chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the worse winter ever; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included laceration of foot. Previously administered products included Polio (received on an unknown date, when patient was in school), TB (received on an unknown date, when patient was in school), Tetanus (received on an unknown date for foot cut), Antihistamine (received on an unknown date for reaction to the jab (shot)) and Small pox vaccine (received in 1978).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not had many vaccinations and was cautious about the vaccines which were received .  The patient received small pox vaccine when started working in the HS (Health Service) and then again and again when the patient was in contact with one involved with the outbreak in State.  The patient had one flu vaccine when they started inoculating HS staff but the patient had the worse winter ever due to the unspecified adverse reaction and then after the patient refuses to have any more flu vaccines.
Information has been received from a nurse concerning her 18 year old daughter who, on unspecified dates, was vaccinated with first, second, and third doses of Gardasil. Subsequently, after each dose the patient experienced severe pain at the injection site. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  COMPLEX PARTIAL EPILEPSY, RECURRENT EPILEPSY, UNSPECIFIED EPILEPSY, COMPLEX PARTIAL SEIZURES, INTRACTABLE W STATUS EPILEPTICUS  11/22/2022 -- RECURRENCE OF SAME SYMPTOMS
red welt; This case was reported by a consumer via interactive digital media and described the occurrence of erythema urticarial in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was recovered/resolved.   It was unknown if the reporter considered the erythema urticarial to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self reported the case. The age at vaccination was not reported. The patient received Shingles shot like two weeks ago and had the biggest red welt that just kept getting bigger for like 4 days. The patient stated that hopefully his/her next one would be easier. The follow up would not be possible as no contact details were available.
Nausea, headache, fever. Left clinic with extreme frontal headache. Came into clinic next day with fever 102. Strep test (-). Vomiting and nausea.
Vaccine given 8/8/02. DTaP and Hep B/Hib (Comvax) given in L thigh. On 8/9/02 pt presented with diffuse swelling of L thigh. Vaccine sites were warm and moderately red. No itching or breathing difficulty.
No additional AEs; vaccine administered after temperature excursions; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 08-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection (0.5ml, lot #X011979, expiration date: 18-JUL-2024; strength was not provided) intramuscularly for prophylaxis. It was reported the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) was administered after temperature excursions of 18.3-degree Fahrenheit for a time frame of 1 hour and 5 minutes. There was no previous temperature excursion. No additional information was provided. No additional adverse events (AEs) or product quality complaint (PQC) were reported.
EPIPLOIC APPENDAGITIS; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included anti-inflammatory therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced epiploic appendagitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from epiploic appendagitis. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
PT received TDAP on 5/02/16, by 5/7/16 she had a redness raised mark the size of a dime. PT came back to clinic 5/9/16. By this time red area grew to 7cm. and was painful to touch. PCP ordered f/u with Team RN.
Patient claimed she saw spots and was then unresponsive to the mother.  Blood pressure was taken prior to EMT arrival with blood pressure of 105/68 and pulse of 70. Patient barely ate that day prior to coming in for the vaccine. Mother later disclosed that the patient had a event similar to this prior (date unknown) with the patient after getting an IV injection.
Narrative: Hospital-foot cold and white, blood clots in foot and groin, was advised from covid. Pfizer vaccine x 2
tested positive for COVID-19; tested positive for COVID-19 and general malaise and flu-like symptoms with fever; This is a spontaneous report from a contactable consumer(patient).  A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021, at 45-year-old, as single dose (Batch/Lot number was not reported) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021, at 45-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he was tested positive for COVID-19 on an unspecified date in 2021. Symptoms included general malaise and flu-like symptoms with fever (102.7 F) on 10Aug2021. Patient felt better and was self-isolating at home. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA), LEVOTHYROXINE, CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Very bad headache). On 22-Mar-2021, HEADACHE (Very bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication for the event included Acetaminophen.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 11-year-old male patient who received MENVEO for prophylaxis. In August 2018, the patient received MENVEO. In August 2018, less than a week after receiving MENVEO, the patient experienced injection site erythema, injection site swelling and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling and pain in arm were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and pain in arm to be related to MENVEO. Additional details were reported as follows: A week prior to reporting date, the patient received a dose of MENVEO and had redness and swelling at the injection site. The patient had arm soreness lasting for more than 5 days.
Redness, swelling and itching at injection site for 2-3 days one week after injection. Sore a little day 1-2 and then fine. Reaction started later.
have a lump under my arm; I have swelling under my left arm; This is a spontaneous report from a contactable consumer or other non-health-care-professional.  A 61-year-old female patient received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution for injection Batch/Lot Number: 30145BA Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 30Sep2021 as (At the age of 61-year-old) dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient calling because she took the shot (Covid Vaccine) on 30Sep2021 and she have a lump under his arm, a big lump under his arm that was the side effect she do not know how long it going to last but so already have an issue with his arms so she have a big lump so, she just wanted to report it, she call Pfizer and wait in a long line, when you have a symptom you should go straight through the Pfizer, it make you feel like you go through regular appointment, you should go under regular appointment we should have phone number of the Pfizer to go straight through, she have swelling under his left arm. It was reported that patient was not received any tenement for events, she does not know what to take, and that why she is calling what should she do for swelling. The Outcome of both events was unknown.  Follow-up attempts are completed. No further information is expected.
First vaccination, I had a headache.  Then for the 2nd vaccination, I had ended up in the hospital, the shot triggered my asthma, I had to miss a couple of days of work. The third vaccination, booster, I had a headache. The last booster, I ended up in the emergency room from 2:30pm -3am, they thought I had blood clots, and my asthma was acting up, I had an asthma attack as well.
His head feels stuffed up and he has this pain feeling in his head.; he did not get a good nights sleep; really really bad headache like sinus headache; woke up with a feeling that he seemed to be getting the flu; little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: EN6208) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "blister on his lung" (unspecified if ongoing), notes: (many years ago), When the lung blister happened they stapled it together.; "Smoker" (unspecified if ongoing), notes: he smoked. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot#EN6198, Anatomical location: Left arm), administration date: 20Feb2021, when the patient was 74 years old, for COVID-19 IMMUNIZATION, reaction(s): "sore arm". The following information was reported: SINUS HEADACHE (non-serious) with onset 14Mar2021, outcome "not recovered", described as "really really bad headache like sinus headache"; FATIGUE (non-serious) with onset 13Mar2021 19:00, outcome "recovering", described as "little tired"; INFLUENZA (non-serious) with onset 14Mar2021, outcome "unknown", described as "woke up with a feeling that he seemed to be getting the flu"; FEELING ABNORMAL (non-serious) with onset 15Mar2021, outcome "unknown", described as "His head feels stuffed up and he has this pain feeling in his head."; SLEEP DISORDER (non-serious) with onset 15Mar2021, outcome "unknown", described as "he did not get a good nights sleep". Therapeutic measures were taken as a result of sinus headache.  Additional information: The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. With the second Covid 19 vaccine on Saturday, 13Mar2021 the patient felt a little tired on Saturday evening. It was not unusual for that time of night around 7pm. Then on Sunday 14Mar2021, the patient woke up with a feeling that seemed to be getting the flu. The day went on and around 3pm he and his wife were supposed to meet with friends. But on that day 14Mar2021, he woke up with a really really bad headache, like a sinus headache, in the front of his face and nasal area. May just be a part of the process of the particular shot so he let it go. He took a nap that day afternoon (14Mar2021) for about 2 hours. The whole nap his head was pounding. He was supposed to meet with friends and he told his wife he doesn't want to go and she said ok and they didn't go. That continued into the evening. The headache, was still there, and that went on until the next day morning (15Mar2021). His head felt stuffed up and he had this pain feeling in his head. He was still a little tired but he did not get a good nights sleep. He woke up around 4:30 am in the morning and his head felt sore and he had a Tylenol and it seemed to go away but it was not gone completely away and it was like it was concentrating on him.   No follow-up attempts are possible. No further information is expected.
I did not have an adverse reaction to the vaccine. On 11/25/22, I work up in the middle of the night and started to get up to go to the bathroom and got very lightheaded. I went on into the bathroom and got back to bed hoping to go back to sleep. I went to the emergency room for evaluation. My blood pressure was low and all other vitals where within normal range. The doctor and nurses in the emergency room said that I got up to fast. They told me I needed to slow down getting up in the morning.
blisters on his finger tips; chills; vomiting; tired; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters on his finger tips), CHILLS (chills), VOMITING (vomiting) and FATIGUE (tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills), VOMITING (vomiting) and FATIGUE (tired). On 29-Apr-2021, the patient experienced BLISTER (blisters on his finger tips). At the time of the report, BLISTER (blisters on his finger tips), CHILLS (chills), VOMITING (vomiting) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information was not provided by the reporter.   This case was linked to MOD21-084330, US-MODERNATX, INC.-MOD-2021-098427 (E2B Linked Report). This case was linked to MOD-2021-097957 (Patient Link).; Sender's Comments:  MOD21-084330: US-MODERNATX, INC.-MOD-2021-098427:fiance case 2nd dosage
Dose #2 of COVID vaccine was given 6 days before minimum interval of 3 weeks. Not within the 4 day grace period. No adverse reaction.
Myocarditis Associated With COVID-19 Vaccination; This is a literature report.  A 23 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for covid-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis Associated With COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: brain natriuretic peptide: 12.1 pg/mL, notes: Initial; ejection fraction: 61 percent, notes: Initial CMR; 62 percent, notes: Follow-up CMR; electrocardiogram: no st abnormality, notes: Follow-up; st-segment elevations, notes: Initial; investigation: notes: mL/m2; Initial CMR; notes: mL/m2; Follow-up CMR; magnetic resonance imaging heart: late gadolinium enhancement; patchy lge a/il segments, notes: Initial CMR; near resolution, lge in mid al segments, notes: Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; magnetic resonance imaging heart: notes: units-ms; Follow-up CMR; n-terminal prohormone brain natriuretic peptide: 6.2 pg/mL, notes: Follow-up; troponin i (normal high range 60.4): 5.2 ng/L, notes: Follow-up; troponin: 16.6 ng/ml, notes: Initial. Clinical course: Intermediate-term (6-month) follow-up demonstrated improvement or resolution of CMR findings of myocarditis.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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-202200508742 Same article/Event/Drug and different patient
Patient received the first Moderna COVID Bivalent vaccine & hadn't had anything to eat yet that day. She had a syncopal episode after receiving the vaccine. She also had a PPD placed before the incident as well.
Expired dose of IPOL was given to a patient with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered expired dose of IPV (vero) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 30-Jul-2022, the patient received 0.5 mL dose of suspect IPV (VERO) (lot T1D481M, expiry date: 25-Jul-2022; formulation, strength not reported) via intramuscular route in the left deltoid for immunization.  On 30-Jul-2022, the patient was administered expired dose of IPV (vero) [IPOL] with no reported adverse event (expired product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. ; Sender's Comments:  01223666:
Patient fainted after receiving flu vaccine. She started to seize shortly thereafter. EMS were called to respond. Patient seized for approximately 10 seconds. EMS transported her to hospital for further evaluation.
10AUG98 2PM given 11AUG98 930AM pt c/o fever 101.4, nausea, abd pain, vomiting, diarrhea;given compazine;
I started to receive an abnormal feeling in my body near my heart. I had palpitations where my heart rate would jump from 60 bpm to 100 bpm. This has never occurred before and I believe this is a result of the Janssen vaccine. I had drank plenty of water the days after the vaccine, and I was not anxious about anything. These palpitations occurred in the middle of the night. Feeling that this was abnormal, I rushed myself to the nearest emergency room   I was given a few lab tests (basic metabolic panel, complete blood cell count, troponin I). Two electrocardiograms were also performed. The nurses provided one liter of lactacted ringer during my stay at the hospital. I was discharged and left with a  bill where over  was requested to be paid by the patient.
swollen area between her neck and the left shoulder joint; Arm hurts; Bluish vein sticking out from her neck; 2 red patches on the area of the injection; Fever (T-100.7 F); Body aches; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection) and PAIN IN EXTREMITY (Arm hurts) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck). On 25-Feb-2021, PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
pt recvd vax & devel t100.5, chills, aching; took APAP;pt planned to call pt back but no answer;wrote letter to f/u-no response
covid vaccine breakthrough case  dose 1 3/5/21  Pfizer  EL9265
pt recvd vax & dev urticaria/wheals in same general area as inject (LA) but not adjacent to or contiguous w/ inject site;
10/10/2022:Pt fainted approx. 1/2 hour after receiving vaccines. 3:00pm Pt was assessed by a MD, orthostatic vitals performed, oxygen administered, feet elevated.  Crash cart on hand.  Pt was alert x 3 left with his mother at approx. 3:20pm.    10/13/2022: Pt mother was contacted and she states Pt is fine with no other side effects or pain at injection sites. Gave permission to report to VAERS.