chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low immune system; cardiac arrest; Swelling/foot got swollen; This is a spontaneous report from a contactable consumer.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization; immunoglobulin human normal (HIZENTRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  The patient medical history was not reported.  The patient had unspecified concomitant medications.   On 20Apr2021, the patient experienced cardiac arrest, which was noted as a medical emergency with outcome of unknown; swelling/foot got swollen on 20Apr2021 with outcome of unknown; low immune system on an unspecified date with outcome of unknown. The consumer reported the events as non-serious.  Details were as follows: patient had a medical emergency (cardiac arrest), with swelling and she was administered with a steroid injection Decadron and was prescribed furosemide (LASIX) 40mg tablets for 5 days.  Patient reported that she has an immune support CBIs. The medical emergency she experienced the day prior was a reaction to the medication Hizentra for low immune system, so it was suspended. The action taken in response to the events for BNT162B2 was not applicable, and for immunoglobulin human normal was permanently withdrawn on an unspecified date.  Therapeutic measures were taken as a result of swelling/foot got swollen as aforementioned.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Headaches, migraines, diarrhea, vomiting, nausea, tiredness, dizziness, bloody nose and pains in the neck.
Extreme nausea, lots of vomiting (had no food on stomach) of bile for 2 days, July 28 and July 29, chills, fever (highest recorded: 100.9), weakness, fatigue, really terrible headache.  Heavy pain at injection site following vaccine.   Slept a lot, tried to drink water, ate a few saltine crackers so I wouldn't take Tylenol on an empty stomach.   Vaccine administered on July 27.
Received MMR vaccine as part of employment reqt's on 9-7-11. Reported to empl. health on 10/12/11 with c/o warmth and tenderness, increasing at injection site. Sought medical treatment and was prescribed prednisone.
The pt experienced a 11 cm x 6cm swollen, red, warm, and itchy area. Treated with Benadryl. 3 days later the reaction is resolving.
Patient receive vaccine at 8:56am  and around 9:03am she reported rashes all over her body. Pharmacist gave her one diphenhydramine 25mg capsule and continued monitoring her.  She got better showed that rashes around stomach went away. Mother came to pick her up.
Approx after 1 hour pt became flushed, face reddened and developed itchy flat rash neck/arms bilaterally with tight feeling around mouth. Took Benadryl 50mg and sx began resolving after 20 minutes. Pt rash lessening but remained on arms. Advised to take exact dose every 6 hours.
Left arm pain in the area of vaccination started in the evening after the vaccination. The pain persists at least until the time when he was seen 4/6/16 - Her alone. Left arm is still sore from receiving BEXSERO vaccine 3/23/16. Afebrile. Had BEXSERO shot two weeks ago today in left arm. No fever or swelling noted. Started to hurt that night and has continued to hurt. Was laying around because had wisdom teeth removed. Still limited motion and pain in arm. Can't lay on that side. Occ tingling when uses it. No numbness.
swollen lt arm @ site of inject hot, red, swollen approx 6" in diameter of Td;
Headache; RIGHT ARM - Pruritus, burning, pain, warmth, erythema, induration. Maximum lesion diameter 16 cm x 24 cm.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 73 year old  female. The patient's weight was 150 pounds, and height was not reported. The patient's concurrent conditions included breast cancer, pollen allergy, non-alcoholic, and non-smoker. The patient had no history of drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 12-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021 and a week after, on 26-MAY-2021, the patient did antibody testing both of which came negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20210556839-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient experienced syncope a few minutes after flu shot administered. Was sitting in chair, head slumped forward, called her name, and tapped her shoulder and she regained consciousness.  Had patient lay flat, cool damp cloth applied. She felt better and was observed with no further issues.
Covid-19; 1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 040A21A) for COVID-19 vaccination.     Previously administered products included for Flu vaccination: flu vaccine (She had flu vaccine sometime in Oct or Noc2021.) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Asthma and Fibromyalgia. Concomitant products included OXYCODONE, GABAPENTIN and SERTRALINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021). On 18-Jan-2022, the patient experienced COVID-19 (Covid-19). On 23-Jan-2022, COVID-19 (Covid-19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 22-Mar-2021; 2nd dose - 29-Apr-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Had Covid-19 on 18Jan2022.         The patient had no allergies.  Patient was receiving few other medications which she could not provide at the time of the call. The patient had flu vaccine sometime in Oct-2021 or Nov-2021. The patient had Covid-19 on 18-Jan-2022 which she described as the worst flu one could ever have for about 5 days. No treatment drug was reported.  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced  non-serious unexpected AESI of COVID-19. The event occurred approximately 9 months after the 2nd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administered since time between doses was more than 35 days. The patient described it as the worst flu she could ever have that lasted for about 5 days. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513772 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced  non-serious unexpected AESI of COVID-19. The event occurred approximately 9 months after the 2nd dose of the mRNA-1273. Additionally, there was an inappropriate schedule of product administered since time between doses was more than 35 days. The patient described it as the worst flu she could ever have that lasted for about 5 days. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A red swollen itchy and painful  bump appeared at the injection site the day after the second Pfizer dose. It?s gotten bigger in the last few days. It?s still painful when I move my arm above shoulder level, and itches throughout the day.
Fever 101.1 x 1 day headache x 1 day muscle aches x 3 days fuzzy head x 3 days
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo.  It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo.  I had complete vision loss in my left eye.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for COVID-19". This report is from a contactable consumer communicated to a Pfizer colleague. This colleague received the information: "my brother about one of his friends. He reported to my brother that he received 2 doses of the Pfizer vaccine, the second one approximately 6 months ago. Within past several days he experienced fever, relatively mild symptoms including loss of taste and smell, and tested positive for COVID-19. I have no more details, but colleague has agreed that it is ok to reach him to obtain any additional information. On 28Sep2021 colleague confirms awareness date as 27Sep2021, but did not have contact info until this morning 28Sep2021.  The patient underwent the following laboratory tests and procedures: Body temperature increased: (unspecified date) Unknown results; SARS-CoV-2 test: (2021) Positive, notes: tested positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (01Nov2021): Follow-up attempts completed. No further information expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the reported events cannot be ruled out.
Pt became limp and extremely pale after vaccination administration within 2-3 minutes. Slight cyanosis around mouth.
fever of 101F; headache that would not stop and lasted all day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101F) and HEADACHE (headache that would not stop and lasted all day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever of 101F) and HEADACHE (headache that would not stop and lasted all day). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at a dose of 2 dosage form. At the time of the report, PYREXIA (fever of 101F) and HEADACHE (headache that would not stop and lasted all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 101 f (High) 101 F.         No concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Passed out /Lost all awareness; Light-headed; Hyperventilating; He caught his breath; Elevated heart rate; Tingling sensation; He was unable to form cohesive sentences; Muscles movements were impeded; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6206) single dose, in the left arm, on 08Mar2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks. Relevant medical history and concomitant medications were unknown. No known allergies were reported. The patient had not experienced COVID-19 prior vaccination. On 08Mar2021, at 12:00 PM, 5 minutes after vaccination, the patient became very light-headed. In a few seconds his vision went dark and he passed out. After an unknown amount of time, he became semiconscious and was hyperventilating. While hyperventilating, his eyes were open, but he could not see anything. Once he caught his breath, after about 15 seconds, his vision came back and he lost all awareness of where he was. After about 30 seconds, the patient realized he was in the observation area for the facility and alerted the medical professionals near his vehicle he was sitting in. Medical professionals checked his vitals, which were fine other than an elevated heart rate, and he had a tingling sensation over his body for the next two minutes. In this time, he was unable to form cohesive sentences, and his muscles movements were impeded. It took another 40 minutes to return to a relatively normal state. No treatment was received. The patient recovered from the adverse events. Post the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Woke up in middle of the night with very high blood sugar. I was also experiencing a high fever at 101.2, extreme tightness/soreness in my armpit shoulder area, teeth-chattering chills, and mental confusion.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for the prevention of shingles. On an unknown date, after receiving the vaccination, the patient suffered a painful rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster. The patient did not recover from the event as she continued to suffer the effects of herpes zoster at the time of the report. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms and diagnoses resulted in physical limitations not present prior to using the product and  the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), 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. The causality assessment was reported as related. Herpes zoster is considered to be disabling.
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMRV vaccine (non-GSK, Merck) given on 17 June 2014; IPV (non-GSK, Sanofi) given on 17 June 2014. The subject had no allergy and no reaction to previous vaccination. On 17 June 2014 the subject received 5th dose of INFANRIX (0.5 ml, intramuscular, right thigh). On 17 June 2014, immediately after vaccination with INFANRIX, the subject experienced injection site redness which progressed over 24 hours to injection site cellulitis. The subject also developed injection site pruritus. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX since 19 June 2014 and her mother gave her some BENADRYL for pruritus. At the time of reporting, pruritus decreased but redness and cellulitis were unresolved. This was one of 3 cases reported by the same reporter. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
6.0 X 6.5 cm area of redness (R) thigh. No keflax 2Seg 1.5 T sp  Its x 1od almost clear by 4/30/2007
Information has been received on 08/29/2001 from a physician concerning a male with no known drug allergies who "about one year ago" in approximately 2000 wsa vaccinated with the first and second dose of varicella vaccine. Concomitant therapy included albuterol and Flovent. On 08/17/2001 a titer was taken that did not show seroconversion. There were no symptoms noted. The pt sought unspecified medical attention. Additional info has been requested.
8 days after receiving the first dose of the Moderna COVID-19 vaccine, I noticed my left arm/shoulder area was suddenly itchy.  I looked at it and noticed I had a red skin rash. It expanded over the next 24 hours to be ~5" H x ~3" W.  Then it quickly faded.  In total the skin changes were present for about 48 hours.  They occurred on the same arm where I had received the vaccination, but not directly around the vaccine site itself (I had a small bruise where the vaccine was administered, and the rash was not in the same location.)
A report has been received from a Healthcare Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 03-Jan-2012. The patient experienced ADMINISTER EXPIRED FLUMIST which started on 03-Jan-2013. The outcome of the event of ADMINISTER EXPIRED FLUMIST is unknown. Expired FLUMIST administered to a set of siblings. The report was considered to be non-serious.
Pt devel flu-like sxs 1wk p/recvd flu vax; these sx persist as of 4DEC91;
dizziness/nausea occurred on 3/13/21, vaccine received on 3/10/21
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 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-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 reported. No Treatment medications were reported.
Sever painful and itchy rash on both arms, similar to hives.  Sores/rash on knees, hips, lower back and feet. Rash/sores in feet made it difficult to walk.  Swollen hands and feet. Unable to close right hand for several  days.  Mild shortness of breath.
Patient returned to pharmacy about an hr later w/chief complaint of redness. Her arm did not present w/a severe redness.
Generalized rash, streaks, itching, no temp taken, no N/V, no H/A.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Grass" (unspecified if ongoing); "Known allergies: Trees" (unspecified if ongoing); "Known allergies: dogs, cats" (unspecified if ongoing). Concomitant medications included: VALACYCLOVIR HCL; TRIUMEQ; ROSUVASTATIN, stop date: 19May2022; FLUTICASONE PROPIONATE, stop date: 19May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 18May2022 to 23May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
0755 took shot. Went home and went to sleep. Woke up at 8 PM and the whole left side of face was red, swollen, broken out in a rash and burning like it was on fire. Pain and burning worse than a bad sunburn. Unsure the exact time it began as I work nights and slept in today since not working tonight.
pt devl mild generalized urticaria approx 2 hrs p/receiving 1st Hep B vax; treatment was DPH;
Reaction with Shingrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The pharmacist mentioned that one of their patients experienced reaction with Shingrix.  The reporter was asked what reaction did the patient experienced with the product however she refused to provide it and mentioned that she would contact manufacturer. No additional information was obtained.
on 11/11/23 left deltoid noted red, warm and swollen, denies any pain.
I noticed when I woke up that something was weird with the left side of my face. I waited to see if it would go away throughout the day and it didn't. The left side of my face wasn't moving with the right side of my face. One side of my face was asymmetrical over night. I waited over night and then called my doctor and they got my an appointment. I saw a doctor and she told me it was bell's palsy. They gave me steroids and I think prednisone. It has slowly been getting better although it has taken a while.
Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it
Left-sided supraclavicular lymphadenopathy was appreciated approximately 48 hours after vaccine. Lymphadenopathy was noted on the same side as the vaccine. Ultrasound was performed by PCP and node was 1 cm in diameter. Node is present and has not reduced in size.
Red warm rash at injection site on (R) anterior thigh 10.0 cm x 6.0 cm.