chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurred vision; discomfort in left eye; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and O13M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache). At the time of the report, VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.         Treatment information not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-079942 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079942:DOSE1
Patient presented to pharmacy 5 days after vaccine, with redness and pain that was spreading starting 2 days prior. Advise patient to go to ER to seek medical attention.
I noticed a lump under my shoulder area leading to my breast; I had muscle and bone pain the next day; I had muscle and bone pain the next day, my knee caps were even hurting; My heart was throbbing; There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed.; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Dec2021 at 19:45 (Lot number: unknown) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications.  Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of Administration: Unspecified), administration date: an unknown date in May2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of Administration: Unspecified), administration date: an unknown date in Jun2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 at 19:45, outcome "unknown", described as "Dose received 3"; MYALGIA (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day"; BONE PAIN (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "I had muscle and bone pain the next day, my knee caps were even hurting"; PALPITATIONS (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "My heart was throbbing"; PAIN IN EXTREMITY (non-serious) with onset 31Dec2021 at 19:45, outcome "not recovered", described as "There was pain on the arm that I got the vaccine on. On Saturday the pain in the arm where I received the vaccine had progressed"; MASS (non-serious) with onset 01Jan2022, outcome "not recovered", described as "I noticed a lump under my shoulder area leading to my breast". Therapeutic measures were not taken as a result of myalgia, bone pain, palpitations, pain in extremity and mass.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient   The lot number for BNT162b2 was not provided and will be requested during follow up.
10-3 face flushed, c/o upper lip numbness, tingling and throat scratchy. BENADRYL given as ordered. 10-3-12 after going home went to E.R. with c/o swelling worse - fluids and more BENADRYL given. 10-4-12 - back to E.R. x 2 with c/o severe itching, eyes swelling and difficulty swallowing. Treated and released. 10-5-12 visit to allergist and family doctor- both in agreeance reaction to flu shot. Patient stated on 10/3/12 during visit at time of reaction she was allergic to thermisol but had received flu vaccines before without problems patient did not report this on vaccine questionnaire. Patient has fully recovered.
Information has been received from a physician concerning a 10-year-old female with no known drug allergies, who on 04-APR-1997 was vaccinated subcutaneously in the RAT with a dose of Varivax. Subsequently, on 23-JUN-2006, the patient developed chickenpox with multiple lesions on her trunk. The outcome was unknown. Additional information has been requested.
Rash on neck, chest and abdomen; Hypersensitivity; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No relevant medical history was provided.     On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity). At the time of the report, RASH (Rash on neck, chest and abdomen) and HYPERSENSITIVITY (Hypersensitivity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERSENSITIVITY (Hypersensitivity) to be related. No further causality assessment was provided for RASH (Rash on neck, chest and abdomen).    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added Vaccine hypersensitivity/anaphalyxis form
funky feeling on throat; funky taste on mouth; odd taste but not in the sinus; feeling like something was stuck on her throat, like swallowing a pill; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN for Blood pressure.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill). At the time of the report, OROPHARYNGEAL DISCOMFORT (funky feeling on throat), TASTE DISORDER (funky taste on mouth), TASTE DISORDER (odd taste but not in the sinus) and SENSATION OF FOREIGN BODY (feeling like something was stuck on her throat, like swallowing a pill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Case number PHEH2014US020994 is an initial spontaneous report from the patient received on 17 OCT 2014. This report refers to a 42-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 16 OCT 2014. The patient felt that the FLUVIRIN vaccine received by her was not kept in the refrigerator. No adverse event reported following this medication error (incorrect storage of drug).
Progressive sensorimotor changes first starting one day after Moderna COVID vaccine on 5/3,  initially with itching in palms of hands and feet then gradually ascending pain and numbness, with weakness starting in right lower extremity first noted on 5/20 and gradually progressing such that she had difficulty ambulating independently since 5/23. Diagnosed with acute inflammatory demyelinating polyneuropathy on 5/24/21, starting five days of treatment with IVIG.
This is a spontaneous report from a contactable Nurse. A 18-years-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 mg, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headaches, chills and nausea on an unspecified date (the day after vaccination) with outcome of recovered after 2 days.
Itching, swelling, tingling and headache, redness in (L) deltoid. Joint hurt b/c patient - has arthritis.
Cough sore throat vomiting diarrhea high fever up to 105. 3 ER visits one Monday night. On Friday early morning one. Friday late morning  diagnosed on 9/27 second ER visit as pneumonia treatment azythromycin.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects noted
Fever to 101.8 degrees x 2 days post vaccination. On the morining of day 3 small red, papular rash began at vaccine administration site and progressively spread to other areas of the body.
eye swelling 10 days after 1st Moderna shot; 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 EYE SWELLING (eye swelling 10 days after 1st Moderna shot) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (eye swelling 10 days after 1st Moderna shot). At the time of the report, EYE SWELLING (eye swelling 10 days after 1st Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (expiration date 20-SEP-2017) (dose, unit and route unknown). The vaccine was exposed to 47F for 15 minutes, 47F for 40 minutes, 47.3F for 40 minutes, 50F for 1 hour. No previous temperature excursion. Data logger was involved. No adverse effects reported. Lot number M00268 is an invalid lot number for hepatitis A vaccine, inactivated. This is one of two reports received from the same source. Additional information has been requested.
Case number PHEH2015US026849, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 46-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 12 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degree). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors (incorrect storage of drug). Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
PATIENT URINATED ON THE GROUND AND FELL ASLEEP ON THE WAITING CHAIR.
eyes went bad within a month; This spontaneous case was reported by a patient and describes the occurrence of EYE DISORDER (eyes went bad within a month) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (eyes went bad within a month). At the time of the report, EYE DISORDER (eyes went bad within a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EYE DISORDER (eyes went bad within a month) to be related.    Patient had no allergies.  Patient did not had any Medical History.  It was reported that patients eye sight was perfect before receiving the vaccination.  Reportedly, Patient needs glasses now and his doctor thinks it was possible that the Moderna shot had an effect on his eyes. Patient threatened to call an attorney.  Treatment details were not reported by the reporter.
No Fever, no pain in ER 04/28/2002. Redness, edema, itching over upper arm (Noncircumferential). Good capillary refill distally. Strong medial and radial pulses. Doctor reports reaction to pertussis of DTaP. Benadryl , continue cool compresses. Child not to receive pertussis anymore.
Pt had immun @ 1PM on 6SEP91; general malaise & fever by 5PM; given APAP; @ 12MN father report choked on APAP tablet; stiffened, out w/rigidity;
Started as whining and tired 24 hrs after shot.  Awoke in morning with 104 temp.  Nausea, throwing up (3x)  Very whiny and lethargic.  Next morning temp 104.8.  Bowels normal, threw up 3-4x during day.  4th day temp 100.8, up as high as 102.5, whiny, and lethargic.  This morning is temp is 100.8.  He has had no appetite in 4 days.
Approximately 10 - 15 minutes after receiving her flu vaccine, which she has had yearly for at least 6 years, my daughter "blacked out" in the car while we were driving.  She wasn't out very long, but then reported feeling dizzy and said the trees "looked blurry".  She lost all her color and became very shaky and after about 5 minutes said she was nauseous.  Within a few minutes she threw up.  We returned to the health department, where they gave her some orange juice and had her sit in a chair for about 10 minutes.  They were very kind and reassuring, but this has shaken patient up quite a bit.  She was not ill, nor was she feeling very nervous about getting a shot.  A nurse at our church said there had been a report about this happening to teenagers, so I thought you should be aware of it.
Extreme muscle and joint pain.  Minor Loss of motor function in legs. Loss of arm motor function in right arm associated with pain
Sore arm on the left side; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 24Apr2021 16:30 (Lot number: EW0165) at the age of 73 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Apr2021, outcome "recovered" (26Apr2021), described as "Sore arm on the left side".  Additional Information: The patient had no prior vaccinations (within 4 weeks) and no adverse effects following prior vaccinations. The patient was calling about the COVID-19 vaccine. The patient had her first vaccine on 24Apr2021, and everything is fine other than a sore arm. The sore arm was on the left side after the patient's injection and her arm did not bother her anymore 26Apr2021 (Monday). The patient had no other side effects, she feels great. The patient's second COVID-19 vaccine is scheduled for 22May2021 and that is 4 weeks instead of 3. The patient was asking if that is still going to be effective.  No follow-up attempts are needed. No further information is expected.
Pt had No Adverse reactions to vaccine. Mother was informed pt was given Moderna 6-11 yrs old, Instead of Moderna 6mnth- 5yrs
Patient reported feeling heart racing; Assessed as tachycardic, HR 130, BP 134/64 @11:40, BP 150/80 @11:55, BP 167/105 @12:03, BP 181/96 @12:24; O2 sat 99%.  Transported to the ED. Spent 3 hours in the ED BP down to 130/  Then discharged home.  No recurrent episodes.  Does not have history of high blood pressure.
patient was administered an expired dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The pharmacist reported that male patient was administered an expired dose of Havrix on which led to expired vaccine used. Pharmacist did not have vaccine lot number at the time of reporting, but knew the vaccine expired in January 2023. The reporter did not have any patient details available at time of reporting. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. The case is linked with US2023101232, same reporter.
Multiple calcified granulomas in lung liver and spleen; Multiple calcified granulomas in lung liver and spleen; Multiple calcified granulomas in lung liver and spleen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jul2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer", start date: 2018 (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD; "ECT" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. The patient received other medications within 2 weeks of vaccination. The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Not available/provided to reporter at the time of report completion), administration date: 09Jun2021, when the patient was 39 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PULMONARY GRANULOMA (disability), GRANULOMATOUS LIVER DISEASE (disability), SPLENIC GRANULOMA (disability) all with onset 13Jul2021, outcome "not recovered" and all described as "Multiple calcified granulomas in lung liver and spleen". The event "multiple calcified granulomas in lung liver and spleen" was evaluated at the physician office visit. The patient underwent COVID-19 test/ sars-cov-2 test: (13Jul2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of pulmonary granuloma, granulomatous liver disease, splenic granuloma. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events PULMONARY GRANULOMA, GRANULOMATOUS LIVER DISEASE, SPLENIC GRANULOMA and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Case number PHEH2014US003875 is an initial spontaneous report received from a nurse on 21 Feb 2014: This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
A few days after receiving the vaccine, I had gone to the mall and went up to the second floor and started walking when I began to feel over heated and was suddenly not feeling well. It felt like I was having a panic attack. I started to become dizzy and felt like I was going to pass out so I grabbed on to the railing near by and knelt down a bit and waited for it to subside. I had tunnel vision for a while and it started to get better. It felt as though it lasted a long time but was most likely only 10 minutes or so. I eventually was able to get down stairs and back to my car to get home. I called my doctor the next day to see what was going on because everywhere I went, I would feel dizzy and unsteady on my feet. I was concerned about an inner ear issue but the doctor implied that it my be due to my vaccine. She prescribed a steroid Z pack and everything seemed to get better.
Sore and swollen injection site, low grade fever, chills, head and body aches, tired.
Narrative: The patient was admitted to the hospital on 6 Oct 2021 with chest pain. The patient was discharged on 8 Oct 2021. The patient was readmitted on 16 Oct 21 with chest pain and coughing. The patient was discharged on 19 Oct 21. The patient presented to the ED with worsening shortness of breath and coughing on 20 Nov 2021 and was admitted to the hospital on 21 Nov 21. The patient was discharged in stable condition on 24 Nov 21. The patient presented to the ED with chest pain and shortness of breath on 1 Jan 2022 and was admitted. The patient was discharged on 6 Jan 2022. The  patient was readmitted on 10 Jan 2022 with chest pain and tested positive for COVID 19. The patient was discharged on 11 Jan 2022 in stable condition. The patient was readmitted to the hospital on 23 Feb 2022 with chest pain and shortness of breath. The patient is diagnosed with ischemic cardiomyopathy. Reported per EUA.