chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he couldn't pee; low appetite; he thought he may pass out; Chills; severe headache every time he got up; feel sick to his stomach but never vomited; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (he couldn't pee) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A2L1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced URINARY RETENTION (he couldn't pee) (seriousness criterion medically significant), DECREASED APPETITE (low appetite), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired). On 23-Apr-2021, DECREASED APPETITE (low appetite) had resolved. On 25-Apr-2021, URINARY RETENTION (he couldn't pee), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired) had resolved.            The reporter stated, the patient had similar side effect from what he had from the 1st dose.  Additional concomitant medications included Blood pressure pills, Cholesterol pills and maybe back pain pill. Treatment medication included Tylenol.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.      Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: An additional document received on 26 Apr 2021 has information Upgraded case to serious, updated suspect product details, concomitant medication, treatment medication and event details.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.
continued achiness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in January 2020. please refer the case US2020AMR103242).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Three weeks after receiving the 2nd dose of Shingrix vaccine the patient had some continued achiness, tiredness. The patient asked how long do shingles vaccine side effects last.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR103242:Same Patient
SEVERE HEAT (FELT LIKE BODY WAS ON FIRE), THEN BODY WAS COLD (CHILL SYMPTOMS), LASTED ALL DAY LONG SINCE 8/2 UNTIL PRESENT STILL EXPERIENCING THESE SYMPTOMS STOMACH HUNGRY BUT DOESN'T WANT TO EAT BECAUSE EVERYTHING TASTES  NASTY (COPPER TASTE) AND UPSETS STOMACH WHEN SHE DOES EAT DIARRHEA
Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 15th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was selected as adult as per product indication. Consumer states that they received a dose of Shingrix yesterday from the day of reporting and that they had soreness at the injection site. Did not consent to follow-up. The case had been linked with US2020206901 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206901:same reporter
About 1 hr after receiving vaccine got flushing, facial swelling and tightness of chest. Gave IM BENADRYL 50mg x 1 dose. Resolved in about 1/2 hr.
Reaction began 3/23/07 - "Little red bumps" on shoulder & chest. Had a few on back and leg - afebrile, no other symptoms. 3/16/07 Rec'd vaccine at Air force base.  04/09/2007 MR received for an ER visit for a c/o rash and a resolving local reaction to small pox vax. PE:  macular papular rash noted on trunk mainly with a few lesions on arms and legs. Local reaction healing well per ID consult.  Otherwise WNL. Discharged home on contact isolation. Principal DX: Reaction to Vaccinia vaccination.
MENVEO was administered Thursday 09/13/2018 and patient began experiencing pain immediately after administration. Starting Saturday 09/15/2018 patient began to notice redness and warmness below the site of the injection. Today 09/16/2018 the site of redness is larger and warm as well as itchy. The muscle is still painful and tight. The patient has been icing the site. Recommended to patient to continue with ice and to start diphenhydramine as well. If improvement is not seen or symptoms get worse recommended to see primary care physician.
"Moderna COVID-19 Vaccine EUA" Had Covid infection on Nov 29 2020 - Moderate severity (chills, fever, cough, loss of taste/smell, muscle aches, burning chest and nose) 4 day duration of fever, 10 day duration of reported symptoms SINCE THEN - Chronic Fatigue, foggy brain, shortness of breath, chest burning, elevated heart rate, inability to function at normal routine, cough,  Symptoms wax and wane, but persist to this day. Severe enough to cause near fainting episodes during routine work day, inability to work  Symptoms were the same before and after Moderna Vaccination, but are persistent through time to get the next booster
Patient was administered a dose of Flublok quadrivalent by accident;  he wanted a booster for Moderna  booster
Patient reported dizziness, progressing to include feelings of weakness, nausea, and auditory disturbances. Patient was visibly pale. Patient was moved to a supine position. Palpable radial pulse was present when the patient was moved to the exam table. Patient reported complete recovery from apparent hypotensive episode in about 10 minutes and stated that she had felt some anxiety prior to the administration of the vaccine which she believed to have elevated her pulse even before the shot.
Pruritus vesiculopapular rash in underarm, chest, groin, and shaft of penis.
Patient presented for first dose Moderna.  Nurse inserted needle into arm and realized there was no vaccine in syringe.  Removed syringe and explained what happened to patient and daughter who was present.  Patient was revaccinated without incident.  Reviewed workflow with nurse to prevent error from happening again.
This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching) 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 21-May-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 ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching). At the time of the report, ALLERGY TO VACCINE (Allergic reaction) and PRURITUS (face, neck, arm is itching) had not resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medication reported. No treatment information reported.
BLOOD IN STOOL; SORENESS; DIARRHEA; VOMITING; PRICKLING IN CHEST; ACID REFLUX; SICK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination patient felt fine for the first few days. On an unspecified date, the patient had soreness and fever. Patient stated would estimate it was low grade fever and indicated that had a fever now. Patient had prickling in chest and stated could not eat and hold food down, it came out both ways. Patient reported vomiting for 2 days along with pooting, which patient implied as excessive bowel movements, potentially diarrhea. Patient indicated that now had bleeding when pooting. Patient also had acid reflux. Patient was concerned about the blood which was seen. The caller informed patient to seek medical attention from HCP, urgent care or ER (especially if symptoms are worsening). The caller then stated that patient was starting to get sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, fever, blood in stool, diarrhea, vomiting, prickling in chest, acid reflux, and the outcome of sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210544936-Covid-19 vaccine ad26.cov2.s-Blood in stool. 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).
Aches and pains; Slight fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea). On 22-Mar-2021, MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-372093, MOD-2021-372417 (Patient Link).
Patient has a history of being scared of needles. He became discolored, sweaty palms and then tensed up. He then loss consciousness for 20 to 30 seconds. He urinated on himself. Once he gained consciousness he was confused but checked by EMT. Vitals: normal. He refused treatment and stayed at the pharmacy for 30 to 40 minutes. Before he left he was much more alert and oriented.
tingling; numbness on the right side of her body, like her full right side; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 21Apr2021 10:00 (at the age of 58-year-old) (Lot Number: EW0153; Expiration Date: Jul2021) as dose 1, single for COVID-19 immunisation. Medical history included birth defect spinal stenosis. There were no concomitant medications. On 21Apr2021, the patient experienced numbness on the right side of her body, like her full right side. Clinical course reported: the patient had her first dose of the Pfizer COVID-19 vaccine last 21Apr2021 and after that, for 3 days (24Apr2021), she experienced numbness on the right side of her body, like her full right side. After 3 days (24Apr2021), it became tingling and lasted for 2-3 days (Apr2021) and because of that, she did not get her second dose (date of supposedly second dose not confirmed) and she was not sure if what she experienced was from the shot or not. She wanted to know if she can still get the Pfizer COVID-19 vaccine considering the duration of interval from her first dose, or if it has been too long. She wanted to know if she can still get the second dose of the Pfizer COVID-19 vaccine after the side effect that she may have experienced with the vaccine. Additional information: she had her first Pfizer shot on 21Apr2021. After for 3 days, she had numbness on the right side. She looked up the side effect. She didn't see anything. She did see Bell's Palsy, but she didn't know if the full right side would be impacted with that. It went away over a week. She was not sure if it was actually the shot or not. She didn't get the second vaccine. She asked if she would now be able to get the second dose or if it was advisable to do due to the side effect. The patient also added she experienced numbness on the right side: it was her complete right side that had numbness. It was like a shot they get at the dentist where the full mouth was numb. The full numbness lasted for 3 days. Then it was tingly for another 2 to 3 days. Vaccine was given in left arm. She had been doing research and this one seemed like the one she was more comfortable with. She has had bloodwork since and everything was normal and ok (unspecified date), but she did not have any bloodwork related to this. The patient had no additional vaccines administered on same date of the Pfizer Suspect. The event numbness on the right side started within 3 hours of receiving the vaccine on 21Apr2021. The patient did not require a visit to emergency room and physician office. The patient had no prior vaccinations (within 4 weeks). No family medical history relevant to events and no relevant tests. The outcome of the event numbness on the right side of her body, like her full right side was recovered on 24Apr2021 and tingling was recovered on an unspecified date in Apr2021.  Follow-up attempts are completed. No further information is expected.
seizure; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced a seizure for which he was hospitalized. On 20th September 2019, the patient was discharged from the hospital. The reporter consented to follow up.
pt recv vax & devel a fever of 101, malaise, extreme arm pain;also exp an inj site rxn;pt had recv vax in early OCT95;
Nothing at the time, but a few days later - developed serious itchiness over the entire body and redness.  Presently, experiencing chronic spontaneous urticaria daily on my arms and hands. This occurs at nighttime, where I initially become very itchy and then develop macular wheels that flare and are warm. T
Intense edema of feet and ankles.  This is a reaction I have had to antibiotics in the past.  I took 2 diuretic pills (8 hours apart),  and the swelling was gone by the next morning.
Severe and painful swelling (like golf balls under my skin) of the lymph nodes in my armpits. Masses are squishy yet extremely painful when touched or pressed. Left lymph node is more swollen than right, but both are affected.
Patient complained of headache after see another patient transported to the medics. Patient blood pressure was slightly elevated, reassess after 30mins normal limits . After drinking a bottle of water patient reports headache improved.
Immunization given and within 10 seconds syncope occurred for approximately 30-60 sec. Post-ictal confusion x 5-10 minutes.
Patient showed up 2 days after getting the vaccine.  He arm was red and swollen from the injection site to a couple of inches above the elbow.  Arm was very sore.  No muscle weakness or fever.  Used ice and motrin for discomfort.
Headache, muscle and joint pain,chills, fever, nausea, and fatigue
Fever (101 F), headache, muscle aches, chest pressure, upset stomach (pain, lack of appetite, but no nausea, no vomiting, no diarrhea). Most symptoms lasted approximately 18 hours, but headache and upset stomach lasted 36 hours.
Bad pain in the back of the neck that turned into pain in the back of the head and a sore bump in the same location.
was having problems with the legs; legs got really weak; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak) 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak). At the time of the report, LIMB DISCOMFORT (was having problems with the legs) and MUSCULAR WEAKNESS (legs got really weak) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not reported.   This case was linked to MOD-2021-393282 (Patient Link).
I am getting dozy for a few weeks. I wonder if it could be Covid vaccine? A lady friend has the same symptoms. We both 75 but I smoke and drink. She does no smoke or drink. Mine cardiologist regular check ups are clear. The lady's are also clear.. I have been taken my medicines (listed below) for many years. I've been under doctor's care for over 35 years. I have not complaint of this situation to my doctor, However sporadic blood pressure checks are always around 120-130/70-80. I fear is the covid vaccine side effect.
my arm felt cold but i drove home and thought that was normal...the next day i felt the same way but it was tolerable, but the next day, and forevermore, i felt pain on certain movements, up to my neck and shoulder and down to my elbow and wrist and my arm always feels tired....at night it is worse.  Every once in awhile i think it is better, and then it gets much worse after i think it is getting better. Nothing helps it.  I tried cold, warm compresses, i went to dr office twice about it.  She gave me a prescription for an MRI but they cancelled that day and then covid scared me and i didnt make another appointment and i think i better do it.  It was suggested i had the shot given into my bursa area and /or maybe it is a shoulder injury from it and nerve damage to rotator cuff? The second Pfizer shot was given in the other arm and i had no problems.  This is not getting better, i think i need to report this as not getting any better now in almost 9 months and i think it might actually be worse than ever.
Event occurred after 2nd dose. Patient was diagnosed with COVID Remdesivir, Tylenol In-patient
I developed a red and itchy and hot spot at the injection site one week after the vaccine was administered. It hasn't gone away yet. No other side effects, but I was told to report this issue. I will contact my PCP as well to report this in case it is something I should be concerned about.
SARS-COV-2 test: Positive; SARS-COV-2 test: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 09:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 at 13:45 as dose 1, single (Batch/Lot number: unknown), in right arm, on 22Mar2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in right arm, on 12Oct2021 at 08:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN PLUS; LEVOTHYROXINE; DULOXETINE; AMLODIPINE; ADVIL [IBUPROFEN]; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-COV-2 test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Client phoned with concerns of chest tightness and "just didn't feel right." Client has past med hx of a MI. Nurse was unable to establish date of previous MI
Temp of 101, severe headache, joint pain, large golf ball size knot with heat and redness at injection site, joint pain, eso left shoulder, nausea and vomiting.
Patient seemed fine at the time of injection, upon leaving his seat and walking into the store he became light headed, pupils dilated, and fainted on the floor.  This was approximately 3 to 4 minutes after injection. He seemed almost immediately fine, vision fine, and was able to talk and drink water.  Monitored for 30 minutes after and no other signs / symptoms during this time.
Patient received a Monovalent dose of Moderna when they were scheduled to receive a bivalent booster.  Patient had no adverse reactions.
Had achey joints. Arm got a little swollen and hurt to sleep on that side. Had a big red rash on the upper arm/shoulder. Had fever/chills. Was moaning and groaning. Still has a little rash on arm but otherwise recovered.
Breakthrough case admission after 3 vaccines Moderna 3/31/21 lot# 017B21A;  Moderna 4/28/21 lot# 006C21A;  Moderna 10/29/21 lot# 017F21A
Patient found to have platelet count of 7  on routine labs checked 2 days after vaccine.  Confirmed on repeat testing.