chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received first dose of Moderna COVID-19 Vaccine .  0.5 ml of vaccine was administered IM to client's left deltoid at 9:10 AM. At 9:11 AM, client reported feeling dizzy. Client remained seated and oxygen was administered at 6L via non-rebreather mask for 10 minutes. Vital signs, pulse and respirations were monitored for 15 minutes. Client reported feeling well after 15 minutes and was able to leave vaccination site on her after been escorted by site lead.
Sore arm / achy; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm / achy), FATIGUE (Fatigue) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosis (Systemic Lupus from 30 years.), Renal disease (lupus related kidney disease.), Heart disease, unspecified (lupus related heart disease.) and Immunocompromised (chronically immunosuppressed.). Concomitant products included PREDNISONE for Systemic lupus erythematosis, MIRTAZAPINE, ROSUVASTATIN, WARFARIN and LISINOPRIL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (Sore arm / achy), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, MYALGIA (Sore arm / achy), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 with the event was considered as not applicable.   This case was linked to MOD-2021-304463, MOD-2021-304574 (Patient Link).
Pt had DTaP #5 on 3/21/03 developed rash-erythematous mildly tender itchy and warm to touch on left upper thigh at the site of injection, size 3 x 2.5 inches.
injection site reaction, ~1.5 inch in diameter, hard, red, warm to touch, itchy
10/31/06 had flu vacc, 11/02/06 began flu symptoms, feverish, chills, headache, achy, productive cough, runny nose, sore throat, will observe for now.
11/11/21 presents to EC ED for "fever, confusion". PMH of "htn, afib on eliquis, R AKA, CHF, c diff, DVT"
feeling sick; body aches; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 15:45 (Lot number: ER8733) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "feeling sick"; PAIN (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "body aches"; HEADACHE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Headache"; FATIGUE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Fatigue". Therapeutic measures were not taken as a result of malaise, pain, headache, fatigue.  Additional information: The patient reported Few hours after the first dose started feeling sick, body aches head ache and fatigue, this lasted 48 hours. No other vaccine in four weeks. No other Medication in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Other medical history reported none was in good health prior to vaccination.   No follow-up attempts are possible. No further information is expected.
The first night I had chills and couldn't get warm with a sore arm The next day chills with hot flashes, fatigue, sore arm, body aches, and headache Presently, sore arm, swollen, slightly discolored, and solid where the vaccine was administered
flush face, ears red and hot to the touch, scratchy throat, red rash in both armpits, eczema flared over the next few days on right hand.
Red area around injection site 3 inches in diameter. Irritated looking. Not raised or warm to touch. No fever or SOB.
Redness, edema, multiple small hives, pruritis. Ice to site, Benadryl 50 mg IM, observe for 30 minutes. Gave mother of child discharge instructions. PHN contacted pt.'s pediatrician, Dr. and reported occurrence. PHN called pt.'s home and left message to call PHN.
5/27/14: Seen in office - developed itching at site and then redness and warmth was increasing x 1 wk after administration. Moderate erythema with minimal warmth over upper left arm without tenderness or drainage. Redness decreased. Resolving tx with ice and hydrocortisone.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patient of unknown age and gender. On unknown dates, since 01-JUN-2015, the patients were vaccinated with unspecified number of improperly stored doses of VARIVAX lot # K005426. No adverse effects were reported. The outcome of incorrect product storage was unknown. This case was linked to 1507USA010868 and 1507USA004524 as it was received from the same source. Additional information has been requested.
Saturday Rash started welts,red,itching on neck continued getting worse until Monday then rash ran down my spine and along  sweat lines waist, underarms, neck. Dr suggested benadryl started on Tuesday . it is now Wednesday evening and rash is slowly going away, Today swollen glands and more body aches still able to go about items of daily living with out any problems.
pt received johnson & johnson covid-19 vaccine and developed acute urticaria about 8 hours later.
1415 Patient experienced dizziness post vaccination. Provided juice. VS HR 100 regular rate. B/P 110/60 RR 20 even and non labored. Pulse ox rate of 96%. Asked patient to stay an additional 15 minutes for observation. Spoke with patient's father who was present on site. Advised of current situation and the need to stay an additional 15 minutes. 1430 no further complaints voiced. Followed up with patient and father, provided education on after care and to contact MD for any additional issues. Voiced understanding. 1445 no complaints at this time and allowed to leave vaccination site at this time. RN.
Unspecified patient was administered an improperly stored dose of Varivax; The patient experienced no symptoms; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 03-JAN-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S021320, expiration date 09-JUL-2021 (dose, frequency, route of administration were not provided), for prophylaxis. Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion from -9 to 8 C (-7.11C) for 46 hours. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. The sterile diluent used for the administration was stored properly. The patient experienced no symptoms.  The case is non valid due to lack of the patients' identifiers.
Approx  4 days after shot, when redness and tenderness subsided, began to have sporadic itching at the site.  By 8 days after vaccine, I developed red rash, inflammation, and intense itching at same location near the injection site. Have been using topical Benadryl and cortisone creams 3 times daily.  Seems slightly less red and itchy now, on day 11.
itchiness; rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), RASH (rash) and ERYTHEMA (redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (itchiness), RASH (rash) and ERYTHEMA (redness). On 11-Feb-2021, PRURITUS (itchiness) and ERYTHEMA (redness) had resolved. At the time of the report, RASH (rash) had not resolved.        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.
Sore, stiff slightly swollen arm. The following day, and very mild the third day. Neck muscles,  each side,  slightly tight 8 hours after injection, and slightly the next day.
SLEPT ALOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On APR-2021, the subject experienced slept alot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept alot on APR-2021. This report was non-serious.
Lethargic/sleepy after injection; next day arm was red with edema, had flu-like achiness and headache-resolved over 3 days; swelling area > 9 days to resolve, Benadryl.
Pt administered pfizer infant covid-19 dose instead of pfizer pediatric covid-19 dose
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with MMR II.  Subsequently the patient experienced a fever as high as 103 F, a papular rash and submandibular lymphadenopathy two weeks after vaccination.  The patient sought unspecified medical attention.  Subsequently, on an unspecified date the patient recovered from these events.  Additional information has been requested.
After receiving my second shot in June 2021 I experienced extreme eye sensitivity and pain for hours after the shot until the next day. Also 24 hours after receiving my second shot I got my period two weeks early. My period lasted six weeks and five days exactly. I experienced very heavy blood flow during my time as well as many blood clots. My normal period is not very heavy and only lasts 4-5 days due to it being regulated by birth control. Recently, on January 6th at 9 a.m. I received my booster shot. At 8 p.m. on January 6th I experienced extreme light sensitivity and eye pain which lasted until 12 p.m. the following day. At 4 p.m. on January 7th a little over 24 hours after receiving my booster I got my period three weeks early. As of today January 17, 2022 I still have my period. I am still taking the same birth control I was taking back on June 24th when I received my second shot of Moderna.
Headache after a few hours she experienced lower abd pain, cramps, nausea and for one day experienced vaginal discharge and bleeding, unrelated to her menses.  She did not call her PCP or go to the urgent care, she decided to rest and monitor herself, she did take 400mg Motrin for the headache stated that most of the adverse reactions have resolved except for the nausea and cramps. RN recommended rest, light meals such as soup and lots of fluids and to continue to monitor herself and if these sx continue to make an appt with her PCP for further evaluation. She was agreeable.
Extreme anxiety and agitation after all Moderna injections. I have had 5, and I did not sleep after them. The fifth injection caused a panic attack.
lots of blood in eye.  Still have almost a week later...not better.  Chills malaise and sick feeling for 2 days
adverse reaction began within 2-4hrs of vaccine lasted a full 24 hours post vaccine Blurred vision/difficulty seeing balance "off" Nausea and vomiting unable to remain "awake' mental fog body aches chills
Mother called on 12/19/09am and  stated her son had woke up from a nap and fever was 103.8F. So took him to ER and they got the fever down with Tylenol and Ibuprophen.  Went home and no further problems reported in phone conversation on 12/19.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 19-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reported. Additional information has been requested.
This report described the occurrence of joint pain in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 6/11/99, 7/8/99, and unspecified date in July 2000 according to the client. On 9/3/03, the patient's attorney alleged that the patient suffered joint and muscle pain. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
No adverse symptoms reported; patient was vaccinated with Recombivax on 10/3/2014and 7/30/2019, and the patient would like to receive a third dose now.; This spontaneous report was received from a medical assistant, referring to a 5 year old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions, previous drug reactions or allergies were not reported.    On 03-OCT-2014, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (strength, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On 30-JUL-2019, the patient received the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration) (strength, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported).  The reporter stated that the patient would like to receive the third dose now. No adverse symptoms or events were reported.
I  had left chest wall pain (lateral) while  breathing and laughing. I don't believe it was muscular.
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with a doses of improperly stored VARIVAX in immunization series (lot # M009767 with expiry date 23-FEB-2018, lot # M019642 with expiry date 20-APR-2018, lot # M024678 with expiry date 18-MAY-2018, dose, strength, vaccination site, route of administration were unspecified) for prophylaxis. The vaccine was exposed to a cumulative temperature of -13.4 degrees Celsius (C) for 40 hours 32 minutes. The previous temperature excursions included -13.8C for 9 hours on 19-SEP-2016, -13.6 for 18 hours 28 minutes on 20-SEP-2016, -13.4 for 12 hours 34 minutes on 21-SEP-2016 and -15.9 C for 30 minutes on 25-SEP-2016. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved.  Lot number # M024678 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck). Follow up information has been received on 01-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. No additional information is available.; Sender's Comments: ,MERCK 1610USA004625:Mfr number.
One hour after receiving first dose, I had a horribly burning throat that lasted all day. In the late afternoon, it looked like my tongue was getting thick.   My sister took me to the Emergency Center but the doctors could not ascertain the problem. For the next thirty days, I had terrible headaches, sore throat, extreme fatigue, waves of nausea, dizziness, diarrhea, a sore chest and loss of appetite. I also could not taste my food very well.  I went to the same emergency room on April 16, 2021 because I was shaking and terribly cold after taking a Claritin-D because of congestion and ear fluid/ringing.  The facility ran labs and saw that my salt level was critically low; the doctors gave me a COVID test at that time, but it was negative.  I was then transported to the Medical Center.  On the 31st day from the first vaccine dose all my symptoms disappeared.
threw up; tired; nauseous; sweaty; lost my appetite; warm; diarrhea; had low energy, lethargic; lethargic; getting the flu; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea) and ASTHENIA (had low energy, lethargic) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Allergy to animals (cat dander) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea), ASTHENIA (had low energy, lethargic), LETHARGY (lethargic), INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous). On 13-Apr-2021, the patient experienced FATIGUE (tired). On 14-Apr-2021, the patient experienced VOMITING (threw up). On 11-Apr-2021, DECREASED APPETITE (lost my appetite) had resolved. On 14-Apr-2021, FATIGUE (tired) had resolved. On 15-Apr-2021, DIARRHOEA (diarrhea) and VOMITING (threw up) had resolved. On 08-May-2021, LETHARGY (lethargic) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), SKIN WARM (warm) and ASTHENIA (had low energy, lethargic) outcome was unknown and INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-139980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18 may 2021  included  patient's demographics and medical history, second dose details, concomitant drug added and events resolved was updated for lethargy, vomiting, diarrhea.
This spontaneous report was received from a 59 year old female patient reporting on herself. Pertinent medical history was not reported. Patient had an allergy to "biophosphate", penicillin and DERMABOND. Concomitant therapies included lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 10-SEP-2014 the patient was vaccinated with one shot of ZOSTAVAX into the arm. It was reported that roughly 18 hours after the vaccination, the patient developed by noon on 11-SEP-2014 severe nausea and pain in the upper abdomen that lasted 3-4 hours and then stopped. Right after that, a rash "extending from elbow into armpit" appeared on her injection arm. Patient described it as a foot long, red and itchy with swelling and pain in arm and armpit radiating to her side. The rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness but no pain. There was no lab diagnostics studies performed. Product Quality Complaint (PQC) was not involved. The patient sought medical attention and she went to the pharmacy. She received the treatment for the adverse events, she took ZYRTEC. The outcomes of the severe nausea and pain in the upper abdomen were reported as recovered/resolved (on 11-SEP-2014). The outcome of rash "with pain" was recovered/resolved as of 15-SEP-2014. The outcomes of rash "a foot long, red and itchy with swelling" was reported as recovering (reported as "rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness"). The causality between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Briefly this is a 5 yo F with hx of neonatal stroke with L sided weakness and epilepsy presenting with breakthrough seizure. Pt had COVID-19 vaccine 2 days ago. Visiting. No fevers, URI sx. Typical seizure starts with vomiting, hand jerking/shaking, and L eye deviation. Last breakthrough seizure in Feb 2021. Sibling with runny nose. 5 yo F with epilepsy and breakthrough seizure. No symptoms of illness. Unclear if COVID vaccination was trigger for breakthrough seizure. Upon arrival, pt was post-ictal with intermittent L eye deviation and now with hand jerking which was concerning for ongoing seizure activity. Pt was given intranasal midazolam with improvement, but seizure activity returned prompting IV ativan and IV keppra load. Seizure activity stopped and pt became responsive to voice but post-ictal. 2nd IV access obtained. Labs sent with normal glucose, reassuring CBC and electrolytes. Depakote level is in therapeutic range. Pt given home dose of depakote IV (missed AM dose). Neuro at the bedside throughout resuscitation.    COVID neg.     Care transitioned to the inpatient  Neurology attending. Pt was stable at the time of admission. MRI Brain 11/12/21: IMPRESSION: Images were significantly degraded by motion artifact. 1.No evidence of acute intracranial abnormality within limitation of motion artifact. 2.Posterior frontal porencephalic cyst with associated paucity of posterior frontal and right parietal periventricular white matter. On the morning of discharge, smile was symmetric, but she was noted to be ataxic, although much less than the day prior, so we drew a peak VPA level which was 150 (peak), with otherwise normal LFTs, normal platelets and no other signs of VPA toxicity. Thus, it was felt that the ataxia is likely secondary to medication effects in the last 24-48hrs with relatively high depakote level, Midaz 0.5mg/kg total, IV Ativan, and addition of Levetiracetam. Higher level of depakote was attributed to increased bioavailability of IV medication.  We observed her through the afternoon and felt that she was stable for discharge with close Neurology follow-up with Dr. calling on Tuesday 11/16/21. We will request Neurology follow up in clinic prior to  at the end of the month.  Family is considering whether they will get her the 2nd dose of COVID vaccine.  Risks and benefits discussed.  Discussed not flying back within 2 days of dose as much harder to manage if she were to have a prolonged seizure in flight.