chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 PEOPLE GOT THE SHOT, STILL BROKE OUT WITH SHINGLESsuspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the Shingles shot and still broke out with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR186373, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186373:Same reporter
Platelets dropped drastically for the first time in my life.  It was 201 in my February 2021 report.  The blood report dated 09/04/2021 shows a drastic drop to 106.  My PCP has done another test and I am seeing him 09/15/2021.  Please advice if there is anything I should do about it.  Please also inform him about anything that he needs to look in to. Thanks
Patient reported having a large raised rash on left arm after vaccination that was also painful. 4  months after vaccination patient is still complaining of severe pain in the arm and is unable to raise her arm beyond her shoulder without experiencing severe pain. She is undergoing further medical evaluation in which doctor is suggesting potential surgery for rotator cuff issue stemming from vaccination.
sweats; TENDERNESS ON RIGHT SIDE; DIFFICULT SLEEPING; FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE; SWOLLEN LYMPH NODES ON LEFT SIDE; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE), INSOMNIA (DIFFICULT SLEEPING), PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE) and LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE). On 12-Dec-2021, the patient experienced PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE). On 16-Dec-2021, the patient experienced HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE) and INSOMNIA (DIFFICULT SLEEPING). On 16-Dec-2021, LYMPHADENOPATHY (SWOLLEN LYMPH NODES ON LEFT SIDE) had resolved. At the time of the report, HYPERHIDROSIS (sweats), TENDERNESS (TENDERNESS ON RIGHT SIDE), INSOMNIA (DIFFICULT SLEEPING) and PSORIASIS (FULL FLARE UP PLAQUE PSORIASIS FLARES IN THE SCALP AND GROIN AREAS AND APPEARANCE) was resolving.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of SWEATS, SWOLLEN LYMPH NODES ON LEFT SIDE, TENDERNESS ON RIGHT SIDE and DIFFICULT SLEEPING with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FULL FLARE UP OF THE PLAQUE PSORIASIS IN THE SCALP AND GROIN AREAS AND APPEARANCE with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Live Significant Follow-up - Updated Event information, Suspect Drug Information, Narrative description and Medical History received.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 06-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion; No Adverse event; 3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). No concomitant medication information was provided.  No vaccines in this lot have been administered since the temperature excursion. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter. US-MODERNATX, INC.-MOD-2022-654336:same reporter.
she had very high fever 102.3F; chills; extreme body aches; fatigue, Still feeling fatigue.; woke up with night sweats,her bed sheets, pillows, linen and hair completely soaked with sweats; arm hurt,really sore after both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (woke up with night sweats,her bed sheets, pillows, linen and hair completely soaked with sweats), VACCINATION SITE PAIN (arm hurt,really sore after both vaccines), PYREXIA (she had very high fever 102.3F), CHILLS (chills) and MYALGIA (extreme body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, THYROID (ARMOUR THYROID) for an unknown indication.   On 31-Dec-2020 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (arm hurt,really sore after both vaccines). On 30-Jan-2021, the patient experienced NIGHT SWEATS (woke up with night sweats,her bed sheets, pillows, linen and hair completely soaked with sweats). On an unknown date, the patient experienced PYREXIA (she had very high fever 102.3F) and CHILLS (chills). an unknown date, the patient experienced MYALGIA (extreme body aches) and FATIGUE (fatigue, Still feeling fatigue.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg three times a day. At the time of the report, NIGHT SWEATS (woke up with night sweats,her bed sheets, pillows, linen and hair completely soaked with sweats), VACCINATION SITE PAIN (arm hurt,really sore after both vaccines), PYREXIA (she had very high fever 102.3F), CHILLS (chills), MYALGIA (extreme body aches) and FATIGUE (fatigue, Still feeling fatigue.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-019200, MOD-2021-019200 (Patient Link).
On November 12, 2022, I woke up with a very mild sore throat.  I tested on the 13th, and it was positive for COVID-19.  I didn't have any symptoms for a couple of days.  I tried to go to urgent care on the 13th, but they were too busy.  The following day I went to another urgent care with minor sore throat with a little bit of cough.    I saw a physician's assistant.  She gave me Paxlovid prescription.  Also, a lidocaine to gargle for sore throat.  My throat became severely sore.  I had fatigue.  I took OTC cold medications.  After about 5 days, I was better except for a bit of fatigue and a bit of "fog".
pt returned to clinic 30MAY97 for hep B#2 & told attending RN that had onset of body rash w/pruritus 1wk p/vax;started w/patch on rt arm & spread over body w/some blisters that lasted 1 1/2wk;no SOB;no chest pains;no med care obtained;
This spontaneous report as received from a Registered Nurse refers to a 0 day old neonate female patient. On 20-MAY-2014 at 3:00 AM the patient was vaccinated on a public clinic with public founds with an improperly stored of RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse symptoms reported. The storage temperature of RECOMBIVAX HB was between 0 and 1 degrees, on 18 different episodes between 14-MAY-2014 and 21-JUL-2014. The registered nurse reported that it was no possible to identify how long the temperatures were down because it was not documented accordingly, since all recorded temperatures by morning and by night were within 2 and 8 degrees. It was reported that the vaccine was removed once the problem was identified and it had not been used after 21-JUL-2014. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
The day after the vaccine, I had flu like symptoms. Fever of 101, body aches, chills, and fatigue that lasted for 2 days. I then started to develop headaches. The headaches comes and goes but I do have them everyday. The headaches continue to the present. It feels like a sinus headache with lots of pressure. My doctor prescribed Augmentin for 14 days. which did not help. I was referred to an ENT, the doctor put a camera scope up my nose and did not see anything like an infection or anything for a concern. I was sent for a CT Scan of my sinus which came back fine and then was referred to a neurologist. I had an MRI to rule out a brain tumor and a MRA to rule out an aneurysm. I then had a 3rd MRI which I have not gotten the results back yet. I was prescribed Nurtec for the headaches, steroids, and Flexeril for a muscle relaxer.
This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: food allergy, pollen allergy, and sensitivity to medicines, and allergy to certain insects. The patient reported she had no drug allergies but she did not want the Moderna or Pfizer vaccine due to the PEG content.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A expiry: Unknown) dose was not reported, 01 total, administered on 30-JUL-2021 at left arm for prophylactic vaccination.  On 30-JUL-2021, around midnight,  the patient felt like her tongue tasted salty. On 31-JUL-2021, the patient experienced tiredness. On 14-AUG-2021, 2 weeks later, the patient was advised to go to ER (Emergency room) by someone from JNJ for a bruise on right arm even though injection was in left arm (dose number in series 1). At the hospital (ER) the patient had blood test and all was normal. Laboratory  tests included APTT (NR: not provided) Not reported, Basic metabolic panel (NR: not provided) Not reported, Blood test (NR: not provided) Normal, CBC (NR: not provided) Not reported, INR (NR: not provided) Not reported, Prothrombin time (NR: not provided) Not reported.  The patient recovered from tiredness on 31-JUL-2021, tongue tasted salty on 07-AUG-2021 and bruise in right arm on 18-AUG-2021 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: Unknown) dose was not reported, 01 total, administered on 10-DEC-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-DEC-2021, in the morning, the patient experienced salty taste on tongue. On 20-Dec-2021, the patient experienced same sensation again (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue tasted salty (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20211245128.
PATIENT SHOULD RECEIVE FULL DOSE OF 0.5 ML SINCE IT IS 1ST DOSE . PATIENT WAS ADMINISTERED BOOSTER DOSE OF 0.25 ML INSTEAD.
Information has been received from a nurse concerning a 61 year old female who on 11-SEP-2007 was vaccinated IM in the left arm with a dose of PNEUMOVAX.  One day post vaccination on 12-SEP-2007 the patient experienced an adverse reaction.  The patient was in the physician's office, her left arm was red, swollen 6 to 8 centimeter area at the injection site.  The physician thought it might be an allergic reaction, no cellulitis, no treatment.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
swollen lymph node, neck.  Prior to this flu shot, I never had adverse event to Flu shot, I have gotten flu shot every year for years.
Very tired; Very low energy; This case was reported by a consumer and described the occurrence of fatigue in a 69-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue and energy decreased. On an unknown date, the outcome of the fatigue and energy decreased were unknown.   It was unknown if the reporter considered the fatigue and energy decreased to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient had a flu shot about 2 weeks ago from the date of reporting and a pneumonia shot a couple days after that. But symptoms occurred at the time of reporting and lasted 3 or 4 days. This case linked with US2019AMR189658, reported by same reporter for the same patient.
Most Bothersome is "brain fogginess " for 12 days.  Others - fever - 1 day ; myalgia, fatigue, malaise
Arm shows redness and bruising spots; Arm shows redness and bruising spots; I have experienced a bad reaction after my Covid-19 Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm shows redness and bruising spots and experienced a bad reaction after covid-19 pfizer vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
chills; nausea; vomiting; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches). At the time of the report, CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was provided by reporter.  Patient reported that 1 day in bed and muscle aches. He said this symptoms lasted 3 days.  No treatment medication was provided by reporter.
Woke up with strong shivers, hard jawquivering; 103 degree fever; extreme muscle fatigue; Slept a full day; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non pregnant female patient received the unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, lot no: unknown) via unspecified route of administration on 27Mar2021 at 14:30 (at the age of 23-years-old) as a Dose number Unknown, Single for COVID-19 immunization. The medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, at 03:00, the patient had woken up with strong shivers, hard jaw quivering, 103-degree fever, extreme muscle fatigue and had slept a full day. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The patient underwent lab tests and procedures that included Body temperature of 103 degree. The clinical outcome of the events shivers, hard jaw quivering, fever, muscle fatigue and sleepy were recovered/resolved on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added; 2. 103 degree fever added as lab data.
Pt had a milder side effect with the first Moderna injection with muscle cramping and sinus congestion within 2 hours that did not require treatment.  She took Benadryl 25mg and Zyrtec 10mg PO prior to the 2nd inj at 08:30.  At 09:30 she developed some chest tightness and the sensation of her throat swelling.  An IV HL was inserted and she was given Solumedrol 125mg IVP, Benadryl 25mg IVP and Famotidine 20mg IVP along with NS 250ml IV.  Pt had resolution of symptoms within 30 mins.  Pt was DC'd to home after monitoring of 2 hours.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 25-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 25-JUN-2016, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's spouse forwarned RPH that patient passes out after each and every injection; patient did faint but was responsive; he did recover after about 5 mins. RPH contacted to inform them of the inicident as well.
Patient woke up at night with swollen ears, red cheeks, swelling face -> ER (night of immunization). In the ER, she was treated with steroids, BENADRYL and EPIPEN for allergy.
Covid vaccine documentation: PT admitted 12/12/21.  POC SARS COV2 ANTIGEN POS 12/12/21. PT documented to have been admitted and discharged 12/14/21 from another hospital for covid-19 pneumonia. Pt required oxygen at that time and was and was discharged on oral steroids. PT currently admitted. Pfizer dose 1 8/25/21 Lot EW0179. Pfizer dose 2 9/15/21 Lot EW0167.
Patient received vaccine 12/28/20. On 1/2/21, patient develop large, sore, red splotchy area around site of injection. Area itched. As of today 1/4/21, are larger - Patient will be seen by provider to determine if cellulitis and further treatment necessary.
Flushed, all over body rash with hives, burning sensation, all over itching, tingling of face, lips. Wheezing. Fever 101.5 all over joint and muscle pain.