chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like her muscles and nerves are not working; "no strength when walking"; feels like her muscles and nerves are not working; She feels like her muscles and nerves are not working; She feels like her muscles and nerves are not working; right leg pain; cannot sleep; "legs give up on her"; feeling sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Two previous heart attacks.). Concurrent medical conditions included Diabetes and Kidney cancer.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced MALAISE (feeling sick). On 02-May-2021, the patient experienced NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working) (seriousness criterion medically significant), MYOPATHY (She feels like her muscles and nerves are not working), PAIN IN EXTREMITY (right leg pain), INSOMNIA (cannot sleep), GAIT INABILITY ("legs give up on her"), ASTHENIA ("no strength when walking") and MYALGIA (feels like her muscles and nerves are not working). On an unknown date, the patient experienced NEURALGIA (feels like her muscles and nerves are not working). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working), MYOPATHY (She feels like her muscles and nerves are not working), INSOMNIA (cannot sleep), GAIT INABILITY ("legs give up on her"), NEURALGIA (feels like her muscles and nerves are not working), ASTHENIA ("no strength when walking"), MALAISE (feeling sick) and MYALGIA (feels like her muscles and nerves are not working) outcome was unknown and PAIN IN EXTREMITY (right leg pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Per report,  the patient did not experience any adverse events on the day of vaccine administration. On 02-May-2021, the patient experienced a persistent, unbearable pain in her lower right leg. She was scheduled to visit her doctor for treatment on 13-May-2021. Treatment included unspecified creams. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia is consistent with the product known safety profile.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Myalgia is consistent with the product known safety profile
Approximately 10 minutes after vaccine administered patient reported itching on chest and funny feeling down both arms. Both palms had severe redness and welts on them, as well as some minor swelling. Patient was given 50mg of Diphenhydramine capsule and monitored for an additional 45 minutes. At time of leaving pharmacy the redness was still present on palms, but the white welts had gone down quite a bit. Pharmacist recommended patient go straight to urgent care for further treatment. Patient never had any difficulty breathing, speaking or swallowing during event.
This spontaneous report was received from a pharmacist concerning a 51 year old female patient with no pertinent medical history or drug reaction/allergies. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, date and route were not reported) lot # K007986, expiration date 03-SEP-2015 with no concomitant therapies. The pharmacist reported that on 23-OCT-2014, the patient came to the pharmacy with a red, warm, 2.5 to 3 inch in diameter circle around the of ZOSTAVAX injection site. Pharmacist reported that red area was not raised and there was no rash present. At the time of the report the outcome was reported as not recovered. Patient sought medical attention at the pharmacy visit and was advised to administer ice packs to the injection site for treatment. No lab diagnostics test were performed. Additional information has been requested.
Pain at the injection site that started about 3hrs after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced pain at the injection site that started about 3 hours after injection. No treatment was provided for the event pain at the injection site. The outcome of the event pain at the injection site was unknown. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
low grade temp; arm sore; fatigue; fever/temp above 100.3; bad headache; her back, neck, shoulder and hips are gone; This is a spontaneous report from a contactable nurse (patient). A (Age: 65; Unit: Unknown) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced low grade temp, arm sore, fatigue, fever/temp above 100.3, bad headache, and her back, neck, shoulder and hips are gone. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 100.3. Caller wanted to know what test she can do that can tell if she has any protection after the second dose. The outcome of the event low grade temp, sore arm was recovered on an unspecified date; and all other events were unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested.
A 29-year-old male patient reported feeling dizzy and tinnitus 7 minutes after receiving his first dose of Janssen. Patient remained standing, walking and oriented x3 at the time of the incident.
Mother called health center and stated R arm swollen, hot, red with streaks going down arm - referred to ER or pediatricians office.
Neuropathy optic nerve  and trigeminal and inflammation nerves behind eye causing pain behind eye and head, blurred vision, pain in temples still in effect as of March 27
transient blindness; optic neuritis; vax given 27SEP93; blindness occurred 14OCT93; same problem last year; vax given 16SEP92, blindness occurred 6OCT92;
LOCALIZED REACTION IN UPPER DELTOID, RED, SWOLLEN WARM TO TOUCH
Sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Beta lactams" (unspecified if ongoing), notes: Known allergies: Beta lactams. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, booster), for Covid-19 immunization; Covid-19 vaccine (Dose 4, booster), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Oct2022 at 06:00, outcome "recovered"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2022 at 06:00, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity, fatigue.
Pt received vaccine at 4:30PM 10/21 PM. Pt started experiencing numbness, pain, paresthesias. Side effects lasted all night. Not relieved by TYLENOL or MOTRIN. Has self resolved by 3PM 10/22.
weakness; This is a spontaneous report from a contactable consumer (patient's son). An 81-year-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID 19 vaccine), dose 2 via an unspecified route of administration on 27Jan2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. Medical history included doesn't sleep. The patient received first dose (Lot Number: EL1284) on 06Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had weakness on 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test was fine. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Patient developed muscle aches and severe itching a week after having H1N1 vaccine. Patient has not seen a doctor. Patient has soaked in a tub of cold water for relief of itching.
several >15 sec sz-like episodes (> over 20min) T99-100, diarrhea,mild before vax was referred prior to vax secondary jitters & inc tone subsequently nl;development nl;
Patient presented with weakness. Patient is currently receiving therapy for lung cancer and resulted positive for COVID. Patient is fully vaccination.
UrticariaPruritus & DRY MOUTH; WHEEZING; RASH; DIARRHEA; URTICARIA INFLUENZA 0.5 ML ONCE
Fever, joint swelling, headache, migraine, fatigue, dizziness, hip & back pain, appetite loss. All symptoms lasted more than 24 hours.
Stomach pain, burning cramps, nausea, vomiting, lost voice, shortness of breath.
sweating; face looked kind of pale; pharmacist said that the dose was 0.7 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (pharmacist said that the dose was 0.7 ml), HYPERHIDROSIS (sweating) and PALLOR (face looked kind of pale) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .7 dosage form. On 27-Jul-2021, the patient experienced ACCIDENTAL OVERDOSE (pharmacist said that the dose was 0.7 ml). On 28-Jul-2021, the patient experienced HYPERHIDROSIS (sweating) and PALLOR (face looked kind of pale). At the time of the report, ACCIDENTAL OVERDOSE (pharmacist said that the dose was 0.7 ml), HYPERHIDROSIS (sweating) and PALLOR (face looked kind of pale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided/unknown by the reporter. Treatment product use was not provided/unknown by the reporter.
Information has been received from a health professional concerning a female with sulfonamide allergy who was vaccinated with Gardasil. The nurse reported that the patient experienced a really bad injection site rash. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.
Went to Pharmacy to get my flu and pneumonia vaccines. Informed pharmacist that I needed preservative free vaccines due to allergy to thimerosal. Was assured that I was getting PF. Received both shots around 4pm. That next morning at 0100, I developed a fever of 101.7, was weak, chilling, achy and had a headache. Unable to get rid of fever and continue today with all of the symptoms. Was seen my by Dr. yesterday. She feel I'm having an adverse reaction to one or both of my shots. I had FLUZONE Quad and PNEUMOVAX 23. Also, the arm I had the injection in is extremely sore, swollen and red.
mother called states child had dime-sized circumference and a little raised knot on (L) arm IM injection site with solid red rash down to elbow
On Sunday 12/4/22 I had a runny nose and sore throat, my son called to say he had tested positive. On Monday I awoke with body aches, feeling bad, my throat was worse, so I took a home COVID-19 test, it came back positive. On Tuesday and Wednesday my symptoms stated progressively getting worse but once my temperature got up to 102.6F I called my doctor's office and was prescribed Paxlovid. I started taking it immediately I did start feeling better, it took two weeks to feel 90% better without fatigue. I do have a lingering cough.
soreness in both arms immediately p/vax;2AM woke-irritable, cont crying, restlessness, extreme thirsty; 730AM APAP given c/o dizziness, nausea 8AM-12noon; vomited x 5; unable to keep liquids down 4PM-MD visit-4" sq redness @ DTP inj site
A report received from a health professional concerning a 15 year old female patient, height 63.0 inches, weight 110.0 pounds. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received Nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration started on 16-NOV-2015. The HCP reported that the spacer came off the FLUMIST sprayer and because of this the entire 0.2ml dose of FLUMIST Quadrivalent was administered to the patients one nostril on 16-NOV-2015. And also product quality complaint was reported. FLUMIST Quadrivalent was discontinued on 16-NOV-2015. But action taken FLUMIST Quadrivalent was reported as none. The patient recovered from 0.2ml dose of FLUMIST was received in one nostril on 16-NOV-2015. And outcome of product quality company was unknown. The report was considered to be non-serious by company physician.
Only received the adjuvant portion; Only received the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 5953S, expiry date 7th November 2022) for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Shingrix. On 11th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The reporter stated that, the patient only received the adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. No additional details were provided by the caller.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213505:FU deleted
pt recv vax & became pale, diaphoretic & faint;pt sit down & began to put head down when jerked backwards, eyes rolled back in head & had approx 3 sec of sz activity;unable to ambulate out of office;emotional rxn to needle;h/a, lethar
Case number PHEH2015US003136, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to an 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 09 Feb 2015. The vaccine had two more other excursion as follows: on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Patient w/ left thigh redness and mild swelling starting about 18 hours after receiving dTAP vaccine in left thigh.  Area appeared somewhat pruritic as patient was scratching at area frequently. No apparent pain.
11/06/2021 The night after my vaccination I ended up with glands under my left arm  swelled up so bad.  I was so hot and had chills. I went to to  doctor and  ended up in the ER.  The glands under my left arm were so big and hot.  This lasted for about 4 days.
Strong allergic reaction; hives; swelling hand; Swelling lips; Swelling other places; dose 3, single (booster dose); This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Ff2593 and expiry sate: not reported), via an unspecified route of administration into right arm on 26Oct2021 at 01:00 PM as dose 3, single (booster dose) (Age at vaccination: 70-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concurrent conditions were none. Concomitant medications (within 2 weeks of vaccination) included: Amoxicillin and patient had competed 10-day course 28Oct2021. The patient had no Known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: En6208), on 16Mar2021 at 11:00 AM as dose 1, single; Second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Er8729), on 09Apr2021 at 11:00 AM as dose 2, single, both doses via an unspecified route of administration into right arm for COVID-19 immunization (The patients age at both first and dose of vaccination was 69-year-old). On 29Oct2021 at 06:00 AM, the patient had Strong allergic reaction, hives, swelling on hand, lips, and other places. Therefore, the patient had visited Emergency room/department or urgent care (Doctor or other healthcare professional office/clinic visit). The patient was not diagnosed with COVID-19 prior to vaccination but was tested for COVID-19 Since the vaccination. The laboratory tests included PCR test (Nasal Swab) on 29Oct2021, and results were pending. The patient was treated with Prednisone for all events. All events were considered serious. Outcome of events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
A temperature excursion occurred 9/21/22 for 1 hour 38 minutes. Unknown at the time the IPOL vaccine was given. The IPOL was claimed as non viable and to be discarded. Family was notified and patient hasn't had any reactions.
Information has been received from a physician concerning a female patient who was vaccinated IM with 0.5 ml dose of Gardasil.  Subsequently the patient experienced red bumps, itching at the injection site 3-4 days after the vaccination.  It was also reported that the patient felt hot and heavy in her arm.  Unspecified medical attention was sought via phone.  At an unknown date the patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided.
bad flare of plaque psoriasis; Wearing off effect; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365197-00 (AbbVie).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Lot number: 1161377), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious) with onset Jan2021, outcome "recovered", described as "bad flare of plaque psoriasis"; THERAPEUTIC RESPONSE SHORTENED (non-serious) with onset 2021, outcome "unknown", described as "Wearing off effect". The action taken for risankizumab was dosage not changed. Additional information: On an unspecified date in Jan2021, the patient had a bad flare of plaque psoriasis after first injection of Covid-19. After taking second covid-19 vaccine, she brought out with psoriasis. She started losing hair after taking booster dose of covid-19 vaccine. She was feeling good. She had Covid-19 in Jul2022. She felt it was like a sinus infection and did not felt good. She reported that when she was close to or month before next Skyrizi injection she had to have itchier scalp, but as soon as she got the Skyrizi injection, it went away. She had no flakes but had a little more itching. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was related to covid vaccine. Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of BAD FLARE OF PLAQUE PSORIASIS AFTER FIRST INJECTION OF COVID-19 VACCINE was not provided. Drug: SKYRIZI(Injection)(RISANKIZUMAB): Causality: Wearing off effect (Therapeutic response shortened): Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Psoriasis flare-up (Psoriasis): Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer biotech COVID-19 Vaccine (Tozinameran): Causality: Wearing off effect (Therapeutic response shortened): Causality as per reporter (Drug/Vaccine): Not Reported. Psoriasis flare-up (Psoriasis): Causality as per reporter (Drug/Vaccine): Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.