chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COld; Osteoarthritis/ Pain in her left arm and shoulder/ Could not hardly lift her left arm; This spontaneous report was received from a 66-year-old female patient via other company (Pfizer). The patient's pertinent medical history, drug allergies/reactions and concurrent conditions were not reported. The patient's historical vaccine included pneumococcal 13-valent conjugate vaccine (PREVAR 13). The patient's concomitant medication included rivaroxaban (XARELTO). On 24-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection in the left arm, up high in the muscle area once (strength, dose, schedule, route of administration, lot# and expiry date was not reported) and influenza virus split virion 3v vaccine inactivated (FLUZONE) injection (strength, dose, schedule, route of administration, lot# and expiry date was not reported) in the right arm both for prophylaxis. On the same day, couple of hours after vaccination, the patient experienced pain in her left arm and shoulder and could hardly lift her left arm. It was also reported that, for the first 6 weeks after vaccination she could not lift her arm due to which she visited the physician, who sent her to sports and rehab physician. She also stated that, her right arm hurt only for a day. On 11-NOV-2019, the patient underwent X-ray which revealed she had osteoarthritis, but the patient did not believe that because, she never had any problem with her left arm until she received the vaccination. On 22-OCT-2019, the patient experienced cold (nasopharyngitis) for which she received unspecified cold medication as treatment. On 11-NOV-2019, the patient received methylprednisolone (MEDROL DOSEPAK) as a treatment for pain in her left arm and shoulder and was told to visit the physician again if the events did not resolve to get a cortisone shot. The patient stated that, the methylprednisolone (MEDROL DOSEPAK) did not help at all and the pain in her left arm and shoulder did not get better and she could still not lift her arm. Outcome of the event osteoarthritis was considered as not recovered (also reported as "ongoing") and outcome of the event nasopharyngitis was considered as recovering (reported as "cold improved because she has been taking a lot of cold medicine").  Causality assessment between the suspect therapies and reported events was not provided.
Similar to after first vaccination, I felt quite sick the next day with fever, body aches, fatigue, etc. I had COVID in March 2020, and it felt similar. I recovered in 24 hours, faster after second vaccine than first. But then Thursday night I developed hives on my inner arms. On Friday morning I woke up and my bottom lip was swollen in one corner.  Swelling became worse.  I took antihistamine, which seemed to help, and consulted with my doctor. But as the day continued  my face became splotchy, my cheeks swelled and warm to touch, and the swelling moved to my upper lip.  That evening the swelling became extreme.  My doctor put me on prednisone.  Next day swelling was reduced. By Sunday morning there was just slight swelling in face. By later Sunday swelling was gone.   I also submitted a report after my first vaccination, which included warmth at vaccination site and rash on arm.  And two days of feeling like I had COVID again.
Patient was in waiting chair post vaccination approximately 2 minutes post vaccination she expressed feeling unwell, pharmacist immediately went to check, pharmacist observed patient eyes roll back and body go limp, patient had some muscle spasms lasting about 15 seconds and then came to and vomited, patient was observed extra time and given water, advised to contact pcp, denied ambulance, patient was contacted later on no repeat incidence
Horrible metallic taste in the mouth; Tingling sensation of the tongue; Dryness of mouth; Slightly tired; Soreness at the site if injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue), DRY MOUTH (Dryness of mouth), FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue), DRY MOUTH (Dryness of mouth), FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Soreness at the site if injection) had resolved. At the time of the report, DYSGEUSIA (Horrible metallic taste in the mouth), PARAESTHESIA ORAL (Tingling sensation of the tongue) and DRY MOUTH (Dryness of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
61 year old male presents with chief complaint rash on his face and neck. States about 2 weeks after he had the shingles vaccine he started having boil type lesions on his face and in his nose and in his ear. He states if the lesions drained they then spread to other parts of his face or neck. (PGN dated 6/5/2013-NP Office).
Severe headache, body aches, extreme fatigue, chills, sweats., dizziness.
Patient had a stroke on 08/22/21 around 1am (9 days after vaccination) and went to hospital. Patient is now paralyzed on the left side of her body.
pt recvd vax & devel sweating, weakness, flushing, & tingling x 2 wks;
3 days after my vaccination (today), I got a rash on a couple places on my body -- on the front of my lower legs and a little on my neck.  This is the same type of reaction that I got after the 2nd Covid shot, although at that time, the rash was over a larger area of my body (chest, legs)
Pain at injection site, sore arm -- 10/4 and beyond Difficulty managing secretions while sleeping, a lot of coughing on first 10/5 while in bed Flare in joint symptoms. Persisitent neck nerve pain. Hand stiffness. Flare in wrist pain.
The patient felt nausea and then passed out. We called 911 and they evaluated him. He was doing better and they said his blood pressure was normal.
FEELS KINDA FOGGY; JOINT PAINS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was knocked out for a whole day when treated with covid-19 vaccine ad26.cov2.s (Janssen series 1) for prophylactic vaccination.  The patient received booster dose with covid-19 vaccine ad26.cov2.s (series 2 from unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the booster made her just feel kinda foggy with a headache and joint pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, joint pains and feels kinda foggy was not reported. This report was non-serious. This case, involving the same patient is linked to 20211164160.
DAUGHTER REFERS THAT PATIENT HAVE A RASH ( ITCHY SMALL BALLS ) 3 DAYS AFTER GETTING THE VACCINE. NO FEVER, NO REDNESS, NO HOT AREA. TODAY 10/29/2018 PATIENT STILL HAVE THE SMALL ITCHY BALLS IN THE ARM.
Approximately 15 minutes after receiving vaccine, patient began to complain of a deeper sounding voice than usual. Patient states that she did not have any difficulty breathing or swallowing. Patient stated that her eyes were watering also. EMS called. Initial blood /pressure of 134/87. Five minutes later, blood pressure was 152/84. Patients eyelids began to swell. Patient still not having any difficulty with breathing or swallowing. EMS arrived on site less than 10 minutes after patient began having symptoms, patient taken to hospital.
After patient received COVID vaccination, he exhibited seizure like activity. Staff moved patient to floor. 911 was dispatched. Patient complained of nausea. Vomited x2. Skin pale and diaphoretic.
Noticed blotchy rash (mild) on abdomen, inner thigh, right and upper left arm and left wrist. States the spots itched but itching has subsided at this time.
Swelling/redness to upper rt arm pain at site. Advise elevation, ice x 24 hrs. Rev if no improvement 24-48 hrs.
No adverse effects reported; Was inadvertently administered one expired dose of VAQTA; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 05-APR-2019, the patient was inadvertently vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) (dose, frequency, route and anatomical site were unknown) lot # N031940, expiration date 23-NOV-2018, for prophylaxis. No adverse effects were reported.
Information has been received from a physician concerning a female in her 70's who on an unknown date was vaccinated with ZOSTER vaccine, 0.65 mL, lot # not reported.  It was reported that the patient developed a case of shingles after receiving the vaccine.  The patient sought unspecified medical attention.  Her outcome is unknown.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received concerning a 76 year old female patient with a medical history of immunisation who on 28-FEB-2008 was vaccinated with ZOSTAVAX (Merck), (lot # 658082/0744U) 0.65 mL, intramuscular route.  In November 2008, the patient developed shingles described as a rash, distributed on mouth, 2 patchy areas.  Photos were not taken and the patient was not evaluated in the office.  On an unspecified date the patient had recovered.  Prior vaccinations included a dose of pneumococcal 23v polysaccharide (MSD) (lot #660718/0551X) on 22-OCT-2008, and a dose of pneumococcal 23v polysaccharide (manufacturer unknown) in 1999; influenza virus vaccine (unspecified) on 15-OCT-2007; a dose of FLUZONE (lot #U2847AA) on 22-OCT-2008 and a dose of diphtheria toxoid (+) tetanus toxoid on 19-MAY-2005.  Additional information is not expected.
Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a consumer (told by nurse). This case involves an 83-years old female patient who experienced numbness up one leg to her calve and Guillain Barre Syndrome, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (about two weeks prior), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unspecified date, the patient developed a serious Guillain Barre Syndrome and a numbness up one leg to her calve one-week following the administration of INFLUENZA VACCINE. It was reported that after injection of about 2 weeks prior and after 1 week started having numbness up one leg to her calve and possible GBS (Guillain Barre Syndrome). (Other relevant tests included no lab data). Final diagnosis was Guillain Barre Syndrome. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for numbness up one leg to her calve and Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: This case involves an 83-years old patient who presented with possible Guillain Barre Syndrome with numbness up one leg to her calve post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Guillain-Barré Syndrome is a expected following FLUZONE HIGH DOSE vaccination. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, lab investigation reports result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
pt recv vax 7JUN97 & 8JUN97 pt devel erythematous rash, h/a, puffiness in eyes, ears were red & enlarged, itchiness on feet & arms & intermittent fever of 102;
Medical assistant calling to check stability o fPEDVAXHIB and rotateq.; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified age and gender. Information regarding the patients' concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # S030965 and expiration date 03-APR-2022; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1688824 and expiration date 07-NOV-2021, both administered as prophylaxis.  The improperly stored doses of the suspect vaccines experienced the following  temperature excursions: of 54.5 degree Fahrenheit (°F) for 11 hours and 30 minutes and 34.9 °F for 30 minutes: previous temperature temperature excursions were reported for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) first 50.9°F for 2 hours 30 minutes, and 35.6°F for 1 hour.  The call was made due to a digital data logger.   This case was classified as non-valid due to no patients identifiers.
Arm soreness, unable to use arm, fever, body aches, chills, headache, insomnia
Sore right arm the night after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025TA20A) for COVID-19 vaccination.     NO Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm the night after the 1st shot). On 22-Jan-2021, PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025TA20A) for COVID-19 vaccination.     NO Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm the night after the 1st shot). On 22-Jan-2021, PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
A 25 year old male with no previous medical conditions, received the 3rd dose of Anthrax vaccine on 09/11/2001.  There were no other vaccines given on this date and no concomitant medications at the time of the event.  The patient did not have an illness at the time of the vaccination and has no history of reactions to previous vaccinations. The day of the vaccination, the patient experienced redness, itching, and heat at the injection site.  three days later, the injection site reached a maximum of 6x3 inches.  The patient took Benadryl with questionable relief and all symptoms resolved within 8 days.  On 09/18/2001 the patient recovered with no residual symptoms.
Serious muscle stiffness and tenderness at and around the point of injection (beginning at 1650 hours) Sensitivity to physical stimuli and chills (beginning at 2335 hours) Fever (beginning at 0017 hours): normal temperature is 97.8°F; Measured 99.3°F at 0108 hours & 100.2°F at 0148 hours.
This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised and Chronic myelogenous leukemia. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. No concomitant medications were reported. Patient had got stroke after one week of receiving Moderna COVID-19 vaccine. The primary physician spoke to patient about the Pfizer prophylactic treatment in immune compromised patients. Patient had enquired whether this treatment would be helpful for her or not. It was reported that patient was an immune compromised with leukemia (CML). No treatment medications were reported. 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. Company Comment: This spontaneous case concerns an immunocompromised, female patient of unknown age with an underlying chronic myelogenous leukemia (CML), who experienced an unexpected, medically significant AESI Cerebrovascular accident 1 week after receiving a 2nd dose of mRNA-1273 vaccine. Outcome of the event was reported as resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's immunocompromised status and underlying CML remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns an immunocompromised, female patient of unknown age with an underlying chronic myelogenous leukemia (CML), who experienced an unexpected, medically significant AESI Cerebrovascular accident 1 week after receiving a 2nd dose of mRNA-1273 vaccine. Outcome of the event was reported as resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's immunocompromised status and underlying CML remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
I was due 11/17/2021. I was diagnosed with polyhydramnios on 9/13/2021. I went into labor after my water broke on the evening of 9/19/2021. My son was born on 9/20/2021 at 10:44 AM; he was 30 weeks and 5 days gestation. He weighed 3 lbs and 12 oz, and he was 17.5 inches long. After delivery, he was diagnosed with esophageal atresia with tracheoesophageal fistula.
This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 80-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 6 hrs after receiving SHINGRIX, the patient experienced feeling cold, shivering, tingling of extremity and grip strength decreased. On an unknown date, the outcome of the feeling cold, shivering, tingling of extremity and grip strength decreased were recovered/resolved. It was unknown if the reporter considered the feeling cold, shivering, tingling of extremity and grip strength decreased to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received dose of SHINGRIX on left arm around 10:00 AM and around 4:00 PM, she started to experience shivering, tingling of feet and hands and she could not hold anything so she used an electric blanket to stay warm. The patient provided contact details of the physician. This case was linked with US2018144788, reported by the same reporter.
?Pfizer-BioNTech COVID-19 Vaccine EUA  2 days after 2nd dose of pfizer in ED for possible unrelated issue, had R scrotal/testicular pain, negative ultrasound. also with tachycardia.
Information has been received from a nurse practitioner concerning a patient who on an unknown date in December 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 13-MAR-2008, the patient was seen by the nurse practitioner for a very mild case of shingles. Additional information has been requested.
COVID arm at 24 hours - red, itching, swollen patch at vaccine site. No treatment, still ongoing Fluctuating fever at 32 hours after vaccination - highest was 101 - at about 56 hours after vaccination fever broke and hasn't returned. Managed with ibuprofen
This is my second shot.  Both times sore arm and injection site. However additional side effects with this second shot include overall body and muscle aches, shivering.  Very slight nausea.  I feel like I have the flu.
Tenderness of deltoid. Fever within 8 hours (2 degrees over baseline temperature),  heart rate not below 100 bpm for 48 hours, fever lasts 48 hours.  Headache 3 days with gradual dissipation.  Dizziness and nausea begin 6:00am on day 3.  Cold sweaty hands and feet along with tremors accompany dizziness.
Patient received 0.2ml of undiluted orange cap (5-11yr) Pfizer Covid-19 vaccine.  The patient's guardian was notified later the same day when the error was discovered.  Situation explained to parent and all questions answered to their satisfaction. Dr. notified. Parents encouraged to reach out to PCP or HCF for further questions or concerns. Parent verbalized understanding and has no further concerns at this time.
Extremely sore and stiff muscles below clavicle across upper back--I believe it is the middle trapezius muscles. This is making it difficult to sleep. It has persisted over a month but seems to be finally lessening with time and/or going out of my way to minimize the use of these muscles.
Pt. developed a skin rash on chest. Denied any difficulty breathing. Benedryl 25 mg was administered. Vitals were wnl. Rash diminished and pt was cleared to leave.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative.  A patient of unspecified age, ethnicity and gender started to receive PREVENAR 13 and influenza vaccine (MANUFACTURER UNKNOWN), both via unspecified routes of administration, on unknown dates at a single doses for immunization. The patient's medical history and concomitant medications were not reported.  On an unknown date, after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine, the patient experienced rash. The clinical outcome of the event, rash, was unknown.