chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Balance problem after booster shot; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (Balance problem after booster shot) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Balance problem after booster shot). At the time of the report, BALANCE DISORDER (Balance problem after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient reported that they had balance problems after receiving the COVID-19 booster dose.
Chest wall tightness, difficult to take deep breaths, neck paralysis, nausea and vomiting, low grade fever, vision changes. Onset 4 hours after receiving vaccine, symptoms horrible for 3 days but lasted for 2-3 weeks. Problems with vision and neck tightness still present - pt can see.
The first two shots it took a day or so before his arm got sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0183) at the age of 63 years as dose 2, single and administration date 21Jun2021 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The first two shots it took a day or so before his arm got sore.".  Additional information: Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. The first two shots it took a day or so before his arm got sore. Investigation assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
tingling sensation of the injection arm; not able to perform daily routine activities; lack of sleep; left arm has no strength like before; shooting pain over the shoulder, back, arm, hand of injection arm; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ), VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information included muscle relaxants.
Information has been received from a pharmacist concerning a female consumer with insomnia, quinolones and clavunate acid allergies and a history of shingles who on 20-FEB-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, a couple days after receiving zoster vaccine live (Oka/Merck) the patient experienced shingles pain. It was unknown whether the patient had any rashes. Medical attention was sought, the patient spoke to the pharmacy manager. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information from the pharmacist indicated that the patient was vaccinated in the pharmacy and on an unspecified date developed cold sores in her mouth and outside her lip. The patient has since recovered, and was recently in the pharmacy and "looked fine." The pharmacist did not provide additional information concerning the patient's shingles pain that was initially reported.
Vaccine administered per Doctor order. After administration of vaccine pt was laid down supine and shortly after dad called out for help. Pt seemed to be having a vasovagal episode and recovered mins after. Vitals obtained and within normal range. PCP and Nurse at bedside entire time. PCP referred pt to cardiology to have further testing done
fever 102.6, chills, headache lasted 36 hours.  started around 4-6 hours after her shot.  no anaphylaxis.  patient does not want to experience this again and refuses second shot.
cough, sneeze, runny nose, upper lips swelled & rt side of nose red patch on side of nose-rt eye swelled, tongue swollen; no resp involvement noted;
Shoulder pain; Trouble sleeping due to the pain; Still in pain when she lays down or does motion exercises. It hurts when she is taking her shirt off; Arm pain; This spontaneous case was received on 22-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05910) and concerned a 55-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included levothyroxine, used for an unreported indication.  On 28-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was P100267084.  On 30-Oct-2020, 48 hours after receiving Afluria Quadrivalent, the patient felt shoulder pain, arm pain and had trouble sleeping due to the pain. She was in pain when she was laying down or did motion exercises and it hurt when she was taking her shirt off.  On an unspecified date in 2020, the patient visited physician's office three times and was treated with muscle relaxants tizanidine and hydrocodone.   At the time of initial reporting, on 22-Dec-2020, the patient had not recovered from all events. The patient was still on muscle relaxant.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.   This case is linked to case 202008405 (due to same reporter).  Company comment: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.; Sender's Comments: A 55-year-old patient was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient arthralgia, pain in extremity, pain upon movement and had trouble sleeping due to the pain. Sleeping disorder is assessed as not related to the suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for arthralgia, pain in extremity and pain upon movement.
has covid; has covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 in the afternoon (Lot number: RS737) at the age of 59 years as dose 1, single and administered in arm right, administration date 27Apr2021 17:00 (Lot number: EW0171) intramuscular as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 05Nov2020 (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: had for years since there is something wrong with her blood; "High blood pressure" (unspecified if ongoing), notes: diagnosed more than 20 years ago; "Glucose" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); CETIRIZINE more than 20 years taken for multiple allergies (ongoing); MONTELUKAST taken for multiple allergies; GLIFAGE XR taken for blood glucose. She was diagnosed with covid 14Jan2022, however, her symptoms started Monday 10Jan2022. The patient had a choke and 13Jan2022 or 14Jan2022, cannot breathe in the night. Treatment received. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "has covid". Vein is clean the patient went to the doctor paid lot of money for the doctor to see what is the problem and they say it may be about the vaccine took the Pfizer. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive; (Jan2022) unknown result. Therapeutic measures were taken as a result of covid-19, vaccination failure. Conclusion of Previously Completed Investigation (RA): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.
Tested positive for COVID after having received the vaccine; Tested positive for COVID after having received the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is second of 2 reports.  A 7-decade-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiration date Mar2021), via an unspecified route of administration on 19Dec2020 at 0.3 mL, single in the left deltoid for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 30Dec2020, the patient tested positive for COVID after having received the vaccine. The reporter said that they had been vaccinating people at their work. The reporter had vaccinated two people now who within about a week after, they tested positive for COVID. The patient was exposed to COVID outside of work. This patient was a healthcare worker (Doctor) in his 60's, weight within normal limits. He seemed healthy. He was fit. He showed up for work everyday. He was vaccinated on 19Dec2020, then tested positive for COVID yesterday, on 30Dec2020. The reporter was wondering if the patient should still get the second dose in 3 weeks, or wait 90 days after tested positive. The reporter needed to know whether to stick with the 21 day time period for the second dose, or wait 90 days. They had been telling people who were already positive, or who had COVID in the past, to wait 90 days to get the vaccine. The reporter had read all of the literature and looked online and could not find any information on this. The outcome of the event "tested positive for COVID after having received the vaccine" was not recovered. The event was assessed as non-serious, and unrelated to vaccine by reporter. She did not think, with either of these patients that them getting COVID had anything to do with the vaccine. She thought it was a coincidence and they were obviously exposed prior to receiving the vaccine.; Sender's Comments: Based on the information currently available, the reported event "tested positive for COVID" which was further reported as getting COVID by the nurse, was likely related to patient's exposure to SARS-CoV-2 virus prior to vaccination, and unlikely causally related to BNT162B2 vaccine.  Further information like confirmative virus genome /nucleic acid detection needed for more meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021001215 Same drug and events, different patient
cellulitis, redness & swelling around each inj site (the size of a lemon);firm to touch;hot soaks & APAP;this is the 3rd this this happened on ATB 1st 2 times;
tenderness @ site of inject, elevated temp, aching all over, h/a for 1 wk, seen by MD, was put on symmetril missed 4 1/2 days work;
Right arm pain and swelling next day after vaccination. Woke on Wednesday April 7th with headache, neck pain, nausea and vomiting and chills/fever and weakness.
Have not started menstruating since receiving the first dose of the vaccine; Severe cramping for 1 day around the time should have been menstruating, but it never came; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 07Aug2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Aug2021, since receiving the first dose of the vaccine, the patient had not started menstruating. It was supposed to start on 30Aug2021, but the patient was 18 days late so far (at the time of report). On an unknown date in 2021, the patient had taken two pregnancy tests (one 2 weeks ago and another 1 week ago) and the results were unknown. The patient stated that minor fluctuations occurred in her normal cycle and she had never been this late prior to vaccination, without being pregnant. On an unknown date in Aug2021, the patient did experience severe cramping for one day around the time she should have been menstruating, but it never came. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe cramping for 1 day around the time should have been menstruating, but it never came was recovered on an unknown date in 2021. The clinical outcome of the event have not started menstruating since receiving the first dose of the vaccine was not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 39308A) via an unspecified route of administration in the left arm on 14Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.
Lethargy, nausea, general feeling of illness which progressed to severe body aches, chills, fever over 100, weakness.
Alopecia; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Alopecia".  Additional information: Reporter received a call from (Name) (last name and name of practice here) who wanted education on starting a patient of Dr. (Name) on Xeljanz. The patient's diagnosis was Alopecia, (Name) indicated this was caused by the Pfizer Covid- 19 vaccine. (Name) stated the office had reported the side effect to Pfizer Covid compliance. Reporter called Xelsource and inquired about the process to have Xeljanz covered through assistance off label. I did not give any information about the office or patient. I asked if the process is the same as a Medicare patient denial. I called Dr. (Name) office and informed (Name) that the process would be the same as that she does for her Medicare denied patients. Event did not take place after use of the product Xeljanz.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
That evening I started feeling nauseous and developed a very high fever and chills.  My body was shaking.  My heartrate was high and racing.  The military issued watch and ring that monitors heartrate kept alarming and going off because of my fast heartbeat.   I could not eat and my body would not get warm.
Abdomen: burning sensation, Mood Anxiety, heart arrhythmia, arthritis, arthrosis, blood pressure: high, Blood, high cpk levels, bowels: irritable, Bradycardia: Sinus, Costochondritis, cough, Cramp-s legs, Major depression, dermatitis, digestive gagging, Digestive nausea, throwing up, digestive problems, Dyspahagia, dyspnea, energy loss, fatigue chronic, fibromyalgia, flatulence (passing gas), flulike symptoms, gastritis, headaches: migraines, hearing: poor tolerance for loud noises, heart angina, hypertension, Hyperventilation, hypertophy, immune system: autoimmune disorder, infection: chronic to include ear and sinus, infection: constant, sleep: insomnia, joint: stiffness, laryngitis, malaise, Lymphocytosis, neurological: depression, mood swings, anxious, angry, irritable, neuralgia, Neuritis, numbness and tingling: fingers, pain: legs, pain: right shoulder, hips and leg, pain: Right hip and chest, pain: going, pain: back, respiratory shortness of breath, sleep: problems, swelling: joints, tendon disorder, thirst: increased, throat: swelling and closing, tiredness, Urinary infection, vascular disease, peripheral, vision problems, vomiting, walking trouble, walking difficulty, weakness, weigh gain, weight loss, illeus, elevated sed rate, rheumatic fever.
No Adverse event; Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received 0.5 milliliter of the dark blue cap vaccine for 6-11 years old instead of the new bivalent vaccine).    No concomitant medications were reported.   It was reported that 15 patients received 0.5ml of the dark blue cap vaccine(Monovalent) for 6-11 years old instead of the new Bivalent vaccine on 08-Oct-2022.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
This spontaneous report was received from a physician, via a company representative, referring to an adolescent male patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the third dose of VAQTA for prophylaxis (strength, route, dosage schedule and lot number were not reported). No adverse effects were reported.
Soreness and redness at injection site - very red 1/5/21 with low grade fever. Better today - not as red.
Chest pain; Severe headache; White flashes in eyes; This is a spontaneous report from a contactable consumer. This consumer reported for a 35-year-old male patient (reporter's son) received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), dose 1 via an unspecified route of administration on May2021 as dose 1, single for COVID-19 immunisation. Medical history included covid-19 from Jan2020 to an unknown date had covid in Jan2020. The patient's concomitant medications were not reported. On 2021, the patient experienced chest pain, severe headache and white flashes in eyes. Patient received covid vaccine approx 2 months ago, 1st dose, he had chest pain severe headache white flashes in eyes, he is 35 years old and had covid in Jan2020, he went to doctor after having this for 2 weeks, no tests were done but was told do not have 2nd shot or you will have stroke. I got him in to see cardiologist they ordered tests to be done, his insurance denied tests being done except a blood test. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.