chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling (feet, legs, fingers); Soreness in rear end; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 10:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications for birth control and attention deficit hyperactivity disorder from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient experienced swelling (feet, legs, fingers) and soreness in rear end. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling (feet, legs, fingers) and soreness in rear end was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 15-week-old male with a possible milk allergy and no other pertinent medical history on 01-AUG-2006 was vaccinated with by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653754/0139F).  Concomitant vaccinations administered on that same day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  There was no other concomitant therapy.  The physician reported that on 03-AUG-2006, the patient presented with loose stools times 4 which were green and watery with bright red blood specks.  The patient was afebrile and well hydrated.  His abdomen was benign and he was nursing well.  The patient was seen again on 10-AUG-2006 after continuing with diarrhea 4-7 times per day.  At that time, a physical examination was normal.  No laboratory/diagnostic tests were performed.  The patient was treated with dextrose (+) electrolytes (unspecified) (Pedialyte).  At the time of this report, the patient was recovering.  Upon internal review, stools with bright red blood specks was determined to be an other important medical event. (OMIC)
Violent shaking that subsided after an hour (not chills, but uncontrollable teeth-chattering, couldn?t hold phone or type or walk)  Simultaneous burning in chest  Simultaneous lack of circulation to hands and feet.  Subsided after about an hour.
Pain, tingling which increased over time... now in 3rd month... doctor said nerve damage from needle... sharp pain with lifting or reaching of arm or taking off clothes.
Client reported feeling warm, shortness of breath, and anxious to EMTs. The client stated she started feeling warm after sitting in the observation area for a few minutes. Vitals obtained at 6:56 PM were as follows: O2 99% and HR 112. The client removed her mask and stated that her shortness of breath resolved. The client ambulated, sat down, and was reclined in the anti-gravity chair. The client denied any signs and symptoms of anaphylaxis at that time. The client reported feeling warm and thirsty. Vitals obtained at 7:05PM were as follows: BP 156/90, HR 110, and O2 99%. The client stated that she was pregnant, but did not disclose how many weeks pregnant. The client stated that her blood pressure has been stable at her previous OBGYN appointments. The client stated she has the equipment to obtain her BP at home. Assessed the client's skin and vaccination site and noted no hives or redness. The client stated that the mild redness proximal to her elbow was normal. Noted flushing of the client's cheeks and confirmed this was abnormal for the client. The client drove herself to the vaccination site. RN offered the client Diphenhydramine. The client declined the Diphenhydramine. The client was provided ice packs and she placed them on her face and on the back of her neck. The client has no known allergies. She is currently taking a low dose of Aspirin. The client took a couple sips of her water. Vitals obtained at 7:10PM were as follows: HR 93, O2 98%, and BP 142/80. The client stated, "I think it's better. My breathing is fine, there is no tightness." The client stated she did not drink very much water today, but did eat about one hour ago. The client stated that she felt mildly warm while standing inside the vaccination room prior to receiving the COVID vaccine Pfizer. The client denied any other s/s of anaphylaxis. Repeat vitals obtained at 7:17PM were as follows: HR 97, BP 144/78, and O2 98%. The client stated that she was "still warm." The client denied any other s/s of anaphylaxis. RN provided the client with education regarding s/s of anaphylaxis and when to seek EMS. RN recommended the client follow up with her PCP and OBGYN regarding her BP. The client voiced understanding of this educations. RN recommended the client wait until 7:26PM before leaving the vaccination site. The client reported still feeling warm. The client declined waiting and left the vaccination site at 7:23 PM. She ambulated out of the observation area unassisted with a steady gait.
Patient states that she received her Johnson and Johnson vaccine on 4/7. That night she started feeling fatigued, developed a headache, had some body aches and chills that lasted through the following day, then symptoms resolved.  One week later on 4/14 she developed severe bilateral joint pain, specifically in bilateral shoulders, elbows, and knees- to the point where she could barely walk. She was also very fatigued and had chills. This lasted through the following day and started to subside, but then noticed small, papular lesions scattered across chest and arms. The lesions are itchy, small- 1-2 mm, and follow no particular pattern.  She states that today her symptoms have overall improved other than the small itchy bumps. Denies any headache, abdominal pain, joint pain, fever, chest pain, shortness of breath, or redness/swelling of extremities.
Body aches; Pain; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (Body aches), PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PAIN (Pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication not provided by the reporter.  Treatment information was not provided by the reporter.
Light headedness, 24 hours Swelling pain right arm 48 + Nausea started 24 hours after and  5 hours
Pain to the R arm (side of injection) from shoulder to wrist, limiting range of motion; redness/tenderness to site of injection
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 13-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          Treatment information was not provided. Concomitant medications included unspecified NSAIDs.Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-059087 (Patient Link).
Chills, fatigue, mental fog starting about 8 hours after injection. Symptoms lasted about 8 to 10 hours.
bright white flashes of light in my left peripheral vision . I initially thought this was the reflection of light in my glasses. When these flashes of light appeared in my L peripheral vision on 10/19 when I did not have my glasses on I scheduled an appointment with my eye Dr. on 10/20/2022. At that time I was diagnosed with a "posterior vitreal detachment " in my L eye.  There is no history of this nor did I have any trauma to my head or eye. There is no history of diabetes or hypertension. I was given a 25# weight lifting restriction as I was at risk for a retinal injury or detachment.  I work in the Emergency room as a nurse and my employer was unable to accomadate this restriction and was told by my manager I needed to "file a leave with PRIVATE "(our short term disability company with Hospital) "and contact employee health.  You can't return to work until cleared with no restrictions. We have no light duty in the ER"
Severe Muscle Ache, Fever over 102F, shivers, rapid heart beat, headache.
sore throat/neck, chills, joint pain, injection site itchy and red, heart palpitations on yesterday, lips tingling
feeling cold; feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 13-Apr-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 an unknown date, the patient experienced FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy). At the time of the report, FEELING COLD (feeling cold) and DIZZINESS (feeling dizzy) outcome was unknown. Not Provided          NO concomitant medication was reported. No treatment medications were reported.    Reporter did not allow further contact
pt recv vax & exp an inj site rxn described as the size of a quarter that was sl hard like a bump;pt also devel a few vesicles around the needle puncture;area was painful to touch but had not no problems moving arm;
Developed Redness, warmth, itching and swelling at the site of the injection.
fever intermittent 5 days;sore lips, tongue, gums which also swollen;
Asthma; Sinus; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as first dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced asthma and sinus. The patient went to the doctor because of the events and was prescribed antibiotic Amox Clav 875 mg which she started taking last Saturday (29May2021) and had been taking it for 6 days and had finished with the antibiotics. Later she clarified that she has one dose left of antibiotics. The patient's next appointment for the second dose was 05Jun2021 (Saturday). Outcome of both the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
some of the vaccine leaked out onto the patient's arm during administration; some of the vaccine leaked out onto the patient's arm during administration; A spontaneous report was received on 02 FEB 2021 from a healthcare professional concerning a patient, unknown age, unknown gender, who received Moderna's COVID-19 vaccine experienced some of the vaccine leaked out on to the patient's arm during administration.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, patient received mRNA-1273(Lot number: unknown), intramuscularly on patient's arm for the prophylaxis of COVID-19 infection.  On unknown date, the patient experienced some of it was leaked out on the patient's arm when administered. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, some of the vaccine leaked out on to the patient's arm during administration was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Device connection issue, and Underdose for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Device connection issue, and Underdose.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) lot # K005428, expiration date 15-APR-2016 and lot # L001335, expiration date 13-JAN-2017, 0.5 ml, once, subcutaneous (anatomical location was not reported). No concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
Fatigue/malaise, aching joints, low-grade fever, slight headache--all began approx. 23 1/2 hours after vaccine.  Chills began approx. 36 hours after vaccine.  Extra-strength acetaminophen (2 tabs) taken approx. every six hours during daytime hours when symptoms began.  Symptoms continued for approx. 50 hours after they initiated.
Five minutes after given the two vaccines, the pt went into a deep sleep, pt will move with painful stimuli (rubbing the sternum) but will not open the eyes. NL, HR, RR and O2 sat. NL capillary refill, she remained like this for 25 minutes. The same thing happened with previous vaccinations.
3 wks p/vax pt exp pain in jaw;fever & wrist pain followed in JAN-FEB 2-3 months p/vax;situation worsened then Crohn's disease was dx'd;tx for Crohn's
Student began c/o tingling to face, finger weakness to lower extremities. Went to Emergency room - FLUMIST and HPV given at about 10AM on 11/6/2014. Symptoms started about 5:30PM.
Swelling to left anterior thigh, red, warm, blanches, slightly raised, no pustules, no fever, no other rash. Occurred within 24 hours of vaccination. Patient taking oral BENADRYL and apply cold compresses. Slight improvement with treatment.
Sick; Tested positive for Coivd after vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given). At the time of the report, MALAISE (Sick) and COVID-19 (Tested positive for Coivd after vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
patient tested positive for COVID 19 on 7/1/2022, hemodialysis patient admitted on 6/28/2022 on 4 l NC, over the course of the first few days oxygen needs increased from NC to non-rebreather to bipap to high flow nasal cannula. patient was a DNR and expired on 7/24/2022.
Headache, Arthralgia,  Fatigue, chills, injection site pain and swelling
Patient called in and reported extreme pain in right arm. Pain scale 10 on scale of 1-10. She took 2 Ibuprofen & one VICODIN, with no relief of pain. Advised her to contact her physician. He advised ice to area without seeing patient. Pain resolved with ice treatment. Next day, patient was pain free.
Fever Fever of 102 with chills and sweating and arm pain on 1/22/21, symptoms improved on 1/21/2021. Narrative:
pt devel persistent high pitched cry 12 hrs p/DTP/HIB/OPV; had severe local reaction, fever 105 x 1-2 days; irritability lasted 7 days;
This spontaneous report has been received from an office manager referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On an unknown date, the patients were vaccinated with VARIVAX lot # N024567, expiration date of 07-SEP-2019, for prophylaxis (strength, dose, route and anatomical location were not provided). No adverse events reported. The vaccine was exposed to a temperature range of 39.5°F, during a time frame of 15 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1802USA011938: US-009507513-1802USA012115.
The pt reports post vaccine she developed a rash all over the abdomen, slightly raised and itchy.
received one Shingrix vaccine in 2017 and two in 2019; diagnosis of Shingles/ Suspected vaccination faliure; diagnosis of Shingles; Skin lesion; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11-MAY-2023, 4 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: diagnosis of Shingles/ Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: diagnosis of Shingles) and skin lesion (Verbatim: Skin lesion). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: received one Shingrix vaccine in 2017 and two in 2019). The patient was treated with valaciclovir (Valacyclovir), gabapentin and cannabidiol (Cbd). The outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown and the outcome of the skin lesion was resolving.  It was unknown if the reporter considered the vaccination failure, shingles and skin lesion to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles and skin lesion to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 30-MAY-2023 The patient self-reported this case. In 2017, the patient received first and in 2019, second Shingrix vaccine. On approximately, 11 May 2023, he had noted one lesion. Two days later, two more lesions appeared, then more started coming up. He went to his healthcare professional (HCP) and was diagnosed with Shingles on 25th May 2023. His physician prescribed Valacylovir 500 mg tid and gabapentin 300 mg tid and he was also using a cannabidiol (CBD) cream which seems to be helping dry the lesions. He was referred to HCP for decision whether to vaccinated again and provided Medical Information telephone number. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
24hr p/vax arthralgia, muscle aches, pain vax given 2JUN97 sx have persisted 20JUN97;
DEVELOPED B/L HIGH PITCH TINNITUS NON STOP 1 WEEK AFTER VACCINATION. NEVER HAD ANY ISSUES PRIOR
Left upper arm - close to shoulder - was felt weak, difficult to raise arm, along with a throbbing pain.  This pain has persisted, and weakness has persisted as well, somewhat lessened.
Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 30-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional information: Report was related to a study or programme. Details: 159558; COVAX Support. Reason for no lot number of Tetanus Shot was reported as reporter unwilling to complete the report. Reporter on line who was 77-year-old and got the Bivalent COVID-19 Vaccine on Friday. She had another friend of hers who got 3 shots together, her friend got that shot and the tetanus and just got a headache. Her friend was like 30 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling at injection site with rash and pain.  Red, pimply rash and soft tissue swelling.
This is a spontaneous report from a non-contactable consumer. A 16-month-old male patient of an unspecified race received PREVNAR 13 on unknown date at single dose for immunization. The patient medical history and concomitant medications were not reported. 7 days later was diagnosed with pneumonia. He had a fever a 104.9.  No follow up attempts are possible. No further information is expected.
Large (softball size) swollen, hot, itchy, sore to the touch area  around injection site appearing several hours after injection.  Had the Same reaction after the first dose and that spot lasted 3 weeks. Had the second injection in the other arm.
HEADACHE, DIZZINESS, NAUSEA FOR 2 DAYS THEN LARGE AREA OF REDNESS, SWELLING, SLIGHT TENDERNESS BOTH ARMS MORE ON RIGHT THAN LEFT WHERE SHOTS WAS GIVEN; GETTING BETTER AFTER 3RD DAY.
100 hour migraine, aches and pains over entire body, sleeplessness, chills, shivering for 4 days.
Chills starting that night. Fever, nausea, and headache the next day.
Information was received from a healthcare worker concerning a 41 month old female with asthma who on 05 SEP 2002 was vaccinated with a dose of Varicella.  Subsequently the patient experienced chickenpox.  Unspecified medical attention was sought. A product complaint was not involved.  Follow-up information was received from a physcian who indicated that on 10 FEB 2005 the patient developed Varicella with lesions clustered in the perineal area.  It was unknown it the patient recovered.  No further information is expected
Member came into immunizations clinic on Saturday, 11/01/03 in the morning. He received 2 shots. Early in the afternoon, he began to feel lightheaded, dizzy, warm and sweaty with mild nausea. He came into the clinic and was assessed by the provider.
Pain in arm, then progressed to extreme chills, fatigue, shivering, shaking, and sweating. All joints very sore, prior traumatic injury form 11 years ago to foot experienced abnormally high sharp pains, headache,  stomach cramps and gas.  Symptoms elevated beginning around 10 PM and lasted through the night.  Symptoms began to subside around 5AM.
Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 154/97 (pulse 94), 98% O2 sat.