chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have been feeling sick ever since getting the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Have been feeling sick ever since getting the Moderna vaccine) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Have been feeling sick ever since getting the Moderna vaccine). At the time of the report, MALAISE (Have been feeling sick ever since getting the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.
PATIENT CALLS THE PHARMACY ABOUT 2 HRS AFTER RECEIVING THE SHOT AND COMPLAINED OF BLURRY VISION, DIZZINESS, NUMBNESS AND SORENESS IN THE ARM WITH THE INJECTION.  I INFORMED PT TO CALL MD REGARDING THE BLURRY VISION IN CASE FOLLOW-UP  IS NEEDED.  I INFORMED PT SHE CAN TAKE SOME TYLENOL TO HELP WITH THE SORENESS AND DISCOMFORT IN THE INJECTION ARM.  I TOLD PT I WOULD CALL HER BACK IN ABOUT 2-3 HRS TO CHECK ON HER. CALLED TODAY 8/16/20 AT 5PM, PT DIDN'T ANSWER AND I WAS ONLY ABLE TO LEAVE A MESSAGE
Swollen, redness and warmth, 1-3 days after injection. BENADRYL. TYLENOL.
Death:  04/20/2021 Causes of death listed on death certificate: 1) Covid
administration on 6/30/2021of Infanrix/ pregnant patient; administration on 6/30/2021of Infanrix/17 year old; Infanrix instead of Boostrix.; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 11th August 2021. The patient received Infanrix at an unknown time during the pregnancy. On 30th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the patient experienced drug exposure during pregnancy. On an unknown date, the outcome of the wrong vaccine administered, drug exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had taken Infanrix instead if Boostrix, which led to wrong vaccine administered. The patient had taken Infanrix at inappropriate age during pregnancy, which led to Inappropriate age at vaccine administration. The patient was 32 weeks pregnant at the time of call. No further events were reported. The reporter agreed on follow up. This case is linked to the case US2021149596 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149596:Same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) Negative; (2023) Negative; (2023) Positive, notes: Positive test with symptoms after two negative tests 48 hours apart. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid  from  25Jul2023 to 29Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid-19 and suspect drug cannot be excluded completely
ERYTHEMA OR REDNESS AROUD THE INJECTION SITE. NO SWELLING. NO FEVER. SORE ARM.
Allergic reaction; everything was swelling up, my feet, my toes, my hands, my stomach everything; profuse sweating; everything was swelling up, my feet, my toes, my hands; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration in the upper right arm on 06Apr2021 as dose 1, single for COVID-19 immunization (at the age of 57-years-old). Medical history included cholesterol problem from an unknown date and unknown if ongoing. Concomitant medication(s) included simvastatin and omeprazole, it was a 20mg tablet but she always took half of it so it was 10mg, taken for an unspecified indication, start and stop date were not reported. Patient initially stated she was wondering if she had an allergic reaction. She was much better that day (07Apr2021) than she was yesterday (06Apr2021). She was on Simvastatin and omeprazole and took them the night before she got her shot. Later she clarified that she had an allergic reaction to her first vaccine shot. Well, it was an allergic reaction it started out within 20 minutes (on 06Apr2021, date of vaccination) profuse sweating and she kind of brushed that off because it lasted for about she did not know off and on about an hour. And then she noticed everything was swelling up, her feet her toes her hands her stomach everything and that was when she realized she was having an allergic reaction. So, she went ahead and chewed up some Benadryl lied down took a nap slept most of the night. She was seeing signs of relief then, she meant her feet had gone down her hands had gone down her stomach had gone down. So, but she thought it was just an allergic reaction. Patient also stated that she tended to be sensitive to drugs (unspecified medications) anyway so she did not think that was anything unusual for her body because it just hated anything, it just does not like to take drugs. Patient further added that she had just a little bit of a cholesterol problem that she was on medication for. And she also wanted to ask, she was not told, not to take her usual meds the day before so she went ahead and took that statin the night before like she always did. And she wondered if that (Simvastatin) did not have something to do with it too and she also had acid reducers (Unspecified Medications, patient might be referring to Omeprazole) so she took that yesterday morning as well. Treatment was that she took Benadryl once she realized what she was going through, she went ahead and took some Benadryl. She believed it was 24 mg because she just chewed up a kitty sized one. The clinical outcome for the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Ears ringing or tinnitus on a constant basis. This is affecting my sleep and life in general and definitely as a result of the second dose of the Covid vaccine.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported. It had been stated that first vial Lot number: 050E21A Administered on 05-Nov-2021 and second vial Lot number: 050E21A Administered on 12-Nov-2021. The vial was initially stored in the refrigerator on 04-Nov-2021. The vial did not undergo any temperature excursions. Dose reported as booster. No Treatment medication reported.
First ever yeast infection with so much swelling of the labia that it felt almost hard. The symptoms were very sudden and have no underlying causes. No other changes in lifestyle or diet were made except for receiving the vaccine.
Patient was sitting in chair while person giving vaccine was standing at elevated level.  Pain Immediately  injection sight once given,  Nerve was hit by needle  Right arm/shoulder: pins/needles, numbness, muscle spasms/twitching Right Face: Pins and needles
Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/17, Pfizer, dose #2 07/16 COVID swab, result: NOT detected 09/30, Pfizer, dose #3 08/16 pt cc: chills, cough, fever, myalgias, rhinorrhea, sore throat exposure: unknown 08/17 COVID swab, result: detected
Had an itchy rash on both arms that started at wrist and and became worse. Rash also appeared on edges of both earlobes.
Tingling in arms and legs.  Cold feet, burning in the arms and trunk of the body.
On Thursday I had a little irritated throat 04MAY2023 on 05MAY2023 I felt tired on 06MAY2023 I felt pretty fatigued and had to take a nap at the Hotel.  The fatigue and body aaches continued through 08MAY2023 me thinking it was jet lag.  09MAY2023 I got an email someone had tested positve  in our vaction/tour group for COVID-19 and I took a home test and spoke with my Doctor who prescribed medications and I qaurantined for five days being vey tired and achy with no fever, I had terrible insominia. 13MAY2023 I was definitely improved getting better daily and I mask when going out with the fatigue easing and in the next few days I will go back to my exercise routine.  I used my inhaler once during this time an Abutrerol inhaler.
Patient is a 73 yo male with a history of Colon CA, s/p ileostomy, CAD s/p cardiac stent on ASA, OSA on CPAP, BPH, HTN, HLD, gout, who presented to the ED complaining of SOB. Patient was diagnosed with COVID on 9/22/21. He had no prior diagnosis of COVID. He is fully vaccinated with Pfizer in February 2021. He received Regeneron on 9/24/21. He complains of concurrent cough, loss of taste and smell, fever. There is no abdominal pain, nausea/vomiting, nor bowel habit changes. He has chronic loose stool in ileostomy. Patient states he had been hypotensive at home and therefore had not been taking his blood pressure medications. He also notes frequent urination with incomplete emptying.  Upon presentation, TMax 100.2 degrees F, BP 118/57, he was satting 94% on 3L. Laboratory values showed hyponatremia, metabolic acidosis, AKI. CXR showed prominent interstitial and few airspace opacities bilaterally. Left basal airspace opacity.  He was given decadron and admitted to med tele.
Lot# is on card at work. Had COVID in April. Flu like symptoms. Tired, ached from head to toe. No appetite. Went home and slept for 5 hours.  Next day felt a little better. Today she is back to normal.
Sore arm at injection arm over 1 month after receiving the second vaccine.; Muscle soreness in injection arm.; Hurts to lift arms over head.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 13:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 13:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 14:00, the patient experienced sore arm at injection arm over 1 month after receiving the second vaccine, it hurt to lift arms over head and the patient also experienced muscle soreness in injection arm. 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 events sore arm at injection arm, it hurt to lift arms over head and muscle soreness in injection arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The day after PENTACEL and ROTARIX vaccines were given patient's labia became red and swollen and that her lower lip became swollen. Both symptoms resolved.
1. Shot 29th ~10 AM.  2. Notice enlarging rash anteriolateral left thigh with pruritus 30th.  3. Continued enlargement of rash 8x6 inch nearly semicircle left thigh pruritic, Tx with BENADRYL.  4. 2nd May present for eval.
This spontaneous report as received from a registered nurse, refers to a 17 years old female patient. No information on patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2015, the patient was vaccinated with the first dose of PROQUAD, subcutaneously (dose, albumin status, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
I noticed I do not bleed much when I get cut or bruise when I hit my arm. This is a obvious change. I actually thought I needed to have a clotting test done prior to getting the vaccine. I would bleed nonstop for small cuts. I would bruise easily, but that does not happen now. My eyesight has also declined significantly since having COVID-19 in January.
Tested NAAT positive for COVID 12/1/21 after being fully vaccinated.
Clogged milk duct - noticed approximately 6 hours after vaccine, but it may had been there at least 4 hours prior. I had never had a clogged milk duct before even though I had been breastfeeding for about 4 months.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 16-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Intense abdominal pain on the right side of my body/ The abdominal pain (came and went) but lasted nearly 6 days and was very severe at times (like being stabbed); I also started to lose my appetite and became very weak; I also started to lose my appetite and became very weak; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 31Mar2021 at 09:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, day 4 after the first jab the patient began to feel intense abdominal pain on the right side of the body. The patient also started to lose appetite and became very weak. The abdominal pain (came and went) but lasted nearly 6 days and was very severe at times like being stabbed. Pain medications (Tylenol and Advil) helped mitigate some of the side effects. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with acetaminophen (TYLENOL) and ibuprofen (ADVIL). On 07Apr2021, the patient underwent rapid COVID-19 nasal swab test and the result was negative. The clinical outcome of the events intense abdominal pain on the right side of body like being stabbed, lose appetite and became very weak was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
p/vax pt devel a reddened sandpaper-type rash on trunk;pt exp stiff, sore neck, laryngitis, sore throat;exp fatigue, poor appetite & fever 100.3;tx w/APAP;eyes were open w/fixed gaze during this period;went to sleep;dx parasomnia;
After my second shot of Moderna. I had a low grade fever, was very achy, headache and fatigue. Also had pain at injection site as well as swelling and a red rash that that made my skin hot.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 19-AUG-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This improperly stored vaccine was exposed to temperature excursion for a sum of 72 hours, at a lowest temperature recorded of 34 degrees F (1.11111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 2 minutes after injection, patient reported he didn't feel well.  Came towards him to check on him because he looked like he was in pain. He was sitting in chair and gripping the arms of chair, looking as though he was in pain but stated he couldn't see.  Immediately, we got him to the floor and elevated his feet on the chair.  His skin was sweaty and and was breathing rapidly. Called 911 and EMT came.  Tried calming him down to slow his breathing. His blood pressure was low but started to resolve. He said his head was starting to hurt.so  after consultation he eventually went to ER to be checked out.
no additional AE's were reported; an adult patient was administered a dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 59-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022, the adult patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, at dose of 0.5 milliliter, lot number U028183 was verified to be a valid number, expiration date reported and established as 08-MAR-2023, administered subcutaneously for prophylaxis (strength was not provided) (product administered to patient of inappropriate age). No additional adverse event was reported.
Very severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very severe reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (Very severe reaction). At the time of the report, VACCINATION COMPLICATION (Very severe reaction) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 183 days after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to dTpa vaccine. Additional details were received as follows: As per reporter the number of cases was definitely dropped over the past few years. The reporter said, he was one of the lucky few to get it even with being vaccinated 6 months ago. The patient's wife had asthma and lung disease. Another social media person stated that, he or she also get whooping cough before his or her grandchildren born. But he or she did not regret. The patient stated that, in see no connection it was 7 months later, the patient received dtap before his or her grandchild born. The patient's wife would have gotten the whooping cough if she had not got the dtap vaccine. She never had the single symptoms. The patient decided to get a vaccine dose again if required.
I started having body aches and chills at about 9:30pm, I took 500mg Tylenol as I had a fever temp of 100.4. as the night progressed fever continued to climb to temp 102.5 and I started to get nausea. When I took a second round of Tylenol at 2:00am, I vomited 30 min later. Couldn?t keep water or Tylenol down until 4:00am when my fever was temp 101.2