chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore right arm; Minor fatigue; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 05Mar2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy (sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. On 05Mar2021 at 18:00, the patient experienced very sore right arm and minor fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very sore right arm and minor fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
12/3/07 at 0930, Tdap 0.5cc and HPV 0.5cc IM LD.  Client immediately lost consciousness.
fell back on the bed; She was unable to stand up on her own; dehydrated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell back on the bed), DYSSTASIA (She was unable to stand up on her own) and DEHYDRATION (dehydrated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (fell back on the bed) (seriousness criterion hospitalization), DYSSTASIA (She was unable to stand up on her own) (seriousness criterion hospitalization), DEHYDRATION (dehydrated) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (sore arm). At the time of the report, FALL (fell back on the bed), DYSSTASIA (She was unable to stand up on her own) and DEHYDRATION (dehydrated) had resolved and VACCINATION SITE PAIN (sore arm) outcome was unknown.            The concomitant medication was not reported. Patient took IV liquids. Patient did not have any symptoms after leaving the emergency room.  Company Comment: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected serious (hospitalization) events of Fall, dehydration and dysstasia. The events occurred after the second dose of mRNA 1273 vaccine. Patient received IV hydration.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-393428, MOD-2021-393454 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected serious (hospitalization) events of Fall, dehydration and dysstasia. The events occurred after the second dose of mRNA 1273 vaccine. Patient received IV hydration.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Moderna COVID-19 Vaccine EUA.  One week post injection, site of injection has swelled, become warm, and developed pruritus. Attempted to use OTC topical steroid  and ibuprofen with little effect.
pt adm to hosp w/sz activity which was noted 5 hr p/vax; temp was noted @ 104.7 & antipyretics valium and IV Rocephin given; pt improved & was discharged 1 1/2d later;
This case was reported by a physician and described the occurrence of vomiting in a 15-year-old female subject who was vaccinated with CERVARIX. On 25 April 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 25 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced vomiting, headache and mydriasis. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 May 2011: Concurrent medical conditions included asthma and seasonal allergy. Lot number was provided. The vaccine was administered in right deltoid. On 25 April 2011, less than one day after vaccination with CERVARIX, the subject experienced vomiting, and mydriasis. On 26 April 2011, one day after vaccination with CERVARIX, the subject experienced headache, queasy, vision disturbance and irritation when opening the eyes. A blood test was performed and showed no abnormality. On 28 April 2011, the events were improved. On 6 May 2011, the headache and queasy recurred. Follow-up information received on 18 May 2011: Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 March 2011. This case has been linked to case B0718792A because it was a duplicate. All future correspondence will be submitted to B0716098A. Follow-up information received on 26 May 2011: The subject was treated with unknown (Infusion) and unknown (Unknown medication).
Patient received High Dose influenza vaccine approximately 2 weeks ago from PCP. Family reports developed dizziness "sometime" after vaccine administration and subsequently seen by ENT provider. Admitted to Medical Center 11/13/15 for possible stroke. On 11/17/15 seen by ID diagnosed with severe encephalitis. Hospital MRI of brain unavailable due to patient's large size. CSF with 24 WBCs, 97% lymphocytes, protein 91, glucose 58 on 11/15/15. CSF HSV PCR negative. Additional tests in process include PPD, heavy metal screen, Arbor virus serologies, serum cryptococcal antigen, HIV test. Prognosis very guarded to poor. Consider possible ADR flu vaccine-report FDA.
CHILD SEEN IN EMERGENCY ROOM FOR FACIAL SWELLING AND WHEEZING. VACCINE APPOINTMENT AT 1:45 PM VACCINE GIVEN APROXIMITLY AT 2:15 PM. ER PERSONNEL STATES MOM GAVE BENADRYL AT HOME. CHILD BROUGHT IN FOR WHEEZING AROUND 4:15PM. CALL PLACED TO OUR CLINIC TO INQUIRE OF VACCINE GIVEN AT ABOUT 4:45PM. CHILD WILL BE DISCHARGED TO HOME THIS EVENING.
This is a non serious spontaneous case from a nurse of a medication error. The reporter causality was not provided to Flumist. A nurse reported a series of medication errors. The nurse misunderstood the dosing instructions for FluMist and administered a double dose of vaccine to seven pt's . Prior to the administration of the vaccine she removed the dose divider clip thereby giving 0.50ml per nostril versus the prescribed dose of 0.25 ml per nostril. On 26Oct04, at 2:00 in the afternoon, reporter gave a double dose of FluMist to a 24 year old female pt whose medical history was not reported. The reporter stated the pt experienced headache, diarrhea and was sweaty by 6:30PM on 26Oct04. The pt's sweating and diarrhea resolved on 27Oct04 and as of 01Nov04 the pt continued to have mild headaches. No further information is available.
Very sore right arm for about 48 hours, beginning 4/15 (day after vaccination) Sore, tight muscles in right shoulder and neck for about 48 hours, beginning 4/15 (day after vaccination) General lethargy  for about 36 hours, beginning 4/15 (day after vaccination) Minor bruising at injection site, beginning 4/16 (2 days after vaccination)  Treated with OTC ibuprofen, all symptoms EXCEPT bruising resolved within 72 hours after vaccination; bruising resolved within 5 days.
Near-syncope Symptoms started as an intense wave of nausea. I sat down. Within 30 seconds to one minute, I become very hot and diaphoretic. Then, black spots appeared in my vision, and I heard ringing in my right ear. I felt like I might lose consciousness, so I laid down on the ground. Within another minute, the symptoms started to pass. I never lost consciousness. This event only occurred one time.
HEADACHE; This spontaneous report received from a consumer 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 not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210407212.
NauseaVomiting, flusing Narrative: intermittent flushing and nausea for 2.5 weeks.
immed p/vax pt devel blotchy rash on face which spread to torso;pt cried then fell asleep;while examined was alert,smiling;
Generalized malaise, body aches within a few hours; asthma attack. Induration at site followed by localized urticaria and chest tightness.
COVID-19 like symptoms; Aggresive cough; Sinuses are inflamed; Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), COUGH (Aggresive cough), SINUSITIS (Sinuses are inflamed) and COVID-19 (COVID-19 like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Mar-2021, the patient experienced THROAT IRRITATION (Scratchy throat). On 06-Apr-2021, the patient experienced COUGH (Aggresive cough) and SINUSITIS (Sinuses are inflamed). On an unknown date, the patient experienced COVID-19 (COVID-19 like symptoms). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Scratchy throat), COUGH (Aggresive cough), SINUSITIS (Sinuses are inflamed) and COVID-19 (COVID-19 like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-apr-2021 new event was updated.
5am 10/24/23 vomiting and diarrhea which was frequent and intense until 2pm. Continued nausea and hot flashes
Patient vaccinated on 3/13/2003. Take response read 3/20/2003. Patient reported to Hospital ER 3/26/2003 with approximately 18.5 cm X 12 cm reaction at vaccination site on day 13 post vaccination. Patient denied any symptoms related to inflammation. According to Dr., ER physician the site appeared to have superior margins, redish vesicular lesion and slight purplish lip. Center of lesion is black in color and approximately 8cm X 6cm. According to the patient,  the site developed within 24 hours and the size of the site is unchanged since her take evaluations on 3/20/2003. Telephone conference held today to discuss adverse event. Outcome of telephone conference is to perform antigery testing on the patient using candida and mumps to determine T-Cell response and to continue to observe the site to determine if regression is occuring. Photographs to be taken daily and reveiwed by physicians listed above to determine continued adverse reaction and/or regression.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter stated that, he/she know the people (patient) that came down with shingles 2 days after the Shingle shot. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR195403, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195403:same reporter
PATIENT FELT DIZZY AFTER BEING ADMINISTERED PFIZER DOSE 1 COVID-19. REMAINED FAINT FOR >45 MIN AFTER WHILE REMAINING SEATED.  EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO LOCAL ER.
BREAKTHROUGH COVID INFECTION - PT TESTED POSITIVE ON AUG 25 2021, PT FULLY VACCINATED APRIL 11 2021.
Tingling, numbness and loss of strength involving fingers and toes. Tremors around eyes.
no pain upon injection.  next day no symptoms. 2nd day swelling of upper left arm. 3rd day area red, wam and swollen.  size 8 inches high and 4 inches wide with medial and posterior progression from injection site.
Bed ridden after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bed ridden after the 2nd dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Bed ridden after the 2nd dose). At the time of the report, BEDRIDDEN (Bed ridden after the 2nd dose) had resolved.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-386949 (Patient Link).
I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep; pain; upset stomach; Leg and neck and shoulder pain; cramping; Back and neck pains; Bad headache; Leg and neck and shoulder pain; Leg and neck and shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Sep2021 14:30 (Lot number: FC3184) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 01:30, Site and route of injection: , Anatomical site if injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EW0151 Covid-19 Pfizer,withheld), administration date: 08Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "pains", "stiffness", "really sick", "my shoulder, still hurt and do does my legs", "I wake with pain all through my body disoriented".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Sep2021 14:30, outcome "unknown" and all described as "I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "pain"; ABDOMINAL DISCOMFORT (non-serious) with onset 08Sep2021, outcome "not recovered", described as "upset stomach"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Sep2021, outcome "not recovered" and all described as "Leg and neck and shoulder pain"; MUSCLE SPASMS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "cramping"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Back and neck pains"; HEADACHE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Bad headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, neck pain, back pain, headache, pain in extremity, arthralgia.  Additional information: On an unspecified date in 2021, patient undergone unspecified test and it was negative. On 04Aug2021 and 09Aug2021, patient had Covid-19 test and the result was negative.  No follow-up attempts are possible. No further information is expected.
Pt was to received the initial Moderna Primary Series along with Influenza Vaccine.  Received the Moderna Bivalent Booster.  Spoke with CDC, per guidelines: Repeat 1 monovalent dose immediately (no minimum interval) because administration of the bosterdose will result in a lower-than-authorized dose.  Discussed CDC's recommendation with provider.  Provider discussed with pt.  Patient did receive the Moderna Primary Series prior to leaving clinic.
7 days post vaccination mother stated several pin size to quart size non inflammed, no colored palpulas appeared on bilateral inner thighs and bilateral forearms. No tx needed, lasted 2 days, denies any other problems.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a "shot"  (reported as "your shot") yesterday morning 23Jan2021. The patient thought better to report it and asked if the patient should do anything for this or it will go away by itself. The patient came down with diarrhea at the time of report on 24Jan2021. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
can a patient get her 2nd dose outside the 42 days interval after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can a patient get her 2nd dose outside the 42 days interval after the 1st dose) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can a patient get her 2nd dose outside the 42 days interval after the 1st dose). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can a patient get her 2nd dose outside the 42 days interval after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Within two days of the vaccine, I broke out in a severe rash across my face. Within about a month it had spread all over my neck, chest, arms, and back. Within approximately several more months the rash had spread to my legs.
I developed a rash / redness on my neck (right side) that became really painful after 10 days of getting the vaccine. I?ve never had that happen to me before and then my throat started to hurt as well.  I developed sore throat that has not gone away with phlegm and sneezing. I usually don?t get bad flu symptoms because I work at a health clinic and I have pretty good immune system. These ?flu-like? symptoms are different. My body usually experiences sore throat for about 2 days then it goes away on its own. This is not the case anymore.
This spontaneous report was received from a nurse refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (Lot# K018181, expiry date 04-JUN-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Had generalized tonic-clonic convulsions. CT scan of the head revealed a subarachnoid hemorrhage in the L cerebral hemisphere.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (route, dose, lot number and expiration date were not reported). There was no concomitant medication reported. The nurse stated that on an unspecified date the patient exhibited "Autism like behavior" for two weeks after the administration of the M-M-R II. Additional information has been requested.
2 years patient was given Fluzone High Dose by mistake/ No AE; 2 years patient was given Fluzone High Dose by mistake/ No AE; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA257558 same reporter.  This case involves a 2 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ246AA via intramuscular route in the right thigh on 09-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Reports right shoulder pain since the Twinrix vaccine on 7/12/23.  Reports mild pain at 2/10 that comes and goes.  Able to do his normal activities.  Denies any fever, redness, warmth or any other issues.  Reports he had never had shoulder pain last this long after a vaccine so wanted to let provider know.
Injection site reaction. Her arm had a red warm raised area with a little hard spot in the middle about 4 inches in diameter.
Chills; Flu Like Symptoms; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case: US2019AMR135288).   On 22nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced chills, influenza-like symptoms and dizziness. On an unknown date, the outcome of the chills and influenza-like symptoms were recovering/resolving and the outcome of the dizziness was unknown.   It was unknown if the reporter considered the chills, influenza-like symptoms and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient stated that with the second dose of Shingrix vaccine she experienced chills, flu like symptoms and dizziness. The chills and flu like symptoms had gotten better at the time of reporting. The reporter had consented to follow up. No further details were provided.