chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 08-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002963: US-009507513-2104USA002944: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Patient states that she felt dizzy and was not able to see. Patient was diaphoretic but denies chest pain, SOB. V/S 130/100 - 54 - 99%. Called and was sent to ER for further evaluation
36 yo patient received her Pfizer booster at  Covid clinic on 01/15/2022. Vaccine given at 1407 in left deltoid. Lot number was FJ5682, expiration 04/01/2022. Patient had no reaction after first 2 pfizer vaccines.Patient wanted to stay for 15 minute observation.   Within the first 2-4 minutes after vaccine she developed warm feeling all over and was flushed, she felt she had a hard time taking a deep breath. She was given water and she said she felt better. At 2:25  she said she was feeling shaky and appeared very anxious.She was laid down on the cart and her BP was 144/84, pulse ox 100, HR 140. She was encouraged to take slow deep breaths and sips of water. She denied itchy feeling or difficulty swallowing.She continued to have feelings of not getting enough breath and emergency was called at 2:45.The squad came at 2:50 and placed her on gurney to transport to ER. She called her mother prior to leaving Covid Clinic.  She has allergy to Penicillin. No present illness. She has a history of depression and Anxiety but has been off medication x 1 year. She took no medication earlier today.
Hives; 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 URTICARIA (Hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. no Concomitant products were provided. no treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
At first very sore arm, painful at site and can't lift without pain. Then the next morning, I felt flulike symptoms like chills, then hot, achy all over and later in day, headache. Also, stomach feels weird, not much appetite. I just feel like I am getting the flu. Fever was 99.9 F.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Lot number: 3303fb) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 10 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks (Insulin). Patient received Anti-viral treatment for COVID-19 with Paxlovid from 29Jun2022 to 03Jul2022.  No follow-up attempts are possible. No further information is expected.
That night and following day patient reports headache and took Tylenol then Excedrin. Temperature was 99 F and was achy for 2 days.
Primary reporter is the patient. She called to report that, after being administered ZOSTAVAX, she has had tingling, numbness and "terrible pain" in her arms and legs. She stated that about 2 weeks ago she woke up in the night with "terrible pain" in her arm and tingling and numbness at that lasted for 18 hours or more. Her symptoms continued over multiple nights and have spread to her other arm and legs. The patient visited her primary physician, who ruled out stroke, and sent her to neurologist. Neurologist results are still pending. The patient reports that her symptoms have not improved. No further information provided.
Significant upper body and neck aches morning of 10/09 . Fever of 100.4F in am of 10/09 . Fatigue on 10/09. All symptoms subsided by 10/10
Information has been received from a registered nurse concerning an adult female healthcare worker who was vaccinated with a dose of varicella virus vaccine live. Recently, in approximately June 2005, it was found that the patient did not seroconvert. A product quality complaint was not involved. Additional information has been requested.
Deep febrile seizure 11 days after MMR and VARIVAX given at well visit. Also had otitis media. Was intubated overnight and very unresponsive - good early recovery is underway. Required Dopamine. 10/16/09 Received hospital records and DC summary for dates 9/14/09 to 9/22/09. DC DX: Febrile seizure with respiratory arrest, influenza pneumonia, mechanical ventilation and withdrawal symptoms. Presenting SX: parent states found pt having trouble breathing, eyes deviated to the left shaking arms and legs for a few minutes then limp and unresponsive. During route to hospital EMS witnessed another seizure; eyes deviated to left no return to baseline mental status. Arrived to ER in full respiratory arrest. Pt. intubated in ER and admitted. Assessment: Appeared in respiratory distress, lethargic, poor eye contact, tachycardia, altered mental status. h/o MMR 9/9 and parent states previous two weeks had periods where pt would deviate eyes to the left and then run to the left in a circle. On admission had normal papillary reaction. Intense respiratory congestion. Pt had 5 days of vent. support. Influenza A(+). After extubated pt had withdrawal symptoms and tx. Pt was stable at time of DC, but with a poor appetite, fully alert, smiling and playful. ICD9 codes: 038.9, 780.97, 518.81, 780.32, 346.30, 292.0, 995.92, 780.8, 487.1, 493.90, 304.0  bhp
Information was received from a physician assistant via a company representative concerning a 24 year old female patient. The patient's medical history, concurrent conditions, and concomitant medication was not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose number, lot number, dosage, and route of administration were not provided). After receiving the GARDASIL, on an unknown date, the patient developed cervical dysplasia. The patient was seeing an OB/GYN. It was reported that the patient was planning on getting a loop electrosurgical excision procedure (LEEP) done "to remove the precancerous tissue" that was found. The outcome of the cervical dysplasia and precancerous tissue is unknown. Additional information is not expected.
Cough, headache, fever, chills, right lymph node armpit swollen.
Headache; Throw up; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm (left shoulder), administration date 22Mar2021 07:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Headache"; VOMITING (non-serious) with onset 23Mar2021 14:00, outcome "recovering", described as "Throw up". The events "headache" and "throw up" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vomiting.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. He has no allergies to medications, food, or other products. Tylenol and other medicine were subscribed as treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 years old administrated with adult dose; Adult product administered to child; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old male patient who received HAV (Havrix adult) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 25th January 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Vaccine coordinator reported that a 15 years old patient was administrated with adult dose of Havrix which led to overdose and adult product administered to child.  No adverse event was reported. The reporter did not consent to follow up.
About 6 days later, left arm, injection site became Itchy, red blotchy area , comes and goes. Slight hardening of injection area, sore at point o finjection still after 8 days. Seems to be itchy over scalp and other areas of body at times - thought I was going crazy until I read an article on this side effect.  Writing in as I am in the midst.  Hope it does not get any worse.
pt phoned MD office where inj was given & informed medical assistant that arm which inj was given was swollen & warm from deltoid muscle to the elbow;pt instructed to pub cold soaks on site;
Arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm hurt). The outcome of the pain in arm was resolved (duration 2 weeks).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The shot for shingles made patient arm hurt bad for two weeks. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
PT sts after first dose she did not experience any Sx.  Second dose in series 28 days later, PT waited in observation area.  While seated, she began to feel lightheaded and "hot."  BP 114/70, HR 74, RR 16.  Drank water on provider orders,.  Neg LOC or confusion observed. STS cool air helps. By PT request, she attempted to stand which brought back symptoms.  PT observed to have blanched appearance and was placed on stretcher with feet raised on 2 LPM O2, second vitals set 1115/74, HR 72, RR 18.  When attempting to sit up after 15 minutes dizziness returned and nausea began. 3rd vitals set 119/79, HR 63, RR 18, O2 increased to 3 LPM by provider, PT occasionally sat up to drink water as her mouth felt dry and dizziness was persistent.  30 minutes after symptoms began, medical staff noted new onset of confusion.  PT sts Sx began to resolve 55 minutes after onset.  PT removed from O2 and was able to walk without aid to awaiting vehicle.
sore arm for 3 days, extreme fatigue for 3 days, headache for 3 days
Urticaria, fever, confusion, GI- N/V/H. Treatment received by MD for urticaria with hives still present as of 9/3/21
9:50am I received the PFIZER vaccine, I instantly had a reaction of body rash, burning. Hand no difficulty with breathing.
My entire body ached; muscle and joint pain; muscle and joint pain; Very fatigued; Slept most of the day; feeling very weak; severe headache in both temples and behind eyes; Injection site became extremely painful; Freezing and a feeling like I had a bad cold; Freezing and a feeling like I had a bad cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 12:15 (Lot number: EW0187) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Adult-Onset Still's Disease" (unspecified if ongoing); "DVT (Right Leg)" (unspecified if ongoing); "Bilateral Pulmonary Embolisms" (unspecified if ongoing); "Neuroendocrine tumors on pancreas - had Whipple surgery", start date: 19Aug2021 (unspecified if ongoing); "Neuroendocrine tumors on pancreas" (unspecified if ongoing); "Depression" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Acid reflux Disease" (unspecified if ongoing). Concomitant medication(s) included: LANSOPRAZOLE; EFFEXOR; ELIQUIS; VALSARTAN HCTZ. Vaccination history included: Bnt162b2 (Brand: Pfizer, Dose Number: 2, Batch/Lot No: EW0162, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 13Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Brand: Pfizer, Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 23Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 24Nov2021 17:00, outcome "recovering", described as "feeling very weak"; Headache(non-serious) with onset 24Nov2021 17:00, outcome "recovering", described as "severe headache in both temples and behind eyes"; Vaccination site pain (non-serious) with onset 24Nov2021 17:00, outcome "recovering", described as "Injection site became extremely painful"; Feeling cold (non-serious), Nasopharyngitis(non-serious) all with onset 24Nov2021 17:00, outcome "recovering" and all described as "Freezing and a feeling like I had a bad cold"; Pain(non-serious) with onset 25Nov2021, outcome "recovering", described as "My entire body ached"; Myalgia(non-serious), Arthralgia(non-serious) all with onset 25Nov2021, outcome "recovering" and all described as "muscle and joint pain"; Fatigue(non-serious) with onset 25Nov2021, outcome "recovering", described as "Very fatigued"; Somnolence(non-serious) with onset 25Nov2021, outcome "recovering", described as "Slept most of the day". Therapeutic measures were not taken as a result of asthenia, headache, vaccination site pain, feeling cold, nasopharyngitis, pain, myalgia, arthralgia, fatigue, somnolence.  Follow-up (01Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
I experienced a cold, achy joints, sore throat, headache, runny nose, coughing, and fevers.
fever w/pain & swelling @ inj site;resolving as of 19JAN96;
Mom stated that after 2-4 weeks of 12 mths vaccines child develop a rash all over body mom visted ER at Hospital and was Dx with scabies no medication was given.
On 12/19/2018 child was hot with fever and fussy and suddenly eyes rolled up and froth came from the mouth with stiff body. The whole episode lasted for a couple of seconds and then said "mama" and was responding well. Mom gave Ibuprofen 3mL and then she fell asleep.
Flu Vaccine administered on 11/12/2002 at place of employment. Chronic Daily Headaches started 11/16/2002. Chronic Pansinusitus. Per follow up 9/20/05 Chronic daily headaches.
she had fever; still felt weak; felt light tightness in her chest; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiration date not reported), via an unspecified route of administration on 04Jan2021 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her Covid vaccine first dose last Monday evening, on 04Jan2021. After getting the vaccine, she had fever in Jan2021. She felt better yesterday but still felt weak and felt light tightness in her chest in Jan2021. Outcome of the event of fever was recovering, while other events was unknown.  Information on lot/batch number was requested.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient came in to the pharmacy on 7/21/2021 to report that she had left her band-aid on (applied after vaccine on 6/15/2021) for several weeks after receiving the vaccine, stating she forgot to take it off. She showed her arm, which showed mild skin irritation in the shape of a band-aid. Referred patient to see a physician at urgent care or a dermatologist. She went to urgent care and had a topical remedy prescribed.
Pfizer-BioNTech COVID-19 Vaccine EUA patient described having tingling in the throat. No swelling of lips or tongue. Patient said symptoms came on about 20 minutes after vaccine. Patient was observed over 30 minutes and patient left feeling fine.
numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient himself). A 50-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date was unknown), intramuscularly on the right arm on 18Dec2020 at 12:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had no Covid prior to vaccination. He was not tested for Covid post vaccination. On an unspecified date, following the first vaccine, the patient had numbness in his right hand for two (x2) days. The patient did not receive any treatment for the event. The patient recovered from the event "numbness in his right hand" on an unspecified date.
Pt recvd vax & exp severe pain  @ the inject site & the entire arm; CNS involvement consisting of tingling, numbness & heaviness in the inject arm, lightheadedness, & dizziness; No further details were provided;
Chills, fever, running nose, fatigue, joint pains, muscle pain, nausea, loss of appetite; lasted two days.  Took Tylenol
red; still itching; Arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041671A) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma. Concurrent medical conditions included Fruit allergy (Oranges) and Food allergy (Tamatoes).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at injection site). On 31-Jan-2021, the patient experienced PRURITUS (still itching). On 04-Feb-2021, the patient experienced ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041671A) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma. Concurrent medical conditions included Fruit allergy (Oranges) and Food allergy (Tamatoes).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at injection site). On 31-Jan-2021, the patient experienced PRURITUS (still itching). On 04-Feb-2021, the patient experienced ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (Arm pain at injection site), PRURITUS (still itching) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.