chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after receiving vaccine, patient began to feel faint. While sitting for the 15 minute observation period following vaccine administration, the patient fainted and her mother was observing her and asked for help and requested we call 911.  Meanwhile, mom sprinkled water onto her face and was speaking with patient to see if she is conscious and breathing.  Two pharmacists confirmed with mom that she is breathing and not needing CPR while paramedics arrived and took over.
She has redness and swelling from injection site in deltoid and down to elbow. She has been icing the shoulder and noticed some improvement. She reports the reaction occurred about 3-4 hours after injection and progressed to elbow, noticed the next morning upon awakening.
Between baseball and golfball size itchy red whelt at injection site still present 3 days after vaccine dose administered.
axillary lymph node was the size of a golf ball; fever of 101.6 then 102.2; hallucinations; dizziness; confusion; severe headache; body aches; nausea; vomiting; A spontaneous report was received from a healthcare professional concerning a 47 years-old, female patient who experienced hallucinations/MedDRA PT: hallucination, confusion/MedDRA PT: confusion, dizziness/MedDRA PT: dizziness, severe headache/MedDRA PT: headache, body aches/MedDRA PT: myalgia, fever of 101.6 then 102.2/MedDRA PT: pyrexia, nausea/MedDRA PT: nausea, vomiting/MedDRA PT: vomiting, and axillary lymph node was the size of a golf ball/MedDRA PT: vaccination site lymphadenopathy.  The patient's medical history was not provided. Concomitant product use included levothyroxine, lisinopril, metformin, liraglutide, atorvastatin, furosemide, famotidine, cetirizine hydrochloride and vitamins NOS.  The patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) on 07 Jan 2021. On 03 Feb 2021 at 4:00pm, approximately 4 and a half hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly, in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 03 Feb 2021 at approximately 8:30pm, the patient began to experience severe headache and body aches. By midnight, the patient had a fever of 101.6 then 102.2 which was the highest reading.  The patient experienced nausea and vomiting for 36 hours and couldn't keep food down.  On Thursday (04 Feb 2021), patient had dizziness, confusion and hallucinations - patient had a conversation with spouse who was not at home. Patient's axillary lymph node was the size of a golf ball. Patient took Tylenol at the 25 hour mark once symptoms began which was about 5:00pm on Thursday. By Friday night (05 Feb 2021) patient was able to keep food down. By Sunday (07 Feb 2021) the patient felt 85% better. The patient still had axillary lymph node swelling but reported 90% improvement. Patient had ongoing headaches at the time of this report for which Tylenol is taken daily.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The event severe headache was not resolved. The events hallucinations, confusion, dizziness, body aches, fever of 101.6 then 102.2, nausea, vomiting, and and axillary lymph node was the size of a golf ball were resolving.; Reporter's Comments: This case concerns a 47-year-old female with serious expected Hallucinations, NS unexpected confusion, dizziness and NS expected fever, headache, myalgia, nausea, vomiting, vaccination site lymphadenopathy.  Event onset 29 days after first dose and 4 hours after second dose mRNA-1273. Treatment with Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Inconsolable screaming for hours, leg swelling twice it's size. Went to hospital around 6. Swelling went down, screaming stopped on own.
Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA.  BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP  walked patient out of clinic.
27AUG93 general malaise, achy all over body-soreness @ inject site; temp 103, slept all day; shoulder & neck very sore; 30AUG93 arm still hot to touch, red, inflammed & bumpy; referred to pvt MD;
Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Additional Details: rash developed on patient's legs the night of vaccine, lasted about 2 days, mom gave Benadryl
On 4/29, I bit down and got a pain my tooth that never went away. I went to the dentist who said I had an injection. I was on antibiotics for 10 days. I went back to the dentists on 5/11 where he said he could not save it and the tooth was pulled. Again on 6/4, I had pain in my tooth and went to the dentist. I was told I had an infection again. After being on antibiotics the tooth could not be saved and was pulled on 6/16. Once again, this cycle happened again in August. I had itching in my legs with no rash. I went to a PCP and dermatologist but was unable to get treatment because there is no rash present. It is from inside and I am always itching. I was given a cortisone shot which did not help. I was also given a cream that I put on the areas.
Fainted/passed out within 3 mins of vaccination. Situation did not escalate beyond the store.
swollen left leg, warm to touch, painful  steroid given for swelling and pain by parent prior to coming to see the physician
Pt rec'd flu vaccine (see attached copy of lot etc) then 2 hrs later started with hoarse voice; throat tightness.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was new onset atrial fibrillation.
First injection 1/27/2021 042120A: increased heart rate from 63bpm to 105 for 36 hours. Second injection February 24, 2021 007M20A after 10 days I started an arthritis flare that continued for 2.5 - 3 months.
This spontaneous report was received from a medical assistant refers to 1 month old patient of unknown gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 22-SEP-2016, the patient was inadvertently vaccinated with VAQTA (lot # M032492, expiry date 02-MAR-2018, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
inadvertently administered an expired Boostrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 1st March 2022, the patient received Boostrix. On 1st March 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received an expired dose of Boostrix, which led to expired vaccine used. The reporter inquired, if the patient needed to be revaccinated or not and if a dose was valid. The reporter was unable to provide vaccine and patient details. The reporter did not consent to follow up.
Injection area swelled, turned bright red, and felt like 20 pea sized balls under skin. Applied cold pack to cool warm spot down. Spot turned purple, more lumps occurred. For one week, patient had hives rash all over body, at least 4 times a day. Extremely bad hives. Physician had us give patient Benadryl. Sept 30 the hives resided, as well as the spot at the injection site.
Patient was scheduled to receive her second Pfizer primary series vaccine. She received the Pfizer Bivalent instead. No adverse reaction occurred. No treatment was needed.
Pt received SHINGRIX (1st shot) on 10/5/18 Friday (approximately 11:30 AM). He lost his consciousness and fainted in his bathroom on Sat morning (approximately 7-8 AM) 10/6/18 and he hurt his back side of head and taken to ER. He was advised to stay overnight at the hospital but he got discharged on his own.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/07/22. When error discovered facility contacted for course of action. At direction of the facility, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
Presented to hospital on 12/28 after 3 days of progressive dyspnea. Had been to PCP office where COVID-19 test positive.  He was started on dexamethasone and doxycycline. Remedesivir held due to poor renal function. VQ scan showed high probability for PE so started on apixaban. Worsening hypoxia with pulmonary consult. Lab results showed bacterial process so antibiotics continued for pneumonia treatment. Pt. had several days of mild epistaxis requiring nasal packing.  Started hemodialysis. Up trending tachycardia and WBC count. CT showed worsening pneumonia. Added coverage for MRSA with zyvox and ID added voriconazole. Due to continued decline family asked for transition to palliative care on 1/17.
Body Aches, Chills, headache, tired. Started at 11am then got worse as day progressed. Took Tylenol at 7. Heavy sweat (fever broke) at about 8pm. Felt a little better 10. Took Advil and went to sleep. Felt fine by 7am.
pt recv vax & devel inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;
Possible signs of bell palsy, swelling and soreness on left side of face, droopy eye, teary eye. Sagging of left side of face. MR and received revealing a previously healthy 61 year old (no meds) who presented with left facial weakness of 2 weeks duration. Symptoms began several days after his flu shot. He also complained of hearing loss in the left ear as well as tenderness in the left mastoid region. He was intially seen by his PCP (unknown) and treated with steroids which did not improve the problem. Speech articulation was also affected.  Corneal reflex markedly decreased on the left.  Initial Assessment: Left peripheral facial weakness with decreased hearing and sensation of left face, suggesting a lesion in the brainstem/left CP angle/or menigeal lesions, or of multiple cranial nerves.   Addendum following MRI results-Flu shot neuritis
Very fussy since shots were given and localized redness both thighs. Tylenol was given round the clock.
Pt. was sitting in a chair before, during, and after vaccination and after about 5 mins after vaccination, she seemed to lose consciousness for about 5-10 seconds and became conscious quickly. Said she was okay and had her relaxed for a awhile and had he boyfriend picked her up and she said she'll will follow up w/her primary doctor.
Couldn't sleep at night, freezing cold (despite thermal underwear and down comforter), muscle pain for 2-3 hours, then given TYLENOL, melatonin, extra sweater and fleece pants--slept, woke up with headache and body aches for entire next day.
Patient received Covid vaccine BUD. Vaccine expired on 7/7/2022 and patient received vaccine on 7/9/22
I tested positive for COVID-19 on 12/10/2022. It started with body aches and the feeling of a head cold. At the peak of the symptoms, I had severe sore throat and I felt that in my ear drums. I was prescribed Paxlovid and took that. By the end of the dosage, I felt better.
C/o persistent pain to (L) deltoid s/p flu vaccine. Administered 10/13/15 no pain at time. 10/14/15 c/o "ache" at site. 10/15/15 c/o pain deep in muscle. Used ice and ibuprofen.
Headache, Myalgia, Arthralgia, Fever,  Chills, Fatigue, Injection site pain
pt recv vax NOV96 & JAN97 it was noted that pt had atrophy @ the inj site described as necrosis to subdermal layers of site-uppermost layers intact;
Patient waited 15 minutes after vaccination  was given ,per protocol and did not have any side effects/ symptoms.
Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (-0.2C for 116 hours, 24 minutes, and data logger was involved) doses of PNEUMOVAX 23 (dose, frequency and route were unknown, lot # L048265, expiration date 10-JUN-2017, another lot # M013156, expiration date 15-OCT-2017). The PNEUMOVAX 23 didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one several reports received from the same reporter.
4/3/21 - Noticed Skin eruptions on arms and legs  4/11/21 Skin eruptions were getting worse  4/19/21 - began heavy vaginal bleeding  4/20/21 - began feeling dizzy, light headed, hard to breath  4/22/21 - admitted into hospital with Cellulitis, Sepsis,  Sever Anemia - discharged 8 days later Red blood count was 5
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 4:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 4:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.52.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues
Patient was immunized against shingles in May and developed clinical shingles in two separate dermatomes in June and again in November.  His level of immunosuppression (15 mg/wk MTX and prednisone 5 mg/d) was not considered a contraindication to vaccination.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent and historical conditions, as well as the drug reactions/allergies were not reported. Concomitant medications included Merck sterile diluent. On an unknown dates in March 2018 (reported as administered on or after 15-MAR-2018), the patients were vaccinated improperly stored doses of M-M-R II (lot # M039913 with expiration date of 26-SEP-2018, lot # N020924 with expiration date of 01-AUG-2019) (strength, route, and anatomical location were not reported); PNEUMOVAX 23, (lot # N013541 with expiration date of 21-JAN-2019, lot # N013521 with expiration date of 23-JAN-2019, lot # N025656 with expiration date of 19-APR-2019) (strength, route, and anatomical location were not reported); ROTATEQ (orally), (lot # N005077 with expiration date of 21-NOV-2018, lot # N010707 with expiration date of 03-DEC-2018) (strength was not reported) and VAQTA (lot # N019924 with expiration date of 21-SEP-2018, lot # reported as N032753 with expiration date of 23-MAR-2019) (strength, route, and anatomical location were not reported); all vaccines were given for prophylaxis. No adverse effects were reported. It was reported that the abovementioned vaccines suffered a temperature excursion which ranged between 9 degrees C to 25 degrees C during 3 hours and 7 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Exactly 7 days after injection, I've developed an itchy, red, raised rash at & around the injection site. It is slightly larger than a quarter in size. I also feel slightly dizzy & tingly, especially in my feet & lower extremities.
Thyroid hormone levels increased; Breathing problems; Chest Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THYROID HORMONES INCREASED (Thyroid hormone levels increased), DYSPNOEA (Breathing problems) and CHEST PAIN (Chest Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperthyroidism.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced THYROID HORMONES INCREASED (Thyroid hormone levels increased), DYSPNOEA (Breathing problems) and CHEST PAIN (Chest Pain). At the time of the report, THYROID HORMONES INCREASED (Thyroid hormone levels increased), DYSPNOEA (Breathing problems) and CHEST PAIN (Chest Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood thyroid stimulating hormone: increased (High) Thyroid hormone levels increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their wife who received their 1st dose of Moderna vaccine and post receiving the vaccine the patient had breathing problems, chest pain and their thyroid hormone levels increased that the patient ended up going to hospital.   Reportedly, the patient had a medical history of thyroid  No Concomitant product use was reported.  No treatment information was provided.
Information has been received form a physician and a nurse concerning a 39 year old female with an allergy to penicillin who on 25JUL2003 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent.  On 26JUL2003, 24 hours past vaccination, the pt experienced injection site redness and swelling, fever and nausea. The pt was seen in a walk in clinic on 26JUL2003, and was prescribed the abx "Levoquin" for 5 days. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information was received from the physician which indicated that on the evening of 25JUL2003 the pt's arm was sore. On 26JUL2003 the arm was red and inflamed. The pt had a fever of 100.7 and had complaints of nausea and fatigue. On 27JUL2003 the arm was still sore, red and inflamed. It was noted that the patient stated that she felt better. No further information is expected.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain). At the time of the report, LIMB DISCOMFORT (Couldn't lift or put my left arm down), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Can't lay down, can't lay flat from the pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included hydrocodone, ibuprofen, and acetaminophen.  She went to urgent care for the pain and received pain medications. She has taken 4 tablets of Vicodin 5-325mg taken 4 tablets so far and alternates between Motrin and Tylenol so she is taking medications around the clock as the Vicodin is not enough.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 included no new information; Reporter'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.