chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from other non-health professional (consumer) on 24-Oct-2018, concerns a 1-year-old, male infant patient. The patient's historical conditions included heart murmur, stomach/intestines intersection and the patient had visited emergency room. On 15-Oct-2018, the patient was administered Influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date in Oct-2018, after vaccination, the patient experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient received MOTRIN. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious. This case 201804858 was cross-linked to case 201804857 due to the same reporter.
Vaccination site pain; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A2LA and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). On 31-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant medications were not reported and treatment included applying ice to left arm.
pain spread to her wrist; could barely move her hands; pain now moving up both arms; pain is now spreading to her neck; patient is not able to drive as a result of these conditions; Infection or inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) and INFECTION (Infection or inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for Pain.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain spread to her wrist) (seriousness criterion medically significant), MOBILITY DECREASED (could barely move her hands) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain now moving up both arms) (seriousness criterion medically significant), NECK PAIN (pain is now spreading to her neck) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) (seriousness criterion medically significant) and INFECTION (Infection or inflammation) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck) and IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) outcome was unknown and INFECTION (Infection or inflammation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: increased (High) increased.         The patient had appointments with accupuncture , rheumatology and a chiropractor The patient was tested for Lupus, Leukemia, Carpal Tunnel and all were ruled out.  Treatment medications include steroid injection and steroid cream for pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Contact Dermatitis; Itching on the rash; Rash on right forearm /Rash on left forearm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Contact Dermatitis), PRURITUS (Itching on the rash) and RASH (Rash on right forearm /Rash on left forearm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DERMATITIS CONTACT (Contact Dermatitis), PRURITUS (Itching on the rash) and RASH (Rash on right forearm /Rash on left forearm). The patient was treated with ALOE VERA (ALOE DERMA) for Rash, at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Contact Dermatitis) and PRURITUS (Itching on the rash) had not resolved and RASH (Rash on right forearm /Rash on left forearm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. patient has Contact Dermatitis, and wanted to put her on steroids but patient gets upset stomach with steroids medication and do not want to take them.
pt found on the floor in an independent living facility; reports URI sx x 1 wk; found to be positive for COVID; admitted to hosp; per death certificate, pt's cause of death was cardiac arrest, hypoxia, COVID
pt recv vax;devel muscle weakness,itching,face edema,edema of extremities,muscle soreness & itching on stomach;
Injection site not healing, patient feeling pain and tingling sensation upon touch of the injection site - also complain of numbness of left hand occasional.
Symptoms: Shortness of breath, palpitations, Chest tightness/pain, light headed, fatigue,  I went to the emergency room on Nov 6 2021 for all of the symptoms listed above.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old male patient who received SHINGRIX for prophylaxis.  On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th June 2018, 1 days after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 27th June 2018, the patient experienced raised rash. On 1st July 2018, the outcome of the injection site swelling, raised rash and injection site pain were recovered/resolved.  It was unknown if the reporter considered the injection site swelling, raised rash and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The next day after vaccination, the patient experienced soreness and swollen at the injection site. The symptoms lasted for about 5 days before resolving. His saw his physician for a different reason on 29th June 2018 and since he was there had his physician look at the reaction.  They physician recommended not getting the 2nd dose since the reaction had lasted so long. He had not decided if he would get the 2nd dose or not. The patient had denied permission to contact their physician.
Rash involving face, chest, both arms x 3 hrs; painful lumps behind ears x 2 days;
Information has been received from a medical assistant (MA), concerning a patient (age and gender not specified) who was vaccinated on an unspecified date, with a dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient developed a "minimal reaction," though the patient did not return to the office for evaluation.  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 1 patient experienced cellulitis (WAES #0707USA04634), and 4 patients developed significant reactions of fatigue, warmth, redness, unable to lift arm, and pain, after vaccination (WAES #0707USA04971).  Additional information has been requested.
Immediately after administration pt had palpable lump from about 1" in diameter and visible to the eye.
Client, was given pediatric Pfizer dose by RN when they were 12 years of age.  No observable adverse side effects observed by family or facility staff after 1st dose.  Patient correctly vaccinated by staff for 2nd dose.
Moderna COVID-19 Vaccine EUA On Feb 17, one week after the first shot, I woke up with the injection site itching. The injection area was red and  covered about 3-4? in diameter. Cortisone helped with the itching but it continued to itch.  The redness continued over the next 4 days as well as itching and tenderness.   As of 2/20, 5:00 pm, it is better but hasn?t completely disappeared.
Headache; brain fog; nauseous; sleepless night; swelling injection site; pain at injection site; muscle aches; extreme tiredness (body feels like it has weights on it); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date (at the age of 33-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) in the left arm on an unknown date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included dust allergy, pollen allergy and allergy to molds. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 14Apr2021 the patient experienced headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date, the patient underwent SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcomes of the events headache, brain fog, nauseous, sleepless night, swelling at injection site, pain at injection site, muscle aches and extreme tiredness (body feels like it has weights on it) was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Chronic, generalized urticaria with extreme itching x 1 month. Began 6 days after booster shot. Saw rheumatologist and dermatologist for treatment. Currently on Claritin, Pepcid, Zyrtec, Benadryl (PRN)? without resolve.   Additionally:  Extreme daily fatigue. Eye swelling, redness and pain? saw Ophthalmologist for exam.  Breast, nipple severe pain and swelling.   Low grade fever. Diarrhea and nausea daily.
I started feeling a lot of body pain and a headache in the middle of the night.  This morning I woke up with a migraine and nausea.  I have been exhausted and sore all over my body all day.
Joint inflammation; Pain; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Joint inflammation), PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) On an unknown date, the patient experienced ARTHRITIS (Joint inflammation), PAIN (Pain) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, ARTHRITIS (Joint inflammation) had resolved, PAIN (Pain) had not resolved and MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            No concomitant product was reported. No treatment information was reported. For event Joint inflammation, Dechallenge with suspect was reported as Yes. No rechallenge was done. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Humira for the event Joint inflammation was no reasonable possibility and for event Pain was reasonable possibility. 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.
Patient received dose more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose more than 12 hours post-puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter stated that the vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is 46 degree Fahrenheit to 77 degree Fahrenheit) was a little over 25 hours and 20 minutes before the first dose was administered.  No treatment information was provided.   This case was linked to MOD-2022-532654, MOD-2022-532500, MOD-2022-532655 (Patient Link).
Red blister like spots at injection site. Advised to use BENADRYL or CLAMIONE lotion.
This case was reported by a physician via sales representative and described the occurrence of Bell's palsy in an adult male subject who was vaccinated with Influenza vaccine (unspecified), (manufacturer unspecified). On an unspecified date in 2003 the subject received unspecified dose of Influenza vaccine (unspecified) (unknown). On an unspecified date in 2003, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced Bell's palsy. Approximately 10 years ago in 2003, the subject received influenza vaccination and experienced Bell's palsy; brand name or manufacturer was unknown. The sales representative reported that the healthcare professional wanted to remain anonymous. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. An adult male subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX (season was not specified). The physician associated the Bell's Palsy with the FLUARIX vaccine, lot number was not available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bell's Palsy was unspecified. The subject developed Bell's Palsy within 24 hours of being vaccinated with FLUARIX in 2012, for this case please see A1023598A.
Patient reports developing a rash/raised bump at injection site on night of vaccination. Called the pharmacy two days later and reported that the rash and slightly worsened. Did not experience any other adverse reactions.
??Headache ~ 4/23/21 @ 1:30 p.m. through 4/25/21 @ 5 p.m. ??Nausea ~ 4/23/21 @ 2 p.m. through 4/25/21 @ 9 p.m. ??Vomitting ~ 4/24/21 @ 10 a.m.  ?? Fever ~ 4/24/21 @ 8:30 a.m. 99.6
Arm hurt and itched from 1st day of injection (11/14/05). Injection site became hard and raised 25 cent sized, became red. Itching continued for 6 days. On 7th day she noticed red ring around site, 9 cm x 10 cm. Interior of ring is pink, warm to touch, still itches, less pain. "Arthus reaction" No fever, headache.
I received the Covid Pfizer vaccine. By 6pm 12/18/2020 I started having arm pain and pain lifting right arm as well as nausea. By 11:30pm on 12/18/2020 I started having joint pain in the hips and knees  and shortly after body aches. Upon waking up at 7am on 12/19/2020 I still had previous symptoms as well as right underarm tenderness.
pt recvd vax 1130AM bout 3PM devel swelling in the knees, warm to touch;states that during noc pain & swelling inc; pain persisted but got some relief w/Ibuprofen 800mg; returned to clinic 28SEP
Waking up in the middle of the night burning, sweating and heart palpitations. Her muscles trembles, extreme weight and muscle tone lost.  Get tired very easy and memory loss. She also has insomnia.
Pentacel was given when DTaP was ordered. Provider, and parent notified. Patient suffered no adverse reaction.
After taking the second dose of the pfizer covid19 shot on 1/19/21. that evening I started to feel a little bit fatigued. After waking up for work on 1/20/21 at 4:30 i was extremely fatigued, also felt some aches in my shoulders. I took 650mg of Tylenol and went to work.  During my shift i was fatigued and started feeling chills. at 11:00 am i took 1000mg of Tylenol. I went to the hospital nurse and was sent home. 1/21/21. woke for work and am still feeling fatigued but i do feel like its lessening and I'm getting better.
Vaccines were given per MD's orders. Patient had a reaction to Prevnar13. Vaccine was administered IM on RT Thigh. Patient developed a small induration. I immediately notified MD. She re-examined the patient.
ARM HURTING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the subject experienced arm hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurting was not reported. This report was non-serious. This case, from the same reporter is linked to 20210637808.
Stiff neck and shoulder on injection side  Swollen arm and pain on injection side  Intensified period cramps and back pain on opposite side of injection
On 10/15 received flu vax. About 6 hours later felt discomfort in area of the shot. Next day had the worst pain in elbow. Few days later received Pneumo vax - shot was given in the arm became very sore red and tender. Lasted 2 days.
rebound of Covid ,Tested positive on antigen test 6 days later after testing negative; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (rebound of Covid ,Tested positive on antigen test 6 days later after testing negative) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (rebound of Covid ,Tested positive on antigen test 6 days later after testing negative). At the time of the report, COVID-19 (rebound of Covid ,Tested positive on antigen test 6 days later after testing negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  It was reported that rebound of Covid after taking Paxlovid for 5 days. Tested positive on antigen test 6 days later after testing negative. Patient had initial vaccination then two bosters, last in Jan of 2022  CC: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a dose of mRNA-1273 vaccine administration. Patient reported that rebound of Covid-19 infection occurred after taking Paxlovid for 5 days. Patient tested positive on antigen test 6 days later after testing negative. Patient had completed the primary series of COVID-19 vaccines, then two booster doses, last in Jan of 2022. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a dose of mRNA-1273 vaccine administration. Patient reported that rebound of Covid-19 infection occurred after taking Paxlovid for 5 days. Patient tested positive on antigen test 6 days later after testing negative. Patient had completed the primary series of COVID-19 vaccines, then two booster doses, last in Jan of 2022. The diagnosis of COVID-19 was supported by SARS-CoV-2 test which was positive. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a physician's office manager concerning a 9-year-old daughter who in approximately 1998, at 1-year-old, was vaccinated with a dose of Varivax. In approximately March 2006, the patient broke out in a chickenpox rash. Subsequently, the patient recovered. No treatment was given. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Abdominal bloating, gassiness, discomfort for several weeks, beginning one week after each dose of GARDASIL & progressively worse. 10/13/09 Medical records received for date 9/24/09. DX: Abdominal pain, gassiness after gardasil vaccine, no clear relationship. Presenting symptoms: pt c/o three weeks of abdominal bloating, pain, pressure beginning 1 week after getting gardasil vaccine dose 1 and 2. On dose 3 same symptoms plus weight gain, 2 to 3 weeks bad HA, constipation but daily BM, feeling groggy. Had similar abdominal pain 3yrs prior in which diet changes and exercised helped. Assessment: PE WNL except LLQ diffusely tender.