chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood sugar has been running high; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood sugar has been running high) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar has been running high). At the time of the report, HYPERGLYCAEMIA (Blood sugar has been running high) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood glucose: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 25-JUN-2021 included no new information.
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
Background info: about 25 years ago I had a classic case of shingles.  I subsequently received two courses of shingles vaccines, the single vaccine and the more recent double vaccine.  About a week after I received the booster COVID vaccine, I broke out on my upper back shoulder and around the top of my right shoulder.  At first I thought it was an allergic reaction to something else but didn't know what it could be.  Over the next week, the rash traveled across my back in a straight line. I took one leftover Valtrex pill that calmed the breakout and it was then I thought it could be a Shingles breakout.  I scheduled a visit with my PCP.  She had not seen any research on a relationship between the COVID vaccine.
FLUZONE QUADRIVALENT vaccine that was given in error with No reported adverse event; Initial information regarding an unsolicited valid non-serious case from United states was received from other health professional via call centre General medical inquiry inbound (reference number-00791319) and transmitted to Sanofi on 29-Sep-2021.  This case involved a 67-year old female patient when received fluzone quadrivalent vaccine that was given in error with no reported adverse event (Wrong product administered) while receiving vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] and influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing immunosuppression.  On 28-Sep-2021, the patient received a 0.5 ml of suspect influenza quadrival a-b vaccine (lot number not reported and expiry date-30-Jun-2022) via intramuscular route in the deltoid not otherwise specified for prophylactic vaccination.  On an unknown date, the patient received an of suspect influenza quadrival a-b high dose hv vaccine (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 28-Sep-2021, 1 day following the administration of influenza quadrival a-b vaccine the patient developed a non-serious event "fluzone quadrivalent vaccine that was given in error with no reported adverse event" (Wrong product administered).  It was reported "HCP (health care professional) states that a patient, over 65, who is immunosuppressed, requested a fluzone high dose quadrivalent vaccine, however the HCP accidentally pulled the flu vaccine from the wrong box and gave the fluzone quadrivalent vaccine instead. The HCP asks if she can give the patient a fluzone high dose quadrivalent vaccine in addition to the fluzone quadrivalent vaccine since she is over 65 and is immunosuppressed".  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event wrong product administered.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.  No further information was provided.
Pt developed headache, fever (8 hrs later), chills, nausea, pain at the injection site, and a splotchy, macular rash (23 hrs later) on bilateral forearms.
Headache, body aches, muscle aches, fever, fatigue, starting 24 hour after injection of the mRNA and lasting 2-3 days. Diarrhea on day 3. However, the headache, fatigue and muscle aches lasted 6-7 days. At that point, she began to develop pitting edema in both ankles and legs, this was worst on day 8-9 and is slightly improved, but still noticeable 2 weeks later. Also, left arm soreness for 3 days at the site.
Left arm pain lasting 2+ weeks. Left elbow pain and stiffness and left hand digits numbness and tingling.
A nurse reported that a 63 year old female received Pnu-Imune 23 and Fluzone vaccines on 11/13/00. Within 24 hours, post vax, the pt developed vomiting, general myalgia and alternating feelings of hot and cold. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration, were not specified. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 469133).
Patient was hospitalized on 10/20/2022 for Covid, shortness of breath.
pt recvd vax & had t 103.2 x 4 days; had a maculo papular rash on face, neck, extending to trunk, back over 24 hrs; localized induration & erythema at time of inject; tx w/ apap;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) positive, notes: Tested positive first time on 31Dec2022; (09Jan2023) positive, notes: tested positive again on 09Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sudden hearing loss both ears. High-frequency hearing loss in both ears. Tinnitus high pitch ringing in both ears.
Had all the reactions symptom just keeps going to get worse; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold). At the time of the report, VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  On Friday night at 5 o'clock patient got the Moderna booster and  by 2 AM patient  had all the reactions symptoms. It was reported that patient  took an home test (unspecified test)  and it was negative.
Case previously recorded as MA2009-6460. Initial case report received via Med Com from a health care professional on 30 NOV 2009. A 2-year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 1013263P) on 30 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008898.
Pt presents to EMS with a complaint of feeling a lump in her throat after receiving her first dose of Pfizer vaccine, pt states she thinks her throat is closing up. Pt has a past medical history of anemia, only known allergies are to mushrooms which give her hives. Pt states she has never received a vaccine before and does not take any medication at home. She was taken into hallway with her daughter who also received her first vaccine today as well. Pt was given a bottle of water and was asked to see if she had any difficulty swallowing, pt swallowed water but states she finds it difficult. Upon assessment no swelling or hives noted. Lung sounds were clear, no wheezing noted. Pt continued to talk to paramedics without any difficulty. Pt in no acute distress at this time. Vitals were obtained: BP-123/81 SPO2 -100%  HR-94 RR-14 After 5 minutes of observation pt states she feels better and is able to swallow water without any difficulty. No airway compromise noted, pt continues to speak without difficulty. Vitals reassessed: BP- 119/75 SPO2-100%  HR-71 RR-14 Heart rate dropped and pt seemed to be more calm. Lungs sounds are still clear. Pt went back into main arena to finish observation time.
GBS- pt developed Guillain-Barre Synd p/receiving Tetanus Toxoid Adsorbed (manfacturer unknown).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 11-MAR-2014 at 10:00, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26/; Jan 09, 36/22; Jan 11, 26/40/; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17,26/20. This is one of several reports received from the same source. Additional information is not expected.
Headache - centralized at front of head, from temples to forehead; no treatment taken; resolved after a nap; lasted about 4 hours
Moderna bivalent vaccine was administered after a temperture excursion; No adverse event; Moderna bivalent vaccine was administered as dose 1; Moderna bivalent vaccine was administered after a temperture excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Patient didn't had any known allergies.  Concurrent medical conditions included Hypertension.    On 04-Oct-2022 at 3:56 PM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Oct-2022 at 3:56 PM, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1) and POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1), POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna bivalent vaccine was administered after a temperture excursion), WRONG PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered as dose 1) and POOR QUALITY PRODUCT ADMINISTERED (Moderna bivalent vaccine was administered after a temperture excursion).    It was unknown if the patient had ever been diagnosed or tested positive for Covid-19. Acute illness at the time of vaccination and up to one month before was unknown. No concomitant medication was reported.  It was reported that Moderna bivalent vaccine was administered after a temperature excursion. Patient did not reported any adverse events.   No treatment information was provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-680467 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-680467:same reporter
Redness at the injection site had spread from the injection site down the arm to near the elbow; Arm soreness; pain at injection site; shivering; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and shivering. On 7th September 2019, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the injection site pain, erythema of extremities, shivering and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, erythema of extremities, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose one of Shingrix and experienced injection site pain.  The patient also reports shivering and arm soreness.   The patient reported that one day after, the redness at the injection site had spread from the injection site down the arm to near the elbow. The reporter had consented to follow up.
Pt alert and coherent. Anxiety reaction, resulted in asthma attack, slight wheezing  Described that she felt like she got anxious and started having an asthma attack. Patient treatment:  2:35pm  BP: 140/92, Pulse OX 100%, 92 pulse, treatment given Albuterol HFA 90mg, pt. own Famotidine 10 mg, lowered BP pulse improved 2:40 pm BP: 136/86, 72 pulse -Treatment given: Benadryl 25 mg - as prophylaxes, pt. monitored for 1 hr. after no symptoms, then went home with instructions to call 911 if anything else occurred 5:00 pm follow up, patient at home, no symptoms Pt primary prescriber contacted with hour of monitoring, and agree patient could be released home.
Patient's husband awakened patient from seizure like activity and sweats day after vaccination.  Since then, patient has cough, body aches, fatigue to the point that she remains unable to return to work
12/07/2021: admitted from nursing home with low oxygen saturation, altered mental status, positive for COVID x 6 days, health has been declining over the last 5 days. Pt received 2 doses of Pfizer COVID-19 vaccines (on 3/2/21 and 3/30/21) 12/08/2021: treated with vancomycin for bacteremia. Consulted with nephrologist for AKI  12/11/2021: Patient's HR and oxygen levels started dropping 10-15 minutes into dialysis. Not respond to code. Patient was put on comfort care and pronounced deceased at 1206
Night sweats; Elevated d-dimer; rapid heart rate of 120; lab tests showed elevated reactive protein; chest pain when she inhaled; Chills; Fever; feeling achy; sore arm after the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 19th October 2021, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On 20th October 2021, the patient experienced pain. On 21st October 2021, the patient experienced chest pain, chills and fever. On an unknown date, the patient experienced night sweat, fibrin d dimer increased, heart rate increased and c-reactive protein increased. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and heart rate increased were recovered/resolved and the outcome of the night sweat, chills and fever were not recovered/not resolved and the outcome of the fibrin d dimer increased, c-reactive protein increased, chest pain and pain were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the night sweat, fibrin d dimer increased, heart rate increased, c-reactive protein increased, chest pain, chills, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix in her left deltoid intramuscularly and experienced sore arm after the injection which was resolved.  One day after the vaccine, she reported feeling achy (unknown if currently resolved). Two days after the vaccine, she reported chest pain when she inhaled (unknown if resolved), and a fever for which she went to the doctor.  The physician sent her to the emergency room twice over the course of the past 2 weeks (dates unknown) due to chest pain, fever, chills, and rapid heart rate of 120.  Patient reported that her lab tests showed elevated reactive protein and elevated d-dimer (exact date and lab value unknown).  CT scan, chest x-ray, blood tests, and EKG performed on the patient were all normal (dates performed unknown).  Patient's cardiologist had told her that her heart appeared normal but the doctor ordered and echocardiogram once her fever was resolved.  Patient currently reported her elevated heart rate had resolved, but that she still had fever and night sweats which were unresolved and the patient reported taking Tylenol and Ibuprofen for symptom relief. Patient did not have lot or expiration date of vaccine given. The reporter consented to follow up.
This spontaneous case report was received from a pharmacist (PVX2019-332) on 05-Feb-2019. The report describes a 27-year-old male consumer who "had a sandwich after taking Vaxchora". The consumer was receiving Vaxchora for an unknown indication. It was reported that the consumer had a sandwich about half an hour after taking VAXCHORA. The action taken with VAXCHORA with respect to the event "had a sandwich after taking VAXCHORA" was not applicable. The clinical outcome of the event "had a sandwich after taking VAXCHORA" was unknown. Company's Comment: The causality of the event "had a sandwich after taking VAXCHORA" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "had a sandwich after taking VAXCHORA" was considered as not applicable.
Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. On 13th June 2022, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: This case was self reported by patient. The patient received first dose of Shingrix at noon and in evening the patient developed a headache which had not resolved till the time of reporting.  The reporter provided medical advise disclaimer and referred to HCP (health care professional).  The reporter provided information per PI (package insert) on adverse reactions. The reporter consented to follow up.
Pressure headache behind both ears. Began 8AM 2-14-2021. Began taking UP and UP brand of Acetaminophen gelcaps 500mg, took 2, every 4 hours . Continued throughout the day  on Sunday.  Monday 2-15-2021, headache still present along with being nauseaous throughout the day.  Continued taking Acetaminophen every 4 hours Tuesday 2-16-2021, headache down to dull but present throught the day. continuted Acetaminophen, every 4 hours Wednesday 2-17-2021 headache was dull, began taking EQUALINE brand of Ibuprofen200mg. took 2 every 4 hours through out the day. Thursday 2-18-2021 headache cam on around 9:30am.  Took Acetaminophen every 4 hours. Headache still present at time of my filling out this form
I started feeling tired and I had postnasal drip. I started getting more of a runny nose and being tired. Then I developed a fever of around 100 as well as chills. I completed an at home COVID-19 test which was positive. I went to the clinic and was prescribed an anti-virials to shorten the symptoms. I took them for 3 days I felt better. It took about 8 to 9 days to be symptom free. I have another cough now along with another sinus infection. I am not sure whether having COVID-19 is making me more susceptible to sinus infections which I had not had in years prior.
Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.