chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive with Covid-19; tested positive with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had Paxlovid a little more than a month ago because he tested positive with Covid-19. Patient already had the first 2 shots of the vaccine and got the booster 7 months ago. He would like to get another booster as soon as possible and he would like to know if there was a waiting period after taking Paxlovid to get a booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 3 to 5 hrs after receiving the FLUZONE vaccine, pt developed a round, red, raised, hard bump around injection site. Warm to touch. Localized to upper arm. Woke pt up in middle of night due to pain (about 8 on 1-10 scale). No fever, no rash elsewhere on body. No MD visit.
Patient reported that she broke out in a head to toe rash the following day after receiving her covid booster.  Also states this happened after her second vaccine but she did not correlate the two at that time.
not feeling well; This is a spontaneous report from a Pfizer-sponsored program received via a contactable consumer or other non-health care professional (patient). A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On and unspecified date in Apr2021, the patient after receiving 1st shot experienced not feeling well. She stated that she received her 1st Pfizer Covid 19 vaccine at the end of Apr, 2nd vaccine was scheduled on 04May and was opted not to go back because she was feeling unwell after receiving 1st shot (did not go in to detail regarding symptoms). She would now like to know what the efficacy of the 1st shot is, if she can still get her 2nd shot or if she needs to begin the vaccination series again. She wanted to know if there will be a need to retake the entire vaccination series of the Pfizer BioNTech Covid-19 Vaccine if there 3 weeks dosing interval of the first and the second dose was not observed. She was advised by her doctor to not take the 2nd dose because she was not feeling well. She wanted to know the risks associated after receiving a dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know the efficacy of the Pfizer BioNTech covid-19 vaccine after one dose and wanted to know if she will be contraindicated in getting the second dose of the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shortness of breath,  rash, vomiting, diarrhea, hand cramps
Developed tachycardia and shortness of breath on 3/1/21 which was significantly worse on 3/2/2021.  Went to ER and CT angio showed diffuse bilateral pulmonary embolism.  Spent the night for heparin, telemetry monitoring and lab work.
It was reported that a 21 y.o. female received a TD-adult vaccination administered in her right deltoid, on Tues, 10/4/01 at a medical center, prior to leaving for college. On 10/8/01, the PT started to develop a large local reaction on her right deltoid. She presented to a health center on 10/10/01 w/a 60x80 cm area of erythema with heat and a swollen right deltoid. There is about 30x40 cm of induration. PT was told to use cold packs and take whatever she would for discomfort i.e., Tylenol and was offered antibiotics. She declined saying if it didn't get better, she would return.
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95).
I was completely healthy and went from 100% fine to spiking a fever at 12:45PM on Thursday, November 3, 2022. It was followed by a fever, chills, congestion, vomiting, severe headache. I called my primary care's office. The nurse called me and she noted that the doctor would like me to get a COVID-19 test and it came back positive. The doctor called in a prescription for PAXLOVID and cough pearls and ZOFRAN. I had started having diarrhea as well. I did 5 days of PAXLOVID and I had a fever that ranged from 103.4 to low grade 102 that persisted. I talked to the doctor the 5th day on Tuesday when I finished the PAXLOVID and told him I still had symptoms. He noted that if I took another test, it would still be positive. The vomiting and diarrhea had slowed down and I still had a fever and what seemed to be a bad head cold. My head didn't hurt as badly, and I was coughing with no production. I couldn't get a deep breath all the way. The doctor had me do a Z-PAK as well for 1 a day for 5 days. He did that in the hopes that if there was secondary infection of any kind, it would be taken care of. I talked to the nurse about every other day as I still had a low grade fever, fatigue, and trouble with deep breathing. On Wednesday 11/16/2022 when I talked to my doctor, he suggested that I go to urgent care and get a chest x-ray and let him talk to the doctor for the results. The results showed no pneumonia or bronchitis. They suspected inflammation and listened to me breathe. They also tested me for flu and I was negative. I talked to my doctor again and he noted that I was one of those people where after effects were still present, but I was not contagious. He noted there was no other treatments and recommended I stay inside due to the weather. On Friday 11/18 was the first time that I noted no fever at all. The doctor noted to just monitor the progression and he noted that I could be vulnerable. He suggested to be careful and to wear a mask for protection. I am definitely not 100%. I still have the head cold feeling, but it's not as strong. I am still fatigued and my voice is not back to normal.
seen by a provider on 04/29/2007 due to a localized reaction 25 - 30 mm upper left arm. Anthrax shot given on 4/27/2007. Also seen on 4/30/2007 by another provider LT deltoid area 19mm single raised blister with 30 mm diameter.
rt upper arm became reddened, blotchy w/in 15-20" of vax;
aboit 50 minutes after the shot numbness that started in the lower extremeties, then spread to hands and face.  Then followed by neck pain
Vaccine adminsitered on 10/13/15. (Flu shot). Complained that arm hurt where received vaccination. Arm got worse over time. Got to a point where couldn't move arm. Went to Dr. on 11/2/15. Dr. says needs physical therapy three times a week.
Itchy and red rash along stomach area lasting approximately 5 hours.  She applied alcohol to the area to help relieve itchiness.  No other symptoms.
Asthma flare up requiring multiple prescriptions of Prednisone & continual use of nebulizer over 4 months. Eventual referral to pulmonologist, allergy testing, lung function test - all proved normal, eventual change to trying a new preventative Advair, in July,. Helped some but never returned to condition, prior to start of flare in April
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 3/24/2023 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and second at 4 days after first dose I've had occular migraines in the past, but haven't had one in the past 10 years. I've had two in the last 24 hours. Occular migraine event for me is temporary blindness with floating bright object in line of vision with mild dizziness. Requires about 20 minutes to fully subside.
Heart Palpiations; elevated resting heart rate; This is a spontaneous report from a contactable consumer reported for herself. This 31-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration In the right arm on 07Apr2021 12:45 PM at single dose for COVID-19 Immunization. Medical history included migraine. Family history of penicillin allergy. Concomitant medications included folic acid supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations/elevated resting heart rate on 07Apr2021 12:45 AM. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 12:08 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 12:08 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that, vaccine was administered on 29-Mar-2022 at 12:08:55 Its 30 days expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022 No treatment information provided.   This case was linked to MOD-2022-542869.
Deja Vu; blurry/black vision, confusion, disorientation, headache, muscle weakness, muscle aches, fever
C/O droop to left side of face with drooling,  watery left eye, pain to face.
Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K019372, expiration date: 16-JUL-2016) (strength and dose unknown, oral). Lot# K089901 (expiration date: 08-MAY-2016) was not a valid lot number for ROTATEQ. There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
tinnitus/ ringing in my ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL296Z), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "tinnitus/ ringing in my ear". No follow-up attempts are possible. No further information is expected.  Additional information: Patient reported that after getting the second dose she developed a tinnitus and she was about to get the booster shot. She was refusing to get the Booster shot because she was afraid or scared about her tinnitus might be worsened after getting the booster shot. So, she was basically asking for an advice if she can skip getting the booster shot. Patient stated "I got the first and second Pfizer vaccine and then after the second one I noticed I was getting very strong tinnitus, ringing in my ear and it has not gone away, that was back in Feb and it is strong. Now while they are talking about getting a booster shot and how the variant is all over the world and my Doctor does not recommend I get the booster and I am not getting the booster because I don't want to this tinnitus to get any worst. But I don't know Pfizer must have other people who have got tinnitus and I was wondering do you know if after a longer time, well I was one of the first ones if they have found that it has gone better or what do you suggest for people who cannot get the booster? Now, I know Pfizer is going to come out with pills that are antiviral pills. They have not approved yet. But the FDA has approved something by Astra Zeneca, it is an injection an antibody treatment which I am thinking well may be that is an equivalent sort of a booster."  Follow-up attempts are completed. No further information is expected.
exacerbation of pre-existing parenthesias of foot; now paresthesias-envolving cranial nerves; new lower motor neuron weakness;
Having chills and aches like body ache; Having chills and aches like body ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Lot number: Unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "Having chills and aches like body ache". The patient wanted to know if it is normal to have that side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Guillain Barre syndrome.  Presented with rapid onset L >R leg weakness, numbness and radicular pain.  Symptoms came on overnight.  3 days later developing hand symptoms.
Chills/shivering, low grade fever 100.2, muscle aches, bone pain, severe headache, nausea, dry heaves, general malaise lasting for approximately 24 hours.
Pt describes reproducible likely non-IgE mediated reactions to influenza vaccinations received in 2009, 10, 11, 13, 14, and 15. Two weeks following vaccine on each occasion, fevers 101-104, body aches, upper and lower resp. congestion, and cough - with cough persisting for several weeks thereafter. Reproducible with subsequent vaccinations, of approximately same severity. Because works as an RN in hospital, did not decline yearly vaccinations until recently.
2 hrs after receiving vaccine, pt. experienced swelling and redness in right arm, swelling went to elbow, very sore, swollen, took diphenhydramine that night, had extreme night sweats that night. Went to urgent care next day was told she had cellulitis and given Abx. Went to reg. doc that same day was told not to take Abx unless fever went to 100.5. Fever only went to 99.9, never took Abx. spoke to pt on Friday, still slight redness towards elbow, sore, swelling gone, still taking BENADRYL and ZYRTEC. Feels much better.
Narrative: 68yo M with h/o: Low back pain Spinal stenosis of lumbar region Allergic rhinitis Osteoarthritis Chronic pain Bacterial arthritis Hyperlipidemia Glaucoma BPH Anemia Received covid vaccines on 2/14/21 & 3/13/21. Pt died on 6/26/21 of unknown cause. No recent notes available in past 4/2021 regarding only eyeglass appointments. Not enough information to assess if vaccinations were related to death. However likely death not related as pt's death was >90 days after last covid vaccination.
2 DAYS AFTER VACCINE WAS ADMINSITERED INTO LEFT ARM, PATIENT DEVELOPED A "GOLF BALL" SIZED SPOT ON THE ARM OF THE INJECTION LOCATED AROUND THE BACKSIDE OF THE ARM.
Adverse Reaction: The next day after receiving the vaccine, I woke up with terrible body aches and fatigue like a had the flu. Over the next week, on my right side, my scalp became hypersensitive, and numbness crept down my neck, shoulder and right arm. In the second and third weeks, my arm became weak and uncoordinated to the point where I could not hold things or do much with my right, dominant arm. I additionally felt weak, fatigued and had terrible restless legs. During the fourth week after the vaccine, I began to lose balance and could not stand without holding onto something. I also lost strength and coordination in my right leg. My gait was not normal, and I could only take small steps. I was so fatigued that I could hardly do anything for myself. My body was completely weak, and my right side was partially paralyzed.  Treatment: After initially seeing a doctor, I was immediately sent to a neurologist, and I remain under care of a neurologist to this day. An MRI was performed on July 6, 2011 which revealed transverse myelitis. I was given a five-day 1000 mg treatment of IV steroids (methylprednisone). I elected to do this out-patient due to cost and family at home. I then did physical therapy over the next six months.  Outcome: The steroid treatment did not improve symptoms but did stop further progression. With time and therapy, I have regained sensation that was lost. Strength has improved on my right side but remains weak, and my gait is not always normal. In 2016, I was diagnosed with multiple sclerosis.
The day after vaccination I had redness and swelling in my right eyelid. My eyelid was very red and almost swollen shut. I was told that the problems I was having had to do with the Vaccine by telehealth. After seven days because of the bruised look I consulted another doctor who told me that it was an infected Sty in my eye. I was prescribed an oral  antibiotic Doxycycline.  I have never had a Sty in my eye before and it is still a little red spot after two months.
Patient received second dose of Pfizer vaccine on 02/12.  On 02/13 she experienced extreme vertigo. Hx of same but this is worse than her usual.  She continues to experience this although it has improved over the days since.  She reports nausea starting 02/15 or 02/16 and vomited one time yesterday 02/17.  She is experiencing intermittent chills but no fever, highest temp was 97.6.
This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB strength 10/1.0 microgram/ml, (lot # M044032 with expiry date of 03-JUL-2019) (lot# N020613 with expiry date of 05-MAY-2020), GARDASIL 9 (lot #N022583 with expiry date of 20-JUN-2020), M-M-R II (lot #N020925 with expiry date of 01-AUG-2019), PROQUAD) (lot #R002935 with expiry date of 29-JUL-2019) and VARIVAX (lot #M046926 with expiry date of 28-NOV-2018) (lot #M046004 with expiry date of 18-NOV-2018) (dose, frequency, strength and route of administration were not reported for any of the vaccines) for prophylaxis. All the vaccines were administered to the patients after temperature excursions (product storage error). No adverse effects were reported. The temperature/time frame were 15 Fahrenheit(F) to 46 fahrenheit (-9 celsius to 8 celsius) (45.5F) for 24 hours for VARIVAX and PROQUAD 47 fahrenheit to 77 fahrenheit (9 celsius to 25 celsius) (53.4F) for 6 days and below 32 F/0 celsius(15 fahrenheit) for 3 hours 50 minutes for remaining vaccines. No previous temperature excursion were reported. The call was due to data logger. No product quality complaint was filed. This is a non-valid case due to lack of patient identifiers.
Menveo reconstituted with different diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30th November 2023) for prophylaxis.   On 3rd November 2022, the patient received Menveo. On 3rd November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The nurse called to ask for information about the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid conjugate. The reporter asked how to proceed with patient vaccination. Did not consent to follow-up. Additional supportive information; The patient received Menveo vaccine which was reconstituted with a different diluent, which led to wrong solution used in drug reconstitution.
this is 1 of 6 pt from this site to inadvertently recv intracutaneous inj of Td rather than PPD;pt devel an inj site rxn characterized by swelling, redness, pain, itching & warmth;
Rash appeared on pts hands - reddened, tiny raised nodules in clusters and individual. Rash spread to legs - non-raised just spots.
Very sore arm, swollen. No bruising or redness. Resolved in 2 days. In comparison received Boostrix and quad flu in the past with no soreness.
Had body aches with the 1st two shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Had body aches with the 1st two shot) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Had body aches with the 1st two shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Had body aches with the 1st two shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-419483, MOD-2021-419496 (Patient Link).
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. On 13-APR-2015, the patient who was not on dialysis, was inadvertently administered the dialysis formulation of RECOMBIVAX HB intramuscularly, dose and lot# were not reported. No adverse effects reported. Additional information has been requested.