chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of shot, pt felt burning immediately as shot was given. For 2 days after had no use of the arm. She was in pain the entire time. After 3 plus weeks pt still feels pain, has minimal use of her arm and had and cannot lie down on this arm. TYLENOL extra strength makes it feel 75% better for a short time.
This spontaneous report as received from a physician refers to a 62 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX (once, lot number not provided) on approximately 08-OCT-2012, a week ago. No other co-suspects were reported. No concomitant medications were reported. The following day, on 09-OCT-2012 the patient came back to the office because the injection site was red and hot. The next day, on 10-OCT-2012 the patient came back again because the reaction area was larger and there was a white spot in the middle, which the doctor thought could be an infection. The doctor also stated that there were vesicles and that it could be rash. Antibiotics and steroids were given as treatment for adverse event. Adverse event improved after stopping therapy. Additional information has been requested.
Post vax, pt noted to have brief and frequent tonic activity, including dystonic movements of the mouth. No concrete pallor noted. Episode lasting 20 -30 seconds, followed by clenching of fists and crying. Notified EMS and pt given Benadryl IV in ambulance and brought to ER. Dr stated in his records that this episode highly unlikely due to vaccines.
On evening of vaccination at approximately 9:00 PM, patient had slurred speech. By late Thursday 8/12/04, patient acted drunk, was staggering and had slurred speech. On Friday, 8/13/04, patient complained of headaches, dizziness, and had mild fever, vomiting and neck pain on palpation. Was taken to ER; blood and urine tests normal. Was treated with Toredal and Naprosyn. Reaction attributed by ER MD to vaccines. Symptoms gone by Saturday 8/14/04 but returned in mild form 8/15/04. 8/17/04 no further symptoms.
This case was reported by a nurse practitioner and described the occurrence of possible muscular atophy or fat necrosis in a 7-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 24 November 2003, the patient received the second dose of Pediarix in his right thigh (lot 21893D9). On the same day, the patient received Haemophilus influenze type b conjugate vaccine (manufacturer unknown) and Influenza virus vaccine (manufacturer unknown). The site for the administration of Haemophilus influenzae type b conjugate vaccine and Influenza virus vaccine was not specified. On the same day, the patient experienced redness, and swelling at the injection site. On 26 November 2003, approximately two days after administration of Pediatrix, the swelling and redness at the injection site resolved and the patient developed "what appeared to be" and indentation at the injection site and "possible muscle atrophy or fat necrosis." Approximately two months later, " the patient was examined at the physician's office." The nurse practitioner considered the events to possibly be related to vaccination with Pediarix.
Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Symptoms similar to conjunctivitis; Eyes hurt with movement; Eyes red, lining of eye swollen and red; Eyes red, lining of eye swollen and red; Eyes red; fever; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 37-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0171), via an unspecified route of administration, in arm left on 22Apr2021 at 14:30 (age at vaccination 37 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient had any allergy or not. No other vaccine was taken in four weeks. The patient did not have covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: Er8737), via an unspecified route of administration, in arm left on 01Apr2021at 09:00 (age at vaccination 37 years) as dose 1, single for covid-19 immunisation. On 23Apr2021 at 14:30 the patient had eyes red and lining of eye was swollen and red, his eyes hurt with movement first few days of symptoms, reported the symptoms were similar to conjunctivitis on ,the symptoms occurred overnight after 2nd dose along with other more common side effects such as fever, chills, and headache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for covid post vaccination. The patient underwent lab tests included body temperature with unknown results on unknown date. Therapeutic measures were taken as a result of the events Eyes red, lining of eye swollen and red. Eyes hurt with movement first few days of symptoms. Symptoms similar to conjunctivitis with steroid eye drops as well as antibacterial. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient started to develop a rash on 8/31/2019.  The rash was spreading down his right arm.  He was seen by an instacare provider, which prescribed him triamcinolone cream.
Night of shingles immunization developed itch rash to arm and scalp, felt like her lips and hands were swelling. Patient took Benadryl and two days later presented to urgent care with red, rash to arms and hands. Still swollen, hard/red spot to injection site.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, chills, fever and mobility decreased. On an unknown date, the outcome of the pain in arm, chills and fever were unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, fever and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. On the evening of vaccination, the patient experienced arm pain, and was unable to move it for a while. The patient also experienced fever and chills.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Date the Vial was placed in refrigerator 21-SEP-2021. There was no temperature excursion. The patient did not experience any adverse event.      No treatment medications were provided by the reporter.
Patient c/o headache, fever up to 102.7 and left shoulder pain.  Small bruise at center of left shoulder.  Patient received both flu shot and Pneumovax at 9 a.m. 10/2/08 in the left deltoid.  Patient reported that several hours later she started developing symptoms (HA, fever, shoulder pain).  She presented to the immediate care the following day.  Beyond ANSAIDS and ice/heat, the MD ordered her to follow up in 2-3 days unless completely better.  There has been no follow up from patient.
dizziness; This is a spontaneous report from a contactable consumer (patient 's wife).  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 03Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was having some issues, he says he keeps getting dizziness. Outcome is unknown. Information on the lot/batch number has been requested.
My menstrual cycle after the first dose came four days late and was much different than normal. After the second dose,  I had Spotting or light menstrual cycle come two weeks earlier than expected. I normally have very consistent cycles and no spotting. I am unsure if the 9 days of spotting I have experienced after my second dose is my menstrual cycle coming two weeks early or breakthrough spotting.
While in clinic for shots on 7-24-07 (4-month old shots), grandmother and mother of infant reported that on the evening following initial two month old shots given on 4-10-07, infant broke out with rash on scalp and body.  Infant was not ill at time of shots but was on Amoxil since 4-9-07 to treat pharyngitis and Rondec for cough since 4-5-07.  Hepb, IPV, DTAP, Hib, and PCV7 administered on 7-24-07.  Telephoned grandmother on 7-25-07 who stated infant had no adverse event.
I awoke at 2:45 am feeling unwell and almost immediately starting feeling terrible.  I remained lying down in bed, but struggled to stay conscious.  I woke my husband and asked him to take my temperature - I had no fever.  I then asked him to call 911 to ask if my symptom was typical of the vaccine.  They sent paramedics to my house and before they arrived I started feeling better so there was no treatment performed.  The whole bad episode lasted 10-15 minutes and I felt like I was going to die.  It was not repeated.
first 5 days arm ached, by day 9 arm itches swollen still swollen and red today itching is less but still present taking Claritin daily
Difficulty sleeping night of vaccination and mild nausea Saturday (next day): Fever (max 100.8), chills, headache, and body aches that started to resolve late Saturday night; fatigue and lack of appetite Sunday & Monday: Fatigue and brain fog
6/29, allergic reaction to immun. IPV or DTAP 16:30 returned to clinic with itching, swelling around eyes, hives 16:40. Benadryl, IM given, 16:50 Epi .2 1:000, SC. 6/30, returned for follow-up and left deltoid with 7cm x 4cm erythematous patch, 7/01-no erythema per pt.
Patient reports itchy hives starting 1.5 days after vaccine administration. Patient states reaction has gotten worse over the past several days, with the reaction moving toward her back and up her neck (mostly itching). Patient reports taking claritin BID since the reaction started.
SWELLING, REDDNESS, HOT TO TOUCH TO INJECTION SITE, SWOLLEN LYMPH NODES TO LEFT SIDE OF ARM AND GROIN, PAINFUL
11 hours after 2nd dose of Pfizer COVID 19 mRNA vaccine patient developed tingling and numbness to R side of face.  Persisted another three days which prompted mother to page pediatrician. Recommended to be seen in ED
No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant products were not reported.  It was reported that patient received the Moderna bivalent to 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml. All of these patients had their monovalent and a previous booster dose of bivalent vaccine.   Treatment medications were not reported.  Case corresponds to patient number 6 of elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:(Elderly Patient no 1)
Breakthrough case admission after 5 vaccines Pfizer 1/27/21 Lot# EL9264;  Pfizer 2/17/21 Lot# EN6201;  9/13/21 Pfizer Lot# FF2588;  Pfizer 3/30/22 Lot# Fl3209;  Pfizer 9/20/22 Lot# GH9702
Information has been received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients were administered doses of improperly stored PROQUAD (Merck) (dose, route and lot# were not reported) on unspecified dates since 26-FEB-2015. No adverse effect reported. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
severe cramping, the next day-fever, the following day-rash, vomiting & diarrhea, fatigue, vaginal bleeding, chest pain.
Left side face pain for 3 days. Bell's Palsy. Referred to ENT 12/08/09.
Heartbeat was out of rhythm/ every 5th heart beat was skipping; Heartbeat was out of rhythm/ every 5th heart beat was skipping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), EXTRASYSTOLES (non-serious), outcome "unknown" and all described as "Heartbeat was out of rhythm/ every 5th heart beat was skipping". The event was reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
Soreness and swelling at the injection site, panful sensation while lifting the arm, chills, headache, fatigue, drowsiness.
This case was reported by a nurse and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with TWINRIX for prophylaxis. On unspecified dates, the subject received the 1st, 2nd and 3rd doses of TWINRIX (unknown). Antibody levels were measured one to two months after completion of the three dose series. The subject had hepatitis B antibody titers of less than 10 mIU/mL.
Patient received expired vaccine. Local Health Department and Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Patient declined.
Swelling, redness, rash, unable to straighten arm completely, skin is hard, redness in bicep and upper chest area.
Generalized seizure x 2 approximately 54 hours after vaccine administration.  6/10/08 Reviewed hospital medical recods of 5/4-5/5/2008. FINAL DX: seizures Records reveal patient experienced low grade fever, had vomited several times since vaccinations & was constipated.  On day of admit, patient had fallen over & lay on floor w/clenched fists, staring, decreased respirations & unresponsive for approx 1 min.  Had vomited several times day before.  Had witnessed gen tonic-clonic seizures x 2 w/n 1 hour for approx 1 min each & postictal while in ER.  Tx w/meds & admitted overnight for observation.  LP done.  No further seizure activity & d/c to home w/diastat for further neuro w/u including EEG.
pain in the arm returned in his left side; after effect which felt like he was punched in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm returned in his left side) and VACCINATION SITE PAIN (after effect which felt like he was punched in the left arm) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (after effect which felt like he was punched in the left arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm returned in his left side). At the time of the report, PAIN IN EXTREMITY (pain in the arm returned in his left side) outcome was unknown and VACCINATION SITE PAIN (after effect which felt like he was punched in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
This report was initially received from a manufacturer and was assigned a manufacturer control number. The original reporter was a physician. Additional information has been received from the vaccine administrator of a 24 month old female with a purulent upper respiratory infection (DX: PURI) who on 5/12/03 at approximately 11:)) AM was vaccinated with a first dose of varicella virus vaccine live (lot # 641991/0323M), SC in the thigh. Concomitant therapy that day included amoxicillin for purulent upper respiratory infection. On 5/12/03, less than 10 minutes from immunization the patient began sneezing. The patient left the office and came back 15 minutes later. She was reportedly fussy with diffused red eruptions, and had swelling of extremities and trunk. The patinet was given diphenhydramine HCl and two teaspoons of prednisolone. The patient then fell asleep. Observations continued for approximately 45 minutes. The patient was sent home with diphenhydramine HCl. The patient recovered on 5/14/03. The reporter considered sneezing, fussy, diffused red eruptions, swelling of extremities and trunk to be other important medical events. Additional information has been requested.
Fever 102, chills/shakes, nauseous stomach, headache and severe body aches. Subside with Tylenol but they come back.
Patient presented itching, swelling at the site, and tenderness. Patient stated swelling and itching started the morning following vaccination with not much change in the swelling over the course of the four days.
Left arm where immunization given very sore, red, requiring cold compresses, Ibuprofen.
After 3 injections patient ambulated to waiting room & lost consciousness. No apparent injury. Regained consciousness with ammonia inhalant. Ambulated alert & cheerful from department 45 minutes later.
1114  C/O SOB 4 MINUTES AFTER  RECEIVENG SECOND MODERNA DOSE  1123  98% ROOM AIR 137/74 BP 72 HR PPT C/O SOB 4 MINUTES AFTER RECEIVING SECOND DOSE OF MODERNA VACCINE VITALS STAABLE, OC SAT 98R/A. PATIENT DOES NOT APPEAR TO BE IN DISTRESS. PATIENT GIVEN WATER TO DRINK. WILL CONTINUE TO MONITOR   1127 PATIENT REPORTS HE FEELS BETTER. INSTRUICTED PATIENT TO STAY IN OBSERVATION FOR AT LEAST 30 MINUTES, WILL FOLLOWUP WITH HIM BEFORE LEAVING. PATIEN ADVISED IF CHANGE IN PHYSICAL CONDITION ONCE LEAVING, NOTIFY PCP, IF LIFE THREATENING CALL 911 OR GO TO NEAREST ER
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, the patient had his first dose of the vaccine and he was scheduled to go back 13Apr2021 for his second dose. Yesterday, 10Apr2021 (also reported as 11Apr2021, he had a COVID test that was positive. He knows he will probably have to quarantine but doesn't know if he can go back and get the second dose? He is going to have to miss his second dose and doesn't know what to do about getting it. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 10Apr2021. The outcome of the events was unknown. The events were considered as serious (medically significant).  Information on the lot/batch number has been requested.
her friend tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program, CEP 159558. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On 31Mar2021, the patient tested positive for Covid. The patient 2nd dose is scheduled for 19Apr2021.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient received 2nd dose of Shingrix on 6/6/2021. The patient came in today 6/9/21 with a large rash around the injection site that she says is painful. She also added that she felt very fatigued and could barely get out of bed but she is feeling better now. She will follow up with her doctor.