chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Pfizer/ Dose Number 2:Pfizer/ Dose Number 1:Pfizer; tested positive/ COVID 19 Treatment; tested positive/ COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6200), in right arm, on 24Mar2021 as dose 2, single (Lot number: ER2613), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 06SK21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "mild GERD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "dry macular degeneration" (unspecified if ongoing); "food sensitivities" (unspecified if ongoing), notes: a couple of food sensitivities, but no allergies. The patient took concomitant medications included herbs and other supplements. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: codeine (but not derivitives). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022, outcome "recovering" and all described as "tested positive/ COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering", described as "Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Pfizer/ Dose Number 2:Pfizer/ Dose Number 1:Pfizer". The patient took Paxlovid same day when she first tested positive (09Nov2022). Took the full course as directed. Felt better in a couple of days or so. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Nov2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
injection site pain; injection site hard; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain and injection site induration. On an unknown date, the outcome of the injection site pain and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site induration to be related to Shingles vaccine.     Additional Information: GSK receipt date:13-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media  The patient received the shingle vaccine and experienced the injection site is painful and hard.  The patient asked was this normal.
Information has been received from a consumer concerning a 13 month old male with no medical history or drug allergy who on 05-JUN-2006 was vaccinated with MMR II (lot # 649829/0376R). Suspect therapy included VARIVAX (lot # 652665/1025R). On 05-JUN-2006 the patient experienced seizure and fever. The patient recovered from seizure and fever on 06-JUN-2006. She also reported that the patient was diagnosed with autism when the patient was 19 months old. The patient did not perform any lab diagnostics studies. The patient still had the autism. The physician saw the patient. Upon internal review the patient's seizure and autism were both determined to be other important medical events. Additional information has been requested.
The patient starting feeling dizzy and like she might faint about 15 minutes after the shot, it progressed to feeling like she could not swallow and itching across her chest. I attempted to give her oral Benadryl, but was not working fast enough so I administered 50mg of IM Benadryl. She still complained of not being able to move her arms or legs and feeling tingling all over so I called 911. She declined going to the hospital and went home. I did call her today and she was feeling better.
Lost full range of motion is my left shoulder. I honestly feel like it is more due to the placement of the injection. It was given into my shoulder joint.
Information has been received from a licensed practical nurse concerning a 13 year old female patient with no pertinent medical history and no allergies who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. On 09-AUG-2010 the patient developed chickenpox, with more than 50 spots on her head, abdomen, back and legs. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Yellow fever reaction. ? elevated LFTS post vaccine. Patient came in for IPV polio booster for international travel and recounted the following information. Received Yellow fever vaccine here on August 18 2005. Lot no UE498AA Exp date Jan 2006. 5ml left arm sq by RN. No other immunizations were given that day. She did have Hepatitis A, Tetanus dip booster, and oral Typhoid at another facility after that date in Sept 05. She says that the Y fever vaccine made her arm feel sensitive at the time it was given and it got red at the site right away. Saturday 8-20th am noted local inflammation about 6" at vaccine site, red, hot raised, sore, burning sensations and it lasted for 2 days more. The next week she had a PE HX scheduled with her PMD (routine) and labs were done because she is taking Aldactone for acne and the MD wanted to check renal labs with this medication. She has been notified by her MD about the elevated LFT labs from that visit and was wondering if they might be associated with the YF reaction?  The MD also drew labs for hepatitis and she is negative for A and C both, she has had prior HBV vaccination as she is a nurse practitioner here.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported for two patients. A 79 year-old female patient received, on 20Feb2015, PREVNAR 13 single dose. Relevant medical history was unknown. Concomitant medications included COZAAR, pravastatin, atenolol, and levothyroxine. On an unspecified date, in 2015, probably the day after the shot, the patient had very large red area on the arm that was cellulitis. Cellulitis went down into the armpit. The patient did not recover from the event at time of this report. There was a reasonable possibility that the event was related to PREVNAR 13.
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection.  Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022; No adverse event; We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) and NO ADVERSE EVENT (No adverse event) in a 15-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07Aug2022, dose of that vaccine were given on 08Aug2022.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 08Jul2022 with a BUD of 07-Aug-2022 and vaccine were given on 08Aug2022).    No concomitant medication information provided. On 08-Jul-2022, the vial was initially stored in the refrigerator. The  did not cause patient to seek medical care. The vial  had not undergone any temperature excursions. No treatment details reported.   T
Patient had area of blotchy redness, pain, and sensation of heat on skin. This area was about 5 inches in diameter on the upper arm at the location of the injection.
Bloody diarrhea (6-8 episodes) in a well appearing well hydrated child.
Caller may have gotten the second booster dose before authorized time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 043B20A and 337K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller may have gotten the second booster dose before authorized time) outcome was unknown.            As per the event verbatim it was stated that patient had taken second booster dose on 02-FEB-2021 , which is a discrepant information, because 1st booster was given on 01-NOV-2021, if that is the case then second booster should be given after NOV-2021.  No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contained NNI- No New Information.
A couple months after the vaccine I developed a ringing in my left ear followed by hearing loss which I still have the loss to date. Was referred to an ENT who did an MRI and CT Scan but nothing was found on either as to the cause of the ringing and hearing loss. I had a constant bugging in my ear daily. The ENT specialist performed a hearing test and saw there was drastic hearing loss associated with the ringing in my ear but states there is nothing further they can do because they are unaware of what the cause is and suggested a hearing aid but does not know the cause.
Within 24-48 hours of vaccine patient developed a sensation that his finger was cold & turned white. This comes & goes but happen about 1/wk
Patient waited the required 15 minutes after I administered his second dose of the Moderna vaccine. When he handed the timer back to me, he said he was starting to feel a strange pain on the right side his jaw, ear and throat suddenly. I told him to have a seat so that I can monitor him further. A few minutes later he said his vision started to become blurry and his mouth became very dry. We brought him a bottle of water. He said he didn't feel any better and was feeling worse. I suggested to the caregiver that was with him to take him to the emergency room since he was able to talk, walk and breath on his own still. I told his caregiver to call me back at the pharmacy to update me on his status. The caregiver did call me back and it was confirmed that he was having an allergic reaction and he had to be given high dose Benadryl.
4.5 days after vaccination he woke from a sound sleep with extremely fast heart, unable to breath, Apple Watch said "Afib".  went to ER and cardioverted on his own and was discharged after 5 hours.  MD later increased his HCTZ.
Information has been received from a registered nurse concerning an 18 year old female with no medical history who in October 2006 or November 2006 was vaccinated with her second dose of HPV VLP vaccine (yeast) (0.5 mg), intramuscularly. There was no concomitant medication. Subsequently, the patient experienced intermittent vertigo 5 days later. The patient was "recently" administered her third dose of HPV VLP vaccine and was "now" experiencing constant vertigo.  It was noted that the patient had a family history of vertigo.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient had not recovered.  Additional information has been requested.
excessive menstrual bleeding; This is a spontaneous report from a contactable physician. A non-pregnant female patient of an unspecified age received 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 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient had other vaccine in four weeks. It was unknown if the patient had covid prior vaccination and covid tested post vaccination. The patient experienced excessive menstrual bleeding since an unspecified date. Outcome of the event was unknown.  Lot/batch number has been requested.
patient fainted, then came to, had nausea, then vomited. Had patient sit and drink water afterwards ~30 minutes.
5 days with fevers to 103.7F and macular rash on face, arms and torso.
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
autoimmune disease; body pains; nausea; rash under both of her breast and upper stomach; Sick; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included guselkumab (TREMFYA) taken for psoriatic arthritis, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. With the second shot on Wednesday, she got sick, had body pains, nausea, rash under both of her breast and upper stomach on an unspecified date. She wanted to know if this is from the vaccine or if she should go to the doctor. Stated that she has an autoimmune disease which she does not know if it is the reason why she is having the reaction. She also has psoriatic arthritis and has not taken the injection since 19 Mar - she takes Tremfiya. She wanted to know if others had reported it. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Itching in groin and thigh area. Itching redness on hands started on 24 Feb 13.
This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.
(R) shoulder 2 patches of erythema - ice, BENADRYL, PEPCID AC 24 hours.
red and swollen at the injection site; Red and swollen at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (red and swollen at the injection site) and VACCINATION SITE SWELLING (Red and swollen at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included VITAMINS NOS, ESTRADIOL, PROGESTERONE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red and swollen at the injection site) and VACCINATION SITE SWELLING (Red and swollen at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site) had resolved and VACCINATION SITE ERYTHEMA (red and swollen at the injection site) and VACCINATION SITE SWELLING (Red and swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received the vaccine nine days ago, and had swelling at the injection site but they resolved after three days She woke up today, and it was red and swollen at the injection site.  The treatment information included ice pack.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt. from tent 16 in observation lane complained of fluttery chest, difficulty swallowing, headache, dry mouth.  Paramedics assessed pt.  once symptoms subsided paramedic released pt. to leave.
Loss of consciousness; Seizure; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and SEIZURE (Seizure) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and SEIZURE (Seizure) 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.   The patient lost consciousness seconds after vaccine. This was followed by seizure activity for 20 seconds. Blood pressure and heart rate were measured by emergency medical service, however results were not provided.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
I had all the vacs with no issues. Received Omni booster and that evening experienced chills which lasted approx 3 hours and headache. I am not sure if related or not.
On December 1, 2014 I had a routine physical exam at Doctors office. Doctor stated that because of my age; I was due for a tetanus shot. I have had a regular tetanus shot before years ago without any adverse reactions or side effects. I was not told by the doctor that I was getting a combination of Tetanus Toxoid, TDAP. I assumed it was a regular tetanus injection. But after the ADACEL I had pain a large nodule at the site and severe pruritus. The pruritus progress to through my body. Then large nodules and huge angioedemas began to surface and my extremities swelled. At that point I went to the hospital. They swellings were so large that a Doppler was done to see if a clot had formed. The swelling looked so bad that they looked infected. The attending put me on KEFLEX, BACTRIM and BENADRYL; none of them helped. Therefore I went to the doctor's office explained what happened and medication prescribed. When she seen the large swellings she wanted to do a Doppler also. I told her the hospital already did a Doppler on another swelling and it was negative for a clot. She diagnosed it as a reaction to ADACEL vaccine. Since BENADRYL wasn't working she ordered a prescription antihistamine, MEDROL Dosepak. I have two days left of medications. However, the intense itching has returned and the nodules are manifesting again. My problem started 1/12/2014 and 12/20/2014 I am still dealing with it. This is a bad vaccine. It should not be give to people over 50. Because anyone that has a reaction with this vaccine has have no way of knowing what part of the vaccine they are reacting to; the Pertussis and Diphtheria. Also, based on the testimonies of others it is not safe to mix these diseases; then overwhelm the immune system with this injection.