chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH; EYE PAIN; EAR PAIN; PAIN IN THE ARM; FEVER; NOT FEELING GOOD; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced pain in the arm. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced not feeling good. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced eye pain. On 11-MAR-2021, the subject experienced ear pain. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from pain in the arm, not feeling good, headache, eye pain, ear pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
FLU Shot 10/15/2010 Approximately 2:20pm. Fluzone HD**2010-11 PFS (SAN). There was a little bleeding from the shot. Came home. Ate asparagus. Felt OK. (This was about 4:30 p.m.) At about 5:30 p.m. I started to feel uncomfortable. A little dizzy and cold. By 6:30 p.m. I had the chills. I was coughing a lot. I got a sore throat. Eyes watering. By 7:00 p.m. I had the chills and was nauseous. I had the dry heaves one time. I had a slight fever. Stomach ache. Bloated. The chills continued. I turned the heat up to 80 degrees and covered myself with several blankets. I sipped Coke to settle my stomach. I would try to sleep. I would wake up about every hour and would sip Coke. Still had the chills. About 4:30 a.m. I started to feel OK, but still week and slightly dizzy. I slept in until about 9:00a.m. By then I felt normal, although a little weak. After my shower I felt OK.
COVID infection. Specimen collected 8/19/21. Hospitalized on 8/22/21. Still hospitalized at this time.
Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-OCT-2021 and administered on 25-OCT-2021 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains primary reporter address updated.
Vaccination received on 10/3 and wasn't long before nausea, headache and tiredness started (same as 1st dose) On 10/4 at approximately 1:30 am, I woke up with extreme nausea, vomiting, extreme abdominal pain, as well as extreme head pain (worse than a migraine). I was unable to speak and therefore unable to tell my husband to take me to the hospital. Body temperature dropped to 93.6 causing me to be extremely cold.  It took 4 blankets and my husband laying on me to keep me warm where I eventually passed out. I had Zofran from a prior surgery a year ago which thankfully helped with the vomiting. Although not sure how long I was out as he thought I fell asleep and had no idea that I had passed out. My body temperature had raised to 103.8 by early morning. The remaining day on 10/4 was high fevers controlled by Advil and Tylenol, migraine type headaches, nausea, extreme fatigue.  By 10/5, fevers were lower and again controlled by Advil and Tylenol. Late that evening, I woke up with my face tingling and lips numb feeling, tight chest with shortness of breath, chest pain, headache, left shoulder pain, and left hand tingling/numbness. My husband took me to the ER and we arrived early morning 10/6. Blood work to check for cardiac and blood clot factors was performed (2 in 2 hours), 2 EKGs, chest x-ray, CT scan of chest and head with contrast. Received fluids, medication for pain and nausea and a migraine cocktail since the headache evolved into a full blown migraine. I was eventually released that morning. Because of the severe reactions to the vaccine, they thought I may have COVID and just didn't know it. It was negative.  I still to this day get tingling/numb feeling in my face and lips as well as a difficult time catching my breath at times. Before this dose, I was working out 6 days a week with no issues breathing through HIIT, cardio or even running. I now have to take breaks to catch my breath even something as simple as going up and down the stairs or running a short distance.
MILD STUFFY NOSE; DIARRHEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sildenafil citrate for drug used for unknown indication. On 2021, the subject experienced mild stuffy nose. On 2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and mild stuffy nose was not reported. This report was non-serious. This case, involving the same patient is linked.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and feeling abnormal. On an unknown date, the outcome of the pain and feeling abnormal were unknown. It was unknown if the reporter considered the pain and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. While discussing the side effects of SHINGRIX, the pharmacist stated that she had the patient stating that the vaccine hurt and it made the patient feel yucky. The patient worked with the pharmacist and stated that she did not think she would get the 2nd dose due to how bad it made her feel. The pharmacist told the patient that these were expected and this was how she would know that the vaccine was working. This case was linked with US2018GSK119913, reported by the same reporter.
my lips were swollen about 4 times the normal size, extremely hard like a rock, and painful to the touch. Hard to close my mouth,; my lips were swollen about 4 times the normal size, extremely hard like a rock, and painful to the touch. Hard to close my mouth,; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Apr2021, second night after the vaccination, the patient experienced her lips were swollen about 4 times the normal size, extremely hard like a rock, and painful to touch and hard to close her mouth, but she took Benadryl right away and continued the following day as well and the swelling subsided. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lips were swollen about 4 times the normal size, extremely hard like a rock, and painful to touch and hard to close mouth was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Bilateral Breast Pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 02Apr2021 at 14:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had known allergies to Depoprovera. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced bilateral breast pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bilateral breast pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.
I recieved the covid booster along with the flu shot on september the 7th around 345 and was fine the next day i started on a fluconazole 150mg treatment and soon after i got a rash which lasted a little over 24 hours and I have used fluconazole several time in last few years without issue including around 3 months prior to the booster
Left thigh swollen the day after the shot. Swelling had increased to 25-50 cent piece size on left thigh with redness within 7 days; still evident on 2/25/00. Cranky since shots, wakes 2-3 times a night.
Started with flu like symptoms with headache that would not go away after several days ended up in hospital to have lumbar puncture to relieve pressure. Had increased intracranial fluid pressure
45 minutes after receiving flu shot developed severe shortness of breath and chest pain. Troponin I, note: pt is not allergic to eggs. Additional terms from Dis Dummary rec'd on 12/02/2005: Tachycardia, Resp. Distress, Wheeze, React Aggrav, Lab Test Abnormal/sr
This study case was received from the investigator on 27 September 2012. A 20 year-old male subject was found to have non-specific myocarditis 15 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 09 May 2012. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 01.22 on 19 May 2012, an abnormal ECG on 30 May 2012, a normal Echocardiogram on 19 May 2012 and results of an MRI (heart) not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Provider reported that her supervisor instructed the school nurses not to chart the doses administered because the clinic that provided the vaccines to the school district had to complete the charting and documentation. Per the Health regulations, there was no provider agreement for their school nurses to administer vaccines. School nurses never temperature checked throughout the day and did not keep track, it was above 46 degrees F after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She stated the vaccines were kept in hot weather during transport, and believed the vaccine could have been exposed to temperatures around 90 degrees F in the car. She reported that the average temperature was 82 to 88 degrees F in April-2021. No relevant concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-250613 (Patient Link).
Myalgia CHILLS ; FATIGUE Narrative: CHILLS; FATIGUE AND MYALGIA DAY 2 AND CONTINUES TO HAVE SOME FATIGUE AND MYALGIA TODAY
1 hr following vax pt exp swelling & redness @ site of inject; The following day the swelling @ the site was the size of a baseball according to pt;
Pt had routine Td 8/23/05. Reported to clinic next day with T 101.5 c/o chest pain, swelling, said it was from vaccine, sent to ER.
Shortness of breath; Joint pain; Feeling unwell; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient) and in response to Non HCP letter sent. A 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 10Feb2021 at 01:45 on Arm left (at the age of 84-year-old) as 2ND DOSE, SINGLE DOSE (1 shot) for COVID-19 immunisation in Hospital. Vaccine wasn't administered at a Facility. No other products were taken together. There are predisposing factors. The patients medical history was not reported. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 20Jan2021 (at the age of 84-year-old) as 1ST DOSE, SINGLE DOSE for for COVID-19 immunisation. Patient had her 1st shot of the vaccine yesterday (20Jan2021). On the 03Feb2021, she is scheduled to have surgery on her head patient is aware that they will put a shot in it. On 11Feb2021 at 08:00, the patient experienced shortness of breath, Joint pain and feeling unwell. No admission to hospital was involved. No treatment received was received. Patient was feeling fine now. No visit to emergency room and Physician Office. No culture was performed. Outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
The day following vax the patient developed dull ache on posterior side to underarm going to shoulder. Patient states pain level is a 2. Patient states difficulty sleeping. Treated with Tylenol, but not effective.
This child is a twin, and both received the flu vaccine 926-12. When I made a follow-up call to the mother inquiring about another incident, the parent informed me that both girls developed a rash 9-30-12 in axillae and on abdomen. She took them to the pediatrician who did not know what it was and Rx's ZYRTECC and cortisone cream. Mother gave oatmeal baths.
Information has been received from a health professional concerning a female consumer (age not reported) with allergic reaction to antibiotics (therapy not specified) who on approximately 29-MAR-2007 about three weeks ago, was vaccinated with a second dose of Pneumovax 23 (lot #651330/1048P), 0.5 ml, SC.  Concomitant medication was not reported.  On approximately 29-MAR-2007 about three weeks ago, the patient developed an injection site reaction.  The patient's arm became red, hot to touch and painful.  The patient developed edema from the injection site in the upper arm to the level of the elbow.  The patient was placed on antibiotics for 7 days and the swelling, redness and pain resolved after completing the antibiotics.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a certified medical assistant concerning a 60 year old female Estate Trustee with allergic reaction to antibiotics (therapy not specified) and a history of heart disease who on 26-MAR-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot #651330/1048P), 0.5 ml, SC in the left upper extremity. Concomitant medication included LANOXIN and EVISTA. Illness at time of vaccination was reported as none. On 27-MAR-2007, the patient presented to the emergency department, the area where vaccination occurred was becoming red, swollenand very tender. The patient also reported that she was lightheaded, dizzy and she developed a fever. The patient had no nausea, vomiting or diarrhea. She just felt lightheaded and dizzy. She developed a little bit of a sore throat this evening and she was not experiencing and earache. The patient's temperature was 100.9 degrees, pulse was 90, respirations was 18 and blood pressure was 146/80. The patient was hydrated with saline and given a gram of VANCOMYCIN. The patient was prescribed KEFLEX and SEPTRA and was instructed touse warm compresses on the area, 15 minutes 3 times a day. The patient was diagnosed with cellulitis left arm versus inflammatory reaction from PNEUMOVAX 23. The patient recovered from the events on 06-APR-2007. Additional information is not expected.
I ended up with meningitis, spent time in the hospital. Was out of work for 8 weeks. Traveled to a specialist. I had a horrible headache the entire time. Had to be taken off of all my medications completely.
VARIVAX given in R.T. on 7/20/10.  After going home child had hives on both legs.  Advised to give BENADRYL.  PCV 13 given in L.T. on 8/2/10.  Child has 3-4 cm. erythema, induration.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FC3181), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "I am on a immune suppressant." (unspecified if ongoing), notes: Other Medical History: I am on a immune suppressant. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid.
The patient called stating she had redness, swelling, warmth at injection site and also was experiencing a fever and chills 3 days after the vaccine. She said she also had a rash over her entire arm where the injection occurred and wasn't sure if it was an allergy or cellulitis. I advised her to seek medical treatment to diagnose which adverse reaction she was experiencing.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 21-NOV-2012 at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-JUL-2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. Patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Swollen lymph node in neck on the side of injection started 4 days after injection and is getting worse.
Fatigue - 2 hours prior. Muscle aches/pain - 32 hours prior. Chills - 32 hours prior. Extreme fatigue- 32 hours prior. Headache - 35 hours prior.