chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; COVID Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Ex-smoker. Concurrent medical conditions included Lung disease (patient states that he has an underlying condition on his lungs which he sleeps with masks and takes medication ). Concomitant products included BISACODYL (ELITON [BISACODYL]) and SALMETEROL XINAFOATE (PULMOTEROL) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization) and COVID-19 PNEUMONIA (COVID Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Apr-2021 to 15-May-2021 due to COVID-19 and COVID-19 PNEUMONIA. At the time of the report, COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient refers that he didn't receive any treatment after discharge and does not recall the treatment he received while hospitalized.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
About two and a half months after receiving the bivalent Moderna vaccine, I started to show symptoms of sickness. I experienced a sore throat, ear/nasal congestion, a cough and a fever. I tested myself at home on 01/01/2023, but the test came back negative. On 01/02/2023 I had tested positive, and I went to the ER. While at the ER, they prescribed me Paxlovid. I feel that it may have helped me with my symptoms. I have not tested again to see if I have a negative result, but I will be testing tomorrow.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Additional Details: Patient called in reporting she went to the ER because her arm was swollen and red after receiving a booster vaccine. She was diagnosed with cellulitis and is being treated with antibioitcs. She stated her symptoms were resolving.
02/27/2021: Dizzy, nauseous, cramps in legs were so painful it was difficult to walk 02/27/2021-03/14/2021: cramps in legs continued to be a problem without any sign of relief 03/14/2021: Woke up at 4am thinking I had appendicitis, decided to go to the ER on 03/14/2021 at Hospital with severe abdominal pain, nothing was found on CT scan  03/14/2021-Present: continued to have abdominal pain reaching around to my lower right side of my back, was seen by OBGYN (03/30/21), Primary Care Provider (05/03/21), Gastroenterology (05/11/21), Physiatry (05/11/21) and now Neurology. Was told in to do physical therapy (05/11/21) for over a month before an MRI would be ordered. 1st MRI was ordered and came back abnormal. 2nd MRI was order with contrast and displayed a lesion at T11 in the spinal cord, 3rd MRI was ordered of the brain and cervical spine displaying lesions within the brain as well.
Gallbladder attack; This is a spontaneous report from a contactable Other-HCP (patient).   A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 02Mar2021 at 08:30 (at the age of 30-year-old)  as single dose for COVID-19 immunisation. Patient had no known allergies or other medical history. Patient did not receive any other vaccine in four weeks of vaccination. Other medications (concomitant) administered within two weeks of vaccination included Spironolactone and desogestrel, ethinylestradiol [Azurette] both administered on unspecified dates for unspecified indication. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. On 03Mar2021, at 13:15, patient had a gallbladder attack. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was treated in response to the event with pain medication: unspecified. Outcome of the event was recovering.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient).   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms.  She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm.  Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
heart attack; heart rate was low; some heavy chest pain symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had a second heart operation and in the past three weeks, four weeks" (unspecified if ongoing), notes: I had a second heart operation and in the past three weeks, four weeks. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN, The first dose was on 13Jan2021), administration date: 13Jan2021, for COVID-19 immunization; coviD-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN, The second dose was 11Feb2021), administration date: 11Feb2021, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "heart rate was low"; CHEST PAIN (non-serious), outcome "unknown", described as "some heavy chest pain symptoms". The patient underwent the following laboratory tests and procedures: Heart rate: low, notes: My heart rate was low.  Clinical course: Consumer stated that, I laid in the bed for couple of day. Well it was the third COVID shot (Pfizer COVID-19 Vaccine) that knocked me out. That COVID shot was so bad that I had a heart attack with it. My heart rate was low and I had a second heart operation and in the past three weeks, four weeks, I was given some heavy chest pain symptoms and I am trying to find out can I get a prescription refill as a preventive measure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received TWINRIX (batch number B457F, expiry date 25th September 2015).  Concomitant products included TWINRIX, TWINRIX, influenza vaccine, and TDAP. On 17th February 2015, the patient received the 3rd dose of TWINRIX. On an unknown date, less than a month after receiving TWINRIX, the patient experienced fatigue and elevated liver enzymes. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the fatigue and elevated liver enzymes to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. On 8th December 2014, the patient received a dose of Influenza (batch number TS53109, non-GSK vaccine) in an unknown deltoid. On 12th January 2015, the patient received a dose of TDAP (batch number U4870BA, expiry date 3rd October 2016, non-GSK vaccine) in right deltoid. On the same day, the patient received the 1st dose of TWINRIX (batch number B457F, expiry date 25th September 2015) in left deltoid. On 19th January 2015, the patient received the 2nd dose of TWINRIX  (batch number B45TF) in left deltoid. The patient received the 3rd dose of TWINRIX and soon after receiving vaccine, she started feeling fatigue. This feeling of fatigue had lasted for over a year. The dosage amount of the product was unknown and the patient could not locate the information on her paperwork. In addition, the patient had blood work done a year later after receiving the 3rd dose (preparation for a 12 month booster dose) and she was informed she had elevated liver enzymes. The reporter was unable to provide all of the expiration dates. The reported batch number (B45TF and B457) for 2nd and 3rd dose of TWINRIX did not exist and were updated to B457F, according to sales database.
A medical assistant reported that a 4 year old child received an injection of Acel-Immune on 09/07/00. On 09/10/00, the child developed an injection site reaction and was treated with Augmentin. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Positive COVID test; A spontaneous report was received from a nurse concerning an 71 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a positive COVID test (SARS-CoV-2 test positive).     The patient's medical history was not provided.  Concomitant product use was not provided.  On 19 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number 041120A) intramuscularly in the arm for the prophylaxis of COVID-19 infection.  On 2 FEB 2021, the patient had a positive COVID test.   No treatment medication information was provided.    Action taken with second dose of mRNA-1273 is unknown.  The patient was due for his second mRNA-1273 vaccination on 23 Feb 2021.  The outcome of the event, positive COVID test, was unknown.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273
12-year-old patient administered lower-than-authorized dose. He was given 0.2mL Pfizer-BioNTech COVID-19 pediatric 5y-11y.
The nurse in charge of vaccination at that time made an administration error; The COVID-19 vaccine was given for children between the ages of 5 to 11 years (10 mcg) instead of the vaccine for children aged 6 months to 4 years (3 mcg) that corresponded to the patient by their current age: 3 years and 9 months. Patient has not had any side effects or adverse reactions at the moment.
Patient experienced a sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient experienced a sore left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced VACCINATION SITE PAIN (Patient experienced a sore left arm). At the time of the report, VACCINATION SITE PAIN (Patient experienced a sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-405045 (Patient Link).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
Before COVID vaccine I had no health condition, all vitals were never showed anything abnormal, APE done on June-2021 was fully good but post vaccine in July-2021 every thing changed below are the details:  Had covid: Tested positive for COVID on 15-April-2021 and recovered fully in 2 weeks with negative COVID test report. Blood work done on 3rd-June and July-23rd were completely fine but somewhere around 2-3 week of Aug,  I intermittently started feeling shortness of breath, fatigue, stomach ache, was continuously consulting PCP but no medicine any other advise provided.   In 3rd week of Oct-2021 patient had-Shortness of breath, change in urine color to pink, abdominal pain, and feeling tired all time and went to see PCP again. There was a blood work done 1st week on NOv-2021 which had following major issues- Low Hemoglobin 8.0 High Protein leak in urine Blood in urine no advise from PCP other than OTC iron supplement and repeat blood work after 6-8 weeks.   Repeat blood work done in Jan-2022 had many severely bad reading with creatinine level above 9, which pushed me to ER and blood work done in ER had creatinine > 10 .   This whole this caused major injury to kidneys, several blood work, procedures were performed including plasmapheresis 3 Chemo infusions.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fever, chills, general body pain and myalgia of lower extremities. On 25th October 2018, the patient experienced fatigue, injection site erythema and injection site swelling. The patient was treated with ADVIL and BENADRYL. On 31st October 2018, the outcome of the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The caller has been already informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline (GSK). The reporter had agreed to have GSK's Safety team follow-up with them via postal mail. On the day of getting the vaccine, the patient experienced flu like symptoms, headache, fever, chill, body aches, and muscle pain in legs. The next morning (on 25th October 2018), when the patient woke up she had a temperature of 100.2 degree F, along with headache, and fatigue. The injection site was red and swollen which covered an area of 1.5 by 1.5 inch. On Thursday morning, the patient called her family doctor and she spoke with nurse. She was advised to take ADVIL for fever and pain. Her physician called back and said if the area of swelling increased in size he wanted her to go to the urgent care. She was also advised to take BENADRYL. On Friday 26th October 2018, night the redness and swelling increased in size to 2.5 by 3 inches. On Saturday morning 27th October 2018, she went to the urgent care, she had a nasal swab test done for flu, which was negative. She was advised to continue taking ADVIL and BENADRYL. Her symptoms lasted for total of 7 days and she fully recovered on Wednesday. Consent to follow up was given by the reporter. No further details were provided. The patient was referred to healthcare professional for second dose recommendation. The event did no included product complaint.
Vaccination occurred 1-8-2021 right arm began to itch and become reddened on evening of 1-20-2021.  Redness remains present and a topical hydrocortisone applied to stop itching.  This was helpful and no further issues have occurred
1:05 pm pt received H1N1 vaccine nasal spray. 1:10 pm Pt returned to vaccination area and large splotches on upper chest, face, and upper arms. No respiratory distress. No itching. 1:15 pm nurse administered BENADRYL 40 mg IM to RD. 1:30 pm rash improving. 1:45 pm rash almost completely gone. INAD. 1:50 pm pt released to care of family.
Nurse did not use the correct amount of diluent when mixing the covid vaccine. Nurse mixed the vaccine with 1.3mL of diluent instead of 2.2mL. Nurse identified error after patient left clinic. Provider aware. Charge nurse reached out to family via phone. No response from family.
Eye?s, lids, underneath swelled almost shut, blurred vision,  Itching eyes, drainage, headache, body itching, nauseous, low grade fever, -treated with Benadryl, took 4 days to return to normal eyes  With the second shot-red hot hives all on my legs and body throwing up-3/13/21
Pt c/o (BUE) Both upper extremities tingling started @ 12:56PM  Pt also c/o facial tingling in her face and her mouth. Pt. denies SOB, chest pain, SOs 97%, HR 98% 1:21PM c/o feeling light headed
This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom woke up this morning and has lost all vision following #1 of 2 Covid-19 vaccination on 02/25/2021
vaccines administered on 10/19/07, seen on 10/22/07 with muscle aches and fever. Quick strep and throat culture (-), mother states on 10/24/07 c/o severe calf pain and still has fever up to 103 deg, seen in office again on 10/25/07 with muscle pain and weakness and sent for bloodwork. ASO + Lyme were (-) but total CK 5554, diagnosed with acute benign myositis
Chills; Myalgias/arthralgias; arthralgias; Headache; This is a spontaneous report from a Non-Contactable Other HCP (Patient). A 25-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 11Mar2021 at 08:00 (batch/lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 25-years-old). The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S) and birth control taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient previously received first dose of Covid 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization at hospital. The patient has not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after receiving the second dose of vaccine on 11Mar2021 at 21:00 the patient experienced chills, myalgias/arthralgias and headache. No treatment was received in response to the adverse events. The patient was recovering from all the events at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.