chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of injection site redness in a 42-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  Concurrent medical conditions included allergy to macrolides and sulfa allergy.  On 21 October 2009 in the afternoon, the subject received unspecified dose of FLUARIX (subcutaneous, left arm).  On 21 October 2009, at an unspecified time after vaccination with FLUARIX, the subject experienced injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route.  At the time of reporting injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route were unresolved.  The pharmacist considered injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route were probably related to vaccination with FLUARIX.  The pharmacist reported that the subject was supposed to receive a tuberculosis shot, but instead the subject received FLUARIX via subcutaneous as opposed to intramuscular.  The subject experienced redness and warmth at the injection site.  No further information was provided.
HPV booster shot, was done in left arm, when needle was taken out blood squirt everywhere, was bleeding badly. My son seemed fine after (they didn't even ask to sit for a bit to wait for side effects) we got to the front area, lady at desk gave me a change of address I forgot to finish & my son was behind me at time I started finishing up then I heard a thud, and I turn around and drop everything, my son was already on the floor. I started screaming in panic hollering his name, try to get him up, his eyes rolling back in his head sounding as if he was aspirating! He told me he didn't remember anything after he all of a sudden felt like he was going to vomit and felt dizzy! He couldn't even tell me or grab me, it happened so fast! Doctor let him stay until he was a bit more alert, but still out of it. He couldn't even walk. I asked repeatedly also, which I know he did hit his head! But the lady at desk never told me what she saw happen when he went down so quickly! Oh and as soon as he was able to open his eyes, he had a nosebleed.
Patient received undiluted dose of pfizer vaccine. Followed up with patient and he felt fine, no side effects. Will moniter patient and follow up
arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2021, the patient received Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shots 3 days ago and his/her arm was still sore.
Pt turned 12yo on 11/11/21. On 11/13/21, pt received 10mcg/0.2mL of the Peds Pfizer COVID vaccine intended for 5-11yo (instead of the Pfizer COVID vaccine for 12yo and up). Error was not discovered until she came back to receive her 2nd dose on 12/4/21. For the 2nd dose, pt received the correct 30mcg/0.3mL of Pfizer COVID vaccine for 12yo and up. There is no adverse event that occurred with the pt. This event is reported as an administration error.
ZOSTAVAX administered on 11-10-15 at pharmacy. Few days later - non-specific bumps on both thighs. No pain, not fluid-filled. Last wk noted zoster-like rash on (L) lower abdomen; groups of bumps on lower back and left hip, left lower abdomen and inguinal area.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00616843) and transmitted to Sanofi on 26-May-2021.  This case involves an eight-year-old female patient who received 0.5 mL dose of expired IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 26-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  The reporter was asking what the accuracy of expiration date was and the potential for immunity for this administration.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, 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 the 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.
Right eyelid twitches; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 at 12:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 12:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, at 17:00 the patient experienced right eyelid twitches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right eyelid twitches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This was a Booster shoot. I had been vaccinated with the Moderna last shot on April 6th 2021. I had shot in right arm..but my whole left arm and hand in excruciating pain..still painting as I submit this complaint.  Shoulders hurt..I experienced fever the 1st 24 hrs.
I tested positive for COVID-19 on October 17,2022. I have severe congestion like as if I have a head cold. A little bite of a sore throat but not as bad as the head cold. Lack of an appetite. I do feel like I am recovering since Monday positive results.
admitted to hospital the day after vaccine (6/13) with encephalopathy, found to have seizures, required prolonged hospitalization for persistent encephalopathy after seizure. Hospitalized 11 days, required discharge to advanced care (was at home prior to admission)
Pt with extreme discomfort following inj.  LOC after standing up- approx 10-15 min to fully recover- pt symptoms Hx of LOC with vaccine, but mother has similar Hx.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 36 year old female. Initial information was processed along with additional information on 05-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic hypersomnia, anxiety, environmental allergies, and ceclor allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 at left arm for covid-19 prophylaxis. Age at time of vaccination 34 years old. Concomitant medications included citalopram hydrobromide, fluticasone furoate, guaifenesin, loratadine, modafinil, naproxen sodium, paracetamol, phenylephrine hydrochloride, pseudoephedrine hydrochloride, and saccharomyces boulardii for drug used for unknown indication. The patient additionally received moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route was not reported, batch number: 037F21A expiry: Unknown) dose was not reported, administered on 04-NOV-2021 at left arm for covid-19 prophylaxis. On an unspecified date in AUG-2022, the patient had confirmed covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). The patient received paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 08-AUG-2022 to 12-AUG-2022 for covid-19 infection. From 12-AUG-2022 to 19-AUG-2022, the patient tested negative for covid-19. The patient stopped testing since it had been a week since end of paxlovid and no positive tests. On 20-AUG-2022, the patient had worse cough and thought may be due to covid bronchitis. The cough was with white mucus. On 21-AUG-2022 morning, covid-19 test was performed and found to be positive.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000249247.; Sender's Comments: V0:20220904994-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Headache, CoughWheeze, Diarrhea, FEELING OF THROAT CLOSING WITHIN 8 MIN OF VACCINE SHE BEGAN COUGHING AND HAD FEELING OF THROUGH CLOSING. LASTED A FEW MINUTES. SORE THROAT CAME LATER THAT DAY .NEXT DAY SHE HAD DIARRHEA  ALL DAY AND THIS AM SHE AWOKE WITH A HEADACHE
Shortness of Breath; A spontaneous report  was received from a consumer, concerning herself, an 85-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shortness of breath.   The patient's medical history was not provided. The patient had no concomitant medications.   On 22-Jan-2021 at 02:00PM, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, 1 week after the first shot of the Moderna vaccine the patient experienced shortness of breath. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event shortness of breath was not provided.; Reporter's Comments: This spontaneous report concerns an 85-year-old female patient who experienced the event of shortness of breath 1 week after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown).  No treatment was reported, and outcome is unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine.  Patient is of an advanced age and critical details regarding the patient's medical history is lacking. Main field defaults to possibly related'
Blood clot in urine (black in color) (described it as mucous like and black in color).; Blood in urine (Red in color)(described it as mucous like and black in color).; Aways thirsty; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) (seriousness criterion medically significant), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty). At the time of the report, HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.. No allergy reported. No treatment done. Patient did not inform health care provider yet.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash and "some whelps" on legs, arms, back and abdomen and diarrhea. Itching noted by foster mom. She reports rash worse on left arm. Signs and symptom reported by foster mom - not observed by clinic that administered vaccines. Treated with BENADRYL and given prednisone by urgent care MD.
Flu-like symptoms; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) had resolved.          Concomitant medications were not provided.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-025737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: TCR of Both Doses . patient state that she  had the reported symptoms for about 1.5-2days after each shot, then the symptoms resolved.and she didn't have email for follow up
Mom called and states she has a red bump where shot was given, mild tenderness, no drainage, no fever. Bump persisted was seen in office 06/01/2017, has FROM, no s/s of infection. Reassurance provided.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccine placed in refrigerator on 29 Oct 2021. Vial did not undergo temperature excursion. No adverse event reported.  Treatment medications were not reported.
pain, erythema, extensive limb swelling, ulnar nerve pain with left pinky tingling (pt is anesthesiologist and describes pain as neuropathic) 11/9/2009 Ed records for 10/31/2009. DC Dx reaction to vaccine Patient with c/o's lt shoulder pain, paresthesias, rash and itching at injection site.  Dc'd with Prednisone/Lortab
chest pains- nocturnal awakening: high BP 210/94 Diagnosis: NSTEMI (non-ST elevation myocardial infarction)
Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 10 month old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject's vaccine history included 3 doses of PENTACEL: lot C4081AA received on 06 December 2011, lot C4158AB received on 16 February 2012, and lot C4158AB received on 24 April 2012 (route and site of administration not reported). Approximately 4 months after the last dose, on 07 August 2012, she developed a cough. On 15 August 2012, she developed a paroxysmal cough without a whoop. She also experienced symptoms of apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 14 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 August 2012. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
severe brain fog; trouble navigating thoughts; tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue). At the time of the report, FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU-Event Outcome Updated. TCR Received.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unknown date the patient was vaccinated either with PNEUMOVAX 23, (lot#, route and indication for use were unknown) or PREVNAR, (lot#, route and indication for use were unknown). On an unknown date after receiving the vaccine, the patient experienced rash or her torso, chills and a fever. Laboratory data was unknown. It was unknown if any treatment was provided. The physician instructed the patient to obtain the vaccination record from the pharmacy to confirm the name of the vaccine that she received. The physician reported that as of 28-JUN-2017 the patient was in stable condition; however, the physician did not know the outcome of rash on her torso, fever and chills. It was unknown if the patient would continue to take the unknown vaccine. Additional information has been requested.
Sx began with bil calf pain, admitted on 30-31 Jan and assessed with viral myositis. Sx increased, now with upper extremity weakness, readmitted 06 Feb; pos EMG findings, Increased CSF protein. Received IVIG x4 with Improvement. Assessed with monophasic polyneuropathy with complete recovery by 05 Mar 13.
In April 2023, I took my blood pressure and it read 258/185. Then I took again at several time again home, and it was consistently high for longer than a week. I visited the doctor mid-April. My pressure was high at the doctor as well.
Patient experienced Syncopal episode and fell to floor,  laid patient on back and elevated feet,  with time and hydration fully recovered within 30 minutes
Shoulder pain and limited mobility (extremely limited d/t pain) for 48+ hours now; not quite 72 hours. pt taking high-dose ibuprofen and tylenol and will f/u this week with me if symptoms persist.
Entire head felt swollen; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old male patient received the second dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. EW0175) at single dose, in the left deltoid, on 23Apr2021 at 11:00, at the age of 44 years, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 02Apr2021 at 11:00, received the first dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. ER8737) at single dose, in the left deltoid, for COVID-19 immunisation. After the first dose, since 03Apr2021, the patient experienced severe headache, nausea, no appetite. The patient received treatment from 11Apr2021. Symptoms persist. On an unspecified date, in Jul2021, the patient's entire head felt swollen. Relevant laboratory test included CBC with differential platelet (full blood count) unknown results on 30Apr2021, Helicobacter test (H. Pylori test) negative on 30Apr2021, laboratory test (unspecified): nothing abnormal on 29Apr2021, magnetic resonance imaging (MRI) TBD on 02Aug2021 and metabolic panel unknown results on 30Apr2021. Clinical outcome of the adverse event was unknown at time of this report. The adverse event was assessed non-serious (Medically Significant).  Follow-up attempts completed. No further information expected.