chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FATIGUE FOR A FEW DAYS/ LESS ENERGY THAN USUAL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue for a few days/ less energy than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue for a few days/ less energy than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210458955.
The area around the injection site was warm, indurated and erythematous (15cm X 13cm and 4cm X 3.5cm).
Pain in leg, limping, walking sideways, 104 fever that is unresponsive to a piggybacking of Tylenol and ibuprofen.
Moderna COVID-19 Vaccine EUA  Severe headache Fatigue  Nausea Body aches
Severe swelling around the T-Band (bridge of nose, eye lids, eye sockets) more severe on the right side began 36 hours after injection. Headaches, body aches, and chills began within 6 hours of injection. Went to Urgent Care 48 hours after injection and was prescribed Prednisone 20 MG - 1 tablet per day for 5 days.
PATIENT PRESENTED TO THE PHARMACY FOR A COVID VACCINE. PATIENT SAID IT WAS HIS FIRST DOSE. WHEN I SAW HE MARKED THAT HE WAS IMMUNOCOMPROMISED, I ASKED HIM AGAIN IF THIS WAS HIS FIRST DOSE OF A COVID VACCINE AND HE SAID YES. WHEN IMPACTSIS FOR WAS DONE TECH PUT NAME INSTEAD OF FULL NAME WHICH BROUGHT NOTHING UP. I THEN GAVE THE VACCINATION AND WHEN SPEAKING WITH HIM HE MENTIONED HOW HE DID FINE WITH ALL HIS OTHER SHOTS LIKE SHINGLES AND HEPATITIS SO I KNEW SOMETHING WASN'T ADDING UP. I DID IMPACTSIS MYSELF LATER WITH PT AS FIRST NAME WHICH BROUGHT UP HIS WHOLE VACCINATION HISTORY AND THAT HE HAD RECEIVED JANSSEN ON 3/6/2021.
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported. Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported. The event did not cause the patient to seek medical care. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow-up: Quality complaint no. only added.
Vaccine reaction with rescusitation. 4 year old boy here for annual physician/screening received DTaP, Polio (IM), MMR 21 hours ago. Subsequently, child noted to become limp, vomited, and had a BM about 15 minutes after administration of above vaccine. The child was placed on the couch, opened eyes spontaneously to his name, pulse fast for about 10 minutes, RR 30-40. Approximately 10-15 minutes later, had a second episode of vomiting, child went limp, pulse not palpable, sat 67%. Started on O2 4L/anbubag IV line started. About 20cc NS given. Sat climbed up to 90%, HR 144, lungs: grunting sounds but clear. Spontaneous pulse after about 5 minutes of cardiac compressing. Child transferred to ER. Per discharge summary, pt experienced hypoglycemia, hypokalemia, dehydration, seizure and anemia.
Patient was given her second dose of Moderna today, patient reported numbness and tingling of lips.  BP was taking 134/ 72 .  Medical provider did a neuro and cognitive evaluation and was normal, patient stated this happens to her when she has migraines. Patient was observed for 30 mins after getting vaccine.
temp of 102.4 for two days, sevee headache for three days, vomiting and diarrhea for two days, confusion, aches all over
Temperature at time of vaccination was 98.6F. Mom reports child had a mild temperature the day before. States that child cried quite a bit after vaccination. The morning of 2/26/02, the child was covered head to toe with a rash and crying. Would not eat or drink. Child felt warm, temperature was not taken by mom. On 2/27/02, mom states rash is gone, child is fussy but would take fluids. Not seen by a physician.
1/18/21: I woke up around 9 in the morning feeling my heart racing and pounding. I put on my Apple watch and to check my heart rate and it was 140 beats per minute. The highest it went up to was 175 beats per minute. I was not feeling anxious or having an anxiety attack so I'm not sure what caused this. I have had anxiety attacks in the past, but I've never felt my heart pound and race like that.  My heart rate went down to 115 - 130 beats per minute. At around 11 am when  my heart rate was still not going down, I went to the Urgent Care where I was referred to go to the Emergency Room.
bone pain on the back; rare painful rash on injection site; red bump rash around the injection site; Injection site pain; Acid Reflux; back pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VACCINATION SITE RASH (rare painful rash on injection site) and VOMITING (vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Heart disorder.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BACK PAIN (back pain) and VACCINATION SITE PAIN (Injection site pain). In February 2021, the patient experienced VOMITING (vomiting). On 23-Feb-2021, the patient experienced BONE PAIN (bone pain on the back), VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site). The patient was treated with LANSOPRAZOLE for Acid reflux (esophageal), at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site) outcome was unknown and VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Additional treatment includes rubbing hemp oil on skin.
Pt reports that he had the first round of the COVID vaccine on Tuesday (2/9/21), and he began having L sided eye weakness/watering and L sided facial droop/weakness on Thursday (2/11/21) that has been worsening since. This resulted in a visit to the ER and workup for Bell's Palsy vs stroke - presented to ER on 2/15/21.
Client sitting post vaccine approx. 5 min. after, and looked to have a vagal vagus response. Fell side ways in chair- was unconscious for approx 10-15 sec.  No injury. Came to  Alert and oriented  x 3 no memory of passing out. Did state he felt a flushing feeling and ears get muffled. 911 called by co worker. B/P stable @ 05:12 -96/42 HR 64 done by reporter. EMS arrived approx. 17:25- client awake and speaking. B/P by EMS- 120/80, HR 61, sats 99%. Client refused further treatment at hospital. Stayed another 1/2 hour and was picked up pt parents. Client walked out of site without further incident. Spoke to client next day stated he felt fine. Encouraged him to speak to PMD before next vaccine.
My penis does not work; It is all due to the vaccine. It is the vaccine, my penis does not work because of your vaccine; 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), 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: PENIS DISORDER (non-serious), outcome "unknown", described as "My penis does not work; It is all due to the vaccine. It is the vaccine, my penis does not work because of your vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient woke up feeling sick and developed a very large ring around the area of the shot. Patient also carried a fever. Later he developed redness, swelling and red strips down his arm and the arm was hot to touch.
Muscle and joint pain for 1 week - intense, headache for three days, fatigue for 1 week, lessening gradually. At the end of the week I also had an asthma episode (usually infrequent)  but not sure whether this s related.
On May 8, 07, I was injected with the vaccine. On May 9, 07, I had diarrhea the whole day. On May 10th, 07, I had soft stools. No treatment was given.
Received Td vaccine 09/22/2003 left deltoid.  12 hours after vaccination noted hives/pruritis.  No shortness of breath.
Patient up until this day was healthy and active until dec25 /2021 patient woke in the morning In severe pai in his shoulders and hip and extremely weak ! Was diagnosed with poly myalgia rumetica
Covid-19.  Fatigue, loss of smell and taste. Took naproxen.
Pt was to received 3rd primary dose but incorrectly received bivalent booster instead.
BODY ACHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever. This report was non-serious.
BODY ACHES; EXTREME CHILLS ( ALMOST CONVULSANT AND SHAKES); NAUSEA; SEVERE HEADACHE; EXTREMELY HIGH FEVER; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient didn't took any medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 19:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced extreme chills ( almost convulsant and shakes). On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced extremely high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, extreme chills ( almost convulsant and shakes), nausea, severe headache, and extremely high fever on 08-APR-2021. This report was non-serious.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: patient already had injured shoulder and limited movement prior to the vaccine and states that vaccine made her shoulder and arm hurt even more. she had a routine appotintment with her physical therapist during which she said she would discuss the adverse event.  we reccomended to her to consult her pcp
vertigo; dizziness; Could not get of my bed; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Got the shot on a Tuesday, had normal side effects (swelling, redness, pain at site). Those side effects were gone by Saturday. Noticed some discoloration of the injection site on Sunday/Monday. By Monday night a small lump and redness had reappeared. Tuesday morning the lump had gotten bigger and hot to the touch, itchy as well. Wednesday even itchier and bigger and hotter. Went to urgent care and was given cephalexin for cellulitis. Today is a Thursday, the itchiness has gone down but the lump is much bigger and still warm to the touch.
Pt received Menactra and Hep A #2 on 11/20/07 - developed temp 100.4 on 12/04/07 along with mild petechial rash scattered sparsely over body.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
pt recv vax 25NOV98 & NOV98 pt exp a high fever up to 105 which lasted 24-48hr;
Nurse practitioner stated that patient had flushing and mild edema of arm and hand and that patient stated she was seeing things such a men, cats, and writing on her room walls, but knew the objects were not real
Information has been received from a pharmacist referring to her 56 year old male husband with diabetic. On 10-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route not provided) and an unspecified dose of influenza vaccine (manufacturer unknown, dose, lot number and route not provided). On the night of 10-OCT-2015, the patient experienced body aches, chills and a fever of 99.9 F. The outcome of the body aches, chills and fever was not provided. It was also reported the patient died (detail information not reported, estimated onset date October 2015). Additional information has been requested.
patient admitted to in patient psych unit. tested + while staying there. Patient doesn't feel good. She was running temperature yesterday 100.3 and c/o diarrhea. She has been coughing. She had diarrhea. She slept well last night. Staff reports anxiety. She is received Ativan yesterday evening.
A couple of weeks after the vaccine, I started getting itchiness and pain around the injection site. The pain spread to my right shoulder and I couldn't lift my arm. I went to the doctor on 3/2.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On an unknown date the patient was intended to be vaccinated with a dose of MMR II, (lot#, expiration date and route not reported). When it was discovered the flip-cap was missing from one of the ten vials of MMR II the health care professional did not wanted to use any of the vials and the patient missed a dose. A product quality complained (PQC) was filed. The patient was in the office to get the vaccinations needed to attend college and would return next week. Patient also received titration titre bloodwork to determine if she needed one dose or two. No adverse event (AE) symptoms were indicated. This is one of the several reports from the same source. Follow-up information received on 22-APR-2013. On 22-APR-2013, a phone call was placed to the office of the office manager. The receptionist transferred the call to the voicemail of the office manager. A voicemail message was left with the office manager to please call back regarding the multiple patients and MMR II. All telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested.
Some glands under her left arm where she got the shot are sore; Headache; Fever; Sore on the left side of her breast is sore under her breast; started to feel pretty sick; she got her COVID Booster shot; Throw up; throwing up several more times since then; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 (Lot number: FH8027) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for anxiety, depression. Vaccination history included: Bnt162b2 (LOT# of 1st shot: EP7534), administration date: 31Mar2021, when the patient was 17 years old, for COVID-19 immunization; Bnt162b2 (LOT# of 2nd shot: ER8729), administration date: 21Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "she got her COVID Booster shot"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Some glands under her left arm where she got the shot were sore"; VOMITING (non-serious) with onset 16Dec2021, outcome "unknown", described as "Throw up; throwing up several more times since then"; MALAISE (non-serious) with onset 17Dec2021, outcome "unknown", described as "started to feel pretty sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Sore on the left side of her breast is sore under her breast". Relevant laboratory tests and procedures were available in the appropriate section. Therapeutic measures (Tylenol once) were taken as a result of vaccination site pain, vomiting, malaise, headache, pyrexia, pain.  Additional information: Reporter stated, "So her daughter was 17 and she got her COVID Booster shot on Thursday afternoon and she throw up Thursday night and then yesterday she started to feel pretty sick. She has a headache a fever. Some glands under her left arm where she got the shot were sore. Sore on the left side of her breast was sore under her breast and she was throwing up several more times since then. She did not have any of this reaction with her first two shots. She just kind of report and wondering what we should do (voice distortion) advise of a doctor this morning. She just want to kind of report it. She just want to report her side effects because they seem like they were out of the normal side effects". Reporter further stated, "was there somebody on your staff like another phone number I can call to talk to like a doctor or nurse to find out what we should be doing. Was there a doctor or a nurse on your staff at Pfizer that I can call to talk to about this to find out what I should be doing for her".
A report was received from a health care professional on 12/17/03 concerning a 49 year old female vaccinee who experienced a red, raised, painful area at the injection site within two hours of receiving Fluvirin on an unspecified date in October 2002. On an unspecified date in October 2002, the vaccinee experienced a red, raised, painful 5cm area at the injection site. The reaction resolved without medical intervention within 2 to 3 days. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Further information received from a health care professional indicated that the vaccinee developed a round raised wheal 30 minutes following vaccination, which resolved 3 to 4 days later. The vaccinee did not have any previous exposure to Fluvirin. The reporter has assessed the relationship of the vaccination to the round raised wheal as probable. Follow up pending.
Patient received the COVID19 Monovalent dose instead of the COVID19 Bivalent dose as a booster. No signs of a reaction.
Pt recvd 3 doses of Engerix-B & was found to be a non-responder; p/1st 2 doses of Engerix-B exp pain @ site of inject & felt bad;
2/14/23- sore arm; 2/15/23- congestion, rhinorrhea, body aches, fever up to 102.2, headache, sore gums