chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tingling in a 65-year-old male patient who received Shingrix (batch number L349E, expiry date 22nd February 2020) for prophylaxis. On 27th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2018, 12 hrs after receiving Shingrix, the patient experienced injection site tingling and injection site erythema. On 27th August 2018, the patient experienced blister and shingles. On an unknown date, the outcome of the injection site tingling, blister, injection site erythema and shingles were not recovered/not resolved. It was unknown if the reporter considered the injection site tingling, blister, injection site erythema and shingles to be related to Shingrix. Additional details were provided as follows: At 14:40 hours, the patient received his Shingrix on left deltoid. The patient developed tingling and redness at the injection site 12 hours later. Three hours later, he developed what appear to be shingles blisters that were big, round and filled with fluid.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, GUANFACINE, APIXABAN (ELIQUIS), VALSARTAN, SIMVASTATIN and FLUOXETINE for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Initial report was received from a patient on 20 September 2011. A 77-year-old female patient (date of birth not reported) had received a FLUZONE HIGH-DOSE (lot number, route and site of administration not reported). In September 2011, following vaccination the patient developed fever, chills, vomiting, chest congestion, unable to swallow, neck pain, arm soreness and shoulder blade pain; stated she has been feeling sick since last "Thursday". However, she had contact her healthcare provider but had declined to see her "today". The patient stated that she is allergic to latex and should have not received the vaccine shot since it "contain latex". The patient had several regular flu vaccines. No further information was available at the time of the report. The patient outcome was not recovered/not resolved.
Patient received an undiluted dose of pediatric Pfizer COVID-19 vaccine. No side effects reported at this time.
Pt was okay immediately after receiving vaccine. She stood in line at the front counter for a water and she passed out approximately 10 to 15 minutes after getting the vaccine. Placed her in chair and gave her a cold water bottle on her neck and a cold popsicle.  She complained that she was very hot and had not eaten since breakfast. The store was very hot and humid inside. We called 911 and she deferred help. She was able to answer the questions from the EMS.
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/17/2023 ADENOCARCINOMA, BODY OF PANCREAS I21.4 ACUTE NON ST ELEVATION MI 1/20/2023 ADENOCARCINOMA, BODY OF PANCREAS I26.99 ACUTE PULMONARY EMBOLISM 1/21/2023 ADENOCARCINOMA, BODY OF PANCREAS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/2/2023 ADENOCARCINOMA, BODY OF PANCREAS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/17/2023 ADENOCARCINOMA, BODY OF PANCREAS I21.4 ACUTE NON ST ELEVATION MI 1/20/2023 ADENOCARCINOMA, BODY OF PANCREAS I26.99 ACUTE PULMONARY EMBOLISM 1/21/2023 ADENOCARCINOMA, BODY OF PANCREAS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/2/2023 ADENOCARCINOMA, BODY OF PANCREAS G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/17/2023 PANCREATIC CANCER, UNSPECIFIED SITE I21.4 ACUTE NON ST ELEVATION MI 1/20/2023 PANCREATIC CANCER, UNSPECIFIED SITE I26.99 ACUTE PULMONARY EMBOLISM 1/21/2023 PANCREATIC CANCER, UNSPECIFIED SITE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/2/2023 PANCREATIC CANCER, UNSPECIFIED SITE G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 1/17/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I21.4 ACUTE NON ST ELEVATION MI 1/20/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I26.99 ACUTE PULMONARY EMBOLISM 1/21/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 2/2/2023 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
I was fatigue, very congested, headache, shortness, and dizziness. I tested positive for COVID-19 at home. I spoke to my doctor, and he said that it would get better and give it time. He recommended that I take over the counters for congestion. In the last couple of weeks some of the dizziness came back.
The day after vaccination, my vision changed. Things began to look shimmery, or static -y.  As though there is a faint shimmer or screen over everything. After my first dose, my vision changed slightly as well, things looked more contrasted and ?flashy.?  In addition, I developed a ringing in my ears. The ringing is not loud, it is faint, but still audible. I did not have either of these symptoms before my second dose.  These symptoms are still present and do not appear to be going away and I am concerned.
Thirst, headache, muscle aches, dizziness, incontinence (urination every 20-30 minutes, all night long), insomnia.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/8/2021 and 2/5/2021. On 10/9/2021 presented to ED with complaints of dyspnea, back pain, chest pain and nausea.  Patient was noted to require high O2 requirements and ultimately required intubation. Echo with findings of acute drop in EF compounded with significant elevation in biomarker's.  Patient given DAPT + Heparin infusion for maximal medical management.  Pt pancultured and negative but developed worsening cardiogenic shock.  Patient maxed out on vasopressors and later developed worsening leukocytosis and fever.  Abx broadened but further progressed into multiple organ failure.  Family elected to transition to full comfort measures.  Patient passed away on 10/15/2021.
On Monday Jan. 10, 2022 at 10 AM, we discovered we added wrong amount of diluent.   0.13 ml was added instead of 1.3 mls. The dose was administered to the patient at 4:07 pm on Friday Jan. 7th, 2022.  Upon informing the error to grandmother on Jan. 10th. 2022, she stated the patient has been doing fine with no symptoms.
Information has been received from a registered nurse concerning a 19 year old female who on an unspecified date was vaccinated intramuscularly with Gardasil (0.5 ml) (Lot # 658094/0524U).  Subsequently, following vaccination, the patient fainted.  Unspecified medical attention was sought. It was noted that the nurces are having patients lay down prior to administration of the vaccine.  The patient subsequently recovered.  The nurse reported that the patient has had no problems since this incident.  Additional information has been requested.  This is one of two reports from the same source.
Entered observation as a "30 minute" Observant, r/t her past vaccine (Pfizer first dose).  States she was dizzy for about 4hrs after 1st vaccination.  Onset 45mins, after 1st vaccination.  Became dizzy around (1710) while in observation.  This nurse and staff assisted pt to bed to lay down in vaccination clinic.  Denies SOB, chest pain, or trouble breathing when asked.  Currently remains laying down on bed @ present time (1720).  Cold compress applied to help alleviate s/s of dizziness.  Still voices s/s of dizziness @ 1730.  This nurse asked pt if she would like to be sent to ER.  Pt voiced she was "ok", and did not want to be sent to ER.  Pt called family @ 1730, r/t having a ride home.  This nurse insisted to pt that she did not need to drive "herself".  Pt, left w/ family @ 1750, voices slight dizziness upon leaving.  Transported via w/c by this nurse w/ family.  Left observation @ 1750.
Nausea, vomiting, diarrhea, fever (100 degrees F). Clear liquids and OTC pain/fever reliever.
There has been no adverse reaction to date.  This dose was given too soon.  Instead of 8 weeks between the 2nd and 3rd dose there was only 4 weeks.  Only symptom experienced was soreness at the site.
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site & exp muscle aches to point could not lift arms;
pt had c/o fever >99.5 muscle pain, severe fatigue, headache, loss of taste & smell. Pt told CNA that today is the first day she hasn't felt horrible and her fever is down to 99.5, still very weak and fatigued.
Bruising on Lower Legs and Arms -   Severe Stinging Sensation on lower legs and arms Swelling on Left Collar Bone
Moderna COVID-19 Vaccine EUA 3/6-chills; 3/7- 102-degree fever,  mild headache; 3/8- queasiness, no more fever; 3/9-dizziness; 3/10-12-lightheadedness; 3/13-sleepy; 3/14-no further side effects  treatment- bed rest, acetaminophen for fever and headache (24 hours)
Fever, pain at injection site, aches, migraine, chills, flu like symptoms, gi discomfort
Pt received PNEUMOVAX 23 R delt on 1/15/19 at 1:30pm. At 8 pm site became tender, red, slightly swollen, and very warm to touch. Pt returned to office 1/16/19 and was advised to apply cool compressed and prednisone taper ordered. Pt contacted 1/17/19 and reports improvement in symptoms.
only had a sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Daughter) reported for a 90-year-old female patient (mother) received second dose in left arm on 13Feb2021 at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (Lot Number: EL1283) on 21Jan2021. The patient reported that her mother received the 2nd dose of vaccine 3 weeks and 2 days (2 days late) on 13Feb2021. Patient only had a sore arm, no other symptoms, no treatment received. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (22Mar2021): New information reported from a contactable consumer included: add event "only had a sore arm", remove event "Received the 2nd dose of vaccine 3weeks and 2 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 hive on her back; This is a spontaneous report from a non-contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as dose 1, single for -19 immunization. Patient's relevant medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient reported that she had 1 hive on her back that didn't stay there long, stating " It could have been a mosquito bite". Outcome of the event was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVId Vaccine Breakthrough Case  Moderna Dose 1 3/9/21 (036A21A) Moderna Dose 2 4/5/21 (016B21A) Moderna Dose 3 12/8/21 (939909) COVID Positive 12/15/21  12/15/21: -Patient is a 95 yo male from Nursing home with medical history of atrial fibrillation on anticoagulation , CKD stage 3, DMT2 with peripheral neuropathy , GERD, HTN, HLD, hypothyroidism , Dementia  -He was brought to the ER primarily because of bradycardia which is now resolved  -He also had cough and SOB and tested positive for COVID  -Patient is a poor historian because of underlying dementia  -His vitals on arrival no fever, HR 60s, RR 20s, BP 157/66 maintaining oxygen saturating on room air  -Lab remarkable for AKI Cr 1.28, elevated proBNP 7K, ALP 122, trop elevation 0.05 x 2, VBG ( PH 7.32, pCO2 55, pO2 35) , CBC unremarkable, urinalysis unremarkable, INR 2.0 influenza negative . EKG showed ventricular paced rhythm. Blood culture sent.  -CXR showed increased streaky opacity in right lung base could represent atelectasis versus infiltrate.  -Patient received Duoneb Tx , IV Ceftriaxone and Azithromycin IV lasix 40mg in the ER  -During encounter was impulsive, appears to be sundowning  12/20/21:  95-year-old male resident of a nursing home with dementia, atrial fibrillation anticoagulated on warfarin, permanent pacemaker, type 2 diabetes mellitus, hypertension presented with cough, shortness of breath and bradycardia.  Patient admitted for COVID-19 with superimposed bacterial pneumonia, sinus bradycardia which has resolved on arrival to the hospital.  Patient treated with antibiotics, IV dexamethasone and breathing treatments.  Due to his bradycardia remdesivir was not given.  Patient was briefly on oxygen subsequently weaned off to room air , shortness of breath and cough has improved.  Had an episode of a fall during the hospitalization with no sequelae, head CT was unremarkable for acute abnormalities.  Patient has supratherapeutic INR with no evidence of bleeding, was given vitamin K 2.5 mg p.o. x1 and warfarin was held on discharge.  INR will be checked in 2 days of discharge to be followed by patient's primary care provider.  PTOT evaluated patient and recommended returning to assisted living with VNA.  On discharge patient was a febrile and hemodynamically stable.  Patient the will be on Medrol Dosepak.
Patient may be getting a vaccine from a refrozen vial; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial) 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 PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial). At the time of the report, PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
A report has been received from a Health Professional concerning a 52 year old, Male subject, who had been receiving FLUMIST, (intranasal). The patient's concurrent disease(s) included Type 2 Diabetes, Hypertension and Hypercholesterolemia. Concomitant medications included metformin, lisinopril, hydrochlorothiazide, amlodipine and pravastatin. FLUMIST started on 01-Nov-2013. It was reported that the patient over 50 years of age patient received FLUMIST which started on 01-Nov-2013. The outcome of the event of over 50 years of age patient received FLUMIS is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health professional: Form completed date was updated. Action taken was updated. Dechallenge rechallenge was updated. Concomitant drugs were added. Concomitant diseases added. Reporter tab updated.
Patient hospitalized for hematuria, bladder stones on 4/14/2021. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 for urinary retention and hematuria. These visits are within 6 weeks of receiving COVID vaccination.
Dizziness; Fatigue; Extreme nausea; This is a spontaneous report received from a contactable consumer or other non-health care professional. This consumer reported similar events for 4 patients. This is Fourth of four reports. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, I keep hearing and various communication sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. patient personally was down and out for three days with dizziness, fatigue and extreme nausea on unknown date. Three of my friends had the same thing. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101224287 same, reporter and drug and event, different patient; US-PFIZER INC-202101224267 same, reporter and drug and event, different patient; US-PFIZER INC-202101224286 same, reporter and drug and event, different patient.
Within one week of receiving vaccine, IBS escalated from 1-2 days per week to 3-4 days per week.  One Jan 27, 2021, optometrist found swelling in optic nerve during annual eye exam.
01/05/2021 @ 15:41 Received COVID-19 Vaccine (moderna) IM to L deltoid 1543: Patient c/o "anxious feeling" and dizzy. pt placed supine with legs elevated. BP 106/60, patient reports is a normal BP for her; HR 74, RR 20. Denies SOB, denies Chest pain, 1545: Patient reports "feeling better," assisted to sitting position. Denies any further complaints, refuses need for EMS/ER refused to contact family member for transport. Report she has never had a reaction to a vaccine in the past. She reports hx of anxiety and feelings of anxiety "in these situations." Patient is A&O x4. VS stable. Patient reports "feeling ok to drive." No further s/sx.
Felt the pinch of the needle; She hasn't had anything happen, she has not felt different what so ever; This is a spontaneous report from a contactable consumer (patient herself). This 90-year-old healthy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185), via an unspecified route of administration on 26May2021 10:00 (this past Wednesday) (age at vaccination: 90 years) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179) on 05May2021 for COVID-19 immunization. On 26May2021, the patient experienced felt the pinch of the needle, she hasn't had anything happen, she has not felt different whatsoever. She keeps waiting for the other shoe to drop. She wants to know if this has been reported before. Patient said that she got the shot Wednesday morning and now it is Friday morning and she has not had anything happen, she has not felt different what so ever and she wondered if this is normal because she has not felt anything, nothing at all. She said that was so complicated she just wants to know if this is normal. The outcome of the events was unknown.   Follow up needed, further information has been requested.
After the first dose, after about a week, he got a little circle around where the shot was; it was pink.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Atrial fibrillation.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.). At the time of the report, VACCINATION SITE ERYTHEMA (After the first dose, after about a week, he got a little circle around where the shot was; it was pink.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medications were reported by the reporter. The patient had a severe reaction on the last one. The doctor told him it might be best not to take the booster. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-546749 (Patient Link).
SHOOTING PAIN IN THE HEART; This spontaneous report received from a consumer concerned a 24 year old male. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, treatment medications included: acetylsalicylic acid. On 06-APR-2021, the subject experienced shooting pain in the heart. On 09-APR-2021, Laboratory data included: Blood glucose normal (NR: not provided) okay, Blood pressure (NR: not provided) okay, Blood test (NR: not provided) okay, Cardiac function test (NR: not provided) okay, EKG (NR: not provided) okay, Oxygen saturation (NR: not provided) okay, and Triglycerides (NR: not provided) okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shooting pain in the heart. 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.
(R) arm rx to Imm. Slight tender, swollen, red. Pt given ABX & topical cream.
Hacking, painful cough. Took Delsym DM and Robitusin DM; they did not help Sent for x-ray; negative result Given prescripton for Codeine-Guaifen 10-100MG/5ML SOL
Severe headache; Diarrhoea; sore throat; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FAT484), via an unspecified route of administration in arm right on 29Jul2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included asthma. The patient known allergies were reported as antibiotic bactrim, pears, corn, environment allergies. The other medications in two weeks were reported as yes. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient previously took bactrim and experienced drug hypersensitivity. On 29Jul2021, the patient experienced severe headache, diarrhoea, sore throat and runny nose. The patient received no treatment for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Patient received booster dose of Pfizer vaccine too early. Pt felt dizzy after vaccine, BP 140/80, pulse 88, regular respiratory rhythm. No CP no SOB, no rash. Pt states he had not eaten prior; was given water, food and stated he felt better after. Pt was released.