chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt immunized 27MAY91 PM; Morning of 28MAY, t102+, fussy & irritable all day, vomited 4 times in 2 days; Mom describes twitching while asleep & awake (1 second duration); As of 30MAY, fever disappeared & pt doing better;
This spontaneous report as received from a physician refers to a patient of unknown age. On 05-JUL-2013 the patient was vaccinated with an expired ZOSTAVAX (0.65 ml, subcutaneous) (lot: 670542/0619AA exp. date 26-JUL-2012) for prevention of herpes zoster. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
She has a lump on the injection site; I have a lump in my arm where I receive the injection; I didn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 25Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cough", start date: 2020 (unspecified if ongoing), notes: I have 'annual' issue with the bad cough last, not last, in 2020 (Intent: history). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "She has a lump on the injection site; I have a lump in my arm where I receive the injection"; MALAISE (non-serious), outcome "unknown", described as "I didn't feel well". Therapeutic measures were taken as a result of vaccination site mass, malaise.  Additional information: Dates for She has a lump on the injection site: Patient had a lump in her arm where she received the injection: (From: Unspecified To: Unspecified). Dates for she has cancelled her booster shot (COVID 19 Vaccine) schedule for tomorrow because of cough: She already cancelled the booster dose because she had been coughing: (From: Unspecified To: Unspecified) Dates for I didn't feel well: (From: Unspecified To: Unspecified) Patient stated that 'she had to cancel her appointment for tomorrow because she had her 2 vaccines, one was on 25Jun of past year and the other one was 16Jul past year and tomorrow would be her booster but she was concerned that she didn't knew what are the symptoms are for the virus, She had 'annual' issue with the bad cough last, not last, in 2020 (Intent: history), she spent in ICU because she drank too much water trying to stop the cough and had (voice not clear) anyway. So what right now, the reason she cancelled it was she had lump in her arm where she received the injection, they gave them both in the same place, anyway so she did not feel well and she needed to use nebulizers (Intent: Treatment). So she cancelled the appointment and she said when you are doing better, but she gave me the number to call and report this and that's what I am trying to do.'  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt is a 43 y/o F w/ PMH of RCC s/p kidney removal, NIDDM type 2 who is presenting due to syncope episode.  A rapid response had occurred due to pt arriving in ER valet due to syncope.  Pt reports hitting the right side of her head.  Syncope witnessed by her husband.  Pt reports she feels much better now and back to her baseline.  States she is vaccinated w/ moderna.  Denies sob, cough, fever, chills.  Reports right shoulder pain.  No complaints otherwise.  Review of Systems     CONSTITUTIONAL: Denies weight loss, fever and chills.  HEENT: Denies changes in vision and hearing.  RESPIRATORY: Denies SOB and cough.  CV: Denies palpitations and CP.  GI: Denies abdominal pain, nausea, vomiting and diarrhea.  GU: Denies dysuria and urinary frequency.  MSK: Denies myalgia and joint pain.  SKIN: Denies rash and pruritus.  NEUROLOGICAL: +headache and syncope
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
the morning after my first dose of the PfizerCovid-19 vaccine I noticed a much louder then normal ringing. I have had tinnitus for about 8 years with ringing  mainly in the left ear with occasional swooshing/pounding sounds in both left and right ears but its been in the background and manageable. The morning after the vaccine the ringing  increased by about 40-50%, is now a constant 24/7 high pitch ringing in both ears  that has moved front and center and no longer is in the background. I advised my doctor of the increase and am scheduling an appointment with an audiologist.
Feeling warm (pt did not take temperature). Diarrhea. Frontal and occipital headache.
products were exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center from The Agency on 06-Jan-2021.  This case involved a 86-year old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE 0.7 mL pre-filled syringe (lot number: UJ469AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 05-Jan-2021, it was reported that the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event (Product storage error).   It was an actual medication error due to product storage error.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a healthcare worker and refers to unspecified patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX (strength, dose, frequency, route and anatomical location were not reported), (lot # L001335 with expiration date: 13-JAN-2017 and lot # L006384 with expiration date: 25-FEB-2017), which were improperly storage. No adverse events were reported. Additional information has been requested.
Around where shot was given on my left shoulder; skin was raised and a dark red, warm, circle formed. It was about three inches in diameter. Continued to be swollen for entire day and night. I took a CLARITIN in the morning and then another one at bedtime. The circle remained for another day, so two days in total. My arm is still sore to the touch as well, especially where circle was at.
Chest pain exacerbated with deep inspiration. Sharp. Localized to upper left side of chest.
I have extreme sharp pain in my spine/back and it is burning, Its sort of hard to walk it happened hours after my vaccine I have fever extreme loss of appetite dry mouth headache Pain in arm
pt recvd booster dose of MMR vax on 4APR91, was also given OPV; immed following vax pt exp hives; pt was treated w/Epi & recovered; no further details were provided;
Pt. reports myalgias at site (R shoulder) persisting to 1/19/2010 and rash (8 scabbed lesions on R shoulder in to neck and 3 faint lesions on frontal scalp. Pt requesting narcotics and muscle relaxants for shoulder pain. ZANAFLEX Rx'd 1-19-2010. ATARAX Rx'd 1-13-2010.
2 Days after receiving Pfizer Booster, my pulse began running between 130 and 145 bpm (tachycardia) for a period of over 12 hours before the bpm began to get back to normal.  My blood pressure was not affected, only the heart rate.  I have never had heart issues or health issues so attribute this incident to the booster vaccine.  I had no issues with the initial double dose vaccine.  I checked the internet to see if this was a side effect and it did mention a handful of incidents.  I am fine and back to normal now
pt recv vax 23JAN98 & devel a sterile abscess @ the inj site;MD noted that it was like a marble under the skin;
extreme swelling in deltoid; extreme redness; extreme pain; This case was reported by a physician via sales rep and described the occurrence of muscle swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced muscle swelling, localized erythema and pain. On an unknown date, the outcome of the muscle swelling, localized erythema and pain were recovered/resolved.   It was unknown if the reporter considered the muscle swelling, localized erythema and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received first dose of shingrix and experienced extreme redness, pain and swelling in deltoid which lasted a few days. The reporter refused additional information.
patient reports at 8:20am she began to feel "off balance".  Staff spoke with patient for 15mins, at 8:42am her symptoms resolved.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE   ACUTE PULMONARY EMBOLISM
My first period started 01Feb and that was on time and lasted 5 days like normal.; I was fine one 1 day and then I started tothrow up every morning and throughout the day I had a sour stomach; I was fine one 1 day and then I started tothrow up every morning and throughout the day I had a sour stomach; This is a spontaneous report from a contactable other HCP. This 28-year-old non-pregnant female other HCP (patient) reported that she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via an unspecified route of administration on 04Feb2021 (at 28-year-old) on left arm, as dose 1, single for COVID-19 immunization. Medical history of the patient included anxiety, depression and hyperhidrosis from an unknown date and unknown if ongoing. The patient received anxiety and depressions meds and sweat pills. It was mentioned that patient had no covid prior to the vaccination and was not tested for covid post vaccination. She had no allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249) via Intramuscular route of administration on 14Jan2021 as dose 1, single (at 28-year-old) on left arm as dose 1, single for COVID-19 immunization. On an unknown date in Apr2021 it was reported that her first period started 01Feb and that was on time and lasted 5 days like normal. She got my second vaccine on 04Feb. Her period started on time in March and April again but my May period started a week early she did not have any symptoms at all (cramps, headache etc.) it lasted 4 days, she was fine one 1 day and then she started to throw up every morning and throughout the day she had a sour stomach. Her June period started a week early again just like the other and now she was am throwing up every morning and had a sour stomach throughout the day. She have taken 2 pregnancy tests and they were negative. No treatment was received for events. The patient was recovering. The device timestamp:02Jun2021.  Follow-Up (19Jul2021): Follow-up attempts were completed. No further information was expected.
Injection given in AM 8/8/07.  By 4 PM same day temperature was 104, area was hot, edematous and red.  Pronounced pain at site.  By next AM edema had spread to hand, redness was circumstantial and extended from hand to neck.  Skin on that arm eventually peeled.
Pt experience continuous sore arm during day and night for 2 to 3 weeks. Pt states that pain is progressing due to the flu shot on right arm.
developed various autoimmune maladies; developed the first of several outbreaks of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.      On or around April 2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).         On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) vaccine being administered, pt developed the first of several outbreaks of shingles (herpes zoster) and various autoimmune maladies (autoimmune disorder). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to this vaccine use and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Pt sustained severe and permanent personal injuries; 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. Pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At reporting time, pt was not recovered from the events and they were considered to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and autoimmune disorder were considered as disabling events.  Upon internal review, autoimmune disorder was considered to be a medically significant event.
pt recv vax & w/in 20-30min p/vax pt was tired, exp flu-like sx, a sore arm & stiff neck & became high (drugged) or stoned;
Approx 20 discrete scabbed spots on taros, scalp, buttocks, no fever.
Day of vaccine left thigh with quarter size red area. On 9/16/04 area increased to 3-4 inch oval shape, red, warm and hard. Temp 9/15/04 was 102-102.6. Today 9/16/04 101 later afternoon, N in Am
Dizziness & Tachycardia Narrative: Employee feeling slight dizziness, pulse ox 97% HR 110. Emp. feeling well requested to return to work even though HR 110. Pt instructed to to ER if symptomatic, released from clinic observation with pulse ox to monitor self. At clinic f/u call, she reported HR remained 110 x24hr post-vaccine and then returned to 80s.
This spontaneous case was reported by a non-health professional and describes the occurrence of EPISTAXIS (Several incidences of bloody nose) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019h22a) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Nov-2022, the patient experienced EPISTAXIS (Several incidences of bloody nose). At the time of the report, EPISTAXIS (Several incidences of bloody nose) had resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine. No treatment medications are reported. Reporter did not allow further contact.
Patient was feeling nauseous. Felt stabbing pain in her stomach. Felt lump in her throat.
Patient was asymptomatic immediately after her vaccination. Recently called patient to confirm appointment, was advised patient had an allergic reaction and she will not be coming for her second dose by her PCP.
got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided. first dose of the Moderna vaccine on 21May2021 at the same facility, and was scheduled to get the second dose on 28Jun2021 but did not attended the appointment at the time
patient reported they stopped medication because it stopped working after they received their covid vaccine. dr aware, no more info.
This spontaneous report was received from a consumer concerning a 73 year old female patient with no pertinent medical history. Patient's current condition included iodine allergy. On 09-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously in her left arm (dose, lot number unspecified). Concomitant medications included unspecified cholesterol medicine, unspecified thyroid medicine and aspirin. On 09-OCT-2012 the patient experienced fever, itching at the site of injection. She was unable to sleep after the vaccination. No treatment was provided. The consumer referred her to a physician due to itching and inquired that how long to stay away from newborns. The outcome of unable to sleep after the vaccine, itching at the site of injection and fever was unknown. The relatedness for fever, unable to sleep after the vaccine and itching at the site of injection was unknown for ZOSTAVAX. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
Per mom, approximately 12:15 on 07/12/2003, she noticed patients left arm.  States from shoulder to elbow, the area was red, hot to the touch, and swollen.  States patient was irritable, but it was late at night.  Denies fever, trouble breathing, or any other problems.
Patient presented to the ER following her first COVID immunization. Symptoms started an hour after the vaccine was administered. Stated her heart felt like it was racing, she had increased SOB, headache, was tired, nauseous, and had nasal burning.
A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult patient of unknown gender. The patient's medical history, concurrent diseases and concomitant medications were not reported. On an unknown date, the patient received FLUMIST (intranasal). The patient experienced Bell's Palsy. The action taken with the suspecting drug FLUMIST was unknown. The outcome of the event was unknown. The reporter assessed the event of Bell's Palsy to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of Bell's Palsy to be not related to FLUMIST.
mild pain on the arm where I got my shot; nasal issues after shot; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (Patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 19Jan2021 as first dose, single dose and on 09Feb2021 as second dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild pain on the arm where she got her shot, nasal issues after shot. Patient stated that he took both covid vaccine. He also had nasal issues after shot. The patient underwent lab tests and procedures which included antibody test found and the result was under 3.8 (negative) as per his oncologist recommended. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
About 6 hours after vaccination on 3/8, flu-like symptoms: chills, weakness, fatigue, headache. That lasted into the following ~1.5 days and was relieved with Tylenol and bed rest. Mild nausea on 3/9-3/10. The most concerning possible adverse event started on the evening of 3/12. I noticed my achilles area was itchy after taking a shower that night. I woke up the following morning on 3/13 VERY itchy on my left arm and ankles. I started to break out in hives on my lower legs and bilateral arms into the afternoon. I took Benadryl as directed on the package to try and relieve the hives. In the evening on 3/13 I tried taking a lukewarm bath with 1/2 cup of baking soda and epsom salt. After soaking for about 30 minutes, the hives had worsened and about 65% of my body was covered in hives. I called my primary care's emergency line that night and was prescribed 40mg Pepcid x 7 days and a Methylprednisolone pack to take in addition to the Benadryl. I took the 40mg Pepcid along with Benadryl and was able to relieve most of the hives. I did not take the methylprednisolone at all. I did wake up in the middle of the night with a scratchy throat and took another Benadryl to relieve that. The following morning on 3/14 I woke up and had some hives on my hands that disappeared that early afternoon without having to take Benadryl. In the evening on 3/14 at around 6pm the hives started to reappear on bilateral arms as well as legs. I took the 40mg Pepcid as well as Benadryl and the hives did not completely disappear before bed. The following morning on 3/15 it appears that the hives had disappeared. They did not reappear the following evening but I still took the 40mg Pepcid the evening of 3/15. Today is 3/16 and I have continued to be hive-free. One other detail to note, on 3/15 at around 4 in the afternoon I took an old supplement - Cranberry with Vitamin C. So I am not sure if this reaction was related to the expired supplement, the vaccine, or both.