chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, nausea, fatigue, chills, and feelings of anxiety began at approx 5PM 4/8/2021- treated with 1000mg acetaminophen at 5PM and again at 11PM. Lingering headache on 4/9/2021- treated with 200mg ibuprofen 11AM and again at 4PM. Tongue numbness began 12:30PM on 4/9/2021. Numbness was initially located on both sides and began to affect the lips at 3PM. Numbness was localized to the right side of the tongue by 8AM 4/10/2021 and still persists as of 2PM 4/13/2021. No treatment sought.
No physical reaction. Patient was given a dose of Moderna after having received Janssen previously. Patient had stated they needed their second dose of Moderna but forgot their card. A look up in state database showed no first dose given so Moderna was given to patient. In October, patient presented vaccine card which showed Janssen as first dose.
Pt received Td on 9/27/04. On approximately 10/17/204, pt noticed pain in right upper arm. Felt like a bad muscle bruise. Today 10/22/2004. Pt felt like pain lessened. Instructed to see physician.
No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 29-JUN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Extreme arm pain, nausea, vomiting, swollen lymph nodes, muscle pain, fatigue, severe headache, pain throughout entire left arm, shoulder and hand.
Pt got shots, walked out into hallway and said he felt "queasy" and passed out. He was out approx. 30 seconds and was very pale and weak for hours. Severe headache for the rest of the day.
August 2021: patient had a CT Chest Dye which showed "STABLE CORONARY ATHEROSCLEROSIS"...this chest scan showed major improvement from previous chest scans in 2016 and 2017. November 20, 2021 patient received Pfizer booster. The day after the booster she had side effects that lasted about 2 days. Side effects included fevers, chills, sweats, lethargy.  November 25: patient reported swollen gums and had to go to the dentist for support with dentures December 3-4: patient didn't' feel good, felt sinus pressure, lethargy, and just overall not "feeling well".  Patient was not seen by doctor due to long wait time December 29, 2021: patient found dead on the floor of her home. Medical examiner ruled heart failure. Autopsy later found a heart attack.
She was having regular menstrual periods every 28 days (first menstrual period approximately 8-12 months before). Shortly after the second Covid vaccine, she had her period approximately 1-2 weeks later and then has not had menstrual period since then (approximately 2.5 months since LMP). She has no medical issues, no stress, no excessive exercise, no change in diet. Taking no medications. Otherwise completely healthy.
Left arm pain and tremor in left arm that occurs on a daily basis. Pain is significant and interferes with daily activity. Tremor occurs at rest. Saw a neurologist for this who has prescribed different medicines to treat symptoms (gabapentin and Cymbalta) but symptoms have persisted. Evaluation by myself 1/27/2022 and neurologist 3/22/2022. Numerous phone discussions to discuss symptoms.
relates tightness in chest approximately 4 hours after injection-relieved by po Benadryl. Symptoms returned x 2 in next 20 hrs both times relieved by po Benadryl.
arm swollen, red, welt approx 1"x3:;lasted about 1 1/2wk;
When the name of the vaccine recipient was called, the wrong patient came in. Patient did not understand the language and thought his name was called and mistakenly verbally affirmed to the question if he's here for the COVID vaccine. The pharmacist gave the shot after the verbal affirmation in error. After realizing that it was the wrong patient, pt. asked if he had his COVID vaccine shots. He said he had 2 Moderna shots last one in 3/23 Patient said he was fine. Consulted patient that he may or may not experience the Moderna vaccine adverse reactions and that he will be contacted in 14 days to get his planned Shingles vaccine.
Allergic reaction. Hives/redness on injection site (arm). Hives/redness, mottled skin on chest and abdomen. Patient has had anaphylaxis to shellfish stated it felt the same as before.
I started with pounding in my chest, heart beating rapidly, weeks went by and became intense. I thought I had Hypoxia from wearing of mask. I went to doctor, she said it was anxiety. I went home tried to relax. In July 2021 went to see Cardiologist and told to relax prescribed antidepressant. Then I had a procedure with injection told my heart is normal. The pounding wasn't going away, increasing intensity. In September 2021 having issues at work had physical open sores all over my body. I went to see a Immunologist, told the same thing still had al these horrible skin lesions. I went to see a Dermatologist, was able to help me was prescribed Taltz medication that is very costly. After 6 weeks of taking Taltz heart doesn't pound as much and my skin is back normal.
This case was reported by a nurse and described the occurrence of arm swelling in a 4 year old female subject who was vaccinated with Infanrix for prophylaxis. On 6/08/05, the subject received the 4th dose of Infanrix, the subject experienced swelling at the injection site and "swelling in the left arm". The subject was seen at a physician's office and was treated with paracetamol (Tylenol), Benadryl and ice pack. On 6/13/05, the events resolved. The nurse considered the event to possibly be related to vaccination with Infanrix.
Generalized body rash involving areas from neck to knees. Red raised areas with itching. Still present on day 2. Went to ER in early evening on March 1, 2021. RX given for Pepcid and Kenalog. Dx: Allergic reaction to Covid-19 vaccine.
After receiving the first dose I have had fast-beating, fluttering, and pounding heart when I am active as well as on and off chest pain since vaccination. I have experienced prolong periods of fatigue, headaches, muscle pain, joint pain, sleeplessness, brain fog, forgetfullness, cold sores, erectile dysfunction, reoccuring ear infection, labrinthitus, dizziness, and blurred vision.
As reported by the mother to me the pharmacist. Mother reported her son had coughing and shortness of breath that started within an hour after receiving the flu shot. She gave him some BENADRYL and his symptoms resolved. The next morning her son said that he did not feel well. He vomited, and she told him to go back to bed to rest. Later in the day, he was sleeping and he was unresponsive and not waking up although he was breathing. They took him to the ER. The ER doctor said that his reflexes were not normal. They gave him fluids and ibuprofen and he was better, became responsive. They sent him home and said to watch him and bring him back if any symptoms returned.
Rt arm 1- site hard, painful 3 hrs post shot ice, pain killer recommended. 2- much of arm red, swollen, hot the next day, elevation, AUGMENTIN 875 BID x/8d
soreness in her arm; little fever.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in her arm) and PYREXIA (little fever.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No relevant medical history provided.  Concomitant products included DULOXETINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm) and PYREXIA (little fever.). At the time of the report, VACCINATION SITE PAIN (soreness in her arm) and PYREXIA (little fever.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included birth control medication.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090321 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090321:
She says that in the last 2 years they have had a mild case of COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (She says that in the last 2 years they have had a mild case of COVID) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She says that in the last 2 years they have had a mild case of COVID). At the time of the report, COVID-19 (She says that in the last 2 years they have had a mild case of COVID) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received 4 Moderna COVID-19 vaccines so far. Patient was going on a cruise on 6AUG2023 and are debating getting another dose of the Moderna COVID-19 vaccine. Patient never had any side effects from the vaccine so far but are concerned about that with another dose. in the last 2 years they have had a mild case of COVID.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734082 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734082:Same Reporter
Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative; Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "not recovered" and all described as "Positive rapid test 22Aug2022; symptoms started 21Aug2022 but rapid test was negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Negative, notes: COVID test type post vaccination: Nasal Swab; (22Aug2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria not Results in death/ Life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect. Facility type vaccine was unknown. Patient received no other vaccine in four weeks. Other medications in two weeks were unknown. Positive rapid test 22Aug2022; symptoms started 21Aug2022, but rapid test was negative. Patient had no covid prior vaccination. Patient tested covid post vaccination. Awareness date: 22Aug2022; Device timestamp: 23Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe orthostatic hypotension resulting in fall starting about 10 hours after vaccination, remained orthostatic for 24 hours and then it gradually resolved, accompanied by nausea, dry-heaving, and other symptoms, including chills, fever (not measured), body aches, headache, and fatigue.
Neck stiffness, knot under the injection site, redness around the injection site (size of flattened tennis ball), pain, hot to touch, severe headache, dizziness, elevated BP and generalized joint pain. Dr treating with Cephalexin 500 mg. If non-responsive to treatment, patient will be hospitalized.
c/o "something is stuck in my throat".  benadryl 50 mg im given by MD's order
8-10 hours following vaccine: Myalgia throughout body, severe pain at injection site - unable to raise arm above shoulder level and painful to move and touch. (resolved) 3 days following vaccine: Sudden onset chills, fever of 101.1, myalgia throughout body and fatigue. I slept for 14 hours straight, still have slight fever of 99.6 and some myalgia, but mostly resolved.
Pt received PNEUMOVAX vaccine shot in his left arm. Pt received the shot in the left bicep instead of the deltoid. Pt left arm is swollen & red w/warm to touch.
2:00 after the vaccine - Chills and tired/fatigue (I noticed that I had to cover up more). I felt like I was going to get a fever but I don't usually get a fever. In the morning, I had extreme light sensitivity. I couldn't read the computer and do my work. I went outside about noon and that is when I could first tolerate the light. I took the day off mostly. I was fatigued. I started getting achy and flu symptoms. And that went away. The 1st weekend of April, I had hip pain (and I normally don't have it). It was making me limp it was so bad - on the right side. That hip pain lasted two days. Around time of hip pain, I started feeling a dizzy, balance problem and had to really concentrate on my steps. I had a televisit with the NP in April. That lasted for about a month. I had difficulty walking around. My husband had the balance issue, too. I'm normally not ever dizzy. In May, it felt like my brain was inflamed. Like there was swelling in brain. The dizziness and balance issues continued into May. Those all lasted until the end of May. Around June 16th, I was starting to feel really sad for no reason, though. I realized I better get some depression meds again. I just started them this week. The one I take acts pretty quick. I had run out of refills and I had stopped taking them because I had been feeling fine all spring. I contacted my NP, and he got me a refill this week. And the medication seems to be helping with the depression. I don't have the balance thing anymore or the dizziness.
A 3 inch area around injection site is very swollen, reddish and has a rash.  Was given diphenhydramine HCI 25mg at 11:00 pm.
Woke up "feeling bad"; Not able to get up; Felt very sick; "Can't get around much"; Chills; Fever 102.6F; "Feels worn out"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much") and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation, Hypertension (High blood pressure) and Hyperlipidemia (High cholesterol). Concurrent medical conditions included Seasonal allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much"), CHILLS (Chills), PYREXIA (Fever 102.6F) and FATIGUE ("Feels worn out"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Woke up "feeling bad"), SLEEP PARALYSIS (Not able to get up), ILLNESS (Felt very sick), DYSPNOEA ("Can't get around much"), CHILLS (Chills), PYREXIA (Fever 102.6F) and FATIGUE ("Feels worn out") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 102.6 (Inconclusive) 102.6F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.89.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After receiving vaccine - GARDASIL #1 child fainted. Fell off exam table onto side of his body. No head injury at all. Child did come right to & did recover successfully.
Less than 24 hours after receiving 2nd COVID vaccine my mother develop a weird rash that mirrors a pair of socks reaching to the knees that is red in appearance bilaterally.  Then her feet began to swell to roughly triple the size of her feet.  They then turned and angry red and her toes turned purple.  Her feet have been sore and she at times is not able to walk on them because they are extremely sore. My mother developed what the medical professionals are calling COVID toe. She was taken to the ED 3 times in the course of 3 weeks and had appt's with PCP 2 times 1st PCP on day #4 was given a course of Fexeril which she finished as directed by PCP.   Enormous swelling and redness and was treated for cellulitis and peripheral edema via ED on day #6.   She has had 2 ultrasounds which have turned negative for blood clots  She has had blood work that has returned negative for any concerns. She is currently waiting on results from a CT. This is still ongoing for my mom.
pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 11th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a month after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The reporter was patient herself. One month before the reporting date, the patient received flu vaccine (unknown manufacturer). The patient experienced pain at the injection site. The patient planned to follow up with her physician on an unknown date. The patient consented to follow up. This case has been linked to US2019203732, reported by the same reporter.
At the time of vax, pt had tiny raised clear blisters on his wrist. A few days post vax, he experienced aching knee joints and then a stomach "virus." On 4/19/01, he developed "huge" hives. He was treated with Pedipred but the hives persisted. Concomitant therapy included Singulair, Claritin and "Homocort."
Varicella received 7-15-08 L arm, 7-15-08 red at site 7-16 AM increased redness 1/3 diam, RX HC BENADRYL PO and Ibuprofen, 7-18-08 less red, warm 2 cm x 3 cm. Erythematous hard, lesion hot- RX Keflex warm pack.
Patient entered the covid 19 vaccination clinic stating that they needed their bi-valent booster. Both vaccines were administered. After administration and documention, noticed they had already been vaccinated 2+ months ago with the bi-valent. Patient departed the premises prior to being aware of error. Patient did not appear to have any adverse reactions to doses prior to leaving the facility. Attempted to notify patients, but there was no answer.