chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a hospital (Emergency department) for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacist refers to a female patient of unknown age. In approximately July 2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed injection site reaction as redness and rash at the injection site about 4 or 5 weeks ago in approximately July 2012. The injection site reaction and rash was reported to have developed about a day after vaccinations with ZOSTAVAX. The injection site reaction and rash was treated with cold compresses and ADVIL and resolved after an unspecified number of days, in approximately July 2012. No other information was reported. Additional information has been requested. This is one of several reports from the same source.
4 Hours after vaccines, face began to swell and had difficulty breathing. Parents took client to the ER and he was given a steroid and benadryl and sent home. Continued the benadryl for 3 days and according to parents, swelling down and client no longer having issues with breathing.
Developed cellulitis.  PCP diagnosed and prescribed RX for Cephalexin  500mg  4X/day for 10 days.  Condition cleared with no additional adverse affects
Immediately upon injection I felt totally dizzy as though I was drunk, slight pain at base of tongue left side. The dizziness somewhat passed within 40 minutes but not totally, same with slight pain at base of tongue left side. Went to bed as normal but awoke to having great difficulty breathing as soft tissue around entire neck was swollen as were lymph glands around neck area, that was pressing against my airway making it seem like I was suffocating slowly, being strangled by all the swelling. Hospital injected me with mega dose cocktail of large amount of steroids, Benadryl.  Symptoms subsided quite a bit at hospital only to keep continuing for nearly 2 weeks after. Because of this on Tues March 2, 2021 I had an appointment with my family doctor because the swelling was still quite intense. She put me on a 3-5 day dose of Prednisone.  I still have some swelling going on in my neck area from it today 3/20/21.  On item 21 I clicked Permanent damage as I'm unsure if this swelling will be permanent and continue to come and go at this time or totally subside eventually. It's unknown at this time.
No additional AE/PQCs reported; Administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis, lot number reported as T015598 and expiration date as 02-NOV-2021 (dose, vaccination scheme and route of administration were not provided). No additional adverse event reported.             The vaccine had a temperature excursion of 20.5°F (degree Fahrenheit) for a time frame of 1 hour 54 minutes, and the data was recorded by a digital data logger. It was also reported a previous temperature excursion of 6°F to 14°F (12.3°F) for 23 hours.
Immediate cry after vaccine administration, held breath, chills vs shaking, arms & legs lasted about 10 mins. Shaking stopped when arms or legs are held. Fever of 102 around 1:00 p.m.
Initial report received from a healthcare professional on 25 October 2012. A 53-year-old male patient had had no known allergies and no relevant medical conditions; had received 1st intradermal dose of FLUZONE ID (Lot number unknown) in left deltoid on 24 October 2012. The patient had received several doses of FLUZONE intramuscular on an unspecified date. The patient concomitant medication detail was not reported. As per reporter illness at the time of vaccination was none. On 24 October 2012, in the afternoon the patient experienced soreness at the injection site and swelling. Later that night the patient began to experience more swelling and redness at injection site which was 2-3 inches around injection site. The patient also experienced swollen glands of upper neck at left side of the neck. The forehead felt slightly warm and did know if the patient had fever. The lab investigations and treatment medications were not reported. At the time of this report, the outcome of the events was not recovered. Documents held by sender: None.
It was reported that a 40 year old male pt received a dose of Typhim Vi and a dose of hep A in the deltoid on 10/28/03. The following day, the pt developed facial swelling and a dry throat. Treatment included Benadryl and Medrol dose-pack. The pt's recovery status is currently unknown.
Rash,full of rash, on face, back, stomach, and stated it's traveling to my whole body; fatigue; headache; Muscle pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash,full of rash, on face, back, stomach, and stated it's traveling to my whole body), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012020A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Cholesterol. Concomitant products included TRAMADOL and VITAMIN D NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and PYREXIA (fever). On 07-Feb-2021, the patient experienced RASH (Rash,full of rash, on face, back, stomach, and stated it's traveling to my whole body). On 07-Feb-2021, FATIGUE (fatigue), HEADACHE (headache), MYALGIA (Muscle pain) and PYREXIA (fever) had resolved. At the time of the report, RASH (Rash,full of rash, on face, back, stomach, and stated it's traveling to my whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as Cholesterol Medicine, Thyroid medicine No Treatment information provided; 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, a causal relationship cannot be excluded.
Right arm swollen from shoulder to elbow and warm to touch. Tx: Motrin, Benadryl PRN and cool compress X 24 hours.
After several hours, patient describes pain, numbness and cramping down left arm, muscle spasms causing fingers to curl, shortly thereafter generalized muscle aches and fever up to 101.  3 days later rash which has now been identified,  with PCP,  as herpes zoster.  She has no known history of shingles in the past.
102 fever, extreme chills for several hours. Achy and fatigued for over 24 hours after vaccine
General pain in the arm with pressure feeling going up the neck, reaching the ear.  Feeling of weakness. Episodes of extreme nausea with a feeling of a hot flash (feeling very hot all of a sudden). Almost to the point that it feels like I'm going to pass out. Abdominal cramps with diarrhea.  Headache.
Severe muscle aches, temp 102.3, localized swelling of right deltoid region, approximately 8cm diameter red area with 2 other 1cm small  areas, lymph node swelling under right arm.
Dizzyness, Blacking Out/Fainting upon first getting out of bed in the morning. Had to ease myself down to the floor to avoid possible fainting and hitting the floor. Regained normal functioning after a short while.
Redness and swelling below injection site. Warm to touch. Area roughly 2 in x 1in
I was notified by the school nurse, that this patient was have an itchy throat and a swollen tongue for over 30 minutes after vaccination.  I spoke to the patient. She said that her symptoms has not change in intensity during her wait. In consultation with the nurse, I decided to give a 50 mg Diphenhydramine dose and check on her progress after a few minutes.  After 10 to 15 minutes,  the patient said her symptoms seems to be lessening. But, the symptoms were still there.  EMS was called. They evaluated the patient and decided to take her to the closest hospital.
pt recvd vax;approx 2 hrs later, c/o pain at area of shot;felt tired,had low grade T;apap for fever;vx1; c/o ha; rash enlarged in rt arm;noted macular rash; rash has  slightly raised borders;
severe shakes; felt warm/as the day went by he got hotter and hotter; reaction was like a reoccurring malaria; 100.5°F temperature/high fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills). On 11-Apr-2021, TREMOR (severe shakes), FEELING HOT (felt warm/as the day went by he got hotter and hotter), VACCINATION COMPLICATION (reaction was like a reoccurring malaria), PYREXIA (100.5°F temperature/high fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 100.5f (High) fever.         No concomitant medications were reported. No treatment medications were reported. The shaking and the high fever started and lasted probably 4-6 hour and chills that lasted 4 hours.   This case was linked to MOD-2021-067714, MOD-2021-395970 (Patient Link).
At trampoline park 3 days prior to onset of sx. Onset of arm weakness and paresthesias about 12/29. Seen in local peds er 12/30 and seen again with progression/worsening on 12/31. Abnml spine MRI from C4 to T1, admitted to Hospital 12/31 with dx of transverse myelitis. Loss of grip in hands, arm weakness, numbness, and progression to truncal numbness/abd discomfort. Progression until unable to ambulate. Brain MRI nml, Given high dose steroids and plasmapharesis with gradual improvement. D/C home on 1/10/2019. F/U with neurologist dr. Still with bilateral upper ext weakness and numbness with slow improvement. Labs for systemic inflammatory illnesses neg. Aquaporin-4 antibody neg. Plan repeat labs and MRI in 3 months.
multiple, unknown patients developed "COVID arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm) 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 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 VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm). At the time of the report, VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided Concomitant drugs were not provided
Chest pains occurring around 4 hours after vaccination.  More acute than generalized, located on the left side of the chest, a few 3-4 fingers above & inside the left nipple.  Filling this form out during the first 45-60min of symptoms, relatively acute pain has also ebbs/flows, comes in waves - eg few on, 1 off.
Slight body aches; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 15Feb2021 at 11:45 am (age at vaccination was 37 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient had known allergy to gluten. Concomitant medications the patient received within two weeks of vaccination included probiotics and vitamins taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 27Jan2021 at 10:30 am (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Feb2021 at 19:00 pm, the patient experienced slight body aches. No treatment was received for the adverse event. The outcome of the event was resolved on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
Patient's mother referred that her son  presented fever, vomiting and inflammation in the injection-site. He received Tylenol and Pedialyte for 24 hours. He was seen by the pediatrician.
Student returned to imms area approximately 40 min. after receiving Injectable H1N1 stating he was very "dizzy, chest is heavy".  Assisted to cot, placed supine, skin cool and clammy, eyes were dull PER, "my voice feels thick, I don't talk like this".  Oriented to person, time, place.  Parent notified.  student remained pale and dizzy, shallow respirations X 45 minutes, began to feel better, parent did not come to school, student requested to return to class,"feeling fine now".  Permission to return to class given.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 26-JUN-2017, the patient was vaccinated by a nurse with an expired dose of ROTATEQ (lot # L033545, expiration date: 30-MAY-2017) (exact dose, route of administration were not reported) for prophylaxis. No adverse effects was reported. No product quality complaint was involved. Additional information has been requested.
Pt cried for a prolonged period of time, post vax. Also, happened at 4 month exam.
5.5 x 5.5 cm induration and erythema on right upper thigh.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 3:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 2:53 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 9AM, 32 degrees Fahrenheit at 10AM and 34 degrees Fahrenheit at 11AM. 10 vials of same batch number were moved to fridge on 16-Mar-2021, moved to clinic on 21-Mar-2021 and beyond use date for these 10 vials were reported as 15-Apr-2021.   Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 35 degrees Fahrenheit at 3 pm. 30 vials of same batch number were moved to fridge on 09-Feb-2021, moved to clinic on 13-Jan-2021 and beyond use date was reported as 10-Mar-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
I still have bad headaches; it burned my skin instantly; I had fever 103.2 for 4 days; terrible body aches for 3 weeks; I had a red rash on my arm; This is a spontaneous report from a contactable consumer (patient), received via Pfizer RXPathways. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Patient reported that she had the second vaccine 3 weeks ago and she still had bad headaches (2021). Patient had a rash on her arm and it burned her skin instantly (2021). On an unspecified date in 2021, she had fever 103.2 for 4 days, terrible body aches for 3 weeks, she had a red rash on her arm. The clinical outcome for the events was unknown except not recovered for I still have bad headaches and recovered for I had fever 103.2 for 4 days and terrible body aches for 3 weeks on an unspecified date in 2021.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
About six weeks after my second Pfizer mRNA vaccine I had a sudden experience of chest pain/tightness, right in the center of my chest. I considered going to a clinic but after a discussion with a medical professional I decided to wait it out (it didn't seem to be a heart attack). Two weeks later, the pain/tightness was still present so I went to urgent care twice over two weeks and received various tests (EKG, blood pressure, blood tests, and echo-cardiagram) and everything appeared normal. Two weeks after the first symptom started I also started experience pain in my limbs. It has now been over two months since the initial symptom and the symptoms are continuing. Interestingly, the symptoms are very similar to what I experienced when I had Covid (July 2020), which I fully recovered from within about a month and had been symptom-free until June 2021, when the symptoms described above started.  I understand 6 weeks is a long time for symptoms to be related to the vaccine, but due to the remarkable similarity between the post-vaccine symptoms and actually having Covid, along with no other presenting illness, I believe they may be related. I have also spoken to others who mentioned having similar ongoing symptoms after vaccine (chest pressure, limb pain).  After researching on my own, I think the vaccine could have triggered an immune response that is now over-active (autoantibodies). I understand there are current studies underway who are looking at the way autoantibodies may play a role both in long Covid and severe Covid cases.  Anyway, any information you have would be greatly appreciated. I am frustrated by the ongoing symptoms and would really just like to know what might be done, or what research is being done, to help correct an over-active immune response.   Thank you very much.
A couple of weeks ago I noticed a golf ball size swelling on my Left elbow.  I didn't know how it got and didn't even think that it may be an adverse reaction to the COVID-19 vaccination that I had until today.  I was searching the web to see what it might be and then I realized that I had the shot in my left a couple of weeks ago.  That's the only thing I could think that it came from.  I am going to call my Dr.s office on Monday to see if they want to look at it.  It just appeared one morning I noticed that my left elbow was very swollen like the size of a golf ball and it still is.
rash on trunk.  Not itchy.  Appeared the day of vaccinations.  No other symptoms.  Rash persists day 7 after vaccinations.