chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bruise at injection site; Blisters at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADMINISTRATION SITE BRUISE (Bruise at injection site) and INJECTION SITE VESICLES (Blisters at injection site) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ADMINISTRATION SITE BRUISE (Bruise at injection site) and INJECTION SITE VESICLES (Blisters at injection site). At the time of the report, ADMINISTRATION SITE BRUISE (Bruise at injection site) and INJECTION SITE VESICLES (Blisters at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Unspecified concomitant medications were taken by the patient. Treatment medications were unknown.
Initial unsolicited report received from a consumer on 30 November 2015. This case involves a 81 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (Manufacturer, Batch number, expiry date was unknown; dose, dose in series, route and site of administration were not reported) on 20 October 2015 and with an injection of PREVNAR 13 (Manufacturer: Pfizer; Batch number: Unknown; dose, dose in series, route and site of administration were not reported) on 20 October 2015. The patient had received vaccine in doctor's office. In 2002 the patient had realized that she had cervical stenosis and in 2013 the patient was diagnosed with L4-L5 lumbar stenosis and then in June and July 2014 she had lumbar laminectomies for L3-4, L4-5. It was reported that the patient rides her bike but can feel back problem (lower back problem) while walking (ongoing). The patient had some ongoing digestive problems and noticed that when she was around 40 years old she had constipation and laminectomy exacerbated the constipation. The patient had received fiber as concomitant medications. On an unknown date in 2015, one week following the vaccination, the patient had itchiness first and then rash like a pimple (hard and pink). It was reported that the rash was first on her hip, one on her right breast, one under her arm (very itchy) and one on her left arm (little itchy) with one or two of the pimples. Laboratory data included good EKG and blood work in last July and had a great echocardiogram recently, within the last month. The patient was treated with Caladryl for rash. The patient was not recovered from all the events. List of documents held by sender: none.
mom states gave APAP a/bed on day of shot; had fitful right; fever in AM; gave APAP all day; to ER 9PM 25AUG92 t105 & sponge bath; fever going down on 26AUG92 by 27AUG92 fever nl; MD did not comment on other shots;
Bilateral pulmonary clots, bilateral lower extremity clots, right heart strain, atrial fibrillation, right atrial clot, heart attack
Dizzy; Weak; Sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Hives on the face cheek, body itch, dissiness.  I took benadryl 25mg Po, checked my Blood pressure 99/60 pulse 68, blood sugar lvls 87mg/dl
Patient got Flu and PNEUMOVAX at office. She started felling sick and not well Tue. and there was red streaks on her arm. She went to urgent clinic of some sort and they gave her KEFLEX, inj. thinking about may be cellulitis. She still not fee well on Wed. and she got one more KEFLEX shot.
Extreme irritability starting 2 hours after vaccination. Exam revealed induration, tenderness, and redness at left thigh injection site. Symptoms tapered that night and into next day.
About 20 minutes after IMZ, patient came back to the pharmacy and stated she felt like she was having an allergic rxn to the shot, similar to what she feels like when she has shellfish. Patient stated itchy feeling in her mouth/ lips. She said she is a nurse and is going home to take BENADRYL She went home and took 2 BENADRYL and a nap. At around 9 pm, symptoms came back so she took 2 more BENADRYL and went to bed. Next day was fine except some arm soreness and nausea. Patient is planning on still getting the second shot- wants to take on a day she isn't working so she can take BENADRYL before the shot.
Information has been received from a registered nurse (R.N.) concerning a 12 year old male who on 17-NOV-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot#, dose and route not reported). It was reported that the patient called the physician on 18-NOV-2010 to report that his whole arm swelled up to the point where he was having a difficult time moving his arm. The physician instructed the patient to go to his primary care doctor. The patient did not seek medical attention. At the time of reporting, the outcome as unknown. Additional information has been requested.
Site where administered the Pneumovax, red, warm, very tender, swelling 9x11cm and fever. Started 24 hours after vaccine. Continued for 4-5 days. Pt ok after antibiotic and antihistamine treatment.
Influenza vaccine given 11/14. That night had fever 104.05 and extreme irritability 11/15. Still very irritable; no fever.
MMR and Varicella vaccines given 07/11/2016. Shorts given seperatly. Fever experienced the next day it lasted 2 days. Hand, wrist pain started 24 hours after shots. Diarrhea started 2 days after shots. Stomach pain lasted for 1 week. Swelling of hands and wrists along with pain to hands/wrists lasted 2-3 weeks.
2 hours after receiving vaccine started fever, HA, chills and sore throat.  Was diagnosed with tonsillitis 2 days later and treated with Zithromax.
Headache, Arthralgia, injection site pain Narrative: Joint pain, malaise, headache, fatigue, injection site pain. I was vaccinated on Friday 1/8/21 and had to use sick leave for 1.5 days the following Mon-Tues due to lingering symptoms of malaise & fatigue lasting for longer than 3 days.
Mother stated her son came out of his bed room from playing with his brother and said the his brother hurt him, the injection site was red and swollen.
Myalgia Narrative:  Muscle soreness and swelling to arm x2 days; chills
Redness around mouth; painful mouth; burning mouth syndrome/ Burning mouth; Blisters in mouth; blisters on upper lip; completely exhausting; Shingles/ Shingles on butt; Sinus infection/ something affected mouth nerves; Sinus infection/ something affected mouth nerves; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In January 2019, the patient received the 1st dose of Shingrix. In February 2019, 28 days after receiving Shingrix, the patient experienced sinus infection and oral discomfort. On an unknown date, the patient experienced shingles, oral redness, oral pain, burning mouth syndrome, blistering of mouth, lip blister and exhaustion. The patient was treated with amoxicillin trihydrate, potassium clavulanate (Augmentin Bid), ceftriaxone sodium (Rocephin), acyclovir and medication unknown (Nerve Medication). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the sinus infection and oral discomfort were recovered/resolved and the outcome of the oral redness, oral pain, burning mouth syndrome, blistering of mouth, lip blister and exhaustion were unknown.   It was unknown if the reporter considered the shingles, sinus infection, oral discomfort, oral redness, oral pain, burning mouth syndrome, blistering of mouth, lip blister and exhaustion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 74 years or 75 years. Sometime in January 2019, the patient got the 1st injection. The exact date or information regarding the vaccine was unknown. 6 weeks after the 1st dose, the patient experienced first episode of shingles. She took Acyclovir and it dried up within about three days. The patient again had shingles and it was on her butt.  The patient stated, she had shingles before but never like this. But since from receiving Shingrix, the patient had shingles and something affecting the nerves around her mouth. In February 2019, the patient had a sinus infection and it was really bad. The patient needed two Rocephin shots and took Augmentin twice. About the 4th or 5th week following the dose of Shingrix, the patient had redness around her mouth and was extremely painful. Her mouth burned. She thought, what around her mouth was shingles. The patient also went to the dermatologist because of the redness around her mouth and was told it was something with her nerve and she had burning mouth syndrome. The patient also developed blisters in her mouth and upper lip.  She never had fever blisters in her life. It was extreme but they were recovering because she was taking Nerve Renew, which had alphaliphic acid antioxidant support. The patient would felt like it was healing one day but she supposed that due to her mood, she would get a new blister. Since from the past 6 months, the patient had been completely exhausting.
7 days after, sore arm, red rash approximately size of palm of hand, warm to touch,
headache; Sore arm where the shot was administered; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 42-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unknown route of administration on an unknown date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications included Colecalciferol, Echinacea. The patient experienced headache and sore arm where the shot was administered. The outcome of the events was unknown.   No follow-up attempts were needed. No further information was expected.
Tue - normal arm pain from shot, chills, in the evening and following day,   extreme fatigue and chills the following day (wed), first night (tue) - salivary glands reduced or stopped saliva - extreme dry mouth, following day (wed)okay.  Thu morning, woke up fine.
After only having the first dose (1 of 2):  extreme light headed, nausea, weakness, no balance, pain in upper right side ribs below arm pit, Received shot for nausea and stayed in bed all day - mostly better the next day and normal the following day.
Headache, Myalgia & Fever Narrative: fever, chills, headache, body aches, swollen lymph nodes, nausea, loss of appetite
This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with ZOSTAVAX, lot # M042850, expiration date 18-JAN-2018 for prevention of shingles (dosage and route of administration were not reported). ZOSTAVAX was reconstituted with sterile diluent (STERILE DILUENT), lot# reported as "M032268" (verified as not valid for ZOSTAVAX, expiration date 19-APR-2019 (dosage, route of administration were not reported). In approximately September 2017, the patient experienced itching, redness and inflammation above the elbow. On 18-SEP-2017, the patient returned to the pharmacy with the events. The patient's primary physician diagnosed mild skin infection and prescribed unspecified treatment for the event. The outcome of the events and the relatedness between the events and ZOSTAVAX and sterile diluent (STERILE DILUENT) were not reported.
Within 10 seconds patient became diaphoretic, dizzy,  I eased him to ground, eyes rolled back, I did sternal rub, because more awake. Slight loss of conscience. Cold and clammy.
FATIGUE, PAIN IN LOWER BACK, NO ENERGY, MASSIVE HEADACHE, CONGESTION (ONLY SNIFFLING AND POST NASAL DRIP), RIGHT ARM SWOLLEN AND PAINFUL, SORE ARM, VERY SLEEPY, NO APPETITE
Information has been received from a registered nurse (R.N.) concerning a 68 year old female who "2 months ago", in July 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). "A week ago", on approximately 03-SEP-2008 the patient developed a severe case of shingles. Unspecified medical attention was sought. The patient was given FAMVIR within 48 hours to slow the progression of the rash. At the time of this report, the outcome was unknown. The nurse felt that the patient's shingles were an other important medical event. Additional information has been requested.
ShaRp SubsteRnal & paRasteRnal chest pains a/w SaB @ Rest, DOE & oRthopnea
Pt recvd Engerix-B & soon p/1st dose exp generalized rash; received only 1 dose; pt seems alright;
Pain and burning sensation at elbow feels like it?s on fire under my skin 24/7. Numbness from elbow down to pinky and ring finger comes and goes.  Constant pain when gripping fingers or picking  up anything. Dropping items when picking up due to pain radiating up to elbow. Constant aching pain throughout whole left arm needing pain medication and ice for some relief. Pain never goes away completely. Brought to tears a few times  with terrible aching pain down wholearm. Pain when twisting arm  to the left or right.  I feel like I?m loosing strength and use of my left hand and arm with permanent damage.
On 5/9/18, diagnosed with intussusception. Not sure if it is related to vaccine or not.
Had fever day 2, checked it once 5 minutes after drinking cold soda and eating ice cream and it was 100.8, so it was probably higher, would reduce with Advil for awhile but return.  Had all symptoms associated with elevated temp, lethargy, headache, weakness. Also had Leg cramps. Lasted all day, finally broke at 4 am.  Lasted about 24 hours.  All symptoms gone after 24hours but I was tired from leg cramps and slept most of day 3.
Right anterior thigh with 10x10cm area of erythema & induration, mild tenderness noticed about 48 hrs after vaccine given. Warm compresses, BENADRYL & f/u in 2-3 days.
Injection site sore and swollen.  Lasted a few days per patient.  Patient reports soreness when lifts arm.  (Left deltoid).
Laceration of finger; Urinary tract infection; Vaccination site nodule/ Knot in arm; This is a solicited report from a Non-Interventional Study based on information received by Pfizer from AbbVie, MFR Control No. 21K-163-4114081-00). A contactable consumer (patient) reported that a 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, both vaccination site was arm and for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) and no information about ongoing, at unknown dose and frequency for moderate to severe rheumatoid arthritis.  The patient's medical history and concomitant medications was not reported. Patient with events of knee replacement surgery and urinary tract infection, patient cut knuckles and got second covid vaccine and had knot in arm with Rinvoq (upadacitinib). Events onset date was in 2021.The action taken in response to the event(s) for upadacitinib was unknown.  Therapeutic measures were taken as a result of urinary tract infection and cut knuckles included antibiotics. The outcome of Vaccination site nodule/ Knot in arm was recovered in 2021 with duration 4 dyas. The outcome of other events was not recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter's causality for the event(s) of knee replacement surgery, urinary tract infection, patient cut Knuckles and got second covid vaccine and had knot in arm was not provided.   AbbVie's opinion is that there is no reasonable possibility that the events of knee replacement surgery, Patient cut knuckles and got second covid vaccine and had knot in arm are related to Rinvoq (upadacitinib).  AbbVie's opinion is that the event of urinary tract infection is not assessable.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Laceration of finger, Urinary tract infection and Vaccination site nodule. The case will be reassessed further upon receipt of additional information. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Random shooting pains in both legs(mid calf, ankles, medial right knee, behind left knee cap, bottom of both feet), feet feel swollen and hot but no swelling on inspection. Random intermittent pains in both hands. Pins and needles feeling in both legs/feet and hands. Started 6th day after injection to the present (2nd day). This also happened after my 2nd Pfizer covid vaccination. Blood tests came back negative, xray of spine was read as negative. Steroids and gabapentin prescribed after that event.
very sore arm for 2 days;the next day h/a, body aches, chills, & fever 100 the following day all was nl;
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In September 2016, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area.  The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.
Patient stated he had all over muscle and joint pain. This amount of pain caused him to go the the doctor on 1/14/19. The doctor informed him it was an allergic reaction to the second SHINGRIX dose and that something in the serum had changed. Patient received a steroid shot and he said he felt a lot better.
That evening my heart was pounding very hard throughout my entire body that's all I could hear laying down I thought that I was going to either have a heart attack or a stroke. I got up and took one of my blood pressure medications. It's slowed down but I was unable to sleep due to feeling jittery and my heart pounding hard. The next day I felt exhausted my stomach hurt. I have had a sore throat the worst being on the Thursday following. Today Friday things seem to be subsiding.  However my concern is not to get the second dose if I had such a bad reaction the first time I definitely will have a heart attack the second time.
Narrative:  Patient hospitalized x 2 for care related to COVID-19 pneumonia. Admitted 7/31/21 following presentation with c/o 1 week of nonproductive cough, congestion, weakness, mild shortness of breath and diarrhea. Poor appetite and not eating well but no nausea or vomiting. Given IV fluids, IV remdesivir, oxygen, dexamethasone. Dexamethasone worsened hyperglycemia and as patient felt better was held. At discharge - all diarrhea resolved, felt better, appetite improved, able to walk 100 ft without oxygen. Discharged 8/4/21. Readmitted 8/9/21 after presenting with progressing weakness and shortness of breath, new onset chest pain and continued loss of appetite. On admission, afebrile, BP 95/60, 92% O2 saturation on room air with anion gap lactic acidosis. He was resuscitated with 3L IVF and acidosis and AKI resolved. Appetite and oral intake improved with appropriate urine output and bowel movements. Discharged home 8/12/21.
NO APPETITE; HEADACHE; FEVER; NAUSEA; BODY ACHE; FATIGUE; DRY MOUTH; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia, pcos, drain cysts, and drug allergy, and concurrent conditions included non-smoker. The patient was previously treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced dry mouth. Laboratory data included: Body temperature (NR: not provided) 101.8 F, 101.3 F. On an unspecified date, the subject experienced no appetite, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, body ache, fatigue, and dry mouth, and the outcome of no appetite and headache was not reported. This report was non-serious.