chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received injection of Shingrix and Pneumovax 23 on 10/7/19.  Stated she woke up with Right Arm Swelling  which was where the Shingrix was administered.  The injection site was not swollen but her elbow area and around her armpit area were swollen.  She stated she felt achy in that area.
Mom states that pt broke out in "whelps" night of immun; no fever; mom used some cream from MD for rashes; Pt c/o itching for 3 days; "whelps" continued intermittently for 3 days; No further rash or problem noted;
Patient awakened after midnight on 9/10/19 with a swollen tongue.  She reported her heart was "beating out of her chest".  Patient had experienced nightmares leading up to the awakening.  She also reported having had nightmares during at least 1 night since the vaccination, but had not had any other symptoms until the 9/10/19 effects.  Patient reported skin blotches, primarily on her front & back.  She went to the ER after awakening with a swollen tongue.  The ER physician did not administer any treatments, although the nurse told the patient that "she has seen a lot of patients with reactions to the pneumo-23 vaccine".  Patient was not prescribed any medication to treat her reported symptoms.  As of 9/24/19, she does not report any lingering symptoms.
I had chills for about 20 minutes.; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (I had chills for about 20 minutes.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (I had chills for about 20 minutes.). At the time of the report, CHILLS (I had chills for about 20 minutes.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97 (Low) 97'F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.  No treatment medication reported.  The patient received the 1st dose of the Moderna Covid-19 vaccine. Reported having chills for about 20 minutes.  She didn't take her temperature. Her normal temperature was 97degree F. She was always low.  03Feb2021: Received the 2nd dose of the Moderna Covid-19 vaccine. No side effects to report.
Vaccine given in left arm. Patient came in with (L) arm swollen, red, and warm to touch. Arm was sore and difficult to raise or touch. Redness radiated to chest some. Had some trouble breathing. Did an updraft treatment at home and given diphenhydramine 50 mg.
I had a flare up of symptoms that have previously been diagnosed as psoriasis or maybe an allergic reaction; eyes swelled up and the skin around them became red, scaly and painful; eyes swelled up and the skin around them became red, scaly and painful; eyes swelled up and the skin around them became red, scaly and painful; This is a spontaneous report received from a contactable consumer or other non hcp. A 46-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: En6205) via an unspecified route of administration in Arm Left on 07Mar2021 16:00 (age at vaccination 46years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not have Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Mar2021 at 04:00 the patient experienced i had a flare up of symptoms that have previously been diagnosed as psoriasis or maybe an allergic reaction, eyes swelled up and the skin around them became red, scaly and painful. Clinical course was reported as she had a flare up of symptoms that has previously been diagnosed as psoriasis or maybe an allergic reaction. she has never known for sure what it is. But 4 days after her first dose, her eyes swelled up and the skin around them became red, scaly, and painful. This has happened in the past and has never been definitively diagnosed. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Two days after tetanus vaccine, pt developed polyarthritis, jaw stiffness, with redness and warmth at the injection site. Polyarthritis has persisted until now and pt is currently on methotrexate.
Pulse was elevated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Pulse was elevated) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEART RATE INCREASED (Pulse was elevated). At the time of the report, HEART RATE INCREASED (Pulse was elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; Two weeks after my initial Covid Vaccine I had a heart attack that put me in a coma for 9 days; This is a spontaneous report from a contactable consumer (patient).    This 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (Batch/Lot Number: ER8733) as single dose (at 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No family history of heart disease or comorbities.  The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergy. The patient  stated that: on 15Apr2021, two weeks after my initial Covid vaccine I had a heart attack that put me in a coma for 9 days. The events required a visit to the emergency room.  Therapeutic measures were taken as a result of the events included Stent in LAD. The outcome of  the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Seriousness criteria of the events was reported as serious (hospitalization, medically significant, life threatening).
burning sensation in throat; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in throat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 BURNING SENSATION (burning sensation in throat). At the time of the report, BURNING SENSATION (burning sensation in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient had 11cm x 7 cm red, itchy, indurated area surrounding injection site on left arm.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 25-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Eight days after the first vaccine, on March 31st, 2021, approximately 2:15pm at the area where the vaccine was given to me was itchy and felt hot and hard.  I looked at it and it was red and hard pimple like texture to it.   Today is April 1, 2021 and has not grown in diameter but is still very itchy, red, hot, hard, and pimple like.
Diagnostic lab send out04/03/2021 - Pt experienced began experiencing COVID like symptoms after traveling at the end of March (unsure of exact dates). Pt reports he husband tested positive for COVID on 4/3/2021. Pt had 1st dose of Moderna on 02/10/2021. Pt had 2nd dose of Moderna on 03/10/2021.  4/5/2021 -Pt presented to clinic for 1st COVID-19 test. Same day test resulted negative.  4/8/2021- Pt presented to clinic for 2nd COVID-19 test. Same day test resulted negative 4/15/2021- Patient presented to clinic for 3rd COVID-19 test. Test sent out to diagnostic.  4/19/2021 - Pt COVID test resulted positive. Pt continues to have cold like symptoms but has not required hosptialization.
Anaphylaxis (itchy mouth, signs of low blood pressure including visual disturbance, sudden severe fatigue, pale and blue tinged skin, swaying on feet, started to lose consciousness) treated with 0.15 mg intramuscular injection of epinephrine
Subsequent to receiving varicella vaccine, the pt developed chickenpox. Pt was diagnosed with resolving varicella. Pt had up to 50 spots.
pt recv vax 25APR97 & 5MAY97 pt devel a morbilliform rash on trunk & face;presented to MD pt also dx w/OM;
Developed Gout Swelling of the left toe on each foot, swelling of ball of foot as well Dr. prescribed Naproxen                                  Prednisone                                   Sulpha -antibiotic
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine.   About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36  hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
missed the 3rd dose; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On an unknown date, the patient received the 3rd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received 1st RabAvert on 28th July 2020 and 2nd RabAvert on 31st July 2020. The patient missed 3rd dose of RabAvert which supposed to receive on 4th August 2020. which led to incomplete course of vaccination. The reporter declined consent for follow up.   Following internal review it was determined that initial reciept date was 6th August 2020, which is earlier than initially reported.
1 of 3 pts who exp inj site rxn;pt devel swelling, erythema & pain from elbow to shoulder following vax;this is pt's 1st pneumococcal vax;no hx of pneumococcal infect
Tinnitus in left ear for two days, followed by severe Vertigo and headache after over-exercise. Steadily waning over following three days.
Pt 64 y/o female found ambulatory at vaccination site. c/c Allergic reaction post COVID-19 vaccination. Pt received her first dose of Moderna vaccine at approximately 0900. Pt moved to the monitoring area where she was instructed to wait for 30 minutes due to her medical Hx and previous allergic reactions, Pt alerted a clinician stating she felt a tingling sensation around her mouth and minor swelling of her lips. Responded as well as fire department. Pt was given at 2 doses of EPI 1:1000 for a total of 1.0mg (0.5mg/dose) and 50mg of Benadryl. All medicine administered IM. Pt experienced relief post med administration. Pt denied any shortness of breath or chest pain. No headache/blurred vision or tinnitus. Pt denied any nausea or vomiting. Pt had equal grips and pushes. Skinsigns were warm and dry. No hives, redness or itching.  Pt was transported to Hospital by fire department. Vital signs: BP 142/82, HR 78, RR 18 Hx: HTN, Thyroid issues, CA, Allergic reactions ALLERGIES: Sulfa, Seafood MEDS: UKN  Conclusion Pt was identified as a "30 min monitoring" upon check-in. Pt was instructed to wait in the designated area. Upon feeling a reaction to the vaccine, pt promptly notified staff. Immediate response to the incident resulted in a successful pt outcome. System put in place worked as intended. Identified a pt with potential vaccine reaction prior to the administration of medicine. Staff instructed pt to wait in the appropriate area. A timely response, including rapid administration of appropriate medication prevented further swelling and potential airway involvement.
Large hive, greater than the size of a half dollar, jusy below injection site with two smaller hives near it. Treated with a dose of Benadryl and the swelling went down but not completely away.
Later that night after the vaccine I developed a headache, fever, body aches which all lasted about 48 hrs.  On 1/1  my head got really stuffy and started to hurt and my nose got real runny.  I got extremely tired so I took a COVID test and on 1/3 I tested positive to COVID-19.  Im still pretty tired to date but most all symptoms have subsided
Within 48-72 hours after Moderna booster vaccine, patient developed an occipital stroke, confirmed with CT imagining in the ED.  MRI pending during hospital admission.
patient complianing about sour arm and swelling, painful to touch and site a little warm.  Advise patient to take tylenol and see her PCP
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA040917, 2019SA040918 and 2019SA040916 same reporter. This case involves a 13 years old female patient who received first dose 0.5 mL vaccine IPV (VERO) [IPOL] lot P1A242M, expiry date- 26-Apr-2020 via intramuscular route in the left deltoid on 05-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ADACEL for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that after the vaccine had a temp excursion on 04 Feb 2019 and 4 children got the IPOL on 5th Feb 2019. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient had a fever of 101.7 on 11/13.  Her arm also swelled at injection site with redness and discomfort.  She has taken acetaminophen and I encouraged her to try ibuprofen to help with the swelling.
Patient passed out while opening a high cupboard the morning after her vaccinations.  She felt warm and her husband found her cold/clammy.   Pt recovered and was seen by her prescriber the next day who recommended  reporting.
chest pressure; shingles/rash; itch and rash and tenderness on his rib cage; itch and rash and tenderness on his rib cage; chest pain; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 10Apr2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing Cholesterol. Concomitant medication included ongoing atorvastatin taken for blood cholesterol. Patient investigation assessment was No. The patient developed a rash from 16Apr2021. They figured out in the hospital that it was probably shingles. It had developed even more. They want to give him Valacyclovir. He came down with an itch and rash and tenderness on his rib cage from 16Apr2021. He slept on his chest and had pressure on his chest from 18Apr2021 to 19Apr2021. He went to the hospital to rule out a heart attack. The patients father passed away a long time ago of the heart attack and thought it was that as well.  He went to the emergency room and was brought in the hospital under observation status. He was diagnosed with shingles at the hospital from 19Apr2021. They were on the right side. The itching, tenderness and pain got worse on Sunday with chest pain from Apr2021. Patient has not received Valacyclovir yet. The hospital was waiting to give it until after caller speaks with Pfizer. The patient was currently waiting to get the antiviral medication for shingles. The outcome of the event chest pressure was recovered on 19Apr2021, of shingles/rash was not recovered, of other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Person completed vaccine series by getting the Janssen vaccine in March.  Came back to get the Moderna vaccine.
Achy all over, like I have the flu; Felt kind of lousy; About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.; Chills; sore on Especially the lymph nodes on the left side; Lymph nodes were tender; The patient received her second dose on 02Mar2021 and third dose on 01Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills) and LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7 (High) Temperature was 99.7. Then it went away, and the patient felt kind of lousy..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-306517 (Patient Link).
First dose / in July 2018 / unaware until now that there is a second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in July 2018 in left deltoid) and Zostavax (received Zostavax in 2014).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The reporter was the patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired about second dose of Shingrix vaccine.  The patient received her first dose of Shingrix in July 2018 at the pharmacy and was unaware until now that there is a second dose of Shingrix that needs to be administered to complete the series.  The patient stated that, she was neither informed by doctor nor the pharmacist about the second dose of the vaccine to complete the series.  The patient really would not like to get shingles, it was terrible. The patient inquired whether she should restart the series, because it has been almost 3 years since the first dose.  The patient did not know the dose or an exact date of administration, she only remembers that it was given in July 2018 and mentioned that, it might have been given in left arm in the upper region (deltoid), she always get vaccine in her non-dominant arm so it would have been left arm." The patient did not have a doctor's fax number.  The patient stated that she received Zostavax in 2014 and then couple years later she read about Shingrix at the pharmacy and they said it was recommended to get Shingrix even if you had Zostavax before, so patient  said why not, the patient did not want to want to get shingles.  The patient also mentioned that she received a complete series of COVID vaccine (Moderna) in February 2021 (first dose in January 2021 and second dose in February 2021).  The reporter provided a consent to follow up with HCP.