chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.
7 CM REDNESS AND TENDERNESS, TX: BENADRYL AND TYLENOL WARMTH AND COLD COMPRESSES, F/U IN 1 WEEK IF NOT RESOLVED.
I had a headache, chills, and a fever. Then I had tingling in my head. I started breaking out in a rash all over my face, especially on the right side and near my eye. My face swelled up completely. I went to the ER. I was diagnosed with Shingles.  I was given nerve pain medication. Later I saw another ER doctor and I was given an antiviral & steroid medication, but I was nervous to take it. I then visited my PCP, where they checked my eye.
Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured; The patient received Moderna Covid-19 vaccine after the manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date) and PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured) in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date) and PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine administrator was not sure when the vial was initially stored in the refrigerator and thought that vaccine was stored in the freezer and possibly thawed on the dates of administration. Date the vial was first punctured were: 25-Oct-2021 (time not known), 31-Jan-2022 (time not provided) and 22-Apr-2022 (time not provided). No concomitant drug was reported. The vaccine specialist (reporter) had a provider who vaccinated 6 patients with expired Moderna COVID-19 vaccine. The provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to at least 6 patients and 7 doses of vaccine past manufacturers expiration date were administered. The vial had not undergone any temperature excursions. No adverse reactions or side effects were reported. No treatment drug was reported.   This case was linked to MOD-2022-577155, MOD-2022-577164, MOD-2022-577166, MOD-2022-577168, MOD-2022-577176 (Patient Link).
Low grade fever, local reaction; erythema and induration measuring 12 cm x 6 cm, pain and tenderness.
Tachycardia for more than 24 hours with a pulse rate of 130 and low levels of potassium.
Dizziness, lightheadedness, imbalance, ataxia Nausea, vomiting Hospitalized for extensive work-up, Possible diagnoses Guillain-Barre variant (Miller Fisher)
lower back pain; sore throat; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: contains no new information and email id provided by reporter was not correct
Information has been received from a registered nurse concerning a 5 year old female who on 20-JUL-2007 was vaccinated with a dose of Gardasil. Unspecified medical attention was sought. No adverse event was reported. Additional information has been requested.
12 hours post 2nd vaccine,  severe chills and severe body aches followed by temp of 102.2 for 14 hours. After 14 hours symptoms improved with mild low grade temp of 99.3 and no flu like symptoms.
Patient received 2nd dose of Moderna Covid vaccine 7 days too early.  First dose was given on 7/13/2022, 2nd dose was given on 8/3/2022.  No adverse events/outcomes.
Information has been received from a physician concerning a 10 year old female with Crohn's Disease who on 03-SEP-1999 was vaccinated with varicella virus vaccine live (Oka/Merck) ("Lot # 0424"). Concomitant therapy included Remicade and Imuran. On an unreported date, approximately NOV 2007, the patient developed a disseminated rash with > 200 lesions of face, trunk, groin and extremities. It was noted that the patient had no recent immunization at the time. On 30 November 2007, a specimen was obtained from a vesicular lesion as part of the VZV identification program. The specimen was submitted to "differentiate vaccine reactivation". The laboratory findings indicated the specimen was of a wild type strain. The patient had not had any recent exposure to chickenpox or shingles. At the time of reporting the patient had recovered (date unspecified). Additional information is not expected.
Injection hit a blood vessel and had blood running down the arm; A spontaneous report  was received from a consumer concerning a 70-year-old, male patient, who experienced injection hit a blood vessel and experienced blood running down the arm/vaccination site hemorrhage.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 11 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) for prophylaxis of COVID-19 infection.   On 11 Feb 2021, after receiving the vaccination, the patient reported that the injection hit a blood vessel and had blood running down the arm.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection hit a blood vessel and had blood vessel running down the arm, was not reported..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.
No menstruation April 2021 - June 2021. Normal menstruation July 2021 - December 2021. Received Covid Booster 01/06/2022. Moderna Lot 068H21A at Pharmacy. No menstruation and extreme hot flashes January 2022 - April 2022. Dr ordered Progesterone challenge early May to try and jumpstart system.  Mild menstruation May 2022 - September 2022.  No menstruation since. Dr guess is the vaccine pushed me into menopause/infertility. Ongoing investigation for answers.
Extreme fatigue, lasting about 2 days.  Occasional fever.  Achy joints.  Mild nausea (no vomiting).
Post vax, the pt had a temperature of 101.6. Injection site was very painful with decreased range of motion. Took portion of meperidine tablet. He then developed hot/cold flashes and took ibuprofen.
Breakthrough Case of COVID, Runny nose, congestion, Mild headache, sneezing, a little cough, I did not feel right, I could not stop sneezing. Second day I had a very bad cough, and then it was like going into my chest, I don't want to eat, and I could not smell anything, bad cough, I can't sleep and lots of congestion, just very tired. My eyes were starting to burn, more burning eyes than a headache.
Breakthrough case admission after three vaccines Pfizer 3/18/21 Lot# EN6207;  4/13/21 Pfizer Lot# Ew0158;  Pfizer 11/30/21 Lot# 320308D
REDNESS AND ITCHING AT INJECTION SITE AND FEELING OF THROAT CLOSING UP. TOOK BENADRYL WITH SOME RELIEF AND THEN URGENT CARE AND PRESCRIBE STEROIDS.
patient developed severe thrombocytopenia approx 2-3 weeks after Moderna COVID booster
DIARRHEA; STOMACH CRAMPS; SWELLING IN ARM; PAIN IN  ARM; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive stomach.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced stomach cramps. On 10-APR-2021, the subject experienced swelling in arm. On 10-APR-2021, the subject experienced pain in arm. On 10-APR-2021, the subject experienced tired. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in arm, and pain in arm, was recovering from stomach cramps, and tired, and had not recovered from diarrhea. This report was non-serious.
Red, feverish large bump where injection was made. It hurts and itches terribly. Body aches so bad you cannot sleep.
afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, in the left arm, on 09Feb2021 09:45 at a single dose (at the age of 68-years-old) for COVID-19 immunization in a public health department. The patient received the first dose of BNT162B2 (lot number: EL1283) on 19Jan2021 09:30, in the left arm (at the age of 68-years-old) for COVID-19 immunization. Medical history included asthma and known allergies with sulfa and penicillin (reported as "pennicillian"). Concomitant medications included losartan; amlodipine; potassium chloride (POTASSIUM CHLORIDE CR WM); and hydrochlorothiazide; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had a lump formed at the site of the injection appearing the second day (11Feb2021) after injection. The lump was not going away. Itches also. The patient did not know if she should see a doctor or not. The patient wanted to know if she should take Benadryl or take pain relief. The patient was afraid. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The events were considered non-serious by the patient. The patient has not recovered from the events.
COVID-19; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ulcerative colitis and Ankylosing spondylitis.    No known allergies reported.  Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis) and Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Pre filled injection. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown regimen. On an unknown date, the patient experienced COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms). At the time of the report, COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication was reported  Patient took Second dose and third dose booster via intramuscular route with no associated events reported. No Treatment medication was reported Company comment This spontaneous case reported by a consumer, concerns a male patient of unknown age, with concurrent illness with Ulcerative colitis and Ankylosing spondylitis, on treatment with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of covid 19 Infection, unknown days after receiving the 1 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of clinical course, labs, diagnostic investigations and treatment were not provided. Ongoing Covid 19 pandemia and concomitant use of Adalimumab could be considered as confounders to the event. Patient took Second dose and third dose booster via intramuscular route with no associated events reported. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a male patient of unknown age, with concurrent illness with Ulcerative colitis and Ankylosing spondylitis, on treatment with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of covid 19 Infection, unknown days after receiving the 1 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of clinical course, labs, diagnostic investigations and treatment were not provided. Ongoing Covid 19 pandemia and concomitant use of Adalimumab could be considered as confounders to the event. Patient took Second dose and third dose booster via intramuscular route with no associated events reported. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
The day after the vaccine I experiences sciatica on my left side. Even now , almost 2 months later, it?s in both legs
This is a spontaneous report from a nurse practitioner who reported for a patient, through a Pfizer Sales Representative. This patient (age, gender and race unknown) received PREVNAR 13 on 25Apr2014, single dose for immunization. Relevant medical history and concomitant medications were unknown. On unknown date in Apr2014 the patient was experiencing fever, swelling in arm at the site of injection and stiffness in neck due to which the patient was admitted to emergency department (ED) on 28Apr2014. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported events were not provided. Clinical outcome of the reported events was unknown at the time of the report. Follow-up (26JUN2014): Follow-up attempts completed. No further information expected.
2hr post vax pt was noted to be choking & gagging, eyes rolled back, arms & legs were moving about;thought to be apneic (was nl);EEG in hosp w/in 24hr was nl;reflux & gagging requiring apnea monitor;
The condition he was diagnosed with pemphigus vulgaris is also happening to other people; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people) in a male 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) 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people). At the time of the report, PEMPHIGUS (The condition he was diagnosed with pemphigus vulgaris is also happening to other people) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated he was diagnosed with pemphigus vulgaris was also happening to other people which received the vaccine.  Concomitant product use was not provided by reporter.  Treatment information was not provided.; Sender's Comments: This case concerns a male subject with no relevant medical history, who experienced the unexpected event of Pemphigus. Time to onset from vaccination was not reported. The rechallenge was unknown as vaccination dates are not reported. The benefit-risk relationship of drug Spikevax is not affected by this report. Despite the event Pemphigus is on IME list this event was assessed as non serious according with regulatory authority assessment and narrative.
pt recv vax 22MAR99 1145AM& 12PM mom returned w/child itching, inc nasal congestion, watery eyes, wheezing sl given DPH;VS WNL;911 called;no worsening of sx;left w/mom & EMS people;
Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination. Patient died on 6/23/2021.
pt recv vax & devel pain;pain appeared to start @ the point of inj & travel up to collar bone area;MD found mass infect in a joint directly connected to clavicle bone;back pain;poss nerve damaged;test showed small peptic ulcer;
fever; Chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills) and FATIGUE (extreme fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, PROPRANOLOL, LISINOPRIL, ESOMEPRAZOLE, DIAZEPAM and SERTRALINE for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and FATIGUE (extreme fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever), CHILLS (Chills) and FATIGUE (extreme fatigue) outcome was unknown.            Action taken with mRNA-1273 Moderna vaccine was Not applicable.
Patient received vaccine in clinic on April 17 and felt some soreness which subsided by end of next day. On April 30 she woke up and felt soreness in the same arm and worried it might be from the vaccine.  She returned to the clinic on May 3, 2018 to ask about soreness. Soreness had abated. Only sore when she pushed on it. No abnormal temperature or fever. Denied shortness of breath or any other symptom. Patient stated that cause "might also be sleeping wrong." No color or swelling noted at injection site. Patient notified that we would complete a VAERS report and to call 911 or return to clinic if symptoms didn't subside in next few days.
Within two and a half hours had diarrhea and vomiting. Body aches started right away me were severe by the night.  Fever started the first night and  continued  through 4 days.  Severe fatigue ongoing 5 days out. Trouble concentrating. No focus. Dizziness. Headache. Vomiting returned day 4.
That evening (early on), I took a nap and went to roll over and my arm wouldn't even come. I had to lift it and move it myself, it was the right arm. It was a 10 pain wise. It was unbelievable. That went on for two months before I could lift it on my own. My doctor said that I was hit in the bursa muscle because it was not moving. That evening also I got a fever that went up to 101. I had total flu like symptoms. Body pain, aches and couldn't open my eyes. Those symptoms lasted for about 36 hours until I could finally get out of bed and start to function again. A week after the vaccine, my neck started to be stiff where I couldn't turn it all the way, couldn't turn it to left or right. It is still that way. (Started on the right side and then it was my entire neck) and I still notice now that it's difficult to turn my neck. Physically, my entire body changed with pain. Still today, my gait is off; my left groin, I have to have help getting my leg lifted up to get into a car. I never had body pain before. I have trouble lifting my left leg. No treatment except ibuprofen on occasion. I take it when I am in bed and can't get out of bed due to a lot of discomfort. They recommended physical therapy, I can't start yet because I'm in so much discomfort. I can't do the therapy yet. I do try to lift it on my own without assistance but it doesn't work. I went to see a neurosurgeon because my pain started to vibrate to the hips and lower back. He told me I just have to deal with it because there is not much he can do about it. He said I could take gabapentin but the side effects are significant and I do not want those side effects.