chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented with history of cough, which she says has been ongoing since April.  She says it started after she received her second Pfizer COVID injection on 4/22/2021.  She says cough has been mild up until the last several days where it has become much more productive with mucus as well as having some mild dime sized hemoptysis.  She denies any clots.  She has had some associated shortness of breath especially with ambulation.  She does note that she had her Pfizer booster on 12/10/2021, which she thinks is when her symptoms worsened.  S She has some associated right-sided chest pain which is pleuritic in nature, moderate in severity.  She says that her pain is worsened when she lays flat and she does have some mild shortness of breath when she does this.  She says that her family has extensive clotting history including on mother and father side.   She was noted to be 83% on room air upon arrival, but recovered with rest and has since been on room air.  Diagnosised with bilateral saddle pulmonary embolism
arm started to swell up; red circle below injection site; itchy below injection site; the are is warm to touch; fatigue; arm was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was tender and sore), PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site) and INJECTION SITE WARMTH (the are is warm to touch) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2DA) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the adult was diagnosed with PAIN IN EXTREMITY (arm was tender and sore). On 26-Jan-2021, the adult was diagnosed with PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 20-Jan-2021, PAIN IN EXTREMITY (arm was tender and sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant conmeds reported.  Treatment provided: Benadryl (diphenhydramine) and Tylenol (paracetamol).
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-OCT-2015, the patient was treated at a hospital emergency room for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Approx 1 hour after injection, had onset of diarrhea. On 3/8/16 developed itching. On 3/9/16 had diffuse hives. 3/10/16 continued to have hives, chills, and slight tachycardia. Had some treatment per family MD on 3/9/16, but on 3/10/16 went to ER. Was treated with Benadryl, Decadron, Zantac. Sent home with medications as well.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: Patient reported lightheadedness and dizziness, BP was 110/60 and Pulse was 61. Performed basic blood pressure management activity alongside potential hypoglycemic episode provisions.
6 days later, I've had a headache that feels like pressure all over my head, jaw, and ears.  Also, I have 1 step from my back room to my kitchen that is usually easily maneuvered but my thighs hurt.  My buttocks hurt.  I feel achy and slept 11 hours 4 nights after my vaccine.  I usually sleep 7.
Dizziness, sweating, fatigue 6 hrs later Narrative: Called off work.
13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-364572, MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received  contains no new information.
Tested positive for Covid and he had the Pfizer vaccine; Tested positive for Covid and he had the Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown; expiration date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history was not provided. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA). On an unspecified date patient tested positive for covid and patient has not had any issues other than loss of smell. Patient had the Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives and itching up and down both forearms, then pressure in left side of face along with pain in jaw, then left side of face went numb, then left side of tongue and and cheek went numb, eventually left arm went numb as well as upper lip, couldn't swallow at one point. 50mg Benadryl, Epipen, Pepcid, steroids. Sent home with medication and told to rest.
Patient reports moderate pain in the upper muscle since the time of the injection (51 days). Pain worsens with movement and is only relieved with rest and heat.
Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2008USA003287), concerning to a 67-year-old female patient.  In October 2016, October 2017, October 2018, October 2019, and October 2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered).; Sender's Comments:  US-009507513-2008USA003287:
2 weeks post-vaccination, pt developed flu-like symptoms. In addition on left thigh he developed multiple papules, some similar lesions on the back and chest.
Left upper arm - tenderness/pain at injection site. Area of induration - 9 cm width/6 cm length. Slightly erythematous. Pt c/o itching/burning pain. Tx warm compresses observation .
Rec'd 4 yo immunization on 11/13/06 developed fever 11/14/06 and red arm seen in office diagnosed with cellulitis treated with Keflex.
No additional AE.; Caller stated the vaccine was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications.  On 21-JAN-2022, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot # U020239, expiration date 28-JUN-2023, (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse events were reported (no adverse event). There was no product quality complaint involved.  For varicella virus vaccine live (oka/merck) (VARIVAX), temperature excursion was reported as -14.1 Celsius (C) degree for 12 minutes. There was no previous temperature excursion reported.
VAGINAL BLEEDING (PATIENT JUST FINISHED PERIOD 12 DAYS AGO); PAIN IN THE SKULL SINCE LAST NIGHT; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, non-smoker, and non-alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 30-AUG-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced pain in the skull since last night. On 31-AUG-2021, the patient experienced vaginal bleeding (patient just finished period 12 days ago). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaginal bleeding (patient just finished period 12 days ago), and the outcome of pain in the skull since last night was not reported. This report was non-serious.
My nose would not stop running, I just felt absolutely exhausted and tired. I tested positive on 03/17/2022. I was prescribed Paxlovid 03/20/2023 and I felt a little better afterwards but not hundred percent better. Shortly after finishing my prescriptions the symptoms did not get better and did not get worse for about 20 days.
Administered incorrectly the vaccine: COVID 19 Pfizer for primary series instead of COVID 19 Pfizer Updated Booster Dose
After the second injection I experienced sharp pain shooting through my left arm which felt like electric shocks sporadically shooting down my arm the day following the injection. Then in June I began to have discomfort around my heart. feeling of gas like pressure around the heart, occasional pinching feeling and irregular palpitations and a feeling of exaggerated heart beat, mostly while resting. I also had some dizziness.. Due to these unusual and new symptoms, I have had an ECG, Blood draw to check my thyroid levels and I am currently seeing a Cardiologist for a heart scan and having a Holter heart monitor for 48 hour monitoring. I go back to the Cardiologist next week to see what has been detected by the tests. I don't know if these issues have any tie to the Covid shot but I do feel it is possible and want to be sure it is reported.
Patient reportds severe brusing at/near the site of injection. Patient reports arm pain, tenderness and swelling, persisting to present day. Patient says she feels there is a "mass" in the arm.
Information has been received from a office assistant concerning a 14 year old female with unspecified drug reactions/allergies and medical history, who on unspecified date in August 2008 and on 21-Oct-2008 received first and second doses respectively of GARDASIL (lot number for the second dose: 661044/0548X, route not reported). There was unspecified concomitant medication. The office assistant reported the patient was given the first dose of the vaccine and 5 minutes later the patient "passed out" on an unspecified date in August 2008. Also the office assistant stated the second time, the patient was given the vaccine, syncopal episode was more severe and more "seizure like" and the "patient's eyes rolled back" (approximately 21-Oct-2008). On an unspecified date the patient was recovered from this, but was not given the third dose. The patient sought medical attention by consulted physician. Follow up information has been received from the office assistant who reported the patient with no known allergies with attention deficit / hyperactivity disorder and she took STRATTERA 26mg each morning. On 01-Aug-2008, the only vaccine was the first dose of GARDASIL and that was the only vaccine received that day. Five minutes after injection, the patient passed out at the reception desk and she did not need treatment and recovered quickly. On 21-Oct-2008, the only vaccine administered was the second dose of the GARDASIL vaccine and  on that date the reaction was worse, with "eyes rolling back". The patient did not lose consciousness and the physician was able to speak with her during the event. The office assistant said the physician was able to speak with her during the event. The office assistant said the physician used the term "seizure like", but in fact the patient did not have a seizure. Again no treatment was necessary. No labs / diagnostic were performed. The patient did not need to go to the ER. And the patient will be not receiving the third dose.  No further information is available.
She is experiencing chills; The site again is hard and hot; The site again is hard and hot; She is experiencing chills and overall fatigue; feeling terrible; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site induration, shingrix with an associated reaction of injection site warmth and shingrix with an associated reaction of injection site pain (For the tolerability of 1st dose, refer case US2020AMR063768 reported for same patient).   On 10th April 2020, the patient received the 2nd dose of Shingrix. On 11th April 2020, 1 days after receiving Shingrix, the patient experienced chills, injection site warmth, injection site induration, fatigue and feels awful. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, injection site warmth, injection site induration, fatigue and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the chills, injection site warmth, injection site induration, fatigue and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was feeling terrible. The site again was hard and hot. The patient was experiencing chills and overall fatigue.
Patient received Moderna vaccine 1st dose on 9/13/21 at pharmacy, then came to our facility on 10/13/21 and received his 2nd dose as Pfizer
Widespread skin pain (tactile allodynia) from scalp to soles of feet; muscle pain.
Right medial knee pain Dull ache  Effects gait  No swelling no redness  My brother in Arizona has the same exact pain w Moderna vaccine shot as well. Same right knee & symptoms.
I was already dealing with C Diff and still am, but it caused me to become extremely motion sick in the car ride home and I had to keep pulling over to vomit. As soon as I got home my injection arm started to hurt really bad and now the morning after I can't move my arm due to the pain.
A day following the injection the patient experienced a twinging pain in the shoulder that then started to spread from her rt shoulder to her left shoulder. It continued to spread to her hip and tailbone and started to itch and scratch excessively. The patient saw her MD and he surmised that she is having an autoimmune response to the vaccine. Her started her prednisone.
Bad stomach cramps; Sweating; Feels over heated, then gets cold; Worsening of knee and shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included open heart surgery, colon cancer, shoulder pain and knee pain.   On 19th December 2022, the patient received the 2nd dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced stomach cramps, sweating, feeling hot and cold and arthralgia. On an unknown date, the outcome of the stomach cramps, sweating, feeling hot and cold and arthralgia were unknown.   It was unknown if the reporter considered the stomach cramps, sweating, feeling hot and cold and arthralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comment: The reporter was the patient. The patient received Shingrix on right arm. The patient reported that he was experiencing bad stomach cramps and sweating. He felt over heated, and then he got cold. The patient also experienced worsening of knee and shoulder pain.  The reporter consented to follow up with healthcare professional.
received Moderna Covid-19 vaccine that was past the 30 day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received Moderna Covid-19 vaccine that was past the 30 day use by date).    No concomitant medications was reported. No additional information was provided by the Pharmacist. No treatment drug details was reported.   Reporter did not allow further contact
First two does are fine. I did not get any side effect other than minor fatigue. However, when i receive my booster (lot# FG3527) , my period cycle is delayed. My period cycle was accurate. It is usually 29-30 days and stays the same over 2-3 years. I got my booster shot one week before my period and my period is delayed for 6 days.  There is no potential for me to get pregnant or anything. I will keep tracking my period cycle for the future but it is very strange that my period cycle is delayed
5/1/12 Pt states she started to have pain (Lt) axilla & (Lt) arm in 4 days swelling/lump on deltoid. Redness on whole (Lt) arm up to elbow 4/28/12, 4/29/12. Started getting better 4/30/12. On 4/20/12 pt was sent from our office with a hgb of 83 for blood transfusion at medical center 2 units packed cells on 4-26-12.
Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication not reported.  Treatment medication not reported.  Patient received the 1st dose of Moderna COVID-19 vaccine on 22 Jan 2021. A week later was diagnosed positive of COVID-19.   This case was linked to MOD-2021-264483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received contains updated information on action taken from Unknown to No change and the event coding updated from COVID-19 virus test positive to COVID-19. The event start date and  dose 2 information added in the case.
After the HPV shot, she got an intense headache, we sat her down, she said her arm hurt. Them her head slumped, she kicked and flapped her arms a couple times. Her body got stuff and she wasn't conscious. We called 911. She regained consciousness, she complained of her throat hurting. She was very pale, clammy, and said her heart was racing. The paramedics came took all her vital signs and suggested we take her to her doctor, which we did immediately. They said fainting is a adverse reaction.
Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.
PATIENT HAS VASCULITIS UP AND DOWN RIGHT AND LEFT LEG. WHEN OBSERVED THE PATIENT WAS SENT TO THE EMERGENCY ROOM TO BE EVALUATED ON 11/03/21
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine