chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Receive both initial vaccines (Pfizer) in early 2021. Received J&J booster on 12/10/21. I woke up at 3 am on 12/12 with a fever and body aches. This is still persisting as of 12/15/21. On the evening of Tuesday, 12/14/21, I began to experience slight tingling in the finger tips of my right hand. After waking on Wednesday, 12/15/21, my entire right hand is tingling (best described as pins and needles). Temperature will sitting around 99.3-99.5. Fatigue persists, accompanied by brain fog.
Feels like he has been hit by a freight train; Low grade fever; had chills, and he has been all over the place; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 06Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Caller stated that he got his first shot on 06Jul2021, and now he is exuding several symptoms. He feels like he has been hit by a freight train, and he has a low-grade fever. He tried calling urgent medical and they said they didn't know what to do. He is trying to figure out what he can do to stop feeling like total dog crap. The patient had chills, and he has been all over the place. He feels like he has Covid just from getting the shot. He wants to feel better. The patient wants someone to prescribe him something to get this out of his system. The patient doesn't think he is going to get the second shot because he feels like absolute dog crap, and he doesn't think he is getting the second shot. He asks how he can alleviate these symptoms that he is having from the vaccine. He will just call his doctor. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Pt received PREVNAR 13 and FLUZONE High Dose same days. Same arm -2 days later arm still red from elbow to shoulder - warm - not painful.
Information has been received from a Registered Nurse regarding the Pregnancy registry for HPV concerning a 24 year-old female with penicillin and dyes allergy and a history of abnormal pap smear, who on 01-MAY-2008 was vaccinated with the first dose of GARDASIL, on 01-JUL-2008 was vaccinated with the second dose of GARDASIL, and on 04-NOV-2008 was vaccinated with the third dose of GARDASIL (lot # 659962/1740U) 0.5 ml via intramuscular. There was no concomitant therapy. The patient saw the nurse. Urine pregnancy test was performed. The patient became pregnant after receiving GARDASIL and her last menstrual period was on 09-OCT-2008 and EDC is on 16-JUL-2009. Follow-up information has been received from a completed questionnaire on 14-JAN-2009 which reported: A female patient on 01-MAY-2008, 01-JUL-2008 and 04-NOV-2008 was vaccinated with three doses of GARDASIL (lot # 659962/1740U) respectively. The third dose of GARDASIL was also reported as WP-M902. The patient had one previous full term pregnancy, with no complications. It was confirmed that the patient's LMP was 09-OCT-2008 and the EDC was 16-JUL-2008. On 24-NOV-2008, the patient underwent an ultrasound due to pelvic pain. The result indicated Intrauterine Pregnancy at 6 weeks and 2 days and a ruptured corpus luteal cyst. Follow-up information has been received from the Registered Nurse on 16-Jan-2009 which reported: The patient remained pregnant and as of 05-DEC-2008, the ruptured corpus luteal cyst had completely resolved. Additional information has been requested.
Chest pains with pounding heartbeats and skips in beats.  Started 2 weeks after shot.  Continued for two weeks.  Eventually resolved.
Patient developed B/L LE DVT 1 week s/p 2nd vaccine; This is a spontaneous report from a contactable physician. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included estradiol taken for menopausal symptoms, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. No other vaccines received withing 4 weeks. The patient developed B/L LE DVT 1 week s/p 2nd vaccine on 27Apr2021. Event resulted in physician's clinic visit and was given anticoagulation. Outcome of the events was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported DVT and the use of BNT162B2 cannot be fully  excluded. However, the age of the patient and use of estradiol may confound the reported drug event pair. The case will be assessed further upon receipt of additional information.  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.
Lingering right shoulder pain 3 weeks after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid.
This spontaneous report as received from a "doctor's nurse" refers to 7-8 patients of unknown age and gender. The patients were vaccinated with a 0.65 ml of ZOSTAVAX (lot# and route not reported) on 02-OCT-2012. Concomitant therapy included "flu vaccine" (manufacturer unknown) given in their other arm. On an unknown date, within a couple hours of getting the vaccines, the patients experienced pain and swelling at the injection site. The patient sought unspecified medical attention. No treatment information was reported. The outcome of patients were reported as recovered/resolved "within a day or two". The relatedness for pain and swelling at the injection site were unknown for ZOSTAVAX by reporting nurse. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
PATIENT WAS GIVEN DOSE FROM VIAL PUNCTERED OUTSIDE OF 12 HOUR WINDOW.  PATIENT REPORTED NO ADVERSE EVENTS.
Felt a ball or mass that moved through his head; ringing in ears; felt like something hit him on back of head; changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward; shortness of breath, somewhat having difficulty of breathing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head), HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward), DYSPNOEA (shortness of breath, somewhat having difficulty of breathing) and MASS (Felt a ball or mass that moved through his head) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Fall on 05-Mar-2021. Concomitant products included IBUPROFEN from an unknown date to 16-Apr-2021 for Pain and Fall.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, somewhat having difficulty of breathing). On 16-Apr-2021, the patient experienced TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head) and HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward). On 19-Apr-2021, the patient experienced MASS (Felt a ball or mass that moved through his head). At the time of the report, TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head), HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward), DYSPNOEA (shortness of breath, somewhat having difficulty of breathing) and MASS (Felt a ball or mass that moved through his head) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: events was updated , contact information was updated.
Pt. stated, "I felt dizzy one minute after getting vaccinated."  B/P 118/82, R 18. At 11:55am, pt. stated, "I feel better now." At 12:01pm, pt. stated, "I think I'm ready to go home." Pt. went home at 12:02pm  with family member.
received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6201), in right arm, on 30Mar2021 as dose 2, single (Lot number: RR8134), in right arm, on 11Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative by the 5th day; Positive, notes: became symptomatic and started testing positive again 8 days. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical information: Anti viral details: product-COVID 19 Treatment, brand-Paxlovid, from 04May2022 to 09May2022, Indication: Treatment of COVID-19.  Conclusion: The complaint for lack of effect of the Pfizer- Biontech Covid-19 Vaccine injectable lot FC3183 and EN6201 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657 and lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Infected eye gland; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Infected eye gland) in a 62-year-old female patient 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 EYE INFECTION (Infected eye gland). At the time of the report, EYE INFECTION (Infected eye gland) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058189 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information was received on 28 Apr, patient initials updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058189:Case of reporter
Patient has not been feeling well since they received the second booster; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient has not been feeling well since they received the second booster) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient has not been feeling well since they received the second booster). At the time of the report, MALAISE (Patient has not been feeling well since they received the second booster) outcome was unknown.            No concomitant medication were reported.  It was mentioned in the emails subject that this inquiry was about the second booster No treatment information was provided by the reporter.
A non-serious spontaneous report of "a 15-month-old male got a dose of  H1N1 LAIV" was received from a health professional concerning a 14-month-old male patient. The patient neither had any past medical history nor was on any concomitant medications. On 25-Nov-2009, the patient received H1N1, Intranasal vaccine for an unknown indication. The child had remained well, happy, and healthy, without flu-like symptoms or any form of illness after vaccination. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. Additional information was received on 09-Dec-2009 and incorporated into the narrative: medical history, concomitant medications and no occurrence of any adverse event besides vaccination error was confirmed.
This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, medical history, drug allergies and concomitant therapy were not reported. On 30-OCT-2015, the patient was vaccinated with second dose of GARDASIL. On 01-NOV-2015 (reported as approximately 2 days after vaccination), the patient experienced a small fine rash on the arm that the injection was given. On an unspecified date in November 2015, the rash became itchy and had the appearance of hives. He also developed a rash on his face that appeared to be blisters. He sought medical assistance and was prescribed BENADRYL and an unspecified ointment for the rash on an unspecified date. At the time of reporting the patient was still suffering from the rash. The outcome of the events was reported as not recovered. The reporter did not provide the relatedness of the events with GARDASIL. Additional information has been requested.
I was at a class where you get up and down to do the exercises. All of a sudden, the room started spinning and got really dizzy. I stopped my activity and the dizziness subsided and when I moved around, I would get dizzy again. I stopped the activities and went home. Symptoms included Light headedness and dizziness for the next couple days. Vomiting. Treated it with a maneuver with the Epley maneuver to help with the ear crystals. Took an anti-nausea medication meclizine and by the end of the week I haven't experienced any symptoms. Did have a telehealth visit with my doctor. Symptoms have resolved.
Pt reported having a fever, chills, body aches for about 24 hrs after both doses. Onset of symptoms was about 6-8 hours after shot given
Pt recv vax on 11/12/98; 5 min post vax pt exp warm/ swollen/ red LA; tx=ice applied
I went for an epidural on Friday 07/29/2022 and when I returned home, I noticed my throat was scratchy, so I took an at home COVID-19 test and it was positive. I had been experiencing some sinus infection like symptoms since the beginning of the week, but I didn't think much of it. I called my doctor's office who advised that I seek out monoclonal antibody therapy. I was unable to locate any of that treatment, so I called my doctor's office again. They were hesitant to prescribe an antiviral medication due to the known side effects but ultimately ended up prescribing me Paxlovid. I began taking that on Friday and I have felt better despite slightly elevated blood pressure and some diarrhea. I have taken some Imodium for the diarrhea and that has helped. At this point I am feeling better and have not run a temperature. The only thing that I am concerned about is the possible rebound effect from the Paxlovid. I believe that Paxlovid should be administered to elderly people in a longer and lighter dose range than for others to prevent rebound effects.
Woke up this AM with upper left arm pain and pain in the armpit. The upper arm is swollen, red, warm to touch and slightly itchy. There is increased pain with range of motion. Started upon waking this AM with minor swelling and slight ache. Has increased steadily throughout the day in both pain and swelling.
It was and still is very painful...with pain, redness, swelling at the injection site, severe muscle pain, tiredness, low energy, upset stomach. All this occurred after the injection and I am still battling with it.
Half hour after vaccines were administered developed hives on injection site, right deltoid and scattered in the back.
Pt had sore throat, swollen glands, fever 105.9, pale, weak;
Headache that comes and goes; Didn't feel right; Nauseous; Achy; Injection site warm; A bump appeared at the injection site; Injection site itchy; injection site got red; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Didn't feel right), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site got red) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adrenal insufficiency. Concomitant products included HYDROCORTISONE and FLUDROCORTISONE ACETATE (FLORINEF) for an unknown indication.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills). On 10-Jan-2021, the patient experienced NAUSEA (Nauseous) and MYALGIA (Achy). On 11-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel right). On 12-Jan-2021, the patient experienced HEADACHE (Headache that comes and goes). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE MASS (A bump appeared at the injection site), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site got red) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Didn't feel right), NAUSEA (Nauseous), MYALGIA (Achy) and HEADACHE (Headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that redness was as big as a half dollar. She mentioned that she does not have adrenal glands so she takes steroids daily to supplement her body with the ones that would be missing.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Itchy rash starting in groin area, spreading rapidly onto legs/torso/face/arms.  Runny nose for 3-4 days.  Subject warmth, some scratching.
This is a spontaneous report from a contactable nurse. This is first of the four reports from the same reporter. This nurse reported for a 2-month-old female patient who received the first dose of PREVNAR 13 via the intramuscular route, ROTATEQ orally, DTaP, PENTACEL via the intramuscular route on 26Mar2012 at 9:55 am. The relevant medical history and relevant concomitant medications were unknown. The nurse mentioned that the patient experienced extra puffiness, crying excessively, fever, and fussiness since 26Mar2012. The relevant laboratory data was unknown. The patient did not receive treatment for the events. The outcomes of the events extra puffiness and crying excessively were reported as recovering. The outcomes of the events fever and fussiness were reported as recovered on 26Mar2012. Follow-up (17Apr2012): New information received from a contactable physician included confirmation of events, route of administration of vaccine products, treatment details, outcome information, and additional adverse event of fever and fussiness with onset and resolution dates. Follow-up (23MAY2012) Follow-up attempts completed. No further information expected.
Patient reports to the ED with complaints of sudden onset abdominal pain with nausea and vomiting. Patient's daughter reports that she had Covid the 2nd of this month (August) and lives with the patient. She reports she quarantined within the home after being diagnosed. She stated that her and the patient are fully vaccinated. Patient's daughter reports her quarantining is over.. Patient received first dose 03/11/2021 and second dose 04/08/2021.