chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on abdomen; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-AUG-2022.  Reporter's Comments: The patient self-reported this case. The patient got first Shingles vaccine and had developed a rash on his/her abdomen. The patient was asking that was this a possible side effect. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Patient complained of tingling upper lip after receiving vacine.  Onsite EMS was called vitals BP 184/90 HR 94  99% O2. 50 mg Diphenhydramine orally given. She was monitored & felt beter and was released.
Case number PHEH2015US026873 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 53-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
CLIENT WOKE UP WITH LOWER BACK PAIN A 5 ON THE SCALE OF 1:10. ALSO HAD SOME SLIGHT STIFFNESS TO THE BACK OF NECK THAT WAS TRANSIENT COMING AND GOING. LATER IN THE MORNING AT 8:00 AM TOOK SOME TYLENOL FOR A MILD HEADACHE THAT WAS RESOLVED BY TAKING THE TYLENOL.  HER BACK STILL HURT BUT HURT ONLY WHEN SHE MOVED NOT WHEN SHE WAS SITTING OR LYING DOWN. LOWER BACK PAIN WAS UNCOMFORTABLE WHEN WALKING AT A FAST PACE. DENIES PROBLEMS WITH ARMS OR LEGS. INFORMED CLIENT TO SEE DOCTOR IF SYMPTOMS WORSENED AND TO LET CLINIC KNOW IF SYMPTOMS HAD NOT RESOLVED.
Child's mother called the office at 413pm on 4/26/2022 and reported child was having blurry vision, seeing  floaters, ad nauseated. Mother was directed to take child to ER. Attempts to reach family to update on the status of child's status have unsuccessful.
Next morning muscle soreness, pt ran fever and tenderness. Rash to the inside of the arm. Patient reported inflammation has been subsiding and almost fully resolved.
Information has been received from a nurse concerning an 11 year old female patient. The patient fainted during the administration of the first dose of GARDASIL (dose and route not reported). The nurse reported that the patient received her second and third dose of GARDASIL and did not faint. No other information to report. Additional information has been requested.
Swelling especially of the tongue, unable to breath, rash, itchiness, dizziness,
This case was reported by a healthcare professional and described the occurrence of stiffness in a 34-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Blood pressure medication. On 2 November 2010 at 11:00 the subject received a dose of FLULAVAL (unknown route, right arm). On 2 November 2010, 8 hours after vaccination with FLULAVAL, the subject experienced stiffness and pain in right shoulder joint. On 5 November 2010 the subject experienced right shoulder pain and painful to move right arm. The subject called the healthcare professional's office on 5 November 2010 to report that she had pain upon rotation in right shoulder and arm. On 16 November 2010, she came to the healthcare professional's office for another reason and indicated that she still had pain upon movement. The healthcare professional reported that the pain brought tears to the eyes of the subject. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
All over body itching began about 5 hours after injection, continued for 24 hours and then I took Benadryl and the itching stopped. I also experienced mild symptoms consistent with the vaccine response, chills, fatigue, sore injection site. I did not experience any redness or itching at the injection site.
temperature 101.2 degrees F, 99.9 this morning; fever during the night, 101.3 degrees in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever during the night, 101.3 degrees in the middle of the night) and PYREXIA (temperature 101.2 degrees F, 99.9 this morning) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     no medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included SERTRALINE, DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) and BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (fever during the night, 101.3 degrees in the middle of the night). On 10-Feb-2021, the patient experienced PYREXIA (temperature 101.2 degrees F, 99.9 this morning). At the time of the report, PYREXIA (fever during the night, 101.3 degrees in the middle of the night) and PYREXIA (temperature 101.2 degrees F, 99.9 this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Advil, Tylenol.
After the shot throat swelling, thyroids possibly, headache & couldn?t  take  deep breath. I?m used to allergic reactions so it wasn?t a big thing to me. Later the injection site was very painful and was swelling turning red then days later turned purple/red. Very painful, itchy a little & weeks later still have weakness in my left arm & blue/purple bruise.
erythema of advancing size, eccentric, from site of inject; treated as presumed bacterial contamination w/cellulitis;
pt recv vax & 2wk post vax began to exp muscle tightening in groin & legs;pt has had progressive stiffness & diff lifting legs;It was painful to move them;pt was found to have myositis of lower extremities;pt being evaluated by specialist
COVID arm after getting booster vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (COVID arm after getting booster vaccine) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm after getting booster vaccine). At the time of the report, VACCINATION COMPLICATION (COVID arm after getting booster vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that she did not have antibody when tested after that she was going to get another anti-body test. No treatment medications were provided.   This case was linked to MOD-2021-341126 (Patient Link).
A non-serious, spontaneous report of administration of expired FLUMIST was received from a health professional concerning a seven-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 02-Dec-2010. The patient received the expired FLUMIST on 08-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
lethargic; achy; chills; arm soreness; felt bad/she felt pretty bad/not feeling right; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lethargy (received 1st dose 2months ago, refer case US2019215519.).   In November 2019, the patient received the 2nd dose of Shingrix (intramuscular). In November 2019, 4 hrs after receiving Shingrix, the patient experienced lethargy, pain, chills, pain in arm, feeling bad and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the lethargy, pain, chills, pain in arm, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix one week ago in her right arm and experienced lethargy, achiness, chills, not feeling right, arm soreness and she felt bad and did not feel well.  She claims that the side effects all lasted for two whole days and then resolved. The reporter consented to follow up. The reporter can follow up with the patient directly and the pharmacy.
Narrative: 75 yr old with hx of Non ischemic cardimyopathy s/p ICD, IDDM, Compensated NASH cirrhosis of liver with hepatomegaly and splenomegaly 13 cm and chronic thrombocytopenia from the above with the plts ranging between 70-80's for over several years, acutely dropped after COVID19 vaccination in Aug 2021. # Thrombocytopenia - likely multifactorial. Contributing factors include cirrhosis, splenomegaly, and immune-mediated process aggravated by taking COVID19 vaccine booster. - Patient has now completed steroids off of it for 3 weeks ,received ivig and Rituxan (C4/4 on 10/21). -IVIG 90 mg IV QD on 12/13/21 and 12/14/21. -Now his plts are back to his base line at 70-80k.
Patient experienced noticeable fatigue and headache with 1st and 2nd vaccine. Pt experienced severe fatigue and was bed ridden for days, headaches, weakness, aches, progressively getting worse, and memory loss. Pt was diagnosed with chronic fatigue and fibromyalgia. 60 day follow up states pt has not recovered. Has developed chronic fatigue and had to resign from job
Woke up feeling ill. Thought it was my sinuses or that I might be catching a cold. Took my OTC's and went to work. On 12/01/2016 went to work feeling ill and ended up having an asthma attack.
Cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M209) for COVID-19 vaccination.     No medical history was provided by the reporter.   Concomitant products included PRAVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING COLD (Cold). At the time of the report, FEELING COLD (Cold) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   Concomitant product also include unspecified blood pressure pills (in the morning).  Treatment medication was not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event outcome was updated.
third dose; erectile dysfunction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for Covid-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Nov2021, outcome "unknown", described as "third dose"; ERECTILE DYSFUNCTION (medically significant) with onset 11Nov2021, outcome "not recovered", described as "erectile dysfunction". The clinical course: On 11Nov2021, Patient was vaccinated with the third dose of your Pfizer vaccine against Covid 19 and from that same day he have suffered from erectile dysfunction. He would like to know if this effect lasts long because he have almost completed three weeks and patient have not had an erection again and that already has him very worried because something like this had never happened to him and patient had erections without any problem every day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
she felt l ke she got hit by a truck so it was much worse; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and third dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse). At the time of the report, FEELING ABNORMAL (she felt l ke she got hit by a truck so it was much worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
At stated time, began to have chills, body aches, and uncontrollable shaking. This lasted 3-5 hours. The following day and for about 24 additional hours, experienced extreme fatigue and malaise.
Felt Pain; COVID; Fatigue caused due to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt Pain), COVID-19 (COVID) and FATIGUE (Fatigue caused due to vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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. In April 2021, the patient experienced FATIGUE (Fatigue caused due to vaccine). On an unknown date, the patient experienced PAIN (Felt Pain) and COVID-19 (COVID). In April 2021, FATIGUE (Fatigue caused due to vaccine) had resolved. At the time of the report, PAIN (Felt Pain) had not resolved and COVID-19 (COVID) outcome was unknown.            Concomitant Drugs were not reported. Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a medical technologist concerning her 16 year old daughter and follow up information has been received from license practical nurse. The patient with no relevant medical history and no history of drug reactions/allergies who on 14-JUN-2007 was vaccinated (route not reported) in the left deltoid with a first dose of GARDASIL (lot # 657736/0389U). Concomitant therapy included ZYRTEC and ERYTHROMYCIN BASE. On 14-JUN-2007, about 5 minutes after receiving the first dose, the patient experienced severe hives. The hives were everywhere (on top of the head mentioned) and she had terrible itching. The patient took BENADRYL and was okay. On 15-JUN-2007, the patient recovered. On 20-AUG-2007, the patient received the second dose of GARDASIL (lot # 658282/0929U). Post vaccination, the patient complained of not feeling well, she was pale,cool, clammy so patient mother laid her on the floor. The patient was not in pain. The patient passed out in the exam room and recovered shortly thereafter. The doctor instructed for the patient's vitals to be taken. Vitals taken at 3:40 pm were BP, 98/60 right arm seated, Pulse 60 (right arm), vitals taken at 3:48pm were BP:90/60 right arm seated, Pulse:72 (right arm) the pulse was regular and respiratory rate: 16. The patient insisted that she was feeling better so the patient's mother stated she was taking her home. The patient mother stated that the patient was worried about getting her 2nd GARDISIL vaccination today and thinks tha's why she reacted this way. Doctor was notified patient was feeling better and going home. The patient broke out in hives after going home. The patient was treated with BENADRYL.NO additional information is expected.
Rash shoulder / chest; hives neck/face; Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; Generalized erythema- right shoulder, chest; Red eye and itchy eyes; Red eye; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 26Mar2021 09:30 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included, rheumatoid arthritis from 2004 and ongoing, ongoing osteoarthritis (replaces left knee, left hip, left shoulder), ongoing left adrenal tumor, neuropathy, sleep disorder. Family history included osteoarthritis, adrenal tumor and brother deceased kidney cancer. Concomitant medications included ongoing gabapentin (NEUROTIN) taken for neuropathy; ongoing tramadol taken for arthritis; ongoing tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis; colecalciferol (VITAMIN D) taken for an unspecified indication; vitamins NOS (MVI) taken for an unspecified indication; ongoing zolpidem tartrate (AMBIN) taken for sleep; all from an unspecified start date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in the Right shoulder, on 05Mar2021 09:30, Lot/Batch number-EN6206, for COVID-19 immunization. The patient also took IVP dye and Avelox and experienced hives. If IV contrast to be used must do steroid/Benadryl combo. The patient experienced rash - shoulder, chest and hives neck/face, urticaria on face, eyelid, head, eyes. Rash started 9 hrs after, hives 1 1/2 days after (36 hrs). Had generalized urticaria (neck x 6 days), generalized erythema on right shoulder and chest, Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; and Red and itchy eyes-eyelids. Antihistamine: Benadryl every 6 hours initial 50mg, took 25 then X 6 days was given as treatment. The patient was not hospitalized/admitted in the ICU or seen in the emergency department. The patient did not receive any recent vaccines for any other conditions prior to the event or around the time of Pfizer-BioNTech COVID-19 vaccination. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Presented on 04/01/2002 with 5-10 chicken pox lesions on arms and trunk and one on forehead.
Pericarditis diagnosed with EKG changes.  12/7/07 Reviewed clinic medical records which reveal patient experienced dussen onset diffusechest pain, inability to lie down or tke deep breaths.  Went to ER & admitted 12/2-12/3/2007 for cardiac w/u.  Seen in cardiology clinic 12/4/07   FINAL DX: acute pericarditis. 12/18/07 Received v/m from reporter w/vax lot #.  VAERS database updated w/same.
Head ache, nausea, weakness, hard to think, long lasting headache. I don't feel right, and this is the second time this has happened to me in 2 months.
Left hand started to feel weak; slight pins-and-needles feeling; Left hand continues to hurt; Sciatica pain in my left leg; a sharp pain at the bottom of my tummy; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient..  A 40 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Apr2021 11:30 (Lot number: F-EP7533) at the age of 40 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hand weakness" (unspecified if ongoing); "Pinched nerves in her spine" (unspecified if ongoing). Concomitant medications included: SPIRONOLACTONE; OCELLA; DEXEDRINE; YAZ. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Left hand started to feel weak"; PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "slight pins-and-needles feeling"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Left hand continues to hurt"; SCIATICA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Sciatica pain in my left leg"; ABDOMINAL PAIN LOWER (non-serious) with onset Apr2021, outcome "not recovered", described as "a sharp pain at the bottom of my tummy". Therapeutic measures were not taken as a result of muscular weakness, paraesthesia, pain in extremity, sciatica, abdominal pain lower. Additional information: Patient also experienced the events after the second much the same way but with higher intensity than after the first shot. Patient has not taken other vaccine within four weeks. Patient did not have COVID prior to the vaccination and had not tested for COVID since the vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494829 Same patient/product; different events/dose
COAGULOPATHY, UNSPECIFIED TYPE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Joint pain and swelling that moved from joint to joint in my body for 6 weeks, the first week being most intense pain. Advil and Tylenol as well as a prescription Naproxen for a time.
Patient was fully vaccinated with pfizer as of 2/22/21. Patient has tested positive for COVID & is symptomatic with mild symptoms.