chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received only the liquidcomponent of Menveo; received only the liquid component of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquidcomponent of Menveo) and inappropriate dose of vaccine administered (Verbatim: received only the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter was a medical assistant. The reporter consented to follow up. The reporter reported that a patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: hot at administration site-Medium
The week of getting my second vaccine I noticed my heart rate was at times up to 115 bpm. The day after I received the vaccine I was very tired feeling, my left arm very sore, and I noticed my heart rate was staying higher. At one point at work my heart rate went up to 140 bpm. I went to the doctor after work and was diagnosed with sinus tachycardia. I was prescribed metoprolol for tachycardia. I do not know what caused my heart rate to increase, but the metoprolol has my rate controlled now. I felt the fatigue lasted about 3-4 days and then I was back to normal.
Slight fever (99.3-99.5 degrees); headache, nausea/gagging, whole body aches/ very fatigued for approximately 24-36 hours.  Took ibuprofen, and slept it off.
This spontaneous report was received from a consumer referring herself as a 68 year old female patient. The patient's concurrent conditions included elevated cholesterol. The patient was allergic to peanuts and flower. The patient's concomitant medication included pravastatin (manufacturer unknown). On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, once) (lot # N024385 and expiration date: 18-05-2019) intramuscularly at left arm as pneumonia vaccination. On 01-MAR-2018, patient received less than a full dose of PNEUMOVAX 23 and reported that patient was unsure how much vaccine patient received because patient left arm felt wet (accidental underdose, accidental exposure to product and exposure via skin contact) after receiving dose of PNEUMOVAX 23. It was also reported that, patient experienced unspecified soreness at injection site in left arm (injection site pain). The patient did not seek any medical attention and did not receive any treatment for the events. The outcome of the event injection site pain was reported as recovering. The reporter did not provide the causal relationship for the event injection site pain with suspect therapy PNEUMOVAX 23. No product quality complaint was involved.
Severe neck and left shoulder pain. I used pain meds and heating pad but pain has persisted still today 11/4/2013.  Pain moving my head and neck. Difficult to sleep with pain. Could this be due to flu shot.  I read a comment from a person that they experienced the same symptoms.
My period started the 2nd of April, the morning following my second vaccine. I had a 10 day cycle that was the heaviest cycle that I have ever experienced. Since that cycle, I have not had another period. it has been 95 days.
sharp radiating pain left arm, face, neck swollen,redness,naseau, rapid heart beat, dizziness, tinitus,anxiety, hives, headache, slurred speech, hard to move, felt faint, body pain, swollen lymphnodes, , naseau
Mom states pt cried screaming unconsolable all noc long the 2nd noc p/vax recvd;
PATIENT REPORTED SIGNIFICANT LOCAL REACTION THAT INCLUDED REDNESS THAT HAD THE LIKENESS OF A SUNBURN ACROSS HER UPPER ARM (NOT JUST IN SITE OF ADMINISTRATION). IT FELT AS THOUGH IT WAS SWOLLEN OR BLISTED LIKE A SUNBURN BUT DID NOT ACTUALLY BLISTER (FLUID FILLED SACS). SHE STATES THAT THERE WAS HEAT TO THE TOUGH AS WELL. IT ENDED UP BRUISING AS WELL. SHE REPORTS THAT THE ARM WAS VERY VERY SORE, MUCH MORE THOUGH THAT ANTICIPATED. SHE SAID IT MADE THE ARM DIFFICULT TO USE. THESE SYMPTOMS LASTED ABOUT A WEEK. SHE HAD NO SYSTEMIC SYMTOMS.
Intense pain in left arm (can't lift it); Groggy; This is a spontaneous report received from a contactable reporter (consumer) from a sales representative. The reporter is the patient.  A male patient in his 40's received bnt162b2 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: had previously contracted covid. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Intense pain in left arm (can't lift it)"; SOMNOLENCE (non-serious), outcome "unknown", described as "Groggy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant concerning a 71-year-old female who was vaccinated with a dose of ZOSTAVAX (lot# 657558/0461U). On an unspecified date the patient developed an injection site welt with no rash. Unspecified medical attention was sought. The outcome is not reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
improperly stored doses of varivax was administered to one patient; no adverse event; This spontaneous report was received from an administrator, refers to a patient of unknown age. The patient's medical history and concurrent conditions were unknown.  On 11-JUN-2019, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (frequency unknown) lot # R018931, expiry: 02-JUL-2020, subcutaneous for prophylaxis.  The sterile diluent (DILUENT MRK INJ), that was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No adverse effect reported. Product quality complaints was not involved.  Temperature or Time frame:   -14-degree C to -10-degree C (-13. 8C) for 6 hours and 38 minutes  -50-degree C to -15-degree C (-14.8C) for 4 minutes  Previous temperature excursion:  -50-degree C to -15-degree C (-14. 7 C) for 7 minutes  -14-degree C to -10-degree C (-13.1 C) for 1 hour and 22 minutes  The report was because of a data logger.  This is one of two reports received from the same reporter.
Patient was inadvertently given the 1/2 dose (third shot booster) too early.  Patient had stated the previous dose had be over 6 months ago but administrator realized after dose was given that only 114 days had passed since the second dose was administered.  Patient did not have immunocompromising qualifications for early administration. Patient was informed of the early administration and advised of likely adverse reactions.  Patient reported nothing other than a sore arm (as with previous doses) when called for follow-up then next morning
about 36 hours after injection, injection site area is red and swollen and warm to touch. swollen area seems to be increasing in size and is also painful
Initial unsolicited report received from a pharmacist on 24 August 2015. This case involves a 42 years female patient who got exposed to vaccine due to nasal aspiration of Typhim VI (batch number not applicable) on 22 August 2015. The patient's medical history and concomitant medications were not reported. Patient previous medication includes Thyroid medications. It was a case of occupational exposure via inhalation of product due to needle issue as the needle came loose from the syringe, and she aspirated some of the vaccine while administering it to another patient. On 22 August 2015, same day following the exposure, the patient experienced burning in her nose and could smell the vaccine. No other symptoms reported. Lab data and corrective treatments were not reported. It was reported that the event lasted in few minutes. List of documents held by sender: none.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A child patient of an unspecified ethnicity and gender received the first dose of TRUMENBA (lot number L13514, expiration date Jul2016), via an unspecified route of administration at single dose on 08Dec2015. The patient medical history and concomitant medications were not reported. On 10Dec2015, the patient experienced headache, dizziness, flu like symptoms. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Additional Details: Patient ate a bowl of ceral and heart medication prior to taking the 3rd moderna booster shot.  She had a flu shot on tuesday 11/16/21.  The 1st and 2nd moderna shot was fine and normal.
STARTED GETTING HEADACHE ON THE WAY FROM DAUGHTERS; BECAME SOB; PASSED OUT 3-4 TIMES WHILE @ HOME; BEGAN CHILLS & FREEZING; BECAME VERY WEAK, DIARRHEA; AMBULANCE TO ER VISIT TO LOCAL HOSPITAL; AIRLIFTED TO HOSPITAL WHERE SHE WAS  HOSPITALIZED FROM 10/29/2010 UNTIL 10/31/2010."
Extreme pain in bicep, shoulder, and armpit of injected arm.  (Could not raise arm above shoulder level)., Temperature 99.9, fever, chills, fatigue.
PT SAYS THEY WOKE UP AT 3am with a red face after receiving the flu shot that night. Took benadryl and redness went away.
No adverse event; vial was initially stored in the refrigerator was 04-Jun-2022 and administered on 15-Jul-2022; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator was 04-Jun-2022 and administered on 15-Jul-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator was 04-Jun-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator was 04-Jun-2022 and administered on 15-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator was 04-Jun-2022 and administered on 15-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
While in observation area, patient stated she "felt funny" and skin was pale. Patient was with her father. Patient reported to feeling fearful about getting the vaccine. Patient was given a snack and ice pack was given to father to place on the back of the neck of the patient. Patient waited in observation for 30 minutes. At the end of the 30 minutes, patient stated she was feeling better. No other symptoms were noted and patient left with father after the 30 minute wait. Prior to leaving, father was instructed to seek medical attention for patient if she displayed any signs of adverse reaction.
ANAPHYLAXIS: Pt received his second Moderna COVID19 shot on 12Apr2021 at approximately 2:30pm. He waited the required 20 minutes to check for any adverse reaction and then left the facility to drive home. On his drive home, at approximately 3:30pm, he started feeling light headed and lost consciousness, striking a telephone pole. He was gasping and struggling to breathe, so the ambulance treated him with oxygen. When he arrived at the ER , the doctor assessed his condition and confirmed that he was experiencing an anaphylactic reaction related to the COVID vaccine and treated him with an epinephrine injection, steroids, benadryl, and nebulized albuterol.to open his airways. He remained at the ER for ~ 6 hours for observation until his blood oxygen levels increased and he was stable to be released. The car accident resulted in PT suffering a fractured sternum as confirmed via Chest CT Scan by his primary doctor. PT has no history of any allergic reaction to any medication or vaccine. Although he does have well-regulated asthma, this incident was not characteristic of any asthma-related reaction he has ever experienced.
Began feeling weak 2 hours after vaccine administration.  Awoke 4:00 a.m. (13.5 hours after vaccination) with left numbness and weakness and assumed normal side effects.  Re-awoke at 8:30 a.m. with clear signs of neurologic issues and called nurse and was taken immediately to ER Hospital Center. DX: Acute right pontine CVA with associated left-side numbness with upper and lower extremity weakness, gait imbalance & slurred speech. Hospitalized 4/29 - 5/2/21.  Discharge to home with PT/OT visits scheduled.
allergic reaction; swollen lips with hives within 4 hours; swollen lips with hives within 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), LIP SWELLING (swollen lips with hives within 4 hours) and URTICARIA (swollen lips with hives within 4 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), LIP SWELLING (swollen lips with hives within 4 hours) and URTICARIA (swollen lips with hives within 4 hours). At the time of the report, HYPERSENSITIVITY (allergic reaction), LIP SWELLING (swollen lips with hives within 4 hours) and URTICARIA (swollen lips with hives within 4 hours) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
PT BECAME DIZZY, LIGHT HEADED AND SLEEPY IMMEDIATELY AFTER RECEIVING THE MODERNA VACCINE.  OBSERVED HER FOR 30 MINUTES AND SHE WAS STILL DIZZY AND SLEEPY OBSERVED FOR ANOTHER 15 MINUTES AND NOW HAD SEVERE HEADACHE AND STILL SLEEPY.  AFTER ANOTHER 15 MINUTES SOME OF THE FATIGUE HAD LIFTED BUT STILL HAD  HEADACHE BUT FELT WELL ENOUGH TO LEAVE AND GO HOME.
Received pneumococcal vaccine in office on 5/15/09. Calls office on 5/17/09 and is seen in Urgent Care. Experiencing redness Lt deltoid, warmth reported with pain L shoulder to hand, (+) nausea, lethargy, dry heaves diarrhea.
tightness in chest, wheezing 4hrs p/vax; no local rxn;seen in ER & treated w/EP & released; sxs reoccurred & was adm to hosp 31OCT95;stable & expected d/c 3NOV95
A month after the second dose and 2 days before my mensural cycle I collapsed on  the floor of my kitchen.    The pain was so bad that I was throwing up.
C/O CHEST PAIN, SOB, DIZZINESS, SELF-ADMINISTERED ALBUTEROL INHALER. REPORTED HAVING SIMILAR SYMPTOMS WITH FIRST DOSE OF MODERNA. PARAMEDIC CAME, WAS GIVEN WATER, NITRO SPRAY, WAS TRANSPORTED TO HOSPITAL
This spontaneous prospective pregnancy report was received from a health professional refers to a 40 year old female patient. Patient's pertinent medical history and drug reactions were not reported. Patient was reported to be 34 weeks pregnant. The patient became pregnant with LMP of 08-JUL-2014 and EDD of 14-APR-2015. On 09-MAR-2015 the patient received a dose of GARDASIL (lot # K011492, expiry date: 22-JUN-2016), in error. Concomitant medications were not reported. The patient was prescribed to receive a Tdap vaccine on an unspecified date. The health professional stated that the error was not due to medication confusion, the error was human error. No adverse effect has been reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of pertussis in a patient who received DTaP vaccine for prophylaxis. Concomitant products included DTaP vaccine. On an unknown date, the patient received the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown. It was unknown if the reporter considered the pertussis to be related to DTaP vaccine. Additional details were provided as follows: The patient received DTap vaccine at 2 and 4 months old and came down with polymerase chain reaction (PCR) confirmed pertussis. Lab Comments: On an unknown date, the polymerase chain reaction (PCR) was performed and it confirmed Pertussis.
Pt vaccinated /w MMR felt dizzy BP dropping 60/40, pt was admitted to hosp. received IV fluids. Pt was stabilized.
Booster dose administered prior to the recommended interval. Nurse practitioner notified.  Vitals within normal limits, O2 sat 97%. . He c/o headache and body ache. Acetaminophen 650mg administered, instructed minor to apply a cold compress to injection site. Minor was made aware and verbalized understanding, educated about possible side effects and to notify health office if any signs and symptoms arise.
Mother stated that child complaining of body aching and has blotchy areas on arms and buttocks, no fever noted. Kept child home from school. No complains of nausea, vomiting or difficulty breathing.
Information has been received from a newspaper which indicated that a mother reported that her 16 year old daughter who 3 years ago (in November 2008), was vaccinated with GARDASIL vaccine (dose and lot # not reported). Subsequently the patient had been debilitated by headache, pains and seizure brought on by the vaccine and could no longer attend school.
Within 5 minutes of receiving the vaccine, the end of my tongue began to tingle and feel numb. I felt some hot sensations down my left leg. Then my throat began to feel itchy and irritated. I could still breathe and swallow so I did not alert the pharmacy staff. I took a Benadryl allergy pill and went home. The tongue and throat irritation continued into the night but seemed to be better the next day. Since then, however, I continue to have tongue and throat irritation on a daily basis. The severity can change but the irritation hasn't gone away. My tongue feels like I licked a bad-tasting stamp. My throat isn't sore, it's more of an internal itch/irritation, like how I imagine it would be to have Poison Ivy in my throat. I take Benadryl daily for run-of-the-mill allergies from pollen, hay fever, etc. It's not having an effect. I feel like I want cold, frozen items to soothe my throat.  I have not yet seen my family doctor about this, but I may do so if the symptoms worsen or I can no longer tolerate them -- or I become concerned about getting my second dose scheduled for April 10.
The patient complains of soreness at injection site.  Redness and swelling is also noted. The patient was encouraged to apply a cool pack and alternate with heat. The patient was also encouraged to call MD if symptoms worsen or decreased mobility in limbs. 12/26/00 the patient called and the symptoms subsided, no further problems.
p/vax pt's head would drop back, eyes rolled back, arms & legs w/spastic movements; took to MD on 1JUN94;
Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Previous doses were from Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (Allergic to Ceclor).  On 10-Sep-2022, 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 12-Sep-2022, the patient experienced COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid 19 after receiving The Moderna Covid 19 bivalent vaccine) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2022, SARS-CoV-1 test: (Positive) Positive.    Concomitant medication were Thyroid medication and statins. Patient stated that she had leg ache, so she decided to take a test and it became positive.   This case was linked to MOD-2022-650981 (Patient Link).
it still hurts/ pain in the right side of her body and her right leg hurt; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026LZ0A and 026220A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc. Concurrent medical conditions included Pre-diabetic, Cholesterol and Penicillin allergy. Concomitant products included METFORMIN for Pre-diabetic.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Steroid pills since 5Feb up to 10Feb2021.  Concomitant medication includes cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: contains information about patient demographics and allergies of patient  was added and event outcome were updated