chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 42 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The health care professional stated that, the dose of Shingrix was administered in May or June 2019. 6 weeks after vaccination with Shingrix, the patient experienced shingles. The reporter consented to follow up.
w/in 4 hrs p/vax pt report rt eye was half closed; seen by neurologist 2 days later; no treatment initiated; also exp an inject site react which included soreness; hx of lupus-Predisone started 3 wks prior to immun;
Stiff neck; soreness in my arm; severe pain in neck; squeezing on a nerve; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  When the patient tried to turn around to speak to nurse (reporter), she complained of a stiff neck. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N012093 with expiration date 13-JAN-2020, lot# M024261with expiration date 30-JUL-2018, and lot# M044717 with expiration date 19-JUL-2019, for prophylaxis. No adverse event was reported. The doses of GARDASIL 9 were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002994: US-009507513-1708USA002995:
A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 14Apr2021 at single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date after first dose, few days later in Apr2021 patient experienced itching on both of upper thighs. On 17Apr2021, three days later patient got hives three later in certain area, which looks like hives or a rash. Patient was scheduled for her second dose on 05May2021 and patient thinking is it ok to have the second dose, sow her healthcare professional who confirmed its not related to the shot and advised her to proceed with her second dose. The outcome of all the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose). On 19th April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 10th May 2018, 21 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be unlikely related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reporting that one of their patients who received 2nd dose of SHINGRIX and developed shingles infection on for which he was being treated with oral antiviral medication. The caller was unable to provide any concomitant medications since patient does not get medications regularly from their pharmacy. Follow up information received from the pharmacist on 21st June 2018: The patient received SHINGRIX intramuscularly. The reporter's details were updated. The VAERS details were updated. Sender's Comments: US2018091654: Previous VAERS submission in paper format.
Patient reports that 2 days after receiving the both doses of the Pfizer Covid-19 vaccination she developed myalgia, fatigue & tremor in both hands.
On the day- mild light headedness, muscles spasms with 30 minutes then it went away. Arm tenderness, Cold sweat in the middle of the night. Then it all went away. In Oct 2021- Nov 2021- bleeding in between my period the whole month. No pain, COVID- 10 Dec2021 headache and diarrhea, fatigue, 14Dec2021 my daughter was positive and I got tested positive. Fatigue. My symptoms got worse, got migraine headache and extreme fatigue and upset stomach and sore throat and chest was tight and congestion. 12/15/2021- mild stomach discomfort and the rest of the symptoms still exist.
large lump rt ant thigh where DTP given; able to move, nl activity, not crying p/vax;
vaccination site pruritus; vaccination site rash; Vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) had not resolved.            No concomitant medication were provided.   Patient also reported using itch cream  as treatment medication for this third episode of COVID arm. (vaccination site reaction). She reported diphenhydramine (Benadryl) and the itch cream did not help.   The patient reported she started to have Covid arm  for a third time on the same area of vaccination on 10-May-2021. The patient reported that her Covid arm  took a month each time to (go) away after her vaccinations. The Covid arm  she got was of nice size and itchy when it started and she stated that it was weird that she was getting another event after two months. The patient reported she received an unknown shot (injection in arm) for an unknown indication 17 days prior to her 1st dose of Moderna Covid-10 vaccine in the same arm .  Company Comment: 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. Further information has been requested; 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. Further information has been requested
swelling/brusing, postulate at point of needle insertion, bruising all around.  No fever, no itching at this time.
Had multiple syncope episodes, cough. Admitted for dehydration, acute kidney injusry. Pt was discharged 10/09/2021
"Moderna COVID-19 Vaccine EUA"; experienced itchiness at the injection site about 2 hours after the injection.  After about 48 hours developed a circular rash at the injection site and it continued to itch.  Applied a topical OTC hydrocortisone 1% ointment on the affected area at about 9:00 PM on the second day after the vaccine.  The itchiness has thus far subsided as of this report.
I tested positive for COVID-19 on 12/13/22. I had a fever of 103, fatigue, headache, nonproductive, cough, brain fog, and body aches. I contacted my doctor and was recommended to take over-the-counter TYLENOL, ROBITUSSIN, dextromethorphan, and guaifenesin. He did not prescribe PAXLOVID because he does not believe it works. He has had too many patients have a rebound case after 5 days. I am feeling much better now.
Mom stated that pt c/o tightness in chest shortly p/receiving immun & w/in hr devel hives; Pt was referred to MD; mom instructed to talk w/MD about allerg react pt exp;
I had a migraine off and on again for several days.  (I am prone to migraines, but this vaccine seemed to exacerbate the issue.)
I became very confused days after getting the vaccine to the point I ended up in the Emergency room and didn't know who I was or where I was. The hospital I went to treated me like a drug Addict I've never done drugs in my life. I just want my life back I have to see a series of doctors now because they still don't know what wrong. the only thing that I've done in the past couple weeks was get the shot. Please help me with this.
After day of vaccination, all of sudden he started giving up on feeding and stop turning on side. That never happen before vaccinations. His growth percentile was perfect at his 2 months pediatric visit (the day he got his 2 months vaccines).
Information has been received from a case in litigation via Litigation Reports concerning a 15 month old male patient who on 14-MAR-2000 was vaccinated with a dose of MMR II (lot# not reported). ON 30-MAR-2000 (16 days after vaccination), the patient experienced a seizure "with eye rolling and choking". Patient was admitted to the ER and had an MRI of his brain taken which was interpreted by the treating radiologist as "most consistent with demyelinating process of immune etiology such as may be seen with acute disseminated encephalomyelitis (ADEM) or perhaps post-vaccination". It was noted that the patient's ADEM led to Pervasive Developmental Delay (PDD), a condition from which the patient continued to suffer. No further information is available.
Persistent hives, emerged 9 days post vaccine, treated by doctor with cortisone injection, 3 antihistamines, oral prednisone. Hives still appearing, 4 days now.
This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The doctor said that the patient experienced fever (the patient's body temperature was recorded as 101 degree F) and body aches for 2 days following the first dose of SHINGRIX. No measures were taken.
Pale/unresponsive approx. 1 min after receiving vaccine. Appeared to have a seizure.   After about 5-7 min appeared to improve.  Reported after event that she had hx of "vasvagals".  Transported to local hospital for further assessment.
body pain/soreness; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event onset date was provided.
Fever, body went limp and lifeless, only moans and groans were made, threw up twice, the first time she just threw up and didn't move, I had to move her so she wouldn't choke on her own sickness. 16 poopy diapers within 14 hrs.
No Adverse event; expired dose of Moderna Covid-19 vaccine (Monovalent) was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered) and NO ADVERSE EVENT (No Adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine (Monovalent) was administered).    Concomitant medications were not reported.  The vial size was 5.5 ml. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Several hrs p/DTP pt became listless & pale- & had brief period of high pitched crying;
acute respiratory failure; Pulmonary embolisms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Jan2021 (Lot number: EL8982) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tape" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; APIXBAN; PREDNISONE; ALLOPURINOL. Past drug history included: Known allergies: demerol, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose: 1, product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EL3246,, lot unknown=False,, administration date=07Jan2021,, dose number=1,, vaccine location=Left arm), administration date: 07Jan2021, for COVID-19 immunization. The following information was reported: ACUTE RESPIRATORY FAILURE (hospitalization, life threatening) with onset 27Jan2021, outcome "not recovered", described as "acute respiratory failure"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 27Jan2021, outcome "not recovered", described as "Pulmonary embolisms". The patient was hospitalized for acute respiratory failure (start date: 11Dec2021, hospitalization duration: 16 day(s)); for pulmonary embolism (start date: Jul2021, hospitalization duration: 16 day(s)). The events "acute respiratory failure" and "pulmonary embolisms" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of acute respiratory failure, pulmonary embolism. Clinical course: No other vaccine in four weeks. I received my last vaccine (injection #02) on 21Jan2021. On 27Jan2021 I was admitted to the hospital with acute respiratory failure. In Jul2021 I was admitted for multiple unprovoked bilateral Pulmonary embolisms. On 03Dec2021 I received my booster (injection #03). On 11Dec2021 I was again admitted to the hospital for Acute Respiratory Failure. Prior to the vaccines, I have never had any lung or respiratory issues. Now, I have to have supplemental O2. Adverse event start date: 27Jan2021. Ae resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No days hospitalization: 16. Patient was not Recovered. AE treatment included Supplemental O2 at home, Lifetime Eliquis for PE's. No covid prior vaccination. Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: EW0178), in left arm and on 13Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Negative; (24Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
24 hours, post vax, mother states son's temperature was 101.2F; he complained of dizziness, sore throat and nausea. For the next 2 consecutive days, his temperature spiked to 102F in the evening. Strept test was negative on 8/6/02.
Rash/Hives on both arms not relieved by oral Benadryl, that spread to chest and torso by the next day. RPh advised visit to MD for evaluation and possible steroid.
Severe flu-like symptoms, 6-day headache, nausea, sore joints, no appetite, severe fatigue lasting four days
positive for Covid-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for Covid-19) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for Covid-19). At the time of the report, COVID-19 (positive for Covid-19) outcome was unknown. Asymptomatic with positive COVID-19 test    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  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.
Narrative: COVID infection following COVID vaccine series 04/04 Janssen, dose #1 private sector, non-agency 08/16 pt cc: cough, headache, myalgias, fever,diarrhea exposure: unknown 08/18 COVID swab, result: detected 08/19 - 09/05 pt symptoms continue 08/25 cc: low oxygen levelc, dx:Acute hypoxic respiratory failure due to Covid 19 Pneumonia LOS: 7 days 08/25 CRP result: 21.583 08/26 Ferritin result: 876.2 08/25 ddimer result: 0.74 08/25 SARS-COV-2 IGG result 0:05 8/25 SARS-CoV-2 AB, spike result: >25.00 08/25 CXR impression: Moderate bilateral perihilar and peripheral infiltrates suspicious for infection. Covid pneumonia can have this appearance. Recommend clinical correlation. 08/26 FIBRINOGEN result: 480 08/26 DDIMER result: 1.16 08/26 ESR result: 97 08/26 CTA PE impression: No obvious pulmonary embolus. 2. Extensive bilateral changes of COVID 19 pneumonia, involving all pulmonary lobes. 3. Right lower paratracheal adenopathy is potentially reactive. 08/27 SARS-COV-2 IGG result 0.06 08/27 FIBRINOGEN result: 378 08/27DDIMER result: 1.23 08/27 ESR result: 92 08/28 FIBRINOGEN result: 378 08/28 DDIMER result: 1.40 08/28 ESR result: 93 H 08/28 SARS-COV-2 TOTAL AB, SPIKE SEMI QN result: >2500.0 H 08/28 DDIMER result: 1.52 08/29 CTA PE impression: 1. No definite evidence for pulmonary embolus.2. Similar bilateral groundglass opacities, consistent with COVID pneumonia. 08/30 DDIMER result: 2.27 H 08/31FIBRINOGEN result: 347 08/31 DDIMER result: 1.60 08/31 ESR result: 33 H 09/01 FIBRINOGEN result: 312 09/01 DDIMER result: 1.49 09/01 ESR 48 h 09/6 clinically resolved
itchy periorbital areas (rt > lt); itchy,watery eyes; blurry vision; periorbital bumps; swelling at injection site; no anaphylactic symptoms; used warm compress for relief
Nose bleed 5 min after vaccine administered; This is a spontaneous report from a contactable physician, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899), intramuscularly in the left arm on 26Dec2020 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient did not have any 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 medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 26Dec2020 at 12:05, the patient experienced a nose bleed five minutes after the vaccine was administered. No therapeutic measures were taken as a result of the event. The clinical outcome of the nose bleed was resolved on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.