chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients of unknown age and gender. On unknown dates, each of the patients were vaccinated with 2 separate doses of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On an unknown date the patients was found to have lower than normal titers after the 2 doses of VARIVAX (Merck). The outcome of event was unknown. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax; fever, aches all over; h/a, redness of throat; pleursy pains in chest; dizzy started 2 days after vax; 7nov94 pc to pt this am regarding flu-like sxs;cont to have sore throat;app to see PMD;8nov pc to pt,improved; atb given;
Fever of 100 deg, chills, myalgias similar to previous but not as bad.
4:00 pm 9/17 pt calls and described a rash on left arm, tingling in both hands and feet, and generalized itching. Advised pt to take 50 mg BENADRYL. Seek help at ER if not better or worse. MD was called early morning, did not hear back as of 4:00pm 9/17.
Swelling and moderate pain under left arm.; Swelling and moderate pain under left arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient experienced swelling and moderate pain under left arm, which was going on since five days (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling and moderate pain under left arm were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine breakthrough, symptomatic. Inpatient admit 9/21 to present.
15FEB98 revisited MD dx cellulitis, prescribed 500mg Duricef x 2 a day;4" red rash, hot "burning" to touch, hard lump under skin size of a brussel sprout, painful to move arm;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 05-JUN-2008, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-MAY-2016, the patient was treated at an urgent care center for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Woke up all night; Chest Pain; Left arm was painful; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced difficulty sleeping, chest pain and pain in arm. On an unknown date, the outcome of the difficulty sleeping, chest pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, chest pain and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient woke up all night, experienced chest pain, and her left arm was painful for four to five days after the injection. The patient's reaction was very severe. The reporter did not consent to follow-up.
Chills came on about 12h post vaccination; hot; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration in the left arm on 16Feb2021 08:45 as single dose and was previously administered the first dose of BNT162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 27Jan2021  08:00 as a single dose for covid-19 immunization. Patient was 32-years-old and was not pregnant at the time of vaccination. Vaccination facility type was Workplace Clinic.  Relevant medical history was allergy to latex. The concomitant medications included ethinylestradiol, norgestrel (CRYSELLE) and lifitegrast (XIIDRA). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 16Feb2021 at 20:00, the patient experienced chills came on about 12h post-vaccination. Took an Advil and slept it off. Woke up about 5 h after start of chills and was hot. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-044370 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: TCR Received on 05 Jun 2021 and contains no new information. Patient denied further follow up
half dose administered for first dose on accident; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 16-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident). On 16-Nov-2021, ACCIDENTAL UNDERDOSE (half dose administered for first dose on accident) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  A nursing home resident received a half dose of 0.25mL Moderna first dose administered on accident. No symptoms reported by health care professional.   Reporter did not allow further contact
Moderna COVID-19 Vaccine EUA; I felt fine until I laid down at night, immensely tired.  I was restless in my sleep and had auditory and sometimes visual hallucinations, it is now Wednesday (got the booster Monday) and I still have a relentless headache.  I was highly sensitive to anything touching my body and had immense chills.  My fever has not broken below 100 in two days.  I cannot stand up without getting a migraine.  I could not eat for a while also.  Restless when I try to sleep and fatigued when awake.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. Sender's Comments: US-009507513-1708USA013519: US-009507513-1708USA013518: US-009507513-1708USA013516: US-009507513-1708USA013488.
Severe fever; Shivering for 24 hours; Unable to sleep or do anything else / Didn't do anything except lay in bed and try to sleep for 24 hours; Unable to sleep or do anything else; Pain all over, Pain enough to make me lay in bed; Pain all over, every joint; Pain all over, every joint, every muscle; Pain enough to make me lay in bed and cry for hours; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the right arm on 08May2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with constipation (IBS-C). The patient's allergies included asthma from eggs, nothing else. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) daily, taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 17Apr2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 00:00, the patient experienced severe fever, shivering for 24 hours, unable to sleep or do anything else, pain all over, every joint, every muscle. It started at midnight the day of the vaccination and continued until midnight of 10May2021, the following day. Pain enough to make the patient lay in bed and cry for hours. Did not do anything except lying in bed and tried to sleep for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fever, shivering, unable to sleep or do anything else, pain all over, every joint, every muscle, pain enough to make the patient lay in bed and cry for hours and did not do anything except lying in bed and tried to sleep for 24 hours was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received immunizations on 12/27/03. On 12/28/03 in PM, right thigh with 4 inch red raised swollen area at injections ite; area itches at times and slightly painful. Seen in PCP's office on 12/29/03.
The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care  and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.
2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; Received First dose on 03Apr2021, Second dose on 17Apr2021; Received First dose on 03Apr2021, Second dose on 17Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Apr2021 17:00 (at age of 55 years old) (Lot Number: EW0172) as single dose for covid-19 immunisation. The patient other medical history was none. No known allergies. The patient's concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 03Apr2021 17:00 (Lot Number: EW0150), also at age of 55 years old for covid-19 immunization. The patient reported that 2 hours after 2nd dose, he started to cough and wheeze and felt his throat was closing. He didn't want to go to the hospital and it felt better after his wife gave him diphenhydramine (BENADRYL). Adverse event start date was reported as on 24Apr2021 19:00 (CLARIFICATION PENDING). Events were reported as non-serious. AE treatment was reported as "no" (CLARIFICATION PENDING). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered in Apr2021.
This spontaneous case reported by a nurse, describes the occurrence of product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included surgery (patient had a surgery after the first dose of vaccine). On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 18, 2021, patient experienced product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose). At the time of the report, product dose omission issue (vaccine first administered Jan 18, 2021; patient is yet to receive second dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant products or treatment information.
24 hours after my 2nd Moderna vaccine, I developed tinnitus in my right ear. It never went away. I just received my Moderna booster, and it is MUCH worse and quite loud. I also have vertigo on my right side when I move my head.
Metallic taste; Body aches; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills). At the time of the report, DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Patient was fully vaccinated with the Moderna on 3/2/21 and 4/1/21 but developed COVID 19. Patient presented with cough, shortness of breath, fatigue, generalized weakness.  Patient states he has had generalized weakness and fatigue and cough for 2 to 3 weeks which is worsened over the past few days with increased shortness of breath. He is currently admitted with COVID 19
Tues 1100 injection. 20 hours after: temp 100.6, all over body muscle aches, bone aches,  ( duration of 24 hours), redness 1" diameter warm and soreness to injection site, and fatigue, (duration of 3 days). Starting  28 hours after: lymph edema and pain under arm of injected arm (duration Wed PM-Sat.PM).  Thursday AM woke with eyeball pain and headache. (lasted 2 hours).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 13-OCT-2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 12-OCT-2016, the patient was treated by a healthcare provider at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Fever, sweats, chills, headache, fatigue, insomnia, injection site pain  Used Tylenol and Ibuprofen to control temperature and headaches.  I did have Covid in the beginning of August 2020
didn't get the 2nd shot until almost 10 months later; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The received the 1st dose of shingles vaccination, but didn't get the 2nd shot until almost 10 months later, which led to lengthening of vaccination schedule. The patient also enquired if a third shot was required within the period of 2 to 6 months.
administered FLUZONE QIV NP after the expiration date with no reported adverse event; Initial information received fon 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves 18 months old female patient who was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] after the expiration date 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 hepatitis A vaccine (hepatitis A) for Prophylactic vaccination.  On 15-Sep-2022, the patient received suspect influenza quadrival A-B vaccine at a dose of 0.5 ml total (lot UT7407MA, expiry date: 30-Jun-2022) via intramuscular route in the left thigh for immunisation.  On 15-Sep-2022 the patient was administered fluzone qiv np after the expiration date with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   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.
Running fever that increased to 102 & vomited.  Taken to ER & was then adm for 24 hour observation.
Pt. received 1st vaccine on 9-28-10. Bloody stool on 9/29/10.
I received the pfizer vaccine on May 6 2021 around 430pm. I woke up this morning with swelling right above my left collar bone / neck area.  I can feel a small ball /  lump in the area
Approximately 40 after receiving Influenza Vaccine, Participant alerted nurse she was having difficulty breathing.
Got nasal mist 11am on Sat. First complained about stomach ache around 7PM Sunday, then overnight was coughing, had 101 fever and complained of leg pain.
Erythema, raised, hot to touch, sore center area of red location had a lighter discoloration. Appearance of an arthus-like reaction.
1" rash at site of injection on left deltoid reported day after administration (10/9/16).
Breakthrough case admission after 2 vaccines; patient expired NO LOT NUMBER AVAILABLE ON Vaccine received on 3/10/21
pt had DTP/HIBtiter vax on 4JUN93; pt had to go to ER on 8JUN93 w/a hx of 2 days of fever progressively inc to 104 @ home; fever max 103.9 in the ER;
Information has been received from a physician concerning 2 pts who were vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pts experienced red, swollen and warm arms from their elbow to shoulder. It was reported that it was the vaccinated arm that developed the reactions. Unspecified medical attention was sought. Follow-up information, indicated that the pt recovered with "local care."
Patient describes "numbness and tingling feeling to left cheek off and on. feels like my face was injected with lidocaine".
Patient reported feeling weak, fever, severely swollen and tender arm, and localized rash. Symptoms lasted 9/7/17 through 9/11/17. Rash is still present as of 9/11/17.