chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient called pharmacy around 12:00am on 8-24-21  stating she had just left the emergency room after having an anaphylactic reaction. She states that the reaction started as itching and hives, and that her throat started closing and she became hoarse and began to lose her voice within 10 minutes of receiving the shot. She states the pharmacist wanted to call 911 for an ambulance for her, but that since her husband drove her and the hospital is so close to our store she opted to have him transport her instead.  At the ER she was given epinephrine, prednisone, and diphenhydramine. The patient says the ER told her to contact the pharmacy to have us input the VAERs event, and she was discharged to home. She reports no trouble breathing after discharge, but she was still having some itching.
The morning after the vax, the pt felt ill when she went to work. She felt progressively worse until she left work early. She had an itchy sore throat, chills, headache, nausea and generalized joint soreness. The pt also states that some of her co-workers have missed work due to illness recently.
The evening of 4/18 my daughter began feeling short of breath, and had pains in her chest.  She waited a while but then had difficulty breathing and extreme chest pain so she went to the ED.  Over the next several hours they performed a chest Xray, EKG, urine tests, and blood tests (metabolic panel, CBC,  test for heart muscle injury, blood clotting problem test)
I woke up unable to take a deep breath. My chest felt heavy with pain, and I was not able to lay down.
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm.  She has not had history of reaction before.  Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing.  She has a history of afib and last night she had two runs of it and took metoprolol.
47 y/o female reports a reaction after receiving the TDAP vaccination on 5/27/2021 . No prior reaction to immunization in the past.  She reports a onset of pain and swelling at the injection site (left deltoid area) that worsened during the day on (Thursday)  followed by a generalized frontal headache , nausea but  no vomiting, and hives( starting in left arm,  that radiated to left hand  and jawline, chills.  No shortness of breath.  She developed a fever which lasted three days:  on Friday 5/28/21  , temp 101.0 and 100.8-100.1 on Saturday 5/29/21 .On Sunday 5/31/21   temp  was 99.9. she later took  Diclofenac for pain with minimal improvement.  Tuesday 6/1/21 She is afebrile temp 98.7 and still c/o soreness and swelling at site but feels symptoms are resolving.  Advised her to come in to site today to be assessed. She is sensitive to tactile stimuli. No redness or warmth at the injection site  site. FNP
HEADACHE, CHILLS,BODY ACHES, NAUSEA, FATIGUE
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, jaw pain Narrative:  Other Relevant History:
This case was reported by a consumer and described the occurrence of shingles in a male patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, scalp pain, scalp disorder, local swelling and localized erythema. On an unknown date, the outcome of the shingles, scalp pain and scalp disorder were unknown and the outcome of the local swelling and localized erythema were recovered/resolved. It was unknown if the reporter considered the shingles, scalp pain, scalp disorder, local swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient took the new SHINGRIX shot on 2nd of February, as the patient's pharmacist warned to the patient. The patient had experienced large arm knot on it with a red circle around it and it went away 3 to 4 days later. Three to four days later after the patient got the shot he started noticing a soreness in the scalp on the left side of his head, after another two or three days he asked his wife to look at his head and found that his scalp was covered with bumps and it had been quite painful. On the day of reporting the patient finally went to the doctor and said he had shingles. The patient stated that he know the story line was that the shot could not cause shingles but this timing was extremely close. The doctor said to the patient there was no treatment except within the first 2 to 3 days so guess the patient would just have to live with the pain until it goes away. The patient know this was a brand new drug and said that the GlaxoSmithKline might appreciate this feedback.
4 month old infant was given a Hepatitis B vaccine at 4 months and 11 days instead of 6 months old.  No adverse reactions, signs or symptoms were noted at time of injection.
Information was received from licensed practical nurse concerning multiple patients of unknown age or gender. It was reported that on multiple unspecified dates after a 20-JUL-2015 temperature excursion, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot #L008660, expiration date 10-NOV-2016) (dosages and routes of administration not provided) or PEDVAXHIB (MARRS# 1510USA014422). Oral, ROTATEQ, PNEUMOVAX23 (pre-filled syringe), and RECOMBIVAX HB (lot #004754, expiration date 10-NOV-2016) appeared on a product list because temperature stability information was asked, but no doses were administered to any patients. No additional information available. This is one of two reports from the same reporter. Additional information has been requested.
Lack of Response - information has been received from a physician concerning a 25 year old female family member who was vaccinated in December.  1995 and January.  1996 with the first and second doses of varicella virus vaccine live (unspecified site) respectively.  On 23 apr 1996, the patien had negative varicella antibody titers of less than 0.86 which indicates that the patient is not immune.  the patient received unspecified medial attention.  No further information is available.
At approximately 1420, Lead Nurse that patient had an appointment for a 2nd dose Moderna. Patient's database record showed he received a complete series of Pfizer Covid Vaccine at Pharmacy and a single dose of Moderna Covid Vaccine (LOT# 037C21A, exp. 8/22/21) at the Vaccine POD on 7/30/2021. RN spoke with patient. Patient confirmed he received the completed series of the Pfizer Covid Vaccine. Patient also confirmed he received a single dose of the Moderna Covid Vaccine and scheduled that appointment as a 1st dose. Patient reported he had organ transplants in 2020 and had a Covid antibody test which showed no Covid antibodies. Patient's PCP recommended he receive a complete series of the Moderna Covid Vaccine. Lead Nurse elevated situation to Leads. Lead Nurse educated patient on interim clinical considerations regarding additional doses, to follow up with PCP, and to sign up on v-safe. Patient verbalized understanding. Patient did not receive a 2nd dose of Moderna. At approximately 1455, patient left facility with unlabored respirations and steady gait.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness/Heaviness/Pain-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Within 2 minutes after administration patient alerted pharmacist she felt out-of-breath, chest tightness and an overall warm feeling. At 5 minutes, blood pressure and heart rate checked with arm blood pressure kit. All numbers were normal. At this time, patient felt a little better. At 10 minutes, I offered Benadryl and/or Zyrtec but patient declined. She stated she felt much better. She could go home with no issues.
I went to a party and like 13 people got sick. The night of 07/28/2021 I started feeling chills and I had a sore throat. When I was asleep my throat closed and it hurt to swallow. I started getting a runny nose and cough. I had low grade fever for like 2 days but I tok Tylenol and I felt better. I was very sleepy. I went to get a Covid test on 07/29/2021. It came back positive.  I still have fatigue, runny nose, cough, ear pressure, loss of smell ad taste, and low back pain. I also got blood work done and it came back positive for antibodies.
Chills, fever, shivering, body ache, headache, nausea.
Arm was sore and swollen for 3 days post injection. Minor swelling and firmness from injection site and slightly below continued. On 1/5/2021 (a week after the injection), redness formed and 3 big spots measuring about 1-1/2 inches appeared.  Spots are firm to touch. No pain, itching.
This is a spontaneous report from a contactable nurse communicated to a sales representative. This nurse reported similar events for six patients. This is the third of six reports. A patient received PREVNAR13, on an unknown date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccination, the patient developed dark red, hard and raised swelling at the site of injection. It was reported that no emergency room or physical visit was required. At the time of this report, the outcome of the event was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further informtion expected.
SHOT SITE 50MMX60MM SWOLLEN AREA AND REDDENED. SITE WARM TO TOUCH. DR. OBSERVED REACTION AND RECOMMENDED ORAL BENADRYL AND ICE TO SITE. PT INSTRUCTED TO FOLLOW UP IF ANY CHANGES.
It started out with my glands in the back of my neck and around in the front of my torso being swollen up to eight weeks and in about three weeks after the shot I started having feelings like my heart was stretching
On 3/21/16 developed pain and tingling down L arm. On 3/24 developed papulovesicular lesions on upper L arm and was seen by me diagnosed with zoster and treated with valacyclovir.
Day 1: Vaccination Sore throat/hoarse voice: Day 3-4.  Used cough drops, drank tea, subsided after 2 days Dull ache in L armpit: Day 6-9. No treatment, subsided after 4 days. Minor skin irritation on L side of neck: Day 7-10.  Applied topical hydrocortisone cream, subsided after 4 days.
Information has been received from a physician and registered nurse concerning a 21 year old female with no medical history of drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the left deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  Concomitant therapy included possible hormonal contraceptives (unspecified).  On 27-JUL-2006 the patient experienced extreme pain at the injection site.  The onset of the pain was immediate and lasted for 5 to 6 minutes and then resolved.  Unspecified medical attention was sought.  It was reported that the patient does not wish to continue the series of vaccinations.  Additional information has been requested.
The nurse administered the vaccine intramuscular rather than subcutaneous.  She reported it to the clinic lead who, in turn, sent an e-mail to manufacturer   They responded that there is no need to revaccinate the patient.
patient went to the hospital the night of the vaccine experiencing pain on her right side from shoulder to her feet. hospital prescribed and discharged on a muscle relaxer. patient still in severe pain and hospital believe it was Sciatica brought on from the vaccine.
Patient stopped in to inquire on the bruise she developed on the site of injection area. The bruise was about 4" x 5" diameter. She was instructed to contact her primary physician 1st thing Monday morning.
4 1/2" site w/diffuse erythema, redness, induration & sl tenderness @ inj site lt deltoid;Ibuprofen for pain;reports dime size induration on 12JAN99;
A rotateq vaccine was administered and it had temperature excursion; No additional AE reported; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided by the reporter.   On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #T033812 and expiration reported as 29-DEC-2021 (strength, dose, frequency and route of administration were not reported).  It was informed that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) temperature excursion was at 47°F during 1 hour. There was no previous temperature excursion and the call was not made because a data logger. No additional adverse event was reported.; Sender's Comments:  US-009507513-2106USA004106:
Information has been received from a medical assistant referring to 3 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were unknown, lot # L050788, expiration date 12-OCT-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm soreness above a server for vaccination.  Next day increased X2, increase tenderness at shot site. Body aches, uneasy sleeping, restless. Arm still sore and body aches to this day (48hrs+) after injection.
Itching around injection site began on day 10 after injection. then on day 14 a red 6 cm rash appeared around injection site
Per Client received first COVID 19 Moderna vaccine on 2/5/2021 at 2:00PM in right arm. Client reported now having low grade fevers 99.6F to 99.8F, and headaches since 2/11/2021 intermittently, occuring during the middle of the day. Client reported taking Tylenol for headaches and following up with PCP. Client informed to continue to monitor symptoms and to continue following up with PCP. Client verbalized understanding information provided.
daughter feeling like "poop"/felt horrible for four hours after receiving the vaccine; This is a spontaneous report form a Pfizer Sponsored Program COVAX US Support. A non-contactable consumer reported for a female patient (daughter). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller indicated that she has been hearing good things about Pfizer and the vaccine and that her daughter received her second dose and other than feeling like "poop" for about four hours, it went great. The patient experienced felt horrible for four hours after receiving the vaccine on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax on 12APR94 & on 22APR94 & 23APR94 pt had ax fever according to mom of 101, along w/body rash; 25APR94 mom brought pt in & had t99 R & generalized exanthema;
36 hours after receiving Rotateq, had a 30 minute episode of crying at the top of his lungs followed by a watery bowel movement.
I did not have an adverse reaction after receiving the vaccine. In 01/2023, I developed gastrointestinal discomfort. I am scheduled colonoscopy and endoscopy this week. At this time, I have altered my diet to see what is causing my issues.
Pt. called today (4/11/2023) stating that she received her first 2 COVID-19 Pfizer vaccines at Facility on 3/26/2021 and 4/17/2021 then about 2 months after her second dose she started not feeling  well and was subsequently diagnoses with AFib.  No allergies or cardiac history reported at the time of vaccination. States she didn't know what it was until she got a fitbit then went to the Dr.  Dr at Heart center.  She received an Echo and Cardiac CT and eventually diagnosed with Afib and put on Metoprolol.  Pt states "they said they are seeing a lot of AFib after COVID Pfizer vaccine."  Pt had a COVID Moderna vaccine on 12/18/2021.
Approximately five hours after receiving the COVID-19 Modern booster and flu shot, I noticed hives on both arms; however, they did not itch or bother me. As expected, my arm had some soreness at the injection spot and I was tired. During the night (10-12 hours after receiving the vaccines, I woke up with a bad case of the chills and presumably a fever. When I got up in the morning, I had a fever but most of the hives had gone away. I took OTC acetaminophen and my fever went away as well. That day (after the vaccine), I had full body aches, was tired and weak, and had a dull headache.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 6 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 6 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
The patient was diagnosed on 30Nov2021 with Covid-19; The patient was diagnosed on 30Nov2021 with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 44-year-old female patient received bnt162b2 (COMIRNATY; Formulation: Solution for Injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 30Nov2021, outcome "recovered" (2021) and all described as "The patient was diagnosed on 30Nov2021 with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative; (30Nov2021) positive, notes: The patient was diagnosed on 30NOV2021 with Covid-19. Action taken for bnt162b2 (COMIRNATY) was not applicable.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (13Dec2021): This is a follow-up spontaneous report from a contactable reporter(s) (Pharmacist) from medical information team. Updated information: Outcome of event "Covid-19" was updated to recovered.; Sender's Comments: Based on the information currently available, The casual association between the reported event "Covid-19" and suspected vaccine BNT162B2 cannot be completely excluded.
Redness, warmth, hardness, and sore to touch at injection site. Noticed several days later. Took over the counter Ibuprofen and applied to cold pack to area. Color lightened and warmth lessened, but there is still hardness and soreness with a little bit of warmth.
Initial report received from nurse on 01 Dec 2009: This patient, who was a child younger than 4 years, received FLUVIRIN lot number 1008132P, 0.5 ml intramuscular on 12 Nov 2009. No adverse event was reported.
Information has been received from a physician concerning an approximate 14 year old female, prone to passing out, who on 28-AUG-2009 was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. Approximately a minute after getting GARDASIL, the patient passed out and started snoring and shaking. The patient recovered on 28-AUG-2009. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a 90 year old female patient with dementia. The patient's medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported) during the same office visit on an unknown date. On an unknown date, after receiving the PNEUMOVAX 23 and influenza virus vaccine (unspecified), the patient developed "a reaction at the injection site", the injection site "swelled up, became red, and looked puffy". The patient went to an unspecified emergency department and received BENADRYL (lot, expiration date, manufacturer and dose unknown). It was also reported that "the patient had an unknown reaction to the BENADRYL that they gave her at the emergency department, but the patient got better and recovered in about 1 week". The patient did no required intervention to prevent serious criteria, no life threatening or significant disability or incapacity was presented. The outcome of adverse drug reaction, injection site erythema, injection site swelling, injection site reaction and drug hypersensitivity was reported as recovered/resolved. The causality between adverse drug reaction, injection site erythema, injection site swelling, injection site reaction and drug hypersensitivity with PNEUMOVAX 23 was not reported.
10 days p/vax pt listless, worst case measles on face-everywhere very big; called MD; pt running temp it became very high that noc-convuls; next day eye rolling back up into head; pt was in pain & could not move eye; double elevator palsey
p/giving vax noticed that both legs turned red in a circular area of aprox 3" on rt leg & 4" on lt leg; watched legs for 3-5 mins when noticted lt leg had dime sized whelp occur under area of HIB;