chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scheduled to receive dose second 21 days after first dose; A Little Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A Little Arm Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced PAIN IN EXTREMITY (A Little Arm Pain). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose). At the time of the report, PAIN IN EXTREMITY (A Little Arm Pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment was received by the patient.   No Concomitant medication was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received : Contains No new information
This spontaneous retrospective pregnancy report was received from a medical assistant referring to approximately 25-year-old female patient. The patient's medical history included abnormal pap smear. On 21-NOV-2012, the patient received dose 1 of GARDASIL injection and on 06-FEB-2013 received dose 2 of GARDASIL. When the patient presented for third shot on 03-AUG-2013 the patient complained of feeling bad. On an unknown date in 2013 urine pregnancy test was performed which showed positive. On 27-DEC-2013, the patient underwent cesarean section (hospitalization) and delivered a large baby without any complications. Treatment was received for the adverse event. The patient sought medical attention. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. The event was not life-threatening. The causality of the events was unspecified. No PQC reported. Upon internal review, the event cesarean section was considered medically significant. Additional information has been requested.
Flu-like symptoms, including chills, beginning morning after receiving vaccine. Sore arm, but not too bad (about as expected).
Patient received 2nd Moderna dose on 4/9/21 morning, on 4/10/21 morning, she noticed dark brown reddish urine, increased urinary urgency and frequency, and mild dysuria lasting for 3 days. Denies fever, chill, abdominal pain, nausea, vomiting. patient experienced similar discolored urine after the 1st Moderna dose as well, but lasted < 1 day, so she didn't seek care at that time.  Patient was evaluated on 4/12/21, vital signs and physical assessment within normal limits. Patient was advised to have stat labs done, treated with cephalexin 500 mg BID x 7 days for UTI, advised to increase fluid intake, monitor symptoms and seek follow up care, repeat UA with culture and labs in 4 days.  By 4/14/21, while on antibiotic, patient reports feeling better, urine turning yellow, urgency and frequency resolved.
Immediate shooting pain and tingling down my arm, forearm and into my left pinky and ring finger. For the first few days, I could not move this shoulder, put weight on it or sleep on it. I experienced extreme soreness for over a month. I could not lift my arm to the side or rotate it back without pain for several weeks. Putting weight on the shoulder also hurt for more than a month. I sought out a massage therapist and physical therapist that worked on my shoulder, neck, forearm and hand. After about a month and a half, most of the symptoms seem to have disappeared.
Patient experienced itchiness on her whole body ~5 days after the vaccine as well as swollen lymph nodes so severe she got an ultrasound at her doctor's office because she thought she had breast cancer.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, lot # K011948, expiration date 07-JUN-2016, dose not reported). There was no adverse effect reported. Additional information has been requested.
Swollen arm; Red arm; Itchiness on arm; Fever went to 100F; Chills; Body aches; Headache in front of her head; Didn't want to eat anything; Felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchiness on arm), PYREXIA (Fever went to 100F) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PRURITUS (Itchiness on arm), PYREXIA (Fever went to 100F), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache in front of her head), LETHARGY (Didn't want to eat anything) and ASTHENIA (Felt weak). At the time of the report, PERIPHERAL SWELLING (Swollen arm) was resolving, VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PRURITUS (Itchiness on arm) had not resolved and PYREXIA (Fever went to 100F), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache in front of her head), LETHARGY (Didn't want to eat anything) and ASTHENIA (Felt weak) outcome was unknown.            The concomitant medication was not provided. The treatment information was not reported.
Systemic: dysgeusia-Mild, Additional Details: dysgeusia following vaccination....no other symptoms
Patient was brought in by parent to receive Pedi Pfizer Bivalent booster (5-11yo), in error patient was administered Pedi Pfizer (5-11yo) monovalent, primary series dose instead. Staff contacted parent to notify of error. Patient encourage to return in 2 months for bivalent booster.
Phone call from patient stated afternoon 11-19-02 very achy muscle bone, weak, slight nausea, quarter size local reaction right deltoid. Sore to touch, red. Referred patient to PMD. Stated she would go if no improvement or worsens; patient went to PMD in p.m., given "shot" and cephalexin 500mg potid to take home. 11-21-02 patient states feel "fine" today.
10Aug95 pt recv 1 dose vax. Pt exposed to varicella approx 07Jan98. 21Jan98 pt devel light to moderate chickenpox of 4 maculopapular spots on back, abdomen,legs & face.
Local arm swelling on R deltoid injection one 2 day prior to reevaluation.
hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 22-MAR-2023 The pharmacist called to inform that a patient received the first dose of Shingrix back in July 2020 but had not receive the 2nd dose yet. The vaccine administration facility is the same as primary reporter for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Moderna COVID?19 Vaccine EUA.  Severe headache and meningismus within 24 hours of vaccine.  Sterile CSF studies.
Arm became sore and swollen and warm to the touch. Also on the 4th day showed signs of a reaction, with red patches and appear to mimic the after effects of a bee sting of sorts.
Information has been received from a physician concerning a 11 year old female who on 19-AUG-1996 was vaccinated subcutaneously with 0.5 ml dose of Varivax (Lot #617219/0250D). Concomitant therapy included "DTaP". On 01-JUN-2006, the patient developed full blown varicella rash (more than 50 lesions) after being vaccinated with Varivax. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. The physician also reported that another patient developed full blown varicella rash (more than 50 lesions) after being vaccinated with Varivax (WAES # 0606USA02254). Additional information has been requested.
rash on her shoulder; severe diarrhea; body aches from head to neck; weak; could hardly walk; This case was reported by a consumer via call center representative and described the occurrence of rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced rash, diarrhea, general body pain, weakness and walking difficulty. The patient was treated with valaciclovir hydrochloride (Valtrex) and topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the rash, diarrhea and weakness were not recovered/not resolved and the outcome of the general body pain was recovering/resolving and the outcome of the walking difficulty was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the diarrhea, general body pain, weakness and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had Shingrix and a few days later she started having symptoms and her symptoms really got worse about a week after.  Her symptoms were rash on her shoulder the size of baseball. She visited her dermatologist and was prescribed a steroid ointment. Her dermatologist also put her on Valtrex as a precautionary method, since they were not sure why she was reacting that way to the vaccine.  Patient also experienced severe diarrhea. The diarrhea comes and goes. She still had it until yesterday at least and she lost 7 pounds. Patient also experienced all over aching or body aches from her head, neck, all the way down her body.  The pain was so severe she couldn't get out of bed and could hardly walk due to the pain.  Patient is not having the pain as severely  anymore but said she is still very weak and doesn't feel completely well. The reporter did not consent to follow-up. There is a discrepancy with respect to the outcome of the events rash, diarrhea and weakness In Argus core the outcome is reported as not recovered for these events, however in provided source document it is recovering/resoling. The outcome for these event is retain as per reported.      Lab Comments: Lab test performed on an unknown date
Right hip really hurt; This is a spontaneous report from a contactable consumer.   This 77-year-old female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EWO178) via an unspecified route of administration into the left arm on 06Aug2021 at 13:20 (at the age of 77-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Aug2021, the patient experienced right hip really hurt. She had her shot and she was okay for a couple of days, but on the third day her right hip really hurt and she was wondering if that was a side effect. It was still hurting, that is why she was calling. No history of previous immunization with the Pfizer vaccine considered as suspect, no prior vaccinations (within 4 weeks). Treatment was reported as none. Report not related to a study or programme. No investigation assessment. Outcome of the event was not resolved.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Patient developed infraclavicular lymphadenopathy in two lymph nodes on the left side after the left arm injection of COVID-19 vaccine one week after the injection.  This was followed with ultrasound to confirm morphologically normal enlarged (reactive) lymph nodes, and resolved within 1 month of symptom onset.  No ongoing concerns.
Swollen red arm from shoulder to 2-3 inches above elbow, itching, muscle soreness, joint pain, arm weakness.
2:45pm, 18hours after vaccination, I started to feel unwell. A cold front came in and started a bad what I thought was a fibromyalgia flair up. Muscle pain. I was in severe pain until 4pm when things started going down hill. Muscles were tight all over my body including muscles pulling on my chest. I would describe as pulling heart apart from both sides. Muscles stiff. Torso filled with knots. Hyperventilating. Extreme muscle pain. Pain to where I could not stay still. I had on a blood oxygen reader. My blood oxygen number dropped to 64 and my pulse dropped to 38.  My lips nose fingers toes and whole right side all the way down my leg were tingling .My husband did not tell me the numbers as he did not want to frighten me as I was already panicked. This lasted a half hour. I took my xanax and muscle relaxer. Not sure if this is what helped bring me out of it. Ok at 5pm. Started feeling unwell again at 9:45pm. Took bedtime med and went to sleep and was able to sleep it off. If i knew my numbers were that low I would have had my husband call 911 Felt similar to suspected covid case before tests were available to public. Mar/April 2020
P/4th dose pt exp generalized itching, fever, muscle aches, joint pains, malaise, h/a, dizziness, abdominal pain & hives; maximum fever 103.4;
Cold sensation in the chest; my blood pressure spiked up then after like 3 or 5 min somewhere in between when I lost the heart beat my blood pressure went down; heart beat was very faint; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; Pulse were very faint; Low grade fever; Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is 2nd of 2 reports. This consumer reported for a male patient (Husband) that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right (Right Shoulder)on 23Mar2021 (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included Asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced cold sensation in the chest within 6-7 minutes, My blood pressure spiked up then after like 3 or 5 min somewhere in between when i lost the heart beat my blood pressure went down; heart beat was very faint, I felt like a weird sensation like tired, a little relax; i felt tired like sleepy, Pulse were very faint, Low grade fever,Sore arm on 23Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: spiked up on an unspecified date, blood test: unknown on an unspecified date, heart rate: decreased on an unspecified date. The outcome for all the events was recovered on an unspecified date in 2021 except for the event sore arm it was not recovered.  QR comment: This case might be split case however, it was not made by call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346339 Same reporter/drug/, different patient/ similar events
I was asked to submit this report because I reported trouble sleeping overnight after all three of my COVID shots.  I had trouble falling asleep, then tossed and turned a lot, and had strange dreams.  The problem was not severe and only lasted one night each time, but the fact that it happened after each shot seems significant,  I sought no medical treatment for this.  The other shot symptoms were mild muscle and joint aches and tiredness for a day or so.
Severe stomach pain, nausea, low grade fever. Pain was 10 on a 1-10 scale for 2 full days. Pain tapered off over the next 3 days. No appetite for several days. Stayed in bed 2 full days.
9 days after Covid booster with Pfizer mRNA vaccine I started to have severe exacerbation of typically well controlled chronic headaches; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:15 (Lot number: 33130BA) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "s/p mastectomies" (unspecified if ongoing), notes: s/p mastectomies; "known allergies: Cephalosporin" (unspecified if ongoing), notes: known allergies: Cephalosporin. Concomitant medication(s) included: INFLUENZA taken for immunisation, administration date 13Nov2021; DEXILANT; DEPAKOTE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number unknown), for COVID-19 immunization. The following information was reported: HEADACHE (hospitalization) with onset 19Dec2021 21:00, outcome "recovering", described as "9 days after Covid booster with Pfizer mRNA vaccine I started to have severe exacerbation of typically well controlled chronic headaches". The patient was hospitalized for headache (hospitalization duration: 1 day(s)). The event "9 days after covid booster with pfizer mrna vaccine i started to have severe exacerbation of typically well controlled chronic headaches" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache. Depakote and required steroid course in January to February, as well as multiple other medications. Now, two months later, headaches are slowly getting better. No other trigger identified. No laboratory or brain imaging changes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Device Date : 14Feb2022; Sender's Comments: Based on the available information in the case, the causal association between the event Headache and the suspect drug BNT162B2 cannot be 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.
Patient received expired vaccine (DTAP, HIB) Trihibit.  Mom notified by phone she will be walking in this week for re-vaccination.
Estradiol Transdermal system causing burning; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Estradiol Transdermal system causing burning) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERMAL BURN (Estradiol Transdermal system causing burning). At the time of the report, THERMAL BURN (Estradiol Transdermal system causing burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to AE-2021-8730 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  AE-2021-8730:
This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical histories and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB (lot #L009445, expiry date 01-JUN-2017; lot # K026666, expiry date 22-OCT-2017; L004754, expiry date 10-NOV-2017) through unknown route. Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, Palpitations, NECK PAIN  Narrative:
(L) arm swollen, painful, hot to touch and patient had a fever. Keflex.
A report has been received from a Health Professional concerning a 33 year old, female subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that patient received expired FLUMIST Quadrivalent which started on 05-DEC-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of VAQTA 25 U/.5 ML (Lot # K012457, expiration date 04-JUN-2017) route, dose and anatomical location were not informed. Information regarding concomitant medication was not provided. No adverse effects were reported. On an unknown date, the VAQTA had a temperature excursion for 48 hours, the lowest recorded temperature was 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion", the storage criteria and the storage type were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.