chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Balance problems; Shingles all over head, neck, shoulders, some on back and upper left arm/ now some breaking on right forehead related to the shingles.; Very bad pain; I still had many scars; Still had intense itching on head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Tylenol. In OCT-2022, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles all over head, neck, shoulders, some on back and upper left arm/ now some breaking on right forehead related to the shingles.), pain (Verbatim: Very bad pain), scar (Verbatim: I still had many scars) and pruritus (Verbatim: Still had intense itching on head). On an unknown date, the patient experienced balance difficulty (Verbatim: Balance problems). The action taken with Tylenol was unknown. The outcome of the shingles, scar and pruritus were not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the balance difficulty was not reported.   It was not reported if the reporter considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.     It was not reported if the company considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient had the worst case of shingles that anyone had seen. It was all over my head, my neck, shoulders, some on back and on my upper left arm. Very bad pain. Lived on extra strength Tylenol round the clock. It lasted over 8 weeks and I still have many scars and intense itching on my head. Mine started the 2nd week in October of 2022. Now patient had some breaking out on right forehead they think might be related to shingles. The patient had one shingrix shot but it caused to have balance problems, so patient did not take the second one. if patient had known shingles would have been as bad as they were, thought might have taken the 2nd shot anyway.  Additional supportive information: Follow-up would not possible as no contact details were available. It was not reported if the company considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.
She complained of a headache developing soon after receiving the shot on June 11th until June 13th.  She was tired most of the day on June 11th.  On June 13th, she showed me where a red circle had developed around the injection site.  On June 15th, she complained about sneezing a lot, a sore throat and having a headache throughout the day.  Later that evening around 9:30 pm, she started vomiting (2 episodes) and stated her throat pain was an 8 out of 1 to 10.  After vomiting her throat pain dropped to a 7.
Extreme fatigued arm,elbow and arm pain,ulnar nerve swelling ongoing problem since vaccine
The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse event) in a 9-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) 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 WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label).    Concomitant medication of the patient was not reported.  It was reported that the patient was unvaccinated and was to receive dose 1 of vaccine series 0.25 mL from vial with blue cap and gray bordered label.  Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723727:6-Months-old Infant case
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    No concomitant drug information was provided. It was reported that 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B were administered. No treatment drug information was provided.
Neck stiffness; Ankle muscle swelling; could not sleep; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiffness), JOINT SWELLING (Ankle muscle swelling), INSOMNIA (could not sleep) and GAIT INABILITY (could not walk) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness), JOINT SWELLING (Ankle muscle swelling), INSOMNIA (could not sleep) and GAIT INABILITY (could not walk). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck stiffness) was resolving, JOINT SWELLING (Ankle muscle swelling) had not resolved and INSOMNIA (could not sleep) and GAIT INABILITY (could not walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Severe Fatigue, Brain fog and muscle pain in back arms and legs. Lasted three weeks after first dose. Had second dose 3/26/21.  Minor fatigue began 3 hours after shot. Severe night sweats on 3/26/22. Became severe with brain fog, confusion and forgetfulness , muscle weakness and pain with back pain by 6am 3/29/21.  Sweating throughout day. Difficulty staying awake.
On 5/30 around 10:30 AM started having flu like symptoms that continued to get worse throughout the day & night. The next morning woke up with hives up & down her arm. Recovered 2 days later.
Pain, red, swollen, itching from the injection site to my elbow and up to shoulder. Severe pain throughout my whole body. Extreme chills and upon walking felt like I was falling back. It is the worst pain I have ever had throughout my body. This lasted for approximately 36+ hours. Pain, red, swelling and itching lasted 4 days and I still have a little discomfort and itching in my shoulder and around the injection site.
upper arm soreness that felt like got hit by a 2" x 4 "; forearm pain; headache bigger than; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper arm soreness that felt like got hit by a 2" x 4 "), PAIN (forearm pain) and HEADACHE (headache bigger than) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache bigger than). On an unknown date, the patient experienced PAIN IN EXTREMITY (upper arm soreness that felt like got hit by a 2" x 4 ") and PAIN (forearm pain). At the time of the report, PAIN IN EXTREMITY (upper arm soreness that felt like got hit by a 2" x 4 "), PAIN (forearm pain) and HEADACHE (headache bigger than) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Fever and chills worse than ever previously experienced, body aches, headache, urinary tract infection.., Extreme fatigue.  First 3 days were excessive..nearly went to emergency Dr. Prescribed antibiotics for uti..improved in 1 to 2 days Other Symptoms eased but lasted 7 days, including extreme fatigue
Delayed allergic reaction in the form of a large red raised bump on left arm around the site of injection. Area increased in size and swelling for the following four days after injection, then with Benadryl and ibuprofen reduced swelling and pain until it went away completely 1.5 weeks later.
After the initial arm pain subsided from second Covid shot,  a few days later my whole arm (the arm I received vaccination in) would go numb, I couldn?t feel it at all. There is also a pain which feels like it is in the muscle tissue where I received my shot. This pain prevents me from having full range of motion of my arm. I find it difficult to use this arm now to lift, and I can?t sleep in the position I normally had prior to Covid shot (arm above head). This pain has been going on for almost 3 months now.  I had absolutely no issues prior to the Covid vaccination, had I?ve ruled out any other injury (as I have not gotten injured this past 4 months).
I sent a photo to my doctor. It has been a week since the onset. It is painful and itches.
Information has been received from a nurse, via a company representative, concerning a female patient (age unspecified), who in approximately July 2007 ("about a month ago"), was vaccinated with the first dose of Gardasil (Lot # not provided). Within 48 hours of the vaccination, she developed a rash which "started on her arms and moved down to the legs, then back up to her arms again." She was hospitalized for "a day and a half." Treatment included intravenous therapy (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Rash on face with pain diagnosed as shingles by MD and treated -is now resolved.
pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st March 2019 in left deltoid and experienced arm pain for 2 days which resolved).   On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid of arm. The patient stated that, after vaccination had left arm pain till the elbow which subsequently resolved. The reporter consented to follow up. This case has been linked with cases US2019220403 and US2019AMR221733, reported by same reporter for same patient.
heart attack; lost 30+lbs; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. Medical history included that the patient was considered obese at time of receiving vaccine. The patient had no prior heart conditions or challenges breathing. The patient's concomitant medications were not reported. The patient experienced heart attack and lost 30+lbs on an unspecified date. The patient underwent lab tests and procedures which included weight: has since lost 30+ lbs. on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
patient got pale and felt like he was going to faint.   vomited.  gave water felt better
Onset of severe arthritis-like symptoms approx. 45 days after receiving vaccine with joint, tendon, ligament involvement migrating to multiple joints (knees hips, shoulders, wrists, fingers) with episodes lasting 2-7 days and ongoing.
Immediate intense pain with burning at the injection site, which has lasted over a week now. It  has abated slightly but is stll extremely sore. Cannot even wear clothing with a sleeve as it hurts.  Other symptoms:  nausea, pain radiating from arm across chest and up to chin, headache, insomnia, fatigue.
Headache 2/18. Started having Left shoulder pain ( opposite arm of injection site) states has a torn rotator cuff  that will not be repaired. pain increased on 2/19, at its worst on 2/21, 22,23,24 102 temp on 2/22. Started Aleeve changed to Ibuprofen. Continues either Ibuprofen 2 x day.  Today has a headache.
After the first HPV vaccine was given, within 3 minutes my son passed out with his eyes rolled up.
Throat swelling 3 minutes after application. Took 50mg Benadryl an hour later. It slowed down swelling. 2 hours later swelling grew more rapidly and I went to the emergency room. Given medication. Released 11:30pm.   Next day  12:15pm swelling returned and body became itchy. Subsided after taking medication.   Prednisone 40mg Hydroxyzine HCL 25mg Famotidine 20mg
Pt received vaccine in right arm, got off the exam table and sat in a blue chair right next to the exam table, pt then passed out/lost consciousness and fell out of the chair and landed on her right side. Mother who panicked picked pt up off the floor and then laid her on her back. Pt then became conscious and asked "what just happened." Pt then very upset started to cry. She states she sat in the chair and all of the sudden she got black and white spots in her eyes but does not remember falling. Pt then reports she got a similar feeling earlier this year when she got her finger poked. After event, VS stable, pupils PERRLA, pt alert and oriented x4. No bumps or bruises observed specifically on pts head.  It was unclear if pt hit her head as I did not witness the start or actual fall of the event. Pt did not seem to think she hit her head.  Pt denied any pain after. Pt stable, ambulated out of the clinic with her mother.
Case number PHEH2014US004359 is an initial spontaneous report received from a consumer on 28 FEB 2014. This case refers to a 08 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly in middle of JAN 2014. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 28 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Laboratory and clinical signs of myocarditis. Patient was being routinely screened for myocarditis as his was concominantly starting clozapine so we were monitoring CRP, WBc with Diff, and Troponin weekly.   10/7 #Elevated troponin #Sinus tachycardia  #C/f myocarditis, drug induced vs. Viral Inflammatory markers elevated, and trop mildly elevated but flat. Recent symptomatic COVID infection ~3 weeks ago. Thus far, workup has included a CT PE which was suboptimal due to motion artifact, but did not demonstrate proximal thrombi. TTE demonstrated normal RVEF and size, and a low-normal LVEF. Possible this represents myocarditis, viral or drug induced. Clozaril level is pending. If this comes back at supratherapeutic and he needs to remain on it for psychiatric reasons, would be reasonable to consider lower dose and monitor level. Would not recommend cMRI at this point given he was unable to tolerate PE study yesterday.  - Would recommend lower extremity dopplers to further evaluate for PE/DVT. If positive, could consider repeat CT PE study +/- sedation - discontinue propranolol (d/w primary team) - start metoprolol succinate 25mg daily - start lisinopril 2.5mg daily - if remains on clozaril, would repeat TTE in 2 weeks or sooner if clinical status changes
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 18-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2022 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Information has been received from a physician concerning a 65 year old male patient with a sensitivity to tetanus shot, who on approximately 07-JUN-2010 was vaccinated with a 0.65ml single dose of ZOSTAVAX (Merck) (Lot#: not reported) subcutaneously. The physician advised that the patient had a red circle on their arm the size of a half dollar which was hard a few hours after the administration of the ZOSTAVAX (Merck). The physician believed it was an allergic reaction. The patient sought unspecified medical attention. There were no labs performed. At the time of the report the patient was recovering. Additional information has been requested.
About 15-20 minutes post vaccination the patient hands became itchy. She was given a 50mg dose of diphenhydramine and advised to sit and rest. The staff checked on her every 5-10 minutes for changes, the reaction to her hands was unchanged and she began to feel a lump in her throat. There no visible swelling of her lips and she denied an swelling of her tongue. The patient declined epinephrine  administration or emergency support. She was advised to have a family member pick her up to bring her to immediate care. She left the pharmacy about 7:10pm and by 8:20pm she reported back that she received immediate care and was given a steroid dose pack and feeling well.
Within 1 hour after receiving vax mother noticed a marked increase in irritability which lasted for 24 hours. Mother stated pt did not have a noticeable fever, but it was not checked. Pt was fine the next day without treatment.
Had reactions to the vaccine thinks its allergy related; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), dose 1, via unspecified route of administration on an unspecified date (Batch/Lot number: not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had reactions to the vaccine and thought that it was allergy related. On 24Mar2021, the physician will do a skin test before getting the second dose and will have more information once test was done. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 28 year old female, with no relevant medical history and no known drug allergies, who on 30-MAR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 654540/1161F; site not reported). On 01-JUN-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 0210U; site not reported). On 19-OCT-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 0530U; site not reported). There was no concomitant medication. On 04-JUN-2008, the patient called the office and stated that "she had arthritis from GARDASIL". The patient sought unspecified medical treatment by calling the office. The patient outcome was not reported. No additional information was provided. Additional information has been requested.