chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Very sleepy immediately after vaccines. Became very tense, inconsolable high pitched crying for 4 hours. Had fever the day after vaccines. 3 days after vaccines, had vomiting, diarrhea, diaper rash and eczema. Also had increased spit up after vaccines.
Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly Narrative:  Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly dehydrated. CG/wife reported to APRN on 2/10/21, patient was sleeping and snoring and then began to sleep more quietly. She checked on patient and found that he had no pulse and had passed away
Patient called health department on 6/24/21 @ 0900 to report that she received the 2nd Moderna Covid Vaccine on 6/22/21 and "felt sluggish for a few days, but I woke up this morning and noticed a lump on my collar bone and it moved with I pressed on it".  When asked patient reports not having any shortness of breath, difficulty swallowing or dizziness or change of vision.  Patient encouraged to contact her PCP but patient reports "I don't have one, do I need to go to the ER" Nurse once again verified patient was not having any difficulty breathing or any other reportable symptoms.
Rash 2" x 1.5" on R upper arm, feverish area
Patient received first dose of Pfizer vaccine almost immediately Patient felt flush, anxiety, jittery, nausea.  Patie moved to alcove for additional monitoring. VS  1026 HR 78, BP, 145, 99% 1035 HR 72, 150/97 1046 HR 72 150/89 1056 HR 62, 146/88 1106 HR 60, 143/102 Patient manager notified that patient would be transported to ED as symptoms did not resolve and would be going home. Returned to unit.  Patient accompanied to ED for additional treatment /monitoring."
2 Weeks after receiving my booster - it appears it overstimulated my immune system and caused psoriasis on my knee which has be resolved the past 5 years in been in remission.  Redness covering my knee, swollen-raised rash, pruritus
18 hours after receiving injection, employee presented with small, open area to left upper arm. She stated it had been fluid-filled blister which ruptured. Advised on appropriate wound care and to follow-up with regular clinic if symptoms continue or worsen. Presented again 7 days later. Area appeared slightly improved. Employee counselled to keep area clean & open to air. Nursing coord. notified. Attempted to discover vaccination to review best practices for vaccine administration
had vaccine got shingles/ suspected vaccination failure; got shingles; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles vaccine but got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Pt states she began experiencing pimply areas on her neck, 2 hours, post vax. She continued experiencing skin dermatitis, swollen eyes and low-grade fever up to 3/8/01. Went to MD and was told she had skin dermatitis as a result of a reaction to the shot and also was dx'd with shingles. She was given Famvir 500mg TID.
19MAY92 had rash on stomach this AM & now rash only on lt arm from shoulder halfway to elbow on back of arm; states having no other sx-denises n/v or diarrhea or difficulty breathing; no redness or swelling to inject sites; pt given APAP;
bone ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone ache), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced BONE PAIN (bone ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, BONE PAIN (bone ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
pt exp nausea, SOB & hives 10 days p/the IM booster dose of rabies vax; this lasted 5 days;
pt recv vax & approx 3wk later was dx w/acute promyelocytic leukemia & died on 24JUN96-prev hosp JAN96 unrelated illness prior to vax 2nd dose;dizziness, vertigo, bruising in legs;
Shoulder pain arm pain still do not have full range had severe pain. Almost 3 yrs later still have shoulder pain severe and arm pain started immediately after flu shot.  No previous history of arm or shoulder problem.
2 hours, post vax, pt had shakes, light-headedness, nausea and itchy skin on whole body.
itching and swelling almost one week after shot; itchy and puffy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching and swelling almost one week after shot) and SKIN SWELLING (itchy and puffy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030W20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (itching and swelling almost one week after shot) and SKIN SWELLING (itchy and puffy). At the time of the report, PRURITUS (itching and swelling almost one week after shot) and SKIN SWELLING (itchy and puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
No symptoms were reported by any of the patients; Improperly stored vaccines administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 17-MAY-2021, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T005737, which have been verified to be a valid lot number, expiration date reported and upon internal validation established as 10-JUN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003867: US-009507513-2105USA003871: US-009507513-2105USA003872:
Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 of which are the child's sisters) were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00481, WAES #0304USA00482, WAES #0304USA00483). Additional information has been requested.
Pt had pain in left arm and had problems moving it. Redness and swelling was seen at administration site. Cold compress was recommended with TYLENOL and BENADRYL prn.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.02 on 15-Apr-2021.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021 (Batch number: 044B21A ).  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I woke up with a sore throat and was coughing. I took an at home COVID-19 test which was negative. The next day I woke up feeling worse, I was very tired and had brain fog with body aches. I took two home tests that day and those were both positive. I ended up going in for a test the next day at urgent care. I did check for a fever which I never had but the cough, body aches, and fatigue were the most prominent. I did recover but had the cough and brains fog for another week to a week and a half.
The patient experienced arm soreness at the injection site for 2 days.  She developed a fever, chills, body aches and hot and cold flashes around 2am on 9/29/2021 and she is still experiencing these symptoms 3 days later on 10/01/2021.  The fever is low-grade and is staying  around 99 -100 degree range, but it has never gone away. The patient states her normal temperature is usually around 97.6 -97.8. The patient is also experiencing headaches consistent with having a fever. She had face and teeth pain on 9/29/21, but it lasted one day and went away.
reported administering expired Moderna COVID-19 vaccine to two different individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals). On 10-May-2021, EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported.  No treatment were reported.
numbness of the tongue, lips and cheeks; numbness of the tongue, lips and cheeks; BP went down to 104; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the first dose and experienced numbness of the tongue, lips and cheeks on an unknown date. She also mentioned BP went down to 104 on an unknown date. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feeling dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.            No concomitant medications were provided. The Patient does not reports any adverse reactions after first booster dose. No treatment medication was provided.   This case was linked to MOD-2022-661563, MOD-2022-661585, MOD-2022-661592 (Patient Link).   Reporter did not allow further contact
Large (3 cm) painful supraclavicular lymph node x 1 on the same side as vaccine sight.  The patient also has headache and neck discomfort.  Temp to 100.5.
COVID 19, treatment received; COVID 19, treatment received; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jun2022 at 13:00 as dose number unknown, single (Lot number: F54991) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing); "Cervical spinal stenosis" (unspecified if ongoing), notes: Cervical spinal surgeries. The patient's concomitant medications were not reported. Past drug history included: Avelox, reaction(s): "Drug hypersensitivity"; Clindamycin, reaction(s): "Drug hypersensitivity"; Cipro, reaction(s): "Drug hypersensitivity". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19, treatment received". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19 received; (14Oct2022) Negative; (16Oct2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19. The patient was treated with PF-07321332, ritonavir (PAXLOVID), from 07Oct2022 to 12Oct2022.
Pt presented with cough and hypoxia.  Admitted with COVID-19 pneumonia and acute hypoxic respiratory failure.
got the flu; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves patient who experienced got the flu (influenza), after receiving vaccine INFLUENZA VACCINE  Relevant medical history, concomitant medications and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got the flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
covid-19 like symptoms; covid-19 like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435876-00 (Agency).  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid-19 like symptoms". The action taken for adalimumab was unknown. The reporter considered "covid-19 like symptoms" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Suspected covid-19 and drug ineffective.
tenderness at the injection site/ injection site pain; myalgia; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th May 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the patient experienced myalgia. On an unknown date, the outcome of the injection site tenderness was unknown and the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness and myalgia to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. From the day of vaccination, the patient experienced injection site pain. Also,the patient started to experience whole body myalgia, unspecified the start date, but the myalgia did resolve in 2 weeks. Additional information not provided. The reporter consented to follow up. For tolerance to 2nd dose, refer linked case US2019AMR181546. This is 1 of the 2 cases reported by the same reporter.
3/25/2021   Patient was observed post Covid-19 immunization for 10 minutes as she reused to stay due to anxiety .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness. Assessment : Time of assessment 1148 Alert and oriented, anxiety   Actions taken: VS taken at 1148 BP- 181/118, P- 73, O2- 97%         Medications administered: No medication administered.   Disposition: patient refused further care, concern voiced over elevated BP, and she voiced that it is " usually higher". She refused continued monitoring. She left facility with a friend.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/25/2021 11:38 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
Injection site had been somewhat swollen & painful during the 24-36 hours following vaccination on 1/13, then resolved.  During the evening of 1/21, it began to be itchy & by bedtime it was again swollen & somewhat painful as before.   On the morning of 1/22, the area was more swollen, more painful, somewhat red,  very hard  and also somewhat hot to the touch.  This continued but slowly subsided during the next about 48 hours and eventually completely resolved without any intervention
Day one was low-grade fever and fatigue. Day two was vomiting. Day three through five was vomiting and continuous diarrhea. Hospital admission on day five for dehydration. Diarrhea continued through day eight post vaccination.
First 3 days problem arm. 3 in circle of pain - red and sore. Extended soreness at injection site for 6 days after injection.