chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 29Mar2021 at 11:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included hay fever. Concomitant medication included mometasone furoate (FLONASE) taken for unknown indication. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 08Mar2021 13:45 PM. Prior to vaccination, patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced soreness at injection site, headache and mild nausea. Therapeutic measures taken were acetaminophen 500mg for the events. The clinical outcome of the events injection site pain, headache and nausea was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
acute hives, some erythroderma of soles, puffy eyelids, intense pruritis of feet, then trunk, then scalp, developing immediately after Fluzone, while pt still at my office.  no wheeze or cough.  treated w 30mg Allegra and 15mg Orapred ODT in office.  Mom reports the following a.m. that all sx resolved by 7pm, 3 hrs p immunization given.  no second dose of either med given.  [older sister got Fluzone of same lot at same time; no problem]
Prior to the major events my dad was having heart burn. Weakness on one side which subsided. Felt dizzy at times,  fatigued and reduced appetite. Ejection fraction went from 70% to 35%. Had small stroke in basal ganglia . My father died 8 days after being discharged from hospital. Father passed over on 9/30/21.
Light headed,, racing heart, body aches, swollen armpit, red swollen arm at shot site,
Her son developed symptoms of Covid on 08Apr2021 and on the 09Apr2021 he tested positive; This is a spontaneous report from a contactable Nurse (patient's mom). This case is for the first dose. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The caller was calling on behalf of her son who was 32 years old. He received his first dose of the vaccine on 02Apr2021 and developed Covid/tested positive for Covid on 09Apr2021. Due to this the second dose was delayed, they were told to wait for a 3 month period to get the second dose. His second dose was on 17Jul2021. Now he got the second dose on 17Jul2021but when he got it the pharmacist told him this would be considered the first dose. The caller wants to know if this was true or not. The pharmacist at (withheld) told him that that second dose would now be considered a first dose. The caller wanted to know if that was true. She also adds that her son lives in Colorado and she calling today for her own knowledge and information, she is just surprised at what the pharmacist said. Her son developed symptoms of Covid on 08Apr2021 and on the 09Apr2021 he tested positive. When queried what type of covid test the patient had caller states that it was not a rapid test but she knows it was a nasal swab test. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested.
devel raised lumps on wrist 24hrs p/vax, no itching, 48hrs p/spread to chest & others areas;DPH, Cativate cream no relief
pt recv vax 4JAN97 & 21AUG97 pt devel a shingle type rash which was not eval by MD first hand;
Patient received J&J on 8/7/21, then moderna vaccine on 11/19/21. COVID positive on 3/14/22. Presented to ER on 3/14/22. Hx of fall about 2 months ago with left hip pinning.  Unfortunately was using his walker and fell again on 3/14/22 and imaging shows a new acute fracture.  Routine COVID screening positive.  Denied COVID symptoms on admission.  Admitted and was asymptomatic throughout stay. Discharged on 3/24/22
Patient experienced dry heaves, nausea, rigors, chills, and fever up to 101.4.
Patient vaccinated with first dose of Pfizer COVID-19 vaccine on 2/4/21 and second dose on 3/1/21.  Around June 22, 2021 he started having symptoms of chest pain and presented to the emergency room. He was diagnosed with pleurisy and discharged.   He was admitted to the hospital on 7/19/21 with central pleuritic chest pain and shortness of breath that woke him from sleep. Reported he had had a previous spell like this recently and was diagnosed with pneumonia, he was placed on 5 day course of antibiotics and improved. He was discharged on azithromycin with primary care follow up.  He was admitted back to the hospital on 7/29/21 with worsening shortness of breath, cough, chest discomfort and severe dyspnea on exertion. Chest x-ray showed worsening retrocardiac atelectasis. He noted that his heart rate had been running fast on his Apple Watch with some palpitations. Echo ordered. Cardiology consulted and diagnosed with subacute pericarditis with pre-tamponade physiology. He was started on anti-inflammatory medications - indomethacin and colchicine with improvement.
Daughter did not feel well after getting the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Daughter did not feel well after getting the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Daughter did not feel well after getting the Moderna vaccine). At the time of the report, MALAISE (Daughter did not feel well after getting the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    Patient registry ID was reported.  No concomitant medication information was reported. No treatment information was provided.
Presented with pain, swelling & itching of the left proximal arm. Left arm with small area of induration (about 2mc in diameter), erythema, warmth & swelling however expands down near antecubital fossa.
Shaking; Excruciating migraine; Whole body is freezing; felt Cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking), FEELING COLD (felt Cold), MIGRAINE (Excruciating migraine) and CHILLS (Whole body is freezing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2020, the patient experienced FEELING COLD (felt Cold). On 14-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking), MIGRAINE (Excruciating migraine) and CHILLS (Whole body is freezing). On 15-Jan-2021, MIGRAINE (Excruciating migraine) had resolved. At the time of the report, TREMOR (Shaking), FEELING COLD (felt Cold) and CHILLS (Whole body is freezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Treatment information include patient Health Care Provider told her to take Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI
Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Fever (low grade, then 103 and 104 F); Nausea; Vomiting; Diarrhea; Hurting chills; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021 (lot number: FC3184; Expiry Date: 31Oct2021), at the age of 41 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history was not provided. Concomitant drugs included XANAX and AMBIEN. There was no prior vaccination within 4 weeks of getting the Pfizer vaccine. The patient woke up on the following morning, on 22Aug2021, and started feeling kind of ill, her arm was really sore, she was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, she had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days she started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101286731 similar report from same reporter.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 27-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
According to police report, patient c/o "not feeling well since he got his flu shot".  Patient went to hospital w/ c/o chest pain on 10/26/13 where he was dx with strep throat, prescribed medication and sent home.
I exp sore arm (right) lasting a day. On the second dose sore arm, headache lasted lasted a day and tiredness 3-4 days.
Bleeding at injection site (through band aid), Migraine with aura, sneezing, runny nose, congestion, swollen face, hives rash on neck area, difficulty breathing, upset stomach, vomit and diarrhea, chest congestion, fever, chills, high resting heart rate. Starting day of going into the following week and stomach/breathing issues still present along with fatigue
Lt arm swollen, red. c/o itching; started the evening of shots 10/26/12. BENADRYL tid for 5 days.
9FEB93 early AM lethargy, malaise-evening malaise, myalgia, measles-like rash to face, trunk, itching; 10FEB93 AM swelling, edema rt wrist;
COVID arm Swelling in arm, itching, intense pain, tight shoulder muscle, immobility
Gave vaccines at 8 AM-Pt. sat in lobby for 20 minutes nurse found pt. "laying on floor" at 820. B/P 110/68, PEERL and A at 0x3. EMS called due to previous head injury this past December. Evaluation completed by EMS, mom declined hospital at this time.
General hives all over body- itching and blisters Hand was the worst spot- itching and opened up with clear drainage  Given antibiotics and anti itch cream  2 weeks of symptoms
Patient reported a warm, painful rash on the back and inside of the arm that grew to extend from armpit to elbow (approximately 8 inches) and 4-5 inches wide. It was first reported on 11/8/11 and worsened to a peak on 11/10/11 in the AM. Rash was accompanied by feeling "under the weather" and mild headache, which has persisted until 11/11/11. On 11/8/11, patient was advised to take Tylenol for pain and Benadryl for the reaction. On 11/11, patient reports having taken 50mg Benadryl x2 nights and Advil several times without any notable relief. This morning, the reaction appears to be resolving. It is cool to the touch, itchy, and a lighter pink color. However, around the injection site, a darker red 2x3in patch remains. Patient reports feeling better.
BRIEF OVERVIEW: Admission Date: 8/31/2023 Discharge Date: Sep 5, 2023 Discharge Disposition:  home health care svc DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Septic shock [A41.9, R65.21] COVID-19 [U07.1]   HOSPITAL COURSE: 78 years old woman presented with URI symptoms found to have COVID positive. She also had chest pain on admission with troponin 17 -> 17 -> 28. Discussed with on-call cardiologist, who recommended an echocardiogram on Tuesday. He also recommended daily EKG for her along with EKG if she develops chest pain.    ID was consulted with recommendations for IV remdesivir for 3 days that she completed.  She required vasopressor support with levophed which was weaned off gradually. She was treated with IV vanco/cefepime/flagyl with discontinuation of IV vancomycin with negative MRSA swab.   Medical intensive care unit had been consulted while the patient was in the intensive care unit with  recommendations for 5-7 days of empiric antibiotics.   Of note, the patient had developed anemia with transfusion of 1 unit of pRBC in the setting of her history of known coronary artery disease with some earlier complaints of chest pain hemoglobin had gone down to as low as  6.9 with a baseline thought to be closer to 10. Of note, she has had similar episodes in the past, last noted in March 2022.  Then, she had a hemoglobin of 6 and presented to the ER.  She was transfused 2 units at that time and was advised to be admitted the hospital for further evaluation but she declined this.  Since then, she is had no clinical signs of GI blood loss and her hemoglobin has overall remained stable.  Her hemoglobin did improve after transfusion and went up to 8.5.  There was no clinical signs of GI blood loss.  Discussion was had with the patient in regards to further workup for this but she stated that she would like to follow up with her primary care provider.  Patient was allowed to resume her aspirin therapy on discharge; Clopidogrel was held.  Reviewing the patient's outpatient records, during a previous admission she had been diagnosed with a TIA and was recommended to be on aspirin and Plavix for 1 month, followed by aspirin monotherapy thereafter.  Apparently, she is not been on monotherapy but has been taking clopidogrel and aspirin and she again was advised to remain on just aspirin.   Patient was thought to be medically stable for discharge home on 09/05.
Pfizer Bivalent booster inadvertently administered instead of Pfizer primary dose 1
Narrative: COVID infection following COVID vaccine series 01/07, Pfizer, dose#1 02/01, Pfizer, dose #2 10/04, Pfizer, dose #3 08/31 pt cc: exposure: unknown 08/31 COVID swab, result: detected 09/09 COVID swab, result: NOT detected
viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Noticed day later (9 Feb), redness, sore. Took aspirin and iced. Redness covers area approximately 6-8 inches from elbow up to shoulder, some swelling.
Information has been received from an employee health nurse concerning a 51 year old male who on 06/07/04 was vaccinated with a 10 mcg second dose of hepatitis B virus vaccine rHBsAg (yeast). On 08/01/04, presented to the emergency room with jaundice. It was determined that the patient had a gallstone. He was not admitted to the hospital. A product quality complaint was not involved. Additional information has been requested.
After administration of vaccine it was discovered that the dose given was expired. It had been drawn up into the syringe the previous day about 15 hours prior to being administered. The dose had been sitting in the syringe at room temperature for approximately 15 hours. I spoke to Mom  about 16 hours after vaccine was administered and she reported some muscle soreness at the injection site but no other complaints or local/systemic reactions.
On 9/8/2021, PT started to feel not right. He was complaining of feeling lightheaded and fatigued and weak. On the morning of 9/9/2021, PT was woken from his sleep with a heart rate of 203 beats per minute, he was pale, short of breath and lightheaded. He could feel his heart race and felt like it was going to beat out of his chest. He was brought to the Emergency Department. After a 15 minute wait, his heart rate began to normalize. His ER doctor said that pt. could have a heart monitor to wear at home but said he wouldn?t recommend it as it probably won?t show anything so Jayson felt like he shouldn?t get one.  Since that day, pt. heart rate has been higher than usual with any activity and his resting heart rate is higher than normal for him. PT has seen a primary care physician 9/15/21 and was referred to cardiology
As per mother, patient c/o headache on 6/6/09 - spent 6/7/09 in bed with nausea, h/a - diarrhea began on 6/8 - 6/10.  Seen in hosp on 6/10 - dehydrated IVs X 3 bags - Mother was told patient had a severe TDAP reaction
Information has been received from an immunization coordinator concerning a female patient with rheumatoid arthritis who on 23-JAN-2009 was vaccinated with PNEUMOVAX.  Concomitant medication included "medication for rheumatoid arthritis".  Within 24 hours of vaccination, the patient developed some flu-like symptoms that lasted over the weekend after receiving the PNEUMOVAX vaccine.  At the time of reporting the immunization coordinator stated that the patient was feeling better as of that morning.  Additional information has been requested.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX 23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received on 11-APR-2017 referring to a patient of unknown age and gender. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013522.
Pt experienced sudden hearing loss in right ear. The right ear also has constant ringing. He experienced nausea and vertigo. His balance is off. He has been hospitalized and has seen an eye/ear/nose Dr with no conclusive results. 1/11/2010 Had a Baha device in right ear for hearing lost. 6 days after receiving vaccination had problems with ear still has ringing in ear.
Patient became light-headed, pale immediately following covid vaccine injection. He then stated he's always had trouble after vaccines. Cold compress applied. No loss of consciousness noted. Water given, seat reclined. Slowly raised head to upright over the course of 30 minutes. Monitored VS every 5-10 minutes.