chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaky; Achy; Fever 101°F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TREMOR (Shaky), PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache). On 09-Mar-2021, PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, TREMOR (Shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
rash on arm, mild to moderate, itching keeps her up at night, seems to be spreading; itching keeps her up at night; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm, mild to moderate, itching keeps her up at night, seems to be spreading) and PRURITUS (itching keeps her up at night) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (rash on arm, mild to moderate, itching keeps her up at night, seems to be spreading) and PRURITUS (itching keeps her up at night). At the time of the report, RASH (rash on arm, mild to moderate, itching keeps her up at night, seems to be spreading) and PRURITUS (itching keeps her up at night) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
PAIN AT INJECTION SITE; EXTENSIVE SLEEP; FEELING COLD; MALAISE; FEELING WEAK; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetes, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced extensive sleep. On 25-MAR-2021, the subject experienced feeling cold. On 25-MAR-2021, the subject experienced malaise. On 25-MAR-2021, the subject experienced feeling weak. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle aches. On 27-MAR-2021, the subject experienced pain at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from malaise, feeling weak, headache, muscle aches, extensive sleep, and feeling cold. This report was non-serious.
Signs/Symptoms: Dizziness, headache, sweating Time course: Patient stated that she was nervous about getting booster shot prior to getting vaccine. Patient experiencing this 20 minutes post-vaccination; patient was advised to wait 30 minute d/t anxiety and allergy to multiple antibiotics.  Treatment: Laid patient down on gurney, elevated legs, provided sips of water for an additional 30 minutes/ after symptoms completely subsided.  Patient relieved of symptoms and "felt a lot better" after an additional 20 minutes. Staff recommended she call provider or go to ER if symptoms worsen.
Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. This case was self reported by the patient. The patient experienced the side effect of dizziness. Follow-up would not possible as no contact details were available.
child recv vax & devel chickenpox over entire body;child transmitted this to sibling who devel a full blown case of chickenpox;
if she walks a little way she has shortness of breath.; very tired; urine turned dark; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and 1 patient. This is first of two reports. This 70-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:00 (at the age of 70-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history included thyroid disorder (it was taken out about eight or nine years ago). The patient concomitant medication(s) included VITAMIN D taken for an unspecified indication from an unspecified start date and ongoing; LEVOTHYROXINE (it is a hormone pill) taken for thyroid disorder from an unspecified start date and ongoing. A long time ago there was the Swine flu. She took it and felt kind of bad. She was not sure if it was live. It was only a day or something that she felt bad. Caller did not have lot or expiry for the Swine Flu Vaccine. It could have been 20 or 30 years ago. She had the vaccine on 12Feb2021. For the next few days it was very cold there. For 3 or 4 days, she did not go out the house. By the day (on an unspecified date in Feb2021) she did go out of the house, she noticed she could walk a while and then had shortness of breath. She would have to stop and rest. She was very tired. Then she walk a little more and would have shortness of breath again. She was a lot better now. Her symptoms lasted about two weeks. Her urine turned dark two or three days after vaccine. It has pretty much cleared up. Within the last five or six days she had not had that. What she really wanted to do was report it and see if it was normal. She wants to see if anyone else had gone through it. She did not have side effects for two days it was two weeks. She and her sister went through the same side effects. She was scheduled to go back for the second one today, 05Mar2021. The patient did not visited Emergency Room and Physician Office due do the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244748 same report/drug/AE, different patient.
After receiving the vaccine I experienced a lot of tingling in my face, fingers, and feet. Mainly all over my body were the tingling continues until this day. I experienced cold like symptoms the following day. The cold like symptoms lasted for about two weeks. Also I was experiencing a lot of fatigue and I felt very winded at times, to the point where I would just have to sit down until my breathing got back to normal. I looked at my wearable computing device and my heart rate was very elevated but all of my other levels were fine. I was just very uncomfortable so I went to a doctor and they did the main check up routine and also blood work. They said it will take about a week for the results to come in.
I was fever, nausea, and sore arm. About a week later, I had got a big lump on my arm that was hot to the touch and swollen and would not go down. I went to the ER. They did not know what was going on. They gave me antibiotic's to get the swollen down. My heart rate was evaluate. I went to the ER for the second time. I went to home. Later that night, my fever got worst. So I then I had to go back to the ER. They are not sure why this is happening. Now my white blood cells count is through the roof. I had to go to a cancer doctor and they clear me of any cancers.
Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection; Fever; Severe headache; Dizziness; Sensitive and pain in skin on arms; Sensitive and pain in skin on arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 12:30 (Lot number: FC3181) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: Other medical history: IBS. Concomitant medication(s) included: TYLENOL; MOTRIN [IBUPROFEN]; LEXAPRO. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 06Aug2021, Administration time: 08:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 06Aug2021, when the patient was 14 years old, for Covid-19 Immunisation. The following information was reported: GENITAL ULCERATION (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Primary complaint is Acute Genital Ulcers - negative for STD tests, ulcers have never occurred before and onset began 36 hours after injection"; PYREXIA (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 30Aug2021 08:00, outcome "not recovered", described as "Dizziness"; SENSITIVE SKIN (non-serious), PAIN (non-serious) all with onset 30Aug2021 08:00, outcome "not recovered" and all described as "Sensitive and pain in skin on arms". The events "primary complaint is acute genital ulcers - negative for std tests, ulcers have never occurred before and onset began 36 hours after injection", "fever", "severe headache", "dizziness", "sensitive and pain in skin on arms" and "sensitive and pain in skin on arms" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of genital ulceration, pyrexia, headache, dizziness, sensitive skin, pain. Additional information: The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination, COVID test done post vaccination. No known allergies, AE treatment: Pain medication  Follow-up attempts are completed. No further information is expected.
Sore arm; shaking chills; This is a spontaneous report from a non-contactable consumer.  A 38-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date not reoorted), via an unspecified route of administration on 19Jan2021 12:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She received her first dose of bnt162b2 on 29Dec2020 12:00. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with Covid-19 prior to vaccination. The patient experienced sore arm and shaking chills (reported as non-serious) on 20Jan2021. No treatment was given. The outcome of events was recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pt c/o fast heart beat reported to EMT at 1445. EMT assessed pt. HR: 68, BP: 140/84. Pt denies chest pain, unlabored breathing. Pt reports no allergies to vaccines, denies throat irritation, denies nausea. Pt escorted by EMT outside at 1455. Pt advised to wait an extra 15 minutes. Pt symptoms resolved. Pt left facility at 1530 with her son.
COUGH,CONGESTION OR RUNNY NOSE, S/T AND EAR PAIN Diagnoses   Codes Comments Cough  - Primary ICD-9-CM: 786.2  ICD-10-CM: R05  30 weeks gestation of pregnancy  ICD-9-CM: V22.2  ICD-10-CM: Z3A.30  Exposure to COVID-19 virus  ICD-9-CM: V01.79  ICD-10-CM: Z20.822
feeling unwell; Chills; Joint pain; Headache; Muscle pain; fell getting out of bed; unable to get warm; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (at the age of 78-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 04Mar2021, the patient experienced feeling unwell, chills, fell getting out of bed, joint pain, headache, muscle pain and unable to get warm. The clinical details of the events as follows: Caller stated, she got the shot on Tuesday 02Mar2021, it was fine, no problems, has had everything since then, she never had pain at the injection site and did not have a fever, but other than that she is feeling unwell, chills, was shaking so bad almost fell getting out of bed, unable to get warm, joint pain, headache, muscle pain, scared to get another dose, could she have Covid if she got the shot. It was reported that she had never had a reaction to any other shot. There was no Investigation Assessment provided. The patient outcome of the events feeling unwell, Chills, Joint pain, Headache, Muscle pain was Not resolved, and the outcome of other events was unknown at the time of this report.  No follow-up attempts are possible; No further information is expected.
being dizzy; side effects affecting eye sight, like your vision is going in and out like you seeing spots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "being dizzy"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "side effects affecting eye sight, like your vision is going in and out like you seeing spots". No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chronic pain in my left shoulder at the site of the injection. Pain got worse over a three week period. Ibuprofen and ASPERCREME seem to relieve the pain to some extent. Stretching the shoulder muscles also seems to help.
Sore arm; 6 days after vaccine-tested Covid-19 positive; A Spontaneous report was received from a consumer concerning a 44-years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid 19 and experienced sore arm.  The patient's medical history was not provided. Concomitant medications were not listed.  On 31 Dec 2021, the patient received her first dose of two planned doses mRNA-1273(Lot number:025L20A) for prophylaxis of COVID-19 infection.   On 6 Jan 2021 tested COVID-19 positive and also experienced Sore arm. Treatment details are not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, covid 19 infection and sore arm were unknown.; Reporter's Comments: Based on reporter's causality the event COVID -19 Positive is assessed as unlikely related to mRNA-1273. Further information expected.
Generalized raised itchy rash. Went to PCP and given Prednisone 20mg BID x 3 days 30mg QD x 3 days 20mg QD x3 days ZYRTEC and PEPCID taken OTC dose. Rash lasted 1 month.
Actually began with mild headache on 10/30 a few hours after the shot. The next day headache got worse with fever, dizziness, fatigue, twitching on the side of my face. As of today, 11/04/2015, 3:20 PM, still have symptoms. I have been taking 400 mg of Motrin every 6 hours. Called the doctor today and reported symptoms to receptionist. She said doctor had no availability today. I should report to pharmacy. Pharmacy was very busy and I asked to speak with manager. I told him that I was reporting adverse reaction to flu shot. He said he would have the nurse return my call. Haven't heard back.
Patient received vaccine on 8/11/21.  She developed chest pain that was off and on, lasting less than 15 minutes, described as sharp--not associated with exertion or breathing.   She also noted a warm sensation in her left calf.  Testing, but no further treatment.  Patient is advised to follow up with PCP if needed.
Red, itchy, hot, painful round rash to upper left tricep area - pt went to MD and received CIPRO.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired date 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccine was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient reported that her doctor told her that she has a condition called bronchiectasis; COPD; Emphysema; Bronchitis; but still got Pneumonia in December 2015; pneumonia; This spontaneous report was received from a female patient of unknown age via Pfizer (manufacturer control number 2016076426), referring to herself. The patient never smoked. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.     In February 2015, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot#, expiration date, strength, dose and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic obstructive pulmonary disease (COPD), emphysema and bronchitis.   On 22-DEC-2015, the patient experienced pneumonia.   At the reporting time, the outcome of COPD, emphysema, bronchitis and pneumonia was not reported.   The causal assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Follow up information was received from the patient on 28-MAR-2016. The patient reported that her doctor told her that she had a condition called bronchiectasis, on an unspecified date. She also reported that she would be getting a computarised tomography scan of her lungs on a future (unspecified date).   Follow up information was received from the patient on 25-JAN-2021. The patient reported receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in February 2015 but still got pneumonia in December 2015 (vaccination failure). The patient provided permission to contact her current nurse practitioner but stated this was not the person who administered the vaccine in 2015.
About 12 hours after vaccine was administered my arm at the vaccination site was very sore.  I was extremely fatigued.  Even so I had a fitful nights sleep feeling cold and under blankets. The next morning I was quite ill.  I had a fever, aches and pains, extreme headache even after taking Motrin.  My arm at the vaccination site was so painful that I had trouble moving my arm.  I spent the day in a reclined position only getting up to go to the bathroom.  The next night I slept better and my fever broke in the middle of the night.  I woke up the next day feeling better but still had aches and pains and fatigue.  I basically spent the day sitting around and taking naps.  My arm was still sore but I could move it on this day.  By the end of the day I felt much better.  I was able to move my arm freely at this time.  The next morning (today) I felt almost well but extremely fatigued.
Very itchy rash in injection site; Big rash in injection site, Skin Rash covering whole upper left arm injection site; Normal ache pains; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Normal ache pains), VACCINATION SITE PRURITUS (Very itchy rash in injection site) and VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (NSAIDs Allergy) and Acid reflux (oesophageal) since 1997. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal), PENICILLIN N from 24-Jan-2021 to an unknown date for Tooth extraction.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Normal ache pains). On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy rash in injection site). The patient was treated with LORATADINE (CLARITINE) for Rash, at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION SITE RASH (Big rash in injection site, Skin Rash covering whole upper left arm injection site) had resolved. At the time of the report, PAIN (Normal ache pains) outcome was unknown and VACCINATION SITE PRURITUS (Very itchy rash in injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-080634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Reporter address, patient demographics, allergies, history, concomitant medicines, rechallenge information were updated.
Mild pain with initial injection. Sudden, short term (5 min) of severe burning approx 1 hoir post injection. Morning following injection, site and muscle surrounding injection very painful with limitation in movement involving deltoid muscle
Severe diarrhea (fully liquid) for 2+ days, extreme fatigue, cold sweating, fever.
covid positive Jan 13-received sotrovimab. progressive covid infection requiring hospitalization in neutropenic pt despite full vaccination series.
From 9pm to 4am I experienced extreme fatigue and a mild headache. The next day I felt slightly sore until 2pm.
What occurred I gave patient a 3rd dose of moderna at 0.3ml in the left arm when the pt had recieved 2 prior doses of Pfizer.I called patient and at this time left message. I also asked Dr. at clinic regarding this. I also talked with my supervisor. I looked on CDC web site and saw no adverse reactions with interchanging the vaccine.
Narrative: Fully vaccinated COVID positive upon hospital admission. Presented to hospital with malaise and decreased appetite found to be COVID positive. Patient with hx of prior COVID infection.