chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more). The patient was treated with CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) at a dose of once a week. At the time of the report, PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.    This case was linked to MOD-2021-317462 (Patient Link).
Information has been received from a pharmacist concerning a 77 year old female with sulfonamide allergy who on 12-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (Lot # 657766/0620U). On 12-OCT-2007, 10 minutes after vaccination the patient developed metallic taste. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Pt called in our triage line experiencing redness and swelling on Lt. side of face, states had vaccine given thru work and did well after administration. Woke up next day with swelling in Lt. side of face and puffiness, tried applying ice but caused itchiness, no other sxs reported. Pt was advised to come in and be seen in clinic for evaluation. pt then was added to the schedule same day 2/11/2021 @ 1:45pm .
Proquad was ordered and given instead of MMR. NO ADVERSE REACTION AT THIS TIME
After about 1 hour and 5 minutes, my face started to feel a little different that something was going on, I noticed my face was just a little puffy and raised near the nose area, and my bottom lip felt hot and very red color, just a bit swollen.  Later on in the day I could feel weakness in my body.   (note:  I did wait at the clinic site for 30 minutes in the waiting area), but this happened about an hour later when I was home.
Dose left out at room temperature for more than 24 hours; Dose left out at room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours) and PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours). On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours). On 17-Oct-2021, PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) had resolved. On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose left out at room temperature for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided The pharmacist has a vial of Moderna COVID19 Vaccine that was open yesterday 18Oct2021 around noon. They administered 2 doses of that vial today 18Oct2021 around 11:30 EST.The dates of his first two doses are unknown as he did not receive them from this pharmacy
Information had been received from a consumer concerning his 62 year old wife with shingles around one of her ears, a penicillin allergy and a history of hysterectomy who was vaccinated in December 2006 with a dose of varicella zoster virus vaccine live. Concomitant therapy included medicine for diabetes, high blood pressure and cholesterol. Approximately twelve days after vaccination, she broke out with rashes and hives all over her body. She was hospitalized on 05 Jan 2007. She was currently still hospitalized. Unspecified laboratory test were performed, the results were not reported. The husband mentioned that approximately one month before his wife was vaccinated she had her first outbreak of shingles in the are around one of her ears. She had almost fully recovered from the shingles at the time she was vaccinated. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a health professional concerning a 19 month old patient who was vaccinated with a third dose of rotavirus vaccine. No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
That night: pain in arm/head ache.  Next day: head ache/worsening of pain in arm/ swelling in supraclavicular lymph node/ sweeping about egg size in armpit (all swelling on same side as shot), nausea/ fatigue/ vomiting/ feeling of almost passing out/diarrhea
Arm swelled, hives, fever, itching, pain, tenderness and swelling at injection site. Tenderness/swelling started 11/13/08, approx. 6:30 p.m. Remainder of sx, 11/14/08, AM. Pt. took BENADRYL, p.o.
Around 1PM on 2/3/21 after receiving the second vaccine I started getting a headache and was extremely tired. Around 5PM I started having chills, cold sweats, muscle soreness, nausea, and vomiting. My arm was so sore i could not lift it al all. At some point around 9PM I passed out on my bathroom floor. My 6 year old found me and thought I had died and called her father crying hysterically. I think I was passed out for a few hours before I came too, as my child had the phone on speaker and her and my husband were both yelling at me to wake up. I crawled back to bed and went to sleep.  The next morning 2/4/21, I could hardly move to get my daughter ready for school, I had to call out of work. I was still having  chills, cold sweats, muscle soreness, nausea, and vomiting, headache, and I could hardly move my left arm.  on 2/5/21 I was still very tired, still had nausea, and a headache. 2/6/21 - 2/7/21 I still had a slight headache.  on 2/8/21 I felt better and went to work.
I had a baseball sized lump, with redness and pain at the injection site lasting 7 days. The first 72 hours I was ill with fever, chills, severe muscle and joint pain, dizzyness, nausea, diarrhea,  exhaustion and short of breath. Three days later I developed severe exhaustion, severe muscle and joint pain, stomach pain, nausea, diarrhea, brain fog,  low grade fever, and chills. My PCP prescribed Methylpredisone for 5 days because it worked to resolve symptoms of the first vaccine. It did not help. The severe muscle and joint pain as well as the exhaustion continued but the stomach and diarrhea symptoms were on and off. My right knee developed severe swelling and pain. I had an MRI due to the doctor thinking I had torn my meniscus. It was severe arthritis. I went to Covid clinic because my symptoms had not resolved on May 5, 2021. I could not walk due to the pain and swelling in my knee. They diagnosed me with reactive arthritis and reactive Irritable bowel syndrome from the Covid virus triggered from the second vaccine. I still continue to have exhaustion, severe muscle and joint pain, fever on and off, IBS on and off,  as well as brain fog I was referred to an Immunologist and a Rheumatologist.
This is the 2nd dose of the Shingrix I received. After receiving the shot at my upper right arm,  the area right below my shot site  was swollen and hot to touch.  When I touched the area, the area was firm and appeared to be red like rash. The redness and hardness in the area lasted about a week after the vaccination.  The odd part is the shot site was fine the whole time but the area right below was the problem area!
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929:Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
she feels so tired; her left arm is tender; she has body aches; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. On 19th August 2020, 1 days after receiving Shingrix, the patient experienced tiredness, pain in arm and general body pain. On an unknown date, the outcome of the tiredness, pain in arm and general body pain were not recovered/not resolved.   The reporter considered the tiredness to be related to Shingrix. It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on her left arm and at the time of report, she felt so tired and her left arm was tender and that she had body aches.  The reporter wanted to know how long these reactions would last and if she would have the same reactions with her next dose of Shingrix. The reporter did not consent to follow-up.
Information has been received from a Registered Pharmacist/mother concerning a 5 year old patient, one of 2 cousins (the AE report for another cousin included in the WAES # 1001USA03037) who on an unspecified date was vaccinated with one dose of VARIVAX (Merck).  On 01-JAN-2010, two sisters, one of which was vaccinated with a dose of VARIVAX (Merck) on 12-DEC-2009 and one who developed chickenpox on 25-DEC-2009 (WAES 1001USA02546), were visiting family.  10-14 days after the family gathering 2 cousins, the patient, one of 2 cousins, developed chicken pox with 50-100 lesions.  The patient had not reached to age to receive their second dose.  At the time of the report the patient's outcome was unknown.  It was unknown if the patient sought medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Information has been received from a physician concerning a 3-year-old male with no pertinent medical history and no drug reactions or allergies who in approximately 2005 (at the age of 12 to 15 months) was vaccinated with Varivax. Subsequently, the patient experienced breakthrough varicella and had approximately 30 lesions. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received improperly stored doses of VARIVAX (lot # M014309 with expiration date: 21-MAR-2018 and lot # M010480 with expiration date: 01-MAR-2018) (dose and route of administration were not reported). The administered doses of vaccine were exposed to a temperature of 27 degrees Fahrenheit (F) for 30 minutes. No previous temperature excursions were reported. It was unknown if a data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Immunodeficiency; COVID-19 recurrent; COVID-19 recurrent; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4491669-00 (AbbVie).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Aug2021 as dose 1, single (Batch/Lot number: unknown), on 07Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 recurrent". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On unknown dates, the patient experienced COVID TWICE. The action taken for adalimumab was dosage permanently withdrawn.  Additional information: There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's assessment of the causal relationship of "immunodeficiency" and "covid-19 recurrent" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of covid twice and lower in immune system with adalimumab (HUMIRA) was not provided.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out. The reported events of   "immunodeficiency" is assessed as not related to suspect product Comirnaty and more likely due to the ongoing immunosuppressants  co med adalimumab., given the known mechanism of the drug.
After receiving 2nd Pfizer COVID vaccine on 1/9/21, he developed bilateral ptosis and diplopia on around 1/18/21. He was diagnosed with myasthenia gravis based 2/12/21 evaluation and serologies. Symptoms have essentially resolved as of follow up in clinic without treatment. He took Mestinon at low dose for only several days but stopped as symptoms were already resolving steadily.
Received the 2nd dose 7 months after receiving the 1st dose.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose 7 months after receiving the 1st dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-484276 (Patient Link).
pt recvd vax;high pitched cry;lethargy,unable to awaken;began to get crabby, stopped eating;devel fever 101-102 & wheezing;took to er,was limp & unable to awake when arrived at hosp;P=40-60 per mom;
Began feeling nauseated on Fri 6/27 slight fever noted only at night; sweating during the night as well c/o "aches" in muscles and shoulders. No vomiting.
Extreme pain and soreness for approx 2 week after vaccine. Extreme pain reoccurred several times later after moderate exercise cortisone injection on 30NOV2017 helped some but continued pain and restricted movement.
Injection site swelling; injection site erythema; injection site warmth Information has been received from a registered nurse concerning a 78 year old male with no medical history who on 18-NOV-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). There was no concomitant medication. Subsequently in November 2005, the patient experienced severely swollen, red and warm injection site. No diagnostic laboratory tests were performed. Additional information has been requested.
MIGRAINE; CHILLS; SORE ARM; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on right arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced migraine. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced sore arm. On 21-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, migraine, and sore arm, and the outcome of headaches was not reported. This report was non-serious.
I felt like I had covid all over again, achey joints, hot, then cold, VERY tired.
Swelling on left breast,later moved to her right breast; Discomfort lymph gland under her armpit; Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, 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 experienced BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BREAST SWELLING (Swelling on left breast,later moved to her right breast), DISCOMFORT (Discomfort lymph gland under her armpit) and LYMPHADENOPATHY (Lymph gland under her armpit started to swell/Irritable lymph gland under her armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) The mammogram did not show any malignant.         Concomitant medication were not reported.
No addtional AE; Administered a dose of expired MMR II to patient; This spontaneous report was received from a medical assistant referring to a 2-year-old patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 20-JAN-2022, the health care professional was accidently administered a dose of expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) to a patient (expired product administered) once (lot number T001212, expiration date 12-JAN-2022; dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), had no prior temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Arm became sore and is still sore with any motion - range of motion is decreased - still sore almost 5 weeks later - pt thinks the injection went in bursa sac.