chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hand pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 13Jun2022 as dose number unknown, single (Lot number: FM7553) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Jun2022, outcome "recovered" (13Jun2022), described as "hand pain"; HEADACHE (non-serious) with onset 13Jun2022, outcome "recovered" (13Jun2022). Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: This is the 1st case out of 2 cases. Call was transferred from RA. Concern, transferring agent stated, "I have a report for you, the caller was a patient (consumer) reporting an adverse event, she was also a Pharmacy tech, so she had medical knowledge, she had the Pfizer (Booster) COVID Vaccine Monday of this week and had a sore arm and hand pain for 2 to 3 days and now today she said, she feels like her right side of her face that somebody punched her and then her eye hurting a lot and her face is numb on the right side only. She said that this is the first Pfizer (Booster) shot (COVID Vaccine) that she got. Her (consumer) first vaccine (unspecified vaccine) was Johnson & Johnson. She was getting this (Pfizer COVID Vaccine) as a Booster, she also has a 7 year old daughter that she wants to report having a hand pain and headache for 2 days after this (Pfizer COVID Vaccine) Vaccine on Monday and that was all the information I have."  Consumer's administered Pfizer (Booster) COVID Vaccine LOT#, FM7553 (LOT# captured in the tab)." Patient had asthma." not took any treatment for the event, consumer stated, just my daughter has one Tylenol actually, not me. Vaccination anatomical site, consumer stated, "It is left." Pfizer COVID vaccination date and timing consumer stated, "It was 08Jun2022."   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.- On 04-Nov-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions.
Right flaccid hemiplegia; large left MCA ischemic stroke; treated and then moved to inpatient rehab. Hospital admission within 6 weeks of receiving the COVID vaccine.
developed hives on chest and arms with light headedness. Epi given x1 then transferred to ED
Rash & UrticariaPruritus Narrative:  Employee reports bilateral arm rash post 3 days from receiving vaccine. Advised to use topical antihistamine cream. Condition has not resolved but is improving.
On 3/13 had onset of malaise, brain fog, paresthesia  in arms, leg, and face and a general feeling of being " unwell".. Initially though it may be related to her breast implants but has since had them removed and continues to have the same symptoms. Symptoms are intermittent but have not resolved.
Aches and pain all over; Sore arn; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pain all over) and PERIPHERAL SWELLING (Sore arn) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Aches and pain all over) and PERIPHERAL SWELLING (Sore arn). At the time of the report, PAIN (Aches and pain all over) and PERIPHERAL SWELLING (Sore arn) outcome was unknown.            Concomitant medication also included cholesterol and blood pressure medications. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Dose of vaccine was given on 11/10 when it expired on 11/9. Moderna was contacted and dose was deemed to be effective.
Extreme fatigue, Extreme headache, 101+ fever, joint-muscle ache, body weakness, light sensitive, loss appetite, stomach pain and nausea, inability to do  normal functions for 5 days. I was really sick. Sore on entire left side.
Information has been received from a healthcare worker and a vender referring to a 46 year old female patient with allergies to pencillin, sulfa and codeine. The patient was vaccinated with her first, second and third dose of RECOMBIVAX HB (first dose: lot# and expiration date were not available, second dose: lot # reported as 1519Z, expiration date: 29-MAR-2013, third dose: lot# 0020AE, expiration date: 10-JUN-2014) (strength, route and dose were unknown) on 12-NOV-2011, 13-DEC-2011 and 12-JUN-2012, respectively. The patient received two doses of pediatric RECOMBIVAX HB to make one adult dose on each of the above three dates. The patient was anxious, and she consulted the physician, on an unspecified date, to request antibody titers for Hepatitis B. On 11-APR-2015, the results of the Hepatitis B titers were negative for Hepatitis B antibodies. The patient had experienced any other adverse effects. The outcome of the adverse events was unknown. The relationship of the adverse events and RECOMBIVAX HB was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
syncopal episode, labored breathing, nausea. Evaluated by EMS-Refusal to transport.
The following day 10am exp stomach cramps. On the following day and  12/19 exp severe stomach cramps. I have had no issues since.
Chills began at 1:30am on 2/7, after that began to feel nauseous and achy. Checked temperature and it was at 103°F, but went down after taking Tylenol. Chills and cycles of hot and cold continued throughout the night. Also had a headache. Woke up at 7am and checked temperature and was 101 took 2 Tylenol and it went down to normal. Chills, aches, headache, and fatigue all of 2/7. 2/8 had no fever but still felt tired and achey.
A woman brought her husband to the pharmacy to get an influenza vaccination.  While he was completing the paper work for the influenza vaccination she said her rheumatologist wanted her to go ahead and get her third Covid vaccination.  I ask her when did she get her second Covid vaccination and it was over 6 months.  I told her that we only had the Moderna Vaccine.  She told me that was the vaccine that  was the vaccine that she had gotten for her first two doses.  She completed the complete paperwork and I gave her the vaccination.  I ask for her card and noticed that her first two vaccination were Pfizer.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
On Tuesday October 26, 2021 client was given 0.25ml of the Pfizer vaccine.  Proper dosage is 0.3ml.  No adverse outcomes.  No further treatment needed per CDC guidelines.
My entire left side of my body, went numb and non usable for @ 10 minutes. (Arm, Leg, Foot, Back etc.) I crawled back to bed and Layed down @ 10 minutes later I seemed normal.
signs and symptoms: Cough/throat itching; signs and symptoms: Cough/throat itching; This is a literature report.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: tree nuts; "Anaphylaxis" (unspecified if ongoing), notes: tree nuts. The patient's concomitant medications were not reported. The following information was reported: COUGH (medically significant), THROAT IRRITATION (medically significant), outcome "recovered" and all described as "signs and symptoms: Cough/throat itching". The patient underwent the following laboratory tests and procedures: Brighton score: Insufficient information to meet case definition. Therapeutic measures were taken as a result of cough, throat irritation.  A specialized vaccine clinic evaluated patient's referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All pt.'s were evaluated from May 2021 to February 2022; their families have provided consent for the publication of clinical data. Nine pt.'s were evaluated after experiencing an allergic reaction to the first dose (average age, 13 years; range, 8-17 years). The vaccine was administered as a single dose without premedications. All patients successfully received the second vaccination with no or minimal symptoms.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events cough, throat irritation and the use of suspect product BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Patient complaints of very sore arm x7 days after vaccine. states she cannot lift her arm and can barely use it.
Extreme heavy menstrual bleeding. Treatment is seasonique birth control and medroxyprogesterone also rash all over my body 1-23 days after vaccine and now hearing issues and liquids draining from my right ear. Dizziness, shortness of breath
The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.
Initial information has been received through the Merck Pregnancy Registry from a medical assistant concerning a 19 year old female with asthma who on 22-OCT-2007 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL and on 26-FEB-2008 was vaccinated intramuscularly with the 0.5 ml second dose of GARDASIL. On 19-JUN-2008 the patient was vaccinated intramuscularly with the 0.5 ml third dose of GARDASIL and she was pregnant at that time. The date of her last menstrual period was 28-APR-2008 and her estimated delivery date is 02-FEB-2009. No adverse events reported. The patient's outcome was unknown. The patient called the physician's office. Follow-up information has been received from a physician concerning a 19 year old female with moderate persistent asthma (better past couple of years) and allergies and a history of hospitalization due to her asthma prior to 1996. There was no history of pregnancy. It was reported that the patient received a prior dose of GARDASIL on 28-FEB-2007. Concomitant therapy included fluticasone nasal spray (during allergy season), montelukast sodium (MSD) and QVAR (since before pregnancy). On approximately 26-AUG-2008, during pregnancy, the patient experienced sinus infection. AUGMENTIN and amoxicillin were prescribed. The patient also used other medications for asthma including prednisone and ADVAIR. Ultrasounds were done in 4 times due to the patient was in high risk. All the results were normal. On 22-FEB-2009 the patient delivered a normal, healthy female baby weighing 7 pounds 2 ounces. The baby's length was 19.25 inches and head circumference was 13 inches with Apgar score 8/9. There were no congenital anomalies and other complications/abnormalities. On approximately 22-FEB-2009, during labor, the patient experienced pre-eclampsia and uterine infection. The patient underwent c-section and had meconium birth. The patient's outcomes were unknown. Upon internal review, c-section was determined to be an other important medical event. Additional information has been requested.
One a.m. extreme cold feeling, fever101, inability to sleep.  aching of joints and muscles, cramps in back and leg muscles. Low grade fever the next day, and called Dr.'s office.
I woke up on the 3rd with a sore throat and not feeling well with less than a normal temperature and I had a cough. It was bad enough that I called my Doc and had a virtual appointment. She wanted me to get checked if I was COVID positive so I got a COVID test, Strep test and bloodwork. Both came back negative. Doctor prescribed Codeine cough syrup and Mucinex. I took these for about 10 days and stopped and saw the Doctor about a week and  a half ago and I still had a lingering cough, she told me it would go away and it pretty much has.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number XL527, expiry date 5th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose and experienced, refer case US2019GSK032701). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2019, 1 days after receiving SHINGRIX, the patient experienced fever, headache, nausea and feeling unwell. In February 2019, the patient experienced chills and feelings of weakness. On an unknown date, the patient experienced cold and unable to eat. On 3rd February 2019, the outcome of the fever was recovered/resolved. In February 2019, the outcome of the headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the fever, headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: At 8 PM after receiving the SHINGRIX vaccine, the reporter began to feel cold. By 10:00 PM she began to experience chills. She woke up Saturday morning, 2nd February 2019, and had a fever of 101.5 F add unit, headache, felt nauseous, and felt sick all day. She reports she could not eat anything and only drank liquids. She noted that Saturday night she started feeling better. On Sunday, the fever was gone although she still felt weak. By Monday, 4th February 2019, she was almost fully recovered. She was recovered now. Did not consent to follow-up. This case linked with US2019GSK032701, reported by same reporter for the same patient.
Received VARIVAX 3-17-10 (R) lateral SQ region walked in 3-18-10 with mpm, 24, cm circumference, 7.2 cm x 5.5 cm with redness and induration. Evaluated by Dr told to take BENADRYL for allergic reaction, TYLENOL for discomfort, cool compress to site.
Stomach upset, virus, and diarrhea. My right arm has a sharp pain from my neck down to my fingertips on a daily basis.
There has been no adverse event associated with this vaccine administration. The reason for this report is due to the fact that the second dose of this patient's 3 dose pre-exposure prophylaxis series was given a day early. It was realized on day 20 of the series that she received her second dose on day 6 instead of on the recommended day 7. In contacting the manufacturer, it was stated that the second dose can be administered up to 48 hours prior to or after the recommended day 7 date as long as the third dose was administered as per the recommended schedule. Both the patient and the provider are aware of this incident and the patient did receive her third dose on the recommended date of day 21.
pt believes in retrospect that her COVID vaccines precipitated fluid overload/CHF exacerbations within a week after each dose
23SEP96 pt devel gen blotchy, pruritic papulo-vesicular rash on neck, trunk & extremities;rash progressed inflamed pityriasis rosea, erythema mult or hypersensitivity were suspected;dx lichenoid & spongiotic dermatitis w/Gianotti-Crosti syn
Rash in the neck, upper back and arm. Body Itchy sensation, nausea, headaches, high fever 101-100-102, body ache, muscle pain, sneezing a lot, vomit, bump in the left arm where the vaccine was placed, feeling overtired, chills, and body shaking, leg muscle spasms, runny nose. I have been feeling all of the above since Friday 4/09/21.  As of today (4/12/21) at 12 pm the fever is between 99-100 which is getting lower however, I still have the above reaction.
Child became increasingly more and more ill beginning approximately 2/1/12. Vomiting, diahrrea continued for over a month.
Large raised inflamed area, firm spot in area of vaccine. Very hot and itchy. Uncomfortable when pressed on. Cool compresses and ibuprofen as directed.
The next day I had a headache and back ache and sore arm. The next couple days I had a sore arm. Five days post vaccine I woke up with numb/tingling legs. The following days the numbness and tingling was moving through my body, feet all the way to stomach, arm and neck and moved up into the back of my head.  I began experiencing extreme dizziness for about a week.  The dizziness subsided. However, I had horrible brain fog and weakness. The numbness went away in my stomach and neck. But it has moved to the top of my head and forehead and lower legs. It is constant. A numb/tingling scalp, forehead and lower legs has not stopped and it has been 7 weeks post the vaccine injection.
I am being treated for cellulitis in my right upper arm with Keflex.  Symptoms were first noticed a week after the vaccine was given.  Symptoms included red, swollen upper right arm, hot to the touch, hard and tender knot about 4 inches in diameter.  After 2 days of the antibiotic and steroid cream, the symptoms  decreased.  I went to urgent care because it was after hours and on a Sunday.  I attempted to treat by putting ice on my arm through out the day, but the symptoms worsened during the day.
Muscle aches & pain (neck & back). Abdominal pain. Diarrhea with loose water, yellow stools. No blood. 3-4 times/day. Complaining of chills, coughing, loss of balance.
Got hives and upper and lower respiratory infc. kept hives and sick for a week. Went to (Hospital-ER) called Dr. there. Got prednisone pills and shot of 125 mg and BENARDYL, ZANTAC 50 mg, called in (ATARAX 25 mg) and SINGULAIR 10 mg.
Severe chills, headache, extreme eye ache from 3/9-3/11 a.m.   2" itchy rash at HCHC  Maderna injection site. 01zaz1a
Approx. 12 hours after receiving my booster shot at drug store, I woke up to diminished hearing in my left ear.  48 hours later, it is still very much diminished.  No imbalance, no fever, no nausea.
Fever for three days: 99-101.9, fatigue for 5 days and headache for 5 days.
Body aches sore arm at 11:30 temp 99.5, took 2-200mg Ibuprofen, at 1 pm temp 100.7,  4 pm had chills and achy joints and skin burning. Also slight difficulty with swallowing mucus buildup. Temp 100.9, talk to acetaminophen 325 mg each. My body was freezing, Migraine headache, body aches and skin burning continued at 9:05 pm my watch told me my heart rate was over 120 at rest for a period of time That had never occurred to me before. I took two ibuprofen at this time. By11:30 PM temp was 101.7 all the previous symptoms returned except for the elevated heart rate. I took two acetaminophen. At 3:24 am I woke with the symptoms again temp 101.9 I took two ibuprofen. 6:30 AM I woke to a temp of 101.3 Bodyaches headache chills and took two acetaminophen. I have continued throughout the day with terms of 100.5 to 100.9 migraine headache sore arm and bodyaches.
Injection site pain; Headache; Fatigue; Injection site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 01-Aug-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Injection site pruritus). In March 2021, the patient experienced FATIGUE (Fatigue). March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). In March 2021, FATIGUE (Fatigue) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site pruritus) had not resolved and INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Fatigue, pruritus/itching at injection sites, injection site more pain and headache was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.   Reporter did not allow further contact
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD recombinant human albumin (rHA), lot # N029673, expiration date 21-APR-2019 (dose, site and route of administration were not reported). The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There were no previous excursions reported.
I was fine the day of the vaccine. The day after, I had a large red circle on my arm that was hot and swollen for 2 weeks. Then, the swelling decreased and it became a large purple bruise that I still have 6 weeks later.
pt c/o diffuse body aches, fever 104 x 12 hrs; joint pain to mild leg swelling, abdominal pain that began the next morning lasted 6 hrs; pt has a known h/o IGA deficiency;