chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and FATIGUE (felt tired) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 31-Jan-2021, CHILLS (chills) and FATIGUE (felt tired) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
3:45 3/30  Dizziness 7:30 3/30  Pain at Injection Site Extreme Stomach Pains Dizziness 8:30 3/30  All of the above plus Chills and Headache 9:30 3/30  All of the above Dizziness getting worse 3/31 Dry Mouth Injection Site Pain Chills Severe Dizziness Weakness especially in legs Stomach Pains  Tiredness Headache (Called Doctor and was prescribed Meclizine) 4/1 Arm Pain went away Diarrhea started Extreme dizziness and weakness-Meclizine not helping  Low grade fever of 100.3 Chills Achy Headache Tired  4/2 Bad headache on left side of head Extreme Dizziness and Weakness Fever of 101.4 Chills Tired
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Patient has history of passing out when getting blood drawn. As patient was standing to get vaccination card filled out, he told associate to call RPH that he wasn't feeling well. I ran out to give my attention and patient was sweating and looked dizzy. His eyes started to shut while he was standing and as I was holding his arm and back to support him he started to fall to the ground. Patient gently went to the ground, I pushed him over to one side and he was out for about 3 seconds and woke back up. Patient was very hot and sweaty. He wanted to move to a more private area so I made an area with a privacy panel available to him. Patient stated to me that he has no history of seizure, but suffers from mild anxiety. Myself or one of the associates was with him for approximately 45 minutes just to make sure he was ok. His blood pressure was taken (twice) and water was given. His BP readings were normal. Patient was on his way. Moderna series completed.
This boy had a fist size bump at the injection site and slightly swollen lymph nodes on the side of injections.
1530:This RN to car pt reports hives to chest and swelling to mouth.Urticaria noted to anterior chest.Pt's husband states her cheeks appear swollen.HR100,BP 100/70. EMS called immediately.Pt removed from car 1537 and transported to medical tent, laid flat.Upon arrival to tent pt states "I feel like my throat is closing." Pt did bring her own epi pens. This RN verified epi pen dosage 0.3mg and administered to left thigh 1539.EMS arrived 1542, report given to paramedic.Pt reports feeling better after epi pen administration, hives are improving to neck. EMS team transported pt to back of ambulance and to Hospital. Pt's husband updated.
Dizziness started day after 2nd  dose of vaccine.   I had dizziness the first day after 1st dose, but that went away the next day, and I thought it would go away again.  But after the 2nd dose the dizziness has not gone away, and just the last two days has seemed to increase.  I visited my PCP today and she advised me to report to the CDC  just in case, in addition to treating me with meclizine, exercise and follow up,
Today, my arm started to feel sore again. When I removed my shirt to look at the site I immediately realized this was the injection site. It has a warm, red, raised area that is protruding with a hard lump. It itches slightly and is sore as it was the first bit after the initial injection.
On July 24, 2021, three days after her vaccination, pt fell to the floor in the family room of her home and was unable to sit up or stand.  Paramedics took her to the emergency room at. She was given a series of tests that revealed a major infection - possibly life threatening.  The doctors could not immediately identify the source of the infection.     She was admitted to the hospital, and tests were continued throughout the night.   Early the next morning, an MRI scan revealed that her appendix was about to burst.  She was rushed into surgery where her appendix was removed via laparoscopic surgery.   (Continued on continuation page)The diagnosis of appendicitis was very surprising.  She never had any abdominal pain from the appendicitis.  People her age seldom get appendicitis, but there have been some reports of a slight increase in appendicitis after receiving a Covid19 vaccination.   Her primary care physician did not know if her appendicitis was caused by the vaccination, but other physicians have said that coming down with appendicitis 3 days after her vaccination was too much of a coincidence to not blame the vaccination. After 9 days in the hospital, she was transferred on July 2, 2021, to a Post-Acute Care facility.  At this point her infection had been cured, but she had difficulty walking, even with the aid of a walker. She also suffered from urinary and bowel incontinence.  Unfortunately, a resident in a nearby room, came down with the Delta variant of Covid19.  Therefore, the entire facility was placed in lockdown. Pt had a miserable time at the facility.  During the lockdown, patients were confined to their rooms.  No visitors were allowed.  The facility became vastly understaffed. and members of the staff were unable to attend to her urinary and bowel movement needs in a timely manner.  The food service deteriorated to the point where many meals were almost inedible. The one good thing about her stay at the facility was the physical therapy staff.  They were excellent. Although they could not take patients to their physical therapy gym, they worked with pt in her room.  Her ability to walk around with the aid of a walker improved significantly. Several things needed to be done to prepare for her return home.  Toilet handlebars and a raised toilet seat were added to the bathroom.  It was also necessary to prepare a first-floor room with sleeping facilities for her. This involved a clearing out the room and adding a wardrobe closet, a set of drawers, lamps, and a new bed and mattress. Pts insurance ended its partial coverage partial coverage of nursing home expenses ended after 3 weeks, and she had to pay the entire cost of her final week there.  However, she did get her second dose of the Covid19 vaccine during that extra week. She returned home on July 31, 2021.  She felt like she had just returned to Earth from outer space.  At this point, she no longer had the incontinence problem and could walk reasonably well with a walker. Today she can do some limited walking without the walker.
Pt describes redness beginning Mon eve-Tues. increased redness, itching began. Continued thru yesterday. Today, day 4, after initial vaccine was administered-17 mm long with pink discolored skin-12 mm wide with slight bruising.
Itching burning eyes, severe nasal congestion, severe headache behind eyes, aching joints, cough, flushed and low temp later in the evening
SWOLLEN UPPER LIP; SLIGHTLY NUMB UPPER LIP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced swollen upper lip. On 08-MAR-2021, the subject experienced slightly numb upper lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly numb upper lip on 08-MAR-2021, and was recovering from swollen upper lip. This report was non-serious.
seizures; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 1st February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th July 2021, 13 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). The patient was treated with zonisamide (Zonisamide). On 28th January 2022, the outcome of the seizure was recovered/resolved.   It was unknown if the reporter considered the seizure to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: Consumer reporting patient having seizures after Bexsero administration. The patient had been taking Zonifamide since having seizures.  As per consumer, seizures developed on after Bexsero administration.  Consumer reported patient was still having seizures. It was ok for safety to follow up.  The reporter consented to follow up. This case has been linked to US2021151007, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016259:Same reporter-Deleted case US-GLAXOSMITHKLINE-US2021151007:Same reporter
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 10-NOV-2014 the patient was vaccinated IM with a dose of PNEUMOVAX 23 (lot# and dosage not reported). The pharmacist reported that a patient received a dose of PNEUMOVAX 23 from her physician, and directly afterwards went to the pharmacy and had a second dose of PNEUMOVAX 23 on the same day. No adverse effects reported. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a physician refers to a 36 year old female patient. Patient's concurrent conditions include hypothyroidism. Other relevant medical history was unknown. On 02-AUG-2014 the patient who was pregnant was vaccinated with MMR II (dose and route unspecified). Concomitant therapies included levothyroxine sodium (manufacturer unknown). Ultrasound carried on 22-AUG-2014, confirmed that the patient was pregnant with last menstrual period (LMP) calculated to be 21-JUN-2014 and estimated date of delivery (EDD) of 28-MAR-2015. Initial exposure to MMR II was at 6 week (s). The pregnancy outcome was outcome pending. No adverse events were reported. The patient sought medical attention at the facility of the physician. The outcome of the events was unknown. The causality of the events with MMR II was assessed to be not related. Additional information has been requested.
crying & irritability started about 1 hr p/needles; cont for 5 hrs a/seen; very irritable on exam & cont for several more hrs;swelling of site of DTP;
severe" pain in both thumb joints since the second dose/pretty severe joint pain in only the thumb joint; it has gotten worse/ hurts more after the second vaccine; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation and patient experienced severe joint pain, in thumb joint, both thumbs. She stated she was experiencing pretty severe joint pain in only the thumb joint. It was in both the thumb joints and they hurt pretty bad. She stated she had this event with her first vaccine, but it hurts more, after the second vaccine. She stated it has been about 3 weeks after the second vaccine. She asks if this was something that people have experienced, thumb joint pain? She stated she would like to know if anyone has specifically reported joint pain in the thumb joint. She experienced pain after the first dose of the Pfizer COVID-19 vaccine but it has gotten worse, "severe" pain in both thumb joints since the second dose. Severe joint pain, in thumb joint, both thumbs, after first vaccine, and hurts more after the second vaccine. How long should this last? The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Death 5/13/2021 Causes of death listed on death certificate: 1) COVID-19 Pneumonia
Information has been received from a 27 year old female who was vaccinated with Gardasil. Concomitant therapy Ortho Tri-Cyclen. On 17-MAY-2007 the patient experienced injection site pain, dizziness and mental fogginess that lasted four days after receiving therapy with Gardasil. Subsequently, the patient recovered from injection site pain, dizziness and mental fogginess. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a 27 year old female who was vaccinated with a dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 17-MAY-2007, the patient experienced injection site pain, dizziness, was tired, tingling and mental fogginess that lasted four days after receiving therapy with GARDASIL. It was also reported that the patient experienced pain in her arm which lasted for 5 days. No medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Exactly 5 days after receiving the shot, she started throwing up. She was around 10 girls in similar age with eating same foods. No one else got sick (i.e. stomach bug or food poisoning). She was severely threw up for nearly 20 hours. Not able to hold down any liquids at all, even Gatorade. No one else in household got sick. Younger sister got exact same affects exactly 5 days, with exact same symptoms, after receiving the first dose vaccine, too.
left arm pain; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no prior COVID vaccination. The patient had not tested for COVID post vaccination. No known allergies. The patient experienced left arm pain on 05Feb2021 21:00. The patient did not receive any treatment for AE. Outcome of the event was recovered in Feb2021.  Information on the lot/batch number has been requested.
An unknown allergy to penicillin that I never had before  that resulted In Steven Johnson Syndrome.
What to use for skin rash after shingle shot?; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked what to use for skin rash after receiving shingles shot. The follow-up would not possible as no contact details were available
felt like she was going to pass out; Tingling; blood pressure bottomed out; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported). Concomitant products included PROPOFOL, AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), VITAMIN D NOS and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting). On 29-Mar-2021, PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine came out the sides of the syringe and amount of vaccine given was unknown. She was re vaccinated with another full dose in the right arm. She was told to watch out for side affects and to call the pharmacy if she has side affects, feels lethargic or has a fever for more than 24 hours after the vaccine.
This spontaneous report as received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported for the patients. On an unspecified date in 2015, starting from and after 03-AUG-2015, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K008931, expiration date 04-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
The patient seemed to have an uneventful course until about day 7 when he noticed a red streak that appeared to be coming from his vaccination site, but did not directly emerge from there. He also described it as "very itchy". Upon inspection it appeared that he was having a local reaction to the vaccination which has been seen before in other Primary vaccinees. To be safe we asked him to RTC on Friday for F/U evaluation. Today we saw him and the erythema had extended to 15.7cm x19.2cm; was hot to touch and slightly indurated. Definitely tender to touch.  Dr. was notified and felt that the patient has since started cellulitis and put him on Keflex for treatment. He will start treatment today, so situation has not resolved. We took photos of the site; and marked him with a skin marker. We gave instructions to RTC if erythema continued to extend beyond the marker.
not all vaccine went in her arm, she states some gurgled out; A spontaneous report  was received from a female patient, unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and not all vaccine went in her arm, she stated some gurgled out.  There were no medical history or concomitant medications reported.   On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that, not all the vaccine went into her arm, and some of the vaccine gurgled out of arm when getting the vaccine. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, "not all vaccine went in her arm, she states some gurgled out" was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to the product administration error for mRNA-1273 (Lot number: Unknown).  This case concerns a female patient of unknown age, who experienced incomplete dose administration. There were no reported AEs associated with this case of incomplete dose administered.
Cold chills throughout my whole body all night long, Getting up to urinate at least 15 times during the night on the evening of the shot. The next day I was tired and slept for the most part of the day, then that night I woke up twice with a wet bed from sweating. No appetite either day. I am feeling  better today but still a bit weak.
swelling in hand; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in hand) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SARILUMAB (KEVZARA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Left-handedness and Arthritis.   In 2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 1 dosage form. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in hand). The patient was treated with PREDNISONE for Swelling, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling in hand) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications was reported. Patient was transferred to Specialty to get her a new device for the treatment. Patient had an appointment on 18-MAY-2021.
Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue
Rash 1 day after injection. Red, tiny bumps approx. 3 inch diameter around injection area. Rash itched. No treatment. Resolved in 24 hours.
I developed flu like symptoms (as with earlier moderna shots).  They  lasted approximately 24 hours.  On June 9 my spouse and I were informed that he had been exposed at work. He tested positive on June 12.  I had fatigue and worst sore throat ever but tested negative 4 times (3 over the counter and one PCR) test.  He is currently feeling better, as was I but this afternoon before I returned the phone call directing me here I started with a low grade fever.  I don't know if the Covid counts as an adverse effector not. I did recover from the initial immediate reaction though.