chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a patient's father regarding his two daughters of unknown age. This case report refers to the oldest daughter. The patient's pertinent medical history and concurrent conditions were unspecified. On an unknown date (reported as 5 to 6 years ago) the patient was vaccinated with two out of the three GARDASIL. When it was discovered that she had missed the third dose, more than a year after her last dose, the physician's office vaccinated her with all three doses of GARDASIL. No concomitant medications were reported. The father stated that the patient experienced soreness at the injection site each time she was vaccinated. On an unknown date the patient was diagnosed with bipolar disorder. No product quality complaint (PQC) was involved. The outcome of the events is unknown. The causality assessment for the events soreness at the injection site and bipolar disorder was not provided. This is one of the two reports received from the same reporter. Additional information is not expected, no contact details were provided.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.4 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081834 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021 contains non-significant information included update on reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081834:For First dose
Rec'vd shots 4-16-07 24 hours later tenderness, numbness and itching, fever 101.9. Went to ER dept rx'd Keflex 1000 mg TID x 10 days on R arm.
Case number PHEH2015US013578 is an initial spontaneous report from a pharmacist received on 10 JUL 2015 with the follow-up information received from Quality Assurance Department (reference number: 381256) on 10 AUG 2015 and a combined follow up report from the pharmacist received on 14 JUL 2015 and on 17 AUG 2015. This was also a quality complaint (QA reference number 381256). This report refers to a 55-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with RABAVERT first dose on 22 JUN 2015 (batch number: not reported), second dose on 25 JUN 2015 (batch number: not reported) and third dose on 29 JUN 2015 (batch number 556011A expiry date: FEB 2018). It was reported that after the third dose of RABAVERT, he had urinary burning. He stated that the third dose "appeared cloudy" in the vial. The pharmacist stated that the appearance of the product looked fine for the nurse and they felt that the patient was mostly a nervous patient. The outcome, seriousness and causality assessment of the event was unknown. He received the fourth dose on 06 JUL 2015 and everything appeared normal and there were no issues. IT was reported that this was the first complaint for this batch for this issue. This is the seventh complaint for this batch. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 556011A) was manufactured in accordance with the approved internal procedures and it wa sin compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 381256) on 10 AUG 2015: Updated RABAVERT batch review report. Combined follow up report from the pharmacist received on 14 JUL 2015 and on 17 AUG 2015: Nurse comments regarding the appearance of product and patient's condition after the fourth dose of RABAVERT were updated.
Severe pain which continues to get worse after 1 week and radiates into L clavicle, Limited ROM, swelling and redness.  She is to F-U with dr in 5 days. Given pain meds.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # J005061, expiration date: 22-OCT-2015) (dose, frequency and route of administration were not reported). No adverse effects were reported. No PQC was involved. Additional information has been requested.
SHE CAN'T CONCENTRATE NOR THINK CLEARLY; VISUAL IMPAIRMENT; BLOOD CLOTS IN SPLEEN; CUT OFF BLOOD SUPPLY TO HER BRAIN; MUSCLES DETERIORATING; NOT FEELING WELL/NOT NORMAL/FEELING SICK; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and stroke. Concurrent conditions included: blood clots, cigarette smoker, marijuana use, and non-alcoholic. The patient experienced swollen throat and tongue when treated with olmesartan medoxomil (Benicar). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 15-MAY-2021 in the afternoon at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021, the patient experienced flu-like symptoms, achiness not feeling well and not normal. On 01-JUN-2021, the patient experienced deteriorating muscles. On 12-JUL-2021, the patient was diagnosed with blood clots in spleen which cut off blood supply to her brain and was hospitalized. On 16-JUL-2021, the patient experienced visual impairment (was not able to read questions on the questionnaire on the paper). For 5 days she was hospitalized for the same and discharged on 17-JUL-2021. On 20-AUG-2021, MRI was done, and result was not reported, on an unspecified date, the patient had another MRI scan result was not reported. On an unspecified date the patient was not able to concentrate nor think clearly. Patient has no one to take care of her and felt helpless and sick all the time.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, blood clots in spleen, muscles deteriorating, visual impairment, not feeling well/not normal/feeling sick, cut off blood supply to her brain, and she can't concentrate nor think clearly. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210846635-COVID-19 VACCINE AD26.COV2.S - Blood Clots In Spleen, Cut Off Blood Supply To Her Brain,  Visual Impairment, Flu-Like Symptoms, muscles Deteriorating,  She Can't Concentrate Nor Think Clearly. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210846635-COVID-19 VACCINE AD26.COV2.S -Not Feeling Well/Not Normal/Feeling Sick. This event is labeled  and is therefore considered potentially related.
pt recvd vax; devel chicken pox lesions & blisters all over body; blisters ruptured;reporter indicated that she had "no prior exposure knowledge";
Patient came back to pharmacy on 11/21/21 and showed a large bruise on the right arm near the site of injection. Bruise looked to be 2 inches tall and 4 inches wide, spanning across the upper right arm. Pt reports feeling a prick during the shot and then having a sore arm and noticing the bruise the night of. Reports some swelling that day. Bruise is still present today and there is a small area of redness that appeared. Reports no pain today. Patient counseled to see doctor if worsening of symptoms or increase in pain.
Arm redness; Puffiness continue to spread down my arm.; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment: This case was reported by a consumer via interactive digital media  The patient reported that (date of reporting) today was day 6 since Shingrix vaccination, his/her arm redness and puffiness continue to spread down his/her arm. Additional supportive information: Follow-up would not be possible as no contact details were available.
Patient from unauthorized age group was given Moderna vaccination.  Called patient on Monday, April 26 and she did not complain of any adverse side effects outside the normal range.  Guardian (father) was notified as well.
Local adverse reaction in upper right arm. Reaction happened the same day as injection. Bruising, swelling, hot to the touch, and very sore to the touch. Getting better everyday after initial reaction.
No adverse effect; patient was inadvertently administered GARDASIL 9 that was expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 04-NOV-2019 the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection lot # N001533 expiry date 16-OCT-2019 for prophylaxis (dose and route were not reported) (Expired product administered). No adverse effect was reported.
Nurse missed second verification against vaccine record, and administered Meningococcal Conjugate vaccine to patient before the second dose was recommended thinking it was the initial dose. Nurse caught the administration error, and discussed with patient and father at the time.  Explaining that there would be no side effects because of the additional dose, but that it did not count towards the series, and patient would still require a second dose at a later time.
CAN NOT WALK; CAN NOT STAND; CAN NOT SLEEP; SCIATICA; This spontaneous report received from a patient via a company representative . 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: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination.Batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced sciatica. On JUN-2021, the subject experienced can not walk. On JUN-2021, the subject experienced can not stand. On JUN-2021, the subject experienced can not sleep. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not walk, can not stand, can not sleep, and sciatica. This report was non-serious.
Sessions of chest pains and labored breathing, incessant itching with the appearance of black dots on my skin, lethargy, and nauseau.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the 1st Moderna vaccine @ around 12:30pm on January 6th. That afternoon I felt fatigue and felt sleepy. I went to bed that night as usual. I was tossing and turning and woke my self up because i could feel my heart racing. I then proceeded to check my pulse and time myself. I had gotten 120 heart rate. Which i thought it couldnt be but the i have the oxygen sat that check oxygen and heart rate. I checked and my heart rate went up to 125. My head was pounding, i had a fever, the left side of my body ached, and i felt a lot of tension and my hands as if they were swollen. I took some Tylenol throughout the day and i still felt completely exhausted and horrible. This lasted at least 2 days. I contacted the ER nurse hotline they proceeded to tell me that all the signs and symptoms I had were reactions to the vaccine and if my heart rate went over 135 to go to the ER.
C/o HA, dizziness, tinnitus, fatigue that began 30 minutes after receiving the flu vaccine. By 9/20/17 symptoms have mostly resolved, only fatigue and tinnitus remain.
This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. The patient's medical history and drug reactions or allergies were not reported. The physician reported that on 15-SEP-2017 an unspecified patient may have received an improperly stored dose of VARIVAX lot number: N008077 (expiration date: 09-MAR-2019) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: In the range 9°C to 25°C for 5 hours and 30 minutes. In the range -9°C to 8°C for 7 hours and 30 minutes - Previous temperature excursion: No. No adverse events were reported.
Mild redness at inj site on 3/13. On 3/15 redness and swelling have spread beyond inj site. 3/16 extensive spread of erythema, swelling, now itchy, hot, firm to touch and tender. Dx cellulitis, received rx.
Patient reports she felt like her throat was tight and closing up , she is able to swallow good. patient was monitored by EMS for over 10 minutes, she reports feeling better, symptoms resolved, she  was cleared by EMS. BP 150/88, pulse 76, Spo2 96%
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 03-MAR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.
Numbness on the right hand in the thumb joint area, vision disturbances, headache, seeing things that were not there, hearing sounds but perceiving that they were comming from directions that were different from where they were actually originating from.
First vaccination (Pneumovax) Monday 11/26/2001. Noted that evening low grade fever (temp not taken) and localized myalgia upper left arm. Small area redness and warmth at shot site over next 48 hours swelling, redness, warmth left elbow. Full ROM (NSAID's compresses).
Right side of her body was paralyzed, couldn't move; Couldn't feel her face; Urinated herself; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) (seriousness criterion medically significant), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself). At the time of the report, HEMIPLEGIA (Right side of her body was paralyzed, couldn't move), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: normal (normal) normal. On 13-May-2021, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The caller thought her mother was experiencing a stroke. They denied any numbness, fever, coughing and lethargy. No medications were taken for the symptoms and no concomitant medications were provided. The second dose of the vaccine is scheduled for 12-Jun-2021.  Company comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
felt like a limp dishrag; flu like symptoms; achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a limp dishrag), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and DENOSUMAB (PROLIA) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (felt like a limp dishrag), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, FEELING ABNORMAL (felt like a limp dishrag), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy) had resolved.            Patient's concomitant medications included unspecified  blood pressure medication, cholesterol medication and eye vitamins.
(L) deltoid area with small central eryth papule with very mild erythema and induration approx. 1.5 cm surrounding.
I have a rash with itchy bumps that started in my scalp and has moved to my chest, back, forearms, and stomach.  The rash starts as a pink area and then turns into individual bumps that itch.   I scratch them and they scab over.   I saw my doctor on February 5th since I had been awake the night of Feb. 4, 2016 itching and scratching.  He prescribed Methylprednisolone 4 MG Dosepack and also Benadryl, and Zyrtec.   Also use Desoximetasone that I already had.  I then saw someone at a dermatolgy center on February 8 and 18th.   She believed it was related to our dogs, but I receive allergy injections that covers the dogs.   We treated our dogs and house for fleas, but no evidence of fleas was found. I am still taking the Benadryl and Zyrtec and using the prescription hydrocortisone cream and an over-the-counter one for my face and neck.
Within 2 minutes after injection, patient started to feel very hot and with increased heart rate.  Pt states that she feels "tingly" and is tearful.  Pt denies difficulty breathing.  Patient then started to have a red blotchy rash on her neck and chest.  No redness at injection site.  Pt brought to Emergency room for evaluation/observation.  Pt able to talk in full sentences.  Pt states that she has a history of anxiety and has gone into SVT because of anxiety in the past.   Pt received steroids in ER.
Flu and pneumonia vaccine given in same left arm causing sespis and shoulder injury. Clinic falsified medical records regarding the shots saying 1 was given in each arm. I have photos of arm showing both injection sites and very swollen and red
Pt received second of 2 series zoster shots and that night reports fever, proceeded to have daily fevers for 7 days associated with fatigue, nausea, and diarrhea.