chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in armpit; pain in back and leg; fatigue; muscle pain; Left supraclavicular lymphadenopathy; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain), LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) and ARTHRALGIA (Knee pain). At the time of the report, SWELLING (Swelling in armpit), MYALGIA (muscle pain) and ARTHRALGIA (Knee pain) outcome was unknown and FATIGUE (fatigue) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) had not resolved.            Concomitant product use was not provided.Treatment information was not provided   This case was linked to MOD-2021-002591 (Patient Link).
Heart palpitations for about 2-3; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations for about 2-3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included ATORVASTATIN, EZETIMIBE (ZETIA), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MAGNESIUM CITRATE (MAGNESIUM DIASPORAL 300) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PALPITATIONS (Heart palpitations for about 2-3). At the time of the report, PALPITATIONS (Heart palpitations for about 2-3) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior head and neck ache, and chills.
This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient was vaccinated with PROQUAD (dose number, dose, lot # was not reported) that was improperly stored and which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. The reporter was unable to locate lot numbers and expiration date of PROQUAD that experienced a temperature excursions. The outcome of the events reported is unknown. This case is linked tot he cases 1405USA010623, 1405USA010602, 1405USA008131 via same reporter link. Additional information has been requested.
Patient received her flu vaccine and seemed in good spirits as we left the facility. While in the car driving away (within about 5 min of vaccine administration) pt complained of a painfully sore throat, shaking, and "feeling funny". Her hands would tremble if she tried to hold them steady and she became very pale. She needed to sit and rest for several minutes before she felt well enough to walk around. She gradually improved over the course of an hour and had no further issues.
13:50 vaccine administered 20:00 severe chills and shaking, no fever 00:30 chills subside, fever begins. Body aches, severe headache, nausea. No sleep.  05:30 took 2 advil. fell asleep and woke up at 10:00 feeling mostly normal. Low energy.
w/in 20hr (next morning) felt nauseated, BP dropped 90/50 (nl 120/70) local rxn approx 8" induration;took 3wk for induration to resolve;still has a pea size knot in arm;took DPH;took APAP a/vax;
Thigh is swollen with redness, heat and severe pruritis, skin is tense, no apparent pain. Child given Atarax tsp qid, warm wet compress to be used and returned to clinic in 3 days for follow up.
Fever, redness, limp, site warm. Rx antibiotic - KEFLEX oral on 4/29/11.
UrticariaPruritus Itching and swelling at injection site with redness to arm and armpit area
Began feeling bad within a couple of hours after immunizations.  Was given two, both in left arm.  One was for the seasonal influenza and the other was for the #2 Pneumonia immunization.  Began to feel feverish, achy, and left arm began to be sore and by following evening, Oct 1, the area below immunization site was very red and hot and swelled up.  Had felt sick and feverish all night  the first night after the shots and also the second night.  On second day after shot, the top part of arm underneath injection site is still very swelled up, red and hot.  Tried a cold compress the second morning on it and it seemed to reduce the redness and swelling to some extent.  We took photos of the arm if that would be helpful.  He is still waiting it out to see if it clears up and he gets to feeling better.  Have sought no medical intervention.
BLURRY VISION FOR 15-20 MINUTES; FELT SPACEY; WATERY EYES; OCCULAR HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included occular headache, and chronic lymes disease, and other pre-existing medical conditions included patient had no known allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the patient experienced blurry vision for 15-20 minutes, felt spacey, watery eyes and occular headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision for 15-20 minutes, felt spacey, and watery eyes on 11-MAR-2021, and the outcome of occular headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as the case is non serious
pt recv vax 4NOV96 & 6NOV96 pt exp itching, sl redness & swelling @ the inj site that was described by the pt as annoying;
Deltoid pain when pulling or twisting right arm. Next day after receiving vaccination, patient couldn't move her right arm due to the pain.
After about 3 days I started having a bad Headache, tingling in my body and cold patches in mybody. My noise was also dry and irritated.
Dermatomyositis flare-up following the SARS-CoV-2 vaccine; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), outcome "unknown", described as "Dermatomyositis flare-up following the SARS-CoV-2 vaccine".; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Dermatomyositis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Extreme body ache over entire body (even on bottom of feet), vomiting, shaking chills and fever of 102. It took three days to feel better and the fever to stop. I also noticed my vision was not as good as prior to the shot. I tire easily and get back pain.
Mild flu symptoms the day after vaccination. Dry heaves that night. Onset of severe flu symptoms (nausea, feverish, respiratory ailments, severe congestion, abdominal pain, diarrhea, green stool (2-days), shortness of breath, etc)
Headache, fatigue, injection site pain. Onset approximately 4-6 hours after administration of vaccine.
Shortness of Breath, Chest pressure, Fluttering and fast Beating heart, Sore throat, Swollen Lymph nodes, Burning eyes, Burning Throat, Burning around mouth, Headache, Dizziness, Tiredness, Nausea, Abdominal pain, Double ear pain, Cold symptoms, Nose bleed, Pain and Redness at injection site, hives.
Received Pediarix, Hib, Prevnar 9/29 afternoon, cried all night, temp 101.8, emesis x 2.
rash around site of MMR w/in seconds p/vax;DPH given;
Pt c/o dizziness w/ hx of syncope w/ first Moderna Covid vaccine dose.  VSS.  Fluids offered.  Educated patient regarding S&S to report, rest, fluids/  Pt dizziness resolved pt ok to take Flonase for allergic rhinitis d/t pollen and multivitamins.  Pt stable and released from the vaccination site.
Scattered erythematous lesions-slightly indurated with left arm with central vesicle. Itchy rash started 06/09/04 with 1-2 bumps on forehead, no fever, otherwise acting well. Treatment Benadryl, Aveeno baths.
During an appointment with a different focus, patient informed staff that she had never received 3rd dose of HPV vaccine. Vaccine was administered, and after vaccine had already been given, it was determined based on previous records that the patient had already received the 3rd dose of this vaccine.
feels dizzy; feeling really bad; freezer; Very sick; nauseous; throwing; A spontaneous report was received from a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels dizzy/ dizziness ,nauseous/ nausea, felt like she was going to pass out/loss of consciousness, throwing up/vomiting, feeling really bad/feeling abnormal, freezer and cold /nasopharyngitis and very sick/illness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 18 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On  19  Mar 2021, after receiving mRNA-1273, the patient felt dizzy ,nauseous and felt like she was going to pass out. She tried to talk on the phone but she was throwing up and feeling really bad. She was freezer and cold. Very sick. She's going to the ER right then.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, dizziness, nausea, loss of consciousness , vomiting ,feeling abnormal, nasopharyngitis and illness were not considered to be resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 13-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 PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2022-494221, MOD-2022-494249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received contains no new information.
Student visited health services on 11/7 to report that he had a fever for a day or so after the shot.  He did not record a temperature or return to the health services until 11/7.  Reported that he was tired, achey, and had a fever for a day and a half.
Pt has elevated pertussis Igm (30.9 index) but has had 4 Dtap vaccines.
Fever, chills, fatigue, dizziness, headache, pain in eyes, neck, and shoulder.
aching joints, large reddened rxn @ inj site;person felt awful for 2 days;states eat eggs occassionally but suspects that has been sick from eating eggs in the past;suspicion that maybe allerg to eggs
Began to have red streaks that went fron the wrist of L arm, across my neck, chest and L shoulder blade 1 hour after injection. Then began to have swelling on the L side of my face and neck 2 hours after injection.
10/18/16-Rcv'd Flu Shot at office, 11/4/2016 rcv'd Pneumo 23 at hospital. 11/6/16 admitted to hospital c/o pressure in head x 6 wks. Cold and clammy, low grade fever. D/C'd per pt request. Referred to hospital 12/18/16 for c/o severe abdominal pain/pain all over. (L) foot drop and no power of peroneal muscle on left, marked muscle wasting-sarcopenia->referred to neuro, 12/9/16-hospital->C4/C5 nerve impingement/pain. Nerve deficits C6/C7 and weakness C7. 2/10/17 Medical center Neurology 2/3/17-2/10/17: seen for increasing weakness, distal extremity numbness, tingling, and burning. When admitted: c/o pain and tingling diffusely all extremities, upon d/c it was localized to hands/feet. IVIG for presumed Guillain-Barre Syndrome. Rcv'd 140grams of IVIG over 3 days. High doses of steroids taper. Follow-up with neuro 3/6/17. Discharged to inpatient rehab to improve strength before returning home. AIDP (Acute demyelinating Polyneuropathy). Per Neuro consult: 2/3/17 recent severe weight loss, over past 4 months (70 lbs). Increasing distal extremity numbness, tingling, and burning pain, bilateral foot drop of unknown etiology, also upper extremities generalized weakness and pain. EMG, Lumbar puncture (to rule out infect. disease, chest/abdomen and pelvis CT to rule out malignancy. IVIG and High dose steroid for presumed Guillain-Barre Syndrome. Guillain-Barre vs Acute Inflammatory Demyelinating Polyneuropathy vs CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
I had experienced nauseas, vomiting, and then blurred vison. On 11/7/2021 I contacted my OBGYN office and went to the hospital for monitoring. They said my liver enzymes were elevated. They kept me for 36 hours to monitor my liver enzyme levels that was steadily increasing. I was discharged the next day on 11/8/2021. I follow up with them on 11/11/2021 for repeated lab work. I am recovered from the symptoms of nauseas, vomiting, and blurred vision because I do not experience them anymore, but I am not for sure if my enzymes are back to normal. I have 1 child already, and I am pregnant right now with my 2nd baby. The estimated date of delivery is 2/13/2022.
Mom reported that 15 mins p/vax recvd (had arrived home) & pt became limp, pale then blue, unresponsive; recvd 2 breath (mouth to mouth) by EMT who was present immed perked up & was fine;
Mother called 6 hours after child got immunized states child had projectile vomiting. Advised to consult Dr.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID- 19 INFECTION; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 206A21A and expiry: unknown) dose was not reported, frequency time 1 total administered at right arm on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-SEP-2021, patient tested positive via rapid test (suspected clinical vaccination failure and and suspected covid-19 infection). On 16-SEP-2021, he received infusion (of an unspecified medication). On unspecified date he noted mild symptoms including, slight fever, could not taste and low energy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid- 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0. 20211240687-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211240687-covid-19 vaccine ad26.cov2.s -suspected Covid- 19 infection . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Expired vaccine given. No treatment. No need for revaccination. As per call to Merck these are supported through 6 months after date of expiration. Potency remains unchanged.
I woke up and felt achy and had a headache and muscle aches. I had been at an event over the weekend and another person at the event said her husband tested positive for COVID-19, so I thought I had it too. I took a test on 03/21/23 and it was negative and then I had a positive result on 03/22/23. My symptoms got worse. I developed a cough, sore throat, fever, weakness, chilling, and flu like symptoms. The 22nd and 23rd of March were the worst but it started to gradually ease off. I had to take some time off that week. I called the doctor and the NP said to call if it got worse or wait if it did not. I had another test on 03/29/23 and it was positive, then another test on 03/30/23 and 03/31/23 and they came back negative.
Hypersensitivity, pain in joints, 2" round red welt at point of injection.
Fully vaccinated, and boosted 1/14/22.  COVID infection breakthrough with inpatient hospital stay.
Shortness of breathe, pain in chest that went to his lower back. 911 was called-they checked his blood pressure and said it was ok-only slightly elevated. Pt. did not go to ER-said he felt ok after all..
husband also got the vaccine on same day and was positive for COVID-19 but became very sick; husband also got the vaccine on same day and was positive for COVID-19 but became very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) (seriousness criterion hospitalization) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) (seriousness criterion hospitalization). At the time of the report, ILLNESS (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) and COVID-19 (husband also got the vaccine on same day and was positive for COVID-19 but became very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information  was reported. No treatment medication was reported.  Company Comment This case concerns a male patient of an unknown age with no medical history, who experienced the serious unexpected, event of Illness and the AESI of COVID-19. The events occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409280 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the serious unexpected, event of Illness and the AESI of COVID-19. The events occurred on an unknown date after the first dose of the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Both arms swelling and red - feels hot, nausea, difficulty breathing, red macula rash 3cm (R) arm 4cm (L) arm. Gave DECADRON 8 mg IM BENADRYL/25 mg IM BENADRYL 25 mg 1-2 caps Q4-6 degrees Kenalol cream 0.1% 2-3 times PRN return 7/21/12 or to ER if worse, also done EKG, pt in no distress.
Received Pfizer vaccines on 3/16/21, 4/6/21; tested positive for COVID-19 by PCR on 7/11/21. Mildly symptomatic w/ congestion, dry throat, cough, fatigue. Received Monoclonal antibody therapy on 7/12/21.
Information has been received from a pharmacist concerning a patient (age and gender unspecified) who was vaccinated on an unspecified date with a dose of RECOMBIVAX HB. Subsequently, on an unspecified date, the patient experienced an anaphylactic reaction. It was unspecified if the patient sought medical treatment. The patient was reported to be recovered from anaphylactic reaction. Additional information has been requested.
throwing up all the time after both doses; I got very sick for 2 weeks; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got very sick for 2 weeks) and VOMITING (throwing up all the time after both doses) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got very sick for 2 weeks) and VOMITING (throwing up all the time after both doses). At the time of the report, ILLNESS (I got very sick for 2 weeks) had resolved and VOMITING (throwing up all the time after both doses) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case pertains to Patient 33 out of 63 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714807 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case