chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Worsening muscle and joint aches; Worsening muscle and joint aches; Too uncomfortable to sleep, work, drive etc; Too uncomfortable to sleep, work, drive etc; Too uncomfortable to sleep, work, drive etc; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 23Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to epoxy. The patient received unspecified oral contraceptives within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021 at 04:00, the patient experienced worsening muscle and joint aches in the day after the shot and the patient felt too uncomfortable to sleep, work, drive, etc. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the events worsening muscle and joint aches and the event too uncomfortable to sleep, work, drive etc were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Cellulitis (L) thigh started on KEFLEX and worsened sent to ED 11/4/18 admitted for IV Abx. Clindamycin given.
On 4-30-15 this patient received KINRIX on right deltoid area. Within 24 hours of the administration of the vaccine, patient developed a 3" x 3" area of redness, local warmth and swelling of 2/3 of right upper arm. She also had local tenderness with mild induration. Moderate fever. Treatment with warm compresses and Acetaminophen every 4 hours. Patient was evaluated at the ED on 5-3-15. On 5-4-15 I saw the patient, the swelling, redness and induration had resolved 50% as compared with picture taken by parent on 5-3-15.
Shot 3-17-02, left leg and unable to walk.  3-20-02 tried tread mill.  Condition severe pain.  Left leg, left hip, side of face, left shoulder pain.  Dr. called.  Top of head - pain.  Back of neck pain.  3-25-02 called doctor.  Celibrex given.  Itch, hives.  D/C med.  4-4-08 some relief leg.  Undated report with c/o redness, heat and pain to R upper arm. No office visits or notes post vaccine
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown dates in 2016 (dates ranging from 26-FEB-2016 to 04-MAY-2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, administration site, lot # and expiry date were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion at minimum 29 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. There was previous temperature excursion on 25-FEB-2016, with temperature at minimum 30 Fahrenheit degrees and maximum 39 Fahrenheit degrees for less than 12 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
After my second Covid-19 vaccine injection, I had an injection site reaction consisting of a raised red welt approximately 6 cm in diameter. The welt was firm, warm, and painful, and resolved after 7 days. Following my first Covid vaccination, I had no reaction at all. My first injection was Moderna Lot #026L20A, and the second was Moderna Lot #010M20A.
(1) very pale, white - bluish lip - one minute event in a very warm store (2) "Fainting" duration 5 minutes with in 5 hrs. of vaccine
Patient started to have a reaction to the Moderna vaccine. Pt states About two minutes after receiving the vaccine, her mouth started to feel numb and was described as "feeling like when you go to the dentist and get it numbed".  Pt develop a small red spot that turn into a rash on her upper chest and neck. Pt declined an amb. multiple time. Pt was given oral Benadryl 25 Mg. x2 with water. Pt has stable VS. Pt send to the hospital via private auto. ED was called to advised them of pt's conditions. Site of injection was not assessed by EMS prior to her leaving with an escort (her boyfriend) to go to the ER.
Dec. 29, 2020 - first Moderna Vaccine dose.  On same day I had mild localized injection site soreness/pain & felt minimally tired.  The next day the injection site was a little more sore/panful & I had moderate headache the whole day.  The next day I was fine,   Jan. 26, 2021- second Moderna Vaccine dose.  Six hrs. later the injection site was mildly sore/painful.  12 hrs. after receiving the dose I began to feel body aches, some chills, decreased energy level & did not fall asleep the whole night.  The next day I had moderate headache, continued to have some infrequent chills, body aches, decreased energy level & injection site soreness/pain was still mild but had increased from day before.
The vaccination was expired, no reactions occured, provider contacted mother explained all outcomes and recomendations, a plan of action put into place and submitted  with report of incident to vfc.
This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (strength, dose, anatomical site, lot # and expiration date were unknown), intramuscular for prevention of Human papillomavirus (HPV). The physician reported that the vaccine was administered before learning that the patient was pregnant. No adverse effects were reported.
Rash on forehead, cheeks, chin, beneath chin, neck, chest, back, stomach, left arm.  Swelling on face, swelling of uvula.  Benadryl taken on 04/17/2021.  Emergency room visit on 04/18/21, due to the swelling.  Benadryl and steroid as treatment given at hospital and prescribed for 3 days.  Symptoms decrease with treatment.  Evidence of rash still present at treatment end.
Refridgeration excursions identified; Poor quality product administered; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022 at 2:09 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant product use was reported.  The storage condition at the time of the excursion was refrigerator. Vial underwent previous temperature excursions.  The vial stored was returned to the freezer/refrigerator or maintained at room temperature. Individual vials or unbroken cartons was 2 unbroken cartons 20 vials. Two different lot numbers AS1412B and 057A22A. The vial moved from freezer to refrigerator on 07-Sep-2022. No treatment information was provided.
Patient stated that he felt dizzy after he left pharmacy area and went shopping.  It was almost an hour after the vaccination that he stated he was not feeling well.  He called his daughter and she came and picked him up.  He walked out of the store and seemed to be fine.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 29 year old female who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in an unknown arm.  On 5 October 2007, the same day of vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arm continued to be tender.  Pharmaceutical product complaint was also identified.  These events resolved by 08 October 2007 and were not considered to be related to treatment with Flulaval.  On follow-up, swollen arm an stiffness of the arm lasting two days was reported.  Onset of these events was not specified.  The reporter noted that this occurred in six patients.
client reported numbness to face and throat after receiving 1st Pfizer Covid Vaccine (Lot#EW0161 Exp.4/14/21). Client had completed 15 min observation period when she alerted EMT she was feeling numbness to her face and throat. Warmth sensation that passed through right side of body for a few seconds and was gone. PHN also responded. Offered client to contact paramedics for further assessment. Client denied, wanted to just stay longer in observation. Client alert and oriented, denied shortness of breath, no trouble swallowing. Vitals at 1341: blood pressure 130/90, pulse 78, oxygen 97%. PHN  joined staff. Per client felt a sensation "like when you get anesthesia at the dentist". Feeling at this time only at cheeks and nose. Throat no longer affected, warm sensation had resolved. Me history of allergies. Medical history of lupus and kidney problems secondary to lupus. Current medication: Myfortic and lisinopril. PHN assessed for face flushing and swelling. Client able to answer all questions with no problem and denied shortness of breath. Client informed we could keep 30 mins for further observation. Vitals at 1448: blood pressure: 130/90, pulse 75, oxygen 97%. Client stated sensation returning and smaller area affected now. Denied shortness of breath, no redness or swelling noted. Vitals at 1358: blood pressure: 130/80, pulse 79, oxygen 99%. Per client more improvement. Client advised to speak with provider before second dose. Last vitals at 1408: blood pressure: 126/80, pulse 70, oxygen 98%. Per client sensation almost back completely. Affected area only tip of nose and maxillary sinus area. Client stated well to leave facility. Per client family member waiting outside and would be driving. ER precautions given. Client left facility at 1411 with steady gait.
This case was reported by a physician via call center representative and described the occurrence of tenderness in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced tenderness. On 17th October 2018, the patient experienced pruritus, erythematous rash, shivering and tiredness. On an unknown date, the outcome of the tenderness was recovered/resolved and the outcome of the pruritus and erythematous rash were not recovered/not resolved and the outcome of the shivering and tiredness were unknown. It was unknown if the reporter considered the tenderness, pruritus, erythematous rash, shivering and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. At 14:00 hours, the patient received SHINGRIX in the left deltoid. After receiving SHINGRIX, the patient developed a red, flat non-confluent rash on her arm about 24 hours after the vaccination. The next day, the rash had extended to her inner thighs. This case has been linked with the case US2018190180, reported by the same reporter.
Pt was given HPV GARDASIL #2 Lot # 1171AA, exp: 11/11/2013 on 5/29/12 at approx 350 PM for "nursing visit". Pt mom filled & signed questionnaire & read over VIS - no hx. with problems noted. Pt felt faint & dizzy 10 min after administration & fell to the floor - zero, no injuries sustained. Pt was sweating but denied LOC. Pt brought back & allowed to lay down for 15 more min.
UNEXPECTED BENEFIT FROM THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and concurrent conditions included bursitis, heart problems, copd, arthritis, herniated disc, and pain in shoulder. The patient experienced drug allergy when treated with celecoxib, and dextromethorphan hydrobromide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:20 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced unexpected benefit from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit from the vaccine was not reported. This report was non-serious.
Pt saw medical provider on 7/13/19.  Has L shoulder pain, post pna vaccine on 7/11/19; reports pain in posterior shoulder, radiates down L arm and limited ROM - Reports "over next 48 hours, it's been more painful" and could barely sleep last night - Took Aspirin and Tylenol. with some good effect  - Reports having a "slight fever and achy feeling" on 7/12/19  Pt was given Keflex and medication for pain.  Advised to apply warm compresses.  Pt saw provider on 7/15 and reported improving symptoms.  Provider recommended pt continue antibiotic course to completion.
Itching over entire body; arms, back, bottom of feet and palm of the hands. Took Cetirizine. A week later eyes began to itch, ringing began in left ear.
Swollen; Pain left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen) and ARTHRALGIA (Pain left shoulder) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Pain left shoulder). On 13-Apr-2021, the patient experienced SWELLING (Swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWELLING (Swollen) and ARTHRALGIA (Pain left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from an approximately 77 year old female registered nurse regarding herself. The medical histories of the patient included gallbladder removal surgery, atrial fibrillation and root canal that cause neck and back problems. There were no drug reactions or allergies. On an unknown date in October 2009 (reported as October or November 2009), the patient was vaccinated with 0.65 milliliter (ml) (reported as standard) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously. There were no concomitant medications. On an unknown date in 2013 (reported as in the summer of 2013), she began not feeling well and was experiencing discomfort in her back. By 29-JUN-2013, her shingles rash appeared. The patient sought medical attention. She went to an urgent care facility and was prescribed medications for treatment. The patient was treated with heating pad, hydrocodone and acyclovir. It was unspecified if any lab tests were performed. The patient talked to her primary care physician on 31-JUN-2013 and informed him of the shingles outbreak. The rash presented itself on her upper left chest and back, under her left arm, and her left sternum. The rash was accompanied by itching and pain. The patient was recovering from the events as the patient felt as though she was about 98 percent recovered from the shingles outbreak, however she still has sensitivity in her back. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
3/1/2021 - nausea, vomiting, fever 99.9 3/2/2021 - nausea, sore throat, fever 100.9, headache, fatigue 3/3/2021 - sore throat, fever, cough, fatigue, headache, muscle aches These symptoms lasted through April. I started feeling better for almost a week and then all symptoms returned, but with difficulty breathing, and constant cough. I?ve been to the ER twice.
generalized hives followed by generalized eczematoid rash with intense pruritis.  One 2 cm cluster of small vesicles right lower pre-tibial area.
she was in so much pain; unable to use her hand; This is a spontaneous report from a contactable consumer (patient), via Pfizer-sponsored program Pfizer First Connect. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581), via an unspecified route of administration, on an unspecified date at 13:30 (at the age of 68-year-old), as dose 2, single, in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's past drug included cortisone, taken for dog bite in left hand. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration, on 23Jan2021 (at the age of 68-year-old), as single dose for COVID-19 immunization and experienced no symptoms. On 14Feb2021, after the second dose of vaccine, the patient was unable to use her hand "at all." Patient reported that it was improving but "just still hard to open that hand." Patient thought that the vaccine shot "may have hit a tendon and brought the pain back from the dog bite." On an unspecified date, after the second dose of vaccine, the patient was in so much pain. It was really bad. Patient reported that it was getting better. The clinical outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
Red, warm at injection site - 6 x 6 mm, 55 x 40 mm, (+) tender, no D/C. Noted 4-1 by mother. Rx KEFLEX 250mg/5ml 5 ml 4x1d x 7D, cool compresses, f/u 5D, if worse -> ED.
Swelling in my arm pit; Sever pain in arm where the shot was given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in my arm pit) and VACCINATION SITE PAIN (Sever pain in arm where the shot was given) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling in my arm pit) and VACCINATION SITE PAIN (Sever pain in arm where the shot was given). At the time of the report, LYMPHADENOPATHY (Swelling in my arm pit) and VACCINATION SITE PAIN (Sever pain in arm where the shot was given) outcome was unknown.
c/o "sick for a few days, went home early Wednesday. took Thursday off and went home early Friday. Lot of pain at injection site too". After vaccination. Not first flu shot
Mother brought child in complaining of local reaction on LVL.  Area red, approximately 4x6cm, no induration.  Cool compresses applied at home.
Rash & UrticariaPruritus Narrative: rash on r arm day 1; 1/25- rash on torso; cough;soa;itching- treated with prednisone shot on 1/28
Nickel sized bruise appeared after vaccination and has not gone away yet. Flu-like symptoms began, waking patient at 0300 hours on 2/18 in a state of confusion. noted ringing ears, dizziness, abdominal distress that resulted in diarrhea, as well a headache and backache. After struggling to get up and failing the first time, patient was able to relieve self in bathroom before going back to sleep until about noon.  Patient took ibuprofen before going back to sleep. Flu like symptoms persisted into the next day, and included feverishness and fatigue. Patient was feeling better by 2/19.
Inflammation in left hip area; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021 20:00, at the age of 51-years-old, (Lot Number: Ff2588) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included High blood pressure, acid reflux, and allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Sep2021 20:00, the patient experienced inflammation in left hip area. The event involved Emergency room/department or urgent care. The event was assessed as medically significant. The outcome of the event was unknown.  Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event (Pain med and inflammatory med).