chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back pain before and it got worse after the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "very bad back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain before and it got worse after the second dose".  Additional information: It was reported as asking if she can have a steroid shot because she was experiencing very bad back pain and she was informed not to take any shots after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported itching shortly after receiving the vaccine.  Elevated anxiety noted. Pt's mother was present at the time.  Advised pt to be observed for 30 min before receiving 20 ml liquid benadryl. MD on call Dr. contacted and notified of the situation.  Pt stayed an additional 30 minutes until itching resolved.  Pt was stable, A&O x4  , and was driven by mother to home.
Patient received 2 doses of vaccine and got COVID and was sick for 10-13 days with Covid; Patient received 2 doses of vaccine and got COVID and was sick for 10-13 days with Covid; This is a spontaneous report from a non-contactable Other-HCP (patient) via Pfizer Sales Representative.  A patient of unknown age and gender received 2 doses of (PFIZER-BIONTECH COVID-19 VACCINE) on an unknow date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Patient received 2 doses of vaccine and she/ he got COVID and she/ he was sick for 10-13 days with Covid. The outcome of the events was unknown. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
patient said her entire arm was red, swollen and warm to touch for  3 weeks, patient tried OTC pain meds, cold compress nothing worked
Sore arm for 3 days. On day 8 from vaccine, my arm where my shot was given became itchy and a red tight raised area appeared. Feels tender and hard to touch.
The pain started in my right thumb and index finger, and it traveled up my arm about midway. It gradually got worse and worse.  It's real stiff in the morning, I put warm water and heating pad, it would make it feel better and it would just eventually get worse and worse and worse. That's why I went to the urgent care on 11/29 and had x-rays and was put on prednisone for 6 days and had a brace on it. It was better than it was, it's sore now and not like it was. There was also a point where I had swelling in my fingers at one point, but I do not have that anymore.
Within 30 minutes of receiving vaccine, patient was "crawling out of his skin" and having a "fit" in the waiting room. Since then his anxiety has markedly worsened. His behavior in school and at home are terrible. He can't sit still in school, is disruptive, screams, runs around, and is increasing frustrated. He is on medication for anxiety and ADHD, but was stable with no behavior issues until 30 minutes after he received the COVID vaccine. He is otherwise fully vaccinated and has never had any other issues with vaccines.
Vaccinated on 10/13 - became itchy - not painful that night had a dance class that noc - careful not to overdo activity. 10/14 - Slight temp - area at inj. site warm 10/15 took BENADRYL 10/15 - noticed red circle 1-2" around site of inj - BENADRYL helped quiet reaction. 10/19 - Only slightly itchy - bruised at inj site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Soreness on the injection arm for 3 weeks - pt has tried TYLENOL/ibuprofen hot/cold therapy - but the pain still there. Sometimes can't move her arm.
No periods, severe pain in sides, diagnosed with polycystic ovarian syndrome, insulin resistance, infertility.
Sore arm; Yucky feeling; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine Allergy) and Parkinson's disease.    On 27-Mar-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 PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Yucky feeling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Reporter stated that the events sore arm and yucky feeling didn't last very long.   This case was linked to MOD-2022-521546, MOD-2022-522741 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of weakness on one side in a 15-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 October 2008 the subject received 1st dose of BOOSTRIX (unknown). On 20 October 2008, 3 days after vaccination with BOOSTRIX, the subject experienced weakness on one side, bilateral vision loss, loss of short term memory, balance disorder, chronic migraine. The healthcare professional, the subject's mother, reported the subject experienced one-sided weakness, short term memory loss, balance disorder, chronic migraines and had to be hospitalized several times since receiving the vaccine. The subject also had to be home schooled (inability to perform daily activities). The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the weakness on one side, bilateral vision loss, loss of short term memory and balance disorder were unresolved; chronic migraine and inability to perform daily activities were unspecified. The healthcare professional considered the bilateral vision loss, loss of short term memory and balance disorder were unresolved were probably related to vaccination with BOOSTRIX and weakness on one side was possibly related to vaccination with BOOSTRIX.
Patient woke up this morning with red rash all over both arms.  She stated it is starting to itch.
28sep89 pt vax hepta b. pt ex n/v, sore throat, malaise, and upper respiratory infect.  pt unable to work for 2-3 days and recovered. pt decided to discontinue series.
she was not able to sleep; tired; arm swole like a big watermelon, real bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swole like a big watermelon, real bad), INSOMNIA (she was not able to sleep), HEADACHE (Headache) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 057182496208) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has an appointment with their doctor for a wellness appointment and was told she was in excellent health. Allergies to outside in the air, penicillin and sulfa.  Previously administered products included for an unreported indication: MODERNA COVID-19 VACCINE (1st dose: 19-Feb-2021, batch number: 022M20A  2nd dose: 22-Mar-2021, Batch number: 037A21B Booster 2dose: 05-Oct-2021, Batch number: 048F21A  2nd booster: 03-May-2022, batch number: 056A22A  Last one: 14-Oct-202, batch number: 030G22B) and RSV since an unknown date. Past adverse reactions to the above products included No adverse event with RSV. Concurrent medical conditions included Allergy (Air), Penicillin allergy and Drug allergy (Sulfa drugs).    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PERIPHERAL SWELLING (arm swole like a big watermelon, real bad) and HEADACHE (Headache). On an unknown date, the patient experienced INSOMNIA (she was not able to sleep) and FATIGUE (tired). At the time of the report, PERIPHERAL SWELLING (arm swole like a big watermelon, real bad) and HEADACHE (Headache) had not resolved and INSOMNIA (she was not able to sleep) and FATIGUE (tired) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The caller said they had given Moderna since day one, the patient was not able to sleep last night, arm swollen like a big watermelon, really bad and had to get some arm from the freezer to try to diminish the swelling. Caller said she could feel her heartbeat in her head, throbbing. Caller was kind of tired, has a slight headache. Caller reported with her previous doses were just a little discomfort and told it could take the flu or RSV vaccine with the COVID. Caller denied consent to follow up with HCP.   This case was linked to US-MODERNATX, INC.-MOD-2021-291002, US-MODERNATX, INC.-MOD-2021-291257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-291002:same reporter, different dose US-MODERNATX, INC.-MOD-2021-291257:same reporter, different dose
Upper arm became very hard and hurt. The following day around 6:00 PM a rash developed. It was not itchy but hurt. I applied zinc oxide the next day and continued using it until today. The rash is now gone but the arm is still a little sore.
On March 7, 2023, I had aches and pains and different texture in my mucus.  I tested positive for COVID-19, and I began taking Paxlovid on March 10th and then began having symptoms of sinusitis.  I no longer have COVID-1 symptoms, but I do still have sinusitis.
Ringing in the ears (left ear still ringing from 12/3/20-12/29/20);  Pain in back on left side (for about 1 week after the shot) Upset stomach, chilled skin and sleepy for about 6 hours after shot
feeling sick; i felt terrible; felt pain in my ampit; i had a big lump there; it felt like a swollen ballon; Raising my left arm whch was the site of the injection i felt pain in my ampit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Dec2021 (Lot number: FD8448) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=2, unknown manufacturer), for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose dose number=1, unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "feeling sick"; FEELING ABNORMAL (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i felt terrible"; AXILLARY PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "felt pain in my ampit"; MASS (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "i had a big lump there"; SWELLING (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "it felt like a swollen ballon"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 07:00, outcome "not recovered", described as "Raising my left arm whch was the site of the injection i felt pain in my ampit". Therapeutic measures were not taken as a result of malaise, feeling abnormal, axillary pain, mass, swelling, vaccination site pain.  Additional information: Got the 3rd shot on saturday around 1pm. Got home and started feeling sick. The next day felt terrible and woke up monday feeling better but raising his left arm whch was the site of the injection he felt pain in armpit. He took a look and realized had a big lump there, showed it to his wife and took a picture of it. He touched it and it felt like a swollen balloon. He was still hoping the swelling or lump will go down. It's now 2.33pm on monday 13Dec2021 and yet it's still there. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient did not have any known allergies. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Diagnosed with Afib.  Tiredness,/fatigue for 3 days, palpitations, elevated heart rate 2 days in the hospital receiving intravenous drug treatment (don't know the drugs).  Drug treatment got me to atrial flutter.  Had to have a cardioversion to get back to normal sinus rhythm.  Fine since then.
- Hives, contact hives from scratching itchy areas. - Swelling/inflammation of hands and feet - Joint Paint - Persistent low grade fever. - Potential Esophageal Inflammation or Acid reflux (Unsure)  Symptoms currently persisting and gradually worsening over three days.
Tachycardia with a heart rate in the 120-140s, fever, fatigue, muscle weakness, joint weakness, and headache
This case was reported by a pharmacist via sales rep and described the occurrence of nodule in a adult female patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. On 31st January 2019, 1 days after receiving SHINGRIX, the patient experienced nodule and induration. On an unknown date, the outcome of the nodule and induration were unknown. It was unknown if the reporter considered the nodule and induration to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Wednesday, the patient received SHINGRIX. A following day of vaccination, the patient experienced a hard red nodule. The nodule was growing in size each day and it was painful. The reporter did not agree to follow up from GSK.
pt recvd vax & devel poss complications of the pre-existing COPD & was hospital;addtl info recvd 13OCT95 revealed that pt died while in hosp
On evening of 12/07/2021 05:30PM began to throw up, no fever, chills, fatigue, all in 10 of 20 Moderna side effects listed. Shortness of breath and unknown blacks, exhaustion and felt muscle pains if he laid down any place other than back. During that period if he tried to sleep in any other position felt like muscle strain on organ uncomfortable. Most serious symptoms shortness of breath. Moderate activities would cause exhaustion. 12/09/2021, 5 days during the interview at urgent care the doctor informed the patient that he had passed out twice and he called an ambulance. Concern with gallbladder was a concern to be removed. The admitted and gave fluids and antibiotics and within a few days was recovered and was discharging with home care and follow-up and remained healthy for three months. 2nd hospitalization 03/11/2021 03/15/2021; Relapse three months later and it started with a loss of appetite without nausea. Was being satisfied with 50-75% of meals, was feeling satisfied. Returned with extreme exhausted most noticeable, prior to hospitalization then really exhaustion and temporary dry heaves and exhaustion and nausea went to hospital as white blood cell was 20. Gallbladder was under stress and had slug. Gallstone1st time what happen, not sure he was recover from a cold prior to vaccination. Antibiotic helped get him better. This time there are not as may symptoms and exhaustion. Explanation to do more test for a camera down the throat to stomach to see if something. Slug was not blocking but maybe the MRI or CT scan, by the date. Spike in white blood count before admitted to and after he was admitted to hospital. Body white count went back to normal and have him do certain test primary and Spike in liver enzymes of non alcoholic fatty liver disease but his numbers was rage for that condition. List of symptoms. 2nd hospitalization 03/11/2021 03/15/2021; Breathing was not an issue mile fever varied to high of 101. Hospitalized 12/10/2021 urgent care and during the interview; Regular weekly request for an update. A hospitalization -echo of event in hospitalized.
I had the vaccine and the next day I started feeling really bad. I had a fever and I could not stand up. I would lay in bed all day. The third day I had chills and I was sweating a lot. Those symptoms lasted for a week. Then, I just had a headache. After 10 days I started feeling a little bit better but I felt like I had a cold. I went to the doctor and he said it was a cold and gave me some medication. I have taken 3 Covid tests because of the cold. They all have been negative. The cold comes and goes almost every month. The doctor also gave me some blood pressure medication (Losartan) because my pressure was high when I went to see him. I started with 50 mg once a day and now I take 100 mg once a day.
He was supposed to get Moderna, however we gave Pfizer because that is all we had.
This spontaneous report was received from a nurse refers to a child of unknown age. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. The nurse reported that  a few weeks ago, she saw on the news a case of measles in a child who had a horrible rash on unspecified date. The nurse reported that the mother of the child said her child was completely up to date on vaccines and on an unknown date,  the patient was vaccinated with M-M-R II (dose, strength, route and administration, lot number and expiration date unknown) for prophylaxis. The nurse reported that the mother said she had her child "genotype tested" and the child was "positive for attenuated measles" (measles post vaccine). The nurse reported that, the mother of the patient was accused of being an anti-vaxer and it ruined her daycare business. A sterile diluent was used to reconstitute M-M-R II (lot number and expiration date unknown).The outcome of measles post vaccine was unknown. The causality assessment of measles post vaccine was not reported. No product quality complaints were involved. Upon internal review, measles post vaccine was determined to be medically significant. This is one of the two reports from the same reporter.
mom states pt devel fever of 104 poss higher on 9FEB96;prior to his pt had fever p/vax but not to 104;9FEB96 for approx 72hrs pt also had severe fussiness w/intermittent high pitched cry;pt was inconsolable @ times but did not cry for 3hr
This spontaneous report was received from a nurse and refers to 3 unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377, expiration date 17-JUN-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 49.8 degree Fahrenheit for 30 minutes before administration to the patients. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
Patient received the second Moderna COVID vaccine on 3/31.  She reports last night she developed a red area near the injection site.  This morning it is red, slightly swollen, and itchy.  She reports no pain, no fever.  She was advised that this may be a common localized injection reaction and should resolve within 24-26 hours.  She is going to use ice, tylenol, and rest.  She will call if she develops a fever or symptoms worsen.
I developed a rash at the shot site that spread down my back and across my neck. My blood sugars have been high since Wednesday. I have been struggling to get them within range since then. I have an antihistamine cream that I?m applying and have had to adjust my insulin to improve my blood sugar levels.
Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.  The patient wants the 4th dose because they are immunocompromised.
Pt seen in clinic 5/25/21 and found to have L-sided facial paralysis, possibly Bells Palsy reactivated by recent COVID vaccine. Pt reported that on 5/21, pt experienced drooling on L side, difficulty drinking from a straw, lower extremity weakness, and L-sided headache 7/10 constant, throbbing. Pt reported trying acupuncture which did not help. Dx: Seventh nerve palsy. Prednisone x 1 week prescribed. Pt seen in office again on 6/1/21 with improvement in L facial movement.
The 2nd dose of the Covid-19 vaccine was administered on day 13 which was outside of the established protocol.  There were no adverse reactions reported to myself but this is not say the patient did not experience the common side effects associated with receiving the vaccine.
local skin reaction redness, warmth and swelling antihistamine, icing, analgesic improving