chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a 68 years old female patient with FLAGYL allergy and cold sores. The patient was vaccinated with the first dose of ZOSTAVAX (lot number not reported) under the skin in her left arm in January 2012. No other co-suspects were reported. Concomitant medications included OTC vitamins (unspecified). In January 2012 the patient started getting a cold sore on her lip about once a week for several months after she received ZOSTAVAX in 2012. The patient reported that she was having a history of cold sores since she was born but said she was only getting them about 2 times per year before getting ZOSTAVAX. No treatment was received. No lab diagnostics was received. The outcome was reported as recovered/resolved in April 2012. The patient didn't sought medical attention. Additional information has been requested.
Approximately 10 minutes after receiving her vaccination patient fainted, then once she gained conciousness she vomitted a small amount of water. Family that was present, said that this is a somewhat common occcurence as she's had several episodes similar to this within the past year.
I started developing the symptoms on Feb 15,2022 and at first it was just cold symptoms, which was a sore throat, cough, running nose ear pain, nausea. And then I went to the Dr. the first time and they gave me three medications, one was a nose spray, anti biotic and then a zyrtec, started taking those and I figured that I would be better but instead of getting better I started getting worse, i started getting a lot of ad normal blood sugars, and a ton of weak and dizzy episodes. So I went to my actual DR. office and since I had already been tested for COVID, Flu and Strep,  at the walk in clinic just a few days before, they decided to do blood work that day since my test were all negative. The blood work came back pretty normal except my thyroid, however on Feb 24th I had a loss of bladder control episode where I peed on myself which never happens, and then that same day, I started experiencing chest pains on and off every since then. On Feb 27th I even had left arm pain as well, and during the night of  the 25-26th my heart rate was up to 170 something throughout the entire night. On the 27th I went back to Fast Pace where I was told I need to be seen at the ER and today I still wake up with the same symptoms. Went to the ER and there were too many issues at the ER so I did not stay to be treated.
PATIENT RECEIVED MULTIPLE PNEUMONAX SHOTS STARTING 2012, 2ND, 3RD AND 4TH IN 2016
Moderna COVID-19 Vaccine EUA Swollen Uvula and nasal passages, light headedness
8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.
red rash at the injection site- raised, itchy, burning- started about a week after injection along with constant headache.
Patient had severe side effects with the Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Patient had severe side effects with the Moderna) in a 42-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (Patient has a history of allergies) and Lung function abnormal.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had severe side effects with the Moderna). At the time of the report, IMMUNISATION REACTION (Patient had severe side effects with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was with only 50 percent lung function. Patient reacted very severely to the Moderna vaccines. No treatment information was provided.   Reporter did not allow further contact
1st dose Oct2019, 2nd Oct2022; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XM22G, expiry date 31st August 2023) and (batch number G537F, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2019).   On 1st October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 1st October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
This vaccine was given prior to 5th birthday(18 days early) in error. Mother was informed by me. The CDC was called to make a plan going forward. Although this dose was given prior to age 5 years old, the second dose will be due after his 5th birthday and therefore can be given on time. Mom voiced understanding and was not upset. She plans to return in 3 weeks for his second dose.  Verbal order given to me by Provider. Prior to administration Medical Assistant provided VIS sheet and confirmed with mom that this was the correct vaccination for the patient. Written consent was also obtained.   patient did not experience any adverse reactions at the time of vaccination.  The family has not contacted the office to report any adverse reactions since obtaining vaccination.
Pt had swollen eyelids a few hours after vaccine and continued today, pt also has aches from yesterday to today
Redness, swelling, warmth to left deltoid after receiving TDAP and PNEUMOVAX 10/1/09- Reaction did not occur until approx 24 hours later- ran fever 102 24 hours later took analgesics and resolved - area approximately  9" XS" left upper arm remains warm.
Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to her face and went throughout body.; She also had swelling and itchiness with the rash.; She also had swelling and itchiness with the rash.; Low grade temperature 99.3 degrees; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hodgkin's disease from 2007, cardiac disorder was the patient taking concomitant products. Concomitant medication(s) included losartan (LOSARTAN) taken for cardiac disorder from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for cardiac disorder from an unspecified start date and ongoing; warfarin (WARFARIN) taken for anticoagulant therapy from an unspecified start date and ongoing; Toprolol taken for cardiac disorder from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient did not administered any other vaccine on same date of the suspect. Caller on the line calling about the COVID 19 Vaccine. She was informed to call and report any reactions to the vaccine. She received the vaccine on 02Feb2021 and three days later she developed a rash. The rash started on her feet and spread throughout her whole body. She also had swelling and itchiness with the rash. Caller went to her primary care doctor on Monday 08Feb2021 and it was suggested to her to go see an allergist because the primary care doctor could not determine what this reaction could be other than the vaccine. The rash got worse from day to day as it spread throughout her body. It started on her feet went to her ankles. She then had swelling with it; it was itchy, very itchy. The rash went from there to her face and went throughout body. She noticed it in the afternoon on 05Feb2021. She had socks on and her socks were getting tighter due to swelling. She took her socks off and then noticed the rash. She also added, she had a low grade temperature. It was 99.3 degrees. Initially stated the low grade temperature started on Thursday 04Feb2021, but then stated it could have started Friday, she is not sure. It was one of those days. She thought she had a low grade temperature for two days. She did not even take the temperature the second day because she felt so crappy and did not feel like taking it. The caller was given a name of an allergist and she would go see the allergist on 18Feb2021. The patient did not visited to emergency room. The patient visited to physician's office. Outcome of the events rash, she also had swelling and itchiness with the rash were not recovered and unknown for other event.
Colon Cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of colon cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced colon cancer (Verbatim: Colon Cancer) (serious criteria GSK medically significant).  The outcome of the colon cancer was unknown.   It was unknown if the reporter considered the colon cancer to be related to Shingrix.     It was unknown if the company considered the colon cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2023 The pharmacist requested data on the administration of 2nd dose of Shingrix following completion of chemotherapy for colon cancer. The healthcare professional stated that patient had 1st Shingrix vaccine on 08th October 2022 and started chemotherapy in January 2023 and completed chemotherapy July 2023. The reporter consented to follow up.
Chest tightness per patient 2-3 minutes after vaccinated - administer Albuterol 0.083% per nebulizer - per Dr's order - sent to ER for evaluation and further treatment.
hospital employee did not achieve acceptable titer level p/3 vax w/Engerix-B;
lost partial vision in my left eye for 10 minutes; tunnel vision; This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 14Jan2021 16:00 at single dose, left arm for covid-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as No. The patient experienced "lost partial vision in my left eye for 10 minutes" and tunnel vision on 19Jan2021 18:00 with outcome of recovered. On January 19th at 6 pm, the patient had lost partial vision in his left eye for 10 minutes. He had tunnel vision. The patient went to his eye doctor yesterday and his vision was fine with not noticeable issues. No treatment received for the adverse event. Events reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Irregular bleeding, bleeding outside of expected menstruation, early-onset of period/menstruation (10 days before expected)
patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml; This is a spontaneous report from a contactable healthcare professional. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 34-years-old) as a  0.5 ml single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  This follow-up report is being submitted to amend previously reported information: reaction data updated event to overdose, treatment none, and outcome was UNKNOWN.
I HAD AN ALLERGIC REACTION TO THE VACCINE AND ENDED UP IN THE HOSPITAL 15 MINUTES AFTER THE DOSE I STARTED TO GET HIVES AND SWELLING IN MY LIPS, FACE, AND UPPER BODY. IN THE NIGHT TIME AFTER BEING RELEASED FROM THE HOSPITAL I HAD NIGHT SWEATS AND A HIGH FEVER THROUGH THE NIGHT.  I WAS GIVEN  BENEDRYL 50 ML BY INJECTION AT THE HD AND  DEXAMETHASONE  INJECTION AT THE HOSPITAL AND SEND HOME WITH A STEROID PRESCRIPTION FOR PEPCID  THAT LASTED 7 DAYS.  ALONG WITH THE INSTRUCTION TO CONTINUE TAKING BENEDRYL UNTIL THE HIVES STOPPED COMING BACK AFTER THE SHOT WAS OUT OF MY SYSTEM.  i TOOK THE MEDICATION FOR 5 DAYS UNTIL THE HIVES STOPPED RELAPSING.   2 WEEKS LATER I AM FEELING FINE  BUT DO NOT THINK I WILL BE TAKING THE SECOND DOSE DUE TO THE ALLERGY.
I was positive for COVID-19 on 16FEB2023, I had a cough, severe sore throat and very tired. I went to walking clinic and tested me, than prescribed me paxlovid and I took it for 5 days. I started feeling better about the 4th day.
Left arm more sore than usual. Site red, hot that extended down arm muscle 3-4 inches no fever.
Little tired; Little headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021541961 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RABIES VACCINE, administration date 14Feb2021. Vaccination history included: Bnt162b2 (Dose 1, LOT Number: EL3247, Expiration date May 2021), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Little tired"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Little headaches". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: The received her 1st dose in Jan2021 and her 2nd dose on 11Feb2021. Consumer stated, "No, just those little headaches, I just felt a little tired but I was fine. Three days later, on 14Feb2021 she received a series of rabies vaccinations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was to receive 2nd booster of Pfizer, but Tech did not follow safety protocol, pulled a Janssen & Placed at Pfizer station, drew up 0.3 ml and labelled sheet as Pfizer, documented Pfizer lot number and expiration.  Gave sheet and drawn up syringe to pharmacist, who knew a Moderna and Pfizer were at the stations already.  Pharmacist pulled the Moderna and saw a Pfizer at the station.  Pharmacist gave IM shot to patient, Patient stated it stung .  Pharmacist noted that.  30 minutes later when the tech went to draw the Pfizer doses for the next group.  She realized she had pulled out a Janssen and had set it at the Pfizer station and drew it as a Pfizer.  (at end of the day pharmacist drew out of Pfizer what was left. Based on our shots that day it was one shot over.  Drew out contents of Janssen and sure enough , some vaccine was missing in spite of no Janssen shots scheduled.  Confirmed pt got a substandard dose of Janssen instead of mRNA Pfizer shot).
Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no known drug allergies who on 20-FEB-2009 was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (Lot # 654741/1208F). On the same day she also received a dose of secondary suspect vaccine, hepatitis B vaccine (manufacturer unknown) and a dose of concomitant  therapy, "meningitis vaccine" (manufacturer unknown). "Three minutes after administration of the second dose of GARDASIL", the patient fainted. She "quickly" recovered. No lab diagnostics studies were performed. It was reported that the lot number and date of administration of the first dose of GARDASIL were unknown. Unspecified medical attention was sought. Additional information has been requested.
High blood sugar for 4 days, headache, chest pain (3 days), shortness of breath (3 days), fever (2 days) nausea, terrible pain on left breast- same side as injection-passed out twice Saturday night fatigue. Had to take Monday off due to side effects.
Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.). At the time of the report, VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant no treatment medication were reported.
Itchiness with very light rash on arm. Most Itchiness occurred on head, ears, arms.
Child had a fever of 105.5 at 2am on 3/20/07. This was after his last dose of children's Tylenol wore off.
Presented with generalized weakness; SOB; fatigue; fully vaccinated; Covid + in ED; Admitted with Covid PNA; tx with steroids, maxipime, vanc, doxycycline, merrem, zinc,  He also was found to have acute hypoxic respiratory failure related to covid 19 infection Patient also was found to have a small pulmonary embolism likely related to covid 19 pneumonia Patient had to be admitted to the ICU and was resuscitated with blood transfusion and FFP. Patient bleeding stopped and his hemoglobin improved. He was found to have significant debility related to covid 19 infection and also had oropharyngeal dysphagia. DC'd to Rehab
I immediately knew that the vaccine had been administered too high in my left arm & was into the shoulder joint. Pain started keeping me awake at night. Then began affecting my daily functions: reaching for seat belt, removing clothing over my head, raising my arm to reach for items. So my range of motion has been limited. Constant pain when moving left arm.
QUEASINESS; LIGHT-HEADEDNESS; FEELING LIKE GOING TO PASS OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced queasiness. On 11-MAR-2021, the subject experienced light-headedness. On 11-MAR-2021, the subject experienced feeling like going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from queasiness, light-headedness, and feeling like going to pass out. This report was non-serious.
Pt developed a fever of 103F on 8/29/01 and had seizures and was taken to ER for evaluation.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 15-Jun-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 PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   This case was linked to MOD-2021-262311 (Patient Link).
A severe, dull ache resulted at the vaccination site yesterday several hours after vaccination and radiated down my are, up my neck, and down my back. 1000MG of Tylenal helped, but the ache remains. The arm is swollen, warm to the touch, and black and blue. Today I have a mild fever, some hot flashes, nausea without vomiting, body weakness, and overall muscle aching. This is the sickest I've been in years.
On march 31st the patient had received her 4th covid booster (Pfizer) and tetanus booster. Her liver enzymes  increased from the range of 15-17 to 200-400.  Her liver enzymes are going down. They are doing weekly testing for the patient.  She reported fatigue and shortness of breath.
Pt recvd DPT/HIB#2 5APR91--mom says pt was sick--on ATB for 10 days before recvd vaxs. Pt had high fever on 6APR91 up to 103(R) x 5 days--called MD--mom says took pt to ofc for checkup about wk later. Mom says red area @ DPT site.
The next morning, 10/14  around  at approx. 8:30 am, I started becoming chilled, fatigued, slightly nauseated, slight headache, slight muscle pain and running a slight fever, 100.5.  Injection sight was sore.  Symptoms started to diminish  during the evening of 10/15 and by the morning of 10/16 I was feeling fine, with the exception of injection site was still slightly tender.
Very sore left arm the same evening as shot was administered.  The next day I was unable to move my left arm in certain positions without severe pain and range of motion reduced.  No previous issue with shoulder prior to vaccine shot
After 5 min experienced tunnel vision, felt was going to pass out & tongue swelled Seen @ ER + given benadryl + steroids
Tongue and throat swelling, hives and itching, nausea.  Epinephrine, benadryl, and zofran administered.  Transported to ER.
Nurse administered at a school located clinic.  Mom was present with student.  Approximately 10 minutes after vaccination was done, nurse was called to restroom by Mother who said child was vomiting.  RN laid child on floor.  Child was alert but slow to respond to questions.  Answered questions appropriately.  Appears listless, pale, wet to touch.  Blood pressure 96/58 resprirations 24. Pulse 68.  911 called and student transported to emergency room.  At approximated 2:45 Mother was called, states child was seen that ER doctor did not necessarily think that this was a reaction to the H1N1 vaccine.  States it could have been just a reaction to the situation and getting a shot.  Mom states child is doing fine and enjoying time off from school with her Mom.