chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a 69 years old female patient who on 09-NOV-2012 was vaccinated with a first dose of PNEUMOVAX23 intramuscular (IM) (lot number reported as H013399, expiration date: 07-MAR-2014) (dose and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that the patient developed on injection site after receiving her first vaccination with PNEUMOVAX23. She had swelling from the injection site to her elbow including her entire forearm on 11-NOV-2012. The patient was treated with BENADRYL and ice for the adverse event. The patient sought medical attention, she was seen by health care professional (HCP). At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication  was provided.  No treatment medication  was provided.  Patient stated that Fully vaccinated but have caught a cold.
Patient was vaccinated with a dose of improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-US-009507513-1907USA007468: US-US-009507513-1907USA007439: US-US-009507513-1907USA005368: US-US-009507513-1907USA005362: US-US-009507513-1907USA010550: US-US-009507513-1907USA010551: US-US-009507513-1907USA010553: US-US-009507513-1907USA010554: US-US-009507513-1907USA010555: US-US-009507513-1907USA010556: US-US-009507513-1907USA010557: US-US-00950751301907USA010558:
having a problem breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having a problem breathing) 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 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having a problem breathing). At the time of the report, DYSPNOEA (having a problem breathing) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
My legs swelled, my feet swelled, my hands swelled everything swelled; my body feels hot; I feel drunk; the pain in my leg and in my neck; the pain in my leg and in my neck; This is a spontaneous report from a contactable consumer (patient) reported for herself. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: not reported) via an unspecified route of administration on 21Sep2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine 21Sep2021 and experienced legs swelled, my feet swelled, my hands swelled everything swelled; feels drunk and my body feels hot; and the pain in the leg and neck, the patient did not understand on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Broke out into hives 11 days after covid booster. No prior history of hives or any allergic reaction to anything. Had covid between first and second vaccine
Day of injection red and warm. 2nd day more red, sore, developed headache. 3rd day same then developed bruise and lump where given.
mildly itchy rash on my torso; fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on unknown date. please refer the case US2020AMR230273).   On 14th November 2020, the patient received the 2nd dose of Shingrix. On 14th November 2020, less than a day after receiving Shingrix, the patient experienced fever. On 17th November 2020, the patient experienced itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and itchy rash were unknown.   It was unknown if the reporter considered the fever and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient experienced fever and a fine mildly itchy rash on torso.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230273:Same reporter
Drop in oxygen level; Drop in blood pressure; Really tired, layed down and went to sleep; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN CONSUMPTION DECREASED (Drop in oxygen level), BLOOD PRESSURE DECREASED (Drop in blood pressure) and FATIGUE (Really tired, layed down and went to sleep) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027LZ0A (possibly H) and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Really tired, layed down and went to sleep). On 05-Feb-2021, the patient experienced OXYGEN CONSUMPTION DECREASED (Drop in oxygen level) and BLOOD PRESSURE DECREASED (Drop in blood pressure). At the time of the report, OXYGEN CONSUMPTION DECREASED (Drop in oxygen level), BLOOD PRESSURE DECREASED (Drop in blood pressure) and FATIGUE (Really tired, layed down and went to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: 81/51 mmHg Low. On 05-Feb-2021, Oxygen saturation: 78 % Low. On 09-Feb-2021, Blood pressure measurement: mmHg Low. On 09-Feb-2021, Oxygen saturation: 87 % Low.          Treatment information included oxygen and discontinuation of blood pressure medicine. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-027684 (Patient Link).
The child was taken to ER for projectile vomiting X 3 on 9/9/01. During the exam, the pt stopped crying, eyes glazed over for 5 seconds and had decreased responsiveness. No apnea, color change or desaturations. Heart rate changed from 140 to 90. Pt then resumed normal activity. She was observed overnight and discharged home. No further seizures noted. Vomited 1 X in hospital (small amount of yellow fluid).
Myalgia, Fever, NauseaVomiting, MALAISE, FATIGUE, CHILLS Narrative:
This case was reported by a physician and described the occurrence of fever in a patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  On an unspecified date in January 2003, the patient received the 1st dose of Pediarix (Lot # 21883b2) in the right leg.  On that date, the patient also received injections of Hib (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) in the left leg.  The patient's parents telephoned the physician to report that, six to eight hours post-immunization, the patient experienced fever of 102 to 103 degrees F, irritability, and swelling at the site of Pediarix administration.  The events resolved later on the date of immunization.  The reporting physician considered the events were probably related to vaccination with Pediarix Lot # 21883B2.  Comment:  The reporter indicated that, during January 2003 and February 2003, approximately 15 patients out of 30 vaccinees experienced these events following receipt of Pediarix Lot # 21883B2 for the first or second dose in the immunization series.  However, they are not presently identifiable.
This spontaneous report as receive from nurse via company representative refers to 2 patients of unknown demographics. Patients medical history and current condition was not reported. On an unknown date the patients were vaccinated with GARDASIL (strength dose and frequency not reported). Other co-suspects and concomitant medication was not reported. Product quality complaint was not reported. On an unknown date the patients experienced snoopy after receiving GARDASIL. The outcome of syncope was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Evening of 2nd dose (same day) experienced redness to site, fatigue, body aches and chills.  The following day (2/2) experienced shortness of breath with ANY exertion.  Heart palpitations and tachycardia noted.  Complaint of weakness to legs.  The shortness of breath, palpitations and tachycardia are continuing on 2/5 (4 days post vaccination)  Pt. states the symptoms are frequent and exacerbated with any exertion including just walking short distances.
After my second vaccination, the following night I was very tired and getting a headache. I fell asleep and woke up at around 5:30am feeling dizzy and went to the bathroom to take Tylenol. Before I could take the pills, I remember feeling extremely dizzy and my vision started to go back and I passed out, the first time I have ever fainted. My boyfriend woke me up since he heard me fall and noticed blood on the floor. I had a laceration on the back of my head and we went to the ER to get three staples on it.
Broke out in chills for approximately 10 hrs. Then light headache started afterwards. Took Tylenol.
2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2,  PERL, BP 120/82, HR 88 regular, RR 18.  Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline).  ABDM soft, non tender. Breath sounds clear bilaterally.  1100 IV NS 1L, 30 mg Toradol IV given.  Temp 99.2-102.0 variable throughout the day.  Severe HA.  Tylenol and Motrin alternated q 4hr. 2/24  Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above.  2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above.  Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue.  Pt states "do not feel myself"
I got the vaccine at 6PM on Friday and on Saturday morning around 8 AM started having heart palpitations, I was also feeling tired and a little uneasy.  Spent the day resting in bed, drank a lot of water but when it did not go away until 6 PM, I decided to call a doctor for teleconsultation. She suggested that if I am not having any shortness of breath or chest pain then there is nothing to worry about and advised to drink plenty of fluids and getting some more rest.   Followed her advice ate light dinner(Lentil Soup with rice) and went to bed. The next day I was feeling better, no more palpitations; the whole episode lasted one day.  It's been three months now, I have been jogging/running regularly but never had the palpitations again.
Patient is a confused 82-year-old female presented to the emergency department today from the nursing home for chief complaint of fever and altered mental status.  Patient is a poor historian at this time and appears quite ill.  Reportedly nursing home is having a increase in COVID-positive cases.  Patient was just recently discharged from the hospital on 08/08 for concern of suspected dementia and acute rhabdomyolysis.  Nursing home did a point-of-care COVID test today with a negative result.  They did bring her in for lethargy and altered mental status.  During exam patient is able to wake up and answers 1 question before she falls back asleep.  Patient is acutely ill and being transferred to ICU.  Unable to participate in collection of history.    Work-up in the ED: As above patient does initially meet sepsis criteria with COVID-19, tachycardia, tachypnea, hypotension after fluid bolus, and temperature of 104 °F.  Was given 1500 mL bolus, and cefepime in the ED.  Patient is still notably tachycardic and tachypneic after bolus.  Condition continued to deteriorate upon arrival to the ICU under intermediate status with hypotension after bolus as well as crackles noted on auscultation, patient was started on Levophed.  Initial troponin elevated at 40, second troponin 44, EKG shows no acute signs of ischemia per my view, likely secondary to AKI and hypotension.  Inflammatory markers elevated.  Patient is admitted under critical care status to the hospital service for further work-up and continuation of care.   Clinical Summary Patient was found to have covid contributing to her sepsis and acute respiratory failure as well as encephalopathy.  Patient was started on dexamethasone and remdesivir and patient was weaned back to room air without need for intubation during hospitalization and has been afebrile for greater than 24hrs with the rest of her VS and labs stable.  Patient will be discharged to SNF with dexamethasone 6mg PO daily x6 days with instructions to follow up with PCP.     Discharge diagnosis Septic shock secondary to COVID 19 Acute hypoxic respiratory failure secondary to COVID 19 Acute metabolic encephalopathy Elevated troponin AKI Hypoglycemia Hyperkalemia Hypertension Dementia Anxiety Depression Hyperlipidemia Migraines Sacral ulcer
Patient tolerated immunization and blood draw well. As PPD implant occurred, approximately 10 minutes after immunization, patient had a generalized seizure (completely stiff arms and legs, briefly unresponsive) for approximately 30 seconds. Patient was supported by staff. Patient was immediately afterwards able to respond to his name, identify location, time, and date. Initially diaphoretic. Immediate neuro exam was non focal, with good strength. Vitals taken within one minute. BP 110/70, glucose 117, HR initially 48 with return to 62 within 30 seconds of monitoring, O2 99%. Able to hold conversation and discuss events clearly and coherently without confusion. Patient monitored for 20 minutes in clinic, given an apple and water. Patient reported that he felt well enough, though nervous about what had happened, as he had never had a seizure previously. Reported that he was aware of what was happening throughout episode, but saw flashing lights and heard staff's voices in the distance. Discussed ER-however, patient was immediately medically stable. Labs sent for STAT report to lab. Urgent neurology consult requested. Patient to rest today and check back to clinic. Mother is at home to monitor him. Previously worked up for tremors and ? Parkinson's several years ago. Denies history of absence seizures. Denies recent use of any medications or drugs. Neurological.
A rash/bumps appeared all over my body some of the bumps were red and some were not. I have patches on both legs, both arms, back, forehead, base of neck, and both shoulders. I saw my PCP in September, and she diagnosed the rash as granuloma annular. I saw the dermatologist on 10/5/21, and she did a biopsy; and the biopsy did indicate the diagnosis of granuloma annular. The biopsy also indicated sarcoidal and was advised that I needed to have a chest x-ray to rule out the sarcoidal, and those results came back clean. I had one rash spot on my leg for a couple of years, and it didn't start spreading all over my whole body until I got the vaccine; and it was never diagnosed with this diagnosis until it was spread all over.
I received a vaccine below deltoid and had a delayed allergic reaction with cellulitis. (May be considered hypersensitivity) I was extremely sick Saturday the day after vaccine admin. I was seen by Urgent Care physician at my PCP office and sent to the ED.
This spontaneous report as received from a consumer refers to himself, a 80 year old male patient with penicillin allergy and type 2 diabetes. In August 2010 the patient was vaccinated with ZOSTAVAX, 1 time, subcutaneous (dosing information was not provided). On 01-MAR-2013 the patient experienced pain in his right side of his stomach area, going to his lower back. The patient had seen his physician, who advised him this was not shingles, but the patient has a follow-up visit. No treatment was given for the adverse events. The outcome of pain in his right side of his stomach area is unknown. The pain going to his lower back was reported as increased. The relatedness of the events was not reported for ZOSTAVAX. Additional information has been requested.
Fever 102.2F, body aches, chills,  joint pain,  headache
Information has been received from a physician assistant concerning a currently 22 year old female who "when was still a child" was vaccinated with a dose of MMR II. It was reported that the patient experienced Guillain Barre syndrome after getting MMR II when she was a child. The patient was hospitalized (length and place unspecified) at the time and recovered on an unspecified date. Additional information has been requested.
9/28/06 shingles and Flu vaccine given separate arms. 10/30/06 wife called and stated 3-4 hrs after received vaccines pt didn't feel well, chills, teeth chattering, for 1/2 hrs, jumped out of chair, sweating, dripping water for 15 min. Bilateral shoulder and arm tingling 15 min wife thought from vaccines.
Blister on the Gum; Cold Sore on upper and bottom lips started again; Body aches/achy and Sore all over the body; injection site was swollen again; Tired; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired), NAUSEA (Nausea) and HEADACHE (Headache). On 03-May-2021, the patient experienced GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body) and FATIGUE (Tired/Fatigue). On 23-Apr-2021, FATIGUE (Tired) had resolved. At the time of the report, GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired/Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant drugs were reported.   Treatment included antibiotic Keflex in case if she was dealing with any type of infection and Tylenol for pain by the MD.   This case was linked to MOD-2021-118327 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient have not had a period since 2nd dose, It was been almost 2 months and still did not have period.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (Hashimoto's) for which patient received a low daily dose (0.25mg) of Levothyroxine. The patient had no known allergies to medications, food or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient previously took levothyroxine for hypothyroidism (Hashimoto's), patient take a low daily dose (.25mg). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 the patient received the 2nd dose of Pfizer vaccine on the last day of her last menstrual cycle (March 24th), and she not had a period since. Patient used a tracker app to keep track of her cycle, and she never skipped a period before. The patient was not pregnant, and have not started taking any new medication since receiving the 2nd dose of Pfizer vaccine that would affect her period. That has been almost 2 months and patient still did not had her period. Therapeutic measures were not taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events she not had a period since, has been almost 2 months and patient still did not had her period was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.