chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CLient received dose #4 of DTAP IM on 5/26/09.  Parents report they noted large reddened area with mild swelling at site on 5/27/09.  Client without complaint of discomfort, nor was cleint reportedly irritable.  Parents report redness and swelling resolved by 5/31/09.  Parents called PMD and called HD on 5/29/09.  Parents report PMD not concerned, but inquired which vaccine was given in affected site.
Starting in early June I developed pain in the lymph nodes of my neck. It is now the 19th of June, and the pain has not abated. No other signs of illness are present.
1 HOUR AFTER INFLUENZA IMMUNIZATION BECAME WEAK, DIZZY, HAD NAUSEA AND VOMITED.  COMPLAINED OF STOMACH PAIN CLAMMY AND WEAK. TAKEN TO ER - BECAME HYPOTENSIVE B/P FELL TO 80'S AND 50'S. 1 LITER NACL BOLUS - TENDELENBURG POSITION. Medical Records received on 2/2/2005 states pt experienced diarrhea.
Muscle cramping, AST nl as well as ldh, CK, aldolase, Happened post 2nd covid vax in Jan, getting worse as of Aug 2021, Pfizer, 2nd dose given 1/8/2021
Presented to office with 12.5 cm x 9.5 cm redness and slight swelling, warm and tender to touch. Also a 2.5 cm x 1cm abraded area at center.
Patient had already received a dose of Heplisav-B earlier that day and due to communication issues, a dose of Engerix-B was also given the same day.  Patient wanted Varivax which she did receive as well after we figured out she didn't need Engerix-B from my store.  Patient had no signs of any adverse reactions or symptoms.
Severe hives all over body (particularly if skin is touched by clothing, scratched and etc.). Affected scalp, eyelids, mouth, inside ears, hands, arms, armpits, torso, groin, thighs, lower legs and feet. Difficult to walk as hives on bottoms of feet are painful. Prescribed Benadryl 25mg 3x daily, Zyrtec 1x daily, and prednisone 20mg 1x daily. Also prescribed Benadryl topical cream. Hives persist, but itch has somewhat subsided with treatment.
Was found deceased a little less than 12 hours following COVID vaccination; A spontaneous report was received from a reporter concerning a 96-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found deceased a little less than 12 hours following COVID vaccination.  The patient's medical history included hospice care. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last two days. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the patient died. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 96 year old male patient, who was on hospice care experienced a fatal event of death, after receiving mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Patient was initially given a Moderna dose by accident by. Despite CDC guidelines stating that in such cases a 2nd dose of Moderna should be given, the provider listed in this form refused to provide the vaccine citing an agreement they had with the CDC. I contacted the CDC , who informed me that this was not the case and a 2nd dose was recommended. They further informed me that whether or not the vaccine is administered, a VAERS report should be submitted. Patient's health is currently in good condition, however.
Per the patient's mother, after receiving the 2nd vaccine dose on 2/19/21, patient "became different".  He reported to her that he has "non-stop ringing in the ear", "wanted to kill himself because of ringing"; couldn't sleep all night", had fever. On 2/23, patient's symptoms got worse. He vomited twice, ringing in the ear continued, had headache, fever, and poor appetite. He also couldn't sleep. The mother of the patient was advised by the case management team that it's not uncommon for 2nd shot to cause slight flu-like symptoms for a short while, but she probably needs to call 911 if patient exhibits suicidal tendencies and take him to ED.  She said she already tried over the weekend, called Ambulance. 6 people came to and spoke with patient, including psych. Ambulance left, the patient was not deemed at risk, refused to go anywhere.  She was concerned that he refused to follow up with outside PMD. She was given further instructions to take the patient to the ER and call with any other questions and concerns. She was not heard from since. Attempts were made to contact the patient to follow up, but to no avail. Patient's phone appears to be off.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication with in two weeks. Patient received the treatment Paxlovid from 10Oct2022 to 15Oct2022. There was no known allergies.4 days after testing negative and having no symptoms the Covid symptoms have returned. The patient had  a bad cough and runny nose and very tired. No temperature as of now which I originally had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 hours of extreme chills that night (Friday). Followed by 3 hours of extreme sweats the same night. Then woke up Saturday morning feeling fine.
tested positive for COVID-19 infection with mild symptoms; tested positive for COVID-19 infection with mild symptoms; This is spontaneous report from an agency. The consumer reported same events for two patients. This is the report for her husband. A 43-year-old male patient received bnt162b2 (COMIRNATY, both Lot Number: EW0177) via an unspecified route of administration, on 04Jun2021 as DOSE 2, SINGLE and on 14May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated that her husband and herself received their second dose of the Pfizer COVID-19 vaccine last Jun2021. She states they both have tested positive for COVID-19 infection with mild symptoms on 13Oct2021. Caller is surprised that they have been infected so soon. She states that they have been very cautious and taking all the precautions and they don't understand how they caught it. The patient was diagnosed with Covid 19 virus on Wednesday (13Oct2021), he displayed symptoms first and within 48 hours she had symptoms. He was confirmed positive on 13Oct2021 (nasal swab), and he is also Pending PCR Test results.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101393306 same reporter/drug/event, different patients
01/17/22 presents to ED for "Suicidal ideation". PMHx of "Mood disorder NOS"
Pt developed tingling in face & difficulty swallowing about 15 min after receiving the flu vaccination. BENADRYL 50 mg was administered and pt recovered quickly within 15 mins.
Patient had seizure shortly after being given 2nd of 2 vaccinations. Pfizer bivalent was given in right deltoid, followed by Fluzone quadrivalent being given in same right deltoid. First reaction was non-descript. When I turned around after placing shot into sharps container, the patient appeared to be stretching with her neck thrown back over the top of the chair. Then I saw her eyes roll back a little bit, then she began convulsing. Mom and eye made eye contact and she asked what was going on. I caught her from falling by the arm which ripped her band aids off. Within 5 to 10 seconds, incident was over. Patient felt off, dizzy, and had no memory of seizure. Paramedics were called, assessed patient in consultation room and felt patient was safe to go home. Patient had no history of seizures.  In the two days post seizure, patient has experienced no setbacks of any kind per her mother.
Have pelvic, bladder spasms after I pee; Peeing frequently; bacterial uti; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) dose 1, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bacterial uti on 24Mar2021, experienced pelvic, bladder spasms after she peed and peed frequently on an unspecified date. No fever. It was reported that, patient due for second Pfizer vaccine tomorrow. Patient enquired if she could still get her 2nd vaccine tomorrow. The patient was treated with nitrofurantoin mono. MCR 100 MG (MACROBID) as a result of bacterial uti. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a consumer concerning her daughter who on an unknown date was vaccinated with a first dose of GARDASIL (Lot No. not reported) along with three other vaccines, including tetanus (unspecified manufacturer). Subsequently the patient experienced "deterioration of her body tissue". The patient had been seen by eight different specialists and no one had been able to diagnose her. The consumer noted that the company should look into "immune disorders" associated with GARDASIL. At the time of the report, the patient had not recovered. No further information is available.
I have been suffering from fatigue, chills, headaches, eye pain, pain in my arm (where I received the vaccine) for the past several weeks after my second dose of the Pfizer vaccine. The symptoms started the day after my second dose and continue to persist (almost a month later).
Edema and erythema of right arm. Prescribed with ABX and prednisone and Benadryl.
headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a patient).  A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),lot number unknown, via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported.  The patient experienced headaches and sore throat on 24Jan2021 (also reported as "headaches days 3-6 post-vaccination, Sore throat starting day 6"). The outcome of events was not recovered. Patient did not receive any treatment due to the events.  Follow-up attempts are completed. The following information on the batch number has been requested.
Lost hearing in left ear 36 hours after 2nd vaccination; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Mar2021 16:00 (Batch/Lot Number: EN6207) as 2nd dose, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient has no known allergies. The patient had no other vaccine in four weeks and no covid prior to vaccination. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6148) on 01Mar2021 16:00 in the left arm for COVID-19 immunization. The patient lost hearing in left ear, 36 hours after 2nd vaccination (25Mar2021). The event resulted in doctor or other healthcare professional office/clinic visit. The event was not treated. The patient was not tested for covid post vaccination. The outcome of the event was not recovered.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA006448: US-009507513-1802USA007572: US-009507513-1802USA007575:
Nausea; swollen glands; body aches; headache; jaw pain when talking.
Patient had elevated blood pressure SBP to 190s when she was previously controlled on her chronic meds. She required sublingual captopril at an urgent care and also increased the dose of her chronic med to control the blood pressure.
A few hours post vaccination, the patient developed a rash all over her body and a fever of 100.7F. Unspecified medical attention was sought. Additional information has been requested.
Pain and inflammation left wrist. Began  4 hours after vaccine. Pain is extreme at times. Feels as if wrist is broken. Initial xray , labs were done 05/ 02/21 diagnosis was/is cellulitis. Completed courses of three antibiotics: keflex, cipro, Bactrim. Symptoms remain. Starting new round of antibiotics today, also referred to a bone doctor
Extreme fatigue, resolved within 6 hours. Headache, moderate, resolved in 6 hours
ACUTE RESPIRATORY FAILURE 9/5/2021 PNEUMONIA   HYPOXIA 9/4/2021 PNEUMONIA  ACUTE RESPIRATORY FAILURE 9/5/2021 ASPERGILLUS PNEUMONIA  HYPOXIA 9/4/2021 ASPERGILLUS PNEUMONIA  ACUTE RESPIRATORY FAILURE 9/5/2021 CANCER METASTATIC TO BRAIN  HYPOXIA 9/4/2021 CANCER METASTATIC TO BRAIN  ACUTE RESPIRATORY FAILURE 9/5/2021 CANCER METASTATIC TO BRAIN  HYPOXIA 9/4/2021 CANCER METASTATIC TO BRAIN
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around December 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-MAY-2014, the patient was diagnosed with herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Body aches and  fatigue. Swelling, redness and heat at injection site. Swollen lymph nodes under left arm and alongside of left breast. Painful nipples on both breasts.
I had a cough, stuffy nose and a low grade fever. Was already being treated by my physician for COVID-19 so I tested myself and was positive. I called my doctors office and he recommended the new Pfizer pills as a combination pack which I took for 5 days. My symptoms improved and I am fine.
This spontaneous report was received from a medical assistant referring to a female patent of unknown age. The patient was administered a dose of GARDASIL on 25-OCT-2010 (dose, frequency, indication, route of administration were not reported). On 08-MAR-2016, the patient was in the office and received a dose of GARDASIL 9, (her second dose of a HPV vaccine). No adverse effect reported. This administration schedule was outside the labeled recommendations in both vaccines prescribing information. Additional information has been requested.
Heart feels like it?s racing and then I get short of breath. Pain in my upper left chest and shoulder blade happen around the same times. It has been happening off and on since 8:30am this morning when I woke up.
Approx 2 1/2 hours after my first vaccination I was sitting watching TV and got a very sudden and very intense metal taste in my mouth.  I waited about 2 minutes to see if it would go away abd then got up to go get a drink of water to try to make the taste go away.  As soon as I stood I nearly fell abd felt I was about to pass out.  I told my husband I was not OK abd went a few feet out my front door to an outside chair for more air.  I felt extremely lightheaded.  After maybe 5 minutes the metal taste went away abd I felt a little less light headed.  I went back inside abd sat again but almost instantly the metal taste came back.   I sat outside until the metal taste went away again.  My husband brought me water to drink.  The light headed ness eased up but didn?t go away until 4 PM that afternoon.    It was a terrifying feeling.   I emailed my doctor mg d also called ER to see if I should go to the hospital.  I had an online appointment with an ER doctor who had not heard about those side effects before abd was only interested in whether I was having trouble breathing.  I was not having trouble breathing.  My Dr. emailed back stating I should go for my second shot, which I have not had  yet, and take Benedryl.   I?m scared about having these side effects again.   I nearly passed out and if the second one is worse as I?ve heard I just don?t know if I should have it.
Employee received (L) deltoid IM flu vaccine injection on 10/3/11. Patient reported "significant" (L) shoulder area pain near original injection site 1 month later. Evaluated by PCP who prescribed medicine. Currently asymptomatic denies pain as palpitation. No mass. No redness, no lumps.
Patient had an allergic reaction . Onsite EMS was called vitals BP 126/80  98% O2 room air HR 70. Patient Refused Evaluation/Care, Left aginst medical advice.
Patient states after receiving vaccine on 11/4 that night he began to experience pain in his wrist and they began swelling up . He continued this way for the week and took aspirin to help with swelling and pain. He eventually came in on 11/9 and spoke to the pharmacist on duty who observed it  was swollen compared to his other wrist. He was referred to take Aleeve  and that has helped with the swelling and pain. he states his wrist is now just tender.
approx 2 hrs p/vax pt devel rash all over-under skin-almost blue like in color & red skin; pt became hyperactive (a little), eyes glassy looking; call clinic instructed to take to MD who said was rxn to DTP; sl rash;
02/08/11 - confusion, seizure, convulsing, stiffness. 08/11/11 - headache, nausea, dizziness, crying, hot & cold spells.
Pt was given booster for PNEUMOVAX 8-10-12. On 8-11-12, she awake with sore lt. arm (in area of shot) no redness; had facial redness & was treated for facial cellulitis. Pt. seen 8-15-12 facial rash more consistent with shingles, treated with antiviral rash, by Dr.
with the first shot, she got desperately ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EN6198) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "with the first shot, she got desperately ill".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
PT COLLAPSED AND FELL ON THE FLOOR FACE DOWN ABOUT 5 MINUTES, AROUND 9:35AM  AFTER GETTING 1ST DOSE OF COVID VACCINE. PT WAS TURNED OVER WITH THE HELP OF A SAMARITAN WHILE WE CALLED 911. PT HAD SEVERAL SEIZURE EPISODES. PT REGAINED CONSCIOUSNESS AND BECAME RESPONSIVE AFTER ABOUT 2 MINUTES. PARAMEDICS CAME AND TOOK  OVER. PER PT, NO PRIOR HISTORY OF SEIZURE OR MEDICAL CONDITION. PT CAME FROM 10 HRS  NIGHT SHIFT (2 DAYS IN A ROW) TO GET HIS VACCINE. DAD WAS INFORMED PER PT'S AUTHORIZATION ABOUT INCIDENT AND HE SAID HE WILL BE ON HIS WAY. PT TO BE  TRANSPORTED TO A NEARBY HOSPITAL PER ONE OF THE PARAMEDICS.
I have had hives everyday since 2 weeks after my last vaccination of Moderna.  I have been to an allergist and have been diagnosed with hypersensitivity.  The doctor has called it Mast Cell Activation Syndrome with urticaria (hives), swelling (angioedema) and skin turning red (flushing).
Patient is fully vaccinated.  Patient is a 16-year-old female who presents for Covid 19 concern. Patient was diagnosed with Covid 19 on December 24. Since then patient has been having intermittent fevers. Patient started on antibiotics. Patient states that she has been taking 200 mg of Motrin with minimal improvement of temperature. Patient states that her temperature was 38°C with last dose of Motrin 8 hours prior to arrival. Patient adamantly denies any chest pain, shortness of breath, nausea, vomiting, constipation, dysuria, urgency, frequency, headache, malaise. Positive for congestion and rhinorrhea. CXR demonstrates no acute process. Vitals stable throughout the EC visit. Oxygenation 100%Given Rx for Motrin and Tylenol.  Stable.  Discharged home.
Initial report received from a consumer on 16-Oct-2013. A patient received FLUZONE (lot # and expiration date unknown). It was reported that the pharmacist injected high does flu shot intradermal rather than intramuscular. Documents held by sender: none.
Patient is under the age of 18 and was provided Moderna vaccine.  Per CDC guidance and in consultation with facility direction, the patient was consulted to let him know that a second dose of Moderna vaccine off-label would be the recommended second dose. The patient following discussion with his PCP has determined that he will not receive a second dose of COVID-19 vaccine.
When the dose was administered the syringe exploded.  The clinic tech said this happens from time to time and should be nothing to worry about.  I however think some of the dose went into my arm.  Then when they made a second attempt with a new syringe I ended up with a 110-115% dose.  I ended up getting very sick for 2 weeks.  Major symptoms were fatigue, coughing, fever, difficulty breathing, and muscle aches.  I went to urgent care 6 days after the dose of vaccine and tested positive via PCR test for COVID.  Prior to the vaccination I felt fine and didn?t exhibit any symptoms of CoVID.  I?m convinced I got it from the vaccine.