chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site side effects was pain, tenderness, swelling at injection site, redness and hot to the touch. General side effects was fatigue, headache, muscle pain, chills, fever up to 100.7 and felt extremely bad. All side effects except for 3 lasted until I woked up on Sunday morning on 4/25/2021  around  8:45 am.  The 3 side effects that I still have remaining on Sunday 4/25/2021 are pain at the injection site, hot to the touch and are red around the injection site.
Malfunction of the needle, 2 nd dose administered because less than half of vaccine was given
PATIENT STARTED HAVING PAIN IN HER LEFT ARM A DAY AFTER THE IMMUNIZATION. SHE REPORTED IT TO ME ON 10/18/16. SHE SAID IT CONTINUES TO HURT. SHE VISITED A HOSPITAL ER ON 09/27/16 AND RECEIVED AN RX FOR PREDNISONE 20MG TABLETS #12 TAKE 3 TABS PO DAILY FOR 4 DAYS. SHE IS CURRENTLY SEEING AN ACUPUNCTURIST FOR TREATMENT.
Got flu shot and with in 6 - 8 minutes of injection, my throat started tightening up.  I started itching all over and developed rash starting on upper extremities, chest and stomach.  I became very dizzy and hot.   Has received flu shot for the last 12 yrs without incidence.   Was laid on back and elevated legs.  Received benadryl and prednisone.  Monitored B/P. Recovered fully. No health changes since receiving last flu shot.
dizziness and throat was hoarse, monitored in the EMS room and discharged in stable condition
Please see attached office visit. 11-21-11 - PC from mom - child woke up this am with a red bumpy rash all over his body, arms, legs, trunk, even palms of hands and sole of feet - acting fine child had MMR, VZ flu 10 days ago. No available appt in office. Mom to take child to ER for eval.
Approximately 16:15, temperature  was 101 and was given Motrin. At 18:15, it was 101.8 and repeated Motrin. At 18:45, it was 104.2. Gave a vinegary and water sponge bath. Fever to 105.4. Eating poorly. On 3/29/00, call from mother with this infomation and was encouraged to take child to doctor or ER, now. Says baby has no energy to cry. Plans to take baby to ER. Was dx'd with Strep Throat and to begin antibiotics.
Noticed pruritus on chest, head and legs 48 hours past administration of immunizations - On COUMADIN - petechiae in streaks (where he scratched) noted - Esp on lower legs.
Symptoms consistent with MCAS, ME/CFS, neuropathy, anxiety, panic attacks, anaphylaxis, swelling of throat and tongue, dysautonomia, heart palpitations, widespread inflammation and neuropathy especially at sites of old or previous injury. Cognitive issues consistent with brain fog and extreme confusion.
Arm Pain; Swollen Lymph Nodes; Fever - Temperature as high as 101.0F; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, Pain in arm, Fever and Fatigue, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Swollen lymph nodes, Pain in arm, Fever and Fatigue, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101.0 (High) 101.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.
Similar generalized symptoms with flu vaccine 2 weeks ago without skin reaction - antihistamine worked to control symptoms. Since patient has the next day or two off from work I have recommended BENADRYL 25mg- 50mg every 6-8 hours for the next 24 hours, then resume daily CLARITIN. Ice to area of erythema to LUA. Ibuprofen or TYLENOL for discomfort. Should area of erythema worsen, please call office will need to consider treatment for cellulitis. Similar systemic reactions with last two vaccines - consider premedication with BENADRYL for future immunizations.
HLH (Hemophagocytic Lymphohistiocytosis); Missed second dose (46 days since first one); Extremely weak; Couldn't walk without a walker; Confused; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication, LORATADINE (CLARITINE), VITAMIN D3 and PROBIOTICS NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CONFUSIONAL STATE (Confused). On 23-Mar-2021, the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced ASTHENIA (Extremely weak) and WALKING AID USER (Couldn't walk without a walker). On 30-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)). The patient was hospitalized from 23-Mar-2021 to 29-Mar-2021 due to HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. On 29-Mar-2021, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) and CONFUSIONAL STATE (Confused) had resolved. On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) had resolved. At the time of the report, ASTHENIA (Extremely weak) and WALKING AID USER (Couldn't walk without a walker) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment:57-year-old female patient who missed second dose (product dose omission) after experiencing events of hemophagocytic lymphohistiocytosis, asthenia, walking difficulty and confusion.  The event of product dose omission is assessed as not applicable.  Based on temporality, causality for the other events with mRNA-1273 cannot be excluded.; Sender's Comments: 57-year-old female patient who missed second dose (product dose omission) after experiencing events of hemophagocytic lymphohistiocytosis, asthenia, walking difficulty and confusion.  The event of product dose omission is assessed as not applicable.  Based on temporality, causality for the other events with mRNA-1273 cannot be excluded.
PATIENT RECEIVED EXPIRED AND BEYOND USE VACCINE; VACCINE WAS STORED IN FRIDGE FOR 24 HOURS (VIAL PUNCTURED 24 HOURS PRIOR TO GIVING VACCINE); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 20-MAY-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced subject received expired and beyond use vaccine. On 21-MAY-2021, the subject experienced vaccine was stored in fridge for 24 hours (vial punctured 24 hours prior to giving vaccine). The action taken with covid-19 vaccine  was not applicable. The outcome of the patient received expired and beyond use vaccine and vaccine was stored in fridge for 24 hours (vial punctured 24 hours prior to giving vaccine) was not reported. This report was non-serious.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was inoculated with ZOSTAVAX at a medical facility as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-SEP-2016, the patient was treated at the same medical facility for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head hurts constantly. Tingling still comes and goes. It?s been 5 weeks after vaccination.
shivers, tingling constant-knees to feet, parched throat, very thirsty wist up red skin esp site of vax & neck;itchy eyes, skin all over, losing sleep, weight loss d/t nausea;
2 weeks and 2 days after receiving the vaccination I had a blood clot blown from my nose no before issues with a bloody nose and not after it was a large blood clot there was not any continued bleeding before or after. Also where the shot was given is still sore in that area and does not seem to get better this is my right arm I am exercising and not any improvement.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (Chills). In 2021, CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. On an unknown date patient was on a CPAP machine (Positive airway pressure therapy). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of on a CPAP machine and chills with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vaccinated on Saturday, woke up Sunday with ringing ears, general malaise, dizziness, stuffed up sinuses, red burning eyes, constant sneezing and dripping nose, weak and shaky on my feet. Lose of appetite, constipation and nausea.. It lasted for 4 days and on Wednesday I called my medical care giver and she said that I probably had an allergic reaction to the vaccine and to not take the next dose, as this had been my first. I am still, periodically week and dizzy, and still have little appetite.
Pt was filling dizzy, states she had lots of anxiety. She laid down for about 20 minutes after which she stated she felt better. Her pulse was normal.
Frozen shoulder on injection side.  Until testing negative for covid I have no other info.  Dr visit on April 6th.
Equipment failure - needle detached from the syringe at the time of vaccine administration. Partial dose was given to the patient.
On 12/10/2022 I test positive for COVID-19. I had a sore throat; headache;low grade fever ( 100.0 )My symptoms lasted 5 days. I took  OTC pain relievers as needed.
Shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter had shingles vaccine 10 years ago when it was only 1 dose and asked do he or she need to have a do over with the 2 injections. The reporter knew someone who had one dose of vaccine and just learned on day of reporting that she now had shingles. The permission to follow up denied.
On 3/27/00 the pt developed red papular lesions scattered on his trunk, extremities and groin. It was noted that they were not pustules and not vesicles. There was also a large area at the left deltoid (immunization site) that was red, indurated and raised with pustules at the center. It was noted that the pt had no fever or malaise. Unspecified medical attention was sought. Follow-up states the pt recovered.
Hypoxia, unknown as patient sent by assisted living facility. Patient has dementia. only 70% when on room air.
Muscle and joint pain in both upper arms (elbows and shoulders) and upper legs and hips.
Pt presented to hospital with covid hypoxic failure, pnuemonia, cdiff, VRE in urine, and acute renal failure. Pt continued to delcine with treatment and famliy signed withdrawal of care, pt deceased.
Chief Complaint: Altered Mental Status.  weak, has had decreased oral intake and lethargic.dementia, hypothyroidism, vitamin-D deficiency.  Tested positive for covid today worsening oral intake.  dexamethasone and antibiotics.
After having pins and needles and numbness at different areas all over my body and inside of my mouth and my tounge...I had an onset of a high pitched ringing in both ears. This has remained steady until the time of this report. I have contacted my PA to get an appointment to be seen my an ENT.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 22-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L041205, expiration date 20-OCT-2017 (dose and route of administration were not provided) for prophylaxis. It was reported that this was not supported as per the stability memo. No adverse effects were reported.
Post vax, the pt developed symptoms including profound generalized muscle weakness. No progression of weakness. End of day on 10/18/00, noted tiredness but did not relate to shot. On 10/19/00, pt presented to ER with inability to raise arms and walk.
pt recv vax 6SEP95 & 7JAN97 pt devel full blow chicken pox;pox-like mark appeared, & new sore appeared for approx 3 days;the pox were itchy on the first day;chicken pox were located mostly on pt chest & back;
She began running a fever two hours after getting the vaccine. By 5p her temp was up to 104.5 I took her to the hospital. They said alternate Tylenol and Motrin. She continued running high fevers for three days was vomiting couldn't eat much and was very fussy. I took her back to hospital they said continue Motrin and ibuprofen gave her antibiotic and said bring her back if need be. She continued to run high temps as high as 104.5 for three weeks. She was also fussy had no energy she just wanted to sleep. She was on Pedalyte because she couldn't keep anything down. She would wake up screaming and nothing seemed to sooth her. The site of the vaccination became bruised. She was seen at the hospital 3 times.
Patient received his first dose of COVID vaccine on 4/16/21, and he developed nausea, occasional chest pains, dyspnea, and fever ~ 4/21/21. Patient tested positive for COVID on 4/23/21  and his symptoms progressively worsened until he presented to the ED on 5/1/21. Patient was admitted to the hospital for COVID treatment, but was discharged on 5/2/21 since his symptoms rapidly improved.
Surge in Tinnitus; Burning in muscle at injection site; Sore arthritic like pain in fingers; Sore arthritic like pain in fingers; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), silodosin (SILODOSIN DSEP) at 8 mg amlodipine 2.5 mg. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 at 08:00 AM, patient experienced burning in muscle at injection site, sore arthritic like pain in fingers. On 09Mar021 at 07:00 AM, patient experienced surge in tinnitus. Since the vaccination, the patient had not been tested for COVID-19. The treatment received for the adverse event surge in tinnitus included hearing aid. No treatment was received for the other adverse events. The outcome of the events was not recovered.  Follow up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a few patients of unknown age and gender. The reporter stated that for last few months, few patients experienced burning sensation for a second after the administration of ZOSTAVAX (subcutaneous, dosage and site of administration not reported). No treatment for burning sensation was given. The outcome of burning sensation was unknown. The patients did not seek medical attention. Additional information has been requested.
Flu; 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 INFLUENZA (Flu) 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 INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL (lot # K006191, expiration date: 02-FEB-2017; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
He got his shot on 5/21/21 and on 5/23/21 awoke with profound deafness in both ears.
Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat.  Her PCP started her on oral prednisone and she is now on 10mg qod.
Rash, headache, lymph nodes swelling, fever all happened within an hour. Hair loss within a few days,  still falling out.  Had a headache through June, on June 5th I lost vision in my right eye, and mobility on my right side.  Had dealing problems and slurred speech. Still receiving therapy to walk and get back to day to day normals
Approximately 2 hours after receiving the vaccine I started experiencing sharp, ice pick deep stabbing pains in both anterior thighs. The intense pain was brief and intermittent and not the same in both thighs. This lessened within a few hours but continued over the course of the next couple of days. Since then I have a deep, dull intermittent bone pain in both anterior thighs. It was very infrequent for the last 6 weeks, increasing some at night. The last couple of days the deep pain is occurring more frequently and the episodes are lasting longer. It is in the same location as the original stabbing pains. However, the sensation is more of a deep bone ache.
Flu like symptoms the following day, chills, fever, sore bones, severe headache 2 days after 2nd dose my nose and lips started burning & tingling like I was getting cold sores or fever blisters. Lips swelled up with cold sores and canker sores inside mouth
Inflammation in upper body and hip; Burning; Tingling; Pain in upper body and hip; Feeling terrible; Muscle pain; Pain in upper body and hip; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip) and FEELING ABNORMAL (Feeling terrible) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fatty liver, Arthritis and High cholesterol.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), FEELING ABNORMAL (Feeling terrible), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, INFLAMMATION (Inflammation in upper body and hip), BURNING SENSATION (Burning), PARAESTHESIA (Tingling), PAIN IN EXTREMITY (Pain in upper body and hip), MYALGIA (Muscle pain), ARTHRALGIA (Pain in upper body and hip) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING ABNORMAL (Feeling terrible), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.