chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant swelling of left upper arm-regard office visit 10/27. Possible recession reaction, but we treated as possible infection with antibiotic.
Patient presented to emergency department with complaint of bottom lip and cheek swelling, burning on lips, feeling itchy, and difficulty swallowing. No difficulty breathing. Patient was diagnosed with angioedema/anaphylaxis. Patient was treated with IV dexamethasone 4 mg every 8 hours.  IV famotidine 20 mg twice daily.  IV diphenhydramine 25 mg every 8 hours x3 doses. and IV fluids (lactated ringers). Patient improved over the course of about 12 hours.
About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and started to laugh a lot. It got worse with movement and was containable if I was sitting still. I was unsteady on my feet as well. I kept losing my balance. I would describe it as euphoria or intoxicated. Lasted until about 10:30 pm when I got really tired and fell asleep pretty quickly. This morning I am just tired and sore with a headache.
About 20 min after vaccine, pt reported dizziness, faint, tachycardia. Went to urgent care, then called ambulance from there. Was treated for HTN, tachy, and released. Declined ER visit.
Initial report received from a healthcare professional on 04 September 2012. A female patient had received an intramuscular (IM) first dose of ADACEL vaccine (Sanofi Pasteur Ltd lot number U4384AA) in right deltoid on unspecified date. The date of Last Menstrual Period was 27 December 2011. Estimated Date of Delivery was reported as 29 September 2012. It was reported that the patient did not experienced any adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The patient's outcome was unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been updated to serious. Relevant illness during pregnancy/ongoing was reported as depression, syncope, hypothyroid and GBS(+). Medications used during pregnancy were AMBIEN, NEXIUM, SYNTHROID and VALTREX. The patient had one previous pregnancy with a normal outcome. On 25 September 2012, the patient delivered a normal infant. The patient's outcome for the events of depression, syncope, hypothyroid and GBS(+) was not reported. Documents held by sender: None.
Severe pain, Bells Palsy like symptoms, allergic reaction requiring medication, pain with moving muscles in left upper extremity
Patient receiving pneumococcal vaccine on 6/7 and discharged from hospital. Readmitted to different hospital with signs/symptoms of cellulitis on arm where vaccine was given. Readmission was on 6/8; also signs/symptoms of sepsis. Temp 105 F. Other symptoms: nausea, vomiting, headache, BP 99/61. Positive cellulitis. Sent home on Bactrim. Discharge summary states erythema, chills, cellulitis. msv
(R) arm red, swollen, hot to touch. Bruised, and blistered
Congestive heart failure; Pneumonia; Pulmonary embolism; Lupus has been awakened; This case was reported by a consumer via interactive digital media and described the occurrence of congestive heart failure in a 59-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, 1 day after receiving Tdap Vaccine, the patient experienced congestive heart failure (serious criteria GSK medically significant and life threatening), pneumonia (serious criteria GSK medically significant and life threatening), pulmonary embolism (serious criteria GSK medically significant and life threatening) and systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the congestive heart failure, pneumonia, pulmonary embolism and systemic lupus erythematosus syndrome aggravated were unknown.   It was unknown if the reporter considered the congestive heart failure, pneumonia, pulmonary embolism and systemic lupus erythematosus syndrome aggravated to be related to Tdap Vaccine.  Additional details were provided as follows: It was reported that, Tdap vaccine almost killed the patient 2 weeks before the date of reporting.  The patient was a healthy rambunctious expecting 2 new grand babies within a month. The patient received whooping cough vaccine just to be safe.  The patient had lupus and discussed it with the pharmacist and was told there would be no reportable side effects at all. It was reported that,  24 hours after receiving Tdap, the patient was in the emergency room (ER) with congestive heart failure, pneumonia and a pulmonary embolism.  The patient felt lucky to have survived but the life expectancy was cut much shorter that the lupus had been awakened by the vaccine.
pt fell down, felt numb, unable to move, near syncope state, convuls, passing out, hands white, feet numb x 3hr;7 similar episodes diff breathing, walking;dx GBS;60 day follow-up dated 2/15/01 states pt was lightheaded, extreme low blood pressure and fatigue.Annual follow-up dated 1/22/01 states the pt also experiences dizziness and has nerve damage in feet which causes them to be cold.
The Patient had a shingles symptom and rash appear. Patient states was very weeks knees and had difficulty walking and was not able to work for 3 days.
Fever; Chills; Muscle aches; Tired; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Sep2021 at 16:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 16:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 00:00, the patient experienced fever, chills, muscle aches and tired. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches, and tired were recovered on an unknown date in Sep2021.  The lot number for BNT162b2, was not provided and will be requested during follow up.
One dose of improperly stored PROQUAD was administered to a patient on unspecified date; No adverse effects reported; This spontaneous report was received from a nurse concerning to a female patient of unknown age.No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.  On an unknown date, the patient was vaccinated with one dose of improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # S030213, expiration date of 25-MAR-2021, for prophylaxis (dosage schedule, strength, and route of administration  were not reported) (product storage error). The sterile diluent was stored properly.   The administered dose of the vaccine experienced a temperature excursion of -10.5 Celsius degrees for 2 hours and 31 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.
Information has been received from an office manager referring to an unknown number of unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates started on or after 28-APR-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M003659, expiry date 20-SEP-2017, strength, dose, route and dose number were not provided). The vaccine was exposed to a temperature of 28.6 F for a time frame of 885 hours. There was no previous temperature excursion. "Data logger" was involved. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
IMPROPER STORAGE OF VACCINES.  PATIENT DID NOT HAVE ANY ADVERSE REACTIONS
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Weakness-Mild
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date, the patient "experienced a cold" and had been breaking out in fever blisters which popped up one after another since an unspecified date and sought medical attention when spoke with the pharmacist and did not received a treatment. The outcome of experienced a cold and fever blisters was reported as not recovered at the time of the report. Relatedness between the therapy with NUVARING and the events: experienced a cold and fever blisters was not reported. Additional information has been requested.
No adverse event; The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Quadracel  Past adverse reactions to the above products included No adverse event with Quadracel. Concurrent medical conditions included Autistic disorder.    On 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.).    Patient wasn't taking any medication. Patient had received another vaccine within 4 weeks of COVID-19 vaccination. Patient didn't report any adverse events. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2023: Added additional reporter, updated patient demographics, suspect drug information and I narrative.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    All patients were over the age of 65. No relevant concomitant medications were reported. The batch number was reported as 067H22A. The vaccine was administered in the deltoid site. On 11 May 2023 26 patients were contacted, on 12 May 2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone. No treatment medication reported.   This case was for the 5th patient out of 27 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
could not sleep well; injected on left shoulder feeling pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high, Hypercholesterolaemia (high cholesterol) and Kidney stone.    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 INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache). At the time of the report, INSOMNIA (could not sleep well), ARTHRALGIA (injected on left shoulder feeling pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported. No treatment medications were reported.
Hours after injection localized  sweating and soreness.    Came to homecare office siting discomfort.
Pt came in to receive, third shot of Pfizer, her booster. Pt was registered and brought back to vaccinators. According to pts vaccination card was she was good on time and date to receive third vaccine. Vaccination card only showed two prior shots. With lot numbers and dates. Pt mentioned prior to vaccine administration that she had trouble with getting her first shot, pt had gone to the convention center and was told she could not receive it as per the system she had already gotten it. According the pt this was false and in that instance was her first and onky shot. Per pt, ? had to spend 2 hours with onsite management ? of convention center vaccine clinc to resolve. In conclusion there was an identical persosn of the same name and similar DoB and SSN. For this reason she was ineligible at that time. Situation was resloved per the pt that day soemtime in April 2021.  Pt came in today with a vaccine card showing two prior shots, no reason to suspect more, pt passed screening and willing wanted to receive the shot. Pfizer 0.3ml was given to the pt intramuscular in the Right Arm. Pt waited her 15 mins and left facility. Hours later during a quality check of vaccinated patients , this said pts information showed todays visit was her fifth, unknown how the system did not alert earlier or brought into question. Vaccinator thought it was resolved as per the pts story and vaccine card.  Unable to prove whether the pts story is true or if the system is wrong, a medical error form is being filled up to address.
Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt faint after void vaccine. She had some changes in vision and sat down to relax and drink an orange juice. Vitals were examined. (BP: 90/56 & 90/60; pulse: 62). Parents stated that patient has a history of feeling faint after vaccine administration. Patient was able to walk out under own power. A follow up call was placed and the parents stated that the patient was stable and doing well.
I took my Albuterol, one puff, this morning before going out for a run, and within a minute, started feeling extremely nauseous, this continued and increased for about 5 minutes, I thought I was going to vomit , but didn't.  I did not take my second puff after that.
pt recv vax 16DEC97 & 21DEC97 pt devel erythema mult, diffuse urticaria, hand & feet swelling, a runny nose & fever 103;dx w/serum sickness & tx w/DPH;
Reported by mom as full body twitching and arching back for less than 1 minute with fever T-101 during sleep  This episode occurred <12 hours after receiving MMRV and DTAP/IPV.  No treatment initiated given.
Rash on upper arm at site of injection.  Itchy, redness patch.  Lasting 2-3 days so far.  Using some topical cream helps.
Myocardial infarction - hospitalization from 5/18/21 until 5/28/21.
Child born with cystic hydroma--excised at birth. Other birth defects. First year of life hospitalized. Bloodwork routine when found positive for haemophilus influenzae, type B.
Laid down to take nap four hours after shot, woke suddenly with two different severe cases of vertigo. I have history of vertigo but haven't had it in over a year. After I sat up and was shaking and had chills. Have had no other reoccurrences and have felt fine.
HPV Vaccine was administered at an interval of 7 weeks and 6 days from previous dose and should of been 12 weeks apart.
Injected with 1st Dose of Moderna Covid-19 vaccine. Injection site was above deltoid muscle and next to shoulder bone. Felt pain almost immediately that same day. Continued to be in pain and was admitted to hospital where they conducted blood tests, X Ray and MRI. Determined it was SIRVA.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6204), in right arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 09Sep2021 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; MONTELUKAST; CETIRIZINE; FLUTICASONE; VITAMIN D 3; FISH OIL; MELATONIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (May2022) Negative, notes: Tuesday tested negative using rapid antigen test. Completed Paxlovid regiment on Thursday. Friday tested negative using rapid antigen test; (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medications also in 2 weeks of vaccination. Other medication in 2weeks product also included Vitamin D3. The patient had no known allergy and other medical history. Symptoms started 14May2022 at 1am for COVID and tested positive using rapid antigen test. Started Paxlovid on Saturday 14May2022 at 3pm. Treatment start date was 14May2022 and treatment stop date was 19May2022. No symptoms Monday. Tuesday tested negative using rapid antigen test. Completed Paxlovid regiment on Thursday. Friday tested negative using rapid antigen test. 25May, tested positive using rapid antigen test and mild cough (no other symptoms, no fever).  No follow-up attempts are possible. No further information is expected.
pt said the injection site was red and itchy and his arm was tender to the touch. He said its been getting better. It started after a couple days after the shot but its been a week so he called us. pharmacist advised him to take benadryl and we wil follow up again tomorrow
I have already received two Pfizer Covid vaccines and two Pfizer Covid boosters. I went to the pharmacy to get the new Bivalent Covid booster as well as my annual flu vaccine. The pharmacist assured me that I was indeed getting the new Bivalent booster on 3 separate occasions and I was the first patient in the County to receive this booster. The pharmacist also had collected and read my vaccine card prior to my getting the booster. On 09/09/22, my husband received a call that we were both given the wrong booster and would not be able to get the Bivalent dose for 3 months!! We both had fever, chills and body aches after this shot.
VOMITING 15 OR 20 TIMES LASTING UNTIL 5 AM.  ALSO HAD DIARRHEA; NO FEVER.  ADVISED TO SEEK MEDICAL ATTENTION IF PERSISTS.
2 hours s/p Adacel injection (L) deltoid, pt experienced pain/swelling/erythema, nausea and subjective fevers. Seen by me 2 day s/p injection. 7x4 cm erythema with induration - severely tender to palp.
Several hours after receiving vaccine, he developed pain, swelling and redness around site on upper right arm. This continued into next day along with nausea, headache, chills and worse swelling. Examined 7/15 and still had tenderness with mild erythema and swelling of UE. Improving as of 7/15/04.
BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 17:00 PM  for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, headache and chills was not reported. This report was non-serious.