chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27JUN95 irritable, photophobia; 1JUL95 dec appetite, sl fever-glands swollen-back pain; 2JUL995 faint rash on cheeks-listless; 31JUL95 inc of rash to face-neck inc fever (102) restless; 4JUL95 welts all over-face puffy-starting spells;
Headache, Myalgia, Nausea Vomiting, fatigue and elevated LFT's seen hepatologist Narrative: off work illness
Information has been received from a physician concerning a 12 year old female who in July 2007, was vaccinated with a first dose of Gardasil. In July 2007, the patient passed out and experienced elevated blood pressure after receiving Gardasil. Subsequently, the patient recovered from passing out and elevated blood pressure. The physician considered passing out and elevated blood pressure as other important medical events due to intervention with intravenous and oxygen administration (not further specified). The patient sought medical attention. Additional information has been requested.
Currently 9 weeks 2 days pregnant. Began having spotting the morning after receiving the vaccine
Pt was vaxed w/Hep B following vax pt devel optic neuritis;
Lack of appetite, ate a little and threw up several times. Was dizzy and weak. Seemed fine in the morning, but threw up several times in daycare.
About 1 hour after receiving immunization pt. reported experiencing itching @ the site of injection & a hive erupted.  She later developed a "very itchy hive" under her right eye.  The next morning she called her physician who advised her to take a BENADRYL - which she did.  She reported that it helped w/itching.
Local erythematous macular rash at site of injection left arm 5cm x 4cm size. No induration, no tenderness.
02/15/2022 I had my 3rd vaccination. I was exposed 07/27/2022 to COVID-19 at airport. I tested COVID-19 positive on 08/03/2022. I short of breath. When I saw Dr. was COVID-19 negative but was short of breath. He prescribed an inhaler and doxycycline. My left arm is still weak. I still have a cough but its not still as persistent and I am still a bit fatigued.
Weakness in muscles of upper arms; Severe head aches; Fatigue; Body aches, severe pain in muscles of upper arms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in muscles of upper arms), HEADACHE (Severe head aches), FATIGUE (Fatigue) and MYALGIA (Body aches, severe pain in muscles of upper arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Weakness in muscles of upper arms), HEADACHE (Severe head aches), FATIGUE (Fatigue) and MYALGIA (Body aches, severe pain in muscles of upper arms). At the time of the report, MUSCULAR WEAKNESS (Weakness in muscles of upper arms) and MYALGIA (Body aches, severe pain in muscles of upper arms) had not resolved and HEADACHE (Severe head aches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-227764 (Patient Link).
Fully vaccinated, not boosted.   LOT NUMBERS OF VACCINE NOT RECORDED. COVID infection breakthrough, symptomatic.   Immunosuppressed.   Inpatient hospital stay
Moderna COVID?19 Vaccine EUA. I have had a headache for the last 3 days. Today, Monday and Sunday. It starts as soon as I get out of bed in the morning. It hurts from each ear up over the top of my head. Ibuprofen improves the headache, but it doesn't totally go away until maybe 3pm.
Pt reported itchiness to R forarn, no rash noted.  L-foot numbness, no respiratiory symptoms.  Pt nervous and anxious that resolved when pt tood and shook out leg.  Pt taken to med bay w/ mother. Vitals: (chair) @1613 131/75, 123, 20, 100% -- > semi-fowlers@1616 119/77, 119, 21, 100% Pt given 12.5mg Liquid benadryl @1608.  Attempted to give pt 25mg benadryl due to pt weight of 123lbs but mother refused and requested 1/2 dose as given.  Itchiness and numbness resolved.  Pt stable and released from the vaccination site @1621 Pt educated (w/ mother) to rest @home.  Pt left facility accompanied by  mother and gait was noted to be steady.  Pt ambulated independently.  NAD noted.
Horrible headache, neck tender and nerve pain just below ears and above ears - very sharp/piercing (felt like trigimenal nerve pain. Skin hurt and muscle/joint aches all over. Low fever later about 100.1; Sun. am 100.4. Mon. 99.4. - feel a bit better. Will see my PC Dr. Tues. morning.
This is spontaneous report from a contactable consumer. This consumer reported for his wife. A female patient of an unspecified age received PREVNAR 13, (lot# unknown) via an unspecified route of administration on 22Jun2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was not feeling well that her left upper arm at the injection site was hot to touch and red (redness was about the size of the fist) on an unspecified date. The outcome of events was unknown.
administration of an adult dose to a 17 yo; administration of an adult dose to a 17 yo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administration of an adult dose to a 17 yo) and adult product administered to child (Verbatim: administration of an adult dose to a 17 yo). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter asked how to proceed with this patient. The reporter did not provide patient identifiers nor information about the adult Engerix-B dose given (Lot number, expiry date, date of administration). The follow-up could not be possible as no contact details were available. The patient received an adult dose of Engerix-B, which led to overdose and adult product administered by child.
At 9:45 AM pt received ordered vaccines Menactra and Hepatitis A. Prior to shots, pt screened with history of passing out or problems with shots. None noted by pt or parent. Pt stated she ate breakfast prior to app shots given. After last shot pt stated she felt fine. Pt sat for a few seconds got up easily with steady gait. Pt passed out while checking out mom caught her no head or body injury occurred. Doctor and physicians assistant notified of this. Pt BP rechecked 105/65 at 9:45 am, 108/71 at 10 am, 110/74 at 10:10 am. CPA assessed pt and ok'd her to leave office.
believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; slurred speech; metallic taste in mouth; unable to sit up; arm pain near injection site; A spontaneous report was received from a consumer concerning a 58 years old, male patient who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced a loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 19 Mar 2021,  the patient received their 0.5 ml of planned dose of mRNA-1273 (Lot number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19Mar2021, within 15 minutes of receiving the vaccine, the patient experienced face feeling weird, blurry vision in left eye, blurry vision in right eye, speech slurred, inability to sit up, metallic taste in the mouth,  loss of consciousness, and some arm pain near injection site. The patient went to the emergency room (ER) and underwent electrocardiogram (EKG), unspecified blood work, neurological tests, and computerized tomography (CT scan). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the events loss of consciousness and slurred speech was resolved, and the outcome of the other events was not resolved.   The reported events are loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain, were considered related to mRNA-1273.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Hives observed without respiratory involvement. Patient presented back to vaccination clinic after shot was administered complaining of a rash and it was itching. Patient taken to healthroom at school, Benadryl administered, and pt observed for 30 minutes. Patient returned to class slightly drowsy. Mother was notified before treatment.
This spontaneous report was received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Between 09 to 23-SEP-2015, the patients received unspecified doses (Merck) PROQUAD that were improperly stored (doses and route were not provided). The nurse provided potential lot information for doses administered: L023113 with exp. date on 24-DEC-2016 and L023114 with exp. date on 24-DEC-2016. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Feel a hot spot where Shingrix was given; This case was reported by a consumer via interactive digital media (GSK Chatbot) and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix vaccine and feels hot spot where vaccine was given.
hepatitis B nonresponder; This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 37 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 41 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Temperature increasing throughtout day, everyday since vacination. Starts at 98.4F at wakeup and rises throught the day to about 100.5F.  Causes significant lethargy and napping in afternoon as temperature rises.  She never needed naps previously.  Fever significantly influences her ability to function normally.
This spontaneous report as received from a Licensed Practical Nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, multiple unspecified patients were administered improperly stored VAQTA lot # L030442 expiration date: 19-FEB-2016 (dose, route and site of administration were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations are also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
Case number PHEH2015US024201 is an initial spontaneous report received from a pharmacist on 16 Nov 2015. This report refers to a 60 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly on an unknown date in Nov 2015. On 14 Nov 2015, three days following the injection, the patient experienced headache and dizziness. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Pt recv vax on unknown day; 5 day later pt exp double vision, vomiting & unsteady gait
pretting sick tonight; rashes in her armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (pretting sick tonight) and RASH (rashes in her armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder (Overactive Immune System).    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 ILLNESS (pretting sick tonight) and RASH (rashes in her armpit). At the time of the report, ILLNESS (pretting sick tonight) and RASH (rashes in her armpit) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported. No treatment information was provided.
2 minutes after injection, proceeded to completely black out- the nurse at the time described it as if I was gasping for air, in somewhat of a convulsion. She then proceeded to administer to use an epi-pen, which in turn immediately relieved my symptoms. Paramedics were called, vitals were checked - was eventually able to leave the facility and return home.
Extreme fatigue and disorientation.  Passed out while driving. 4 year old granddaughter was in the car. 2nd day after shot, still feeling fatigued.  Experiencing brain fog.
IPOL was administered to a patient which was exposed to temperature excursion, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA293402 and 2019SA293403 (same reporter).  This case involves 2 month old male patient who received a dose of vaccine IPV (VERO) [IPOL] which was exposed to a temperature excursion.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.   On 18-Oct-2019, the patient received a first dose (0.5 mL) of suspect IPV (VERO) (lot P1F491M, Expiry date: 30-Nov-2020) via subcutaneous route in the left arm.  It was a case of actual medication error due to improper storage of product in use.  It was reported that ActHIB, IPOL opened, Daptacel, Adacel, Fluzone Quadrivalent prefilled syringes 0.25 ml and 0.5 ml and multi dose vial (MDV), for temperature of 33.4 degrees F for 6 hours 48 minutes due to unknown reason. ActHIB (UJ076AA, expiry date: 21-Feb-2020), Daptacel (G5BE3, expiry date: 25-May-2021, Lot: J947T, expiry date: 30MAY2021), Adacel (lot: U6273AA, 24-Apr-2021, Lot: U6321AA, 07-Jun-2021), Fluzone Quadrivalent MDV (UJ223AB, 30-Jun-2020), Fluzone Quadrivalent 0.5 ml prefilled syringes (lot: UJ231AB, 30-Jun-2020) and Fluzone Quadrivalent 0.25 ml prefilled syringes (lot: UT6647JA, expiry date: 30-Jun-2020).  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Upper right arm red, swelled, a big lump under the skin and painful.  It took about a month to heal.   I would not have reported it, except I had mammograph one week later that resulted in having an ultrasound.  Now there is a repeat Ultrasound scheduled in June.  Please note that I get my mammograms every year.  Also, there was no adverse effects from the administration of the first Shingrix shot on 11/12/22.
I have 2 older daughters so I was not looking for adverse event- I'd read papers given to me by County Health Dept & I'd noticed- watch for a "cat cry" - thought "hmm ?" & we went to bed the PM of the shot- the 4mo old's crib was in my bedroom-I had work the next AM so I was tired- the baby woke up screaming & she could not be comforted - I noticed she had a fever so I took her temperature - it was elevated some- she continued to cry - I noticed a unusual sound to her cry- finally I ran a lukewarm/cool bath & sat in the tub with her- I did not call the emergency room- possibly because the vaccine was not from a clinic- it was close to the time we needed to get up - she was crying less after the bath but continued to be restless- she seemed better in the AM - I went to work and her dad took care of her that day.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (lot #, expiration date, dose and route were not reported). No adverse reported. This is one of several reports from the same source. Additional information has been requested.
23 y/o F Pilot trainee presents to the clinic for L hand numbness x 2 days. Patient states she received the 1st dose of the Pfizer vaccine on 22 SEP, was dizzy immediately after the shot but waited 15 minutes and that resolved. She began to feel numbness of the nose w/in 30 minutes of receiving the vaccine but that too resolved in about 20 minutes. Patient received the vaccine in the R arm. Patient states she has woken up the past two days w/ intermittent L hand numbness that has progressed to near-constant timing. Patient also c/o a bump that appeared 2 days ago and has since gone down on the L wrist above her Fitbit, initially TTP w/ sharp shooting pains from the elbow to the 3rd digit. No Hx of reactions to immunizations and no FamHx to Guillain-Barré syndrome. She denies any other systemic symptoms. She thinks her grip strength may too be affected, as her water bottle keeps slipping from her left hand.
first dose of Pentacel at 2 months and then the second at 5 months/no AE; Initial information received on 23-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient(unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] first dose at 2 months of age and then the second at 5 months (inappropriate schedule of product administration) on an unknown date for prophylactic vaccination [batch number, expiry date, dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  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.  There will be no information available on batch number for this case.
Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (patient) via social media.   This case involves Adult male patient (unknown age) who experienced cold, after receiving INFLUENZA VACCINE and COVID-19 VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  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 an unknown route at an unknown administration site for vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for vaccination.  On an unknown date, the patient developed non-serious cold following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I had to COVID-19 shots and the flu shot and I still got a damn cold figure that out".  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case. Sender's Comments:  SanofiPVPortal20211004000693: PORTAL ID
The patient received her first vaccine on 08/13/21. She received the Moderna vaccine. When she returned on 09/10/21, she received the Pfizer vaccine. No adverse effects documented.