chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One week after the second dose, the patient tested positive for covid and since she is at a very high risk; One week after the second dose, the patient tested positive for covid and since she is at a very high risk; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 28Jan2021 at single dose for covid-19 immunisation. It was reported that, patient who received the second dose of the Pfizer covid vaccine (first dose was given on 28Jan). One week after the second dose, the patient tested positive for covid and since she is at a very high risk and came back with abnormal xray results, she was given "bamlanomab". Her question is if the monoclonal antibody may potentially neutralize the vaccine and would this necessitate a repeat of the second dose. The patient underwent lab tests and procedures which included covid: patient tested positive for covid and x-ray: abnormal x-ray results on an unspecified date. The events were considered as serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.
Systemic: Lymph Node Swelling-Mild, Additional Details: Pt notes mild lymph node swelling. She has been alternating Bayer and extra strength Tylenol. Doesn't report pain to touch. She has called her Md who advised that she speak to site where vaccine was administered. She will also try Bendryl for possible histamine response.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 23:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jan2021 at 20:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Aug2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mild cardiovascular disease" (unspecified if ongoing), notes: mild cardiovascular disease; "sulfa" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course : The patient did not receive Other Medication in 2weeks.The Anti-Viral Details included Brand: Paxlovid Treatment Start Date: 29Apr2022 Treatment Stop Date: 03May2022 Indication: Treatment of COVID-19. Resurgence of COVID symptoms 5 days after completing course.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus; same pain only it is far worse; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration, administered in he left arm on 22Mar2021 17:30  (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 01Mar2021 (Lot Number: En6205) in the left arm for COVID-19 immunisation (reported in Pfizer case # 2021314445). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported, that on 22Mar2021 at 05:30 PM, "Immediately after injection the first dose time I had a weird pain in the left side of my head. Today, I received my second dose and I had the same pain only it is far worse. It was within 10 minutes of injection. Within 30 minutes there is a ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus". No treatment for the events was provided. Outcome of the events, ringing sound that is loud. Everything sounds as if it is echoing. What would be described as tenatus and same pain only it is far worse was unknown.
Vaccine was mixed with 1.6 ml of diluent due to using a 5 ml syringe that was provided with the vaccine.  MA did not realize the increments were different than a 3 ml syringe.  We do no use 5 ml syringes for any of our meds or vaccines.  This is what we were shipped with the vaccine.
Atrial fibrillation; Tinnitus in my Right Ear; have a lot of annoying ringing in right ear; inflamed; Tinnitus in my Right Ear; have a lot of annoying ringing in right ear; inflamed; Vertigo; Dizziness; This is a spontaneous report received from a contactable consumer. This consumer (patient) that. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation and methylprednisolone sodium succinate (SOLU-MEDROL), route of administration, start and stop date, batch/lot number and dose were not reported for tinnitus. The patient's medical history and concomitant medications were not reported. On May2021 the patient experienced atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed, vertigo and dizziness. The patient reported that I got my Pfizer Vaccine first (shot) last Tuesday and I was Hospitalized for one of the problem that left me with is I am having Tinnitus in my Right Ear. I had vertigo, dizziness and then it seemed it has gone away but I still have a lot of ringing in my right ear. I went to see my ENT Doctor and at that time he said he would normally put me on steroid (Solu-Medrol) but because when I was in the hospital I had a problem in my heart with (Atrial fibrillation) but he said even that would be resolved, he was afraid to try that. But I saw my Cardiologist on Monday. He said I should stick with steroid like Solu-Medrol dose pack. It's a low dose steroid (Solu-Medrol) for a short period of time. My question is I have to see my ENT Doctor next Friday for follow up. Since I am still having this really annoying ringing in my right ear, how much of a problem if he wants to try the steroid (Solu-Medrol) to take that ringing away and calm the ears and it is probably inflamed by the (Vaccine). Is that going to interfere getting my second shot with getting the full immunity that I need. When probed for second dose due date, consumer stated, I have to get my second shot on 01June2021 but my Doctor needs to use steroid (Solu-Medrol) for my ear. Is that going to be a problem interfering with the immunity to get from the second shot. Therapeutic measures were taken as a result of atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed, vertigo and dizziness. The outcome for the events atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed and vertigo was not recovered. The outcome for the event dizziness was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Syncope, weakness, lightheadedness, somnolense, confusion, hallucination, acute kidney injury, gross hematuria
Fever of 100.6. Fatigue, Body Aches, for 24hrs Severe tenderness and swelling at injection site
Pt came to ER c/o cold chills, fever, headache, covid positive.
Fever 101.9 F with chills that began overnight following 4/17 dose ~5am 8/17/21 and extended until evening the next day. Muscle aches, pain in arm that subsided after 2 days. **Also acute piercing pain in gall bladder area beginning around 5am, that became less painful after a few hours. Sensitive that next day (4/18/21, then lessened). Some tenderness and sensitivity persists (but NOT piercing or acute) to present 5/12/21 but does not interfere with daily activity...can reposition to lessen discomfort, wear less binding clothes. (Note history of low ejection fraction from 2018/19 evaluation).
has serious issues; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (has serious issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (has serious issues). At the time of the report, ADVERSE EVENT (has serious issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
Moderna COVID?19 Vaccine EUA   Received the 2nd dose Mon 3/22 at 1:25pm 3pm: Normal of sore arm/swollen/bruised injection site.  7pm: Normal chills, body aches, fever began, little faster heartbeat 9pm: began menstruating 1am: fever climbed to 101°, did not rest well, faster heartbeat *****Next morning: Tues 7am: felt strange when I woke up. Tried to make coffee/breakfast/get ready, but kept almost blacking out when I would stand more than a few minutes. Vision started blacking out, had a hard time breathing, weak, felt like I was about to faint, nauseated, felt like heart was trying to stop. Would lay down every time this would happen, then ears would ring and would have a headache. Finally was able to eat a banana after a couple of hours of almost blacking out multiple times and the banana seemed to help.  5pm: feel much better.  Wed 3/24: dizzy Thurs/Fri 3/25-26: dizzy and wee bit faint feeling. Didn?t feel right 4/03/21: still a little dizzy/vertigo  Could you shed light if this was an allergic reaction hours later, please?  I need to know so I can figure out what I am allergic to so this doesn?t happen again.
arm is still hot; Hard skin, leathery; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C1A21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma and Septicemia (Blood poisoning). Concurrent medical conditions included Sensitive skin, Psoriasis and Bone density abnormal. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Bone density abnormal.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery). At the time of the report, VACCINATION SITE WARMTH (arm is still hot) and VACCINATION SITE INDURATION (Hard skin, leathery) had not 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 reported treatment of events was with antibiotic cream and allergen on an unknown start date.
Narrative: Patient reports no signs and symptoms currently from the vaccine. Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. *A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or move parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you have the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1 **** Patient answered phone very short of breath. He had his wife talk on the phone for him. Wife stated that he had been in the hospital for COVID-19 with dx of DVT, and bilat PE's prior to receiving the vaccine. She stated he is on blood thinners and has concerns about his recent blood clots and the potential of additional blood clots from the vaccine. She stated that he has some confusion and trouble thinking but it has been like that since he had COVID and does not know if there would be a change with the vaccine. Patient has appointment with PCP tomorrow @ 1100. Patient and wife will discuss further with PCP of their concerns. Patients wife advised that if there are any changes or any increased SOB she is to call 911 or go to the closest emergency department
Initial unsolicited report received from a Physician on 20 February 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. It was reported that patient received flu vaccine two years in a row. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient had a breakthrough of influenza. It was reported that additional testing being needed on whether the patient was immune deficient. Other lab data and corrective treatment were not reported. Outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: Influenza. List of documents held by sender: none. Sender's Comments: This case concerns an unknown age patient received INFLUENZA QUADRIVAL A-B VACCINE 2 years in a row and had a breakthrough of influenza. Time to onset is unknown. This is not a vaccination failure considering that no detail on virus identification was mentioned. Additional information regarding medical history of patient date of vaccination, time to onset, concurrent condition, confirmatory result (for type of influenza) and etiology of disease are needed for complete assessment of the case. Based on the available information no conclusion can be drawn.
Patient came today 11/17/2021 around 3:30 PM to get her 2nd pfizer shot and she also got the flu shot. After the certified technician administered the shots, patient's arm bruised and bled couple of drops from the injection site, technician applied the ice pack to patient's arm, then I asked patient to stay for 15 minutes to monitor, she refused and started yelling and said no she cannot sit down unless w have something for her to lay down and she left the pharmacy.
Information has been received from a 55 year old female patient referring to herself. The patient had high blood pressure, depression and allergy to sulfa, doxycycline, and antibiotics. On 08-APR-2016 the patient was vaccinated with her first dose of ZOSTAVAX (lot number reported as "L040442" with expiration date 15-JAN-2017, strength, dose and route were unknown) in the left arm. Concomitant therapies included CYMBALTA, CELEXA, SINOPRIL and SINGULAR and aniprazol. On 09-APR-2016, the patient experienced a "raised red area, that feels hot", at the site of insertion on her left arm, about the size of "her hand". The outcome of was unknown. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
pt recv vax 6NOV95 & the next day devel a large,painful,edematous area covering upper rt arm & axilla;also devel an itchy throat;pt was treated w/Epi,DPH & cortisone;p/sx pt exp numbness & tingling of entire rt arm;
This spontaneous report was received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of ROTATEQ oral (dose and lot # were not reported). No adverse effects were reported. Additional information has been requested.
24 hours after, started getting tingling in left jaw, left side of neck, left shoulder and left arm; It has been mild but it has been continual; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 09Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose last Tuesday, 09Feb2021, in a local hospital where he lives. It was reported that after the first shot, he had no side effects. On the second shot, he was told possibly, he might have side effects, maybe like a mild flu or aching at the injection site. He did not have that, but about 24 hours after the shot and to the next week, up until the day of the report, he started getting tingling in the left jaw, left side of the neck, left shoulder and left arm - it has been mild but continual. The shot was in the left arm and 24 hours after, he started getting tingling in his left jaw, the left side of his neck, his left shoulder and his left arm. He kept getting that tingling feeling. He went on every website he could find, looking for what side effects were and nowhere that he sees anybody saying anything about the tingling on the left side of the face, jaw, neck, shoulder and arm, the side where he got the injection. He did about 3 days ago, he was turning on the news and caught just the last few seconds of a report, he thinks was talking about this. All he heard was something about tingling in the face means that the vaccine is working and then they went on to something else. I did not get the whole story and again nowhere has there been any report of this as a side effect. The patient had a light tingling, but it has been continual up until the day of the report, and that day, it is just about fading away and that day is day 8 and it started 24 hours after he got the shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Headache chills, hands itching Narrative:  Headache, chills, hands itching. Almost 90 days post COVID positive, given benadryl in facility.
I had a bad outbreak of oral herpes (second only to my initial outbreak decades ago) the day after my Covid vaccine. People with herpes should be warned of the risk and take Vicyclovir or their prescribed preventative medication before getting the vaccine.
Diagnosed with Episcleritis with no history of any vision or eye disorders in the past. Currently just treating with NSAIDs and rest.
Client woke on 12/4/09 with severe pain in legs which worsened over time.  On 12/5/09, client could not bear weight on legs due to pain.  She & her husband were unsure if pain caused by H1N1 Vaccine or new med (Lamotrigine 25 mg hs started on 12/1/09.  Called neurologist who did not return call.  On 12/6/09, she stopped taking Lamotrigine.  Pain continued but decreased slightly.  On 12/8/09, husband reported symptoms to Dept. of Health, then made contact again with neurologist's office.  Went to ER later in day.  No cause for pain found.  Treatment prescribed:  stay off legs, elevate & apply heat & ice.  To follow up with Private Physician on 12/11/09.  No other symptoms or side effects.  No breathing difficulties.  No skin problems.  Pain localized in legs.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Additional Details: Patient was taken to local hospital
pain the arm; feeling a little tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain the arm and feeling a little tired. It was reported that, caller got her 1st dose and had severe reactions to it like cramping, pain in the arm and she was tired. She mentioned even a possible blood clot. She stated she got the 2nd dose yesterday but has had only pain the arm and feeling a little tired. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Regular fever; Regular chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Regular fever) and CHILLS (Regular chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Regular fever) and CHILLS (Regular chills). On 27-Mar-2021, PYREXIA (Regular fever) and CHILLS (Regular chills) had resolved.            This case was linked to MOD-2021-090389 (Patient Link).
Broke out in hives, by the next day I had 78 and by the 17, I had 143 burning bumps.  Had I received the "What you need to know" sheet first, I would have never had the shot.
Covid-19. I experienced diarrhea, really bad sinuses had a fever of 103.0 for 4 days, had no taste or smell, really bad cough that lasted for 25 days. I was taking ibuprofen and MUCINEX which helped out really well and I also have a vitamin D shot.
Janssen COVID-19 Vaccine EAU   I had a terrible headache for 2 days, chills for 2 days but slight chills for 3 days, terribly achy body, dizzy, nauseous, a little trouble focusing my eyes, diarrhea for 2 days the 3rd and 4th days, slightly sore arm.
He received this vaccine at age 17 and he should not have received this immunization because he was not age 18.