chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35 year-old woman with no chronic medical conditions who presents to urgent care with right shoulder pain. She received her influenza vaccination on Wednesday around 1030am and noticed shoulder pain shortly after that, throughout the day the pain worsened and limited her range of motion. The pain also caused some sleep disturbance. She tried some range of motion exercises with minimal improvement. Abduction was limited at 30 degrees Thursday and is slightly better today around 45 degrees.
55mm x 55mm area of induration, erythema, and slight warmth, noted 36 hours after varivax dose #2 at site of injection.  First dose of Varivax was given on 6/15/1995.
Site: Pain at Injection Site-Severe, Systemic: Intense body pain, all over body.-Severe
Moderna COVID-19 Vaccine EUA Fever ranging from 101.2 to 102.6 for 3 days, headache for 5 days, shortness of breath/ difficulty breathing 5 days.
Lost my taste; After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis C back", start date: 2011 (unspecified if ongoing), notes: hepatitis C back in 2011. Concomitant medication(s) included: OXYCODONE; LYRICA; OMEPRAZOLE; ESTRACE; ALBUTEROL HFA; ATROVENT; FLEXERIL [CEFIXIME]; OXYBUTYNIN; MOBIC; AMBIEN. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "Lost my taste"; PAROSMIA (non-serious), outcome "unknown", described as "After receiving the vaccine although she mentions that she was already smelling things which is burning kind of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Patient stated, back in 2011, patient had hepatitis C back in 2011 (History). When all first started giving out the COVID shot and that when patient took first shot because she should take it in two phases of first shot. The first shot patient took and lost her taste, and she could smell stuff strong and when she got tested for COVID she did not have COVID. It was asked if any vaccine prior to 4 weeks of vaccination, consumer stated, no, she never took any type of COVID vaccine before that. Consumer stated, treatment for loss of taste, no medicine. Just her basic medicine patient was taking.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308269 same patient, LOE case;
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX 23 (lot # M022086, expiry date: 09-OCT-2017). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
@1247 once client?s 15 minutes of observation was completed, she stood up to leave and felt dizzy. LPN assisted client to sit down and notified site managers. Client than reported feeling nauseated and dry heaved. RN and Site Supervisor and EMT arrived to client area. @1248 vital signs: 174/100, 82, 97% RA. Client AAOX4. NAD. Skin WNL. HA. EMT called 911 @1250. Fire Department Engine #1 arrived @1258. EMS repeat vitals @1300: 98.2, 187/102, 73, 20, 99% RA. EMS assessed BP/HR while standing, 218/123, 77.  Stroke assessment negative. LAC 20g PIV inserted by Fire Department. BGL 170. County Rescue# 425 arrived @1307. Client showed no signs of improvement and no changes from prior assessment. Client transported to ER via ambulance @1310 in stable condition.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 40, 88, 320, and 232 hours, with the lowest recorded temperature of 34, 30, 29, and 33 degrees Fahrenheit (1.11, -1.11, -1.66, and 0.55 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 22-MAR-2019, the patient was vaccinated for prophylaxis with M-M-R II (lot #, expiration date, dosage schedule, route and anatomical location were not reported) and PROQUAD (lot #, expiration date, dosage schedule, route and anatomical location were not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Patient immediately developed a bump in his left arm below the injection site after the pneumonia vaccine was administered.  Patient reported that the bump disappeared within a couple of days.
During the first week my husband experienced extreme fatigue, being out of breath for simple physical movements, stomach pain, headache, sweats and chills, tingling of his arms and legs.  He is still experiencing fatigue, sweats and chills at night, and tingling over his whole body but not as severely as the first week.
ED visit for aggressive behavior. Behavioral Health admission. Treated and adjusted medications. This visit was within 6 weeks of receiving the COVID vaccine.
Idiopathic Thrombocytopenic Purpura 6 weeks after the immunization. Multiple ecchymosis over upper and lower extremities, back, abdomen and head.   Treated with one dose of IVIG which increased the platelet count from 16ooo to 45ooo. Sent home with follow up with PMD.
Reported received H1N1 vaccine in right arm on Wed. 11-18-09. On Fri. 11-20-09 noted feeling bad all over, had excruciating pain in right arm, unable to use or lift arm due to pain.  Reported to facility ICP who advised her to seek medical attention. Patient f/u with physician.  Temp. at physician office was 99.9, felt faint in office. No test were done. Dr. informed her it appeared she had some sort of reaction to the vaccine. Prescribed Naprosyn for pain relief. No other f/u treatment recommended.  Patient reported today 11-24-09 that she only has some soreness in the right arm, the excruciating pain is gone.  She can now lift her arm.
The patient states he was vaccinated on 8 April 2021 and develop s/s and tested positive for COVID-19 on 26 APR 2021
Approximately one month after receiving my second Moderna COVID19 shot, I started feeling itchy skin.  (Jun 2021) It started at my feet and moved through my entire body.  I later received the booster shot(Jan 2022).  I still experience unbearable itchy skin over my entire body.  During my physical with my doctor, I expressed the concern with my itchy skin.  The doctor did a scratch test along my back and the red welt stayed for some time.  Confirming that my skin was producing too much histamine.  I was prescribed anti-histamines to lessen the itching.  I'm still taking these today to control the itchy feeling in my skin.
The pediatric pfizer vial was not diluted. Patient received 0.2mls of the undiluted immunization.  The vaccine was given around 2:30pm. When error was discovered, patient's mother was contacted around 7:00pm . She stated that the patient was not exhibiting any significant side effects.  Patient's mother states she would consider taking the patient to a physician the following day.
Developed herpes zoster in the thoracic region. Symptoms were noted on 10/19/21 and a rash was noted on the morning of 10/20/21.
bumps on their scalp; losing hair; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair). At the time of the report, SKIN SWELLING (bumps on their scalp) and ALOPECIA (losing hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up received for ID- Mod-20221-322410, but the form  has all reporter case i.e. MOD-2021-322385 Details .Hence attached in both cases. Follow-up non sig for this case
Ever since the second dose, the deltoid muscle where the injection was made, has been extremely sore when my left arm is used. Whenever I have to lift my left arm and engage the deltoid muscle, it is incredibly painful.
paralyzed for 3 hours and could not move; headache; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (arm was sore) and DYSKINESIA (paralyzed for 3 hours and could not move) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache) and PAIN IN EXTREMITY (arm was sore). On 03-Mar-2021, the patient experienced DYSKINESIA (paralyzed for 3 hours and could not move). At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (arm was sore) and DYSKINESIA (paralyzed for 3 hours and could not move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
This spontaneous report was received from a pharmacist via company representative and refers to 2 patients of unspecified age and gender. On an unknown date, two patients were vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot# were not reported). On an unknown date, the patients developed a shingles-like rash. The patients sought unspecified medical attention. The outcome of shingles-like rash was not reported. The relatedness between shingles-like rash and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# 654272/0073X).  Subsequently the patient became violently ill and was throwing up.  The patient was brought back into the office the next day.  Her outcome was not reported and it was unclear whether the patient would continue the GARDASIL series.  Additional information has been requested.
Incorrect dose was given on 10/28/21 of 0.3ml.  Pt was called on the phone x2 and messages left.  If contact is made, will revaccinate with .05ml dose.
This case was reported by a consumer and described the occurrence of injection site inflammation in a female patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. The patient's past medical history included shingles (had a bout of shingles in 2005 or 2006). Previously administered products included Shingle vaccine (original vaccine received on an unknown date). In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site inflammation, injection site warmth, injection site pain, injection site swelling, unwell and product supply issue. On an unknown date, the outcome of the injection site inflammation, injection site warmth, injection site pain, injection site swelling and product supply issue were unknown and the outcome of the unwell was recovered/resolved. It was unknown if the reporter considered the injection site inflammation, injection site warmth, injection site pain, injection site swelling and unwell to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her doctor prescribed the Shingrix vaccine and she got the first injection in late May 2018, and the day after the a vaccination, the injection site on her upper arm was quite inflamed, hot to the touch, painful and puffy. The patient felt ill for a couple of days. After a couple of months, the patient went back for the second injection knowing the second injection was supposed to be within two to six months of the original dose. The vaccine had not been available. First the pharmacy told the patient that end of September 2018 and at the time of reporting pharmacy had informed the patient not until the end of December 2018. The patient stated that this would exceed the six month limit and asked that how would this impact on her immunity. The patient said that the Shingles the first time was awful and did not want back want to have it again. The patient concerned about she paid $66.92 (portion uncovered by my insurance) and she would have to paid again to start the two dose series again, if the time period exceeds six month limit. She asked for advice.
This spontaneous report as received from a physician via a company representative refers to a 16 year old patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL in the buttocks. Dose, route and lot number were not reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a female consumer with no pertinent medical history and an iodine allergy who on 12-JUN-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included MAALOX.  On 01-JUL-207 the patient reported experiencing a stabbing, sharp pain throughout her body.  At the time of reporting the sharp pain had recently subsided, but the patient was still experiencing some mild pain and itching in an area of a past shingles episode.  The patient also reported that in November 2007, she developed cold sores on her lips and inside of her mouth that at the time of reporting had not yet healed.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information was received from a physician who reported that the patient with an allergy to PERCOCET, DARVON, iodine, DEMEROL, PLAVIX, and CIPRO was vaccinated on 12-JUN-2007 subcutaneously into the right arm with a first dose of Zostavax (Oka/Merck) (Lot# "02904").  It was reported that "the patient developed right sided chest pain after the vaccine".  It was unknown if the patient had any illness at the time of vaccination.  There were no lab diagnostic studies performed.  The patient's status was unknown at the time of reporting.  No further information is expected.
sore arm; 100 degree temperature; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE INCREASED (100 degree temperature) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE INCREASED (100 degree temperature). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and BODY TEMPERATURE INCREASED (100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2023, Body temperature: 100 degree Celsius.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient took all the Moderna shots and no problems at all. No treatment information was provided.
Area of injection (R) upper arm large welt. Hives on neck, chest, both arms, both legs, fever, fatigue.
1 of 4 children immunized w/DTAP over the last 2 wks (11JUL-22JUL) who exp a rash around inj site (raised/swollen: approx 1.5" diameter); None of the children reported itching, fever or other systemic rxn. Rashes resolved w/in a few days;
NO REACTION TO INJECTION. DEVELOPMED COVID 19 AFTER BEING INJECTED
Itching sensation on opposite arm; followed by generalized itching  particularly both hands. Loratadine and diphenhydramine administered.
After shot it got progressively painful (2).  I took an Aleve  before bed.  When I woke up  the next day, my vision was blurry.  Pain was a (3-4) then throughout the day increased and moved up my neck.  I became concerned when my Jaw started to ache, however, I thought I'd try an Anti-histamine in case it was an allergic reaction (took at 5pm.  I then fell to sleep and woke up at 4am.  I noticed the pain was going away, so I took another anti-histamine.  When I got up this morning, I had no symptoms, just a little soreness in the injection site.
soft stool and diarrhea, light colored; light colored; stool is very grainy or sandy and dark colored, like ash colored; her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker; Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind; slight headache; pain in the muscle of the arm; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind), DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M007204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Anxiety. Concomitant products included PREDNISONE, FOLIC ACID, IRON and GABAPENTIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm). On 19-Feb-2021, the patient experienced HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm). On 04-Mar-2021, the patient experienced DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker) and LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind). On 05-Mar-2021, the patient experienced FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored). On an unknown date, the patient experienced DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored). On 20-Feb-2021, HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm) had resolved. On 21-Feb-2021, PAIN IN EXTREMITY (pain in her arm) had resolved. On 05-Mar-2021, DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) had resolved. At the time of the report, DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind) and FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
PAIN AT INJECTION SITE THAT EVENING AND THE NEXT DAY.  HIVES/WHELPS APPEARED AROUND 3 PM THE DAY FOLLOWING IMMUNIZATION.   MOTHER REPORTS THAT SHE GAVE CHILD AN AVEENO BATH AND PUT BENADRYL CREAM ON THE HIVES.  CHILD REPORTED FEELING BETTER, BUT SOMETIME IN THE NIGHT WHEN SHE WAS SLEEPING, THE CHILD SCRATCHED SO MUCH THAT THE NEXT MORNING HAD BLEEDING SORES.  THAT FOLLOWING AFTERNOON AT SCHOOL, THE CHILD CAME IN FROM RECESS AND THE HIVES HAD RETURNED WITH WHELPS. THEY WERE ALL OVER TORSO, ARMS, LEGS, AND FACE.   MOTHER TOOK CHILD TO PCP ON FRIDAY AFTERNOON AND WAS GIVEN MEDICATION TO HELP WITH THE HIVES.  MOTHER REPORTS CHILD IS COMPLETELY HEALED WITH NO SIGNS OF HIVES.  MOTHER REPORTS THAT THEY ARE NOT 100% POSITIVE THAT REACTION IS FROM FLU VACCINE, AS THE CHILD HAS HAD YEARLY FLU VACCINES SINCE INFANCY AND HAS NEVER HAD A REACTION.  THEY JUST CANNOT THINK OF ANYTHING THAT IS DIFFERENT OTHER THAN RECEIVING THE INFLUENZA VACCINE.