chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 21 February 2014 from a consumer who is the daughter of the patient. This report represents one of a cluster of two patients reported by the same reporter who each experienced an adverse event following administration of FLUZONE HIGH DOSE. The events of the other patient are captured in case number 2014SA023860. An 84 year old female patient was vaccinated in September 2013 with FLUZONE HIGH DOSE (batch, route, site and exact date of administration) were not reported. The patient's concomitant medications and medical history were not reported. Later that day, the patient began experiencing headache, fever, vomiting, and vision problems. The patient had continued to have vision problems and now on 21 February 2014, the date of this report, the patient is blind in one eye. The patient was diagnosed with optic neuritis on an unreported date. Laboratory tests were not reported. The patient is being seen by her own primary care physician and will be seen by a neurologist. The reporter refused to provide physician names or contact information. No further information is available at the time of this report. Documents held by sender: None.
started feeling symptoms 3 days ago; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced started feeling symptoms 3 days ago on 06Feb2021. Caller stated she received the second dose of the Covid 19 vaccine 3 weeks ago and started feeling symptoms 3 days ago. Caller didn't explain symptoms and refused to provide a safety report. Still having symptoms 3 weeks after getting second dose. She had both doses and is having symptoms, but this will be 3 weeks since her second shot.  She would not think she would still be having them. Her main question is whether she should get a COVID test. The outcome of event was unknown.  Information on lot/batch number has been requested.
This spontaneous report as received from a consumer (patient's mother) refers to a currently 11 years old male patient. The patient's medical history included a "bad reaction" with a flu vaccine (unknown strength/dosage/manufacturer). The patient's concurrent conditions included asthma and eczema. On 06-JUL-2016, the patient was vaccinated with first dose of GARDASIL via intramuscular route (right arm). Concomitant therapies included albuterol. After receiving the first dose of GARDASIL, the patient had an adverse reaction. The reported stated that the reaction started out as a "small red spot" on his foot "just like if someone took a marker and just tapped it on the skin." Then the reaction spread from the feet, to the ankles, to the lower arms, to the chest, and then to the back. It then turned into "blisters with a crust on top of them." The reaction itched and burned for the patient. The patient was taken to the emergency room at the hospital on 10-JUL-2016. The "medics" at the emergency room felt that the reaction was caused by "bug bites". The reporter then stated she had taken the patient to their primary physician on an unspecified date and the physician felt that it might be "hoof and mouth disease." No treatment was given for the adverse events. The patient's present status was reported as recovered. The reporter felt that the reaction was related to GARDASIL. Additional information has been requested.
Patient had 2 previous Pfizer vaccines. She chose to get Moderna as her booster.  After @30 minutes she got an itchy neck and then started getting bumps (hives) on her tongue.   I had her sit in chair with arms and she took 1 Benadryl capsule.  She thought it was working after a couple of minutes (seemed too soon for me).  I gave her 10ml of liquid Benadryl @10:45.  Redness and itching on neck and tongue bumps were subsiding, but I asked her to stay for a few more minutes.  She sat for approx. 10 minutes before leaving.  Left @11am. I recommended her keeping benadryl with her and having her Epipen with her.
02/18 two days post vax, pt complained of itching rash with urticaria. Finished 10 day course of penicillin 02/17. Also complained of joint pain an swelling with 1st episode. 03/03 returns complaining of intermittent episodes of urticaria. Dermatographism noted 1st episode. Question of angioedema, urticarial eosinophilia syndrome. Plan to have allergy work-up.
DEVELOPED REDNESS, SWELLING, & ITCHING AT VACCINATION SITE APPROXIMATELY 12 HOURS AFTER RECEIVING FLU SHOT.  SHE TOOK DIPHENHYDRAMINE  EVERY 4-6 HOURS FOR 24 HOURS BUT BY NEXT DAY (10/22 AM) REPORTED HIVES OVER ENTIRE LEFT ARM AND ACROSS CHEST AND LOWER LIP SWOLLEN.  WAS TREATED AT CLINIC WITH ATARAX AND STEROID INJECTION AND PRESCRIBED ZYRTEC FOR 7 DAYS.
Within 24 hours of the vaccine, I developed  body aches, headache, fever of 101..4 degrees, chills, tiredness, and a sore throat.  The fever, chills, and sore throat lasted for 1 day.  Other symptoms lasted for an additional day, so a total of 2 days.  About 3 days after the vaccine I developed a rash below the site of the injection.  It didn't itch on my actual skin, but deeper in the muscle.  The rash lasted for 4 to 5 days.
feeling sick; stomach cramps; can't go to the bathroom; This is a spontaneous report from a contactable consumer calling on behalf of her husband.  A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband had both received the first dose of Pfizer-BioNTech COVID-19 vaccine and were scheduled today (10Feb2021), at around 2:40 for the second dose. He is feeling sick since this morning (10Feb2021), with stomach cramps, and "can't go to the bathroom". The clinical outcomes of feeling sick, stomach cramps and "can't go to the bathroom" were unknown.    Information about lot/batch number has been requested.
Swelling, redness, heat, fatigue stomach upset, nausea and headache.
Severe local reaction erythema and edema and pain elbow to shoulder 5 days. Paresthesia of lips 5 days.
fever, chills and headache; fever, chills and headache; fever, chills and headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 09:30 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low Thyroid" (unspecified if ongoing); "elevated BP" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Tachycardia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); LISINOPRIL taken for blood pressure increased (ongoing); TOPROL XL taken for tachycardia (ongoing); CRESTOR taken for blood cholesterol increased (ongoing); GABAPENTIN taken for restless legs syndrome (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 09:15, route: Intramuscular), administration date: 15Feb2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 08Mar2021 09:30, outcome "recovered" (09Mar2021 09:30) and all described as "fever, chills and headache". Therapeutic measures were taken as a result of chills.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101499373 same patient and drug, different dose and events
Red, warm and painful to touch with edema. Dx'd with cellulitis of left leg. Treated with antibiotic and Benadryl.
Patient stated she started a day after the shot having a rash on her back on her left side as well as as rash on her chest.
Massive Pulmonary embolism with evidence of right heart strain, acute hypoxic respiratory failure, Axute DVT of right lower extremity. No obvious known provoking factors
pt recv vax 20NOV96 & 28NOV96 pt exp hives & other allergic sx;pt stated that had no hx of allerg rxn;MD was not interested in receiving any confirmation or notification;
2 days, post vax, pt had fatigue and malaise which resolved after 24 hours. Mom called after the fact.
felt flushed; her throat was mildly tight; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EN5318) (at the age of  37-year-old) via an unspecified route of administration in left arm on 11Feb2021 at 1:15-1:20pm as single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. There was no prior vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE(s) and relevant tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient had no allergies. Caller, reporting on the COVID vaccine and who had the first dose and explains she had a question. The first dose was yesterday and after getting it she felt flushed/ flushed- this was in her chest that she felt the flushed sensation and her throat was mildly tight (on 11Feb2021). After 5 minutes it went away. The caller was wondering could that be a reaction, she called the doctor who would not say it was a reaction and was therefore told to call us. Her fear was that with the second dose, could she have a worse reaction after that one. The patient did not visit emergency room or physician office. The patient did not receive any treatment for the events. The outcome of the events was recovered/resolved on 11Feb2021.  Follow-up attempts completed. No further information was expected.
Information has been received from a nurse concerning a male who on 29-JAN-2007 was vaccinated PO with the second 2.0 mL dose of Rotateq (1st dose given on unknown date). The nurse reported that on 13-MAR-2007, the patient developed rotavirus. Unspecified medical attention was sought and laboratory test were performed (tests and results not provided). At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Information has been received from a nurse concerning a 4-month-old male with no medical history who on 29-JAN-2007, at 1500, was vaccinated PO with the second 2.0 mL dose of ROTATEQ (Lot # 652964/0145F) (1st dose given on unknown date).  Concomitant vaccination administered on that same day and time included the second dose in the left vastus lateralis of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot #C2490AA), the second dose in the right vastus lateralis of Hib conj vaccine (OMPC) (MSD) (Lot #654072/1013F), the second dose in the right vastus lateralis of PREVNAR (Lot #B086468) and a SC dose of IPOL (Lot #Y1050).  There was no illness at the time of vaccination.  The nurse reported that on 13-MAR-2007, the patient developed rotavirus.  Unspecified medical attention was sought.  A rotavirus test was positive.  At the time of this report, the outcome was unknown.  Additional information has been requested.
I have had 3 Pfizer vaccines and had self-limiting GI upset (nausea and diarrhea) within 6 hours of each injection, lasting about 12 hours. Dose # 2 was received on 1/18/2021 (lot # EL 1284), also as Hospital. Dose #3 was received on 1/8/2022, (Lot # FL3197), given to me at an immunization site.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received FLUARIX QUADRIVALENT (batch number Y495S,  expiry date June 2017). On 30th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site inflammation. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site inflammation were unknown. The reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site inflammation to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on unknown arm and his arm became swollen and inflamed. It was red and hot to the touch. After receiving the vaccine the patient was away with his father for several days. When the mother next saw him the reaction was present. The mother did not indicate if the symptoms were improving.
Child was at his usual speed and agility class that evening. While climbing up the ropes he felt a pop in his head and had a severe left sided headache with arm and leg weakness. He went to urgent care and then to the ER
given Pfizer imz to patient, at that time was ok waiting on chair for observation for 15 minutes, and after 3 to4 minutes fainted, fall from chair ,called member of management, white code, given water to patient was ok left pharmacy after 30 minutes, was fine when left pharmacy     followed up patient in  around 2:00pm patient was okay, in evening show rx for Keppra, called mom at that time she told her child has autism disorder ,so they went to ER per their  PCP doctor advised may be because of Pfizer vaccine  and his HEALTH condition might have seizure so precautionary have Keppra prescribed and have follow up with dr on Monday, didn't mention health condition at time of injection, per her taking precautionary check up, when follow up with her she was thankful for checking on her child
Diarrhea, N/V, Body Aches, headache, sore throat - 1:00 12/29 - 10:30 12/30/2020
Pt had flu shot, felt lightheaded & got up. Fell & hit head. Paramedics called.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # L008996 with expiration date: 01-DEC-2016 or lot # L033545 with expiration date: 30-MAY-2017 (exact dose was not provided). There were no symptoms reported. Administered doses of vaccines experienced the temperature excursion of 33.2 degrees Celsius for 11 hours and 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe injection site and shoulder pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history included AFib (atrial fibrillation) and had 2 leaking valves. The patient's concomitant medication(s) included apixaban (ELIQUIS) and hydrochlorothiazide (DIURETIC), 80 mg. On an unspecified date in 2021, the patient experienced severe injection site and shoulder pain. The patient mentioned that she had no rash, nausea or vomiting. She wanted to know if it's okay to take Tylenol. She queried if she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She wanted to know how long these side effects lasts, two or more days. Queried if she should exercise the sore arm or use ice packs. The outcome of the events was unknown.  Information requested on Lot/batch number.  Follow-up attempts are completed. No further information was expected.
Fainted about 12 hours after receiving the vaccine after waking up to go to the bathroom/diagnosed with a concussion and syncope; unconscious for an undetermined amount of time; Fell to ground and was then diagnosed with a concussion and syncope at the ER; Fell to ground and was then diagnosed with a concussion and syncope at the ER; fever; body aches; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735) at the age of 31-year-old, via an unspecified route of administration, administered in left arm on 03Apr2021 16:45 as single dose for COVID-19 immunisation. Medical history included allergies to penicillin and seafood, and was diagnosed with COVID-19 prior vaccination. Concomitant medication included clonazepam. The patient was not pregnant at the time of vaccination. On 04Apr2021 05:30AM, the patient fainted (also reported as about 12 hours after receiving the vaccine) after waking up to go to the bathroom, was unconscious for an undetermined amount of time, fell to ground, and was then diagnosed with a concussion and syncope at the ER. CT scan and EKG 12 lead were clear on an unspecified date. In addition to this, the patient also has fever and body aches on 04Apr2021 05:30AM. No treatment was received for the events. The event resulted to emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab: pending results on 04Apr2021. The outcome of the events was not recovered.
Family requested update to VAERS - on 6/15/2007 patient received MMR, Varicella, Hib, PREVNAR. Patient seen 7/11/2007 for seizures and subsequently diagnosed with infantile spasms. Profound developmental delays.
Dosage administered was 0.5mL for a booster and should have been 0.25mL.
Received pneumovax shot on 1/8/02 and developed pain, erythema and limited range of motion X 12 hours, following shot. 12 hours later, still sore to touch with 3" X 3" area of erythema, warmth and pain.
Within 8 hours: muscle aches, headache, body aches, diarrhea, nausea, lightheadedness. Ibuprofen no help.
Vaccine expired on 13-Oct-2021/ refrigerated on 04-Nov-2021/ administered on 13-Dec-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 04-Nov-2021/ administered on 13-Dec-2021) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 04-Nov-2021/ administered on 13-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 04-Nov-2021/ administered on 13-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The healthcare professional (HCP) wanted to know about the protocol for this situation and whether the doses were viable or not. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code is scanned.  There was no temperature excursion and the patient did not experienced any adverse event.  The vaccine was place in the refrigerator on 04-Nov-2021.  No treatment medications were reported.
Every part of body hurt  one day after the injection, didn't eat, Second day everything ran out of me until I pooped yellow liquid. Third day started to eat and be up more and moving around.  Felt like flu. Day 4 checked weight and lost
Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient  got 2nd dose of vaccine and minutes later experienced flushing and redness in chest area and sent to ED for evaluation.  Arrived to ED at 9:52 am and was given diphenhydramine 50 mg and famotidine 20 mg.  Clonidine 0.3 mg given at 12:18 pm for high BP.  At 11:20 am rash almost resolved, feeling better; discharged at 12:30pm
Initial report received from a health care professional on 06 Jan 2010: This patient's was vaccinated with FLUVIRIN on 08 Dec 2009. On 10 Dec 2009 the patient experienced upper and lower extremity pain which became progressively worse and debilitating to the point where she had difficulty dressing. On 31 Dec 2009 the patient experienced low grade persistent fever. The outcome for low grade persistent fever was not reported.
Shivers no fever, head tingling, left eye twitch, lower lip numbness, right ear buzzing, increased anxiety, itching mostly head and face, increased diarrhea and bowel movements
Parent called for home care advice on 11/14/17. Reported that the injection site was red warm and swollen. Cool compress and ibuprofen recommended. Mom called for an appointment on 11/15/17. Child was evaluated by a NP. Left arm was warm and red. Area in question was 4cmX4.5cm. Benadryl TID was prescribed.
headache "almost like sinus headache"; hard lump; back part of her neck really bother; eyes are really bad, left eyes, she is having problem in her left eye; eyes swollen and itchy; left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes swollen and itchy), PAIN IN EXTREMITY (left arm hurt), HEADACHE (headache "almost like sinus headache"), MASS EXCISION (hard lump) and MUSCLE SPASMS (back part of her neck really bother) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced EYE SWELLING (eyes swollen and itchy) and PAIN IN EXTREMITY (left arm hurt). On an unknown date, the patient experienced HEADACHE (headache "almost like sinus headache"), MASS EXCISION (hard lump), MUSCLE SPASMS (back part of her neck really bother) and ASTHENOPIA (eyes are really bad, left eyes, she is having problem in her left eye). At the time of the report, EYE SWELLING (eyes swollen and itchy), PAIN IN EXTREMITY (left arm hurt), HEADACHE (headache "almost like sinus headache"), MASS EXCISION (hard lump), MUSCLE SPASMS (back part of her neck really bother) and ASTHENOPIA (eyes are really bad, left eyes, she is having problem in her left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were thyroids pills. No treatment details were reported.
pt recv vax 7APR97 & 22APR97 pt devel a pruritic, varicella-like rash consisting of 1-10 lesions;missed work, then subsequently recovered;
10min post vax hands started to swell, turn red, itchy, throat closed epi, DPH, pred, hydroxizine given;