chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EL9261) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Menorrhagia" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "headaches" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI FE 1/20, start date: Jan2016; WELLBUTRIN XL, start date: Feb2018; MELATONIN GUMMIES, start date: May2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2022; FLONASE [FLUTICASONE PROPIONATE], start date: Apr2022; ASTELIN [AZELASTINE HYDROCHLORIDE], start date: Apr2022. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: On 17May, had a positive home rapid test, with sore and swollen throat, runny nose, headache and fatigue; (17May2022) Positive, notes: had a positive home rapid test. Therapeutic measures were taken as a result of covid-19.  Clinical Information: On 17May, had a positive home rapid test, with sore and swollen throat, runny nose, headache and fatigue. For a couple days prior had runny nose, but thought it was allergies given history of allergies and local weather reports. Adverse event start date provided as 17May2022. Outcome provided as Unknown.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy cannot be ruled out.
I don't remember all the specifics, and patient's complaints were restated by another pharmacist, but the patient came in for a flu shot. She questioned the shot location being too high and towards her back, but I reassured her that I needed access to her deltoid muscle, which is higher up on her shoulder, and I placed the shot slightly off center (1/2 inch maximum from dead center) of her deltoid. The patient later complained the following day about radiating pain from her shoulder towards her arm and neck. A couple weeks later on 9/27/17, the patient still complained of lingering pain but concentrated primarily in her shoulder.
Patient febrile 09/25/2009 mother took patient to hospital emergency room. While a patient in the emergency room under care of Dr. patient had a febrile seizure.
I'm unsure about the brands of these vaccines. Many of the vaccines were shots, but 1 was oral. Unsure which was a shot and which one was oral, but I am 100% sure of the type of vaccine and the dates. On April 7, 2017, he received these vaccines and on April 15, he began regressing developmentally (no eye contact, inability to track objects, lack of baby sounds). All things that he did well before, as he passed his 2 month check-up, the day of the shots. On April 30, following the regression, he presented the first spasm, and on May 1, he was officially diagnosed with Infantile Spasms (IS) and Multi-focal Epilepsy. He was treated with Prednisolone (steroids) on 2 May, 2017 and TOPAMAX, and all spasms stopped by June 5th. He went 3 months spasm free and began developing again. On August 1, he took the 6 month vaccines (DTAP/HEP B/IPV and PNEUMOCOCCAL Conjugate13-Valent). On Sept 1, 2017, the spasms returned; the delay of spasm return was likely due to the large amount of steroids he still had in his system. He was treated with Prednisolone again on 1 Sept for 3 weeks, and after not working, he began Vigabatrin and continued with TOPAMAX. All spasm stopped on October 5, 2017. He has received no more vaccines since August 1, and remains spasm-free to date. Stopped taking Vigabatrin in April 2018.
I had no adverse reaction to the vaccine. We had been on vacation on a cruise and I tested positive for COVID-19 on 07/18/2022. I had sore throat and a runny nose. I was prescribed PAXLOVID and I felt much better.
Fever, chills, joint pain severe enough to prevent sleep, injection site pain of course. Flu like symptoms.
Explosive diarrhea  occurred four and one half hours after receiving 2nd vaccination.   Single event (so far... its now 6 hours since vaccination).  Diarrhea is not a common health event for me.  It is not listed as one of the common side effects so I thought I should report it.  I have not been been feeling ill.  Event came on very sudden.  I had eating lunch between vaccination and diarrhea.  Only side effect from first shot was a sore shoulder for two days.
7/16/2020 that evening arm felt "a little itchy" 7/17/202 In the AM noticed arm was very itchy, painful, red, raised and firm at the vaccine site.
pt reports seeing spots in eyes p/vax;states had floaters in eyes a/receiving vax but got worse on 23MAY98;saw MD who states eyes are healthy upon exam;pt requested vax package inserts & requested VAERS report be completed;
No adverse effects; patient received unspecified dose o VARIVAX with MMR II / VARlVAX was improperly stored.; This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 01-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX)  injection, (lot # R020673, expiry date 18-JUL-2020; exact dose, route of administration and injection site were not provided) for prophylaxis. On the same date, the patient also received properly stored dose of measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) (M-M-R II) injection(lot # N025897, expiry date 19-SEP-2019, albumin status rHa; exact dose, route of administration and injection site were not provided) also for prophylaxis. The vaccines were reconstituted with sterile diluent (lot # and expiry date were not provided). The varicella virus vaccine live (Oka/Merck)(VARIVAX) was exposed to a temperature of 8.6 Fahrenheit degrees (F) for 1 hour and 36 minutes. Previous temperature excursion included exposition to 6.1 F for 1 hour and 42 minutes. The first temperature excursion started on 27-JUL-2019. Digital data logger was involved. No adverse effects were reported.
uncomfortable; she feels really achy; 5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation; 5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 07Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single), administration date: 04Dec2021, for COVID-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; PAIN (non-serious), outcome "unknown", described as "she feels really achy"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "5 year old female and 10 year old male, who were accidently administered the adult gray cap bivalent formulation".  Additional information: Reported as, Pediatrician stated that two patients 5-year-old female and 10-year-old male, who were accidently administered the adult gray cap bivalent formulation of the Pfizer BioNTech COVID-19 vaccine at their local withheld instead of getting the pediatric 5-11 bivalent orange cap booster. They received their primary series of the monovalent orange formulation on 07Nov2021 and 04Dec2021. He was not worried so much about repercussions of the vaccines, he was more concerned as to whether or not this will affect the series going forward. Physician stated that five year old was getting her butt kicked, that she feels really achy and uncomfortable as reported by her mother. No fever, no headache, no respiratory distress, no chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Brain fog, difficulty sustaining thought -- began 72 hours after first Pfizer COVID shot and continuing to current day (2 weeks after first shot) Jelly legs -- began 72 hours after first shot; replaced by muscle spasms described below. Brain "shaking" -- began 96 hours after first shot and continuing to current day (2 weeks after first shot) Muscle spasms -- began 96 hours after first shot and continually worsening to current day (2 weeks after first shot).  Began with slight head and shoulder jerks; progressed to also include leg, arm, ankle, and wrist spasms and numbness in toes. Extreme insomnia -- brain shaking and muscle spasms prevent sleep.  Have slept a total of 22 hours in the last 240 hours.
Swollen lymphnode in the neck on the right side, throbbing pain, swollen lymphnode in the collarbone area, right side. And Tinnitus.
Immunization provided 2/28/03, presented back to clinic 3/3/03 with c/o red, swollen left leg.  Father stated after immunization leg became red with swollen area, reddness increased to cover anterior and medial aspect of leg.  Pt. was taken to the ED over the weekend, prescribed steroid and antibiotic.  Upon presentation to clinic on 3/3/03, child does not c/o pain, left thigh red, warm to touch, reddness extends from groin to knee and medial.  Measures 7 1/2 in in length, 7 in in width.
Pt develops left leg pain The day after vaccination in AM subsequently drove approximately 150 miles On his way back stopped at his brothers place for lunch. He then collapsed coning down the steps, EMS started CPR. took him to ER  Resuscitated briefly  but went into CardioPulm Arrest again and PEA Resucitaion for aprox 1 hour but was unsuccessful. Noted to have Left leg more swollen than Right by 3 to 4 CM presumed to have died from massive Pulmonary embolism and inferior wall myocardial ischemia
Noted a painful lump 5days ago, happened the same day of her COVID Moderna booster.  Went to the ER and had an ultrasound.  Ultrasound showed only a likely hematoma and NO DVT.  Seems to be smaller now and has bruising that is going down her leg.  Still sore in the lump.  No trauma.  Had a normal workout that day but nothing out of the ordinary.  No other bleeding.  No change in periods,  No other bruising, rectal or gingival bleeding.  Did take some Advil the day of her shot.
A report was received from a consumer on 10/31/03, who is a female vaccinee of unspecified age, who developed approximately 20 raised red itchy spots on her torso, arms and neck 6 days after receiving an unspecified brand of Influenza vaccine on 10/23/03. The vaccinee reported that her husband has poison ivy and that the vaccinee used the same bathtub, which her husband had used the previous day and 24 hours later, the vaccinee developed the spots. The vaccinee has tolerated Flu vaccines in the past without any difficulties. At the time of the report the vaccinee had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
soreness and swelling in arm. fever the next night and night after (not the night immediately following the vaccine), swollen painful lymphnodes in arm with injection- beginning day After shot, until present (2 days so far)
feet were cold like ice cubes; soreness in her joints; soreness in her left arm where she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine). At the time of the report, PERIPHERAL COLDNESS (feet were cold like ice cubes), ARTHRALGIA (soreness in her joints) and VACCINATION SITE PAIN (soreness in her left arm where she received the vaccine) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-375446 (Patient Link).
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am.  hospital and nurse in charge at the facility, has contacted each other.  At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
Pain in the breast/all of a sudden it was just like a shot stinging pain because it's on the same side that I had the injection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142, exp. date: 31Mar2021), via an unspecified route of administration on the arm on unknown date at SINGLE DOSE for COVID-19 immunization.  Medical history included breast cancer from 2015 (reported as about 6 years ago and that doesn't have anything) and thyroid disorder (reported as thyroid).  Concomitant medication included levothyroxine (LEVOTHYROXINE) for thyroid. On an unknown date, the patient had a side effect of pain in the breast and all of a sudden it was just like a shot stinging pain because it's on the same side of the injection. The patient mentioned that it didn't happen that day of injection, it happened the next night and also then the night after but not as bad. The patient was going to her gynecologist next Tuesday (in 2021) and will check her. Outcome of the event was unknown.
Patient presented on 9/23/2016 with c/o swelling and mild pain at the left elbow 2 day after PNEUMOVAX 23 vaccine. Patient prescribed KEFLEX 500mg capsule 1 cap BID X10 days. Patient encouraged to take antibiotic and return in one week for evaluation.
Received the vaccine and then sat in waiting area with no immediate issues.  After about 10 minutes started to feel flushed and a couple seconds later blacked out.  When coming around, felt disoriented and nurse was asking me questions as I was still sitting in chair.  My wife reported that I was having a seizure and stiff against the wall with eyes rolled back and unresponsive for about a minute.  My right arm was cramping, BP 220/180 and pulse 44.  The clinic staff laid me on the floor and call an ambulance that took me to the ER for observation and testing.
p/vax pt exp varicella like lesions, a pruritic rash & was febrile;
Pfizer-BioNTech COVID-19 Vaccine EUA- Received Moderna Covid-19 Vaccine on 1/29/2021. Received Pfizer BioNTech COVID-19 Vaccine today
dose activated one day before administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis.   On 8th February 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a Shingrix dose, activated one day before it was administered, which led to incorrect storage of drug. The reporter consented to follow up.
Graves' disease; Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA); This is a literature report.  A 27-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: BASEDOW'S DISEASE (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "Graves' disease"; ASIA SYNDROME (medically significant), outcome "unknown", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: greater than 40; Autoantibody test: positive; Blood thyroid stimulating hormone: below 0.001; Free thyroxine index: 4.3 ng/dL. Therapeutic measures were taken as a result of basedow's disease, asia syndrome. Additional information: The patient developed hyperthyroid symptoms and ophthalmopathy 2 months after first dose of Pfizer vaccine. Methimazole was started but she developed urticaria. The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Pt vaccinated with DTP/OPV developed unconsolable, high pitched cry longer than 5 hrs. Lt leg swollen, red warm to touch, temp 99. Mom gave tylenol.
Mother presented to clinic with child for "school shots". Most recent copy of child immunization card revealed that shots were needed. When mom asked for her blue card she reports that it is in the car. Immunizations were given and mother returned to clinic room so that today's shots could be added. Card showed documentation that child was actually up to date and did not need the vaccines today.  Mom notiified and was counseled to always present card to vaccine administrators prior to any vaccines being received in the future to avoid future duplication and unecessary vaccinations for the child.
Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world.  The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call.  Follow-up attempts were completed. No further information was expected.