chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The patient thinks that may have received a full dose instead of a half dose; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 012M20A and 043L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (The patient thinks that may have received a full dose instead of a half dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided. Patient did not remember which arm she received the vaccine in.   This case was linked to MOD-2022-658743, MOD-2022-658756 (Patient Link).
Headache, Fever, FATIGUE, PAIN/SWELLING INJ SITE Narrative:  Other Relevant History:
Case number PHEH2013US021847 is an initial spontaneous report from pharmacist received on 17 OCT 2013. This case refers to a female patient of age less than 18 years who was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) on 15 OCT 2013. No  other adverse event was repot following medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2013, a significant correction was done for the information received on 17 OCT 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "rug used in unapproved population".
Quickly after getting the injection I began to experience paresthesia in my left forearm, middle 3 fingers, and pain on both sides of my middle finger. The paresthesia then began to creep up my arm, across my shoulder into my neck and up the back of the left side of my head and then in the left side of my face. I also had random shooting, sharp pain in the left arm and pain if I used the arm to hold anything. This happened all by 6 PM. The paresthesia did not progress to any new areas the rest of the evening. Upon waking today, 10/25/18, the paresthesia in the arm and head is gone but the left side of my face feels very heavy. I do not notice drooping. As the morning is progressing, it is now 10 AM as I write this, the right side of my neck is having a tingling sensation and it is creeping into the right side of my face. I am also having difficulty typing with my left hand as it cramps when I use it.
Patient developed blistery rash on right arm at injection site day after injection. Patient monitored and denied other additional redness, fever, or other symptoms. Rash resolved after 2 days and skin continued to heal with no adverse reactions continuing. Patient contacted clinic on day 6 to notify of rash.
This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unspecified date in August 2015, the patient was vaccinated with improperly stored doses of ROTATEQ, RECOMBIVAX HB, PEDVAXHIB and PNEUMOVAX 23. No adverse effects were reported. Additional information is not expected as the reporter contact details were not reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adolescent male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 16Dec2021 17:00 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Jun2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 23May2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:00, outcome "unknown", described as "Dose Number:3"; HEADACHE (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "pain at injection site"; NAUSEA (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain, nausea.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, The patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse reporting on approximately 10 patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On 06-SEP-2017, the patients received improperly stored doses of M-M-R II lot # M045391 (expiry date 14-NOV-2018) or lot # M040558 (expiry date 03-OCT-2018) for prophylaxis (dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent (MRK). No symptoms reported. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 47.8 degrees Fahrenheit for 1 hour. The reported indicated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004130.
Major cognitive issues. More than brain fog. I feel like my brain stops and I can?t think at all. I lose words. My speech is slurring I have ticks (small twitches) in my face my shoulders and my neck. My balance is off. I feel dizzy 70% of the day.
Light swelling or clot in the nerve near left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included dairy products allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, the patient experienced light swelling or clot in the nerve near left shoulder. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event light swelling or clot in the nerve near left shoulder was unknown at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Injection site area erythema, inflammation, and warm/tender to the touch. Area raised and "size of a softball" (approx. 5 inches in diameter, circular). Reaction started 24 hours post vaccination, worsening through 48 hours post. Denies any systemic reactions. Office visit at 48 hours post, treated with Benadryl, ibuprofen, and ice.
Case number PHEH2015US021118, is an initial spontaneous report received from a Healthcare Professional on 14 Oct 2015. This report refers to a male patient of unknown age. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158425) intramuscularly on 13 Oct 2015. On the same day after vaccination, the patient experienced a reaction described as problems with fine motor skills in the arm where vaccine was administered and it appeared to be a neurological issue. There were also intermittent arm convulsions. Events stop date was mentioned as the same date of onset (13 Oct 2015). Final outcome of the events was not reported. Seriousness and causality of the events were not reported. Seriousness assessment of the events was upgraded (medically significant) based on the information available in the source document.
Information has been received from a 52 year old male physician who in 1998 was vaccinated IM with a second 0.5 ml dose of RECOMBIVAX HB and became lethargic, irritated, and could not concentrate for one day after the vaccination.  There was no concomitant medication.  The physician stated he did not received the third dose.  He sought unspecified medical attention.  The physician recovered on an unknown date.  Additional information has been requested.
When I got the vaccine I had an immediate sharp pain in my arm, almost like a nerve was pinched, and it went down my left leg. It lasted for about 20 minutes then went away. Seven days later I admitted myself o the hospital because my left leg was tingling. No blood clots in my leg were found and a head CT didn't show any abnormalities. I still have the tingling in my left leg that I and going to see a neurologist for and will be getting blood tests done to see what else could be going on.
fatigue; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy multiple" (unspecified if ongoing), notes: Known allergies: yes. Many; "MDS" (unspecified if ongoing); "Greves disease" (unspecified if ongoing); "bone marrow transplant" (unspecified if ongoing); "aplastic anemia" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 20Sep2022 as dose 1, single; SYNTHROID; PREMARIN; TACROLIMUS; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Oct2022 at 18:00, outcome "recovering", described as "pain at the injection site"; FATIGUE (non-serious) with onset 05Oct2022 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: The reporter both the patient and a Pfizer colleague. Other medications in two weeks: vit. No covid tested post vaccination.
PATIENT STATED THAT HER ARM HAD A KNOT AND WAS SWOLLEN AND SORE,  SHE SAID SHE WAS SICK IN BED FOR 2 DAYS.  SHE CONTACTED HER PHYSICIAN WHO ASKED IF SHE WAS HAVING SOB WHEEZING ETC AND IF SO TO GO TO ER.  PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OF ANAPHYLAXSIS.  VACCINE WAS GIVEN 9/21/22 I SPOKE WITH PATIENT THIS AM (9/26/22) SHE SAYS SHE FEELS  BETTER, ARM IS STILL A LITTLE SORE.  SHE EXPRESSED CONCERNS ABOUT SECOND DOSE.  I TOLD HER WE HAVE 6 MONTHS TO THINK ABOUT IT AND WE WILL DISCUSS IT WITH HER PHYSICIAN BEFORE THEN.
Information has been received from a physician's assistant concerning a 31 year old female with an allergy to codeine and hypertension who was vaccinated IM with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast) on 20, Jan 2004 (Lot # 643221/0386M) 25, Feb 2004 (Lot # 646999/0999N), and 13, Feb 2006 (Lot # 649259/0833R) respectively. Concomitant therapy included atenolol and hydrochlorothiazide. On 07, Aug 2006 the patient had a hepatitis B titer that was negative. Unspecified medical attention was sought. There was no product quality complaint involved. Information received on 09, Aug 2006 contained the following adverse experiences: partial thyroidectomy (December 2005)
Case number PHEH2012US011019 is an initial spontaneous report received from a nurse on 29 May 2012 with a follow-up received on 11 Jun 2012: This case refers to an adult male patient. His concomitant vaccinations included administration of yellow fever vaccine (other manufacturer, batch number: UH258AA) subcutaneously, TWINRIX, (other manufacturer, batch number: AHABB223DA) intramuscularly, inactivated polio vaccine (other manufacturer, batch number: 1330-1) subcutaneously and MMR II (other manufacturer, batch number: 0705AA) subcutaneously on 29 May 2012. He was vaccinated with MENVEO (batch number: X11065) intramuscularly on 29 May 2012. The nurse stated that this patient received only the MenCYW-135 liquid conjugate component of MENVEO; did not receive the Men A lyophilized conjugate component of MENVEO. It was also reported that the patient was vaccinated for the purpose of upcoming international travel. No adverse event was reported following vaccination. The same day he was re-vaccinated with the correctly reconstituted MENVEO. He was scheduled to receive VIVOTIF (batch number 3000009) on 30 May 2012. Follow-up received from a nurse on 11 Jun 2012: Updated patient's demographics, concomitantly administered vaccines and details about revaccination with MENVEO.
This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (which had a lot # of M020926 and an expiration date of 11-AUG-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014465: US-009507513-1701USA014466:
Sore Left Arm after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Left Arm after booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 030M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore Left Arm after booster). On 23-Dec-2021, VACCINATION SITE PAIN (Sore Left Arm after booster) had resolved.            No Concomitant medication was reported.    No treatment medications were reported.
pt recvd 3 doses of vax & lab eval in JAN93 revealed that pt was reactive to HBsAG, anti-HBc & anti-HBe; lab eval in APR93 anti-HBs 0.3;  anti-HBc pos;
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H013576 is an invalid lot number for (Zoster Vaccine Live)). (Dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Narrative:  81 year old male, received first dose of COVID-19 vaccine (Pfizer) on 4/5/2021. No medical notes on medical chart. Did not receive second dose. Patient expired 6/10/2021.
Debilitating menstrual cramps with back and full Body pain every month since second vaccine shot
Information has been received from a physician concerning a 21 year old female with an allergy to penicillin. Who on 8/16/06 was vaccinated with the first dose of HPV vaccine. Concomitant therapy included unspecified birth control pills (since 2005). On 11/22/06 the pt was seen by the physician and was scheduled to receive her second dose of HPV vaccine. At that time the pt reported to the physician that the week prior (date not specified) she had suffered a seizure. The physician clarified that the pt had no prior history of seizures and that the pts general health was very good. The physician did not give the pt the second dose of vaccine because she was unsure if the seizure could have been related to the first dose of the vaccine. At the time of this report the pt had recovered from the seizure. Upon internal review the seizure was felt to be an other important medical event (OMIC). Additional information has been requested.
Headache; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (slight fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (slight fever). At the time of the report, HEADACHE (Headache) and PYREXIA (slight fever) outcome was unknown.         Treatment was unknown Action taken with mRNA-1273 in response to the event was not applicable
Hives and erythemaous rash at injection site.  Patient given 1 dose of Benadryl, and hives resolved.
COUGH, HEADACHE, SORE THROAT, CONGESTION/RUNNY NOSE
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concomitant medications. On 1 October 2008 the subject received a dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm. On 1 October 2008, within a few hours following vaccination with FLULAVAL, the subject experienced injection site redness. The area of redness was about 1 inch in diameter and resolved on 4 October 2008. It was also noted that the FLULAVAL was administered via the wrong route. The vaccine should have been administered intramuscularly. The healthcare professional considered that the injection site redness was possibly related to vaccination with FLULAVAL.
Child passed out. Elevated legs, blood pressure taken. O2 sat 99%, pulse 118, HR 110/60.
Patient believes that she has Guillain-Barre Syndrome from the Fluzone HD that she received from us.
ABOUT AN HOUR AFTER MY SON RECIEVED HIB, MMR, AND HIS VARICELLA SHOTS I NOTICED THAT HIS CHIN HAD A RASH ON IT.  THE NEXT DAY IT WORSENED AND SPREAD ALONG HIS JAW LINE AND ONTO HIS CHEEKS. HE RECIEVED THESE SHOTS ON 10-20-2004.  EIGHT DAYS LATER THIS "VIRAL RASH" HIS PEDIATRICIAN CALLED IT IS NOW ALL OVER HIS BODY.
they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Lot number: EW0162) as dose 1, single and administration date 07May2021 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. Relevant medical history included: "lung issues" (unspecified if ongoing), notes: Verbatim: lung issues; "used to smoke" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis.; "pneumonia" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis.; "bronchitis" (unspecified if ongoing), notes: Additional Information for Other Conditions: used to smoke, gets pneumonia and bronchitis. There were no concomitant medications. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Lower back pain, muscle aches in both legs, temperature 100.8 degrees Fahrenheit. Onset of all adverse events was mid afternoon the day after vaccination. Still currently experiencing the adverse events.
Injection site soreness.  Instantly. 8 hrs post injection upper body joints and muscles sore.  (some nausea) 12hrs post injection entire body(muscles/joints) were in extreme pain.  (no more nausea) 36hrs post injection upper body started feeling better, only sore.   40 hrs post injection ONLY lower body was in pain (quads, hamstrings, knees, glutes). 50hrs post injection feeling back to normal.
breakthrough COVID infection after previous Moderna doses; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (breakthrough COVID infection after previous Moderna doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID infection after previous Moderna doses). At the time of the report, COVID-19 (breakthrough COVID infection after previous Moderna doses) outcome was unknown. Concomitant medications details were not reported by the reporter.  Patient stated that she received all Moderna COVID-19 vaccines in the past and had COVID 6 weeks ago.  Treatment details were not reported by the reporter.   Reporter did not allow further contact
Joints stiffened up and it was very hard to walk or get around. Seems to be a permanent increase in ability to be mobile. Has consulted physician.