chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Pfizer vaccine was not reconstituted. The patient received 0.3mL of unmixed Pfizer. We have not heard from the patient on any adverse effects.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 3:26 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 3:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, vaccine was housed in the units. There were excursions noted. Manufactures were notified and the department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Unable to fully raise arm secondary to pain, limited external and internal rotation secondary to pain.  Only able to lift arm to 45 degrees.
Patient received a 0.5ML dose of Moderna Vaccine around 10:39AM.  She was asked to sit in the designated waiting area for the observed time of 15 minutes.  After 10 minutes a staff member went to check on her and the patient was complaining of some mild itching in the throat.  This was then brought the attention of the physician (myself) who came out to evaluate the patient's complaints.  Patient again complained about itching in the throat and mild difficulty in breathing.  Patient was then moved to an exam room, placed on a pulse device, and oxygen was administered.  Her pulse ox read 97-98 % on 3 L of 02.  Patient then became horse and had audible wheezing.  She reported having worsening difficulty in breathing.  Epinephrine was immediately administered, 0.3mg (mL) x 1 dose  in the left thigh.  Patient's symptoms improved within minutes.  Benadryl 50mg IM was also administered.  Vitals were taken at this point, her BP was 120/76 with pulse rate of 93 , respiratory rate of 16, and pulse ox of 98%.  Patient was continued on low dose oxygen and monitored for any progression of symptoms for an additional 25 minutes.  Patient was asked if she would like to be taken to the ER but she refused.  Patient was discharged home in stable condition.  Patient was contacted later on that day to assess for any changes in status and she reported that she had been perfectly fine since the initial intervention.
pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was arthritis; can't hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1284 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was reported as none.On Monday (11Jan2021) morning she had a lot of pain in her legs and knees that went down to her feet. She thought maybe it was arthritis, but it was still there and it still hurts. She can't hardly walk real good cause it hurts. She was wondering if it could be a side effect from that vaccine. She wanted to know if there been a reaction like this in other people. Supposed to get her second dose on 30Jan2021.  The outcome of events was not recovered without treatment involved.  No follow-up attempts are possible. No further information is expected.
Menveo given on 8/26/20 Left upper arm patient woke up 8/27/20 with swelling of Left upper arm with Itching. no pain or fever. 5cm area of (L) upper arm. Dx. Cellulitis Tx Clindamycin & Prednisone
Fever to 101.3 F. Recurrent pruritic lesions on legs, face, consistent with urticaria x 2 days
A female reported that her adult brother received an injection of influenza virus vaccine  on 12/5/02. The pt was seen in the ER for fever and rash, white blood count was increased. No medications were prescribed; however, the pt was admitted to the psychiatric ward. The reporter declined to provide a specific reason or diagnosis and was held until 12/10/02. At that time he was seen by another physician who released him. That physician felt he should have never been in the psychiatric ward. Since that time he has had episodes of excessive eating and drinking, difficulty sleeping, and severe pain in the groin. He has been to the ER three times since and a diagnosis of epididymitis was made; however, they could not find any cause for his other symptoms. The reporter declined further info.
21 days post vax, the pt was brushing teeth and fell into mothers arms and began having seizure like activity. Ambulance called and delivered the pt to the ER. Mother concerned about link with immunizations. Mother reports Cat scan within normal limits. Scheduled to follow-up with primary MD on 01/29/2001. ER report shows pt discharged with febrile seizure activity and anemia and hematuria.
Arm with edema, induration, redness less than 10cm around area of vaccine injection. Onset at 24 hours after injection.
slight headache later that evening with minor nausea.  Cold Chills and intense pain in the joints. I felt cold chills that seem to radiate from the joints out.  My joints were stiff and painful.. felt inflamed. I had to get up at 2am and take a pain pill and muscle relaxer.  I almost feel like it exaggerated or inflamed the pain I was already having due to a spine injury.
Pt developed a fiery red injection site with redness around the outside of site. Edema extends down to the middle of arm, hard in the middle like a mosquito bit.
Itchy, irreg patches 8/26, 8/28, extremities, trunk. Tdap given 8/25/06.
Rotateq given 5/23/06 and 8/4/06 developed intussusception Sept 5th requiring surgical reduction. 99/19/06-received office note for DOS 8/1-9/5/06- note for 9/5/06-vomiting/possible dehydration. vomiting times 2 days, constipated 2 days ago, blood in diaper today, small amount of stool. PE: awake alert responsive, unsmiling. Abdomen soft non-tender, transfer to hospital. Operative Report received from Southwest Texas Methodist Hospital: 9/7/06-Pre operative DX: Intussusception Postoperative DX and DC DX/: Ileo ileocolic intussusception. Procedure: open reduction of intussusception. Incidental appendectomy. Preoperative Note: admitted to hospital with bilious emesis approximately 36 hours ago. Upper GI normal, US failed to disclose a suspected intussusception. Underwent trial of feeds which were unsuccessful. Follow up CT scan disclosed intussusception in right lower quadrant which was masked by overlying small bowel. Open reduction recommended due to failure of hydrostatic reduction in radiology. HX of Present Illness: admitted 9/5/06 with emesis which progressed to bilious and fussiness and dry heaves. Seen in office after 2 hours of emesis and a normal BM. No diarrhea and no fever.  PMH: Bronchitis. PE: Temp 99.5, HR 131, resp rate 32. Slightly lethargic, dry lips and mucous membranes. Mild tachycardia. Lungs clear. ABD: very supple without guarding, soft, nontender and nondistended. Normal bowel sounds.   2 trials of feeds failed with bilious emesis and started to have mucosy bloody stools.  Attempted hydrostatic reduction was unsuccessful.  Surgery 9/7/06 open reduction and intussusception and internal appendectomy. He did not require a bowel resection. Uncomplicated postoperative course with gradual resumption of p.o. feeds. Post op day #3 tolerating goal calorie and fluid diet. Afebrile, vital signs stable.  DC to home follow up in 3-4 weeks.
25 minutes after the shot was administered I felt nauseas; almost passed out; was covered in sweat and became short of breath; was covered in sweat and became short of breath; my jaw hurt; back of my throat hurt; head hurt; cotton mouth; lips turned blue; I immediately had arm pain; foggy head; forgetful; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient (Age at time of vaccination 27-years) received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 11:45 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced lips turned blue on 09Aug2021 at 12:10, I immediately had arm pain on 09Aug2021 at 11:45 and 25 minutes after the shot was administered I felt nauseas, almost passed out, was covered in sweat and became short of breath, my jaw hurt, back of my throat hurt, head hurt and cotton mouth all on 09Aug2021 at 12:10 and foggy head and forgetful on 09Aug2021. Patient reported, I immediately had arm pain and then 25 minutes after the shot was administered I felt nauseas and almost passed out, was covered in sweat and became short of breath, lips turned blue, then my jaw hurt and the back of my throat hurt and my head hurt. Then it faded and I had cotton mouth. The rest of the day I was nauseated, foggy head and forgetful, with really intense arm pain. The event Lips turned blue was reported as serious-medically significant. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Fever; Lack of sleep; Loss of Taste; Loss of Smell; Joint Pain that feels like being mashed or hit by a train; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell), ARTHRALGIA (Joint Pain that feels like being mashed or hit by a train), PYREXIA (Fever) and INSOMNIA (Lack of sleep) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell), ARTHRALGIA (Joint Pain that feels like being mashed or hit by a train) and INSOMNIA (Lack of sleep). On 08-May-2021, the patient experienced PYREXIA (Fever). On 08-May-2021, AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Joint Pain that feels like being mashed or hit by a train) and INSOMNIA (Lack of sleep) 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 concomitant medications were provided. No treatment details were provided.
on the left arm where she got the vaccine is itching; Gums are throbbing; Roof of mouth like a sore and tender.; Headache; Chills on and off; On the left arm where she got the vaccine its red with a big patch; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off), VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) and VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching) outcome was unknown.            Concomitant medications were not reported. It was reported that patient had treated with Tylenol - Unable to provide milligrams however taking medication 2 every six hours as per patient
Day after injection: swelling, redness and tenderness and the site of the injection. No noticeable wheal was present in the 24 hours following vaccination. Injection site side effects cleared within 24 hours. For 7 days following vaccination: migraine, varying fever up to 101.8°F, chills, severe fatigue, sore throat, cough and congestion (excessive mucosal drain resulting in gastro distress, namely diarrhea), swollen lymph nodes of the neck (severely so on the right side), nuchal rigidity. Managed with bed rest, acetaminophen and naproxen, and home remedies for other symptoms. All began to fully/finally resolve the morning of 9/14/2022.
SORENESS AT INJECTION SITE INITIALLY.  THEN CHILLS, FEVER OF 100.4,EXTREME ACHES, MILD HEADACHE AND DISCOMFORT BEHIND EYES AT 0400am THEN FEVER OF 101.4 AT 1030AM 1/16/2021.
lt brown circular area-1 1/4" diameter w/red ring around it & swelling & hardness noted 56hr p/shot;approx 5hr later, area had tripled in size;MD visit required;area still recovering a brown spot 2" in diameter still present;
p/vax pt exp 8x6cm area induration & erythema below inj site rt leg
On July 5, 2021, traveling. I felt like I had a really bad cold/sinus infection. Tuesday morning, was running a low grade fever (99.6-to 99.8)By Wednesday, July 7th, was not feeling better and that morning I noticed I had lost my senses of taste and smell. Decided to have a Covid test done just to be sure. The facility performed a rapid Covid-19  test and it came back positive. As my head was extremely stuff, I was prescribed Prednisone and Fluticasone nasal spray. That evening, my fever had spiked to 102.8. I was achy, tired, and still felt like I had the worst cold/sinus infection. As of today, 7/16/21, I still do not feel 100%.  Am currently taking Augmentin, still using the nasal spray, and taking Sudafed to combat the sinus/stuffy head feeling. Have not had a fever since the 7th.
1-5pm unusual sleepiness. 5pm soreness and redness at site of injection. 5-8pm non-stop crying (screaming).
Medication Administration Error: Patient received his primary Janssen COVID-19 vaccine 3/10/2021 and a booster Janssen dose 10/29/2021. On ~12/15/2021, it was identified that the vaccine administered to this patient had actually expired on 9/21/2021. There was confusion between what was written on the labels and what had been entered into the computer system. Was notified of the error and reached out to the patient for re-vaccination with Pfizer on 12/20/2021.
Arm swollen from elbow to axilla and temperature 102F. Temperature was 106F on admission to the hospital. No other pts experienced this reaction. Immunity problems and further tests are being done. A follow up report received 6/6/2002 adds: Diagnosis was cellulitis.
Beginning in May, Patient reported feeling a tingling in legs and brain fog.  Over the next 3 months, increased numbness, brain fog, forgetfulness, inability to move.  In august, lost much strength.  Couldn?t eat.  Face feeling numb.  Forgetfulness and brain fog worsen.  Inability to stand.  Fell twice.  Vision got very bad.  In sept, sent to ER after a fall and admitted to the PCU.
Rash/hives across chest at back (upper), back of neck, no itching, gone by next am.
Imm. given 04-07-11 in (L) delt. 04/08/11 - morning - had circle of red swollen area that had blister like lesions by afternoon. This proceeded to approximately cover front of deltoid and down to within 2" of elbow & half way around arm. Mother called PHN & was advised to use TYLENOL type analgesic with cold compress to arm & see Dr. if further concern. Mother took child to ER late Sat. night. Recommendation there was cold compress, ibuprofen & BENADRYL. This was done and area has cleared up now (4/11/11 a.m.).
Next monthly menstrual cycle was extremely heavy with clots and has continued since that second vaccine So, March 2021 to this date the cycle have been horrible.; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN06205) via an unspecified route of administration in the arm left on  05Mar2021 at 16:00 (at the age of 46-year-old) and the patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history included kidney transplant. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included immunosuppressants (MANUFACTURER UNKNOWN), from an unknown date for kidney transplant and unknown if ongoing. On an unknown date in Mar2021, the patient experienced next monthly menstrual cycle was extremely heavy with clots and had continued since that second vaccine So, March 2021 to this date the cycle had been horrible. On an unknown date, the patient underwent SARS CoV-2 test (blood test) and the result was unknown. On an unknown date, the patient underwent antibody test and the result was no/undetectable antibodies. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event, menstrual cycle was extremely heavy with clots and had continued since that second vaccine was unknown at the time of the report.
fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a female patient of an unknown age 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 (fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) The patient had fever.         No concomitant medications were reported.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient had three vaccines that day, Boostrix,Pneumovax, and Afluria. PAtient called on 10/20/00 to say that her arm hurt very badly. I was not the one who administered the shots, but instructed her to ice the area and use ibuprofen. patient called 4 hours later and said depsite these measures, she was in extreme pain. Subsequent calls to her from the  supervisor went unanswered.
I had very little  reaction initially, but over the following months I get an ache at random times at the injection site that continues to this day. It?s as if someone has punched me there with their knuckle.  The ache seems to be more consistent in the morning but can appear at any time of day as I move my arm.  Sometimes many days will pass before I feel the ache again. It is not a sharp pain (scale of 5) but still there after all these months, which has made me hesitant to get the booster.
Local reaction to arm, presenting red, slightly swollen by a 4"x4" diameter around injection site. Symptoms present x 3 days before resolving. Patient had no fever or other symptoms during this time. Home care, ADVIL, 10 mg to aid with symptoms.
Within 2 minutes, dizziness. Within 4-5 minutes post injection, LOC for 30-60 seconds. Diaphoretic sweating, clammy, pale, dilated pupils, Recovered within 20-30 minutes fully. EMS evaluation completed and cleared on site.
Vaccine was not given at our facility. Unsure of Manufacturer and/or Lot numbers etc.
5/27 vaccine administered. 5/29 Pt c/o swelling, tenderness, erythema R upper arm post vaccination. MD dx of Cellulitis. Bactrim ordered. 5/30 Per MD cellulitis improved. 5/31 Continues to improve. 6/1 Resolving continues to improve. 6/2 Continue Bactrim until complete. Pt discharged to home.
day 2 post vaccine ear fullness  started and continues, day 7 post vaccine tinnitus in both ears along with facial tingling on right side and around eye.   the tinnitus is still 11 days post vaccine along with ear fullness.
Arm hurt so bad several hours after shot, I could not use it. Went to bed early not feeling well. Woke up the next day. Awful  headache, muscles hurt so bad I could hardly get out of bed, shivers, stomach up set , couldn't eat, extremely tired. Lasted all day , all night and half the next day until I felt right.