chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nose is runny; Aches all over; Feels tired; Pus coming out of the arm from injection site; arm was sore; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over) and INDURATION (Hardness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0026052) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Cirrhosis of liver, Heart disease, unspecified and COVID-19 in October 2020. Concurrent medical conditions included Allergy (allergy to Humira). Concomitant products included TADALAFIL, OXYBUTYNIN and AZITHROMYCIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and INDURATION (Hardness). On 24-Jan-2021, the patient experienced VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site). On 25-Jan-2021, the patient experienced RHINORRHOEA (Nose is runny), PAIN (Aches all over) and FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PUSTULE (Pus coming out of the arm from injection site), RHINORRHOEA (Nose is runny), PAIN (Aches all over), INDURATION (Hardness) and FATIGUE (Feels tired) outcome was unknown.        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.   No treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-significant information
Wife said the patient felt "jittery and aggravated". This started the day after his second dose and lasted two days.
Tested positive 5 days after his first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, 5 days after his first dose, the patient tested positive (SARS-CoV-2 PCR test positive). The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Sick; Chills; Feeling terrible; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 10Feb2021 at 11:00 (at the age of 72-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021 at 03:00, the patient experienced sick, chills, feeling terrible. Reporter stated, "She took Tylenol last night about 10 O' clock last night and she took some at 3 O'clock when she woke up in the morning." The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
never having any heart or blood pressure problems before. on 12-14-21 I had a major heart attack.
NIGHT SWEATS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced night sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night sweats and chills was not reported. This report was non-serious.
Right arm redness, swelling, pain - progressed over 48h to include entire right upper arm then started to decrease.
Information has been received from a patient's mother referring to the patient of unknown age and gender. No medical history or concurrent condition was provided. On an unknown date the patient was vaccinated with GARDASIL 9 (lot#, expiration date and dose unspecified), intramuscularly. On an unknown date, after received the GARDASIL 9, the patient got sick from the shot. The outcome of the event was unknown. Additional information is not expected because no consent to contact.
2-3 minutues following administration of the vaccine the patients left arm, where the vaccine was given began to turn red and develop whelps. Dr. looked at the site and 1 tsp of Benadryl was given. When the patient was leaving the facility the redness was beginning to fade.
Patient with history of COVID vaccines who admitted to the hospital with COVID detected PCR. Provider d/c note: "Patient was admitted to hospital for intractable back pain with new onset of proximal right leg weakness on Friday, 3/31/2023. He had been followed by Neurosurgery for previous kyphoplasties performed at L2 then at L1. He had little relief after his last kyphoplasty and a new compression fracture noted at L3. He was treated with TLSO bracing but unfortunately, his pain worsened with right leg weakness developing three days before his admission. Cervical, thoracic and lumbar spine MRIs were performed investigating both his weakness and pain. No significant canal or foraminal stenosis is noted on lumbar spine though new compression fracture present at L4. He was offered kyphoplasties at these segments."
Breakthrough Case: Had a little bit of a runny nose the day after the vaccine, but all in all was fine. I went to a Nursing home and had to be tested beforehand, and the test came back positive. I felt like I had a little bit of a cold for a few days.
103 degree fever after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 degree fever after the second dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (103 degree fever after the second dose). At the time of the report, PYREXIA (103 degree fever after the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Fever-103 degree.         No concomitant medication were provided. No treatment information were provided.
Confusion, Dizziness, Myalgia, Arthralgia, NauseaVomiting, SOB, difficulty swallowing, dry mouth Narrative: 20 min after the vaccine - hard to breath, hard to swallow, dry mouth, dizzy, nauseous, and thinking process was "foggy". Then had a slight pain across her chest. Rapid response team kept her at the Facility for a prolonged period. She was able to drink water and then started feeling better. She was then walked back to her office and she left work. Couldn't drive because she was dizzy. 1/22, 1/23, 1/24 she had joint and muscle pain. She also had sharp pain in her left side by her groin and one on her right side by her flank. 1/26 now when she breaths her lungs hurt. She has a history of asthma. She still feels achy and her back and neck hurt alot. Her bones in her fingers hurt. Due to prolonged symptoms will test for COVID-19 1/27 - COVID-19 test is negative. Employee reports symptoms persist.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had no pertinent medical history and did not use any concomitant medication. On 11-JAN-2016 at 17:00, the patient was vaccinated with a dose of ZOSTAVAX, lot # L012476, expiry date: 10-JUL-2016, dose: 0.65 ml, subcutaneously in the left arm. On 11-JAN-2016, the patient called the pharmacy to report that she was experiencing "palm-sized redness, shooting pain and itching" at her ZOSTAVAX injection site (onset date of adverse events was in January 2016). The patient did not mention whether or not she was developing a rash and she has not notified her primary healthcare provider. No treatment was given for the adverse events and no lab diagnostics studies were performed. The patient did not recover from the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
4/28 had fever with chills - arm swollen 4/30 threw up.
Day +1 after vaccine, approx 20 hours after shot: immediate onset of intense migraine, nausea, light and sound sensitivity, and trouble focusing eyes. lasted until bedtime at approximately 9:30pm. Day +8 after vaccine: raised red lump at vaccine site, scaly skin, itches and aches. started as 3cm, increased to 5cm.
I gave the monovalent instead of the bivalent dose to this patient.  There was not adverse reaction.   I just need to give the bivalent dose to this patient now.
Pt had sig injection site RXN along w/pre-syncope SXS. Pt was given diphenhydramine 25mg and Prednisone 40mg QDx3days. SXS occurred approximately 4 hrs post injection./He declined ER tx.
Side Effects (including non-adverse ones): 1. Swollen lymph nodes under both armpits, even causing red marks on one side.  2. Fever of 102 after taking fever reducing medicine (1000mg Tylenol taken every 4-6 hours; this 102 fever maintained even after 2000mg was taken over two periods). Switching back and forth between feeling hot and cold.   3. Immediately after the vaccine (within 15 minutes), experienced chest pain. This pain is very similar to the pain I get when I have covid. I even went to the hospital in May about a month after I had Covid in April. After doing chest scans looking for a pulmonary embolism or heart issues, they only found potential residual thymic tissue. I?m not sure what is causing this pain in my chest as I have not gotten tests done immediately when having covid or immediately after the vaccine. It feels like a twisting/burning/tight sensation.   4. My resting heart rate (fully relaxed/laying down ready to sleep) is 100 pulses per minute post-vaccine versus my normal resting, which is around 60. 5. Pain and tenderness around the injection site (although this is a common side effect).  6. Complete full body aches and very painful to move out of bed. Body aches present themselves through muscle pain in every part of my body except my stomach area. The joints in my hands, to my legs, to the tips of my toes ache very painfully.  7. Headache that has not gone away after taking the medicine above/hydrating.  8. Shortness of breath in the 24 hours after vaccination. So far this has gotten better over 24 hours, but as mentioned above, my chest is still tight.
About one month later; started with nausea/vomiting/abdominal pain/headaches. Multiple testing with no results but Dx of chronic migraines, hypermobility syndrome, malaise and fatigue.
Both doses caused my breasts to swell and become tender/painful. The swelling was worse on the side of the injection. It went down a few days after the injection and I did not seek medical attention.
Patient had a low grade fever next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had a low grade fever next day after receiving 1st dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) and ATENOLOL for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Apr-2021, the patient experienced PYREXIA (Patient had a low grade fever next day after receiving 1st dose). At the time of the report, PYREXIA (Patient had a low grade fever next day after receiving 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Since patient is having Low grade fever due to vaccination, Patient  wants to know if can take TYLENOL.
This spontaneous case that was received on 27-Oct-2021 from other non-healthcare professional (reference number: SEQW21-04690) and concerned a 68-year-old, female patient.  The patient's concurrent conditions included asthma. The patient's concomitant medications were not reported. The patient's historical vaccine included Fluad vaccine (unknown if trivalent or quadrivalent) after which the patient had no issues.  On 15-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 312849, expiration date: 08-Jun-2022.  On the same day, right after receiving the vaccine, the patient experienced a sore arm. The patient was afraid that she received a COVID vaccine instead of a flu vaccine because the pharmacy was very busy that day and a lot of people were in the waiting room for a COVID dose.  It was confirmed that lot number provided by her, corresponded to a Fluad lot number.  On 16-Oct-2021, one day after administration of Fluad Quadrivalent, the pain worsened and started to radiate up to her neck above her left collarbone, extending to the side and back. The patient stated that the left side of her head also hurt. She also developed a deep, raspy, dry cough during this time she had never experienced before.  On 17-Oct-2021, the patient states that the symptoms began to lessen.  On 18-Oct-2021, the patient stated that most of the adverse reactions had gone away, but she did experience a sore arm, back pain and pain up the neck. The patient stated that she still had left shoulder and neck pain that extends to the top of the back, and every once in a while, she would experience a "burst" where there will be a spot on her collarbone that "sends a jolt up her neck". No corrective treatment was given for the reactions.   On the same day, the patient recovered from the events of 'headache', 'dry cough' and 'painful arm'.  On an unspecified date in Oct-2021, the patient was nervous about getting Fluad again.  The outcome of the events of 'nervous' and 'fear' was not reported.  At the time of initial reporting on 27-Oct-2021, the patient had not recovered from the events of 'shoulder pain', 'neck pain' and 'back pain'.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.; Sender's Comments: One day after administration of Fluad Quadrivalent, the pain developed pain in arm, neck pain, back pain, headache and dry cough. The events are assessed as possibly related to the Fluad Quadrivalent, due to suggestive time relationship.
Began not feeling well on 12/24 and had a minor cough. 12/25 still had cough and tested for COVID-19 but was negative. Later that day I began having extreme fatigue and chills. It felt as if I had a bad cold. The next morning the symptoms persisted and I developed congestion, headache, and sore throat. I tested positive for COVID-19 and called PCP. PCP prescribed Paxlovid, steroid pack, and cough suppressant. Symptoms improved over the next 5 days, day 7 I was feeling much better, and then my symptoms returned. Took 2.5 weeks for me to completely recover from COVID-19.
Pt developed a sense of warmth, palpitation/heart racing and lightheadedness appx. 2 minutes after injection. Symptoms lasted a few minutes. HR initially was 120 but improved to within a normal range within several minutes. BP was 150/90 and SPO2 was >95%. Pt's symptoms resolved after several minutes and she departed without issue.
An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  No treatment information was reported.
Pt had Flu vaccinaction 1 month, and 6 days ago. Pt still has arm soreness and muscle pain. There is slight swelling.
swollen gland by her jaw  stinging sensation at the sight of vaccination dizziness abdominal pain  SOB
confusion, headache on 12-22, then hospitalized on 12-23 after an auto accident. Diagnosed with stroke, initially received aspirin, which was then stopped b/o small hemorrhages on CT. Discharged on 12-24, slow improvement in symptoms after that.
Pt had unwitnessed seizure on 5/21/09. H/O probable seizure activity in the past 6 wks. After seizure, pt has had complaint of headache, dizziness, weakness, balance difficulty.  7/6/09  MR received for DOS 5/21-24/2009 with D/C DX:  Seizure.  Headache. Pt presented to ER after episode of unresponsiveness with limb flexion, staring, and fall.  Disoriented with slurred speech, inappropriate affect, weakness, tiredness and severeH/A after.  Recent episodes of involuntary fluttering of R hand. Started on Depakote.
fever to 103; c/o abdo pain 930-10PM; sz--grand mal; no local reaction @ inject site;
- Developed heavy sweating and almost passed out, 3/30 @ 3:30am, recovered on own in 3 hrs - numerous periods of low energy days with slight temp - 6/20/21 developed A-Fib at 8:30am and brought to hospital -  put on new meds, Metoprotol  tartrate 12.5mg x2 per day,  Rivaroxaban  20mg x1/day - presently under Cardo Phys care - before COVID 2  shot  never had any cardio issues
Administered TWINRIX vaccine to client.  Misadministration of vaccine.  No licensed for this age pt.
Hives around site then progressed and 2nd day to systemic urticarial response. Placed on Prednisone per dermatologist.
I am experiencing a big jump in my Glucose range after receiving that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "I am experiencing a big jump in my Glucose range after receiving that". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, "Me and my wife received the Bivalent BA.4, 5 booster shot (Confirmed as Pfizer COVID-19 Vaccine and suspect captured as Covid-19 Bivalent Vaccine) on 08Sep2022 okay and I am experiencing a big jump in my Glucose range after receiving that, is that a known side effects?" Consumer was informed about role of Pfizer Drug Safety. Consumer was informed about Pfizer Medical Information and asked to provide the number. Consumer stated, "No, now I am looking online under the Pfizer and this was the number that, I was supposed to call, to report." Consumer was informed about filing safety report and again informed about the role of Pfizer Drug Safety.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & had localized reddened inj site rxn;by 23JUN97 pt states rxn appeared t be getting more reddened, tight & warm to touch, some itching & progression of rxn down to mid-rt arm (upon exam rxn somewhat swollen, hot & splotched;
(B) inner thigh redness, swelling, pain lasting from 4:00p to 8:00pm using BENADRYL. Still has small bumps.
No adverse event; Received expired Monovalent 2nd Booster  after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 030L20A, 011A21A and 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  after manufacturer date of expiry).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 13-sep-2022. The size of the vail was 5.5 ml. The vial did not undergo any temperature excursions.  No treatment drug details were reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-648567 (E2B Linked Report). This case was linked to MOD-2022-648574 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648567:MOD22-024255(Same Reporter)