chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt hot; felt achy; Chills; generalized myalgias; high fever/her highest recorded temperature was 102.5; Deltoid soreness; This is a spontaneous report from a contactable Other HCP. This other hcp (patient) reported for herself that the 32-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Covid-19 Vaccine manufacturer: Pfizer BioNTech), intramuscular into her left deltoid on 17Dec2020 07:30 at single dose for covid-19 immunisation (Prophylaxis). Medical history included  Hypothyroidism, mood and sleep. Concomitant medications included Levothyroxine at 100mcg daily by mouth ongoing for Hypothyroidism started taking at 19 years old, escitalopram oxalate (LEXAPRO) at 10mg once a day by mouth from Dec2020 started it about 2 weeks ago ongoing for mood, zolpidem tartrate (AMBIEN) at 10mg as needed by mouth for sleep and was not taking this at the time. The patient experienced Deltoid soreness from 17Dec2020 to 18Dec2020, Chills from 20Dec2020 to 21Dec2020, generalized myalgias from 20Dec2020 to 21Dec2020, high fever from 20Dec2020 to 21Dec2020. The outcome of the events was recovered. Her vaccination cared is at her house. She received the product at the hospital she works at. The causality of the events Deltoid soreness, Chills, generalized myalgias and high fever was related. Caller is a nurse practitioner that reported that she wanted to report a possible side effect for herself with the Covid-19 vaccine. She said that she herself got vaccinated on Thursday 17Dec2020. She was doing fine except for the deltoid soreness that showed up about 12 hours after receiving the vaccine and lasted for about 12 hours and then it went away.  On Sunday, she had sudden onset of chills, generalized myalgias, and a high fever. Caller said that her highest recorded temperature was 102.5. Her symptoms started at  about 1430 and she said she had no other symptoms aside from what she reported. She said that her chills went away after about 3 hours and then she felt hot, and then she just felt achy and had the generalized myalgias. All were subsided by 0900 this morning. She said that she also had a low grade fever of 99.8 this morning, but it was all gone by 0900. Caller said that she is a emergency room employee and was given the vaccine at the hospital and they was no prescribing physician. Caller said that she has never had a reaction like this to a vaccine before. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) was require a visit to ER or physician office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was None.  Information on the lot/ batch number has been requested.
I tested positive to covid-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program - General Company Information.  A male consumer received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 22Jan2021, the patient tested positive to covid-19. On 23Jan2021, the patient had the Bamlanivimab infusion antibody drug against covid-19. When the patient went back to the hospital to get the scheduled second shot of the suspect vaccine, the patient mentioned that he had the infusion. At the site, they told patient that due to the infusion, he had to wait 90 days. The outcome of the event was unknown. Information about Lot/Batch number is requested.
Did a COVID test and tested positive; Sluggish; Lots of coughing; No appetite; Feeling sick and took nearly two weeks to recover; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and MALAISE (Feeling sick and took nearly two weeks to recover) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite), MALAISE (Feeling sick and took nearly two weeks to recover) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and PYREXIA (Fever) outcome was unknown and MALAISE (Feeling sick and took nearly two weeks to recover) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included paracetamol and cough medicine.   This case was linked to MOD-2021-066366 (Patient Link).
Received message from patient: I think something went seriously wrong with the shots I received yesterday. I woke up in the middle of the night with the most extreme nerve pain I've ever experienced in my life in my left arm (where shots were administered) shooting from my elbow to my neck. I writhed in pain for hours before eventually managing to sleep for a few hours. When I woke up this morning I was still in immense pain and currently cannot move my left arm without severe pain. Hopefully this is just some kind of allergic reaction but I'm worried this is nerve damage of some kind. Please advise RN recommended to seek ED treatment. ED documentation: Musculoskeletal:  Right lower leg: No edema.  Left lower leg: No edema.  Comments: L shoulder and deltoid tender to palpation, full nontender ROM to L elbow and wrist, decreased ROM at shoulder due to pain, no overlying erythema over shoulder joint, compartments soft    Skin: General: Skin is warm and dry.  Comments: 7cmx3cm area of erythema to L deltoid, irregular but well demarcatd borders, no warmth, no fluctuance or induration    This is a 32 Y male who presents to ED with rash and arm pain. On arrival patient's initial triage vitals with tachycardia of 117, in the room patient heart rate below 100. He overall appears comfortable does not appear to be in distress. Left deltoid with well-demarcated area of erythema extending from the injection site, no warmth, no cobble stoning on point-of-care ultrasound, less concerning for cellulitis. Erythema is not overlying the joint, less concerning for septic arthritis. Shoulder x-ray unremarkable, no obvious joint effusion, no effusion noted on point-of-care ultrasound. Patient has 2+ and symmetrical radial pulses, skin is warm and dry, less concerning for acute arterial occlusion. No edema to suggest DVT. Compartments are soft, no recent trauma, compartment syndrome less likely. Suspect likely local inflammatory reaction following flu shot as cause of patient symptoms. Discussed case and imaging with orthopedic surgery with question of need for possible arthrocentesis if flu shot was administered into the joint space. Per Ortho if this is the case treatment would be symptomatic and would not recommend arthrocentesis. Diagnostic testing, findings and plan discussed with patient. Questions answered. Patient discharged home with plan for PCP follow-up and symptom control with Tylenol and ibuprofen.     11/19/2020 Patient sent additional message  They were unable to find the cause of the pain at the ER last night. They took X-rays and performed an ultrasound and I was subsequently released.      As of this morning I am still in pain and have very limited mobility in my left shoulder. Also, there is now a visible red splotch on my left arm around the area where the shots were administered on Tuesday.      I'm not really sure what the next steps are here but I would really like some relief.  RN reviewed with APNP, return message sent to patient with supportive comfort cares and to continue to monitor.
Fever, chills, nausea, vomiting, migraine aura, headache - onset 20 hours after dose. Took Tylenol and fever reduced from 99.9 to 98.6. Head ache persisted for 12 hours following onset. Remainder of side effects resolved within 6 hours of onset.
Approx 12-18 hours after receiving vaccine, pt developed chills, joint pain, lower extremity swelling, shortness of breath, headaches. Reports fatigue x 4 days.
mom phoned in stating pt had whelps & t101 this AM; recvd DTP on 28SEP92; referred to pvt MD: uticara lasted 35 mins;
Starting on 03/26/21 patient reports red, slightly warm itchy area to left arm with a headache. No change at present.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. In 2015, the patient received Tdap vaccination and experienced a sore arm at injection site. This case has been linked with, US2018GSK161255 reported by same reporter for events after SHINGRIX vaccination.
Admitted from facility with UTI and COVID infection. Asymptomatic and did not require treatment for COVID. Fully vaccinated. Discharged.
the patient threw up a white breast milk substance; This spontaneous report was received from a nurse referring to a 2-month-old male patient. The patient had no medical history, concomitant therapies or drug reactions/allergies.    On 22-OCT-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1676322, expiration date 21-APR-2021 at a dose of 2 milliliter, orally for immunization.   On the same date, after 1 minute of receiving the oral vaccine the patient threw up a white breast milk substance (Vomiting of medication).  The outcome of vomiting of medication was unknown.        The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and vomiting of medication was unknown.
Burn feeling, hurt in the left arm and the body. The patient referred to feel numbness and heaviness in both legs and present difficult to walk, hypertension and dry cough.
This spontaneous report was received from a physician refers to a 11 year old female patient. On 15-DEC-2014 the patient was vaccinated with GARDASIL, intramuscular in the leg (dose, frequency, lot # and expiry date not reported). Other suspect therapies included DTaP (manufacturer unknown) and LIQUID PEDVAXHIB. It was reported that DTaP (manufacturer unknown) was administered in one leg, and GARDASIL and LIQUID PEDVAXHIB was administered in the other leg, about one inch apart, at different injection sites. On 15-DEC-2014, after a few hours the patient had redness and swelling of 3 inches in diameter, and grew to size of 6 inches on morning of 18-DEC-2014, and was still red. It was unspecified that the reaction occurred in which leg. Patient did not had fever. It was reported that the parent did not know which vaccine out of the two, caused the reaction. Patient was advised not to be given TYLENOL or BENADRYL, but parent already administered both to the patient. Outcome of the events were not reported. Causality assessment was not provided. Additional information has been requested.
DTaP-HIB and Flu shot #2 (booster) in left thigh 12/30/02. Awoke 12/31/02 with red, swollen thigh; erythema 5"x6" and swelling. Circumference of left thigh 2" larger than right thigh. Walking well and afebrile. Not acting ill.
Patient called 11/8/20 and spoke with Pharmacist on Duty. Patient still having issues 10 days later with ring finger. Patient states shot was placed at the top of the shoulder by RPh. She was taking some ibuprofen twice a day and it has gotten better.
Patient was under the age of 18 at time of admininstration.  No  vaccine related symptoms experienced
With exercise, oxygen saturation drops as low as 79, I had oxygen concentrator at home , was on it 24/7 for 4-5 days,, attached oxygen concentrator to CPAP at night, it has been two weeks, able to be off oxygen during day, since I live alone, still put oxygen on CPAP at night,
Fever, red, dime-sized circle on left upper thigh at Prevnar site. Dx'd with local reaction to Prevnar approx. 1 cm diameter.
In lobby patient became faint, clammy and pale, with nausea and vomiting a small amount of clear liquid. She ate breakfast at 6:10 AM, lunch was a bag of chips. She had drank little amount of fluids during the day. (Blood pressure 113/70;Heart Rate 65) Rescue squad called their assessment and EKG were normal. Mother declined having daughter transported to emergency room, she elect to see PMD the next day. Mother reported daughter being evaluated for cardiac issues by PMD. Third rabies shot not given on advise of clinic.
Severe body aches ,sever headache ,neck pain ,stiffness in neck ,muscle pain ,chills ,fatigue ,Fever ,nausea, small rash at around injection site and burning when rash appeared.
Woke up around 4:00 am on day after vaccination with severe chills, moderate headache, mild body aches. These lasted about 36 hours then gone. Shuddering or fluttering inside right ear started at the same time and is on and off, has gotten worse.
PASSED OUT; LOW BLOOD PRESSURE; DIFFICULTY BREATHING; DIARRHEA; BACK PAIN; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 38 year old of unspecified 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 not reported, batch number: 042A21A) dose was not reported, frequency once total, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) low. The patient experienced side effects of chills, back pain, felt passed out, low blood pressure, headaches and diarrhea. The patient had difficulty breathing and went to emergency room stable at the time of reporting.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, low blood pressure, difficulty breathing, diarrhea, and chills on 06-APR-2021, and had not recovered from back pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414531-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Fever of 102.3F, dizziness, headache, nausea at 12:55 PM, responded to Tylenol 2 1/2 teaspoons given at 1:15 PM. Patient was in office at 2:30 PM with fever of 99.2. Per patient's mother, patient developed red rash around 4:30 PM. Patient was given Benadryl. On 10/26/2010 patient was seen again in the office at 9:30 AM with a temperature of 98.1F and diffuse macular papular rash on face, neck, arms, legs, abdomen, and back. Patient was given Decadron 4/Depomedrol 40 IM and will start Orapred 15/5 2 teaspoons BID x 5 days starting 10/27/2010 along with Benadryl.
SWOLLEN LYMPH NODES, MINOR RASH, SHOULDER DISCOMFORT, ALL SYMPTOMS ARE CURRENTLY RESOLVING
Arm pain at injection site from site to elbow.  8 out of 10 on pain scale if arm is lifted.  At rest hanging by side about a 2.  Pain is upon movement.
Patient received her 1st Moderna COVID vaccine on 6/17/2021.   Upon returning home the patient noted a rash on her left upper arm where she had recieved her Moderna Covid vaccine, as well as on her chest and her right arm. The patient returned to clinic and was seen by provider, MD. He documented the following:  She denies any itching, swelling, or difficulty breathing. only allergy she has had in the past is guaifenesin. The rash is petechial in scattered on both shoulders and chest. She denies taking any over-the-counter or prescription medications.  She has not had any bleeding difficulties. Recommend observation of the rash.  It may spread intake 3-4 weeks to completely resolve.  See again in clinic if she has worsening rash or any bleeding issues occur.  Later on the evening of 6/17/21 this patient reported the patechial rash had spread to her other arm and she felt a pressure in her nose. Our medical team strongly encouraged the patient to go to the Emergency Department for evaluation. Patient agreed. When our team follow up with her the AM of 6/18/21, the patient stated she chose not to go to the hospital. She stated she would go today, because she noticed excessive clotting with her menses. Again, our medical team strongly encouraged her to go to the ED. This is all the information we have up to this point.
I got Moderna Covid 19 vaccines on 03/19 & 04/16. I have been having hives since a few days after the first dose. I have had history of hives before but pretty rare, once or twice a year if any, and they go away in an hour or two. However, this time, they would repeat 2-4 times per week, 1-3 hours each time. Most time in the evenings, in my mid section but also on my legs and neck at times. Severe itches and some anxieties. I have taken zurtek a few times. I noticed no differences. I got severe hives again this morning. It is lasting longer than usual and still spreading, now all the way to my legs.   I would say in the past 5 weeks since I got the vaccine, I have been having hives about every other day. I can?t find any online articles talking about this side effect.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.08  Concomitant products were not provided.  15-Apr-2021Excursion time was reported at 9am with temperature as 34 degrees Fahrenheit respectively , total doses given for the day was 188 ,condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Participant has breakthrough case of COVID 01/17/2022 .  Tele -visit
Patient received J and J covid vaccine on 4/11/21 at an unknown location. Patient presented to hospital in cardiac arrest on 4/12/21. Patient was resuscitated and it was noted the patient had a ST elevation myocardial infarction. Due to the patient's size (246.7kg) she was unable to be treated for her condition with our equipment as she was over the weight limit for our equipment. She was transferred for additional care
Narrative: pt has unresolved joint pain after his second  covid vaccination (Moderna) in spite of RICE/medications.
1 hour after vaccine patient was sent to ER due to headache, weakness, dizziness, nausea. She may have had tongue swelling. Her temperature was 101. She received TYLENOL in the ER.
On 02/27/2003, pt returned to office with erythematous warm area, measuring 11 cm wide and 14 cm long and on 02/28/2003, pt returned with 20cm long and 16 cm wide. Was given Rx for antibiotic and told to use Benadryl.
Fever during the nights of 06/13/2014 and 06/14/2014. A small rash appeared on stomach during PM of 06/15/2014 which had spread to face and chest by 06/16/2015. Rash is slightly itchy.
About 36 hours after administration I started to feel swelling, tenderness in my cheeks.  I did have dermal fillers about 2 years ago in   the affected area.  I have taken Diphenhydramine 25 mg and am applying ice to the area.
shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SHOCK (medically significant), outcome "unknown". Clinical information: The patient reported that they called because they had side effects. They already had the shock and they had serious side effects from it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pregnant 17 weeks, Due August 14 2021 Adverse effects: Muscle aches, headache, low grade fever, sore injection site
Patient presented to emergency room on 11/17/2021 after falling. He was hypoxic and was found to be COVID-19 positive. He was intubated and was transferred to intensive care unit. Patient's admission was complicated by bacterial pneumonia and CVA. Patient was discharged to LTAC on 12/9/2021. Patient's condition continued to worsen and was placed on comfort measures on 1/11/22. Patient expired at LTAC on 1/12/2022.