chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My wife tested positive for COVID-19, I was not having symptoms but my wife said I should take a test to be safe. It was positive but I did not have any symptoms. The next day I was having a fever, chills, a terrible cough, and severe cough. I was basically sleeping through most of it. I did get put on the PAXLOVID as well.
Fever run between 101-102; Chill; This is a spontaneous report received from a contactable pharmacist (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EJ1686, Pfizer ), via an unspecified route of administration on 05Jan2021 and second dose of bnt162b2 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL4262) both as a single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications in two weeks of vaccination. On 08Jan2021, the patient experienced fever run between 101-102 with medications along with chill. Fever still didn't subside after 1 week of the 2nd dose. The events assessed as non-serious. No treatment was received for the events. The outcome of the events was reported as not recovered.   Follow-up (07May2021): Follow-up attempts completed. No further information expected.
1/14/10 3pm - developed more severe wheezing than usual and tingling pain runny down L arm into forefinger and thumb. Treated wheezing w/albuterol and its subsided by 7 pm. Arm pain lasted 3-4 days and now resolved. Did not seek med tx as all sxs. resolved.
pt experienced sensation in left arm shoulder to fingertips, nausea, cotton mouth, cold shivering, hypertension 142/94 pt given 25 mg Benadryl ems transport
I noticed my injection site was itchy and looked in the mirror to see a large red mark; I noticed my injection site was itchy and looked in the mirror to see a large red mark; General aches; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (General aches), VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark), VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 29-Sep-2023, the patient experienced PAIN (General aches). On 30-Sep-2023, the patient experienced VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark) and VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark). At the time of the report, PAIN (General aches), VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark), VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Patient received flu and COVID shot on Thursday at the clinic at around 9:30 A.M.  Patient had fever and chills on Thursday night and general aches on Friday. On that Saturday, the patient went to take a shower and noticed that the injection site was itchy and looked in the mirror to see a large red mark in there.  Treatment information was not provided.
Five days after the shot, I have a large rash/ hives on my left arm, but not at the injection  site. It is lower on the arm at the elbow. It is a large red, angry looking rash with elevated hives/urticaria. Zyrtec helps bring the rash down but showering / heat brings it back. It is painful to the touch.
Fever (did not measure); Vaginal bleeding (off schedule Menstrual period after 2nd shot; 2 Menstrual Periods in FEB2022 Before and after 2nd shot; Sore Left Arm after 2nd shot; Headache after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot), HEADACHE (Headache after 2nd shot) and PYREXIA (Fever (did not measure)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot) and HEADACHE (Headache after 2nd shot). On 18-Feb-2022, the patient experienced PYREXIA (Fever (did not measure)). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (off schedule Menstrual period after 2nd shot), MENSTRUATION IRREGULAR (2 Menstrual Periods in FEB2022 Before and after 2nd shot), VACCINATION SITE PAIN (Sore Left Arm after 2nd shot), HEADACHE (Headache after 2nd shot) and PYREXIA (Fever (did not measure)) outcome was unknown.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-492302 (Patient Link).
1 hour and 30 minutes after the shot I suddenly felt loopy and not steady on my feet - It lasted for 2 hours and then went away
Hives all over body- arm, legs, back. Shoulder, stomach, thighs, buttocks, hips, knees..  Has persisted now for one month following injection although beginning to subside on certain areas like left arm but still present on right arm and other parts.  As hives subside., bruising follow so I suspect Uticarial vasculitis.
Patient woke up with a rash at the injection site on the left arm 8 days after dose 1 of Moderna vaccine. Rash was red and circular with a lighter color in the center and about an inch in width and height. Rash was not painful, firm, warm, or itchy. Rash grew vertically throughout the day to about 3 inches in hight. Patient took an oral antihistamine (alegra) at 7pm. The following morning at 8am rash reverted toward original shape and size. Rash was 99% gone by 11am that second day.
Patient reports redness, pain, swelling, fever at injection site 2 hours after vaccine lasting for several days.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.  No Medical History information was reported.   On 31-Mar-2021 at 3:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 72.47 for dose administered on 31-Mar-2021.  No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
positive of covid 19; positive of covid 19; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive of covid 19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
I begin feeling lightheaded, my face started feeling flushed, my body was tingling, EMT took my blood pressure and it was high with a high heart rate, headache. Kept having chronic daily headache since the vaccination.  Now I'm on medication for the headaches. Having imbalance like I can't walk or feel like I'm going to fall over.
Multiple neurological symptoms which worsened with each injection in symptoms, frequency and intensity. It began with fatigue, dizziness, nausea, scalp rashes, joint and muscle pain, and head pressure and migraines. As symptoms piled up after each of the three injections I began to experience the following symptoms. Some on a daily basis with episodes of increased symptoms: Intention tremor; Muscle spams; Unilateral muscle weakness-left; Flexor response to plantar stimulation;  photophobia; Incoordination; Gait instability; Visual changes; Shuffling gait; Facial droop; Slight left foot drop; Atypical bipolar affective disorder; Diplopia; Cognitive difficulty; Aphasia; Myalgia and myositis; Hypopotassemia; Paresthesia; Hyperreflexia; Vitamin B 12 deficiency; Rashes on scalp and neck; Head pressure; Orthostatic Hypotension; Chronic fatigue; Intractable hemiplegic migraines; Cervicalgia; Low back pain; Sciatica; Abdominal pain; Nausea; Multiple neurological symptoms; Eyelid drooping; Viral warts; Swallowing difficulty; Shortness of breath/difficulty breathing; Syncope; Otisits; Otalgia; Urinary incontinence; Pruritic disorder; Myalgia and Myositis; Malaise and fatigue; Right cervical radiculopathy; Dizziness and giddiness; Migraines with aura. I eventually had to be hospitalized with inability to walk due to weakness, tremors, and vision changes.
Moderna Bivalent Booster 0.25mcg was given to patient, patient was to receive 0.5mcg. Patient received wrong dose.
aches / pains; headache; nausea; fatigue; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Clot" (unspecified if ongoing), notes: patient was on blood thinner; "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for blood cholesterol. Vaccination history included: Bnt162b2 (in left arm at 12:00 as dose 1, single), administration date: 26Jan2021, when the patient was 81 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "aches / pains"; HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 28Feb2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 28Feb2021, outcome "not recovered", described as "no appetite". The events "aches / pains", "headache", "nausea", "fatigue" and "no appetite" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, headache, nausea, fatigue, decreased appetite.  Additional information: It was reported that patient was taking an unspecified blood thinner. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Events were experienced two and a half weeks ago and the patient still had nausea, was "very titrated" and had no appetite. On 02Mar2021, the patient received ninth dose of unspecified product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
inflammation; dizziness; was tired for a couple of days/exhaustion; pain in chest/mild activity it gets worse; hard time breathing like they wanted to faint; confusion; regular symptoms/symptoms were off and on; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (regular symptoms/symptoms were off and on), CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion) and INFLAMMATION (inflammation) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore). On 04-Dec-2021, the patient experienced CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), DIZZINESS (dizziness) and FATIGUE (was tired for a couple of days/exhaustion). On an unknown date, the patient experienced INFLAMMATION (inflammation). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Inflammation, at a dose of 500 mg for past 3 days. In 2021, VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, CHEST PAIN (pain in chest/mild activity it gets worse) and FATIGUE (was tired for a couple of days/exhaustion) had not resolved and DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), INFLAMMATION (inflammation) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient had been taking Tylenol for the past 3 days with hopes that it help with inflammation but had not been working. Patient had never tested positive for covid19 but did note that near the beginning Covid19. The patient had gone to (city name) and came back with a supposedly infection in chest which lasted for 3 months where had constant fever, chest congested, completely wiped out and the only thing that had helped her get better was a steroid. Patient did not have a past medical history of any other heart conditions.
Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Disabled child (16 year old male with special needs disabled and non-verbal) since an unknown date.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The mother of the consumer said the consumer is disabled and non-verbal, but he appears to be fine.
She tested positive  COVID on 12/08/2022 with progressive respiratory symptoms.  She over the course of the next ten days declined from a respiratory standpoint with progressive COVID respiratory symptoms, became unresponsive and expired on 12/18/2022.
Information has been received from a licensed vocational nurse concerning a patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 02-NOV-2015 the patient was administered the first dose of GARDASIL 9 (Lot# L016428 with expire date of 30-JUL-2017), the second dose (Lot# L020015 with expire date of 16-AUG-2017) on 01-FEB-2016, and the third dose (Lot# L043213 with expire date of 28-AUG-2017) on 20-APR-2016 all intramuscularly (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medication and drug reactions / allergies were unknown. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA )Lot # M009786,  expiration date 26-MAY-2017) dose and route were not reported for prophylaxis. No adverse affects were reported. No product quality complaint was involved. Additional information has been requested.
79 y.o. female who presents to ED on 3/16/2021 with body aches, headache and nausea/vomiting.  Patient's daughter reports patient received the Johnson & Johnson single-dose Covid vaccine 4 days ago (on 03/13/2021 at about 3 PM.) prior to ED visit.  The next morning woke up not feeling well.  Has had generalized body aches and headache.  Has also had nausea and vomiting.  Patient is able to tolerate some fluids, but anytime eats anything will vomit.  Reports has had some loose stools.  Denies blood in the stool or vomit.  Reports aching pain to the abdomen, not worse in any particular area.  Has pain to the right side of the chest that has been constant for the last 3 days.  Chest pain is worse with movement and standing, but not worse with exertion.  Denies difficulty breathing, cough, fever, sore throat or congestion.
Sudden onset new blurred vision. Started morning after vaccine, slightly improved on day 2 but not back to normal. Included mild bilateral eye pain.
discomfort; couldn't sleep; joint pain; Injection site discomfort; unexpected benefits; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in late January or early February 2019). Concurrent medical conditions included joint pain (from shingles).   On 20th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, 3 days after receiving Shingrix, the patient experienced joint pain. On 20th May 2019, the patient experienced unexpected therapeutic effect. On 17th June 2019, the patient experienced sleeplessness. On an unknown date, the patient experienced discomfort and injection site discomfort. On an unknown date, the outcome of the unexpected therapeutic effect and sleeplessness were unknown and the outcome of the discomfort, joint pain and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the unexpected therapeutic effect, discomfort, joint pain, sleeplessness and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had to wear a special belt around his waist and brace on his knee due to joint pain from shingles. The patient received the Shingrix dose in left deltoid. After receiving the Shingrix, right away the joint pain went away and he was able to take off the belt and brace, which was unexpected therapeutic effect from the Shingrix. 3 to 4 days after receiving the Shingrix, the joint pain started coming back. On an unknown date, less than a month after receiving the vaccine, the patient had discomfort in his arm at the injection site, that lasted 3 days. On 17th June 2019, the day before reporting date, the patient walked around a lot and last night couldn't sleep due to the discomfort. The reporter did not consent to follow-up.
Almost immediately after the vaccine at the injection site I  got a real bad hot sensation.  For about 2 days it was swollen and had localized pain for about 9 days.  I was very fatigued.   And I developed a severe headache the next day that was so bad I could barely stand it.  4/11 I  went to the Primary Care and saw a  dr who took bloodwork and prescribed some iron because she said I was anemic.  But for about the first 3 days after the vaccine the headache pain intensity level was at a 10, then it lowered on its on to about a level 3 but was still there for about 3 more days and after about day 6 the headache intensity returned to a level 10 and on day 8 I went back to the dr because nothing would relieve the pain and the pain was so intense I couldnt bare it.  I had an MRI on 4/21 which came back normal with sinus pressure present and finally about 4/23 the headaches finally subsided.   I also notice  the next 2 menustral cycles  after I had severe cramping and my breast got really tender and sore and I bled longer than usual which is abnormal for me and I also noticed I had developed a cyst in my right breast and had a mammogram performed which did show that I had a large cyst in my breast
As the RN, I did not reconstitute the bottle of 5-11 year old pfizer COVID vaccine prior to giving the shot. Father is aware, my MD is aware. Patient received 0.03 mcg too much.