chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain/soreness in right upper arm; thumb numbness; weakness in the right arm; headache; This spontaneous report was received from a physician via a company representative referring to a 36-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 04-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis. The patient did not have any complaints after the injection. On 07-AUG-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S020255, expiration date not reported, upon internal validation established as 09-DEC-2021).  On 14-AUG-2020 (reported as 1 week later), the patient experienced pain/soreness in right upper arm, as well as thumb numbness, weakness in the right arm and headache. The outcome of the events was unknown. It was unknown if treatment was given. The causality assessment was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-089378 (E2B Linked Report).; Sender's Comments:  MOD-2021-089378:
Initial report received on 20 September 2011 from a health professional. An 84 year old male patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE HIGH DOSE (lot number not reported) on an unspecified date. An unspecified amount of time later, the patient had complaints of aches and pains. Three days after vaccination, he was hospitalized. The patient's outcome was not reported. The reporter for this case is the same as for case number 2011-09073. Documents held by sender: None.
pt received injection at her place of employment from a public health employee.  Within one hour, pt had high fever, rigors, malaise and felt like throat was swelling.  Tmax 103.8.  She has had to take tylenol and benadryl around the clock since that time to combat these symptoms.  I saw her 4 days after vaccine administration and tested her for covid with NAAT.  This came back positive.  She had a test 3 days prior to vaccine administration at her work that was negative.
Information has been received from a consumer referring to her 2 years old grandson. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in June 1996, the patient was vaccinated with an unspecified chicken pox vaccine (dose 1, dose, route, lot number and expiration date were unknown) (the patient was approximately 2 years when vaccination). On an unknown date in September 1996, after receipt of the initial unspecified chicken pox vaccine, the patient became very sick. The patient developed the following symptoms: fevers over 40 centigrade (reported as 104 degrees), swollen gums and broke out in pox all over the patient's body. The patient also developed a full blown case of shingles, which presented 3 months following the vaccination. The patient sought unspecified medical attention via office visit. No treatment was given for the adverse events. The outcome of the events was reported as recovered (date unspecified). The causal relationship between the unspecified chicken pox vaccine and the events was unknown. This is one of the two reports that received from the same source. Additional information is not expected as there is not consent to contact the physician.
patient did not have any reactions to the MMR-II, no additional AE details provided; M-M-R-II was administered after it had expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-OCT-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA) (M-M-R II) (strength and route were not reported, 0.5 ml, lot # S029457, expiration date: 19-SEP-2021) for prophylaxis (expired product administered). The patient did not have any reactions to the vaccine, no additional adverse event details were provided (no adverse event).
She got her vaccine, she had no reactions at all.  On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling.  She had  a fever up to 100.5.  Her swelling has not gone down on any of the locations.  She cannot even take her wedding bands off.   Her feet are extremely cramped in her shoes.  Her allergies have gone tremendously.  She has been throwing up and have been nauseous a lot.   She has not been taking anything but Benadryl for the reactions.  She also has gained 7# since the vaccine.  Her hands have also been shaky.  She has not notified her doctor of any of these symptoms.
left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 15:45 (at age of 50-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunization.  Medical history included high blood pressure, high cholesterol, obesity. There was known allergies: bee stings and sulfa drugs. Concomitant medications included atorvastatin (LIPITOR); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); and emtricitabine, tenofovir disoproxil fumarate (TRUVADA).  The patient reported "left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly 'drooped' like it does not match the right side of my mouth but you have to stare and look really close to notice it. Should I hold off on getting my second dose in the next 3 or 4 weeks to see how this goes?" The adverse events start time was 06Mar2021 20:45. The events did not result in emergency room visit or physician office visit. It was unknown if treatment received for the events. There was no COVID prior vaccination or COVID tested post vaccination. The outcome of events was not resolved.
Pt called. Pt AO X3, speech clear, comfortable, pt reported continuous muscle aches, headache on/off, mild sob on/off, feeling tired and slight dizziness since 04/14/2021. Pt stated sx not getting better. Pt stated mentioned sx arises after she got her first dose Moderna COVID vaccine on 04/13/2021. Pt has hx of hypothyroidism and taking levothyroxine daily. Recommended pt to got nearest urgent Care for further evaluation/treatment.
WHEEZING; FELT UNWELL; This spontaneous report received from a parent concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 28-JUL-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2022, the patient experienced wheezing, and felt unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wheezing and felt unwell was not reported. This report was non-serious.
Pt received the influenza vaccine at her pediatrician's office. That evening, she developed urticaria. urticaria was spreading, so she seeked care at urgent care on the third day of urticaria. There was no anaphylaxis. There were no other exposures to which the urticaria could be attributed. she was prescribed cetirizine at urgent care.
Extreme pain in joints/body aches developed approximately 12 hours after dose with front/side headache similar to migraine pain level with nausea; treated with Nyquil Cough at 3:40 am, Tylenol-650 mg at 7:30 am, and both at 3:30 pm on 3/11. On 3/12, body pain/aches gone, but left with migraine type headache and fatigue. Treated with Tylenol-650 mg on 3/12 at 7:30 am.  Fatigue continued until at least 10 pm 3/12 but gone on 3/13.   Main reason for report: I had an ablation performed and tubal ligation in December 2018 with no break through bleeding at any time since. On Day 28 after first Moderna dose, there was noticeable cramping in low abdomen not experienced since ablation. On Day 32 from first dose-- the same day as the second Moderna dose, there was cramping again in low abdomen and menstrual fluid appearing in urine- more red in color. On Day 33 post-first dose and Day 1 post-second Moderna dose, there was more break-through menstrual fluid- very dark in color typical of prior "end of period" fluid with similar odor, with continued cramping.  This continued, but lessoned on Day 2 post-second vaccine. I understand there can be failed ablations, but the timing seemed worth noting for you in case there is any pattern with impacts on menstruation.
Allergic reaction rash, swollen area around injection site. Itchy hand etc. Rash is 40mm in length.
Ended up with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Ended up with COVID) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Ended up with COVID). At the time of the report, COVID-19 (Ended up with COVID) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Myocarditis symptoms reported and observed.  Patient took OTC aspirin for chest pains.
#1 Pain Large 3" Red spot injection site (2 1/2 wks) - headache (2 days) - chills - fever= 2 pts - fatigue  #2 Pain injection site 1 day - headache (2 days) Chills - fever (+4 pts) 1 1/2 days - fatigue (4 days)
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 03-JUL-2014 the patient was vaccinated with MMR II (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. Activity date was reported as 22-AUG-2014. This is one of several reports received from the same source. Additional information has been requested.
14 Sep21 8pm constantly feeling my heart beating rapidly took nyquil to go to sleep.  15Sep21 11am left work had numbness in hands and drove slowly home.  Joint pain had left knee go out 3:50pm (previous injury but that has not happened since physical therapy 2008 time frame). Left shoulder pain near heart 7:17pm.  Contacted medical and came in for an appointment on 22 Sept2021
Had a metallic taste in mouth and started getting nasueas. As the day progressed started swelling in hands and feet. Got a rash and had a low grade temp. Also by morning started vomitting and having syncope spells. was incoherent most of the day. Started getting flashers in my eyes that would come and go. Had a severe headache. As time progressed the headaches got worse and I was dizzy a lot.  About 2 weeks later I started noticing  body spasms which in turn put me in the hospital. I was unable to walk without assistance. Seen neurology and was given a diagnosis of myoclonus.
I received my first dose on March 2nd and my second dose on March 30th of the Moderna vaccine. Both times about 7 days into each does I started noticing heart palpitations. I do not have any heart disease except controlled HBP. After the first dose, they started and were happening often and was concerning ? then they stopped after 5 days right before my scheduled second shot. Now after my second dose they have started again a week after the dose.
1 week after shot, developed a large red rash at the vaccination site on my left arm.
Pt was sitting on exam table, denies acute symptoms, reported being anxiety related to getting vaccine. Vaccine was administered by staff in R deltoid. Pt experienced brief episode of loss of consciousness x few seconds, and quickly regained consciousness. Pt did not fall or experience injury, remained seated on exam table. Reported  mild nausea, weakness and sweating after episode which resolved quickly. Pt vital signs were normal. EKG completed SR, RSR V1 suspect normal variant.  Pt was monitored in office >30 minutes, denied further sx. Provider checked in with patient several hours after appointment, no recurrent symptoms or episode reported.
Patient presented to the ED on 3/12/21, was hospitalized on 4/6/21. Patient presented to the ED on 4/13/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was bilateral pulmonary embolism.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with a dose of SHINGRIX and experienced fever up to 101 degree F. At the time of reporting, the patient was due for her second dose and so the healthcare professional inquired whether the second dose of SHINGRIX should be administered or not to the patient, as the patient experienced the adverse events after the first dose. Lab Comments: Relevant tests: Lab test done on an unknown date.
18 hours after receiving the vaccine, she fainted for one minute.  During this time, she first felt presyncope and then fell to the ground and lost consciousness.  She revived within one minute, but has felt dizziness for 2 days after.
10/11/06 given Td IM (lot number 03915) right deltoid. 10/16/06 had 70 x 115 local redness and warmth, no tenderness.
Dizziness,pain in her stomach and diarrhea started that day. As she continued with these symptoms she became weak and ended up at the hospital 2 times, put on an IV for dehydration and low potassium.She was also short of breath and have spells where she would become pale and then complain of her feet being cold.
Case number PHEH2014US024963, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 60- year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 14 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
11/11/14- Afternoon swelling and redness on arm, weak. Tonsil swelled up. Headache for 3 to 4 days. Can't sleep. Vertigo.
Some of the vaccine spilled down the patients arm; Some of the vaccine spilled down the patients arm; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the vaccine spilled down the patient's arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 14 Jan 2021, during administration of the mRNA-1273 vaccine some of the vaccine spilled down the patient's arm. The patient believed things were not screwed on properly. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, some of the vaccine spilled down the patient's arm, was considered resolved on 14 Jan 2021.; Reporter's Comments: This case concerns a male patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Accidental exposure to product.
16 year old female with history of juvenile dermatomyositis that was in remission for several years off medications, started having a disease flare that mainly involved her skin (erythematous Gottron's papules and ulcerations) along with mild weakness. The patient is still under evaluation about the extent of her disease flare but was found to have severely worsened pulmonary function testing parameters (reduced DLCO and lung volumes). Treatment is pending the completion of diagnostic evaluation. Muscle weakness is still not prominent but skin findings are more prominent a month after the onset of disease flare.
Received Full Dose Booster by mistake/Caller received a booster dose of 0.5ml, a full dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 031M20A, and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 05-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE. On 05-Nov-2021, ACCIDENTAL OVERDOSE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes on 05-Nov-2021 Follow Up received - Dose 1,2 and 3 date/batch lot no updated.
large area of induration, redness, and warmth of entire arm --area approx 10 by 8 inches
Hospitalized (11.4.21);  COVID-19 positive (11.3.21);  fully vaccinated  Admission Date: 11/4/2021 Discharge Date: 11/7/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure due to COVID-19 [U07.1, J96.00] COVID-19 [U07.1]   HOSPITAL COURSE: Patient states that her symptoms began October 31, 2021, patient was experiencing weakness, headache, fever, diarrhea and fatigue which has increasingly worsened. November 3, 2021 patient was seen at the emergency department and tested positive for COVID, she was discharged home with a pulse oximeter and told utilize over-the-counter supportive care measures.  Patient states that 11/4 afternoon she was feeling worsening shortness of breath and noted blood oxygen levels to be in the 80s while she was walking around her home and came back to the ED.  The patient was admitted to the hospitalist team for further medical managementof COVID pneumonia.  COVID-19 Assessment & Plan Date of Symptom onset: 10/31/2021 Date of positive COVID-19 test: 11/03/2021 CXR: Small right effusion. Right mid and lower lung zone airspace disease possibly all atelectasis. Small consolidation not excludedThe patient was initiated on dexamethasone and remdesivir and requiring 3 L nasal cannula.  The patient has slowly been able to be weaned from nasal cannula and is currently room air.  Her biggest complaint is cough with minimal sputum production.  The patient wishes to receive 1 more dose of remdesivir this morning and then plan to discharge home.
got sick like I had Covid again; fever of 103; This case is linked to case 2022SA055930(CLUSTER).  Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who got sick like I had covid again and fever of 103, after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history included had Covid and was in hospital for over a month.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date (6 months after Covid), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation: unknown) with lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date, the patient got sick like patient had covid again (malaise) and fever of 103 (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that I had Covid and was in hospital for over a month...almost died. I was never sick before Covid. 6mos. later got my first shot, got sick like I had Covid again...fevers of 103. Will not get anymore shots.  Relevant laboratory test results included: Body temperature - On an unknown date: [103]   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (got sick like I had Covid again, fever of 103).  At time of reporting, the outcome was Unknown for the event got sick like i had covid again and was Unknown for the event fever of 103.
pt woke w/hives on chest, neck, face;eyelids puffy pt given DPH;
The day after I got the first Maderna vaccine I had trigeminal neuralgia begin to mildly flare up.  The evening after I got the second Maderna shot my trigeminal neuralgia was the worst it has ever been.  I wasn't pain free until 7 days after the second shot.
Red, swollen and painful left upper thigh with fever. Local reaction of cellulitis. Treated with antibiotic therapy, Keflex suspension 1 tsp 3 X per day X 10 days.