chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweating more; swelling; pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported.
One day after receiving GARDASIL vaccine, mom reported wheezing, hives, and shortness of breath. No ER visit required. Mom called 6 days after vaccine to report reaction.
This spontaneous report was received from a pharmacy technician and refers to an unspecified patient of unknown age and gender. There was no information about the patients' concurrent condition, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M047658 with an expiration date 28-OCT-2017 for prophylaxis (dose, route of administration were not reported). There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion of 1 degrees Celsius for 93 hours. A digital data logger was involved. There was no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013107: US-009507513-1703USA012989: US-009507513-1703USA013106.
Information has been received from a physician concerning a 16 year old female who was vaccinated with her first dose of GARDASIL. Subsequently, within two weeks the patient experienced a mid-cycle, very heavy menstrual period and then had another period two weeks later when she would normally have her period. No additional issues or concerns and periods went back to normal, but they had "discounted" further doses of GARDASIL until they were more comfortable with the vaccine. Additional information has been requested.
Swelling; STIFFNESS IN BETWEEN; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN). At the time of the report, SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (STIFFNESS IN BETWEEN) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            NO KNOWN ALLERGIES. No concomitant drugs taken. On an unknown date, the patient experienced SWELLING AND STIFFNESS IN BETWEEN. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SWELLING AND STIFFNESS IN BETWEEN unknown onset and SWELLING AND STIFFNESS IN BETWEEN unknown onset with HUMIRA(ADALIMUMAB) was a 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.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Pain was similar to what she experienced in the past after / a shingles shot; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain after Shingles shot which was simlar to the pain experienced by patient after receiving Covid-19 (manufacture Pfizer BioNT)  vaccine 2 weeks before the time of reporting . The information regarding consent to follow up was not reported. The patient received flu vaccine and experienced adverse event for tolerance see case US2021AMR027799; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027799:Same reporter.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that since 24-DEC-2014 the patients were administered ROTATEQ orally (dose and lot no. unspecified) which underwent supported temperature excursions. No adverse events were reported. Additional information has been requested.
Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The reporter was a clinic administrator. The reporter reported that the patient received Havrix vaccine which was expired on 30th January 2023. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Pt given vax per request for immigration. Pt stated she started feeling discomfort, hot and redness as soon as she arrived home from receiving injections.
Narrative:  Admission: Fully vaccinated, COVID positive admitted with sepsis due to COVID
This spontaneous report was received from a nurse refers to a 64 year old female patient with left breast cancer, allergic to DARVON, hypertension, hypothyroidism, sarcoidosis and hyperlipidemia.  On 27-OCT-2014 the patient was vaccinated with ZOSTAVAX vial 19400 PFU, lot # K008884, expiration date: 20-SEP-2014, (route and dosage were not reported). Concomitant therapies included SYNTHROID, DEXILANT, LOSARTAN POTASSIUM, ZOCOR and ALLEGRA. The nurse informed that on 29-OCT-2014, the patient developed tenderness, redness and warmth at the injection site following administration of ZOSTAVAX., Also informed the patient had a red area that was approximately 3 cm by 4 cm in size around the injection site. The adverse events were treated ibuprofen, there were not laboratories studies performed. The patient sought medical attention by an office visit. The outcome of the event was not recovered. Additional information has been requested.
Again after about 2 months after the vaccination for dose 3, I started with this stuff again, I would get up and do my daily routine. I would be getting ready for work and in 30 minutes in I would have to sit down again. Also at this time my heart palpitations began to increase to daily, and again this time I was driving to work it was like bam I hit the wall? I did not really hit the wall? I had palpitations, I was aware that my heart was beating faster and I was aware that I was not able to catch my breath. I was driving and I felt like I was going to pass out again. I was able to instinctively try to slow my heart rate down, I went to ER and they did the tests again and did not find any thing new they had me f/u with cardiologist. Also at this time my 2 middle fingers in my right hand, middle and ring finger one morning I woke up and they hurt and they were very stiff. They would get better throughout the day and then I'd go to bed and then start over all over again the next day. The other thing is that both of my knees had swelled.  It was very painful because it was difficult to walk, it took about a week for those the resolve. My fingers are still sensitive, but the pain level is not like before. I have had a ton of blood work, I wore a heart halter- monitor, carotid artery ultrasound, another echocardiogram. I have seen, endocrinology, rheumatology and blood work looked great. During all of this an ultrasound of my neck and I have nodules in my thyroid, they want to do a biopsy which was benign. Nuclear stress test next week.
Arm became itchy and site developed redness that increased in size over 3 days to include her entire deltoid area. The site was red and raised at leased 10 cm in diameter.
Patient stated that she had disconfort in right arm 30 minutes after administration. Pt states her arm hurt later that night "that I could not lift it to take my blouse off". The next morning pt states her arm where the injection was administered was red and hot and that under her arm was red, hot and slighly swollen. Pt was seen and examined on 11/11/03 and he told her she had a reaction to the pneumonia vaccine. He prescribed Cefadroxil 500mg PO BID X 7 days and Methylprednisone 4mg PO QD X 21 days.
This case was reported by a health professional and described the occurrence of stomach cramps in a 20 yr old male pt (an employee at a dialysis clinic) who received hep B vaccination recombinant (Engerix B). On 13Jan04, the pt received a dose of Engerix B (dose number not specified; Lot ENG5351A4). At an unspecified time following the admin of Engerix B, on 13Jan04, the pt experienced stomach cramps, nausea and vomiting. The pt was seen at an ER. The events resolved on 14Jan04, in about 24 hrs.
Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
5-6 Blood clots, blood clots were present; heart attack; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 12:00 on left arm at single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included high blood pressure, high cholesterol. Concomitant medications included atorvastatin (LIPITOR), amlodipine besilate (NORVASC). Historical Vaccine included first dose of BNT162B2 on 08Mar2021 12:00 on left arm for COVID-19 immunization. The patient experienced 5-6 Blood clots, had heart attack and blood clots were present on 14Apr2021 13:00. The events were resulted in Emergency Room Visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was received for the events included Stent. The outcome of the events were resolving. Information on Lot/Batch number has been requested.
Lymphadenopathy, severe headache, fever of 103, diffuse myalgia for 48 hours and still going
Patient fainted shortly after receiving flu shot. Mom reported feeling weird after receiving flu shot. Paramedics  came and assessed. Patient went to ER for observation. Patient reported diagnosis of vasovagal response and patient recovered completely.
6/14 Nausea, fever up to 102, feet felt like on fire "put in skillet". 6/15 C/O arms and neck burning. No tingling: feet cold with fever: dizziness; rash; itchy; dime size around site.
At twelve hours post injection I awoke with severe chills even though I did not have a temperature.  After taking 1000 mg of Tylenol the chills past in approximately an hour.  The rest of the day I had extreme fatigue, headache, lethargy, and loss of appetite.  By the next morning I still had the fatigue and weakness which improved gradually over the next 12 hours.
Patient came by this morning at 10:30 AM to notify us of fever which has been subsided after patient took Tylenol. Patient also has blister spots all over body. Per father, patient started having these blisters last evening. There were a couple of bigger ones (on index fingertip and sole of foot) that patient said are painful to the touch, but not itchy. I noticed a few more red spots on patient's forehead. Told the patient that the reaction might be from vaccine, to take a dose of Benadryl and call pediatrician as soon as possible.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown name and gender. No concomitant medications, medical history, drug reactions or allergies were reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose and route of administration were not reported, lot # M041669, expiration date 09-JAN-2018), for prophylaxis. The vaccines were stored at the temperature of 11.7 farenheit degrees for 63 hours. Previous temperature excursion was also reported (storage at temperature of 6 to 14 Farenheit degrees for 13 hours). Temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004364:
Pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 27May2021 (at the age of 32-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clarithromycin (MACROBID) and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On an unspecified date, the patient experienced pain in leg for a few days, burning sensation developed and rash; diagnosed with the shingles through a swab. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included valacyclovir (VALTREX). Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
After injecting vaccine the patient began to fell heavy tongue, dizziness and nausea. Vital signs: BP:205/161 mmHg, R:21, 97% oxygen saturation
Patient is 7 years old and received the Pfizer vaccine for individuals aged 12 and over.
Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.
Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Chills, muscle aches after 1 day, lasted approximately 12 hours. Swelling at injection site, pain, redness, warm to the touch, started 12-16 hours after injection, redness widening from quarter size to about 2/2.5 inches inches in diameter by 2 days. Itchiness at injection site began after 2 days
Per patient, she developed hives within 4 hours of initial dose of Pfizer COVID-19 vaccine. Hives started at some time after she had left vaccine clinic observation area. They first developed on her hand and spread to rest of her body. They lasted approximately 12 hours. No shortness of breath, wheezing, lip/tongue swelling or any other signs/symptoms of allergic reaction. She took Benadryl PO and the hives were gone by the next morning. She did not report this reaction to anyone until she showed up at the vaccine clinic for dose #2 in early April.
The patient recieved his immunization and he was given it in the upper arm. His muscle was tense when the shot was given and it was given in the middle of the c formation. He then experienced pain in the arm after the shot but went oversees for 2 months. He said that he feels that it is getting better but when he lifts weights it seems to hurt still. I suggested motrin otc and ice or heat to see what feels better.
strange cry, screaming for over 2 hrs, unconsolable, refused all nutrition, would not take bottle, could not be calmed;
Dizziness for a couple seconds and happen 10 to 15 times a day/LIght headedness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 09:30 (Lot number: ER8731) at the age of 38 years as dose 1, single and intramuscular, administered in arm left, administration date 13May2021 09:20 (Lot number: ELU0176) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. Past drug history included: Aspirin for Aspirin:Allergy. The following information was reported: DIZZINESS (non-serious) with onset 24Apr2021, outcome "recovered" (2021), described as "Dizziness for a couple seconds and happen 10 to 15 times a day/LIght headedness". The event "dizziness for a couple seconds and happen 10 to 15 times a day/light headedness" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of dizziness.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. Device date: 24Jul2021. AE term: 5-6 weeks. Treatment: The physician wanted to do more testing. Approximately 2 days after the 1st vaccine she experienced dizziness/light headedness for a few seconds - it happened 10-15 times a day. The dizziness / light-headedness stopped about 2 weeks after her second dose. She never had issues with either dizziness or light-headedness except when she received the vaccine. Honestly, she thought this side effect was actually worse than when she had covid-19.  No follow-up attempts are possible. No further information is expected.
No additional adverse effect reported; MMR-II that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.      On 13-OCT-2021 the patient was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-RVAXPRO) however reporter was unsure about which lot number administered to patient (Lot T000890 with expiration date reported 08-JAN-2022 and Lot T010650 with expiration date reported 26-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not provided) for prophylaxis, which was improperly stored (product storage error).  The temperature of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-RVAXPRO) was stored had been above was 46F (49.6F) for 2 hours 21 minutes for lot T000890 and was 46F (56.1F) for 3 hours 33 minutes for Lot T010650. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000049: US-009507513-2112USA000050: US-009507513-2112USA000033:
Rash - started on face, appeared in clusters, spread to involve face and UEs, diffusely. Macular and papular, erythematous. Sibling was also affected.
Admitted 1/27-1/29/19 for Left Arm cellulitis, originating from site of injection. Treated with clindamycin.