chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received Dose 1 of Pfizer Covid Vaccine  Lot # EN6200 on 3/25/2021 as well as Pfizer Dose 2 Lot # ER 8732 on 4/15/2021.  Client stated had mild eyelid swelling after both dose 1 and dose 2, but did not keep a journal of the exact days the swelling occurred.  Client stated was unsure whether to report the reaction as she gets the same swelling after taking various medications.  She stated she has been tested for allergies and does not have any.  She reported the eyelid swelling was mild and came and went the weeks following the first dose of vaccine.  She also had some swelling after the second but nothing that would keep her from getting future doses of the vaccine if they become necessary.
stroke; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a adult patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for stroke, postherpetic neuralgia, vision problems and balance problems. The outcome of stroke, postherpetic neuralgia, vision problems and balance problems were not reported. The reporter considered stroke, postherpetic neuralgia, vision problems and balance problems to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be a medically significant event.
passed away about 10 days ago after getting the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 58 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 14Jan2022, outcome "fatal", described as "passed away about 10 days ago after getting the booster". It was unknown if therapeutic measures were taken as a result of death. The patient date of death was 14Jan2022. The reported cause of death was "passed away about 10 days ago after getting the booster". It was not reported if an autopsy was performed. The clinical course was reported as follows: I was with a friend this weekend and she mentioned that her brother in laws friend passed away about 10 days ago after getting the booster- she did not know what booster shot he received.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away about 10 days ago after getting the booster
After a second when I finished gave flu shot to patient, she complained dizzy, almost faint & could not hear. So I immediately monitor pt & saw her face was pale and asked her to take a deep breath in & out and she did that & felt better. I checked with mom who was and present if pt ate yet? Patient said she had not eat anything at all for the whole day (I gave flu shot around 4:20pm). So I gave patient a bottle of water to drink slowly and a Twizzlers at first she refused Twizzlers but mom convince her to eat little, she ate some Twizzler and drink more water & rest for minutes and all was fine for her. Observed her again she confirmed she can hear & well so I let her go.
Had bad heartburn for 2 days eating or drinking anything.  Have not had any before the vaccine and none since.
First experienced Sudden low blood  sugar spells coming every 4-5 hours.  Had not had one in over 20 years.  Not a diabetic but diagnosed with functional hypoglycemia over 50 years ago.  within 2 days started experiencing extreme fatigue which was a huge flare up of my CFS/ME. Had this for 30 years but I was fully functioning and just rested as needed.  Added to this was IBS synthoms which  started within 2 weeks. It was as if my immune system went crazy.  It has been 8 months since this all  started.. I have never in my 80 years experienced any kind of flare up like tbhis..  I still cannot walk around a grocery store because of the fatigue. Am very careful to eat every 5 hours to  keep blood sugar from dropping..
Several pts developed positive titers for HIV for 6 months following adm of Hepatitis B vaccine; No further details were provided;
Vanishing Point Syringe, first half of dose administered without difficulty. For second half of dose syringe jammed and was unable to administer remaining dosage. Correct remaining dose was administered with a new syringe.
2 "50-cent piece sized" red rashes appeared. Rashes were itchy, warm, and uncomfortable. Patient used hydrocortisone cream on rash to stop itch.  Seems to be improving over time.
Raised rash on arms and legs - itchy at times  Painful blisters on hands (15) and on feet (3)
At 1830 child exhibiting ashen color, circumoral cyanosis and stopped breathing for 10-15 seconds, per mother. Child transported to hospital via ambulance with O2. In hospital overnite for observation.
This case was reported by a pharmacist and described the occurrence of rash in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, the subject experienced rash. The rash resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583946A, and A0583947A.
Pt received the vaccine and walked towards the observation area but felt nauseous, dizzy, lightheaded, states he was seeing spots. Went to the bathroom to sit down. Called his girlfriend who was in the waiting area to notify someone. Paramedic and nurses entered bathroom and found pt next to the toilet, alert, stating he was feeling dizzy and nauseous. Vitals at 1317 was BP 90/40, HR 52.  Waited and rechecked vials at 1320 (BP 112/60, HR 66). Pt was able to get up and sit on a wheelchair and lay down on a cot. BP at 1326 was 110/60, HR 75. Gave him juice and time to rest. Pt reports improvement in symptoms. Pt able to walk to chair but reports some lightheadedness and feeling off. Pt sat in chair. Rechecked in 10 mins and reports he felt normal
Complained of redness, swelling and itching at site within 24 hours of injection. The swelling extended up the arm and into the arm pit and side breast tissue as well as swollen lymph node. She saw her family doctor on 3.26.2021 and he referred her to an allergist, informed her to report an adverse reaction and not to take second dose of COVID vaccine.
Public health nurse gave MD wrong dose/type of H1N1. Patients should have received 0.25 ml prescn and instead she gave MD 0.5 ml H1N1 with free preservative
Dizziness/fatigue. Lasted several days. Went to doctor. Never had problem with flu shot before. Is high dose right for people nearing 80 yrs?
Patient immunized with vaccine that has beyond-use-date (BUD) of 7/15/2022; MFG: 11/2021; EXP: 10/31/2022. No temperature excursion during this time period. We have reached out to Pfizer for additional information regarding the vaccine viability past the BUD. Currently waiting on response.
A report was received from a health care professional on 12/8/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin instead of Fluzone on the same day. On 12/8/03, the vaccinee inadvertently received Fluvirin instead of Fluzone. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 4/16/04: Follow up information received from a health care professional indicated that a 3 year old vaccinee inadvertently received 0.25ml Fluvirin on 11/28/03. No adverse events have been reported to date. No follow up pending, all information received.
2 hours after vaccine my entire face and teeth went numb and tingly like pins and needles and my throat felt slightly swollen. I took a benadryl which did help some with my face and throat but my teeth still felt numb and tingly. The next day I felt a bit better my whole face still had a slight numbing sensation but not bad. By friday I felt mostly back to normal.
This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline.  Concurrent medications included Olmesartan medoxomil.  On 31 March 2010 at 10:55 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm.  On 2 April 2010, after vaccination with BOOSTRIX, the subject experienced injection site pruritus, injection site tenderness (level 1) and injection site redness.  It was also noted that when examining the subject's injection site, the site was 1/2 cm in size with induration.  At the time of reporting the events were improved.
Rash a at site of shot appeared 8 days after vaccine . Very red , swollen and itchy. Put hydrocortisone cream and took  Benadryl . This is day four and it is not as red and not itchy . Area was quite large
excessive irritability APAP q 4 hrs & call w/in 2 hrs to see if pt improved;
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Hives and Urticaria all over the body; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives and Urticaria all over the body) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2022. On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced URTICARIA (Hives and Urticaria all over the body). The patient was treated with CETIRIZINE for Hives, at a dose of 2 daily in the morning; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at a dose of 20 milligram once a day and MONTELUKAST SODIUM (SINGULAIR) for Hives, at a dose of 10 milligram once a day. At the time of the report, URTICARIA (Hives and Urticaria all over the body) outcome was unknown.      Concomitant drugs were not reported. Patient received first dose of Moderna COVID-19 vaccine on 22-Apr-2021 Lot number 009C21A, second dose on 20-May-2021 Lot number 006C21A and first booster dose on 22-Nov-2021 Lot number 939909. It was reported that the event restarted after the bivalent booster.   This case was linked to MOD-2022-660885 (Patient Link).
8/19/11 morning after injection, site was swollen slightly - about size of a nickel (per mother). As the progressed site swelled to the size of a golf ball. Area red but denies pain. Dr's eval: 3 inch diameter, fluid filled area (left deltoid), slight warmth, minimal tenderness. Tx: ice, rest, elevation, call if sx worsen.
Per Hospital reporting system "Gave child Dtap,Hep B,IPV, instead of Dtap"
Fever, Body aches, Headache, Tightness/pain in chest... Especially whole laying down.
Patient received shingrix vaccine 5/13/20. Later in the evening started to get redness to the site and soreness before going to bed started with flu like symptoms of body aches and low grade fever. Next day redness was the size of an orange. Took tylenol and today feeling a little better. Redness remains about the size of a fist on day 3. Denied any swelling. No fever at this time. Discussed applying warm or cool compress to area and continue with Tylenol. Advised to call office if redness gets any larger or swelling starts to develop.
High fever; Chills; Body aches; Difficulty breathing; Chest felt like ribs broken; Painful to breath; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534) via an unspecified route of administration in the left arm on 13Mar2021 at 15:15 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included sleep apnea and high blood pressure, all since unknown date. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN) both for an unknown indication. The patient had no known allergies. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 15Mar2021 at 16:00, reportedly experienced high fever, chills, body aches and difficulty breathing which lasted 11 days, chest felt like he broke ribs and was painful to breath which lasted 6 days. The patient continued to have difficulty breathing which improved daily. On 20Mar2021, the patient underwent nasal swab COVID-19 test and the result was negative. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event painful to breath was recovered on 21Mar2021 after the duration of six days, while the clinical outcome of the events high fever, chills, body aches was recovered on 26Mar2021 after the duration of eleven days. The clinical outcome of the events difficulty breathing and chest felt like ribs broken was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Angioedema both times, the second time was a little bit worse; A spontaneous report was received from a healthcare facility staff member concerning an unknown patient who received Moderna's COVID-19 Vaccine, and who experienced angioedema after both doses.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the symptoms, the patient received their two planned doses of mRNA-1273 unknown batch number intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient experienced angioedema both times after vaccination. The second time was a little bit worse and lasted for three days. Treatment for the event included prednisolone, Pepcid and Benadryl.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the event angioedema both times not reported.; Reporter's Comments: This case concerns a patient who received their two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of angioedema after both doses.  Based on the current available information, including reoccurrence of event after second dose and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event of angioedema is considered possibly related to the vaccine.
Patient administered vaccine beyond the published expiration date. Per Moderna, re-vaccination not required. The vaccine determined to still maintain the activity necessary to protect against COVID-19.
24 HOURS AFTER INJECT PT HAD FEVER, HEADACHE, BODY PAIN, SWELLING RED HOT AT SITE. TAKING TYLENOL, COLD COMPRESS AT SITE.
Information has been received from a RN concerning a 6 y/o who on 15Jun98 was vaccinated SC with a dose of varicella virus vaccine live. On 24Jul2003, 2 weeks after exposure to a 4 year old child who on 11Jul2003 was diagnosed with shingles (also reported as a child with chickenpox and a child who had chickenpox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chicken pox. No treatment was required. No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chicken pox. Additional information has been requested.
Client began oral typhoid 07/10/02. Had slight red rash on left side of face one day post #2 dose which she felt was not important, completed #4 dose on 07/16/02 and next day 07/17/02 had rash on nect and rms which is red and flat. She denies any itching or any other adverse symptoms.
Got COVID said that was a crossover event and I should report it.   Ran fever of 100+, congestion, cough, severe chills, body and muscle aches, trouble breathing.    Tested at home with home test kit according to all directions and rules - called Dr.  Was prescribed a medication that was acceptable for those with heart condition and high blood pressure.  Alternative med to most common one prescribed (can?t remember the name)
4JUL red bumpy rash to hands & wrists-1st pos on 5JUL no fever-dec appetite & irritable;not much itching;7MAY97 3 pox 8JUL97 10 very small pox devel-crusted by morning;
lt thigh devel area around inject site approx 3" round red & purple in color; seen 26AUG dx as abscess put on Keflex & cough syrup also had URI;
Narrative:  64 year old male with past medical history of liver/renal transplant in 2019 due to HCV/cirrhosis, diabetes mellitus 2, hypertension, hyperlipidemia, borderline personality disorder, venous insufficiency, and HFpEF presented to the ED for a fever. Then in the ED he was found to be positive for COVID-19. Of note he was fully vaccinated in 1/2021-2/2021 with Pfizer. Other than his fever he had experienced some cough, clear sputum production, and some increased chest tightness for the past 2-3 days. Work-up in the ED was significant for CXR that showed slight opacity of the left costophrenic area but vastly unchanged and then stable anemia/thrombocytopenia. His O2 saturations were >90% and remained >90% during hospitalization apart from during sleep which was suspected to be due untreated OSA. With his overall symptoms being indicative of a mild episode of COVID-19 he was given casirivimab/imdevimib for treatment. He was then admitted to internal medicine due to inability to return to care facility due to quarantine procedures. Once admitted to the floor contact was made with his transplant surgeon and it was determined to hold his mycophenolate for the next two weeks. On 8/17 he was experienced significant wheezing which improved with scheduled albuterol. Throughout 8/18-19 his cough, shortness of breath and sputum production improved. His oxygen saturations remained above goal while he was awake. Remdesivir and dexamethasone was clear by his transplant team but was never given due to his mild symptoms and able to maintain his oxygen saturations. On 8/19, it was determined that he could return to his care facility. He was hemodynamically stable to determined safe to discharge back to his care facility.
Hoarse; lost her voice; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy). At the time of the report, DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy) outcome was unknown.            No concomitant medication was reported.  Patient had experienced events after second dose.  No treatment medication was reported.  Action taken with the mRNA-1273 vaccine in response to the events was not applicable.   This case was linked to MOD-2021-142069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18 May 2021 had no new information regarding first dose.
Redness swelling injection site. Low fever, nausea,  muscle weakness, fatigue,  headache, shivering  upset stomach
12OCT96 rxn to flu vax, swelling on eyes, face & rash, fever for 5 days temp was not measured;
Woke up lethargic, with severe headache, and fever (Temp 101.5).  Neck supple.  Advised tylenol for H/A & fever.  Called back for office visit that evening.  Temp up to 102.5 oral with eye pain, head pain top & front of head.
Redness and rash to injection site remaining after 2 weeks Patient's eyes itching and face is itching
Patient age 10 y.o. received Pfizer COVID-19 (12+) vaccine dose. No adverse reactions noted or reported by patient or parents to date.
Pt vaccinated with DT developed 7 X 5 CM area there is area of size largly heamous under skin.
Swelling of whole thigh (where vaccine was given) & tender. Child limping secondary to pain. This child otherwise as per Mom never complains. BENADRYL & then oral antihistamine QD helped.
More fussy, less interactive, less eye contact, less smiling and cooing, writhing her hands, more easily startled, more stoic.
the patient had a headache and abdominal pain; the patient had a headache and abdominal pain; the patient had "unsteadiness; the patient vomited 4 times; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore; left arm felt heavy, weak and sore/arm being sore; This spontaneous report was received from a registered nurse referring to a 11 year old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies.  On 19-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose was unknown; lot # 1621929, expiration date 06-DEC-2021, via intramuscular in the left arm as routine vaccination (prophylaxis). At the same visit, the patient was also administered a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (dose, route, lot#, expiration date were unknown) for prophylaxis.      On 19-NOV-2019, 30 minutes after having the injections the patient had unsteadiness for 5 minutes and then 6 hours after the injection the patient vomited 4 times. On the same day, the patient's left arm felt heavy, weak and sore. On 20-NOV-2019, the patient had a headache and abdominal pain. The patient's mother called physician office, but no treatment was given for the events. The nurse reported that all of the patient's symptoms have resolved except for the patient's arm being sore. The causality assessment was not provided.