chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dianosis: Left brachial neuritis after HPV/Gardasil vaccinations..History of Illness: 1/20/2009 - Presented for initial evaluation by hand surgeon. By history, patient noticed that her entire left arm was painful 3-4 days after vaccination (Gardasil vac. #2.) Arm pain lasted 24 - 48 hours, then the patient noticed inability to flex the tip of her left thumb. 2/06/2009 - EMG remarkable for left anterior interosseous nerve syndrome. 2/10/2009 -  Patient has no active FPL function and complains of loss of dexterity on the left. 3/10/2009 - No active flexion of her left thumb IP joint. 5/19/2009 - Plan to continue observing her symptoms.  7/27/09 Consultant medical records received DOS 1/20/09 to 5/19/09. Includes neurodiagnostic reports from 12/8/08 and clinical labs from 12/6/08 to 12/26/08. Assessment: Anterior interosseous palsy due to Parsonage Turner syndrome /brachial neuritis.  Patient presented with inability to flex left thumb. Tightness in cubital fossa. Weakness in the hand. Slight weakness in her EDP in her index. Strength is returning.
soreness, tenderness, fever, muscle pain ...no joint pian outerside of atm swollen
Arthralgia, UrticariaPruritus, NauseaVomiting, stomach cramps Narrative: 12/29 approximately 15 min after vaccination, employee reports onset of "foggy brain", stomach cramps, and widespread itching. He was transferred to the ED. Evaluation revealed no rash and the physical exam was normal. He was treated with 50 mg of benadryl PO and observed in the ED for about 90 minutes and discharged back to work. He was given a prescription for hydroxyzine 25 mg po q 6 hours x 5 days. On 12/30 - he reports his arm is sore and he still feels itchy. Now he has some nausea and his joints hurt. He plans to stay home from work to rest today. He had to leave work early yesterday (works night shift). 12/31 - reports he feels better but still has a headache and feels achy. He hasn't taken the hydroxyzine because his itching is not as intense. 1/4 employee reports his symptoms have improved and has mild achiness, fatigue, and itching which he describes as 1-2 on a scale of 1-10.
Swollen lymph nodes, extreme fatigue, rash that got worse over several days, hives. Rash & hives look and felt like dermatitis herpetiformis which I have had in the past with my Celiac disease. Took Tylenol, Benadryl, and occasionally Loratidine
Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.
expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 08-Feb-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was removed from the freezer and placed in the refrigerator and given the 30 day expiration date of 02-Feb-2022. It was kept at the designated temperature in the refrigerator until it was administered on 08-Feb-2022. The lot number was reported as 065F21A with expiration date of 04-Feb-2022. It was reported symptoms were unknown at the time of reporting.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up received. Added patient demographics(initials, date of birth, age and gender) and first dose details.
First noted slight soreness at 8 PM. Then, noted redness at 9 PM. Also, noted slight swelling beneath the area of redness.  Came back to office where vaccine was administered on 10/08/2010 and was examined.  Area of erythema/induration is 2.5 X 3.2 cm involving right deltoid.  No other abnormalities noted.  Patient reassured and will be rechecked on Tuesday.
Patient was admitted for AMS, possible UTI. Patient also tested positive for COVID-19 at this time. He stayed overnight, was felt to be stable and was discharged. He was readmitted 1 day later under observation for weakness, treated, and discharged to a nursing home
There was no reaction from shots but the 4th dose of DTaP, PCV and IPV and Rotavirus were administered @ 8 months 3rd dose of  Hib was given. She had Pentacel on 7/28/2020 and 10/2/2020. PCV - 7/28/2020, 10/2/2020, 12/18/2020 and 2/25/2021 Rotavirus - 7/28/2020. 10/2,2020, 12/18/2020. 2/25/2021 DTaP- Hep B- IPV- 12/18/2020, 2/25/2021 DTaP-Hib- IPV- 7/28/2020, 10/2/2020  Spoke with mom today and Patient is doing good. No symptoms
Couldn't move the arm; Realized that had a ball on the injection site; Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit; Head ache; Chills; Bone hurts/bone pain; Felt little stings on the knees; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site) and AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced BONE PAIN (Bone hurts/bone pain) and PAIN (Felt little stings on the knees). On 10-Oct-2021, the patient experienced MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone hurts/bone pain), PAIN (Felt little stings on the knees), MOBILITY DECREASED (Couldn't move the arm), VACCINATION SITE MASS (Realized that had a ball on the injection site), AXILLARY PAIN (Swollen under the arm pit / hard / little bit swollen / still swollen/mild pain still in the arm pit), HEADACHE (Head ache) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had bone pain on 10 Oct 2021.  Treatment medication was cold water cloths for some body temperature.
fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; some joint pain; increasing joint pain and muscle aches; headache; Did not sleep; excessive pain in all joints( pain on the bottom of my feet)/very sore arm; This is a spontaneous report from a contactable consumer. A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM 9809) via an unspecified route of administration on left arm on 02Feb2021 11:00 AM at single dose for covid-19 immunization. Medical history included Lyme disease (I had lyme disease within the last 3 years) and Allergy. Concomitant medications were not reported. The patient reported, on 09Feb2021 08:30 PM, day after injection she had very sore arm, Wednesday, begun to feel off with stomach and some joint pain. On Thursday, she had increasing joint pain and muscle aches and a base of the skull headache and did not sleep at night. On Friday, it was full blown excessive pain in all joints (pain on the bottom of my feet) and was unable to eat, tried to stay hydrated and slept for one hour at night. On Saturday, hypersensitivity to light, sound and smells, evening all symptoms started to go away and on Sunday, patient was recovering but still fatigued. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the event fatigue was recovering, and rest of the events was recovered.
Information has been received from a 26 year old female consumer with no pertinent medical history or drug reactions/allergies, who on 31-MAR-2010 was vaccinated with the second dose of GARDASIL and was pregnant (gestation= 5 weeks), method of confirmation: urine pregnancy test. There was no concomitant medication. At the time of the report, the patient's outcome was unknown. The patient sought medical attention (office visit). Follow up information was received via telephone call from a Registered Nurse, who indicated that the patient did not have any delivery or pregnancy information from December 2010, the last delivery date for this patient was 19-AUG-2009. The patient had been seen in the office on 18-JAN-2010 for an annual visit and at that time her baby was 5 months old. The nurse then found in the chart a note from 23-JUN-2010 that said the patient had been advised that GARDASIL was not a live virus vaccine and that the patient and her husband felt it would be better to terminate the pregnancy. As far as the Registered Nurse knew this pregnancy was terminated sometime after that but did not have any additional information to provide. There was not a LMP listed for this pregnancy. She did provide the dates of the patient's GARDASIL vaccinations: 1st dose in Feb 2010 (specific date not given), 2nd dose on 31-MAR-2010 and 3rd dose on 14-JUL-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available.
This spontaneous report as received from a consumer refers to a 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 29-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, one shot, route and site of administration were not reported). Concomitant therapies included levothyroxine sodium(manufacturer unknown). On 29-JUN-2013, on the evening, the patient developed an injection-site reaction to ZOSTAVAX. The injection site and the injection-site reaction were reported to be "in an unusual place" which was "on the back of" the patient's left arm. The reaction was reported to be "like a mosquito bite" and included lump, a little redness, and "mostly itching". On an unspecified date in 2013, the itching was bad enough to wake the patient from sleep. The patient was not yet fully recovered from the reaction, also reported the patient is recovering. No lab diagnostics were performed. The patient did not seek medical attention and no treatment was given for the adverse events. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information is not expected.
18JUN92 TC from mom c/o fever 102 highest last 3d w/rash; giving APAP; recommended cont APAP prn, tepid baths; 29JUN92 called mom states all s/s resolved by 21JUN;
Cramping in legs, arms and back; bump; injection site was hard; tender; Stomach sickness; Diarrhea; I had a headache; Was tired; Achy; Injection site was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach sickness), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (injection site was hard) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since an unknown date.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (I had a headache), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness) and DIARRHOEA (Diarrhea). On 13-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PAIN (tender). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 13-Jan-2021, ABDOMINAL DISCOMFORT (Stomach sickness) and HEADACHE (I had a headache) had resolved. On 14-Jan-2021, MUSCLE SPASMS (Cramping in legs, arms and back) had resolved. At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (tender), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for her headache, fatigue, myalgia, vaccination site swelling, vaccination site erythema, abdominal discomfort, and muscle spasms. Treatment for diarrhoea included an unknown medication. Treatment for the events vaccination site induration, vaccination site pain and vaccination mass, included that she rubbed alcohol and put ice and heat on it.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 28APR97 & that afternoon babysitter found pt dead;pt was taken to ER;autopsy results are pending however ER staff attributed this event to SIDS;
Swelling and redness at injection site (upper left arm) that appeared 7 days after receiving vaccine. Skin is very hot to the touch. Swelling and redness worsened the following day (8 days post vaccination).
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. After receiving SHINGRIX, she experienced arm soreness for one week and her right arm was very painful. The pain and soreness resolved after one week. Consent to follow up was given.
heavy, pervasive skin rash on his abdomen, torso, back and his shoulder; This case was reported by a nurse via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On 31st January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st February 2020, 1 days after receiving Shingrix, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: 24 hours after receiving Shingrix, the patient experienced a heavy, pervasive skin rash on his abdomen, torso, back and his shoulder where he received the vaccination. No information as to whether the rash resolved or improved after treatment. Consent to follow up was provided.
This spontaneous report was received from a pharmacist referring to a 55 year old female patient who on 22-AUG-2013, was vaccinated with a dose of PNEUMOVAX23, (lot # not reported) intramuscular in the left deltoid. Concomitant therapies included unspecified steroid inhaler. Pharmacist reported that on 24-AUG-2013, the patient returned to the pharmacy with a red, warm area under her left armpit. No treatment was given for the events and none lab diagnostics test were performed. The outcome of red, warm area under her left armpit was reported as not recovered/not resolved. Additional information has been requested.
Flu shot given around 10:45am 2-6-08.  Cried with shot - continued to cry for 4 hours.  Tried Tylenol and cold pack to leg.  No redness or swelling noted.  Child started complaining of head hurting.  No temperature.  Re-examined child at 1555.
no adverse event; patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2023, 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 26-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023) 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 (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023).    Concomitant medication not reported.   Treatment medication not reported.   Reporter did not allow further contact
inflamed airway; Tested Positive for COVID 19 5 days after second shot and then again on 01Apr2021; Tested Positive for COVID 19 5 days after second shot and then again on 01Apr2021/ trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered on the right arm on 02Feb2021 at 16:30 (Lot number: EL9264) as dose 1, single and on 27Feb2021 04:30 (lot number: EN6202) as dose 2, single for COVID-19 immunisation. Medical history included Parkinson's Disease and Kidney Disease. Concomitant medication included Parkinson's Disease medications. The patient tested positive for COVID 19 5 days after second shot (03Mar2021) and then again on 01Apr2021. With the second positive diagnosis, the only symptom he had was trouble breathing and had to call # for assistance (they said he had an inflamed airway on 01Apr2021 03:00). The event inflamed airway resulted in Emergency room/department or urgent care visit and therapeutic measure was taken as a result of the event which included steroid shot. COVID test type post vaccination: Nasal Swab: positive on 01Apr2021 and 03Mar2021. 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. Outcome of the event inflamed airway was recovering while unknown for the other event.  Follow-up attempts are completed. No further information is expected.
2 years and a half old, received Kinrix; 2 years and a half old, received Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3UMFG, expiry date 13-FEB-2026) for prophylaxis.   On 03-NOV-2023, the patient received Kinrix. On 03-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 years and a half old, received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 2 years and a half old, received Kinrix). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 06-NOV-2023 The physician reported that the 2 years and half old patient received Kinrix. This was the 3rd Dtap dose in the series. The vaccine administration facility was the same as primary reporter. The patient received a dose of Kinrix at an age of 2 years and a half old and it was the 3rd Dtap dose in the series, which led to inappropriate age at vaccine administration and Inappropriate schedule of vaccine administered. The reporter did not consent to follow up.
3 weeks post vax pt began having daily chronic headaches, sore and stiff finger joint, shoulder joint pain, extreme light sensitivity, muscle cramps and muscle pain. Pt also experiencing severe forgetfulness and out of work on disability.
Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had a heart attack that was occurred four days after the second dose of Moderna COVID-19 vaccine. No treatment medications were reported.   Company Comment: This is a spontaneous case concerning an adult male patient (unknown age) and no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Myocardial infarction. The event occurred approximately 4 days after the second dose of mRNA-1273 vaccine. Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.