chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were provided. 20 patients received 0.25mL instead of 0.5mL of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022. No treatment medication was provided.  This case contains information for the 14th of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662859:Patient 2 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662861:Patient 4 US-MODERNATX, INC.-MOD-2022-662863:Patient 5 US-MODERNATX, INC.-MOD-2022-662865:Patient 6 US-MODERNATX, INC.-MOD-2022-662866:Patient 7 US-MODERNATX, INC.-MOD-2022-662869:Patient 8 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662873:Patient 10 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662876:Patient 12 US-MODERNATX, INC.-MOD-2022-662879:Patient 13 US-MODERNATX, INC.-MOD-2022-662958:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 16 US-MODERNATX, INC.-MOD-2022-663011:Patient 18
This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104  , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number.  Information on the lot/ batch number has been requested.
pt recv vax 3NOV95 & reports devel GBS;pt hosp for numbness in fingers & toes;referred to MD;
Patient reports redness and swelling all over arm following vaccination.  She said that the swelling went entirely around the arm like a blood pressure cuff. The reaction came shortly after the vaccination (next morning?) and lasted for several days until it resolved.
PATIENT REPORTED SAYING MORNING AFTER THE VACCINE, HE STARTED PULSATING ALL OVER THE BODY LIKE SHOOTING PAIN. IT WOULD REACH ALL THE WAY FROM HIS HEAD TO FEET AND BACK. WHEN IT CAME BACK IT WAS PULSATING VERY BAD BEHIND HIS EYES LIKE SPURS. HE SAID HE LOST VISION FOR 10 MINUTES AND WAS HAVING FLU LIKE SYMPTOMS. LATER IN THE EVENING HE VOMITED ONCE AND ALL OF HIS SYMPTOMS WENT AWAY AND WAS BACK TO FEELING NORMAL.
I tested positive for COVID-19 at home. I had scratchy throat and nasal congestion. I talked to my doctor, and she prescribed me PAXLOVID for 5 days. I tested negative for a while and then I rebounded. When I rebounded, I had the same symptoms.
This spontaneous report was received from a 24 year old female patient (currently 32 year old), who was reporting on herself. The patient had no known drug reactions or allergies. The patient's concomitant therapies included valacyclovir hydrochloride and zolpidem tartrate (AMBIEN). On 19-FEB-2010, the patient was vaccinated with the third dose of GARDASIL injection for prevention of human papillomavirus (route of administration, lot number and expiration date were not provided). On approximately 21-FEB-2010 (reported as 2 days after the third injection), the patient had a reaction, as her nerve endings became hypersensitive to the point that even air hurt her skin. The hypersensitivity was all over her body and felt like "fire ants". The patient reported that her unspecified physician could not determine if the reaction was from the vaccine or the carrier. The patient sought medical attention by visiting her general practitioner, dermatologist, neurologist, rheumatologist, orthopedic specialist, obstetrician-gynaecologist (reported as OB-GYN) and a pain management physician. The patient also visited emergency room a couple of times, with no hospital admission yet. The performed laboratory diagnostic studies included a full blood work-up a couple of times, 24-hour urinalysis, endoscopy, colonoscopy, electroencephalogram, electrocardiogram, magnetic resonance imaging and computed tomography scan, all on unknown dates. It was also reported that it took five months to determine the way to treat the hypersensitivity. On unknown dates, the patient underwent nerve burning (radio frequency), steroid injections and physical therapy as a treatment. The patient was still being treated for the hypersensitivity with anti-depressants, pain medication and nerve blockers (all unspecified) at the time of this report. It was also reported that when the patient had been stressed the symptoms came back. On an unknown date in 2017 (reported as "earlier this year"), the patient underwent a back surgery for an unspecified back disorder (the reason of the surgery was not reported). The outcome of the hypersensitivity and the air hurting skin was considered as not recovered. The outcome of the unspecified back disorder which required back surgery was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of unspecified back disorder which required a back surgery was considered to be medically significant and the events of hypersensitivity and the air hurting skin have been upgraded to medically significant, as they required nerve burning (radio frequency), steroid injections and physical therapy. Additional information has been requested.
lost use of his left arm; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (wife had shingles and no shot and had pain for over 4 years, but pass on the shot.).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had shots and lost use of his left arm.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203466:same reporter same patient
I am submitting this report because I am hoping to help others with the vaccine and to see if the CDC can assist with any guidance for my treatment with  Cardiologist. I am glad to share any of my medical records if it?s helpful I had a heart condition in 2018 that was fully cleared and recovered over 2 years prior to the moderna vaccine. In Dec 2018 I had congestive heart failure (high heart rate, afib, and swelling). The congestive heart failure was resolved within a week with medication only, no stints or surgery. The recovery of my heart to a health condition was confirmed with a heart MRI on Feb 5th 2019. I still had afib that was confirmed cleared on Feb 12th 2020 by an office visit with my cardiologist. He recommended I continue medication and monitoring.  I continued in a fully cleared condition with no Afib or any issues for a year and 3 months up to my 2nd  moderna shot. I had an annual heart MRI on May 3rd 2021 showing no issues and no afib. I had a visit with my cardiologist who said the test results were great. On May 15th 2021 I had my second moderna shot. My shot was Moderna 025C21A, at Pharmacy. Within 24 hours I was in an afib condition with my heart rate between 90 to 100 bpm resting. I contacted my cardiologist. On 6/11/21 he confirmed the afib condition and the elevated heart rate.  He is now guiding me through procedures to clear my afib. I am quite concerned that my health had fully recovered and now have  heart issues directly related to the 2nd moderna vaccine. Any assistance you can give me, my cardiologist to help us thru this is appreciated.  I hope the information I am sharing can help others with the vaccine.
Generalized rash involving shoulder and upper arm of injected arm. Over the counter Caladryl lotion
Within 15 minutes of receiving vaccine began to c/o itching in left outer arm. (+) warm to touch. (+) raised apparently whelp area about 1/3 of upper arm, just above elbow. No systemic allergic signs or symptoms.
Flulike symptoms began immediately upon receiving the Flu shot, that lasted several days. A debilitating intractable headache continued for months on a pain scale between 8 - 10 daily. That slowly declined over the course of 8-12 months to a lower level, but still daily activity inhibiting headache at pain levels between 3-5. This eventually turned into Amplified Musculoskeletal Pain Syndrome covering much of his body because of chronic unrelenting headache. Finally, after many doc visits / hospital visits & stays, we began therapies and medications to begin to control/reduce the pain, which have lasted the last 2 years. He is functioning better and pain is reducing to a level 1 daily, but still not completely resolved. This has been over 3 years.
Bruise at site of injection (within 4 hours) Soreness at site and in muscle (within 3 hours) Swelling of lymph nodes in that collarbone/shoulder (by 4 hours) Headache & brain fog by 5 hours Neck soreness/ aches/ fatigue by 5 hours Fever 99.5 by 6 hours- 20 hours
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 16-OCT-2018, lot # L048236, expiration date 31-MAR-2018) for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA012808: US-009507513-1708USA012809:
Headache, Myalgia, Diarrhea, Rhinorrhea, sore throat, fatigue, chills
First shot was 3/24/21 and the only side effect was a sore arm near the injection site for 2-3 days.   My second shot was 4/21/21 and the side effects started around 11:30 (about 12 hours after the shot). Started with chills/sweats and a fever. Woke up in the morning dizzy, feverish and chilled. Symptoms lasted all day and fever peaked at 102.1 around 2PM. Slept most of the day off and on. Symptoms were still present 4/23, but much better. I took Advil around 12PM and moderate symptoms remained. Leg muscles started hurting in the afternoon and lasted until mid-day 4/25. Dizzy/light headedness and overall feeling of just being ?slow? has been present since 4/23.
Pt c/o  "feeling of something flowing down across his upper back"... lasting 1 minute and then  dissipated.  Pt denied dizziness, headache, chest pain or shortness of breath or any other symptoms. Pt assessed, vital signs stable. Pt consumed fluids. Reassessed-vs remained stable, no further c/o received and pt released.
Exactly one month after second dose patient began experiencing heart palpitations. Patient went to ER and was diagnosed with atrial fibrillation. Patient is a healthy active male with no prior medical history.
Pt received vaccine around 1302. Pt experienced some minimal injection site bleeding, which was stopped gauze and a non-latex bandage was placed. While patient was at the vaccine table she reported itching around the injection site. Bandage was removed and patient was monitored further. Patient then reported that itching was worse at 1320, spreading to her thigh, head and back. 25mg PO diphenhydramine was administered and the patient was monitored for worsening symptoms. No further symptoms were reported and itching relieved by PO benadryl.
At night felt cold, like chills, run fever of 1 degree. Yesterday felt fine. Today feels fine but has red and hot patch on left arm. It extends from 1 1/2 inch above injection site down the arm. It is a 4 1/2 long by 3 1/2 wide area. Patch is not a complete circle, irregular. Patch gets narrow and wider as go down. Went to doctor and they asked her to go to ER if redness extends outside area they drew on arm. Currently she is icing it but it is tender and sore.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX lot # M025864 exp 24-MAY-2018 for prophylaxis. The vaccine had been stored improperly stored and experienced temperature excursion -14 °C to -10 °C for 29 minutes. The diluent lot# 020945 exp 05-DEC-2018 was stored properly. There was no adverse event. Follow up information was received on 22-AUG-2017 from the Licensed Practical Nurse referring to a 12 months female patient. On 28-JUN-2017 at 09:25 hours, the patient was vaccinated with the first dose of VARIVAX subcutaneously. Concomitant therapies included M-M-R II, VAQTA, RECOMBIVAX HB and sterile diluent (manufacturer unknown). It was confirmed no adverse events reported and data logger was involved. The reporter stated that the patient was vaccinated at private doctor's office/hospital with private funds. No illness at time of vaccination. This is one of two reports received from same source. Sender's Comments:  US-009507513-1707USA004242.
morning after, woke up to dizziness and unstable on my feet, so dizzy at times I think I will pass out, 04/10/2021 symtoms are still going strong have missed 2 weeks of work
Employee received flu vaccination on 10/28/2022 at 3 pm in her clinic. On 10/29/22 at 6 am employee developed right supraclavicular lymphadenopathy with pain, swelling and tenderness. C/O right neck pain and started right temporal headache today-11/1/22 at 6 am. Right shoulder and neck ROM normal. Worse pain on elevation of right shoulder and right neck turning towards right side. Taking Tylenol for pain, heating pad 15 minutes on and off; off duty on 10/31/22 and 11/1/22. Light duty: no pulling, pushing or lifting more than 5 pound till 11/8/22. Employee to follow up on 11/8/22.
Confirmed case of Shingles near the left eye, eyebrow, left side of forehead, left side of scalp.   Symptoms began 6/19, continued treatment through 7/10.
woke up with bad Vertigo continued through out the day, slept most of the day. Next day was slightly better but still not able to function normally. Has continued to get a bit better each day but on day six I am still a bit dizzy
The next morning, patient's trigeminal neuralgia flared up.  There were no other events (weather, wind, etc) that precipitated the outbreak.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, strength, dose number, lot #, expiration date not reported). The reporter stated that the patients were vaccinated with (Oka/Merck) VARIVAX that was exposed to 15F intermittently throughout the day every day for an unknown period of time during the last. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
10-6-17 vaccine given in Rt upper arm. About 30min notice pain and didn't go away. Fri. the next day I call the office and report the problem and told the office person I had pain all night the site was swollen, red and take two TYLENOL only help the pain for two house. Very much in pain with arm movement, fever, chills ear aches muscle aches headaches fatigue when told the office person the condition she said to use warm compresses. It didn't sound right so I ask her to let me speak to provider she stated to use cold not warm. Two weeks later having some of the problems eye pain and movement of lower lip sore arm.
Information has been received from a pharmacist referring to a 68 year old female patient. The patient had no drug reactions/allergies but had unspecified breathing problems. Concomitant medication was unknown. On 19-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # M032141 with expiration date 02-OCT-2017, 0.65 ml/once, subcutaneous). On an unknown date in October 2016 (reported as "about 1 or 2 days ago"), the patient experienced unspecified breathing problems. The patient made an unspecified contact with an unspecified physician and was prescribed oral prednisone. The outcome of the events was unknown. The pharmacist said the ZOSTAVAX was not the cause of the breathing problems. Additional information has been requested.
Injection site is very swollen, red, itchy, painful. The affected area is circular and approximately 4 inches in diameter.
Pfizer vaccine was diluted with Bacteriostatic NS 0.9% which is not recommended for use with Pfizer. CDC recommendations are to repeat affected dose. Pt was notified, all questions answered. Pt repeated dose on 9/15/21. No s/s reported by pt.
Sinus Tachycardia - Visited ER. The ER doctor, handled my care in the ER.  After a few hours of observation, I was discharged from the ER. My pulse, over the course of two days, slowly started to return to normal.  The first and second shot were administer at Stadium.
23MAY 3-4PM felt warm, t 5PM 101.6 R; 5AM t103; vomiting x 2 during night, irritable, rt arm red, swollen, bruise @ site of DTP inject; Given APAP every 3 hrs starting @ 1PM on 23MAY91; no sz;
seropositive rheumatoid arthritis/Rheumatoid Arthritis Multiple Sites; Right ulnar nerve neuropathy; Shingles; Chronic osteoarthritis; Swelling; Myalgia; Neuralgia; cyst in Popliteal fossa; Diffuse Joint Pain (Arthralgia)/ polyarticular pain/worsening joint pain/polyarticular pain; This case was reported by a consumer and described the occurrence of seropositive rheumatoid arthritis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colonic polyp. Concurrent medical conditions included hyperlipidemia and overweight.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced seropositive rheumatoid arthritis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the seropositive rheumatoid arthritis and shingles were unknown.   It was unknown if the reporter considered the seropositive rheumatoid arthritis and shingles to be related to Shingrix.  The initial information received on 29 September 2020, via medical records. As per records dated 12 November 2018, she states that had Shingrix vaccine last week and stated having a shingles breakout on her back, she developed pain in her right shoulder, pain in her knees and lower legs. As per records dated 19 November 2018,she had diffuse Joint Pain (arthralgia's), shoulders, knees, legs comes in with worsening joint pain that has been affecting both her lower extremities and upper extremities. it started suddenly a week ago when she was diagnosed with shingles. These have been the about one to two weeks after she had Shingrix vaccine. It started suddenly a week ago when she diagnosed with shingles. These have been the about one to two weeks at least she had Shingrix vaccine. On 05 December 2018, she had two, cystic areas seen in right popliteal fossa (5.5 x 1.l x 2 cm and 3.7 x 1.2 x 1.6 cm). As per records dated 10 January 2019, she was receiving prednisone 10 mg tablet, Take 30 mg once daily for 7 days, then 25mg once daily for 7 days, then 20mg once daily 7 days, then 10 mg once daily for 7 days. As per records dated 26 February 2019, was receiving prednisone 5 mg tablet, Take 2 tablets daily x 5 days, then 1 tablet daily x 10 days during 15 February 2019 till 26 February 2019. As per records dated 24 October 2019, she follow up with rheumatologist every weeks. Rheumatoid arthritis multiple sites. On February 2019, EMG (Electromyography) performed, showed mildly abnormal. Mild median nerve neuropathy. Right ulnar nerve neuropathy. As per records dated 07 July 2020, she reported sudden onset polyarticular pain and swelling and myalgias after receiving the Shingrix vaccine to right arm. (wrists, right shoulders both knees) and swelling and myalgia's after receiving the Shingrix vaccine, she saw her PCP who started her on Prednisone taper and Gabapentin for neuralgia reportedly did not help.