chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from the healthcare professional on 02-Oct-2014. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of FLUZONE (Lot number UI187AB, Dose number not reported previous dose were reported as many) in the left deltoid, on 29 Sep 2014. On 29 Sep 2014, on the same day of vaccination, the patient's left arm injection site was red, rash area size of a silver dollar which was raised and itchy. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical history were unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was not recovered. Documents held by sender: none. Follow-up unsolicited report received from a healthcare professional on 12 January 2015. It was reported that the patient had not experienced any adverse reaction after the previous vaccination. On an unspecified date the patient was recovered from the event. Documents held by sender: none. Addendum: 05-March-2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product code from 271 to 450.
30 minutes, post vax, pt developed eyelid swelling that lasted 30 minutes. The pt recovered completely. On 4/7/01, HIB skin testing was given and as it was negative, pt was vaccinated without incident. Further testing is pending. This case illustrates the clinical problem of having multiple vaccines given on the same day: when there is an adverse reaction, all of the vaccines become suspect as the causative agent; even if the event cannot be proven to be due to vaccination.
pt's wife had called said on the phone that "my doctor said my husband passed away due to covid vaccine and I was told to call pharmacy"
Patient presented today with "hives" along her left arm, her back, as well as on her chest/breast area and her left underarm. Patient saw her primary physician and received RX for antiviral and pain rx. (Filled elsewhere, so no other info available.) MD told patient to return to Immunization site to assure her reaction was reported.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 42-year-old female patient who received SHINGRIX for prophylaxis. On 29th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, cold and nausea. On 29th November 2018, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the tiredness, muscle pain, cold, nausea and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the tiredness, muscle pain, cold and nausea to be related to SHINGRIX. Additional details were provided as follows: On 29th November 2018 in the late evening the 42-years-old patient received a dose of SHINGRIX vaccine in the left arm, which led to inappropriate age at vaccination. On 30th November 2018 in morning, the patient woke up and experienced tiredness, muscle ache, felt cold and nauseated. The patient called while she was waiting to see her doctor at her doctor's office. The patient did not give consent to follow-up. Emergency room (ER) visit required. No further details were provided.
hive reaction with a rash 10 days after my booster.; still have the rash; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hive reaction with a rash 10 days after my booster.) and RASH (still have the rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hive reaction with a rash 10 days after my booster.) and RASH (still have the rash). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hive reaction with a rash 10 days after my booster.) outcome was unknown and RASH (still have the rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient developed a hive reaction with a rash 10 days after the booster.   This case was linked to MOD-2022-437361 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah) and LETHARGY (lethargic and has no energy whatsoever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, CYANOCOBALAMIN (VITAMIN B12 AAA), ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN, METFORMIN, SEMAGLUTIDE (RYBELSUS) and SEMAGLUTIDE (RYBELSUS) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site). On 17-Feb-2021, the patient experienced DECREASED APPETITE (not eating) and VACCINATION COMPLICATION (not feeling good, blah). On 18-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (throwing up). On 19-Feb-2021, the patient experienced ASTHENIA (no energy) and LETHARGY (lethargic and has no energy whatsoever). On 14-Feb-2021, VACCINATION SITE PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site) had resolved. At the time of the report, DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah), LETHARGY (letargic and has no energy whatsoever) and VOMITING (throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non Significant Follow up appended.  Reporter contact information updated - mail ID provided
Pt had TDAP vaccination in the (L) arm 7/29/09. Following morning she had swelling and a hard lump in the (L) upper arm. The site was itchy and painful.
INJECTION SITE IRRITATION AND ITCHING, SWELLING AT INJECTION SITE AND SOME BLEEDING.
Balance off; Tiredness; Having trouble moving/Having trouble getting up and down; Sore arm at injection site; Having trouble speaking(Slurring words); Forgetfulness; Mushy brain; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 14:15 at age of 68-year-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included diabetic, chronic heart disease, chronic kidney failure, blood clot in lung. Known allergies included warfin. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021 04:45 PM, at age of 68-year-old in Right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); bumetanide (BUMEX); gabapentine (GABAPENTINE).  The patient experienced balance off, tiredness, having trouble moving/having trouble getting up and down, sore arm at injection site, having trouble speaking(Slurring words), forgetfulness, mushy brain on 14May2021 with outcome of not recovered. No treatment was received, the events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately eight hours after receiving the shot, I started getting a headache, body aches, and chills (April 3rd, 8 p.m.).  I went to bed and had severe chills and body sweats for the entire night.  The primary symptom to report is that my heart raced all night.  It felt like it was beating at about 140 to 150 Hz or higher.  When I woke up in the morning, it felt like my chest had been pounded on all night.  The pain was in my sternum area.  The headache and body aches took a little over a day to go away.  The chest pain took a couple of days to die down.  On April 12th, I walked my dogs in the morning and felt out of breath, which isn't normal for me.  In the afternoon, while working at my desk at home, I started getting more and more severe chest pain and then started getting dizzy and felt weak.  I drove myself to the local ER and they tested me for a heart attack.  All tests came back negative.  They suggested going to another facility to get checked for clots or to make an appointment with a cardiologist.  The next day, after talking to a doctor friend, he suggested going to the ER facility to get imaged for clots and to get fully checked out.  No cardiologist appointments were available till the next week.  I went to the ER facility and was there for seven hours getting tested.  They came back and said all test results were negative and that my heart looked fine.  They did not have any suggestions for what might be causing the pain in my chest.
FULL ON FLU SIX HOURS LATER (FULL ON FEVER, LIKE 100 SIX HOURS LATER AND IT WAS HORRIFIC NIGHT INVOLVING "SHEETS ON, SHEETS OFF" (DUE TO BEING FEBRILE); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced full on flu six hours later (full on fever, like 100 six hours later and it was horrific night involving "sheets on, sheets off" (due to being febrile). Laboratory data included: Body temperature (NR: not provided) full on fever like 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full on flu six hours later (full on fever, like 100 six hours later and it was horrific night involving "sheets on, sheets off" (due to being febrile) on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210905634.
About 12 hours after the vaccine, I started developing chills and joint pain.  That night, I developed fevers that persisted for about 24h (spiked about 5 separate times - highest fever was 102). Then, on the third night after the vaccine (about 60 hours post vaccine), I had two separate episodes of night sweats (clothes were drenched, no fever). Later that night I had a bowel movement with bright red blood.  I then went to an urgent care where they drew labs, send a Covid swab, ordered stool studies, and ordered a CT abdomen.
Immediately following administration, while needle was being pulled out of right deltoid, patient reported headache, and subsequently fainted. She was supported into a lying position from a seated position on the exam table. She did not injure her head. Writer was called into the room and observed the patient in a lying position, eyes open with dilated pupils but unresponsive. She was diaphoretic, and exhibited jerking movements of her upper extremities. After a period of about 20 seconds, she regained consciousness. She was alert and oriented x 3, but pale and diaphoretic. She was assisted into a seated position, and vitals were normal for age. Heart rate and rhythm were regular. Pupils reduced back to original size. She reported some nausea, but otherwise no pain.  She was observed in office for a period of 30 minutes, and was released to mother with no further complications. Her mother was at the bedside the entire time. Diagnosis is vasovagal syncope as an adverse reaction to vaccination.
Patient is complaining of shoulder soreness and shooting pain in arm. Pt also stated weakness and inability to lift heavy objects above shoulder.
Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
It was reported that a male patient received a Tripedia, an IPOL, a MMR vaccination and a TB skin test on 1/30/01. Reportedly on 2/1/01, the patient developed a local reaction of redness and swelling. Reportedly the patient recovered from this experience.
fever within 24 hours, signification memory impairment that did not resolve.  Patient went from remembering such as were things were placed or names of objects to being unable to remember where things are located.
The morning after my booster shot, my right armpit had a tennis ball sized swollen area that hurt. While that shrunk over the course of the first week, a lumpy rope seemed to extend into my right breast. My breast hurt along the rope and it looked like a scar, with the breast misshapen from the rope. The pain increased and I went to urgent care at the two week mark. The provider prescribed an urgent ultrasound and consultation with the breast care clinic. The pain persists, especially when braless, and the ultrasound is tomorrow.
Red, blotchy rash forming on and below chest and neck appearing about an hour after vaccination. Not itchy. Resolved within an hour.
Case number PHEH2014US003598 is an initial spontaneous report received from a pharmacist on 20 FEB 2014. This report refers to patient who age was less than 17 years. The patient's medical history and concomitant medications were not reported. This patient who was under 18-years was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unspecified date. No adverse event was reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 20 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a 4-year-old male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018). On 14th August 2017, the patient received KINRIX. On 16th August 2017, 2 days after receiving KINRIX, the patient experienced erythema of extremities, swelling arm and rash. In August 2017, the outcome of the erythema of extremities was recovered/resolved. On an unknown date, the outcome of the swelling arm and rash were unknown. The reporter considered the erythema of extremities to be almost certainly related to KINRIX. It was unknown if the reporter considered the swelling arm and rash to be related to KINRIX. Additional details were reported as follows: The patient received KINRIX in the left deltoid and experienced huge red, swollen rash that covered most of the arm. On 16th August 2017, the patient had a doctor visit. The healthcare professional gave her consent for follow up from safety. This case has been linked to case US2017130468, reported by the same reporter.
65 yr old male who took his meds this morning, Moderna vax given @ 0840; had reaction to vaccine with HA, change in mentation, and diaphoresis,  EMS called and pt transferred to ER;  pt has SOB with POX down to 94 percent;  went to 91 percent;  with epi pen given at 08:51  pt went to 100%;   due to his symptoms, pt sent to ER;
Patient got first vaccine dose 78 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got first vaccine dose 78 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got first vaccine dose 78 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got first vaccine dose 78 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
After the vaccine I had like a stroke and the stroke did not progress because I went to emergency room. Diagnostic: Bell's palsy. Half right of my face was paralyzed and the right eye cries. there is no movement on that side of the face, the nerves are paralyzed. My neck hurts a lot (near the right ear) my ear hurts a lot and I feel like air in my ear. Doctor gave me medicine (asteroids).
Headaches started day after vaccine but subsided within three days. December 23:  Lost consciousness and fell to the floor at 6:45 AM.   Felt nauseated remainder of day. December 24:  Felt better and continued to feel better through December 27 and then started feeling slightly weak at times. December 29:  Felt like I might pass out again so I lay down in recliner.  Went to ER at local hospital but they could not find any reason for lightheadedness or loss of consciousness.  Continued to have intermittent nausea and lightheadedness and consistent but slightly subsiding muscle weakness in arms and legs over the next 6 weeks. January 9:  Had severe nosebleed at 5:00 PM that lasted 20 minutes.  Felt very weak, cold, and dizzy.  Went to ER at local hospital again.  They could find no cause for my symptoms.    I have also had major fatigue and decreased heart function that has ever since December 29. Have visited cardiologist for tests and will have more tests. None of these symptoms were present before the December 18 COVID booster.
Approximately 10 minutes after receiving the MCV4 vaccination we left the Dr. office only to have my daughter say she didn't feel well and she passed out.  Her breathing was heavy until she came within a minute, but she was extremely tired afterwards and just rested the rest of the day.  2 weeks later on July 31, 2009 she had a major (Tonic-Clonic) type seizure, 4 weeks later on August 28, 2009 another seizure.  Since that time she has had 3 more seizures (March 24, 2010, April 26, 2010 and May 1, 2010) for a total of 5 as of this date.  Never had any health issues whatsoever until this vaccination was given!!!
I almost immediately started getting soar in my arm.  After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy.  Headaches were present most of the first day.  That night, around supper time I felt nauseous and then had some severe stomach cramps.  I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head.  Most of the symptoms were gone after 48 hrs.
postherpetic neuralgia; trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered severe sudden pain on the right side of his forehead and right temple region. The patient presented to his medical provided and was diagnosed with postherpetic neuralgia and trigeminal neuralgia. Despite receiving treatment, the patient continued suffering from postherpetic neuralgia and trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient symptoms resulted in physical limitation not present prior to zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's conditions. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, included medical expenses; loss of accumulation; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of postherpetic neuralgia and trigeminal neuralgia were considered to be disabling.
Client received 1st Pfizer COVID vaccine dose lot # FD0809 exp. 10/2021 on his left deltoid. At 1400, client reported to EMT feeling ?dizziness and fast heartbeat?. EMT put client in the zero-gravity chair and provided client with water and chips/Capri Sun who drank only half a bottle of water at 1410 because client told he didn?t eat lunch before coming to get his 1st Pfizer COVID vaccine. Lead nurse came over to assist EMT found client sitting a semi-fowler?s position in the zero-gravity chair, pale and sweaty noted. EMT assessed client who was alert and oriented x 4. Client reports no medical history, no known allergies, or medications. EMT took client?s following vitals at 1400: blood pressure (BP) 125/69, pulse (P) 61, respiration rate (RR) 20 with skin clammy and cold, dizziness and fast heart beat; 1410: BP 146/83, P 73, RR 18, skin cold and dry, reported no more dizziness or fast heart beat; 1415: BP 150/88, P 67, RR 18, skin cold, dry and reported no more dizziness or fast heart beat; 1420: BP 138/82, P 67, RR 20, skin warm and dry, and reported no more dizziness or fast heart beat; 1425: BP 140/84, P 68, RR 18, skin warm, dry and reported no more dizziness or fast heart beat; 1430: BP 138/86, P68, RR 18, skin warm, dry, and no more complaint of dizziness or fast heartbeat. Lead nurse gave education about adverse reactions, ER precautions, and V-Safe. Lead nurse referred client to seek medical care for his high blood pressure and gave him resource to apply for health insurance and connect to a medical home. Client left the facility at 1435 alone in a steady gait to board the city bus home.