chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client called and reported that yesterday when she woke up her left arm was sore. States gradually yesterday the swelling got worse and now is swollen approximately 3" up to shoulder. States area is red swollen and warm to touch. States her arm hurts.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 3rd of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
First dose: my face went numb and tongue felt itchy 1.5 hours roughly for symptoms.  No common side effects; Second dose: calling it a panic attack. Racing heart, felt like I was passing out, mental fogging, trouble swallowing lasted about 1.5 - 2 hours. After 2nd dose I had the normal side effects, headache, chills, body aches fatigue.. After about 2 days of common side effects I noticed I was having trouble swallowing and it felt like I was being choked pulse food regurgitation and diarrhea.  It kept getting worse and worse after a week or so of hell I get an emergency endoscopy showing I have  eosinophilic esophagitis.  I?ve been put on all sorts of meds that are supposed to be treating this but nothing is working.  It?s been near a month now and 2 weeks have been on a hard core elimination diet  symptoms are persistent and discomfort it spreading to what feels like intestines, kidneys and possibly other locations I now have to go in for a colonoscopy soon as the meds should be working and discomfort is spreading.  Loads of headaches can?t sleep with all the discomfort.  Never hungry.  Possible permanent esophagus damage maybe more everything is still being diagnosed and no one is really finding any answers why.  For the last 6 years I?ve been on a health kick working out almost daily and eating very healthy.  No symptoms no warning  signs these one or more diseases it has all just started out of the blue post vaccine nothing else in my life has changed.
06 March 2017 AM, patient presented to ER with pain, redness, and swelling around smallpox injection site. Patient was informed that symptoms are consistent with cellulitis lymphadenitis. Patient was prescribed cephalexin antobiotics and Septra DS to treat infection, along with hydrocodone to manage pain. Pt was advised to f/u.
about 10 hours later increased sob and chest tightness and then hypoxia and hospitalization x 4 days and IV steroids    Patient is a 64 y.o. female with PMH notable for von Willebrand disease, asthma, OSA on CPAP, DMT2, HLD, lumbar stenosis, chronic opioid use, GERD, PUD, and anxiety who presents with SOB, weakness, fever.   Patient with history asthma, controlled on symbicort and PRN albuterol, now with progressive worsening SOB since the day prior to admission, patient received 2nd dose of Moderna COVID-19 vaccine on 03/10/21. Also, with chest tightness, body aches, headache and chills. Was up last night with fever 101F, took ibuprofen. She had worsening wheezing and SOB while bring dog to dog groomer and had groomer call ambulance. EMS called, received albuterol nebs in route with some improvement in symptoms. Chest tightness has improved. SOB improved now at rest but still winded when up to bathroom. Vitals on arrival notable for BP 144/55, HR 125 (sinus tach on EKG), temp 102.1F, RR 22, 92% on RA. Labs notable for WBC 8.6, CR 0.54. Normal LFTs. Lactate 3.3. D-dimer 0.9. pBNP 56, troponin <0.012. COVID-19 PCR panel negative. CXR with Chronic linear atelectasis or scarring at the lung bases, unchanged. CT PE study negative for PE, possibly some mild pulm congestion, increased interstitial markings. Patient given 2L NS in ED as well as ceftriaxone 2g and doxycycline 100mg. Patient will be admitted to inpatient for further evaluation and management of sepsis. Met sepsis criteria given fever, tachycardia, elevated lactate. Infectious source most likely pneumonia (though only slight increase interstitial markings on CT). Could be atypical or viral pneumonia. However, timing of symptoms could also fit with reaction to COVID-19 vaccine and asthma exacerbation.  COVID-19 negative and influenza negative. Was treated with abx for CAP and prednisone + albuterol for asthma exacerbation. Lactate normalized with IVFs, fevers and tachycardia resolved. Patient able to wean to RA, dyspnea and wheezing slowly improved. Abx narrowed to cefzil, doxycycline. 1/2 admission blood cultures positive for streptococcuss. Patient was febrile and septic on admission. Subsequent blood culture without growth to date. Abx returned to IV ceftriaxone given strep + BCx.. Low blood cultures x2 were negative at 48 hours.  Dr. was consulted over the phone and he recommended 5 days of oral amoxicillin on discharge. Chronic medical conditions were stable while hospitalized.  No medication changes were made.
On the evening of February 1 had itching at vaccine site.  Saw a large red area.  No pain.  Now, February 2, the red area is still there.  The itching is less.  No discomfort.  Just wanted to report it in case it is important.
This spontaneous rep rot as received from the director of a health department refers to 12 year old female patient. Information on medical history was not reported. It was reported that in July 2013 reported as last week, the patient was vaccinated with GARADASIL (lot#, expiry date not provided)(dose, strength, route, frequency, indication not reported) and two other unspecified vaccines. Immediately after administration the patient started to see spots and her skin color became pale. It was also reported that the patient did not fully faint. The outcome of the events was unknown. The reporter did not assess relationship between the therapy with GARDASIL and the adverse events. This is one of several reports from the same source. Additional information has been requested.
Headaches starting the next day. They are an uncomfortable pressure feeling, sometimes accompanied by a lack of sharpness in thought. They can occur several times a day.
Malaise; Body ache; Left jaw pain; Chills; Low grade fever; Headaches that were on and off for an entire week; Palms of her hands became red right away; Sweating; Feeling hot, like hot flashes from menopause; Generalized itching that night, with no visible rash; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause), PRURITUS (Generalized itching that night, with no visible rash) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash). On 13-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headaches that were on and off for an entire week). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency; OMEPRAZOLE at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) at an unspecified dose and frequency. On 12-Feb-2021, HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash) had resolved. On 13-Feb-2021, MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ERYTHEMA (Palms of her hands became red right away) and HEADACHE (Headaches that were on and off for an entire week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: low (Low) Low grade fever.     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.   Concomitant product use was not provided by the reporter.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # were not reported). On an unknown date the patient was administered VARIVAX (Merck) which had been improperly stored. No adverse effects were reported. Additional information has been requested.
Reported difficulty breathing post seating down for observation; observed as having shallow tachypnea(24RPM) and conveys reports of chest tightness; monitored by EMT on site, out the door with paramedics/ambulance in the next 9 minutes
Fever; Stomach pains; Overall not feeling well; This is a spontaneous report received from a contactable consumer (patient). A 51-year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; LOT NUMBER EN6203) intramuscularly on 26Feb2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included a positive COVID-19 test on 28Nov2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 05Feb2021 at 11:00 (lot number EN9581) as a single dose for COVID-19 immunization. On 26Feb2021 at 16:00, the patient experienced fever, stomach pains, and overall not feeling well lasted 48 hours. The patient did not receive any treatment for the events. The outcomes of fever, stomach pains, and not feeling well were recovered after 48 hours.   No follow-up attempts are needed. No further information is expected.
involved in a fender bender car accident; missed second dose of vaccine; This is a spontaneous report from a contactable consumer, the parent. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular on 02Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The consumer stated she was 88 years old (case 2021495539 )and her daughter was 65 years old and both got their first Pfizer Covid shot in series on 02Mar2021, stated they both ended up being hospitalized and missed second on 23Mar2021. The patient was involved in a fender bender car accident on 21Mar2021 and hospitalized from 21Mar2021 to Apr2021. The consumer stated she read that as long as you get the second dose within 6 weeks, but it has now been 8 weeks since first shot. The consumer wanted to know do they at this point have to start over with the first dose of the vaccine. The outcome of the event car accident was unknown.  The consumer stated the hospitalization/car accident had nothing to do with the vaccine.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, the event Automobile accident is most likely related to an intercurrent condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. Linked Report(s) : PFIZER INC-2021495539 same reporter/drug/events, different patients
pt recv vax 29OCT97 & 29OCT97 pt devel a local rxn below the inj site described as a hive;
Swelling at injection site, joint pain and fatigue. Over all unwell  for 24 hours after injection.
About two weeks after getting the third dose of my vaccine I was having a Capsule Endoscopy procedure. When I took the Preparation for the procedure I got really sick. I started to feel very shaky and I had a headache. When I went to the procedure the next day my blood pressure was extremely high. It was 200/112, I still had the procedure. I never had a problem with high blood pressure. I still had the procedure but I visited my doctor the next day. I had to return several times to have my blood pressure monitored. It has remained a little high and my doctor has suggested some medication. I was prescribed a low dose Amlodipine. It has been three weeks since the event.
Next day-  Sore arm Body aches  5 days-  Swollen lymph nodes in armpits. Worse on left side.  7 days- Hives on left arm over injection site
hot in the injection site; Redness (2 inches ) in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for Antidepressant therapy, CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Antipsychotic drug level, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METFORMIN for Diabetes, BERBERINE for an unknown indication.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site). At the time of the report, VACCINATION SITE WARMTH (hot in the injection site) and VACCINATION SITE ERYTHEMA (Redness (2 inches ) in the injection site) outcome was unknown. Not Provided          No Treatment medication were provided  Action taken with the mRNA-1273 Moderna was not applicable
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 03-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L043624 with expiration date of 03-NOV-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Seasonal allergies and dust allergies were severely aggravated to the point of significantly increased inflammation of  eye lids, itchy eyes, face, neck, and rash on hands that have persisted for two weeks on a far more severe level of inflammation than ever experienced before.  Prescription for Prednisone 10mg (38 tablets) and over-the counter Cortisone 10 with aloe vera.  Also, washing affected area with Alkaline88 pH-balanced purified water has provided instant relief to itchiness and irritation.
The patient had a fever and apparent febrile seizure within 24 hours of having immunizations.
LITTLE PURPLE GRAPE SIZE BUMP; LEFT ARM STUNG; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. 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 14-MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced left arm stung. On MAR-2021, the subject experienced pain iin left arm. On 18-MAR-2021, the subject experienced little purple grape size bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little purple grape size bump, and the outcome of left arm stung and pain in left arm was not reported. This report was non-serious. this case was associated with product quality complaint number : 90000173607 The suspected product quality complaint has been confirmed to be void ( confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.
Bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells palsy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A2(Z)1A and 037K2(Z)0A) for COVID-19 prophylaxis.     Concurrent medical conditions included Specific allergy (drug) (Losartan), Diabetic and Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy) outcome was unknown.            Patient concomitant medications included diabetic and high blood pressure medications even before first dose of moderna vaccine. It was reported that in the last 2 days, the patient had developed facial paralysis, bells palsy and cant talk very well. Events Facial paralysis and dysarthria are subsume under event Bell's palsy  Patient had no positive covid test or diagnosis. Patient took prednisone and acyclovir to keep virus from replicating.  Company comment: This spontaneous case concerns a 70-year-old male patient, with no relevant medical history who experienced the expected, serious(medically significant) adverse event of special interest Bell's palsy which occurred on an unspecified date after receiving the fourth dose of mRNA1273. The patient was reported to have developed facial paralysis, bell's palsy, can't talk very well. Patient was treated with Prednisone and acyclovir to keep virus from replicating. The clinical course and treatment details were not provided. The patient's advanced age may be considered as a risk factor for Bell's palsy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-588458 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old male patient, with no relevant medical history who experienced the expected, serious(medically significant) adverse event of special interest Bell's palsy which occurred on an unspecified date after receiving the fourth dose of mRNA1273. The patient was reported to have developed facial paralysis, bell's palsy, can't talk very well. Patient was treated with Prednisone and acyclovir to keep virus from replicating. The clinical course and treatment details were not provided. The patient's advanced age may be considered as a risk factor for Bell's palsy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received the three vaccinations listed above around 6:25PM. I requested patient sit in the waiting area following immunization for about 15 minutes to be monitored. Within 5 minutes of sitting down patient appeared to have briefly convulsed then passed out. I yelled her name then exited the pharmacy and went to her at the chair. I shook her and she came to very quickly. I provided patient with water and an ice pack. She remained awake and oriented to time and place for the next 20 minutes. She expressed after this time that she was okay and was comfortable leaving to go home/meet her ride. I called patient the next day to follow up and see how she was feeling but was unable to reach her.
Patient was given the Shingles vaccine 3 weeks prior. Two weeks after the vaccine, he developed a pruritic rash across his upper torso and back. Patient was given shingles vaccine over 3 weeks ago. Within two weeks of vaccine injection, patient developed pruritic maculopapular rash across chest and upper back. Could not identify other possible causes.
2 pts recvd 3 doses of Engerix-B & exp neg titers;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2015, the patient was vaccinated with improperly stored MMR II lot # K008814 and 19-JUN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted after her third covid Pfizer vaccine. She became alert after several minutes. She drank some water and applied cold wet paper towels to her neck.  After several minutes of being alert she was not able to answer questions consistently.  At that time we called the ambulance.  The paramedics arrived and Patient was feeling much better and was consistently able to answer questions. Patient did not require attention from the paramedics.
got both shots at the same time; got both shots at the same time; fever; slept a lot; very sick for 48 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "fever"; SOMNOLENCE (non-serious) with onset Sep2022, outcome "unknown", described as "slept a lot"; MALAISE (non-serious) with onset Sep2022, outcome "unknown", described as "very sick for 48 hours"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 16Sep2022, outcome "unknown" and all described as "got both shots at the same time". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.