chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIGHTNESS OF THROAT; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no known allergies, not on any chronic medications and is not allergic to any medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced allergic reaction. On APR-2021, the subject experienced tightness of throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and tightness of throat was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Inappropriate schedule of vaccine; Headache; Nausea; Low grade fever; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced headache, nausea and low grade fever. On 22nd October 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the headache, nausea, low grade fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the headache, nausea and low grade fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the medical assistant. On 10th Se0tember 2019, the patient received 1st dose of Shingrix. The patient was inadvertently received a 2nd dose of Shingrix, which was earlier than recommended schedule, which led to shortening of the vaccination schedule. The reporter consented to follow up.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN, start date: 01May2018. Past drug history included: Keflex, reaction(s): "Drug hypersensitivity". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID treatment).
strong reaction to dose 1 , including vomiting; nausea; Reaction ( as if digestive virus) lasted several days.; Because of the covid 19 restrictions & concerns, I am not getting second shot in earliest timeframe.; This case was reported by a consumer via call center representative and described the occurrence of vomiting 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, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vomiting, nausea, stomach virus and social problem. On an unknown date, the outcome of the vomiting, nausea and social problem were unknown and the outcome of the stomach virus was recovered/resolved.   It was unknown if the reporter considered the vomiting, nausea and stomach virus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after 1st dose experienced vomiting, nausea and reaction as if digestive virus. The patient because of the covid 19 restrictions & concerns was not getting second shot in earliest timeframe.  The patient asked how far apart can have the 2 doses and have it effective.
Moderna Covid 19 Vaccine received 1/20/2021. On 1/29/21 patient noticed palm sized, flat,  reddened area near injection site. Reports it is not painful, but is slightly tender when touched, and she can feel a small knot under her skin.  Patient to contact her PCP office.
admitted thru the ED with congestion, fatigue and rhinorrhea  as well Fatigue, decreased appetite, dehydration
April 21, 2021  Study Result Narrative Procedure: Duplex ultrasound examination of the lower extremity veins was performed using 2D imaging with color and spectral Doppler.  General: 21 year old female presents for right LE venous duplex to rule out DVT. Pt complains of right posterior calf pain x3 days.  Right: Abnormal right LE venous duplex reveals evidence of acute partial deep venous obstruction involving one of the paired peroneal veins from mid to upper calf level without extension into the popliteal vein at this time.  Conclusions: Acute deep venous thrombosis in a right peroneal vein from mid to upper calf level without extension into the popliteal vein at this time.
the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023; No adverse event; Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 02-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Depression, Hypothyroidism and Gastrointestinal disorder (some stomach acidity).    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 09-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that one of their staff inadvertently administered a bivalent booster dose which was past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the fridge was on 04Feb2023 and the date of administration was 09Mar2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  It was reported that the only other vaccination record they have is that the patient had Pfizer on, not indicated which dose this was. No treatment information was provided by the reporter.
sleeping 10 hours a night; right arm is still very sore; has very poor appetite; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 21Oct2021 13:45 (lot number: 320308D; expiry date: unknown) at the age of 73-years-old, as dose 3 (BOOSTER), single for Covid-19 immunization. The patient had no relevant medical history and family history and was not taking concomitant medications. She had no change in medications, no change in nutritional intake and no significant change in nutritional intake. Patient does not smoke. There were no changes in medical conditions or her health and no exposure to anything. The vaccine was administered in a pharmacy grocery store. The patient previously received 1st dose BNT162B2 on 31Mar2021 (lot number: EP7533) and the 2nd dose on 21Apr2021 (lot number: EN6204) both administered in the right arm for COVID-19 immunization. After the 1st dose she had absolutely no side effects and may have slept well that night and then after the 2nd dose she had nothing regarding no side effects. The patient did not receive other vaccines on the same date as BNT162B2. The patient previously received influenza vaccine (FLUZONE) for immunisation. She had the flu shot for seniors 3 weeks before the 3rd dose of the Pfizer COVID Vaccine and the flu shot was Fluzone HD 65 plus and has the lot number on it of PF2021-22 injection 0.7mL with NDC 49281-0121-65 and it was administered on 28Sep2021. She had received flu shots for many years and never had any side effects from any vaccine or from the flu shots. Patient stated that she had her 3rd dose on 21Oct2021 which was last Thursday, and her right arm was still very sore. She was still sleeping 10 hours a night and only getting up one time and still has very poor appetite. She does not have nausea and does not have fever but still has the sore arm and was still sleeping which was very nice but thought she should do her part and report this. Her arm soreness was a little better and was in her right arm where all three doses of the Pfizer COVID vaccines were administered. She got the 3rd dose of the vaccine at 1:45pm or 1:50pm and by 6:00pm at night was when she started noticing the poor appetite and it was a little better today. The events did not require emergency room and Physician's Office visit. Outcome of the event sleeping 10 hours a night was not recovered, while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATIOND DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/22.
My menstruation came after the vaccine even though I already had it and it?s lasted 2 weeks which is highly unusual, I only spot for 3-4 days. I have also had sharp pains in my left and right temples that come and go.
Severe rash and hives over torsso legs and arms. Dr prescribed Prednisone 5 MG quantity 168 over 40 days.  Patient had Guillain Barre syndrome in 1988.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0622A22) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Nov-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave Moderna Spikevax 6-11 vaccine to a 10-year-old girl 4 days past the expiration date).    Concomitant product use was not provided by the reporter.  On 28-Nov-2022 at 09:00 am, nurse administered expired moderna 6-11 years of age covid vaccine to a 10 year old.  Treatment information was not provided.
back pain unbearable took me to hospital; major life stress/cried screamed couldn't function more stress; one sore on finger worst experience; lost use if left arm and hand; my hand still stiff; Crying; Screaming; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain (serious criteria hospitalization), stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming. On an unknown date, the outcome of the back pain, stress, skin ulcer and mobility decreased were recovered/resolved and the outcome of the limbs stiffness was not recovered/not resolved and the outcome of the crying and screaming were unknown.   It was unknown if the reporter considered the back pain, stress, skin ulcer, mobility decreased, limbs stiffness, crying and screaming to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Patient had 2 shots, and had stress back pain unbearable, which made patient for hospitalization for few days. Patient had one sore on finger lasted six months, also had lost use left arm and hand. Patient cried screamed due to could not function more stress in hand and stiffness. Additional supportive information: Note: It was unknown after which dose number patient experienced events so only one suspect kept with blank dose number.; Sender's Comments:  US-GSK-US2022AMR151161:same reporter
We just received notification 11-15 that she had experienced an adverse reaction she stated her arm at injection site swelled and she has been going to physical therapy since.
On 01/20/2002 the pt felt feverish with right side pain. On 01/24/2002 the pt developed rash sternum right side to back followed nerve path and on 01/28/2002 shingles was diagnosed.
Onset of symptoms reportedly a few days after vaccination.  Patient was hospitalized on 10/18/2009.  Final diagnosis given as atypical Guillain-Barre syndrome.  11/4/09 PCP medical records received service date 9/22/09. Assessment: Diabetes Mellitus Type II with Neurological Manifestations. Hyperlipidemia. Benigh Essention Hypertension. Chronic Obstructive Pulmonary Disease. Lumbar region disc disorder. Patient presents with high blood pressure and back pain. C/O numbness and paresthesias in left hand, wrist, and forearm. Exertional dyspnea. pedal edema.  11/5/09 Hospital records and discharge summary received. Service dates 10/18/09 to 10/24/09. Assessment: Atypical Guillan Barre versus aseptic basilar meningitis. Right ankle fracture. Debilitation.  Patient transferred to this facility with atypical neuropathies. Had fall due to neuropathy resulting in ankle fracture on the right. Bilateral 7th nerve palsies and 6th nerve palsy on the left. Difficulty swallowing. Diplopia.  IVIG administered.
soreness at injection site; tired; tummy confusion; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (Family History) (Father), blister (Family History) (Father), scab (Family History) (Father) and shingles (Family History) (father).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, tiredness and upset stomach. On an unknown date, the outcome of the injection site pain, tiredness and upset stomach were unknown.   It was unknown if the reporter considered the injection site pain, tiredness and upset stomach to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient recently did the series of two injections.  After receiving 1st dose of Shingle vaccine, the patient was tired afterwards, had soreness at injection site and felt a bit of tummy confusion. For tolerance in 2nd dose refer case US2021AMR227228. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227228:same patient same reporter
Fatigue and headache the 1st day. Abdominal  pain, Nausea and vomiting , headache and fatigue the 2nd day.  3rd day fatigue and muscle aches. 4th still having fatigue.
After a few hours, broke out in an itchy rash, felt pressure in the chest and back of the throat. broke out in hives
I felt a tender lump in my armpit in the shower on April 21. This is the same arm I received the vaccine. The lump is still tender and sore today.
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, CHILLS Narrative:
0.2mls of the 10mcg/0.2mls 0.1mls of the 30mcg/0.3mls
Elevated heart bit 137bpm; oxygen level went down (90%); Typical pain arm (L injection); Body ache; Extreme fatigue; Joint pain; Fever (101°F is significant for her, because she typically has 96-97°F); Chills; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Elevated heart bit 137bpm), OXYGEN SATURATION DECREASED (oxygen level went down (90%)), VACCINATION SITE PAIN (Typical pain arm (L injection)), MYALGIA (Body ache) and FATIGUE (Extreme fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), THIAMPHENICOL (IGRALIN) and ETHAMBUTOL DIHYDROCHLORIDE (ATB) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Typical pain arm (L injection)), MYALGIA (Body ache), FATIGUE (Extreme fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever (101°F is significant for her, because she typically has 96-97°F)), CHILLS (Chills) and HEADACHE (Headache). On 28-Feb-2021, the patient experienced TACHYCARDIA (Elevated heart bit 137bpm) and OXYGEN SATURATION DECREASED (oxygen level went down (90%)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Elevated heart bit 137bpm), OXYGEN SATURATION DECREASED (oxygen level went down (90%)), VACCINATION SITE PAIN (Typical pain arm (L injection)), MYALGIA (Body ache), FATIGUE (Extreme fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever (101°F is significant for her, because she typically has 96-97°F)), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101 f (High) High. On 28-Feb-2021, Heart rate: 137 bpm (High) High. On 28-Feb-2021, Oxygen saturation: 90 % (Low) Low.     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.   Other concomitant medications included admix, sibotal 40 mg, immune deficiency medications (H2 and H2 peptide).
Client verbalized facial drooping.  Client was evaluated by onsite paramedic.  Client's symptoms resolved within 10 minutes.  Client was transported to medical Clinic for further evaluation at 1:38 pm.
after about 5 to 6 minutes, pt was seated in waiting area and became rigid seizurelike.  Pharmacist immediate went to aid to make sure did not fall to floor from chair.  Seizure lasted about 10-15 seconds. Patient was diaphoretic and was pale. He regained consciousness within 15 seconds. Was able to answer questions and alert.  Waited about 5 minutes he ask for water & I gave  about 4 ounces of water.  kept him seated in waiting area for another 5 minutes then moved to a sofa in adjacent room . he was evaluated for about 30-45 minutes. was hungry had not eaten all day.  remembered he had a similar  reaction when blood was taken.  I offered to call ambulance various times he stated no. After about 45 minutes he stated he was feeling fine and wished to go.  Patient seemed in good shape. Told him to please make the reaction known to health care practitioner administering second shot.  He will return in 28 days to receive second shot  in 28 days.
rt thigh w/12cm x 8 cm erythema surrounding inject site 2 days p/vax; also circumference of rt leg 2cm> than lt; onset of erythema 8 hrs p/vax; 27JUL94 pt w/dec ambulation & mobility;
pt c/o pain @ vax site, immed p/vax;next day c/o pain, tenderness & stiffness in arm;4mo later mom noticed bruising & a 1 1/2" by 1" wide indentation 1/8" depth;the bruise was purple in color;
Extreme fussiness, fever 101 F, lethargic. A follow up report received 6/6/2002 adds: Continued 24 hours. Tylenol given.
Severe chills, severe muscle aches, and low grade fever about 8 hours after. Severe headache the next morning. Chills, fever and muscle aches 2nd night.
Back ache, blister on Lt side of upper outside of lip, sneezing, dried blood in nose. 3 pox like blisters on Rt side of face.
Chest congestion & coughing (mainly subsided w/i 2 wks); reocurring rash (for about 3 wks); & swelling/sores in nose.
The following  appeared at 3am - 12 hours after the vaccine was administered. Lasted for 24 hours Fever of 100.7° Headache Body aches Fatigue The following appeared 36 hours after vaccination: Rash at injection site currently still present
2 large welts around bicep to armpit-100.4 fever-severe pain-24 hours after shot
Patient described left arm as hurting and then soon after passed out with tensed body and eye shaking. Patient would not wake up for a few minutes even after braking an Ammonia Inhalant under nose.