chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling that there was a cut in the roof of her mouth; not tasting her food; real stuffy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age (reported as 70; no unit provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 as SINGLE DOSE for covid-19 immunisation.  Patient's medical history and concomitant medications were not reported. Patient also reported that she hasn't taken the flu shot for 3 years because she had a "bad reaction" to it one year and her doctor told her not to get it again. Patient reported that prior to getting her COVID vaccine, she took diphenhydramine (BENADRYL) before going just in case. The patient reported that she received the first vaccine on Monday (08Feb2021) and reported that last night (11Feb2021) that she noted that she was not tasting her food and was 'real stuffy'. Patient also reported feeling that there was a cut in the roof of her mouth on an unspecified date. Patient asked if this is normal and also asked what she should do about it. Patient further reported that she tried calling to report her symptoms yesterday but was on hold for about 4 hours and "I gave up".  Patient reported her plan to go online to report her symptoms today. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Had blurry vision for 2 to 2.5 hours; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Had blurry vision for 2 to 2.5 hours) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VISION BLURRED (Had blurry vision for 2 to 2.5 hours). On 28-Feb-2021, VISION BLURRED (Had blurry vision for 2 to 2.5 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she got her first vaccine yesterday, had blurry vision for 2 to 2.5 hours, it had started right after the shot and it lasted the whole 2 hours. Patient said she's fine now.
FRACTURED LEFT ANKLE; mild fever with second covid vaccine; This is a solicited report based (FACILITATED COLLECT) on the information received by Pfizer from AbbVie Inc. (MFR control no.: 21K-163-4166706-00). A contactable 52-year-old female consumer (patient) reported for herself that:  This solicited report by a consumer of a 52 month old female with events of non-serious mild fever with second covid vaccine, fractured left ankle and got COVID with HUMIRA (ADALIMUMAB). There was no reported medical history.  In Apr2020, the patient experienced GOT COVID. In May2021, the patient experienced MILD FEVER WITH SECOND COVID VACCINE. In Oct2021, the patient experienced fractured left ankle. in 2021, the mild fever with second covid vaccine resolved. on an unknown date, got COVID resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Apr2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On 19 May 2021, she received second dose COVID-19 Vaccine manufactured by Pfizer.    Causality for HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of mild fever with second covid vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of fractured left ankle and got COVID was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
In the middle of the night after immunization, patients left side of face and lips began to swell. Patient presented to ARNP. She prescribed H1 & H2 blockers after determining no angioedema no difficulty breathing no tongue swelling. Followed up again 11/30/20 and was started on prednisone as well. Swelling was not subsiding
1 1/2 hours after administration on 9/17/14 - pruritus began and blotchiness on entire body. Used OTC BENADRYL and had relief.
Information has been received from a consumer concerning her 11 year old son who on 09/11/00 was vaccinated with one dose Hepatitis B vaccine recombinant. On 09/12/00, in the early AM, the patient developed a fever of 102 F, was very weak, and tired. The reporter indicated that as of 09/14/00 her son's fever had elevated again and he continued to feel very tired. Unspecified medical attention was sought. Additional info has been requested.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out the first time for about 15-20 seconds then was sat down. Patient passed out again the 2nd time with some convulsions. Paramedics came and took pt away.
Client reports the same day arm had egg sized red area with pain and swelling. Called DR office again and found she just had it in April and this is why she reacted she said she forgot she had it.
Fever of 102. Headache Took 2 aspirin.  Drank some water. Slept about 12 hours. Headache. Took 2 more aspirin. And had some more water.  Slept on and off for another 18 hours. The fever broke about 4 this morning when everything was damp from sweat.  My temperature is at 99.9 now.   I ache all over and my arm is sore. Feeling much better, though.
Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, literature. Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.50ml = 50mcg. Pt reports some nausea today 11/20/23 which is 4 days out from the event but otherwise tolerated without issue.
no taste; lost of appetite; congestion; Headaches; Chills; achy body; throwing up; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 02-Jan-2021. Concomitant products included ASCORBIC ACID (VIT C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted). The patient was treated with ZINC at a dose of 50 milligram, for 5 days and MELATONIN for Booster, at a dose of for 5 days. At the time of the report, AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was provided.
reaction at the injection site, skin rash; skin tender in center; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center). At the time of the report, VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center) outcome was unknown.        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.   No concomitant medications were provided by reporter. No treatment medications provided by the reporter.   This case was linked to MOD-2021-002584 (E2B Linked Report).; 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. MOD-2021-002584:Reporter's case
Vaccine taken in : 1st shot april  2nd shot may  Hypothyroidism diagnosed in november.  Observed  symptoms:  august: weight gain  september: swelling facial and whole body, hoarse voice, tingling in fingers, decreased mobility of arms, hands, fatigue, continued weight gain october: intensification of all symptoms november: intensification of all symptoms leading to severe whole body swelling and eventual diagnosis and treatment intervention with synthetic thyroid hormone
BROKE OUT WITH SHINGLES 11 DAYS AFTER VACCINATION (SHINGLES RASH STARTED 3/29/21)
Vaccine given 02/21/2003. Pt developed rash 03/09/2003 and Dx'd with chicken pox on 03/10/2003
At 9;05 am Patient reported  nausea in recovery sitting in chair R22, B/P132/88, P86.   At 9;36 am B/P 136/88, R20, P88,. patent declined any medical care/transport released at 9;35 to go home.
Information has been received from an x-ray technician concerning an unspecified patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 25-OCT-2016, the patient received 1 dose of improperly stored PEDVAXHIB (lot # M014927, expiration date 18-FEB-2019), dose and route were unspecified. The vaccine was stored at 30 F for 9 hours. The data logger was involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
respiratory distress; hard time breathing; felt a lump in her throat; making it hard to swallow; This is a spontaneous report from a contactable nurse (patient's daughter). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on unspecified date at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient's daughter reported that her mother received the first dose of the Covid vaccine and 2 hours later, her mother had a hard time breathing and felt a lump in her throat, making it hard to swallow. The respiratory distress only lasted a few minutes, but the feeling of a lump in her throat lasted 4 days. The patient's daughter wanted to know if it is ok and safe for her mother to receive the second dose of the vaccine. The patient recovered from the event respiratory distress on an unspecified date. Outcome of the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Left thumb began twitching and spasming about 12 hours following injection. Thumb would "pull" into the side of the hand in an arthritic type motion. Symptom lessened as time has gone on but still occurs, though less frequently, 48 hours following injection.
Pt recv vax on 2/11/98; on 2/27/98 pt exp neck pain, pain when turning head, eye capillary burst, headache; tx=Compazine w/out resolve, Demerol; 3/4/98 pt exp swollen knee w/ fluid on the knee & swollen wrists
Chest/heart  stabbing  pains started 10am following day. Lasted all day until sleep. Woke up  next day and pains had gone
Information has been received from a licensed practical nurse concerning a 79 year old male patient with no known drug reactions/allergies and with a history of heart enlarged and rheumatic fever (at the age of 15 years old), who "few months ago prior to 12-JUN-2009" was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included vitamins (unspecified), TYLENOL with codeine #3, VOLTAREN, montelukast sodium (MSD) and atorvastatin calcium. The licensed practical nurse reported that the patient received the vaccine and " the day after vaccination" the patient's lips were swollen and there were hives in the arm pit area (which arm unspecified). The patient was in the nurse's office on 12-JUN-2009 because of the hives. An unspecified antihistamine was prescribed to treat the event. The ZOSTAVAX was given by another physician. The patient was referred to an unspecified allergist. The outcome of the patient was not reported. Lips were swollen and hives in the arm pit area were considered to be immediately life-threatening and other important medical event. Additional information has been requested.
Patient's guardian, provided inaccurate information regarding patients date of birth. The date of birth provided on the consent form, and subsequent identity verification steps. The correct date of birth was actually making patient only 11 years old, and an ineligible candidate for the Pfizer covid-19 vaccine. Patient received her first dose 05/15/2021 and the second dose on 06/05/2021. No adverse effects were reported to my knowledge.
This spontaneous report as received from a other health professional refers to a 2 year old patient. On 14-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L026740 and expiration date 16-APR-2017, lot # L008574 and expiration date 22-NOV-2016, exact doses were not reported, orally). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Allergic reaction to vaccines given on 6/21/2005 (suspect Varivax). Office visit on 6/22/2005, red raised urticarial ring like rash bottom thighs, left arm where Varivax given.
A report has been received from a Health Professional concerning a 32 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Health Professional reported that two female patients had been administered expired FLUMIST which started on 10-Oct-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
The symptoms were a little sickness and pain in the arm after the shot. I got a headache and nerve pain. The nerve pain was odd. It went away for about a week and then came back. It continually got worse so I went to the doctor and found out I had shingles. The shingles lasted for about 5 weeks. Ever since then I have had odd chest pain that is reminiscent of the shingles pain. It occurs around the upper collarbone. I do not feel like it is in the heart area. I also had a little rash from the shingles, it never blistered but was painful. I was prescribed Valtrex for about 2-3 weeks to treat the shingles.
Visit Diagnoses   COVID-19  BMI 33.0-33.9,adult  Cough  Fever, unspecified fever cause  Body aches  Acute nonintractable headache, unspecified headache type  Chest congestion  Nasal congestion  Close exposure to COVID-19 virus
Patient presents to ER with chest pain that is constant, achy, occasional sharp stabbing, sometimes worse with deep breath and radiates to his back for the last 2-1/2 hours.  He said it started at 10 PM.  He said he has not had anything to eat since about 5 PM and says it does not feel like heartburn. Work-up included a CT angiogram of the thorax which showed findings consistent with pericarditis.  Patient was noted to have diffuse but mild ST elevations on ECG.  Cardiac enzymes remained negative however.  Cardiology was consulted, and the patient was admitted to the hospital where he was started on colchicine and NSAIDs. Serial cardiac enzymes remained negative.  The patient's chest pain steadily improved, and by last night it had completely resolved.  He does have chronic shoulder pain due to osteoarthritis, and this is at its baseline. The patient will finish a 3-month treatment course with colchicine.  I am discharging him on as needed ibuprofen for breakthrough pain. It should be noted that the patient did have a brief period of paroxysmal atrial fibrillation which resolved with 150 mg of amiodarone IV.  The patient has been continuously monitored on telemetry, and atrial fibrillation has not recurred.  After discussion with the patient and his wife, I have elected not to start the patient on aggressive anticoagulation as the period of atrial fibrillation was quite limited and occurred during an acute viral pericarditis episode.  Patient's CHA 2 DS 2 score is 4.  I recommended that he further discuss this with his primary care provider.  Recommend considering an extended Holter monitor.
Late documentation for 8/26/2021. Documented on 9/15/21. Pt was administered menveo on 8/26/21 but were supposed to receive bexsero. Administration error was realized while pt was in the office and then she also received the Bexsero vaccine. Mom and pt aware of error and verbalized understanding with receiving incorrect vaccine. Incident report filled out.
complaint of numbness and tingling 4th and 5th fingers of left hand,  full ROM, normal strength, cap refill <3 sec,  BP- 124/68, O2 sat- 97% Examined by Dr,   repeat BP- 116/83, p-84, O2 sat- 98%  at 10:40 am-  discharged home with ER precautions.  If symptoms persist, recommend follow up with Primary care physician.
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient complains of radiating numbness/tingling down left arm and up the left/back side of her neck, often followed by pain. Review of injection site reveals the poke was not too low or high. Started 12/28 (day after injection) and continuing into today 12/29.
pt recvd vax;7 days later, uncontrollable crying w/ febrile illness, t 103;rx w/ apap;28jan reported conjunctivitis on eye;called MD;29jan t 105 ax;apap given; MD felt rxn to MMR;
Patient started experience burning in the eyes and bilateral tinnitus.  She denied any rash, hives, swelling, facial edema, or pharyngeal edema, wheezing, shortness of breath, or chest pain.  She was given Benadryl at the time and observed.
80mmx60mm reddened swollen and warm to touch on (L) thigh.
Hospitalized for Acute Respiratory Failure with hypoxia 2-7-22 to 2-9-22.
Shivering 8PM to 4AM, couldn't sleep, pounding headache 2AM to 6AM.  All symptoms resolved by 9AM
-Fatigue -Heart Palpitations -Swollen Lymph Nodes in neck region
neck soreness; injection site soreness; felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck soreness), VACCINATION SITE PAIN (injection site soreness) and FATIGUE (felt extremely tired) outcome was unknown.            No concomitant medication were provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non Significant follow up received on 14-JUN-2021 Contains AE contact information updated; Sender's Comments: .
Painful, red area left thigh 80.5mm in diameter. No swelling; patient afebrile. Symptoms began next day following vaccine received. Per doctor, try cool packs, Motrin, or Tylenol.
Headache; Fever; Chills; body aches and her arm is sore; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore) outcome was unknown.        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.   No Concomitant medications were reported.  No Treatment medication were given.
pt recvd vax;devel a rash w/ vesicles;2 wks later, sibling broke out w/ chicken pox;RN indicated that pt ended up having hand, foot & mouth disease & not rxn to vax;