chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 30-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23, 0.5 ml, which had a lot # of L003188 (also reported as "l003188" and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 1080 hours and the lowest recorded temperature reported was 27 Fahrenheit (F) (-2.777777778 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient's son reported a worsening tremor and patient was hospitalized a week after receiving moderna vaccine
constant arm pain/every time raises arm gets worse; constant arm pain that never went away that went to neck and head,; hurts bad were the needle went in; constant arm pain that never went away that went to his neck and head,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (constant arm pain/every time raises arm gets worse), NECK PAIN (constant arm pain that never went away that went to neck and head,), VACCINATION SITE PAIN (hurts bad were the needle went in) and HEADACHE (constant arm pain that never went away that went to his neck and head,) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 097c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D3) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (constant arm pain/every time raises arm gets worse), NECK PAIN (constant arm pain that never went away that went to neck and head,), VACCINATION SITE PAIN (hurts bad were the needle went in) and HEADACHE (constant arm pain that never went away that went to his neck and head,). At the time of the report, PAIN IN EXTREMITY (constant arm pain/every time raises arm gets worse) and VACCINATION SITE PAIN (hurts bad were the needle went in) had not resolved and NECK PAIN (constant arm pain that never went away that went to neck and head,) and HEADACHE (constant arm pain that never went away that went to his neck and head,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant drugs included ingestion pill and blood pressure pill.  On the 7th May 2021 patient started to experience: constant arm pain that never went away that went to his neck and head, "every time he raises his arm gets worse", hurts bad were the needle went in, and needs to stop what he is doing for the pain.  This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history reported, who experienced non serious, unexpected events of Pain in extremity, neck pain, vaccination site pain and headache. The events occurred approximately 2 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395907 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history reported, who experienced non serious, unexpected events of Pain in extremity, neck pain, vaccination site pain and headache. The events occurred approximately 2 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Extreme lethargic, chills, weakness , body aches, soreness from Saturday 04/10 -- 04/13
Fever 100.2°F; Chills; several aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches). At the time of the report, PYREXIA (Fever 100.2°F), CHILLS (Chills) and MYALGIA (several aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 100.2°f degree (plane angle) (High) 100.2°F.         Reporter did not allow further contact
Nausea followed by vomiting beginning around 12AM Sunday November 7. Repeated bouts of vomiting approximately every hour from 12AM until 7AM Sunday November 7. Unable to tolerate food or water from 12AM to 7 AM. No medication given.  Symptoms resolved during the day on November 7 although appetite suppressed. Water and light meals (mostly carbohydrate) tolerated. Patient ate soup at approximately 6:30 PM on November 7 and became nauseous and vomited approximately an hour later. No nausea or vomiting during the night or during the following day Monday November 8, diet normal. On Tuesday morning again became nauseous and vomited approximately an hour following eating graham crackers and milk. No fever was recorded and no other symptoms were reported.
Soreness near sight of injection starting about an hour later, for about 3 days. Took a Tylenol the first night, and an aspirin the next day. Stretched the muscle & did regular p.m. and a.m. exercises, which helped.
This spontaneous report was received from a patient's mother via a company representative and refers to a 13 or 14 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017, the patient was vaccinated with VARIVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of varicella. On the same day, the patient was administered a dose of unspecified meningococcal vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided). On an unspecified date in 2017, reported as shortly after the vaccinations, the patient experienced abdominal pain, nausea, vomiting and swelling of his whole arm, which was also "hot to touch". The mother stated that she attempted to take the patient to the emergency room but was not seen due to the long waiting period. The mother stated she did not go to any other physician for care. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and VARIVAX and unspecified meningococcal vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Patient states that he was given the incorrect Shingles vaccine. Pt was given Zostavax instead of Shingrix. (At our facility we do not have Shingirx) Pt states a few days after receiving his Shingles vaccine a pustular itchy rash started to form on his chest and right side. Pt states his right arm started to swell as well. Pt went to the ER room a few days later and was told that he had Shingles,
Missed second dose of Vivotif and did not take any other doses since then; Spontaneous report received on 21JAN2020.  A nurse reported that a female consumer "missed second dose of Vivotif and did not take any other doses since then" (PT: Product dose omission). She was receiving Vivotif for immunisation. The consumer took first dose of Vivotif on 14JAN2020 at 10:00 pm and had not taken any other dose since then. The nurse reported that she would initiate the process for the consumer to restart the regimen of Vivotif but, she did not specify dates. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Dizziness, NauseaVomiting, Tachycardia, none Narrative:  At 11:04am she complained of nause, dizziness, and elevated heart rate. BP 114/82, PR 106, O2 sat 98%. 11:10am given water to drink. Supervisor notified, rechecked PR 100,. She left going home stable. Dr. was here, she  was sent home.  Other Relevant History:
Left eye started going crossed/turning towards nose on first day of side effects. Next day, both eyes would cross/turn into nose at different times through out the day. Called Neurologist, office stated to go to ER at Hospital to have an MRI. Was admitted to hospital. Ran multiple tests, CT and MRI. NO new lesions on MRI from MS. Doctor stated possible Myasthenia Gravis (MG). Appointment with Dr at Institute. Doctor did not agree with this was MG. Suggested botox injections into eye muscle. No relief from eyes crossed after 3 weeks. Dr stated possible Myasthenia Gravis after first stating he doesn't believe it to be that. Started Pyridostigmine to combat MG on 5/7 at half dose. No relief. after 1 week. Dr increased to full dose 5/14. No relief as of 5/18
I started with a sore throat then came the cough sneezing and a runny nose. I called my dr. for a telehealth visit and I was prescribed a Z-PAK and also cough medicine. I was later given an inhaler & nasal spray, this lasted for over 2 weeks. Finally after about 4 weeks I started feeling better but the symptoms lingered for about another week or so and today I still have the cough sometimes.
Hospitalization Case began symptoms on 06/25/2021 consisting of productive cough, diarrhea, syncope, chest pain, and chills - reports pneumonia, diabetes mellitus, cardiovascular disease, and chronic liver disease as pre-existing medical conditions - case was transported to hospital via EMS, admitted 06/25/2021-06/28/2021
hives from 4/28 to 5/1 - from morning, sporadic, all over body (elbows, legs, arms, stomach, butt) - would go away once I took benedryl or zyrtec or claritin; followed by a sore throat 5/3 to present
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
an ischemic stroke on August 20; This case was reported by a consumer via interactive digital media and described the occurrence of ischemic stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingles vaccine. On 20th August 2022, 18 days after receiving Shingles vaccine, the patient experienced ischemic stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the ischemic stroke was unknown.   It was unknown if the reporter considered the ischemic stroke to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-NOV- 2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingle vaccine and suffered an ischemic stroke. Additional Supportive Information: The follow up would not possible as no contact details were available.
Case number PHEH2013US023237 is an initial spontaneous report received from a pharmacist on 04 NOV 2013. This case refers to a 14-year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly on 03 NOV 2013. No adverse event was reported following this administration error.
eyes watery; need to blink the eye constantly; Mouth soreness; mouth swollen; throat soreness; tongue swollen; whole body itchiness; redness; Tongue Redness; tongue soreness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen) and PRURITUS (whole body itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, CALCIUM CITRATE for Osteoporosis, VITAMIN D3 and DL-ALPHA TOCOPHERYL ACETATE, UBIDECARENONE (COENZYME Q10) for Supplementation therapy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen), PRURITUS (whole body itchiness), ERYTHEMA (redness), TONGUE ERYTHEMA (Tongue Redness) and GLOSSODYNIA (tongue soreness). On 04-Apr-2021, the patient experienced LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly). On 31-Mar-2021, ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness) and SWOLLEN TONGUE (tongue swollen) had resolved. On 02-Apr-2021, PRURITUS (whole body itchiness) and ERYTHEMA (redness) had resolved. At the time of the report, TONGUE ERYTHEMA (Tongue Redness), GLOSSODYNIA (tongue soreness), LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly) outcome was unknown. Not Provided          Treatment medication included Benadryl gel, Anti itch cream and eye drops. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-066647 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: follow up was received on 23 Apr 2021,reporter information and patient initials were updated, cross linked cases were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066647:MOD-2021-066647 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-067694:Crosslinked (MOD21-068818)
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 11Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 25Jan2021, the patient was tested positive to COVID-19. Clinical outcome was unknown at time of this report.   The information on the lot number has been requested.
Administered on accident to patient under age of 60.  Patient did not report any adverse effects.
Suspected vaccination failure; developed a very mild shingles infection; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got both the shots and had very mild shingles. The patient enquired that he/she can't get it again and was there any need to repeat the shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reporter experienced soreness for three days at the injection site after receiving the SHINGRIX vaccination. The reporter gave permission for his physician to be contacted. The reporter filed additional report for his wife (for tolerance see case US2018158150).
Patient received dose of vaccine at age 14. Not realized by provider until vaccination was given. Patient stayed at pharmacy for 15 min and no adverse reactions occured. Phone call to patient's home approximately 1 hour later and spoke with grandmother who is the patient's guardian. She states that the patient still does not present with any signs of additional adverse event(s).
No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). Concomitant medications details were not reported by the reporter. It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. Treatment details were not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-657506, US-MODERNATX, INC.-MOD-2022-657525, US-MODERNATX, INC.-MOD-2022-657552, US-MODERNATX, INC.-MOD-2022-657555, US-MODERNATX, INC.-MOD-2022-657558, US-MODERNATX, INC.-MOD-2022-657564, US-MODERNATX, INC.-MOD-2022-657565, US-MODERNATX, INC.-MOD-2022-657567, US-MODERNATX, INC.-MOD-2022-657613, US-MODERNATX, INC.-MOD-2022-657621, US-MODERNATX, INC.-MOD-2022-657622, US-MODERNATX, INC.-MOD-2022-657623, US-MODERNATX, INC.-MOD-2022-657629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506: US-MODERNATX, INC.-MOD-2022-657525: US-MODERNATX, INC.-MOD-2022-657552: US-MODERNATX, INC.-MOD-2022-657555: US-MODERNATX, INC.-MOD-2022-657558: US-MODERNATX, INC.-MOD-2022-657564: US-MODERNATX, INC.-MOD-2022-657565: US-MODERNATX, INC.-MOD-2022-657567: US-MODERNATX, INC.-MOD-2022-657621: US-MODERNATX, INC.-MOD-2022-657622: US-MODERNATX, INC.-MOD-2022-657623: US-MODERNATX, INC.-MOD-2022-657629:
broke out w/chickenpox 23JUN98;8 to 10 lesions total no itching, low grade temp lasted 4 days;
Flu like symptoms for 4 days, 102 degree fever for two days, nauseous, severe diarea for 4 days.  Several days after I was feeling better my right knee swelled up and became very painful. An orthopedic doctor diagnosed it as gout. I was given a gout med and prednisone.   It is a week later now and still have severe pain and swelling in he knee. I am going to see my PCP in the morning.
death is reported in a pt who recvd flu vax on 2OCT; pt died on 5OCT92 w/no final cause of death given; an autopsy was performed; coroner believed that pt died of CVA; pt had undergone facial sinus surgery 2 wks prior to death;
1/13 Hives, warm, swollen at injection site, redness now spread to elbow
The patient was administered the vaccine at 4 pm. About 20 minutes later, as he was sitting in the waiting area, he fell face first out of his chair and passed out (at minute 12 of his 15 minute wait period). The pharmacist went to tend to him and he came to within a few minutes. A frozen water bottle was place on the back of his neck as he continued to lay on the ground for about 5 minutes. He then moved into the chair a she was starting to feel a little better. At about 4:45 he left to go home on his own.
This spontaneous report as received from a nurse refers to about 8 unspecified patients of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (concentration, dose and route of administration were not reported), lot # L007228, expiration date 03-SEP-2016. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Approximately 15 minutes after receiving the 3rd dose of HBV, client returned to the Health Dept. with his mother.  Cause of severe itching on back mother compared it to fleas.  She said that it had lessened slightly since it started.  No rash noted.  Mother stated she gave him 2 doses of Benedryl 25mg. each.