chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypertension.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were reported by the reporter.  The patient did not received any other medications or products within 2 weeks of starting COVID-19 treatment. It was reported that patient had COVID symptoms relapsed about 3 days after feeling better. Device date:30-May-2022. Company comment: This spontaneous case concerns a patient with unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better) which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment. It was reported that patient had COVID symptoms relapsed about 3 days after feeling better. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a patient with unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Paxlovid was given as treatment of COVID-19/My COVID symptoms relapsed about 3 days after feeling better) which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment. It was reported that patient had COVID symptoms relapsed about 3 days after feeling better. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Insomnia, "nervousness", arthralgias, myalgias, joint stiffness, fever and rigor.
Information has been received from a physician concerning a 14 year old female who 25-FEB-20009 was vaccinated with a dose of GARDASIL (lot # not reported). 1-2 days post vaccination, on approximately 26-FEB-2009 the patient experienced prolonged dizziness. The patient received an ear exam to check for inner ear problems and a neurological exam (results unknown). Unspecified medical attention was sought. Additional information has been requested.
Chills, severe headache, joint and muscle aches all over, nausea and vomiting, fatigue
Fever, chills, low right abdominal pain (severe overnight), nausea, vomitting, loss of appetite, aches and pains in bones.
Patient given adult dose of Hep A vaccine instead of pediatric/adolescent dose of Hep A.
This spontaneous report as received from a health worker on 03-NOV-2014 refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (also reported as PEDVAX HIB) (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Anthrax #6 shot receieved.   After 2 days - itching & redness/seen - by ER. Dx: Cellulittis/Mild dermal reaction Tx: Keflex 500 mg QID
Stroke- effected loss of left side. Hospital 2 week inpatient rehab 6 weeks 4 moths ongoing outpatient rehab.
received an unknown amount due to lure lock syringe becoming detached during injection; needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN from 26-Jun-2021 to an unknown date, SALBUTAMOL (VENTOLINE [SALBUTAMOL]) from 26-Jun-2021 to an unknown date and IBUPROFEN from 10-Mar-2021 to an unknown date for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.). On 10-Sep-2021, DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) to be not related.    No concomitant medications were reported, No treatment medications were reported.  Apparently a bag of syringes with needles was received and the needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration. Patient was unharmed. An email has received to administer on opposite arm.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Significant follow up Appended - New reporter (Physician) added and concomitant drugs added, vaccine facility information added and Incomplete dose administered added.
Soreness began on day of injection.  Has gotten worse since.  Began swelling and getting red. Today swelling and redness is approx. Baseball size.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 72 hours in which the lowest recorded temperature was 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
03/15/2021- Flu like symptoms, low grade fever, body aches, fatigue, chills. Lasted for 12 hours. 03/30/2021 About two weeks after vaccine I had arm rash, swelling and inflammation. Started in April 04/15/2021, hands achy, hard to move fingers, hard to grasp anything, I still feel it in my thumbs.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 22:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Diarrhea, chills, headaches, back aches and severe pain in left foot.
Patient was given 2 shots: Fluzone #1 + Pediarix #2 on 9/30/20 Developing high Fever on Saturday + was seen in ER for simple Febrile Seizure - Rechecked in office on 10/2/20/20 + 10/8/2020. Documented in ER as otitis media but Rechecked in office no concerns of infection. Condition improved
Seizure, for 1 minute approximately. Treatment antibiotic from Tuesday 3/2/04 to 3/5/04. Pt had EEG, MRI, spinal fluid. Hospital record rec'd. CSF drawn during the 3/2/04 admission was normal. This record notes a statement from mother indicating that child's temp was 101F in PMD's office the day prior to admission when she rec'd. these immunizations. In the ER, temp was 100.9F. She was treated empirically w/ cefotaxime as well as with Tylenol. There were no further seizures while the child was hospitalized. She was discharged to home on day 4 w/ a DGX of new onset seizures and w/ with instruction for PMD to withhold future DTaP.
SM developed burning pain, persistent soreness at the PPD site, associated red streaking ascending up the left arm towards the axilla. The member is concerned he may have been given the wrong vaccine at the site. Symptom: Edema at injection site 30-50mm Start: 08/16/2007 Comment: Swelling began approximately 4-6 hours after the PPD was placed Symptoms: Swelling Start: 08/16/2007 Comment: At the PPD site occurred approximately 4-6 hours after the shot Symptom: Erythema Start: 08/17/07 Comment: A streak of redness emanating from the left forearm nodule ascended up the medial aspect of the arm towards the axilla Symptom: Pain Start: 08/16/07 Comment: The left forearm and the nodular PPD site were painful from the time of injection until current.
Information has been received from a physician concerning her approximately 12 month old granddaughter, who is the patient, who on 08-FEB-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot number not reported). Patient received other unspecified vaccines. Sometime after vaccination, the patient started to experience neuromuscular disorder where the patient could not stand and had a loss of balance. On an unknown date, the patient was hospitalized. The neurologist at the hospital, was immediately pinpointing the VARIVAX (Merck) but no cause has been identified. The physician reported that the patient was improving but no prognosis has been identified and did not mention how long the patient has been in the hospital. The patient was recovering at the time of the report. Neuromuscular disorder and loss of balance were considered to be disabling by the physician. Additional information has been requested.
Fever, chills, muscle and joint pain that persisted x 1 wk post influenza vaccine. Occurs every time when he receives the flu shot.   Symptoms: FEVER, UNSPECIFIED(R509), PAIN IN UNSPECIFIED JOINT(M2550), MYALGIA(M791).
Red rash located around site of injection and on front of neck.  Has not tried any treatment, yet.  Came in today questioning reaction and asking for treatment suggestions.
Pain at site, the first day of injection. On day 2 developed  redness at site which has increased daily to a 6cm all around. HOT to the touch, now there is a firm mass at injection site. Increased pain at site. Since 7/23, increased lethargy, nausea, dizziness. Throbbing at site, and slight numbing of rt hand felt last night for the first time.  Warm compresses to the site were applied, with mild relief.  Ibuprofen for pain and to decrease swelling, with minor relief. Called MD this am to request antibiotic therapy for a possible cellulitis.
Approximately 8 hours after second vaccination patient had chills, fever, muscle soreness and fatigue. Patient also developed an acute headache that evening and was unable to sleep more than a few hours that night. Patient administered 800 mg of ibuprofen to relieve headache and also drank lots of water. Patient also awoke multiple times in cold sweat and had to change clothing due to dampness. The following day Patient continued to have the muscle soreness and fatigue as well as loss of appetite. patient did force himself to eat and continued to drink lots of water with occasional Gatorade. Began to feel better mid-afternoon, however by 8 p.m. fever and chills were setting in again. Patient then administered one dose of NyQuil and took an early bed. Patient slept well through the night and woke up the next day and is able to resume regular activity, although at substantially lower energy levels. By 8 p.m. that night, chills, fever and headache was returning however patient attempted to sleep it off. This resulted in highly interrupted sleep and patient resorted to 800 mg of ibuprofen to stop headache again. Patient woke multiple times through the night in a cold sweats and had to change clothing to return to sleep. Patient continued through the day to rest an attempt to recuperate. That brings us to the present moment, where patient is currently experiencing fatigue and muscle soreness.
9 days after first inoculation, my upper arm became red, swollen, hot  -- an area about 3 x 6 inches
Immediately arm hurt and got progressively worse. By evening was in a lot of pain, unable to lift arm to change clothes. Fever, nausea, chills, upset stomach. Took EXCEDRIN, fever went down a bit but around 100 degrees now. No swelling or redness but muscle feels tough. Called doctor this morning but specified that pt probably had something not related to vaccination.
Patient came in 2 days after shot and said her doctor diagnosed her with a topical infection from receiving the shot. Her arm was red from shoulder to elbow.
Scintillating Scotoma Left Eye  Lasted 10-15 mins   Not headache after   No hx of Migranes
25 doses of expired Moderna COVID-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in refrigerator on 04-May-2022. The vial didn't undergone any temperature excursion.  No treatment medications was reported.
Localized erythema and mild induration at vaccine site of left deltoid, pt. c/o fever 100.5 degrees x 1 dy in duration, Also c/o general body ache, stomach ache, and dizziness, sx onset the day after the vaccine and are improved as of 3/22/07
H/o sulfa allergy, monitored for 40 minutes, felt well. 15-20 min later called clinic, felt like throat was closing, advised to go to ER, she arrived in ER while I was on the phone with her. Subsequently developed itching. Was treated in ED with Epi-pen, Benadryl and steroids. Home after observation and improvement. Spoke with patient ( at home) next morning, doing well.  Has appointment scheduled with allergist.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
Patient c/o: "pain & redness & edema to elbow from shoulder, ? cellulitis".
A report has been received from a Physician concerning a 1 year old, subject of unknown gender, who had been receiving nasal QLAIV Accuspray started on 01-NOV-2014. The physician dispensed the QLAIV FLUMIST to the wrong patient population which started on 01-NOV-2014. The outcome of the event of administration of FLUMIST QLAIV to a child less than 2 years old is unknown. The reporter's description of the event(s) was as follows: health child. The report was considered to be non-serious by the reporter. The reporter and the company physician considered that there was no casual relationship between administration of FLUMIST QLAIV to a child less than 2  years old and QLAIV.
10-21-10 Received TIV/PPSV23 into LD. Awoke morning of 10-22-10 awoke with soreness/stiffness left arm increasing in severity through the day. Pain into axilla, rash/redness left shoulder to wrist; given BENADRYL by work nurse. OV 1pm 10-22-10 rash maculopapular, patchy, red & splotchy, wheal like on upper left arm over deltoid. Ecchymosis at injection sites/left deltoid. Area very tender to touch at affecter area, into axilla, into epitrochlear area. Decreased ROM to left arm both abduction & extension. Provider ordered clindamycin 300mg BID x 7 days, BENADRYL 25mg 1-2 q 4 hr PRN, NAPROSYN 500mg 1 BID prn pain 100% improvement by pm 10-23-10.
Case number PHEH2014US024365, is an initial spontaneous report received from a nurse on 02 DEC 2014, with a follow up report received from the nurse on 19 JAN 2015. This report refers to a 80 years old female patient. Historical condition and concomitant medication were not reported. her past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: MAR 2015) intramuscularly in right deltoid at a dose of 0.5 ml on 10 NOV 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 JAN 2015: Vaccination history and site of FLUVIRIN were updated.
Left arm painful, hot, red, swollen evening after injection. Saw MD - induration approx 10 cm. Rx'd cephalexin 500mg q.i.d. times 10 days. Loratadine 10mg b.i.d.
Pt was DOA @ ER on 10FEB92; Family reported pt had fun fever since shots on 10FEB92; temp on arrival was 103.4; Pathology report was presumptive SIDS;
CLIENT HAD NUMBNESS IN FACE AND SCRATCHY THROAT, AS WELL AS DIFFICULTY SWALLOWING. LATER ON SHE DEVELOPED A RASH AND STOMACH PAIN. NUMBNESS CONTINUED IN HER FACE, UNTIL MONDAY. SHE STARTED WITH SYMPTOMS WHILE IN OBSERVATION, BUT DID NOT TELL ANYONE, AT THAT TIME. SHE IS ALLERGIC TO BENADRYL, SO DID NOT TAKE AN ANTIHISTAMINE. SHE DID SEE AN NP, AT HER PHYSICIAN'S OFFICE, ON 03/01.
Pfizer Covid-19 vaccine booster dose administered around 90 minutes beyond syringe expiration time of 11:30am (i.e., over 6 hours after vaccine was mixed).
Patient in waiting room following COVID vaccine - syncope episode, temporary loss of consciousness 15-20 seconds - woke up and was given water - less than 5 minutes later second syncope episode, temporary loss of consciousness 15-20 seconds - 911 called - woke again - more water given - EMS providers then took over care
Pt had vaccines done 3/2/17 3/2/17. She woke up on 3/9/17 with involuntary movements of (R) hand. She was subsequently seen in ED and by neurology and diagnosed with a chorea. Mom questions if this may have been caused by vaccine. CPR slight elevated; ESR nl; nl CBC; negative flu; negative urine Cx
Headache, Myalgia, Fever, CoughWheeze, fatigue, altered taste, pain at injection site Narrative: