chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 62 year old female. 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: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, warmth, headache, and achiness. This report was non-serious. This case, from the same reporter is linked to 20210413415.
Had influenza nasal spray in October 2005, has had sinus problems since. Boggy nasal turbinates today with clear exudate. If not better by next week will CT sinuses. This is third patient that has reacted in this clinic.
Redness at the injection site; Swelling at the injection site; Neck and shoulder stiffness; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site swelling and musculoskeletal stiffness. On an unknown date, the outcome of the injection site erythema, injection site swelling and musculoskeletal stiffness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and musculoskeletal stiffness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix quadrivalent at a pharmacy and experienced redness and swelling at injection site and also experienced neck and shoulder stiffness. The reporter did not consent to follow up.
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
Fever, headache x2 days, Right upper extremity redness and swelling on the lower half of the upper arm (proximal to the elbow), hot and tender to palpation.  All per patient report.
Thursday night 7 PM, 102 fever and fever done on Saturday. On Sunday at 2 AM woke up, Sunday  had chest pains like a big stone sitting on my chest, woke up with pain inflammation on the chest muscles -Costochondritis.  Went to doctor - urgent care because the pain got worst, they checked oxygen level and not a heart issue so it is the muscles or joints. 11/22/2021
102 F fever night after injection; resolved by morning. Body/joint aches; resolved by morning. Injection site soreness 10 days after injection--still occurring.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 16-JAN-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, HYPERtension, vertigo, chest tightness, fatigue, bone pain to bilateral wrist and right shoulder. Narrative:
Beginning about 24 hours after injection, patient's arm was red, swollen, warm to the touch in 3 inch diameter around injection site. Still red, swollen and warm to the touch ~43 hours after injection.
pt c/o feeling lightheaded & weak 1050AM approx 30 mins p/vax;
pt w/ c/o acute sz;pt devel fever p/vax;pt showed tonic clonic sz approx 30seconds;T102.1, alert & oreinted;MD impression acute febrile seizure;mom states pt may have had fever @ time of vax;pt cut molars 7JUL98 5 days p/vax;
Received Flulaval on Thursday 10/13/22 .  Developed symptom of left eyelid drooping on Sunday 10/16/22.  Eye symptom persisted with left eye discomfort and symptom of left side of mouth drooping developed by 10/21/22 along with continued eye and mouth droop.  ED visit on 10/22/22 to rule out symptoms of stroke or Bells Palsy.   ED visit to Hospital.
Burning sensation; Discomfort on both legs; Sensible to touch; Pain; Blisters (like varicella or Shingles); Fever; Myalgia; This case was reported by a other health professional via sales rep and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2015, the patient received Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia. On an unknown date, the outcome of the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia were unknown.   The reporter considered the burning sensation, leg discomfort, touch sensitivity increased, pain, blister, fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and experienced discomfort on both legs, burning sensation, sensible to the touch, pain, blisters, fever and myalgia. The course of treatment was the standard for Shingles. The reporter was very surprised by these side effects.
No additional AE; Improperly stored vaccines administered; This spontaneous report was received from a hospital employee, concerning a 0-days-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 22-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB), first dose, (lot number T022566 with expiration date 03-NOV-2022, established as valid) (exact dose, vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis (product storage error).   On an unreported date the administered vaccine experienced a temperature excursion of -1.4 degrees Celsius (C) during a time frame of 1 hour, as recorded by data logger. There was not previous temperature excursion. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001905: US-009507513-2108USA001990:
Seizure activity and fever to 105.5 requiring ER visit and treatment with one dose of ativan.
No additional AE; vaccinated with 3 doses of GARDASIL 9 and was administered a 4th dose of GARDASIL 9 as patient was unable to locate the shot records; This spontaneous report has been received from a healthcare professional (HCP) concerning a 14-year-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On unreported dates, the patient received the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided for any of them) all as prophylaxis.  On 21-APR-2023, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as the patient was unable to locate the shot records (extra dose administered). No additional events were reported. Also, the HCP wanted to know is there any side effect or precautions that should be noted.
Information has been received from a healthcare worker concerning one person over 40 years old with no remarkable history who on 05/18/04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 648139/0009P). The healthcare worker reported that the pt received the vaccine on 05/18/04 and called the office today (05/19/04). The pt called the office to complaint of redness, swelling and arm pain which was described as occurring over half of the vaccination arm, not just at the vaccination site. The healthcare worker reported that the pt was triage over the phone and told to use ibuprofen and warm compresses as treatments. The pt was told to call back if the redness, swelling and arm pain worsened or did not go away. The pt did not call back. There was no product quality complaint reported. Additional information has been requested. The healthcare worker also reported that two other people over 40 years old had redness, swelling and arm pain over half of their vaccination arm not just at the vaccination site following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 648139/0009P)(WAES # 0405USA01488).
I got my Shingrix shot on aug 16, i broke out in what appears to be hives the next day. The booster "hives" and the Shingrix shot duration of "hives" is still with me. i'm using now some steroids prescribed by my dermatologist.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date:30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injection air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Fever of 101.9 rectally resulted in R/O sepsis w/u and IM Ceftriaxone QD x 2 days.
Sore arm, limited range of motion from day after injection and continuing at date of report on 02/27/2015.
Patient was given the regular pfizer 12+ vaccine instead of the new Bivalent 12+ vaccine
Swelling with redness at L posterior upper arm - site of SQ injection. Child c/o pain to area with onset of swelling. Area red approx 8cm wide length 6 cm. Decreased edema with c/o pain now. Motrin used and Benadryl (children's given x2).
feel "lower back of head pain" which is "more intense at night"; back of her head and lower back hurts; back of the head a bit numb; tingling all over her body/ tingling on her left leg; lower back of head pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "back of the head a bit numb"; PARAESTHESIA (non-serious) with onset 22Nov2021, outcome "unknown", described as "tingling all over her body/ tingling on her left leg"; HEADACHE (non-serious) with onset 22Nov2021, outcome "not recovered", described as "lower back of head pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "feel "lower back of head pain" which is "more intense at night""; BACK PAIN (non-serious), outcome "unknown", described as "back of her head and lower back hurts".  Additional information: Reporter reported that her 57 year old mother received second dose of Pfizer vaccine 22Nov21, within 15 minutes experienced "back of the head a bit numb" "tingling all over her body", the next day "tingling on her left leg". Continues to feel "lower back of head pain" which is "more intense at night". Reporter states "before the vaccine she never felt that". Reporter wants to know of any similar reported AEs. Reporter was calling about the Pfizer covid adult dose. Her mother had some side effects after the second dose that she is worried about since it has been a week and still has the side effects. (Pharmacy name) said its normal. The back of her head, lower back hurts especially at night. Asking if this is normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient presents with 6 day Hx of cold symptoms including persistent cough, diarrhea, and fever. He has had some dyspnea associated with extended coughing fits. Had positive test result for COVID-19 infection despite receiving Pfizer brand vaccinations. Has been prescribed steroid medications by PCP.  Denies any other symptoms.  The onset was 6  days ago.  The course/duration of symptoms is constant.  The character of symptoms is cold symptoms.  Risk factors consist of COVID-19 infection.  Therapy today: prescription medications. Utilized telemedicine to help reduce exposure. Audio only.
Injection site pain persisted, without fading, from 4/29/21 to present.  R arm. Elevated sed rate >50 (details in item #19) 7/19/21 - developed severe nerve pain (C8 dermatome - dorsal pain from R scapula to 4th and 5th digit).   Small rash on ventral surface, 2-3" below R collarbone without pain but some itching.  Assumed to be normal breakouts from brassiere friction (I have macromastia) 8/2/21 - diagnosed as shingles with ventral small rash (7-10 healing pustules).  Rx'd valtrex 1 g tid x 14 d.  Severe nerve pain in C8/ulnar nerve that had worsened since  7/19/21 began to fade.  Some loss of grip strength when holding a fork.  Can still type. 8/9/21 - pain fading but now with weakness in 4th and 5th digits of R hand, further loss of grip strength and now some numbing.
Immediate soreness at site of injection. Throughout the day soreness continued and increased making lifting of the arm painful and restricting movement. Felt fatigued the next day after vaccination and ?out of it?.
Customer received 3 doses of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020) and Shingrix (2nd dose received in February 2021).   In August 2021, the patient received the 3rd dose of Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist called on behalf of a customer who received 3 doses of shingrix at another pharmacy and was now concerned about his health, which led to extra dose administered. The health care professional also reported that the patient was not vaccinated at the pharmacy where the call was made. The reporter did not have the information since the patient received these doses at another pharmacy  The reporter did not consent to follow up.
Dyshidrotic Eczema on hands and soles of feet. Being treated with topical steroidal cream
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Facial swelling occurred 24 hours post injection.  Patient stated that previous dermal fillers could be the likely cause.  Patient went to urgent care and provided steroid injection and oral steroid therapy.
Within 24 hrs the injection site was reddened (50 cent size). In 48 hrs it was baseball sized and warm to touch. The client saw her physician. Was advised to put heat on the site and was given a course of KEFLEX.
Feel cranky; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel cranky) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel cranky). At the time of the report, FEELING ABNORMAL (Feel cranky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment information provided.
pt recv vax; papular rash on LUA starting 24-48 hrs p/ vax; nausea and diarrhea for 12 hrs; generally did not feel good over 5 day period;
Patient presented today, reports onset of increased somnolence and delirium two days after receiving the injection. On day three after the injection, she reports has firm and tender swelling  with small ecchymosis at the site of the injection - left deltoid. Reports somnolence has decreased and delirium  resolved later on the day of onset.  The left deltoid swelling has slowly and progressively worsened, pain minimally increased.  Warm compresses to site, antihistamine, prednisone. Patient taking antibiotics (amoxicillin) for otitis media, changed to Ceclor because she reported medication makes her feel uncomfortable
Information has been received from a NP concerning a 6 year old male who on 09/23/03, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 644795/0335N) after his 12 year old sister broke out with a severe case of shingles. The NP reported that on 10/02/03, the pt developed a papular rash characterized by approximately 20 lesions.  The NP indicated that the lesions were not vesicular or blistered and she was unsure if the rash was varicella.  Unspecified medical attention was sought, but no lab/diagnostic tests were done and no prescription drugs were required to treat the papular rash. The pt was being isolated as a precaution.  The NP indicated that the pt's rash never became vesicular and concluded that the rash was viral in nature versus a rash related to shingles exposure or to varicella virus vaccine live. Subsequently, the pt's viral rash resolved. Additional information is not expected.
THROUT ITCHINESS , SWELLING FEELING  TREATED WITH  EPI AND PREDNISONE.
Headache the first and second day following injection.  Brain fog began day following injection and was very noticable the first week or week and a half and has not completely gone away to this day.
muscle pain/ muscle aches/muscle pain in her leg; weakness; Muscle pain in lower back; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingrix. On 21st October 2022, the patient received Flu vaccine. On 29th October 2022, 1 days after receiving Shingrix and 8 days after receiving Flu vaccine, the patient experienced muscle pain, weakness and muscular back pain. On an unknown date, the outcome of the muscle pain, weakness and muscular back pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, weakness and muscular back pain to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments: The patient reported receiving first Shingrix dose and the next day, she started to experienced weakness as well as muscle aches and muscle pain in her leg and lower back. The patient said the weakness and muscle aches and pain were still present.  The patient said she received the flu vaccine on 21st October 2022.  No other information reported to the agent by the patient.  The reporter did not consent to follow-up.  The reporter declined consent for HCP follow-up.
I started having rapid heart beat after the first dose of the covid vaccine. The rapid heart beat became a daily thing after the second covid shot. I had afib during a surgical procedure in April The rapid heart rate did not stop by July 10 2021 I could not stop the afib it went on for days. I ended up in the hospital for 5 days on medication to get me back into sinus rythm, followed by a emergency ablation. I still have afib and will undergo another ablation.
Patient reported that he had severe pain in his arm at the injections site...this was his booster shot... first 2 shots were Phizer... he also had chills and shakes and felt dizzy... unable to stand, felt very sleepy...
1) Immediate onset headache, reflux, nausea.   Headache has persisted x 2 weeks.    2)  Fatigue x 4 days 3) Dermal irritation (injection site) red softball by end of day x 2 days then small site redness for remaining 1.5 weeks.  4) Onset of welt like red areas beginning 1.5 weeks later.  Has included a welt on each arm (2 cm diameter), hands (starting today and is 1cm).
red, swollen arm-shoulder mid-way to elbow;no pain;advised cool compress APAP if painful