chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was exposed to COVID after getting the first dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient was exposed to COVID after getting the first dose) in a female patient of an unknown age 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, the patient experienced EXPOSURE TO SARS-COV-2 (Patient was exposed to COVID after getting the first dose). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient was exposed to COVID after getting the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment  information were provided no concomitant medications were provided
She states she has had worse than chills; very tired; has thrown up twice and now has a headache; has thrown up twice and now has a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She states she has had worse than chills"; FATIGUE (non-serious), outcome "unknown", described as "very tired"; HEADACHE (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "has thrown up twice and now has a headache".  Additional Information: Patient would like to know how long her symptoms could last. RA: E-transmitting AE due to long hold times, patient does not wish to stay on hold. Patient received the 1st dose of the Pfizer covid vaccine yesterday at 17:00 pm. She states she has had worse than chills, very tired, has thrown up twice and now has a headache. (2nd AE logged on different interaction: 00143571).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Couldn't get comfortable; Fatigued; Chills; Didn't think he was being a good driver; He was feeling irritated; Sensing anger and aggression in himself; Skin was very, very irritated; This is a spontaneous report received from a contactable consumer (reporting on himself). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263 and Expiration Date was not reported) via an unspecified route of administration on 17Feb2021 (at the age of 74-year-old) as single dose for COVID-19 immunization. Medical history included Lyme disease in the past that was treated. He take no day to day medications. The patient's concomitant medications were not reported. It was reported that patient wanted to report experience with BNT162B2. On 17Feb2021 patient received BNT162B2 around mid-day. First day he got the COVID-19 vaccine, by late afternoon his skin was feeling very, very irritated. He was feeling irritated. Started sensing aggression and anger in himself. Couldn't get comfortable. Doesn't know if this is an expected result because he hasn't seen this. Started to get extremely tired. Did have to lay down a couple times later that afternoon to early evening. Worse thing was his whole body felt irritated. 18Feb2021 (Yesterday), he didn't have the same feeling. He had a very good morning. Early afternoon started feeling chills and couldn't get warm. Got into bed with big quilts. Chill sensation lasted two to three hours. Sees that chills are an expected result. 19Feb2021 (Today), so far he has had a good day. He is fatigued now this afternoon. That would be the extent of anything unusual for him. Most concerning was how he was feeling the first day. He doesn't think he was being a good driver at the time. Probably thinks there should be a recommendation to try and not drive or have a designated driver. Patient would like to know if the anger and aggression was within the range of expected results. Stated he doesn't know if there was real value in knowing it at this time unless there are booster shots that come out in the next year or so. Stated he wanted to report to Pfizer so it was known there are other things than what was being seen. The outcome of the events was unknown.
Vasovagal response, patient assisted to floor by significant other. Patient diaphoretic and loss consciousness briefly but quickly regained consciousness. Patients vital signs BP 124/74, HR 67, O2 97%. Patient given orange juice and water. Patient kept for observation for 35 minutes and patient verbalized that she was feeling better. Patient left site via private car driven by her significant other.
when I lay on my right side my left arm hurt really bad( where they gave me my shot at) so I have to lay on my left side and it still hurt but not as bad, I have tried tylenol, aleve and nothing stops it from hurting.  When I am standing up I can barely feel it.  I tried heating pads also. I waited a couple of months to see will it go away and it did not. So I went to see my doctor they gave me 5mg of flexeril and it still hurt. The lady I saw at my doctor office was Dr. and she also said to make sure I report it.
Filing this report due to an administration error not associated with an adverse event.  Employee received second dose earlier than the recommended 28 day timeframe.  First dose administered 2/19/21, second dose administered 3/18/21.  Employee has not had an adverse reaction and no medical treatment has been sought to date.
pt states shortly after receiving the covid vax he got lighted headed and disoriented while trying to walk and cannot drive at this time.  Pt stated she woke up feeling the same way today.  Pt also has pain and burning sensation in left arm from fingertips to neck.  Pt called workplace clinic and they told her to FU in 2 days if symptoms to not subside. Pt will contact allergy specialist Doctor to let him know what is going on.
This spontaneous case, initially received on 05-Oct-2016, was reported by a health professional and concerns a 64-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received ALFURIA from 26-SEP-2016 to 26-SEP-2016. Dose: 0.5ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2016, the patient experienced a local red raise warm reaction size of half dollar and rash from injection area down to elbow from deltoid (outcome: recovered / resolved). Lasted a week, reaction did subside. The healthcare professional considered all events non-serious.
pt recvd 2 vaccines on 13OCT95;15 to 20mins later mom returned w/pt stating pt appeared limp, pale, (pt was well when left MD's office); t102 all labs were WNL;MD thinks pt may have had a sz;
Rash about the size of two human hands. Swelling. Heat. Very painful. Patient reported on 8/25/18.
injection site pain; Swollen lymph node in arm pit/swollen lymph node (left arm pit); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 17:00 (Lot number: F63527) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: PAROXETINE taken for anxiety, start date: 2003 (ongoing); BUPROPION taken for anxiety, start date: 2005 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 10 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot number: ER8734), administration date: 29Mar2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Time: 10 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot number: ER8731), administration date: 26Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Flu (Dose 1 on left arm.), administration date: 30Sep2021. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Oct2021, outcome "recovered", described as "injection site pain"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "recovered" (31Oct2021), described as "Swollen lymph node in arm pit/swollen lymph node (left arm pit)". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy.  Additional information: Booster dose due to high risk of frequent institutional or occupation exposure to coronavirus (and at risk for serious COVID-19 complications). Event took place after use of product. Injection site pain and swollen lymph nodes (left arm pit) manifested (approximately equal) 36 hours after injection. Injection site pain resolved after 24 hours and swollen lymph nodes resolved after (approximately equal) 3 days. Vaccination facility type was pharmacy or drug store. The patient had Flu shot Prior Covid-19 vaccinations within 4 weeks. Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts are possible. No further information is expected.  Follow-up (15Nov2021): New information received from a contactable consumer. This consumer (patient) reported in response to non-hcp letter sent which included that: Patient initials, Patient age at time of vaccination: 41 Years, Vaccination details, RMH, event details.  No follow-up attempts are possible. No further information is expected.
ear ache; swollen glands; uncontrollable vomiting; fatigue; sore arm; 103 fever; a little nausea; not feeling well; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), HEADACHE (really bad headache) and LYMPHADENOPATHY (swollen glands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not feeling well), HEADACHE (really bad headache), PYREXIA (103 fever), NAUSEA (a little nausea) and FATIGUE (fatigue). On 22-Mar-2021, the patient experienced VOMITING (uncontrollable vomiting). On 23-Mar-2021, the patient experienced EAR PAIN (ear ache) and LYMPHADENOPATHY (swollen glands). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Mar-2021, VOMITING (uncontrollable vomiting) had resolved. On 23-Mar-2021, HEADACHE (really bad headache) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), EAR PAIN (ear ache), MALAISE (not feeling well), LYMPHADENOPATHY (swollen glands), PYREXIA (103 fever) and FATIGUE (fatigue) had resolved and NAUSEA (a little nausea) outcome was unknown.            This case was linked to -MODERNATX, INC.-MOD-2021-026134 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-026134:CROSS LINKED TO DOSE 1
Information has been received from a lawyer and a consumer, regarding a case in litigation concerning an 75-year-old female patient. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On 07-JUL-2009 (at 73 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic, as prophylaxis (strength, dose, route of administration, lot number, and expiry date were not provided). On an unspecified date in June 2011, as a result of her receipt of zoster vaccine live (ZOSTAVAX), she was caused to suffer shingles (herpes zoster), including any and all of its sequelae (ill-defined disorder). As a result of her receipt of zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. On 30-MAR-2017 (at 81 years old), the pt passed away (no cause of death was reported) and it was unknown whether an autopsy was performed. At the time of reporting, the outcome of the herpes zoster and ill-defined disorder was not known. The reporter considered herpes zoster and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between the pt's death and zoster vaccine live (ZOSTAVAX) was unknown.
Adverse events: Sore arm, fever around 101.5 for 13 hours, vomiting, nausea, headache, sore muscles and joints Treatment: after hour 12 of fever 2 500mg pills of Tylenol were taken. This broke the fever. 6 hours later this was followed by 200mg of ibuprofen. The fever has not returned.
Patient presents to clinic 04/03/2006 with low grade fever and rash.  Upon assessment by doctor, rash is varicella.  Patient had vaccine 03/22/2006.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter as it was unclear whether the patient experienced any events.
Hives on upper arm near injection site. Two doses of hydroxyzine HCL 25mg at bedtime 10/22 and 10/23/04. By AM 10/25 hives had faded and swelling was gone.
Warm to touch, swelling, area of redness that extends around shoulder to armpit and 3/4 of the way down posterior upper left arm.
This is a spontaneous report from a contactable physician (Internal medicine/pediatrician) via a Pfizer sales representative. A 19-year-old male patient of an unspecified ethnicity received the 2nd dose of TRUMENBA via an unspecified route of administration on 21Jun2017 at single dose for immunisation. Medical history included ongoing allergy to oak, grasses and pollen. The patient's concomitant medications were not reported. The patient previously took TRUMENBA. The patient experienced hives all over upper body on 21Jun2017 Course of events: Patient came in for annual checkup on 21Jun2017.  During his checkup he received his second TRUMENBA vaccine. Patient or his mother called the MD office to report patient had hives all over his upper body on 21Jun2017.  Patient came back into the office the next day, 22Jun2017, to see the MD.  MD prescribed him BENADRYL 50mg twice daily for 3 days.  Patient told to use topical hydrocortisone cream 1-2 times daily for 3 to 5 days.  Patient also told to use special soap, LEVER 2000 with no fragrance.  The MD's nurse called patient back on 28Jun2017 and the rash had cleared up.  Patient has recovered completely on 28Jun2017. No other vaccines given at 21Jun2017 checkup.  No concomitant medications or investigations provided.
Redness, itching, swelling at site (left deltoid). Redness spread across chest, back, right arm. Blood pressure increased, nauseated. (Blood pressure measurement). Benadryl/pain medication at hospital. Medical records add pain, vasodialation. msv
None- vaccine given17 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given17 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given17 days post expiry). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given17 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received vaccine 17 days post expiry dose of the Moderna.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-395985 (Patient Link).
headache; Neck tension; Body aches; Back Pain; This is a spontaneous report from a contactable other healthcare professional. A 41-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administered in Arm Left on 11Jan2021 12:00  (at the age of 41-year-old) at a single dose for COVID-19 immunization. Historical vaccine the patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administered in Arm Left on 22Dec2020 12:00 (at the age of 41-year-old) at a single dose for COVID-19 immunization. Rested, Tylenol was last action taken in response to adverse event. The patient medical history and concomitant medications were not reported. The patient experienced headache, neck tension (musculoskeletal stiffness), body aches (pain), back pain on an unspecified date. The patient was not admitted to hospital. The outcome of event were unknown. The reporter classified the seriousness of the event Non-serious (Medically significant) and assessed the causality of the event as related to bnt162b2.  Information on the lot/batch number has been requested.
Patient received first dose at the Vaccine Drive-Through. Patient appeared curious and asked multiple questions regarding the vaccine. However, the decision was made by the patient to proceed to receive the first dose of Pfizer vaccine. Patient received vaccine at approximately 02:00 pm. Shortly after administration of the vaccine and while in the reaction waiting area, he experienced ?dizziness and difficulty breathing? and requested assistance. Onsite medics state patient leaned his head back and his eyes rolled back in his head. No sign of swelling, itchy, or rash. Vital signs were within normal limit. Paramedic was immediately called at 02:08 pm. EMS arrived at 02:15 pm and departed at 02:20 pm. Paramedics transported non-emergent patient to ED.  ED DX: vasovagal syncope; no signs of anaphylaxis or severe vaccine reaction.  Patient released from emergency department at 03:15 pm with without activity restrictions.
Pt was sitting in a chair & then fell off p/fainting immediately started crying p/hitting the floor;
generalized itching all over, provided diphenhydramine 25mg two times about 5 minutes apart.
Hep A was given mistakenly to 2 month old instead of Hep B. Patients parents were notified and as of 1/11/2023 baby is doing great with now adverse effects.
2 doses of the Dtap and IPV. 1st dose was Pentacel on 6/20/17 and 2nd dose Kinrix on 12/7/2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (1st dose received on 20th June 2017).   On 7th December 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 7th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The reporter reported that 5-year-old patient received only 2 doses of the Dtap and IPV. 1st dose was Pentacel on 20th June 17 and 2nd dose Kinrix on 7th Dec 2021. Patient was 4 years old. Patient was late in the Dtap/IPV series. No side effects reported. According to the CDC catchup schedule the patient would complete the Dtap series by administering Dtap dose 3-now, 6 months in between dose 3 and 4 and 6 months in between dose 4 and 5. The reporter consented to follow up.  Additional supportive information: 4-year-old patient received Kinrix as 2nd dose of Kinrix which led to inappropriate schedule of vaccine administered.
Pt recvd vax & became lethargic, very unhappy & did not feel well in the evening; had no emesis or fever;