chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) lot # M008589 , expiration date: 16-FEB-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-0095713-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001267: US-009507513-1701USA001266:
No adverse reactions reported; received a dose of PROQUAD, when he was scheduled to receive a dose of MMR II; Route of Administration: intramuscular; Product administered to patient of inappropriate age; This spontaneous report was received from a medical assistant concerning to a 57-year-old patient of unknown gender. The patient's historical conditions, previous drug reactions, allergies, and concurrent condition were not provided.     On 17-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (product administered to patient of inappropriate age) intramuscularly (Incorrect route of product administration) for prophylaxis (strength and dose were not reported; lot # R022566 with expiration date 04-FEB-2020); which was previously reconstituted with a properly stored MERCK sterile diluent when the patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered) due to travel plans. No adverse reactions reported.
4 days after 2nd vaccine I broke out in an itchy burning rash on both my legs from groin to ankle. today is day 3  and I still have it.
This spontaneous report as received from a nurse practitioner (NP) refers to a patient of unknown age. On an unspecified date in February 2008 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided) and on 04-MAR-2013 was in the office to receive second dose. No adverse symptoms were reported. Additional information has been requested.
Arm soreness; cold sweats; This is a spontaneous report from a contactable consumer.   A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231) on 21Jan2021 at 12:00  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 21Jan2021 at 16:00 the patient experienced Arm soreness and cold sweat. Treatment for the events were not administered. On an unspecified date the patient recovered from the events.
2 1/2 days after injection I have a large (2?x2.5?) red welt in my arm with a patch of not red in the center. It hurts and is very warm to the touch.  It is NOT at the injection site but about 1.5? below it.  15 hours after injection: Extreme fatigue, head fog, chills for hours then hot for hours, extreme muscle and body aches, mild headache,
pt reports that the bruise at the injection never really went away, and reports that there are tiny bruises all over her body in different sizes. The gaint size bruise (size of silver dollar) behind her upper right leg underneathe her buttock appeared out of nowhere within the past 3 days and it looks black with yellow ring growing around it and hurt to the touch.
freezing, sweating, headach and very weak. I ddin't want to eat and had 3 hives on my body. Had to lay down all day.
Itching  on head, arms, neck, torso over the course of 8+ (2pm - 10 pm) hours after receiving the vaccine.  One hive that I saw.
23FEB99 noted fine rash diaper area-up stomach;father says 2-3PM momsay7PM no other sx;24FEB99 8AM noted rash 2/3 body chest, legs neck patchy raised red areas felt hives;low grade fever 98.8ax, inc tiredness;25FEB99 fine rash, fever 98
injection site swelling; injection site pain; lower back pain; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FD3N, expiry date 7th July 2021) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th May 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site pain and low back pain. On an unknown date, the outcome of the injection site swelling, injection site pain and low back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and low back pain to be related to Shingrix.  Additional details were provided as follows:  The patient received the 1st dose of Shingrix in the right deltoid.  The patient reported with 24 hours on 8th May2019, he developed persistent injection site swelling, pain and lower left back pain.  The events were reported as ongoing.
PAIN IN ARM; ANXIETY ABOUT BLOOD CLOTS; FEVER; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 31 year old of unspecified sex. 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 not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. On 10-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced anxiety about blood clots. On 13-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-APR-2021, was recovering from injection site soreness, and had not recovered from pain in arm, and anxiety about blood clots. This report was non-serious.
Student went to health room just before 11am, after clinic finished student reported had headache right after got flu nasal spray but didn't say anything, went to class & recess, in health room, HR R&R 84/min,  breaths 12/min. lungs clear, no wheeze. Had water, rested, went back class.
Chills without fever, total body pain not just aches, mental fogginess, extreme fatigue
pt recvd vax 27AUG93 stating pt c/o inc pain lt knee-swollen cannot walk & has generalized fever; adv parent to take pt to pediatrician; systemic & local infection lt knee;
slept for the full afternoon; tiredness; weakness; arm hurt; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th January 2020).   On 23rd June 2020, the patient received the 2nd dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th June 2020, the patient experienced sleepiness, tiredness and weakness. In June 2020, the outcome of the pain in arm was recovered/resolved. On 25th June 2020, the outcome of the sleepiness, tiredness and weakness were recovered/resolved.   It was unknown if the reporter considered the sleepiness, tiredness, weakness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was reported for his wife. The patient did not experience any side effects with the 1st dose.  After the 2nd dose, her arm hurt.  The patient experienced the weakness or tiredness on the second day after the injection. She also slept for the full afternoon.  Symptoms were gone the following day. This case was linked with case US2020115707, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115707:same reporter
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number- 011L20A). No treatment medications were reported   This case was linked to MOD-2021-395985.
Patient had facial numbness, nausea and dizziness shortly after receiving vaccination. She has a history of diabetes and recently started on a new insulin medication since last Moderna doses.
1/29/2021: Achy muscles, painful joints, headache and a fever of 100?F started at 3AM. Symptoms and continued and fever was 101.8?F at 10AM.  Advil was then taken. Fever broke and symptoms subsided. Symptoms including painful joints, headache, achy muscles and a fever of 100?F started around 7PM. Advil was taken again. 1/30/21. Woke with a persistent headache; other symptoms did not appear. 1/31/21: No symptoms upon waking.
Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure.  No Previous such diagnosis.  Admitted for 6 days with Metropolo benign only new prescription.  After 2nd shot on February 2 had follow up visits but started experiencing light headless.  On  February suddenly went limp with loss of pulse and breathing.  Taken to Hospital ER, admitted without neurological responses.  Died on February 22.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown dates, the patient received the 3 doses of GARDASIL (lot number, expiry date, dose and route unspecified) vaccination series approximately one year apart. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Around 0200 patient started to feel like he was having mild chills, feels a bit shaky though no visible tremors, feels a bit run down. As patient was talking to SPI the shaky feeling resolved.  Advised if patient does not feel better within three days, runs a fever over 101, or gets tremors/shaking that are visible then should seek tx.
Bruising; Sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MONTELUKAST and VITAMIN 15 for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for product used for unknown indication, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MONTELUKAST and VITAMIN 15 for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for product used for unknown indication, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
He states that Friday night he got chills, vomiting and fever of 101.4. He has red spots to his left arm at and around injection site. He states that even his right shoulder is aching.
9/11 at 7AM: Client developed fever, stomach ache, headache, had difficulty breathing (wheezing). Went to ER at 9/11 at 11AM.
pt recv vax & reporter stated did not know what type of rxn but thinks it was similar to anaphylactic rxn. Anaphylaxis. A nurse reported that a hospitalized 44-year-old female received an injection of flu shield (1998-99 Formula) and IV gamma globulin and subesquently experienced an adverse event. The reporter stated. "I don't know what type of reaction but I think it was similar to anaphylactic reaction." No further information was available at the date of this report. Follow-up information received on 28-FEB-2001 from a healthcare professional indicated the patient has sinced recovered.
Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Employee received both doses of Pfizer Covid vaccine  and had breakthrough  Covid  positive swab  twice .
After first shot, sore arm. Went away in three days. After second dose, two days later I have a fever, G.I. problems, body aches, some trouble catching my breath, and fatigue. The fatigue, trouble catching my breath, GI problems and bodyaches lasted a full week. I haven?t seen my doctor because I have taken medicines at home that are over the counter. However, this kind of reaction has not been reported so I thought I should tell somebody. I?m going to be fine, but it was a surprise. I can breathe better today, so I will not seek medical attention.
40mm x 25mm indurated, red, warm to touch. Advised Benadryl, Tylenol, ice to site.
Developed fever 02/27/2003 and broke out with chicken pox 02/28/2003. ( 20+ pox). Sister recevied varicella vaccine same day, no pox developed.
no adverse effect; unknown amount of vaccine leaked out while administering the injection; a patient received less than full dose; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.      On 13-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032766 has been verified to be a valid lot number, expiration date 31-AUG-2021 (dose and route of administration were not provided) for prophylaxis.   The nurse reported that the patient received less than a full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because an unknown amount of the vaccine leaked out while administering the injection. No adverse effects were reported. The outcome of syringe issue was unknown.  The relatedness between the syringe issue and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Tingling sensation on Right fingertips  BP:148/101 first reading  BP: 169/110 Second reading Pulse 82 BP: 164/106 third reading  Rapid response team activated and team assesed patient  Patient is advised to go to the ER for further evaluation BP: is going up after 15 minutes. Patient refused to go to ER. Patient stated he will consult his primary care physician he feels better. No more tingling sensations. RN witness patient completed statement. "I am doing ok - I am ok thanks all good care greatful to Hospital.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 3:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 3:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.25 for dose administered on 03-Mar-2021 and 68.32 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range of 34, 35 and 51 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A administered on 31-Mar-2021 underwent temperature excursion with temperature range of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Purple spots (bruises on stomach), possible IgA Vasculitis or vasculitis in some other form
Hf of anxiety, crying, but not able to verbalize any physical complaints  BP 162/109 HR 88, only set of vitals emus did.  Pt assured that she was ok, observed for a total of 45 min until she felt calmer, was driven home by husband once stabilized
Patient reported redness and slight swelling around injection sight on 6/14/2011.  She came in 06/16/2011 and the reaction had grown beyond the injection site and was red, swollen.  Symptoms started to subside later that day, with only slight itching and minor pain.  She did not seek medical intervention.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-DEC-2015 at 14:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 4.9 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Fatigue, body aches, low grade fever  Pregnant  DOD 04/11/2021
This case meets criteria for vaccine breakthrough review. SxS include fever, weakness, fatigue, loss of appetite, emesis.
Patient presented to emergency department on 3/20/21 with symptoms of dizziness, nausea, and vomiting. She received the COVID vaccine 2 days prior. Patient has had similar episodes of vertigo in the past. Patient notes vertigo is much more severe than past experiences. During hospitalization patient continued to endorse severe dizziness and nausea. Vertigo increased with eye opening or changes in position. Horizontal nystagmus present. Patient was treated with ondansetron, metoclopramide, methylprednisolone and lorazepam for symptom control. Physical therapy also worked with patient. Patient discharged on 3/23/21 with  new prescriptions for meclizine and ondansetron as needed.
Temperature excursion of 31.8 F during 10 min. Vaxelis was administered to a patient.; This non-serious spontaneous safety report with reference #02089387 was received by a partner on 12-Jan-2022 from a Medical Assistant, and forwarded on 13-Jan-2022.  Due to the nature of the event, the causality between Vaxelis and the reported event of "Temperature excursion for Vaxelis and administered to a patient" was not applicable.  Further information is expected.