chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Under treatment for this illness). Concomitant products included AMLODIPINE and DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) for an unknown indication.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVD-19 Vaccine from 5 vials that where stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received unspecified COVID-19 vaccines, first and second dose on 04 May 2021 and 06 Jun 2021 respectively. Vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022.No temperature excursions occurred. No treatment medication were provided.   This case was linked to MOD-2022-475781 (Patient Link).
MCV4 and flu vaccines administered on 10-21-14 and patient started with redness, swelling and pain to injection site within 24 hrs.
Patient said the night of the day she received her second dose of the Moderna vaccine and spiked a fever of 105 which could not be brought down with an ice bath or Nyquil. She also has inflammation and redness on the arm around the injection which swelled and has not since gone down.
January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.
Patient broke out in a rash which developed into blisters.  Patient was seen in the ER multiple times and was referred to a burn center
Blood pressure went up to 180/90 and has been high since first detected.  Lifelong BP has been 120/70.
EMT observer reports that client states she was "feeling dizzy." EMT assisted client to zero-gravity chair and assessed her pulse to be 75 BPM and BP 138/80. Client stated sitting in chair made her "feel better." EMT observed her for approx. 10 more minutes. EMT offered and client accepted a water bottle. She was informed to contact her physican if symptoms persis or worsen and to call 911 for any emergency. This summary is based on report written by EMT observer
Donor reported that he rode the bus approximately 30 minutes after leaving the center and started feeling hot. Donor states he then lost consciousness for approximately 10-15 seconds. Donor states when he regained consciousness, he drank a bottle of water and felt better.
pt developed red, painful area on her arm a few inches below injection site.  The redness and swelling has gone away, but the pain has not.  She still cannot fully lift her arm over her head.
joint pain which started in the knee then shoulder and hands; left knee lock; This is a spontaneous report from a Pfizer Sponsored Program . A contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received Pfizer Covid-19 vaccine first dose last 20Mar2021 and she experienced joint pain which started in the knee then shoulder and hands on an unknown date in Mar2021. The next morning, she experienced left knee lock. Her 2nd dose will be on 10Apr2021 and she wanted to know if she needed to delay the appointment for the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Employee received her 3rd hepatitis shot in right deltoid experienced hives on anterior right shoulder, pain, and redness. Employee took 25mg of BENADRYL at the time of adverse event and drank Gatorade. She began to have difficulty breathing and took a puff of her PRO-AIR inhaler.  She has been advised to seek medical attention from the nearest ER. Currently stable.
patient reported sudden non-purulent bumps on left foot and right heel starting approximately may 24th. she then noticed dumps on right hand and thumb underneath the nail. patient reports they are painful and non-pruritic. reported to pharmacy at 6/2/21. referred to primary care provider.
This case was reported by a consumer via call center representative and described the occurrence of slowing of urinary stream in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included PREVENAR 13 for prophylaxis. In October 2018, the patient received SHINGRIX and PREVENAR 13. In October 2018, less than a month after receiving SHINGRIX, the patient experienced slowing of urinary stream and micturition disorder. On an unknown date, the outcome of the slowing of urinary stream and micturition disorder were unknown. It was unknown if the reporter considered the slowing of urinary stream and micturition disorder to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received both the SHINGRIX and PREVENAR 13 vaccine on the same day last week. The patient presented slow stream, problems urinating side effect. The normal side effects passed but not this. The reporter wanted to know was this a known side effect.
Pt. had vaccine on 7/31/09 in late afternoon. Pt. then started with fever and had febrile seizure early 8/1/2009.  9/4/09 Received ER records of 8/1/2009. FINAL DX: seizure following immunizations Records reveal patient experienced irritability & fever 100.3.  Had tonic-clonic seizure activity x 5 min followed by crying & normal behavior.  Tx w/antipyretics & d/c to home w/PCP f/u.  Tx w/phenobarbital per labs done 8/30/09.  9/17/09 Hospital records received DOS 8/9/09 to 8/11/09. Assesment: Partial Seizures with secondary generalization. Patient presented after having 3 seizures today. Arm curled up, twitching, eyes, fixed, eyelids twitching. Unresponsive. Flexed tonic posturing. Clonic jerking of extremities. Discharged, had another seizure and brought back to hospital. Shoulder hypotonia. Tachycardia  ICD-9 Codes: 345.50 Localization related epilepsy and epileptic syndrome with simple partial seizures without intractable epilepsy.  9/18/09 Neurological consult DOS 8/29/09. Assessment: Focal and secondary generalized seizures. Neurological exam - normal.
AFTER 1ST DOSE(HEPTAVAX-B 11-8-89) PT EXP FLU-LIKE SYMPTS,JOINT PAIN,ACHES,FEVER,NAUSEA,VOMITING.PHYS FELT IT THE FLU.1ST DOSE ENGERIX-B 2-9-90,PT FELT TIRED.2-10-90 PT HAD JOINT PAIN,SWOLLEN ANKLES/WRISTS,RASH,AND PREVIOUS SYMPTS.ABATE SYM
liquid came out the needle during administration and the patient was administered less than the recommended dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th November 2022) for prophylaxis.   On 14th June 2021, the patient received Shingrix. On 14th June 2021, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The reporter stated that Shingrix liquid came out of the needle during administration and the patient was administered less than the recommended dose which led to underdose. The reporter did not consent to follow up.  Note-As the exact significant amount of dose missed was not mentioned, event underdose was coded conservatively.
pt c/o pain lt arm since pt recvd vax; there is no edema, red areas or swelling then or now;advised to contact MD & report results back to the clinic
it was rpt by RN p/ recv vax pt exp chickenpox lesions. time unk
she felt her heart was pounding and became short of breath for 2 minutes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (she felt her heart was pounding and became short of breath for 2 minutes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (she felt her heart was pounding and became short of breath for 2 minutes). On 22-Feb-2021, DYSPNOEA (she felt her heart was pounding and became short of breath for 2 minutes) had resolved. Not Provided      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.   Reporter did not allow further contact
nausea, myalgia, arthralgia, dizziness, h/a, chills, & diarrhea p/the 1st dose of vax; f/u 12NOV92 recovered;
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an emergency medical technician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:54 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the second booster dose.  Vaccines went into 2-8 degree Celsius thaw state on or about 24 Dec 2021.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
I95.9 HYPOTENSION 8/8/2022 ANEMIA DUE TO BLOOD LOSS J96.00 ACUTE RESPIRATORY FAILURE 7/12/2022 ANEMIA DUE TO BLOOD LOSS I95.9 HYPOTENSION 8/8/2022 HX OF INTRACEREBRAL HEMORRHAGE J96.00 ACUTE RESPIRATORY FAILURE 7/12/2022 HX OF INTRACEREBRAL HEMORRHAGE
Fever, chills, muscle contractions in lower back and stomach for two days. Loss of appetite, lower back pain. My urine was deep orange in color and bowel movements were very loose (not formed). Extreme fatigue for almost 8 full days before I felt any sense of feeling normal.
COVID-19 vaccine dose was not diluted, resulting in patient receiving twice the recommended dose. No significant side effects or adverse events have been noted by the parent. The patient received the 2nd dose on 4/29/2022.
Information has been received from a nurse practitioner referring to 9 patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. Between May 2015 to September 2015 the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L002214, expiration date: 21-JAN-2017, lot # L011082, expiration date 01-APR-2017/07-NOV-2017 (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 05-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Blister at Injection Site; Redness at Injection Site; Swelling at Injection Site; Itching at Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site). In February 2021, VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-052966.   Reporter did not allow further contact
Information has been received from a medical assistant concerning a 22 year old female patient with no pertinent medical history and no known allergies who on 20-MAR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661952/1129X). On 21-MAY-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number reported as 664608/1312Y, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23 (MSD). On 07-JAN-2010 the patient was vaccinated IM with an incomplete dose of GARDASIL (lot number reported as 662968/0229Y, invalid for GARDASIL, but is a valid lot number for VARIVAX (Merck) (MSD) and experienced pain during administration. The medical assistant stated that she encountered some resistance with the plunger of the syringe during administration. When she withdrew the needle less than a 1/4 of the dose spilled at the site of injection. There was no concomitant medication. Unspecified medical attention was sought. There were no lab studies performed. On 07-JAN-2009, the patient had recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. On 8th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, weakness, rash, facial swelling, generalized rash and hives. On an unknown date, the outcome of the shivering, weakness, rash, facial swelling, generalized rash and hives were recovered/resolved. It was unknown if the reporter considered the shivering, weakness, rash, facial swelling, generalized rash and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shivering, weakness, rash on her left torso and some face swelling which resolved within 2 to 3 days. The patient reported that since the shot she seems to be having more cases of rash and hives on her body which resolved within a day. The reporter consented to follow up.
Patient received moderna covid vaccine that was past the BUD. BUD was labeled for 0411 and patient received dose at 1117. No symptoms or adverse event reported.
This case was reported by a healthcare professional and described the occurrence of insomnia in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 03 January 2008, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced insomnia. According to the reporter, the subject was referred to a sleep specialist. At the time of reporting the event was unresolved.
Low grade fever, headache, sore throat, body aches, chest tightness, fatigue
Pt received pneumo 11/9/02. On 11/10/02 noc pt had swelling with bruising from R shoulder to R elbow-went to hospital-given Levaquin 500mg qd x 6d.
MenA Lyophilized Conjugate Compound was diluted with sterile diluent INSTEAD of the accompanying vial of MenCYWLiquid Conjugate Component
approx 1 hr p/vax inj site became reddened & sl swollen;ice was applied to area;pt cried non-stop for 2hrs-no temp
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 01-DEC-2015 at time- 09:20, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.6 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (company representative) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 2021(about three months prior to this report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, after vaccination, the patient got coronavirus infection a month ago prior to this report for two weeks (suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint-90000179462. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210523713-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. 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
He had gotten out of bed in morning, used bathroom, walked down 15 stairs to kitchen area. Felt dizzy sensation in head. As his face went pale gray, he put palm of left hand on forehead and said, "Is my face turning white?" Felt faint. Was standing - father and I grabbed him and walked him to tall stool to sit. I propped him against me so he wouldn't fall off chair. Blank, distant stare in eyes, "life" out of eyes, whites of eyes big, pupils small, no blinking. Unresponsive for several seconds. I had him try to take small sip of water. Waited a few seconds. Another few sips. Dad brought him to kitchen table and sat him down. We prepared oatmeal, and he continued small sips of water. Color came back into face, and he ate oatmeal. Was fine after breakfast. Throughout day, no more syncope episodes. Just fatigue and some chills.
11/10/2006 and 11/11/2006(Dose 2): Mild headache, overall achy feeling, bloating, mild nausea; 11/12/2006, 11/13/2006(Dose 3) and 11/14/2006: Bad heartburn, flatulence, aches, mild headache; 11/15/2006(Dose 4): diarrhea, lethargy and sleepiness; 11/16/2006: sleepiness; 11/17/2006: feel normal.
Information has been received from a physician concerning a 4 month old patient, who on 14-AUG-2007 was vaccinated PO with the second 2.0 mL dose of RotaTeq vaccine. Concomitant vaccinations administered "at the same time included other 4 month vaccinations. " Subsequently the patient developed diarrhea for 10 days. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
About 2 weeks after receiving flu shot I developed a rash over my trunk (front & back) & underarm area which was diagnosed as "lichen planus".
Patient Immediately developed small rash and swelling at the site of injection.  Swelling and rash was evaluated by provider and dissipated and was gone in 15 minutes.
Patient experienced "Covid arm" the morning after the vaccine was administered. Condition is still persisting in the form of a red rash that is warm to the touch and tender on the right arm directly below where the shot was administered.