chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Last night she had a severe asthma attach; This is a spontaneous report from a contactable consumer (patient's mother).  An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 18:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included sports induced asthma from Jan2021 and ongoing. Concomitant medications were not reported. The patient experienced that last night she had a severe asthma attach on 04Aug2021 with outcome of recovered on 04Aug2021. The paramedics were called. They gave her a breathing treatment and they have a doctors appointment scheduled for this afternoon. Therapeutic measures were taken as a result of asthma included Albuterol oxygen.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Flu symptoms, severe migraine from morning to night for both days more severe than usual chronic pain, muscle pain (arms, legs chest/shoulder area) arm swelling at the site of injection, weakness, excruciating toothache, facial pain, swelling, stiff neck. Infection in tooth, gums, sinus, and ear followed shortly after immunization. Complained to doctor staff, was told it was probably a reaction to the doses of two immunizations that I received. That it may have just been "too much for me" Treatment at emergency dentist of Amoxicillin in month of November. Again in December; Amox again, even though I explain to all docs that I am already resistant to two unknown (I forgot) types of antibiotics...then to ER for facial swelling and severe pain, migraine, infections, dehydration; diagnosed w/all but migraine and prescribed clindamycin. Infection not gone. To this day 02/04/2016 I have a reoccurring cyst in my gums, tooth abscess, persistent sinus infection and swelling which won't go away. My children have all caught the flu despite their own flu shots..(physicians) are not readily willing test or confirm the presence of MRSA. We are given antibiotics without bloodwork or nasal swabs to confirm anything. My 8 yr old daughter now has a lung infection with severe chest pain, diarrhea, dehydration, stomach pain, missing school. Her older brother (13 yrs) has type one diabetes with a fever of high as 103 degrees last weekend which got better with close monitoring and medicine, no doctor visit or ER, oldest son (15yrs) was very sick for one week in January, did not get treated or diagnosed, had the flu. Youngest son 10 yrs old had all flu symptoms with difficulty breathing, taken to doctor, given antibiotics as well as Pepto Bismol for throat, Tylenol and Motrin for severe fever of 104, Benadryl for sinusitis, it seems to have gone. Whatever has happened with the virus or whatever this is, our family can't seem to shake it and are all worsening, passing it back and forth and missing school, activities and going to a lot of doctor visits. I'm not understanding why blood testing is becoming a thing of the past nowadays to rule out more serious deficiency or autoimmune disorders which would make these occurrences more easily treated with knowledge of resistance.
Left upper thigh with  large area  of  erythema, inflammation, and  induration.  Tender  to  touch.
Hashimotos thyroid had been under control for about 26 years till I got the vaccine. It got out of control
Arm swelled up, Redness, hot at injection site, nurse in the mobile van put shot lower in my arm, felt the fluid gush in my arm.  15 minutes after on way home started to swell turn red.  Next day very sore swelling was not going down, hard knot from the injection site to my elbow.  NeXT day (today 9/17 still hurt only went down a little.  Went to my doctors around 1:15 pm.  The nurse pract.  looked at it  told to take antihistamines and ice injection site, as of now still red/feverish at site.  This was a Flu shot
Had the second shot around 8:15 am on Feb. 4, 2021. Around 8PM, I started feeling chills and stiff and hot neck. During the night, I did not sleep well. I had aches everywhere throughout my body and developed a fever up to 101.7 F.  I also felt nauseated and had a strong headache. I was not able to stand for more than a few minutes at a time and felt very tired.  I took ibuprofen around 7 am (2 x 200 mg tablets) due to the headache and body aches. Took a second dose of ibuprofen around 1PM. Third time taking ibuprofen around 8pm.  The first time I was able to get out of bed and eat anything was around 8 pm on Feb. 5.  Still had body aches, headaches, nausea, and weakness. I did not sleep well during the night of 4-5th or 5-6th. I did drink plenty of water during this time.  Feb. 6th - Still had body aches, headache, nausea and weakness. Feb. 7th - morning - started feeling somewhat back to normal.
patient reports fever of 100.5, headache, cough, and chest pain. resolved in one day
tested positive; tested positive; symtoms returned and we tested Pos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "symtoms returned and we tested Pos". The event "tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The reporter's husband (patient) received the BNT162B2 COVID-19 vaccines, and tested positive again for COVID despite receiving the BNT162B2 vaccines. The patient woke up with scratchy throats, had fever and headaches during the night. Took the test and was pos, called his Dr. Took the Paxlovid for 5 days, tested Neg. Then 3 and 4 days later symtoms returned and he tested.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201022236 Same reporter/vaccine/event, different patient;US-PFIZER INC-202201105638 Same reporter/vaccine/event, different patient;
Information has been received from a consumer, concerning her 26 month old child, who on 26-OCT-2007 was vaccinated with a dose of PedvaxHIB (lot # not reported). On 30-OCT-2007, the child developed 12 blisters at the injection site, and "upper respiratory problems" (details not specified). After 4 weeks, the child recovered from the blisters, however at the time of this report, he had not recovered from the upper respiratory problems. Unspecified medical attention was sought. Additional information has been requested.
Incorrect DOB given on patient encounter and in EHR and child was given a 0.5 mg dose on 12/3/14. It was later found that child was under 3 years of age on 12/3/14. Administering Nurse was unaware that DOB was incorrect at time of visit. The correct date of birth was found out on 12/30/14 once client returned for a 2nd visit.
This spontaneous report has been received from a pharmacy student referring to a currently 75 years old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 2015, the patient received the first dose of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. Later, on an unspecified date in 2016, the patient received the second dose of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. Subsequently on 21-APR-2017, the patient presented to the office to receive the third dose RECOMBIVAX HB. No adverse effects were reported and no further information was not provided. Additional information is not expected since the reporter refused to be contacted.
Periorbital (around both eyes) swelling; This spontaneous case was received on 29-Sep-2021 from a physician (reference number: SEQW21-02925) with additional document (being process together) received on 02-Oct-2021 from a pharmacist (reference number: SEQW21-03183) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 27-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left deltoid, route of administration, indication, dose: not reported). The batch number was not reported.  On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient had no fever and no pain to site.  On an unspecified date in 2021, the patient visited physician for observation and complete blood count (CBC) and renal function test were performed, and her renal function was fine. The patient was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something and the patient was advised to change mascara.   At the time of initial reporting on 29-Sep-2021, the patient was recovering from the event, as her swelling was almost resolved.   The reporter did not provide a causality assessment. As reported, it was most likely not the flu shot but an allergic reaction to mascara or something.  This case is linked with case 202103663 (due to the same reporter).  Company comment: On 27-Sep-2021, a patient was vaccinated with Afluria Quadrivalent. On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient visited physician for observation and was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something. Causal role of the suspect vaccine cannot be excluded. However, due to unclear temporal relationship and diagnostic findings, causality is unassessable.; Reporter's Comments: As reported, this was most likely not the flu shot but an allergic reaction to mascara or something.; Sender's Comments: On 27-Sep-2021, a patient was vaccinated with Afluria Quadrivalent. On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient visited physician for observation and was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something. Causal role of the suspect vaccine cannot be excluded. However, due to unclear temporal relationship and diagnostic findings, causality is unassessable.
Began feeling nauseated and had a severe headache.  After this, began to feel feverish, but was not able to take temperature.  Felt very cold, but skin was extremely hot to touch.  Muscle and joint aches all over body throughout the night.  Became very dizzy when trying to stand up. Unable to go to hospital because was not in condition to drive and it was the middle of the night. Headache continued through the next day.
Felt achy, fatigue, headache onset approx 16 hrs after shot.  48 hrs after injection, injection site is red, warm, itches.
Pt was administered the above Influenza vaccine (she is a RN) and immediately noticed after the vaccine was administered that it was administered too high in the arm.   Approximately 1-2 hours later she began to feel pain that did not improve and saw MD who dx pt with SIRVA and Bursitis r/t vaccine administration
This spontaneous report was received from a registered pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored dose of VARIVAX (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Administered dose of vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine was exposed to a temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (also reported as 55 degrees Fahrenheit) for 5 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012723 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Feet and hands blue, pt listless, sleeping, seen by Dr at clinic, monitored and discharged with no treatment. Resolved on own. *Should this infant be tested for egg allergy*
very fussy (extreme colic-like rxn) starting 4 hrs p/vax & lasted 5 days; no further pertussis vax planned;
c/o painful right upper arm x 2 weeks. Pain began after flu shot and continues with decrease use of right limb (only due to pain). requires assistance dressing and other activities. Pt tried aspirin x 3 days "no help" Adv: heat, advil. See PMD if sx persist. States " no swelling or discoloration" at sit (right arm). Has full range of motion, normal tempature normal use of hand/ fingers.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history, and allergies were not reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ oral liquid (lot number M019706 with expiration date of 24-OCT-2017) (strength and dosage schedule were not reported). Other suspect and concomitant therapies were not reported. The administered doses experienced a temperature excursion of 46.8 degree Fahrenheit for 9 hours. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of general malaise in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown time after receiving BEXSERO, the patient experienced general malaise and pain in arm. On an unknown date, the outcome of the general malaise and pain in arm were recovered/resolved. It was unknown if the reporter considered the general malaise and pain in arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional called and said that the daughter of one of the practice doctors and a daughter of one of the patient of that doctor experienced pain at the injection site, soreness in injected arm and generalized malaise for 1 week following administration of BEXSERO. The healthcare professional did not have patient demographics or product information or any other information available. This case is link with the case US2017041047 (reported by same reporter).
Within 4 days, severe pain and numbness in left shoulder, arm, and hand. Pain increased in intensity and distribution for 4 weeks.
Patient reported feeling dizzy approximately 10 minutes after immunization. Stated this is normal for him and requested orange juice and crackers. After approximately 20 minutes he reported feeling better and left the store.
Information has been received from a healthcare facility concerning an unidentified pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 633102/1217J). Subsequently, the pt experienced shoulder and elbow pain. The pt sought unspecified medical attention. An additional pt (WAES 00061872) had a similar experience following exposure to the same vaccine. Additional information has been requested.
4 hours after receiving MMR and Hep A vaccines patient's face and arms were flushed and itching at areas, patient was febrile during episode but continued after fever resolved until the next morning, no rash, also large local reaction at left thigh.
Headache, slight chills & no energy.  I didn?t notice what seemed to be an extreme  swelling (lump) & redness (area about size of golf ball) of arm until last evening (Jan 28),  I called dr in the morning:  ice & Advil recommended with antibiotic on staandby.
I contracted COVID-19. I had tightness in my chest and I was scared because I thought it was going to affect my lungs. I previously had Stage 1 Lung cancer in 2015 and I was missing the lower right lobe of my lung. My surgery for that was in June 27, 2016. So that was why I was concerned about the tightness in my chest and I decided to take a COVID-19 test. Later, I was prescribed Paxlovid for my symptom. I am feeling better now.
Temples are noticeably swollen, jaw is sore, slight headache and jaw ache
1-5-2021 uncontrollable Shaking of entire body  Fever started at 99.1 at 9:30 pm  by 11:30  fever was 101.1. I took 2 tylanol at 9:30 and 2 more at 11:30 pm and went to bed the shaking had subsided by  about 11:00pm and woke up about 1 am and the fever was gone.  I woke up at 5 am on 1-6-2021  with the shaking, but no fever and the shaking just lasted about 45 minutes.  I had a headache off and on  1-6-2021 and of course the sore arm.  I was very tired the 2nd day, too.
Cough; Sore throat; Skin burning; Sweating; Fever; Fatigue; Chills; This case was received via an unknown source (no reference has been entered for a license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gluten sensitivity and Milk allergy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, LEVOTHYROXINE for Thyroid function abnormal, THYROID (ARMOUR THYROID) for Thyroid function decreased, LAMOTRIGINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat), SKIN BURNING SENSATION (Skin burning ), HYPERHIDROSIS (Sweating), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017620 (Patient Link).
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer reporting for self. This female patient received the first dose of BNT162B2 (reported as COVID-19 Vaccine, lot number unknown) via unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine on 07Jan2021 and tested positive with COVID-19 on 13Jan2021. The patient was diagnosed with COVID-19 on 13Jan2021. The outcome of event was unknown.   Information on the Lot/Batch number has been requested.
pt recv 2 dose of varicella & lab eval 6-7 wk post vax revealed 11 neg titers & 6 equivocal titers;1 pt devel lesions;another pt devel lesion following vax;
Dizziness, Headache, Myalgia & NauseaVomiting
Small many petechiae in 1/3 inferior of the legs  X 3 days
Broke out in hive type rash; No temp areas to face, arms, legs, torso; c/o itching had been given DPH w/relief;
Vaccinated 3/25/14. 1st noticed red swelling at site 3/26/14 6 pm. Area increasing in size and seen by MD at clinic 3/27/14. 7 mm x 7 mm firm, swollen, red, hot area at injection site.
24 hours after injection of SHINGLES VACCINE developed local VERY SEVERE SWELLING, REDNESS, PRURITUS, PAINFUL, HOT. 3/4 of the arm, encircling it. Can not sleep because of itching and pain. No systemic symptoms. The patient is a Pediatrician well versed in vaccine reactions. The patient takes Advair 100 for mild asthma. Received a flu shot in the same arm, same date, different area of the arm. At 72 hours the reaction persists.
I was paralised from waist down for 1.5 Days with the loss to control over holding my urine
Extreme fatigue; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Extreme fatigue). The outcome of the fatigue was resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was patient itself. The patient was non-healthcare professional. This report was submitted via the online direct entry reporting system.  The event extreme fatigue was not treated. The reporter consented to follow up. The vaccination start date was 19th October 2019 and end date was 27th August 2021 however only one suspect was coded in the case with no vaccination date and dose number. As dose numbers was not clearly mentioned for the reported start and end date of the vaccine administration thus we could not assume if the end date was second dose of Shingrix. Also the onset date was not given in the source document and as it was not clear after which dose fatigue was occurred the suspect was retained only in one case. The drug dose administration interval too long was not considered as it was not stated how many doses of Shingrix patient had received in between as no dose number reference was provided.
2nd dose booster was given too early. Patient received 1st dose booster on 3/1/22.  Second booster not due until 7/1/22.  Patient had no adverse reactions.