chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of erythromelalgia in an 18 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, adverse experiences following previous immunizations, concurrent condition, or concurrent medications. On an unspecified date, the pt received the 1st dose of Engerix B (5376A2). The pt stated that, while he was receiving the injection, "his arm started to go into spasms." The spasms resolved that day. At an unknown time post-immunization, on 6/19/03, the pt experienced erythromelalgia. The pt was hospitalized in intensive care. The erythromelalgia was unresolved as of 7/10/03; the pt remained hospitalized but, was out of the intensive care unit. The reporting pharmacist considered the events were probably related to vaccination with Engerix B. The immunization series was discontinued.
PEDIARIX combination given today. Patient tolerated well. Should have been given single dose DTAP (INFANRIX).
Sensation that throat was closing 10 minutes after she received the 2nd Covid vaccine. She didn't have any symptoms after the first vaccine. She went to the ER and received epinephrine, prednisone, and benadryl.
This spontaneous report as received from a registered nurse, refers to two unspecified patients of unknown age and gender, who on an unknown dates were vaccinated with an improperly stored doses VAQTA (lot# L045713, expiry date 14-JAN-2017) (dose and route were not reported). No adverse effects were reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
No additional AE events; Administration of expired MMR II vaccine; This spontaneous report was received from an administrator and refers to a 16-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 0.5 milliliter, lot #T034391, has been verified to be valid, expiration date: 08-OCT-2022, (strength and route of administration were not provided) for prophylaxis. No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA004097: US-009507513-2210USA003600: US-009507513-2210USA003603: US-009507513-2210USA003897:
Severe arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Dose Number: 2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe arm pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt with gradual onset of headache, fever, confusion following vaccination. Diagnosed with gram positive diplococci meningitis - cultures pending.
Headache, fever, painful joints, painful teeth, sore dry throat, brain fog, fatigue
constantly tired, stiff neck, arms feel as though they will dissconnect @ the shoulder, nausea & fever, sharp pain, numbness;
Pt was at Boyfriend's house the afternoon of 09/20/2001. She fell asleep and then woke up crying approximately 2:30-3am. Stated her left arm felt like "dead weight" was achy and slightly swollen and could barely lift up her arm. Pt has taken Tylenol IHN recommended continue Tylenol and ice intermittently and to call Health Department to see how doing. On 09/24/2001 called patient and she stated arm felt better by Friday evening (09/21/2001).
Hives Started on R side of body and has spread to entire body.  All hives are itching, raised and warm.
The patient began having itching at the injection site approximately 4.5 hrs after the injection. This progressed to generalized itching and rash over the next day which has persisted since that time.
Patient received 1st Pfizer bivalent booster on 9/13. When staff went to patient's worksite for booster dose, patient requested to receive bivalent booster dose on 10/18. Patient was notified that she received another dose of the same vaccine and told her that she was not due for another booster yet when staff found out that she already received a dose on 9/13.
pt recvd flu vax 3NOV93 & c/o sore arm 23NOV93-pt stated arm was broken; 24NOV93 xray of the arm revealed no fracture; pt prev c/o arm pain JUL93;
5:43pm She received her 2nd COVID vaccine in the vaccine clinic. Approximately 5 minutes after getting the vaccine she said she felt hot and the muscles in her neck felt tight. She was placed on vs monitor. HR elevated initially at 122, BP 126/76, O2 sat 97%.  She rested for approximately 10 mins and said she felt better.  BP 119/74, HR 104, O2 sat 99%. BP 122/69. HR 90, O2 sat 100%.  Approximately 15 mins later she said she was not feeling well again. She complained of waves of hot flashes and tightness in her neck. She was shaking her legs and said she wanted to go to the ED after discussion with RN one of the Nurses in the COVID vaccine clinic.  BP 142/73, HR 90, O2 sat 100%.  This EH nurse was also in the vaccine clinic and observed her condition. At 6:10pm She was taken to the ED via wheelchair by RN.
Extremely heavy menses about a week after my first vaccination. Currently over due and absent period -More than 5 days late at this point and no chance of pregnancy.
it was rpt fr MD concerning pt who was vax in 1995 & in 1999 pt exp a varicella like rash w/approx 20 lesions
Weird hives, that are shaped like cris cross hives.  Happened 3 days after 2nd and began again a week ago (almost 3 months) after shot.
Received dose 2 of Moderna vaccine on 3/11/21.  Symptoms worse after 2nd dose, and on March 31, 2021 get worse. On April 4 at church, became very hot and weaker and weaker.  Came home and put him to bed and slept some. At lunch time, ate a bite of jello and sipped 7 up and said he did not feel very good. Took an Alka Seltzer for heart burn, but it did not help.  Went to sleep. Wife unable to waken him later that day. Died 4/4/21.
Developed cold-like symptoms approximately 2 days after vaccine. Shortly thereafter, I began to experience neck pain & stiffness. Then I began having spasms and involuntary movement of neck. Subsequently diagnosed with cervical dystonia.
Breakthrough case admission after 2 vaccines Moderna 3/24/21 Lot# 045A21A;  Moderna 4/22/21 Lot# 038B21A
Shaking woke me up 0400. For next couple hours intermittent shaking then would have shaking less often and Last event time at 1430 pm same day.
Headache, Myalgia, & Fever Narrative:  miss one day of work following second dose due to above symtpom
G62.9 PERIPHERAL NEUROPATHY 2/15/2023 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 1/4/2023 ATHEROSCLEROSIS OF AORTA G62.9 PERIPHERAL NEUROPATHY 2/15/2023 ATHEROSCLEROSIS OF AORTA I95.9 HYPOTENSION 1/4/2023 ATHEROSCLEROSIS OF AORTA
Worsening of menstrual symptoms.  Cramping interfering with daily activities and requiring multiple doses of motrin/tylenol.  Heavier and longer bleeding than is typical.
Patient requested bivalent vaccine covid, but in error received monovalent pfizer covid expired 9.22.2022.
Day of shot 2/19/21: fatigue, sluggish tired, low grade fever 99.8, nausea, headache. Day #1 after shot 2/20/21: tired, sore, body aches, low grade fever 99.6, nausea, headache. Day #2 after shot 2/21/21: nausea, vomiting, woke up with rash on pelvis, hips and thighs. Severe itching with rash. Day #3 after shot 2/22/21: Hives/rash on lower abdomen, more severe below umbilical area and suprapubic area; rash on bilateral upper anterior thighs, and rash on bilateral hips; severe itching; raised red nodules with circular white base.
vaccine given on Oct 24 2019 - sore & red ever since I received it - red area on arm that seems to encircle the shot area - arm swollen.
Severe headache. Stiffness. Pain in legs. Started today (11/13/13) and continues.
Two days post vax, this pt experienced 10x8 cm area of redness with a bull's-eye of 3x4 cm and increased duration. These symptoms began to fade after 24 hours. She then experienced a low grade fever. As of 05/10/99 she had a 1x2 cm inflammation with slight induration. a doctor visit was required. The pt was treated with heat applied in the area. The most recent information received on 05/17/99, report the condition of the pt as ongoing.
30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (30 patients were administered a dose past the expiration date/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to (Patient Link).
to ED with c/o body aches, weakness, increasing SOB, headache, vomiting, diarrhea; sx have worsened over the last week since he was diagnosed positive for COVID 1 wk ago at primary care provider's office; in ED found to be hypotensive and dehydrated; treated for both; admitted to hosp; developed A Fib with RVR; respiratory status quickly declined; on Vapotherm; pt's condition worsened and he was found with altered mental state and right sided weakness with facial droop; unable to perform MRI due to AICD to confirm stroke; DNI/DNR; status deteriorated and he was made comfort measures; he passed away in the hospital
The following morning at 6am I started to vomit and vomited a total of 8 times that day.
Warmness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Warmness) and PRURITUS (Itchiness). At the time of the report, FEELING HOT (Warmness) and PRURITUS (Itchiness) had resolved.            Concomitant medications included: Blood pressure medications  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Includes no new information.
Myalgia; Chills; Taste loss; Smell loss; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), CHILLS (Chills), AGEUSIA (Taste loss) and ANOSMIA (Smell loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination.     No medical history information was provided.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), AGEUSIA (Taste loss) (seriousness criterion death) and ANOSMIA (Smell loss) (seriousness criterion death). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No Concomitant medication information was provided. No treatment medication information was provided.  Company Comment: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Diarrhea, headache and arm pain started the day after and lasted for 3 days. Became dehydrated and almost passed out multiple times, Went to Medical Center ER and was seen on 9/6/21. Bloodwork was crazy. Followed up with my PCP on 9/16 and bloodwork was back to normal. Now I have shingles on my forehead. Symptoms for shingles started approx 9/19.
Woke up with a rash (afternoon nap), mom describes seen burn looking rash on face and neck and upper back, it appeared that his eyes and nose were also puffy.  She was instructed to give him Benadryl and he appears fine this AM-no more symptoms.
Sleeplessness; Diarrhea; Nausea; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer (patient):    A 39-year-old female patient received the 1st doe of bnt162b2 (BNT162B2, batch/lot is unknown misplaced/discarded) at single dose at right arm on 21Jan2021 19:00 for covid-19 immunisation, administered at hospital  Medical history included ankylosing spondylitis, uveitis, coeliac disease, postural orthostatic tachycardia syndrome (POTS), food allergy, mycotic allergy. Allergies: Coconut, ASPIRIN, REGLAN, mold. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: atenolol (manufacturer unknown), cetirizine hydrochloride (ZYRTEC), infliximab (REMICADE). The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 12:00 AM the patient experienced sleeplessness, diarrhea, nausea, headache and fatigue. No treatment received for the adverse events. Events were considered non serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt dizzy, nauseated, and started sweating immediately upon receiving the vaccine. These symptoms passed in about 10 minutes.
Guillan Barre Syndrome 11/12/09 Hospital records received for dates 10/12/09 to 10/17/09. DX: GBS, weakness. Admitted for recurrent GBS. Original DX of GBS on 9/26/09. Previous ER visit presented with HA, irritability, on 9/26. Pt was dc home with dx viral syndrome. Pt returned to ER after parents noticed weakness in LE bilat. trouble walking. Pt. DX w/ GBS after CSF at that time showed high protein and typical picture of acending weakness.This episode 10/12 presented with recurrence of ascending paresis with dysphagia, cough, respiratory distress. Parents state weakness worsening, parents state have been propping pt. up to sit as pt. unable to do so alone. Parents state proximal upper arm weakness, left eye weakness. Tx with repeated doses of IVIG. Assessment: weakness, gross motor exam abnormal by observation, hypotonic, deep tendon reflex(-). Assessment upon dc pt able to sit up, holds cookies in hands, able to bear some weight on rt. leg. BL brachioradialis reflex present.
Pfizer-BioNTech COVID-19 Vaccine EUA Muscle aches, headache, weakness, mild fever, vomited once, diarrhea
Fatigue, temp elevated approx 1.2°, no appetite, most of the day following vac. (3/11) Normal temp, slight fatigue, on 2nd day (3/12) All normal by mid- 3/12. No healthcare sought. (Spouse only.)
extreme pain exactly like shingles; extreme pain exactly like shingles; extreme pain exactly like shingles and in that location where five years ago I had shingles; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (not pregnant) (Batch/Lot Number: eng199) as 2nd dose, single for covid-19 immunisation. Medical history included shingles, transient ischaemic attack, hashimoto's disease, tachycardia, Known allergies: Clams, crabs, Known allergies: all opiods, all from an unknown date.Patient had her first dose of bnt162b2 (Lot number: eng201) for Covid-19 Immunization on 12Feb2021 on left arm. Concomitant medications included levothyroxine sodium (SYNTHROID); metoprolol; colecalciferol (VIT.D3); cyanocobalamin (B12 1000 SR); rosuvastatin calcium (CRESTOR); acetylsalicylic acid (ASPIRIN (E.C.). On Midnight of second dose (05Mar2021), extreme pain exactly like shingles and in that location where five years ago I had shingles. Pain persists with no relief at number 7 most times. The treatment for the adverse events was extra strong tylenol, ultrasound, gabapentin. No covid prior vaccination.Not covid test post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
p/vax pt exp face swelling; some coughing; seen in ER; kept approx 3 hr p/epinephrine; benadryl; pediapred; breathing tx
I had severe dizziness and after it cleared I still had problems walking. My gait was impared.
I had the 2nd dose on 01/23/2021  and on 05/15/2021 I started feeling very tired I saw my local physician, he did some lab work and they found out that I was anemic,  Ultrasound of kidneys- normal, Urinalyses- microscopic blood . He prescribed Iron supplements. I am scheduled for some consults with specialists, one will be a kidney and one will be a GI.
This case was reported by a healthcare professional and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline). On 14 September 2009, the subject received unspecified dose of Flulaval (unknown). On 14 September 2009, almost immediately after vaccination with Flulaval, the subject experienced itching. The reporter stated a subject experiended itching from the inside out which began almost immediately after the shot was given. Specific informaotin was not known. The reporter stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reporter did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reporter did not have an expiration date. At the time of reporting the outcome of the events were unspecified. The reporter stated three additional subjects experienced adverse events; see cases A0807879A, A0807883A, and A0807884A. Follow-up was received from 15 September 2009, via Quality Assurance (QA). QA stated thsi is an adverse Event only and it will not be recorded as a compliant. Follow-up was received on 18 September 2009, via sales representative, who reported the 23-year old female subject received FLuLaval on 14 September 2009. The onset of itchiness (described as skin crawling) at injection site was immediately following injection; symptoms were not long lasting. Subject feeling well prior to vaccine, no fever, no other medications, nor prior history of adverse events following flu vaccine. Subject was evaluated for rash and was negative. The events resolved on 14 September 2009 and was considered possibly related to Flulaval vaccination.
This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of GARDASIL 9 of lot # L026602 with expiry date 19-OCT-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Painful glands and extremely painful jaw. Low grade fever, malaise symptoms. Lasted for 24 hrs post injection.
FATIGUE; This spontaneous report received from a consumer via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217672.
INCOMPLETE DOSE ADMINISTRATION; BROKEN NEEDLE; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered to right arm on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced incomplete dose administration. On 07-MAR-2021, the subject experienced broken needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incomplete dose administration and broken needle was not reported. This report was non-serious.