. Dr provided a T/O of Doxycycline 100mg PO BID x10 Days. Dr. also suggested cool compresses and Ibuprofin PRN. On 8-17-2020, pt called reporting by 8-16-2020, swelling resolved and discomfort decreased significantly - 0 tingling.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus, Sjogren's syndrome, Myopathy (small cell fiber myopathy) and Myalgia (fiber myalgia).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-020819, MOD-2021-020819 (Patient Link).
Pt had immunization 2-3-09 and was fine with injection. On 2-4-09 mom states Pt had 101 degrees temp and pt leg had swollen up the size of baseball where DTaP was given. mom took child to emergency room where ice was applied to injection site.
pt recv vax 5PM & @1015PM pt started screaming & throwing head from side to side;took to ER;BY 11PM pt had calmed;some whining/fussiness for next 1/2hr to hr;ER watched pt, no medication given;
The day after vaccination, father states that child returned from track practice feeling tired. She went to lay down and he found her face down on her bed, unresponsive and cyanotic.
Redness, swelling and itching. Patient was treated with prednisolone (15 mg/5 ml) 1 teaspoon qD x 3 days.
Redness, swelling, heat at vaccine site on right arm plus rash that spread from injection site down arm that itched intensely. It is improving, but she still has the rash.