chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms waste down), MOVEMENT DISORDER (can hardly walk), NERVOUSNESS (shaky at times), MUSCLE SPASMS (back spasms) and BACK PAIN (Lower back pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concurrent medical conditions included Hypertension since 30-Jan-2015, Type 1 diabetes mellitus since 30-May-1999 and Drug allergy (opioid allergy). Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, LISINOPRIL for Hypertension, TOPIRAMATE (TOPAMAX) for Migraine. On 31-Mar-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MUSCLE SPASMS (muscle spasms waste down), MOVEMENT DISORDER (can hardly walk), NERVOUSNESS (shaky at times), MUSCLE SPASMS (back spasms), BACK PAIN (Lower back pain), MYALGIA (Body aches), CHILLS (Chills) and ARTHRALGIA (joint pain). On 08-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction to vaccine). On 09-Apr-2021, the patient experienced MUSCLE SPASMS (spasms throughout body uncontrollably). On an unknown date, the patient experienced PAIN (Extreme pain joints, legs, hips). The patient was treated with Physical therapy for Movement disorder; Physical therapy for Back pain; Physical therapy for Pain; Physical therapy for Pain and Physical therapy for Arthralgia. On 01-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasms waste down), MOVEMENT DISORDER (can hardly walk), NERVOUSNESS (shaky at times), MUSCLE SPASMS (back spasms), ALLERGY TO VACCINE (Allergic reaction to vaccine), MUSCLE SPASMS (spasms throughout body uncontrollably) and MYALGIA (Body aches) outcome was unknown and BACK PAIN (Lower back pain), PAIN (Extreme pain joints, legs, hips) and ARTHRALGIA (joint pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-166743. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant Fu added. On 26-May-2021: Case merged with earlier duplicate case. Case marked for deletion.
Blood flecks in stool 24 hours after 1st dose. Had vomiting twice and no documented fever. Stool guaiac testing negative 5 days after dosing. Decreased eating also noted.
Memory loss; This is a spontaneous report from a contactable consumer. This 26-year old female consumer (patient) reported  for herself. A 26-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number reported as "28416") as DOSE 1, SINGLE for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced memory loss (amnesia) (non-serious) on an unspecified date with outcome of unknown. No lab test were done in the last 2 weeks. No treatment information was reported.    The lot number for the vaccine BNT162B2 was not provided and was not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 047B21A) for COVID-19 immunization. No medical history reported. On Apr 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 30, 2021, patient experienced vaccination site pain (arm pain). The patient treated with paracetamol (oral) for pain in arm, at a dose of 500 mg once. On May 1, 2021, vaccination site pain (arm pain) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or concomitant medication.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EH19899), in right arm and as dose 2, single (Lot number: EL1283), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 3 (booster), single (Lot number: 12F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "sticky platelets" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jun2022; TURMERIC [CURCUMA LONGA], start date: 01Jun2022; ASPIRIN 81, start date: 01Jun2022; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL], start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No known allergies.; Sender's Comments: The causal association of reported events in relation to suspected BNT162B2 vaccine cannot be totally excluded based on temporal relation.  Case will be reassess pending QA investigation and ff-up reports.
This solicited report was received from a 56 year old male patient reporting on himself, as part of a market research program entitled "MRK211: Pharmacy Interactions" conducted by Research Group. The patient's concurrent conditions included blood pressure abnormal, depression and insomnia. The patient's medical history included blood cholesterol abnormal for which he took unspecified medication several years ago. The patient always got bruise when he got injections (needles). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prophylaxis. Concomitant therapies included unspecified medications for blood pressure, depression and insomnia. On an unknown date, the patient experienced bruising after vaccination at the pharmacy.     The outcome of the event was reported as recovered on an unspecified date in October 2016. The reporter considered the event to be related to ZOSTAVAX.  Additional information has been requested.
Afluria Quadrivalent MDV 0.25ml was given to a child between the age of 6 month - 35 months.  On the vial, box the vaccines came in and the instruction sheet. It states okay to give this vaccine to these age groups.    6 month - 35 months 0.25ml   36 months and older 0.50ml The state does not approve this vaccine for the age group of 6 months-35 months. -Due to the amount of mercury and its not preservative free. -The vaccine is prepared from virus grown in embryonated chicken egg and inactivated with beta propiolactone. Each 0.25ml dose contains 12.25 mcg mercury/dose Parents mother state that patient had no reactions to the vaccine. Parent will pick up a form that Dr gave regarding mercury.
Arm was red and swollen about 2 inches past the injection site all around. The parents were told to take BENADRYL and MOTRIN by mouth and apply ice. Called and spoke with the father on 9-19 at 4:10pm and was told she was doing better and the swelling was going down.
Patient complained of worsening shortness of breath, cough, and sputum production for 5 days. Presented to the hospital on 10/7/22 and tested positive for COVID. She was discharged home on 10/13/22.
This spontaneous report was received from a pharmacist concerning a 72 year old male patient. The patient who received his first dose of RECOMBIVAX HB (route and lot # not provided)on 05-SEP-2014, was scheduled to receive his second dose of RECOMBIVAX HB on 05-OCT-2014, however, the patient represented to the pharmacy today on 15-OCT-2014, to receive the second dose RECOMBIVAX HB. The pharmacy stated that he intended to administer the second dose of RECOMBIVAX HB (route and lot # not provided) when the call was disconnected. He stated that the patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Mother reported that patient started to develop small itchy bumps on legs within hours of receiving vaccine. Rash increased. Never had wheezy or difficulty breathing. Went to ER in the early evening_given Benadryl and Prednisone. Pt was determined by ER physician 464247, to be having possible allergic reaction to FLUMIST. Mother reported improvement of symptoms within hours of being in the ER. PT was evaluated in the doctor's office 10-2-09 and rash had completely resolved.
I was going in to have Gallbladder surgery and had to have a COVID-19 test done 72 hours in advance. I tested positive on 11/12/22. I had fatigue, and a low-grade fever at the time of testing positive. Then, it progressed, and I had congestion, increased fatigue, and loss of voice. I was offered PAXLOVID, but I turned it down. I was prescribed albuterol and benzonatate. I was also taking over the counter MUCINEX and SUDAFED. I am feeling much better now.
Administered vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17 year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The nurse reported the Moderna COVID vaccine was given to a 17 year old patient on an unknown date. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine to a 17 year old, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old  female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
After the second immunization patient started experiencing changes in sleep pattern, confusion and difficulty doing simple things like sitting down and eating with a fork. He had never had these problems before. About 2 weeks later, he started having diarrhea all day every day. Saw doctor and only told to Imodium. This did not help the diarrhea. He started experiencing dizziness, worse confusion, and hallucinations in addition to the other symptoms. In early May, he started complaining of dizziness and the hallucinations got worse. He was admitted to hospital on May 14. The symptoms continued. His speech became garbled, and he became more confused at hospital. the diarrhea continued for more of 3 weeks
dermatitis all over body moderate rxn entire body, more on legs, no systemic evident on exam;
Pain at 9 (1-10 scale) in arm, up neck and down left side, can't raise or use arm, headache, low grade fever, hot red skin, swollen at shot site and moving down arm towards elbow, rash, nausea.
Numbness and tingles immediately after shot. Tingly feeling up  left side of neck and into left eye. As days go by more numbness and tingling under my arm pit and down my hand into fingers. Feels like I hit my funny bone from the elbow down when using arm repetitively.  Soreness of left side of neck.
mild area of erythema 8cm surrounding immunization site; pt favoring LVE not moving arms secondary to pain; bandaid had not been removed since vax 2 days earlier;
Hives; Presently being treated with doctors presciption of 10mg of Singulair. Also 10mg of cetirizine.
Narrative:  tingling to arm, itching of arm and swelling feeling to axilla of the same side the injection was given
She said she felt like she was having an a fib attack 2 hours after dose and even went to hospital parking lot in case she needed to go in for about an hour. Also had bp of 165/100 normal for her is 105/70 plus a high heart rate. She had an ablation for a fib in April but had been fine before shot. She?s worrried about second dose
allergic reaction to something environmental and it resulted in a rash that covered large parts of my body; allergic reaction to something environmental and it resulted in a rash that covered large parts of my body; It started off as small red spots (5-1cm) in no particular pattern on stomach, arms, back, butt that became large red welts/hives across; This is a spontaneous report from a contactable consumer (herself). A 25-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 5EN5318) via an unspecified route of administration, in arm left on 27Jan2021 at 15:30 as single dose for covid-19 immunisation. Medical history included allergy to arthropod bite and concomitant medications were not included. It was reported that on 09Feb2021 19:00 (after vaccination) she had experienced allergic reaction to something environmental and it resulted in a rash that covered large parts of her body, it started off as small red spots (5-1cm) in no particular pattern on stomach, arms, back, butt that became large red welts/hives across. The welts disappeared within 2 hours of taking Benadryl. She took 2 pills the first night and it reappeared around 2pm the next day and another Benadryl pill at 16:00. Timeframe between vaccination and starting of symptoms was 13 days 3 hrs 30 min. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & 13 days later started w/szs; dx @ 16days;
Vaccine given 08/30/2005, Dad described today at 02:00PM 09/01/2005, patient fatigued, just woke up, achy and splotchy looking, ash on face.  Yesterday complained of allergy symptoms.  Treated with Claritin towards evening.
dose 3 (booster); Rheumatoid arthritis flare up; Felt terrible; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (manufacturer control number: 21K-163-4141403-00).   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on Sep2021 (at 60-year-old) as dose 3 (booster), single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose and frequency for moderate to severe rheumatoid arthritis. Medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose and second dose, both via intra-muscular route on an unspecified date as single dose for COVID-19 Immunization. The patient experienced rheumatoid arthritis flare up (medically significant) on 2021, felt terrible on 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown.  Causality for BNT162B2: The reporter's causality for the event of felt terrible was possible, for event of rheumatoid arthritis flare up was not provided. Causality for HUMIRA (adalimumab): The reporter's causality for the events of felt terrible and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the causal relationship of the event rheumatoid arthritis flare up with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Immunization. Feeling abnormal,  Rheumatoid arthritis cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No additonal AE information provided; The patient was administered an improperly stored dose of PNEUMOVAX23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 18-NOV-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Started with shaking spells - arms, legs 2 hours after vaccines. Vomited once. Held her breath and would fuss after shaking. Spells would last 30 seconds. Low-grade fever. ED visit that night - normal CBCD, BMP. Improved 48 hours after vaccines were given.
Chronic fatigue syndrome: within 2 months of 2nd dose but diagnosed February 2023  herniated spinal disks: July 2023-adverse effect of chronic fatigue syndrome
Patient presented to the emergency department from home after mother called emergency medical services stating that the child was having a seizure. Upon arrival, patient was found to still be seizing. Patient received intravenous Ativan, after which the seizures stopped. Seizure-like activity did reappear, for which the patient received an additional dose of Ativan with good relief. The patient was transferred to Hospital for observation and treatment. Patient was found to be febrile at presentation (100.6 F), although mother had reported giving the child Children's Tylenol (dose unknown). Patient was also found to have pneumonia as demonstrated on chest x-ray. PLEASE NOTE: Vaccines were identified based on VIS provided by mother, who reports she received them at appointment.
~36hours after vaccination, I have a pain in joints ( elbows, ankles and hips); Never had a problem before with those joints. The pain was gone after 4 hours or so.  (I'm currently breastfeeding if this is important)
Pt vax w/ hepta b; exp flu-like sx, n/v, myalgia, fever.  Tx for fever & aches.  Sx lasted 5 days.  Reporter noted that Sx were worse than for other pts.  Also exp6 h/a, bone pain & D.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not provided). The physician reported that  the patient experienced long QT interval and torsade de pointes after getting the vaccine. At the time of reporting the outcome of the event was unknown. The patient sought medical attention. Upon internal review torsade the pointes was considered to be an other important medical event. This is an amended report. The adverse event Torsade de Pointes was added in the AE info screen as other important medical event. No further information is available.
Body aches, chills, sore arm, redness and heat at injection site started day of injection. By 9-18-18 body aches and chills are gone, but sore arm and heat and redness are still present.
A cough that is different than anything I have ever heard or had.  Had it over a month and it hasn't gotten any better.  It chokes me sometimes and one time I stopped breathing because I was choking.  Energy level very low and usually I have a lot of energy and never get tired.  It is hard to do a little bit of work and I used to go go go all day.  Labored breathing often.  Fatigue.
Tachycardia~ 137. As soon as I opened my eyes that morning I could tell my heart was racing. It probably lasted about a couple of hours. I am afraid to get the latest booster shot because of it and I would appreciate any advise as to what to do as my PA said I may be developing an allergy.
Individual called today to report a reaction to her flu shot 2 days ago. She noticed her heart pounding approx. 5 hours after her flu vaccine. She then began brief periods of shaking over the next 2 hours. Sometimes the shaking began in her thighs and moved upward to her shoulders. Other times the shaking began at the top of her body and moved to lower extremities. She describes it as being intense enough to shake her bed and "almost" seizure-like. The episodes lasted approx 1 min each. Her temperature was 98.1 F. Her husband was with her and they did not seek emergency help. The following day her temperature was 99.6 F and she had a headache, but had no further episodes of shaking. No sore throat or other respiratory symptoms were experienced. 2 days following the flu shot she felt her health was back to normal. She has had many flu shots in the past. She was advised to report these symptoms to her physician and to consult him regarding next year's flu shot.
Aches, fever, sweats, stiffness that night. Within two days he had polyarthralgias which responded to steroids. Now he still has arthralgias of hands, wrists and shoulders with new symptoms in knees.