chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer and describes the occurrence of hyperhidrosis (woke up in sweats), pain in extremity (sore arm), chills, pyrexia (fever) and fatigue in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 019B21A) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 5, 2021, patient experienced pain in extremity (sore arm), chills, pyrexia (fever) and fatigue. On Apr 6, 2021, patient experienced hyperhidrosis (woke up in sweats). At the time of the report, hyperhidrosis (woke up in sweats), pain in extremity (sore arm), chills, pyrexia (fever) and fatigue outcome: unknown. The action taken: not applicable. The patient had already taken the second dose of vaccine. Concomitant drugs not provided. This case linked to MOD21-050937 (patient link).
This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with COMVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   5 vial was initially stored in the refrigerator on 22JUL2021.Patients have received expired vaccine.None have experienced any adverse events and no treatments have been administered.  No relevant concomitant medications reported.
pt has had both doses of the Pfizer Covid vaccination. He took the antibody test on 4/22/21 to find out if he had full immunity from the Covid Virus.  The results were negative.  It read 0.56 but needs to be 0.8.
patient was doing well as outpatient with no significant issues post-allogeneic hematopoietic cell transplant.  Received 1st Moderna COVID19 vaccine on 2/3/2021.  Developed a rash, biopsy showed lichenoid dermatitis, but no other symptoms after that first shot.  Received 2nd Moderna COVID19 vaccine on 3/12/21 and rash persisted (may or may not have worsened, hard to know from patient report) and the patient presented to medical attention on 3/23/21 acutely short of breath and hypoxic, after being able to exercise (walk 2 miles every other day, etc) prior.  Found to have biopsy proven lymphocytic interstitial pneumonitis with diffuse alveolar damage/ARDS requiring supplemental oxygen.  Started on systemic steroids without response.  Also with concurrent mild transaminitis.  From prior recent labs, LFTs were normal prior to presentation with hypoxia.
Arm pain with neuropathy like symptoms on right upper arm; Arm pain with neuropathy like symptoms on right upper arm; Achiness in his chest; Had a problem initially closing his hand; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 25Oct2019, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer. A 68-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# Y03623), via an unspecified route of administration in the right arm, on 18Sep2019, at 0.5 ml single, for immunisation. Medical history and concomitant medications were none. The patient experienced arm pain with neuropathy like symptoms on right upper arm, achiness in his chest, had a problem initially closing his hand all on an unspecified date with outcome of unknown.
had both doses last year, now have a mild case of shingles/ suspected vaccination failure; a mild case of shingles; rash; This case was reported by a consumer via (shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, he/she had both doses of Shingrix last year and now had a rash which seemed like a mild case of shingles. The reporter asked if that was imminent. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles was unknown at the time of reporting. The consent to follow up was requested.
The evening of 1/7/21 she developed a temp of 100.3 with body aches, and rash on bilateral arms/ chest. Took Motrin  at night and had mild temp on 1/8 of 99. and 99.2
Pain at injection site beginning day of vaccine and lasting 5 days. Occurred with both vaccine doses.  Fatigue for 48 hours beginning day after vaccination. Occurred with both doses. Fever for 24 hours beginning day after vaccination. Occurred with second dose only. Nausea for 24 hours beginning day after vaccination. Occurred with second dose only. Two menstrual cycles occurred 14 days apart between first and second doses of vaccine. (Never experienced rapid cycle before.) Menstrual cycle has since returned to normal. Intense muscle and joint pain interfering with mobility and activities began day after first dose of vaccine, and has continued intermittently for two months until present. (June 10, 2021) Pain affects hips, back, knees, ankles, knuckles, wrists, and elbows. Previous to vaccine, pain only experienced in hips and back if over-exercised.
headache; feverish; chills; muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3, SINGLE, Vaccine Administration Time: 05:30 PM, Route of Administration: Intramuscular), administration date: 17Dec2021, when the patient was 26-year-old, for COVID-19 Immunization, reaction(s): "Lethargy", "Headache", "low grade fever", "tiredness"; Bnt162b2 (DOSE 2, SINGLE, Vaccine Administration Time: 06:00 PM), administration date: Jun2021, when the patient was 26 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Vaccine Administration Time: 07:00 PM), administration date: May2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); FATIGUE (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); PYREXIA (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022), described as "feverish"; HEADACHE (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); MYALGIA (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022), described as "muscle aches". Therapeutic measures were not taken as a result of headache, pyrexia, chills, myalgia, fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After Abrysvo vaccine, a bump formed under the skin as well as some bleeding immediately after vaccine was given. No signs of anaphlaxis were present. After 15 minute, bump had receded. Pt did not report any other significant symptoms.
generalized myalgia; fatigue; low grade temps like 100-101/Low grade fever; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is the first of three reports.  A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. Medical history included confirmed COVID-19 months prior and recovered. There were no concomitant medications. The patient had significant systemic  reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as medically significant. The patient recovered from the events in Aug2020.  The physician considered the events to be related to meningococcal group b rlp2086.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the 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,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020315028 same reporter,suspect drug and adverse events in different patient
common reactions such as head ache, sore arm, tired, etc. Additional adverse event/reason for reporting is flare up of cystitis that has otherwise been under control.
myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne.  The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00.  The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
I had went to the doctor for a routine prenatal appointment, but then I found out that I had a very high blood pressure. I was told to go to the ER. I had severe pre-eclampsia with a sudden onset. I had to deliver my baby early. I had severe increase swelling. I had elevated transaminase measurement. I had intrauterine growth restriction affecting antepartum care in my 2nd trimester. I had severely increased kidney functions, increased fluid on lungs, and my liver enzymes were increased. My placenta was undersized and poorly formed which caused malnourishment to my daughter. I delivered my baby, and I had to have a C-section because of her being premature. I had her at 25 weeks. She was 1.8 lbs. My daughter is still in an acute critically stable condition. She is on a CPAP machine. This is my first child. My blood pressure was still high after having my daughter. I was treated for postpartum pre-eclampsia. I'm slowly getting back to normal. I was put on a lot of blood pressure medication. Initially I was prescribed Procardia which was not effective. I was readmitted to the hospital. Then I was prescribed benazepril and labetalol. I did magnesium treatments when I was admitted in the hospital.
Constant ringing in left ear, tinnitus.  So bad on one day it gave me nausea and severe headache, dizziness.  Tried a round of steroids (Methylprednisolone) from doctor, did not improve.
A few days after the vaccination I woke up in the night with severe congestion and a feeling of needing to cough.  My body way aching so bad it felt as if I had been hit by a truck.  Secretion begin to run from my nose and had a horrible cough.  I took cough meds and laid back down but my body was so still so achy all over.  The next morning I was fatigued and sluggish causing me to have to lay around the house.  I took another dose of cough syrup.  The symptoms lasted about 3 days and dimished on its own with no more symptoms afterwards.
Patient reported a lot of pain and redness in arm. Her bicep area had a large red circle covering the majority of her arm. I advised it was a normal reaction and to foll-up with us or primary physician. I followed up with patient and symptoms have resolved.
Autism. Did not reach typical milestones. Will repeat words spoken to him. Uses a few scattered words.
patient reported me to his primary care provider he got his covid 19 vaccine Pfizer through department of health,  he was diagnosed of Bells palsy thereafter and treated
Red rash raised with hives, extremely itchy started Monday afternoon still happening Sunday.  Taking Benadryl and  Metrol Dosepak 4mg oral tablets since Thursday at 4 pm. Nothings helping it.
Red welt day after the immunization and progressed to a large red swollen area on the left arm with fever 5 days later resembling cellulitis. Patient is currently going to an urgent clinic right now to have it looked at by a doctor.
I've never had a reaction to a flu shot, other than minor soreness lasting a few hours. In this case, I had significant soreness for 48 hours, and swelling that has yet to cease (78 hours after injection). The swelling was originally in the upper arm.  It is now also in the lower arm (forearm).  The arm is warm to the touch and the skin is red.  As for treatment, I've been putting an ice-pack on it. That seems to help. The side effects warning mentioned soreness and swelling for 1 - 2 days. It's been 3.25 days so far, so I thought I'd report it.
Within minutes of receiving injection lips tingled. Face became numb (lips, cheeks, nose). Some difficulty swallowing (discomfort in throat and Eustachian tube). Numbness dissipated after 2 hours. Throat/ear discomfort completely dissipated within 8 hours.
No additional AE; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that a patient was administered an improperly stored vaccine.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 29-JUN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #W034912, expiration date 02-NOV-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On unknown dates, the suspect vaccine experienced a temperature excursion. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event).
7/29/16 Mother called the office in am w/concerns about possible side effects from vaccine. T=102.4 and started the evening prior. Mother was told to give ADVIL and reassured. She called back and T=105.8 at 2 pm. She came in for eval. Exam was benign. CBC done. WBC normal - incidental finding of Fe def. anemia.
Information has been received from a physician concerning a female (age not reported) with a history of fainting when receiving vaccines and having blood drawn who was vaccinated (date, route and site not reported) with the 1st dose of Gardasil (lot# not reported).  The patient fainted after receiving the 1st dose of Gardasil.  The patient received unspecified medical attention and recovered.  No additional information is expected.
Received vaccine 10a.m. est on 10/6/21; approx 10:10 developed headached; approx 10:20 heart rate & bp spike but came back down fairly quickly; by 10:30 had dizziness, lightheaded about 10:45 started getting chills.  Was monitored at facility until 10:45 and then went home. Between 12:00-12:30pm developed sudden numbness, tingling & pain in both feet. Around 8:00p.m. arm started to hurt; around 10p.m. was hit with profound fatigue.  On 10/7/21 approx 6:50a.m. had syncopal episode. Went to Emergency room 10/7/21 about 7:30a.m because both feet and lower legs still  numb, tingling and pain. Dr. said he thinks it's my dysautonomia but I respectfully disagree. I have dealt with dysautonomia for many years and have never had sudden numbness and tingling and pain in both feet at the same time.
A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 30-DEC-2014. Health professional reported that we accidentally administered expired FLUMIST Quadrivalent to four patients on 30-DEC-2014. FLUMIST Quadrivalent  was discontinued on 30-DEC-2014. The outcome of the event of accidentally administered expired FLUMIST Quadrivalent to four patients is unknown. The report was considered to be non-serious.
Experienced injection site swelling, heat, and pain 2 days after vaccination. Still has not resolved.
Patient received initial vaccinations for both Anthrax and Typhoid. While waiting at a post-vaccine documentation station a few yards away, patient complained of nausea and light-headedness. A chair was produced and patient was assisted into the chair. On the scene assisting him were two medical professionals, and myself, a physician assistant. Suddenly patient expressed increased tone in bilateral upper extremity. This was followed by an alteration of consciousness, with tonic-clonic movements of upper extremity. Suspected seizure-like activity lasted resolved under 15 seconds. There was a post-ictal period of confusion and fatigue. An ambulance was called.
pt states had rxn-swelling, redness golf ball size knot, took 4-5 days to dec in size;pt broke out w/sore 4-5in long; tenderness;
An odd ache here and there during the day, then at night muscle aches all over the body, chills, slight fever, headache, fast heartbeat. No treatment until morning. Took acetaminophen in the morning, helped with the aches. Heartbeat came down on its own by morning.
Vaccine diluted on 1/19/22 at 1:08pm. Vaccine refrigerated, administered to patient at 10:00am on 1/20/22. Supervisor  contacted manufacturer for guidance, manufacturer advised that diluted refrigerated vaccines are stable for 24 hours.
Nausea, vomiting, headache, diarrhea, swelling under arm of the right arm (injection site), headache, joint pain, extreme exhaustion, chills and dizziness - lasted approximately 5 days (except for vomiting and diarrhea that only happened once at 2 - 4 am), the day after the shot was given.
Patient came to pharmacy two days after injection. Area around shot was red, inflamed and warm to touch. Red area was about size of a baseball. Injection site could be seen and was in correct area.
Urine had a reddish dye not quite blood and loose bowel movement the next day following the first dose.  After eliminating the waste my urine and bowles was back to the normal.  It was quite scary.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include medicine for diabetes.      Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
I spent 3 days in bed, I slept 14 hours at a time; pain in my right injection site arm; feverish; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-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 SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish). At the time of the report, SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding an 11-month-old female patient who experienced streptococcus pneumoniae infection of sinus, throat, and nose area. At 10 months of age, the patient received the third dose on 25-Jul-2009. In Aug-2009 the patient presented to the office with a runny nose, green in color followed by a positive streptococcus pneumoniae nasal culture. The physician reported that the infection was in the sinus, throat and nose area. Treatment consisted of RIFAMPIN and OMNICEF for 10 days which was recently completed. The outcome of the events was reported as recovered. Serotype testing was not performed. No additional information was available at the time of this report.