chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu Like Symptoms; got really sick; fever after each dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like Symptoms), ILLNESS (got really sick) and PYREXIA (fever after each dose) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like Symptoms), ILLNESS (got really sick) and PYREXIA (fever after each dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu Like Symptoms), ILLNESS (got really sick) and PYREXIA (fever after each dose) outcome was unknown.            No Concomitant informations were reported.  No Treatment informations were reported.   This case was linked to MOD-2021-406558, MOD-2021-406820, MOD-2021-406558 (Patient Link).
She was diagnosed with pneumonia after receiving PREVNAR 13. Already finished two antibiotics, still not better. Also complain about lower body temp.
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. this is on of several reports received from the same source. Additional information has been requested.
Almost 4 hours after the vaccination, the patient called complaining of extreme arm pain, shivering, and nausea. She was having some difficulty breathing but did not have an anaphylactic reaction. There was no swelling or redness around the injection site.
MODERNA COVID-19 VACCINE EUA  Rapid Heart, Dizziness, Unbalance, Wheezing, Lower Intestinal Bleeding, Constipation, Irritability
Administered vaccine. Pt looked pale and began to fall forward. Placed pt lying down on exam table with legs extended after 3-4 seconds. Received medical attention from Dr. after 2-3 seconds. HR dropped to 40-45 BPM after 5-7 seconds. HR normal and breathing normal after 10-15 seconds. Pt alert and responding the whole incident. Pt offered lollipop and PEDIALYTE with no problems. After 5 minutes pt sitting up. After 10 mins, pt left office.
Felt tired; Like she was catching a cold; This is a spontaneous report from a contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 09May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. On an unknown date in May2021, the patient felt tired and like she was catching a cold. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events felt tired and like she was catching a cold was unknown at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Extreme lethargy, vomiting, bloody bowel movement occurred less than 24 hours, post vax.
Chills, body aches, and temperature of 100.2 beginning the evening on 1/23/21. All resolved by morning on 1/24/21.
Pain, swelling, and redness at injection site. With time, pain and soreness of shoulder increased and has not completley resolved, even now, almost 4 months later.
losing clumps of hair/hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing clumps of hair/hair loss) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (losing clumps of hair/hair loss). At the time of the report, ALOPECIA (losing clumps of hair/hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
High fever sudden onset extreme weakness dizziness headache cough still fever 103.7 Monday after urgent care Sunday states RXN to shot.
26 y/o male admitted for ascending neuromuscular weakness with CSF remarkable for albuminocytologic dissociation, and EMG c/w Acute inflammatory demyelinating polyradiculoneuropathy (AIDP).  He recieved his final dose of the Anthrax vaccine on 7 Jan 2013.  He developed progressive ascending paresthesias around 1/16/2013. He would go on to have ascending neuromuscular weakness and was admitted to Medical Center on 20 Jan 2013. EMG and CSF were c/w the diagnosis of AIDP. He has no recent history of infection, and is undergoing infectious workup at this time.  He also recieved the influenza vaccine on 2 Oct 2012.  He is currently being treated with IVIG and is doing well clinically.
The patient did not experience any adverse event during or aftere the injection; Patient who received a dose of MMRII on 06-JAN-2021 and it was realized later that the dose he received had expired 24-OCT-2020; This spontaneous report was received from a pharmacist concerning a 21 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.      On 06-JAN-2021, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (expired product administered) for prophylaxis ( lot # R030812 had been determined to be a valid lot number measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 24-OCT-2020) (strength, dose, route of administration and anatomical location were not provided).  No adverse event reported.
Information has been received from a consumer concerning a female who was vaccinated with GARDASIL (Lot # not provided).  After receiving GARDASIL, the patient got sick and was hospitalized.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.
This case was reported by a health professional and described the occurrence of limb swelling in a 15 month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date in May 2003, the patient received Infanrix. Subsequently, the patient experienced hugely abnormal limb swelling. The patient was seen by the physician. As of 5/15/03, the event persisted. The reporter considered the event was possibly related to vaccination with Infanrix.
The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 11-Feb-2023 and was initially stored in refrigerator on 16-FEB-2023).    No concomitant medication was reported.   Date the vial was initially stored in the refrigerator 1 vial on 16-FEB-.2023. The vial did not undergo any temperature excursions.The case involved combination of first dose and some 2nd primary doses. No treatment information was reported.    This case is reported for patient 1 of 6. .   This case was linked to US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715551, US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715545:Patient 02 US-MODERNATX, INC.-MOD-2023-715550:patient 03 US-MODERNATX, INC.-MOD-2023-715549:patient 04 US-MODERNATX, INC.-MOD-2023-715551:patient 05 US-MODERNATX, INC.-MOD-2023-715548:Patient 06
On 12/19 when I got my vaccine at 5:00 pm. When I woke up tingling feeling fingers, feet, face and scalp of head. The following morning I notice a rash around my hairline. I called my associate health was informed to take Benadryl multiple times throughout the day and was prescribed Ativan. The itching is still occurring in my scalp of the head and feet. I dint have to miss any days of work.
MMR #1 given 13Feb2015. On 24 Feb pt developed blood fr. nasopharynx "coughed up blood", also nausea, decreased focus and migraine and a lump under chin, seen in urgent care on 25 Feb pt had fever 102 intermittent until about 27 Feb and rash over trunk, extremities. 3 and 4 March pt reports flare up of rash.
extremely tired; cant focus; cant work due to slow response time and confusion; arm went numb and cold; arm went numb and cold; Chest pains; blacked out 15 minutes after shot; Dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EW-196 and expiration date was not reported), via an unspecified route of administration, administered in Left Arm on 17Jul2021 at 14:30(at the age of 50-years-old) at dose 1, single for COVID-19 immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not have any other medications in two weeks. Patient had no allergies to medications, food or other products; was not diagnosed with COVID-19 prior vaccination and since the vaccination, patient had not tested for covid-19. The patient experienced dizzy, vertigo and blacked out 15 minutes after shot on 17Jul2021at 14:45. Two days later the vaccination(19Jul2021), patient's arm went numb and cold and this would come and go, had the chest pains where the heart was. 3 days after shot patient felt extremely tired, cant focus, cant work due to slow response time and confusion. This has been ongoing since day 3 and now on day 7 (at the time of report). The patient had most recent COVID-19 vaccine at Pharmacy or Drug Store. Patient was given Ibuprofen to resolve the chest pains and unspecified treatment was given for the events. The outcome of the events (tired, cant focus, cant work due to slow response time and confusion) was not recovered where as outcome of ret of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning the 8 year old daughter of a physician who on 3/20/97 was vaccinated SC with a dose of varicella virus vaccine live (lot #621201/0082E). The RN reported that on 7/12/04, the physician diagnosed her daughter with varicella characterized by more than 100 lesions with itching, but no fever. The patient was treated with Acyclovir (400mg, 1.5 tablet QID) and diphenhydramine HCl. Subsequently, the patient recovered from the varicella. Additional information is not expected.
think I have shingles; 'pharmacy' never had second one; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine over 6 months ago and never had second one. The reporter asked would missing second shot make getting shingles more likely. The patient did not want to go physician office due to Covid 19.
Chest pain, fever (102.7), dizziness, exaggerated body pain, metallic taste in mouth, not able to walk, not able to stay awake for more than a few minutes, swollen lymph nodes under armpits on right arm
recurrent blood blisters; Skin Irritation; Pruritus; Dermatitis; recurrent rash/breakout; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (recurrent blood blisters), SKIN IRRITATION (Skin Irritation), PRURITUS (Pruritus), DERMATITIS (Dermatitis) and RASH (recurrent rash/breakout) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tobacco user in 1979. Concurrent medical conditions included Alcoholism since 1979, Penicillin allergy (MANIFESTED BY HIVES AND ANAPHYLACTIC SHOCK), Drug hypersensitivity (MANIFESTED BY HIVES AND RED RASH ON INJECTION SITE), Drug hypersensitivity (Plaquenil), Drug hypersensitivity (Cymbalta allergy, MANIFESTED BY MORE PAIN, A LOT OF SWELLING) and Drug hypersensitivity (Kevzara allergy, MANIFESTED BY HIVES AND RED RASH ON INJECTION SITE). Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), DULOXETINE HYDROCHLORIDE (CYMBALTA), SARILUMAB (KEVZARA), ADALIMUMAB (HUMIRA) and ETANERCEPT (ENBREL) for an unknown indication.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (recurrent blood blisters), SKIN IRRITATION (Skin Irritation), PRURITUS (Pruritus), DERMATITIS (Dermatitis) and RASH (recurrent rash/breakout). The patient was treated with BETAMETHASONE (intramuscular) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, BLOOD BLISTER (recurrent blood blisters) and RASH (recurrent rash/breakout) had resolved, SKIN IRRITATION (Skin Irritation) outcome was unknown and PRURITUS (Pruritus) and DERMATITIS (Dermatitis) had not resolved.            The patient had skin irritation and wondered if it was from using RINVOQ. Patient stopped taking RINVOQ because it took couple of months to get approved and secure supplies for RINVOQ. When the patient started taking RINVO, the skin became darker and the symptoms returned on a regular basis. HCP considered it as dermatitis. During the call, patient was not willing to give the concomitant medication. Before at least one symptom happened, the patient received Covid-19 vaccination and considered as co-suspect product. The expiration date of the covid-19 vaccination was not mentioned in the vaccination card. It was unclear whether the patient enrolled in covid-19 vaccination trial.   This case was linked to MOD-2021-185939, MOD-2021-185939 (Patient Link).
Patient received an expired dose of Engerix B today; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number 97LJ2, expiry date 27th February 2021) for prophylaxis.   On 23rd April 2021, the patient received Engerix B. On 23rd April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: All patient identifiers were reported as well as batch number and expiration date. The pharmacist reported that the patient was vaccinated with dose of Engerix B which was already expired on 27th February 2021. No further clarifications. The reporter consented to follow up.
Following administration of vax, the pt became clumsy and difficult to console. Pt improved spontaneously and recovered. No further information is available.
Initial unsolicited report received from a nurse via other company Pfizer (Manufacturer Report Number: 2017399532) on 07 Nov 2017. This case involves a 16-year-old male patient who was vaccinated with 0.5 ml dose of MENACTRA (expiry date: 17-Mar-2018) at right deltoid and TRUMENBA (expiry date: 31-Jan-2019) at left deltoid via intramuscular route (batch number, dose in series were not reported for both the vaccines) both on 22-Jun-2017 at 18:25 hours. Patient's medical history included scoliosis started on 24-Jun-2015. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of vaccinations. On 22-Jun-2017 at 18:28 hours, 3 minutes after the administration of the vaccination, the patient experienced syncope. It was reported that patient fell from exam table, experienced loss of consciousness, loss unconsciousness, head injury, increased lip and arm or shoulder pain. The patient was referred to emergency department. Patient was previously vaccinated with first dose of MENACTRA on 19-Jul-2012. Lab data included on 22-Jun-2017, neurological exam, CT scan of head, X-ray of left shoulder and EKG were performed, and results were negative. Corrective treatments were not reported. It was reported that patient was advised for reevaluation of vital signs. The events outcome were recovered for all the events on 22-Jun-2017. Follow up information received from a nurse via other company Pfizer on 09-Jan-2018. Patient received 0.5 ml dose of MENACTRA and TRUMENBA intramuscularly and Batch were reported as G7LSL2, U5514AC respectively. MENACTRA was given in right arm. Patient was not hospitalized. It was reported that patient was not deceased. List of documents held by sender: none.
My major symptom was severe and underlying severe dizziness. It lasted for four solid days and it lingered on and off for about three more weeks. The first four days left me non-functioning. It was hard to get out of bed and even move. The entire room was spinning, I've never had vertigo like that.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 04-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916228, 20210916455, 20210916312, 20210916553, 20210916697, 20210915661, 20210916658, 20210915748, 20210916300, 20210915719, 20210917226, 20210916965, 20210916959, 20210915646, 20210917160, 20210916808, 20210915623, 20210916715, 20210917163, 20210916907, 20210916768, 20210917515 and 20210915852.
At 3:30pm after receiving vaccine patient began to notice itching of both arms and anterior of neck.  Said she felt like she had something in had a lump in throat.  She was given Benadryl 25mg tablet, orally and a ice pack placed on injection site due to complaint of pain in arm.  BP was 118/80, pulse 80, respirations 16.  She was alert, skin was pink, warm to touch and dry.   10 minutes later hives started to subside, BP was 116/72, pulse 68, respirations 16, skin was warm, pink and dry.  4:15pm left clinic site being driven by mother - no itching, no lump i throat, redness resolved.
Horrible headache lasting 6 days; Sore arm; Chills; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 (Lot number: FA7484) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Horrible headache lasting 6 days"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm"; CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "Nausea". Therapeutic measures were not taken as a result of headache, pain in extremity, chills, nausea.  Additional information: No known allergies. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Left hand pins and needles, left leg nerve pain. Left breast pain and bump. Fatigue for 3 months.  Left hand pins and needles has not resolved.
Case previously recorded as MA2009-4219. Initial case report received from a nurse, via Novartis Medical Communication on 11 NOV 2009. A patient under 4 year-old was vaccinated with 0.25 ml of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008010.