chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diarrhea, a lower GI problem (got worse after the second); This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Discomfort abdominal, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Stool analysis: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 moderna vaccine was not applicable. Patient takes two blood pressure medications as concomitant medications. Treatment included Pepto Bismo but it did not really help.   This case was linked to US-MODERNATX, INC.-MOD-2021-040930 (E2B Linked Report). This case was linked to MOD-2021-076873 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Lab data and outcome for the event was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-040930:Same reported/different patient (Husband case)
After 2nd Vax sensitivity turned into full blown allergic reaction to ALL meat product; Immediate flush reaction in face.; Sinuses and lymph nodes swell up; Sinuses and lymph nodes swell up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing), notes: Shellfish; "Meat" (unspecified if ongoing), notes: Seemed to have a sensitivity to meat. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Phizer, lot number=EW0151, lot unknown=False, administration date=12Apr2021, administration time=09:30 AM, dose number=1, vaccine location=Left arm, No appetite for two weeks on 1st Vax), administration date: 12Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "No appetite for two weeks on 1st Vax". The following information was reported: FOOD ALLERGY (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "After 2nd Vax sensitivity turned into full blown allergic reaction to ALL meat product"; FLUSHING (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "Immediate flush reaction in face."; LYMPHADENOPATHY (non-serious), SINUSITIS (non-serious) all with onset 04May2021 07:00, outcome "not recovered" and all described as "Sinuses and lymph nodes swell up".  Additional information: No other vaccine was given in four weeks. Allergy Medication was taken in two weeks. Attempted Vegan/vegetarian food for the last 4 weeks since second dose. Although a major life adjustment, has not had any reactions. Had tested once a week with various meat. Same result. The patient got the instant vegan shot. No covid prior vaccination taken. Not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizziness for several days in a raw after tow weeks of receiving the vaccine.  The surrounding of the case is spinning and it lasts approximately 30 seconds per time.
Headache, redness and swelling at the injection site followed by large bruises, skin rash/hives all over body, fever, body aches and joint pain, vaginal bleeding while not menstruating
Conjunctivitis/pink eye. No known contact to person with pink eye.  Seems to be side effect of vaccination. Left eye is red, watery, itching.
TEMP 101.7 H/A, EXTREME FATIGUE NO COUGHING ON MONDAY. ON TUESDAY TEMP 102.7 HAS COUGH AND H/A.
Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Drug Administration amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The have removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
31 weeks pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (31 weeks pregnant) in a 28-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Thrombosis (Superficial blood clot), Spontaneous abortion on 27-Nov-2019 and Depression (Resolved). Concurrent medical conditions included Alcohol use (Alcohol use: 4-5 Drinks per week). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Jun-2020 and the estimated date of delivery was 14-Mar-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (31 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 15-Jan-2021, EXPOSURE DURING PREGNANCY (31 weeks pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor V Leiden carrier: normal (normal) not a carrier. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Scan: normal (normal) Anatomy at 20 weeks. On an unknown date, Ultrasound abdomen: normal (normal) normal.     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.   06 Jul 2020, the pregnancy test was positive.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
The pt's eyes began to itch on 11/5. By 11/6 the pt had full periorbital swelling and itching lasting 4 days. The pt also developed red rash at the vaccine site. Eventually had generalized facial edema.
Uncomfortable cold clammy sensation under right arm.  Sensation of sweating, but not actually sweating.  Seems skin was sensitive to clothing in this area.  Some sensation of around chest and back.  Felt like goose bumps.  Lasted about a month before resolving.
Pt received blisters on Rt, Lt hands & feet. Fluid filled, vesicles on hands numerous vesicles on hands. 3-4 large vesicles on Rt/Lt feet.
fatigue; headaches; nauseous; joints were hurting; bones were hurting; severe flu symptoms; so feverish; still having migraines; feel drugged; I went in severe shake mode; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting) and BONE PAIN (bones were hurting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode). At the time of the report, FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant followup
On the day after the injection, site was red, swollen and painful - about the size of a quarter. By day 3 the swelling of my upper arm was quite significant and the injection site redness had grown to the size of a baseball with a red rash like appearance spreading down my forearm to elbow.  My arm remained quite swollen and painful to the touch for 14 days in total. The swelling and redness subsided a lot this last week.  The injection site is still red, but not swollen or painful. And there is still redness spreading down to my elbow, but it is very faint now. I am due for my second dose in 3 days. And  the injection site from the first dose is not yet fully healed, but getting better slowly, and not worse.
received both vaccines, had shingles again/Suspected vaccination failure; shingles/ This summer i hafd shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had severe case of chickenpox ) and shingles (had shingles when the patient was younger ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 6-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the shingles was something to avoid if possible. The patient had shingles when he/she was younger due to a severe case of chicken pox.  After recovering, the patient made sure he/she received both vaccines. This summer (2022),  the patient had shingles again.  The patient stated that not fun. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Adverse Event: Eyelid edema in right eye Signs: Eyelid appeared droopy Symptoms: Eyelid felt heavy and fuller to the touch Time Course: First noticed after waking up at 8 am. Did not worsen but remained swollen throughout the day, slowly improving. By the next morning, eyelid was back to normal. Treatment: Damp, warm cloth press for 10 minutes Outcome: Problem resolved within 24 hours
About six hours after the vaccine, I started vomiting and had severe diarrhea.  I also had a low grade fever.  I stayed home from work the next day and rested.  By third day I feel fine.
Two days after patient received second dose of Moderna COVID-19 vaccine, he presented to the emergency department with complaints of abdominal pain radiating to his back. He denies alcohol use or fatty meals recently, does not smoke, denies nausea/vomiting/diarrhea, chest pain, shortness of breath, fevers or chills. In ED he was mildly tachycardic, otherwise hemodynamically stable.
6/16/2022   About eight hours after my vaccination, I started having a cough and wheezing. It felt like I was closing up and was having trouble breathing, like an asthma attack.   I thought maybe it was allergies. The not being able to breathe became worse and I had to use my inhaler a lot. My doctor prescribed Prednisone and a medication for the cough. This lasted about a week.
One dose of Novavax was drawn from a vial that was punctured after 12 hours.  Dose was expired around 9 hours. Patient was informed immediately after discovery and advised to come to pharmacy for another dose according to CDC recommendation. Patient understood and will come in for another dose. No harm was done in this incident.
My arm is in extreme pain and I can barely use it. I have had a massive headache for nearly 72 hours now (starting approximately 30 min after I got the vaccine) and my throat is dry and sore. I have had sharp pains in my abdomen or ovaries (can't tell where exactly) and I have very little energy.  I feel absolutely terrible.
Woke up with a headache, body aches, hot flashes (hot, then cold, then hot, then cold - no fever), sensitive/raw feeling skin all over (even scalp) Took ibuprofen, and within 2 hours, all symptoms were gone except the sore arm from injection.
The day after the shot, I felt real tired for at least a half day. My hands tingled on and off, which felt strange and kind of went up my arms slightly. I also felt slightly nausea on and off through the day. I had a slight headache most of the day, which seemed to make my head feel a little warm. About 22 hours after the shot, I felt norm
convuls like sx 7 hrs p/shot; 4 hrs p/inject fever-mom didn't take, irritable, high pitched cry; (tremors ran through while was sleeping);
Woke up this morning and I can feel a firm swelling under the skin of my left arm where the vaccine was administered. The skin is itchy. There is some redness to the skin but not sure if that is from itching or from the swelling. The swelling is about 3? across.
Dizziness; Rash; Nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), RASH (Rash) and NAUSEA (Nausea) in a female patient of an unknown age 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) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness), RASH (Rash) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), RASH (Rash) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reported muscle soreness/pain in arm and neck. Redness, swelling, heat at injection site.
6/1/16 - pt came to store w/open sore on left upper arm (not deltoid). Pt said she's had sore/open sore for several months. Patient told doctor - the problem was on going since the fall. Told Rx - since January 2016. Pt states Dr. lanced wound and cleared out. It was getter better 2 weeks ago and then sore returned. Current Dr. gave her steroid pack and will see next week.
Extreme Diarrhea for 5 days ( soiled pj?s, underwear, and clothes because it came on so fast and was so painful that I couldn?t run to the bathroom quickly enough)  Fever and chills for 5 days ( would wake up 1-2 times each night drenched in sweat) Severe headache for 4 days
Information has been received from a healthcare worker (a certified medical assistant) referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or drug allergies were reported. On 18-JUN-2015 the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (lot# also reported as L005297 with expired date 17-AUG-2016) (dosing regimen and route unknown). No concomitant medications were provided. No adverse effects were reported. Lot verification result has been received on 10-JUL-2015 and lot number L005297 with an expiry date of 17-AUG-2016 has been validated for (Oka-Merck) PROQUAD. All telephone attempts to obtain follow-up information on 03-AUG-2015 have been unsuccessful. Follow up information has been received from a telephone call on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 30-JUL-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, lot # was confirmed to be L005297. This is one of several reports received from the same reporter. Additional information has been requested. Patient's details, product, event information and narrative were updated.
This spontaneous report was received from a currently 29-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (exact dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced allergic reaction to VARIVAX. The outcome of the event was unknown. The reporter considered the event to be related to VARIVAX. This is one of several reports regarding the same patient. Sender's Comments: US-009507513-1808USA002124.
Fever of above 102 developed within 24 hrs baseball sized edema/erythema to thigh with knot.
On day of vaccination, patient reports swelling to lip, relieved with Benadryl. On day 5 after vaccine, presented to Clinic with swelling to left cheek and chin.
12 hours after injection, I developed a fever, chills, and muscle aches that resolved after 24 hours.   36 hours after injection, I developed a mild rash across my torso (mostly on my back, but some on my front) that resolved after 48 hours.
3JUN96 pt recv vax & 3PM became fussy, 4PM given APAP, 530PM called clinic advised to call MD;4JUN96 cried till 9PM given APAP 7PM; up awake till 3AM doing fine now;
CRN confused box of Trihibit and Tripedia. Child given 2 doses of Tripedia in Rt. leg. Rt leg is sore, no temp, no longer sore.
Psoriasis; woke up with hives/rash on body spreading; URTICARIA(Hives); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Lot number: EW0164) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8732 LD, Location of injection: Arm Left), administration date: 03Apr2021, for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 30May2021, outcome "not recovered", described as "URTICARIA(Hives)"; RASH (non-serious) with onset 30May2021, outcome "not recovered", described as "woke up with hives/rash on body spreading"; PSORIASIS (non-serious) with onset 02Jun2021, outcome "not recovered". The events "woke up with hives/rash on body spreading", "urticaria(hives)" and "psoriasis" required physician office visit.  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, psoriasis.
Janssen COVID-19 Vaccine EUA Rash on torso.   Still there at reporting time 48 hours later.
sick /soo sick.; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA293971, 2020SA293986, 2020SA293987, 2020SA293985 and 2020SA293971.  This case involves a patient (age and gender unspecified) who was sick /soo sick. (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick /soo sick. (Illness), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE..   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.