chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunocompromised; My WBC go down to upper ones; This is a spontaneous report received from a contactable physician and a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported Event Term: Immunocompromised, her white blood cell (WBC) go down to upper ones. Outcome of events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on an implied temporal association, a causal relationship between events Immunocompromised and white blood cell (WBC) go down, and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer 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.
L axillary pain beginning approx. 8 hours post-injection escalating to severe throbbing pain (8-9 in severity) 12 to 24 hours following injection. Pain was accompanied by significant axilla, arm, chest and back swelling with a collection of approximately 500-700 ml fluid during peak of lymphadenitis. A small (1 cm x 2 cm) bruise appeared in armpit day 1 post-vaccine followed by 3 more bruises day 3 post-vaccine in armpit and on L chest wall. Pain subsided within 2 days but with waxing and waning of pain and swelling still by day 4 post-vaccination (today).
Overnight after his vaccines, mother noted bulging fontanelle. Also had slight elevated temperature, tmax ~100. Was fussy/irritable. Gave Tylenol around 1 AM. Throughout the next day the fontanelle was less bulging but still present, pulsating in upright position. No seizure activity just irritable. Tolerating formula bottles. Planned to observe given otherwise clinically well.
Face was flushed and redness and warmth to injection site (R arm) at the 15 minutes mark. Benadryl given, child waited another 10 minutes. When re-checked child's symptoms were resolved.
1) Localized symptoms: upper arm around injection site became very red, hot and swollen. At its peak, it covered an area exceeding 5x7 inches. Finally started to improve on 10/11/14. 2) Systemic symptoms: flu-like symptoms including fever, body aches, headache, congestion, and feeling all round awful. This started 10/9, was worst on 10/10, and improved on 10/11.
For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot; I had an allergic reaction to mango sap and waited until symptoms plus one week had past; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (For the second shot I was delayed getting the shot by 2 weeks, a total of 6 weeks 2 days since first shot) and HYPERSENSITIVITY (I had an allergic reaction to mango sap and waited until symptoms plus one week had past) had resolved.
There were no adverse events from this vaccine. The patient told us she was due for her 3rd Hepatitis B vaccine and it was later found that her previous dose was 6/21/22, just a couple weeks before the vaccine we gave her on 7/5/22.  We reversed the insurance claim for the vaccine, filed an incident report that her series was not complete and the 3rd vaccine is invalid due to improper timing, and will give her the next dose at no charge.
Information has been received from a pharmacist referring to a 61 year old female patient with no known allergies and none pertinent medical history. On 05-OCT-2015 the patient was vaccinated with ZOSTAVAX, lot # L020482, expiration date 02-SEP-2016, 0.65 ml, subcutaneous in the left arm. On the same day, the patient was also vaccinated with inactivated flu vaccine in the left arm ((lot#, dose and route not reported). The pharmacist stated the patient developed injection site rash, left arm, post vaccination with ZOSTAVAX (date unspecified). On 08-OCT-2015 ("3 days later"), the patient went for her regular general scheduled appointment at her health care provider office, and lab work showed she had C-reactive protein in the blood. Pharmacist stated he was not sure if this lab result was due to the rash or not. No treatment was given for the events. The pharmacist stated the rash was not shingles, and was just a slight reaction. The rash had resolved on an unspecified date in 2015. The outcome of "C-reactive protein in the blood" was unknown. Additional information has been requested.
Bell's Palsy (facial paralysis) diagnosed at ED visit later that day. Started on valacyclovir and prednisone for 2 week.
Enlarged Lymph Node. From Radiologist report on  annual mammogram: In the left breast, there is a prominent axillary lymph node. There is also an asymmetry seen in the CC view only at posterior depth in the lateral breast. 2. Left axilla: Prominent left axilla lymph node. Recommend targeted ultrasound for further evaluation. BI-RADS Category 0: Incomplete-additional imaging needed.  3. Left breast: Indeterminate asymmetry CC view only posterior depth lateral breast. Recommend additional views and possible ultrasound for further evaluation. BI-RADS Category 0: Incomplete-additional imaging needed.   9. cont'd: Vitamin C, Glucosamine/Chondroitin, fiber capsules.  18 cont'd  BI-RADS 0 -- incomplete assessment    From report on August 11 follow-up imaging:  Additional imaging of the left breast was obtained. The asymmetry in the posterior lateral aspect of the left breast is thought to represent a stable 6 mm mass in the deep 3:00 position of the left breast. This appears to contain fat suggesting that it represents a intramammary lymph node. This is not significant change from the 2017 exam.  Ultrasound was then performed targeting the left axilla. A prominent 4.2 cm fatty replaced lymph node is seen. The finding noted on the screening study is thought to correspond to a 1.6 cm lymph node in the lower axilla. The cortical thickness measures 0.47 cm.   From 11/11/2021 follow-up ultrasound LEFT ULTRASOUND: Targeted ultrasound was performed in the axilla and areas of previous interest. Lymph nodes have decreased in size. The most thickened lymph node has a cortical thickness of 2 to 3 mm, within normal limits, decreased when compared to previous exam when measured approximately 5 mm. There are no suspicious findings.  IMPRESSION AND RECOMMENDATION:  No sonographic signs of malignancy.  Recommend patient resume screening mammography due July 2022, as long as physical exam is unchanged.  BI-RADS Category 2: Benign
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Patient has asthma. During the 15 min wait pt started to experience tightness throat and mucous production. Gave patients two benadryl tablets and waited with patient. She waited until she was feeling better and symptoms cleared
On 09/15/2021, patient showed up in the mobile clinic reporting adverse reaction from first dose of Pfizer, she was advised by her primary care provider to get Janssen for the second dose. Date of last dosage was not verified correctly as the patient claimed she lost her vaccination card and reluctant to give more information. The leadership team found out that the interchanged vaccination was administered less than the minimum interval of 28 days, System shows she received Pfizer on 08/31/21.
Painful muscle aches in legs and arms; slight headache; fatigue. All started gradually and are getting worse. Will take acetaminophen.
Information has been received from a medical assistant concerning a 9 year old female who on 27Nov98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. The pt was see at the doctors office by the physician and no fever was noted. There was no product quality complaint involved. The reporter indicated that two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Nausea, dizziness, shakiness, chills at about 15 minutes. HR 83, O2 sat 94% increased to 98%, bp 140/90. Ladi down, felt better, ate a cookie, went to check out. Felt nauseous again, laid down again. Developed erythematous rash around vaccine site, then spread to neck and shoulders. then slight chest tightness that rapidly resolved. HR 68 spO2 97%, 119/52. T 98.7. Diphenhydramine 50 IM given. Rash receded. At 13:20, HR 59, 113/59, 98% sat. At 13:35 HR 56, 110/56, 100% sat. Continued to feel better. Fexofenadine 180  po given, albuterol inhaler 2 puffs. Continued to feel better. Picked up by husband.
Pt c/o receiving Novavax COVID-19 vax at 1800, then at 1900 developed L CP intermittently, BUE & BLE numbness tingling, decreased BLE strength. NO SOB. Felt swelling in sternal notch while swallowing, which has now resolved.   L CP lasts 1 hr/episode, feels sharp.
Hives in all over her body ( urticaria ) like red welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in all over her body ( urticaria ) like red welts) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Hives in all over her body ( urticaria ) like red welts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 27-Nov-2021 for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives in all over her body ( urticaria ) like red welts) outcome was unknown.            Other concomitant product use included meclatzon.
ache on the right arm; joint pain pretty high on her right shoulder; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 23rd October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and pain in joint involving shoulder region. The patient was treated with naproxen. On an unknown date, the outcome of the pain in arm and pain in joint involving shoulder region were recovering/resolving.   It was unknown if the reporter considered the pain in arm and pain in joint involving shoulder region to be related to Shingrix.  Additional details were received as follows: The patient  had the second dose of Shingrix and she experienced a normal ache on the right arm. The ache continued and became more uncomfortable and she also  joint pain pretty high on her right shoulder depending on the position that she puts her arm in. The patient described the pain as very uncomfortable and she tried taking Neproxin but she still had the pain.  The patient consented to follow up.
Swelling and extreme pain in thumbs, index fingers and wrists as well as pain in right arm and both knees.
CDC reports: 5 mo infant developed fever to 100 & screaming episode following DTP/OPV immunization.
What is known as Covid Arm. Current and active pain and inflammation at injection site.  "Tight, hard skin" similar to a bee sting. Hot around area. No treatment. Numbness from top of shoulder to just below the elbow. Since it has started, I have had fast internal "blasts of cold" almost like a cold chill but much slower from head to toe. Extreme sensitivity to temperature, not just my arm, but my body as a whole.
Within one hour post vax, the noticed redness around her eyes and nose. By the next day her cheeks were red and her extremities were as well. She vomited once. The following morning her face was puffy, her eyes were almost shut.
On this day I was scheduled to receive my annual flu vaccine and have a dental checkup all in one visit (on base).  I received my flu shot and immediately after I began to feel light headed and began to sweat profusely.  Since I was to get a dental exam right after the vaccine I was getting my vitals taken and the technician noticed I was looking a little pale as he's pumping up the blood pressure cuff.  After getting his numbers for my BP, he checked again, and again, and asked how I was feeling.  My BP was 92/58, which is extremely low for me.  I continued to sit and be monitored by the technicians as my condition slowly improved on its own.  Eventually my BP came back up to a normal level and I went on my way.
3pm Tired, 330 headache, 330 muscle pain and soreness, 5 fever and uncontrollable shaking chills, hard to breathe. Was fine by 11pm.
Pt had facial and tongue swelling after dose 1 that resolved after about 4 hours.  She spoke with her primary care who told her she needed to come back to same location for second dose, that benefit outweighed the risk, and she should take daily oral benadryl in prep and bring her epi-pen.  Second dose was approved, given, pt has sensation of burning lips and tongue swelling.  .GSC 15, A&Ox 4 , no swelling observed, slight wheeze in upper left lung, o/w clear throughout.  vitals bp 140/80, HR 71, spO2 94%.  50mg benadryl IM right arm given shortly after symptoms developed.  they did not worsen, slight improvement after 45 min observation, had driver, given emergency recommendations, left to go home in stable condition.
Headache, body aches, fever,chills, fatigue, joint pain Treated with tylenol as needed Resolved in 48hours
76 yo M who presented to the ER with a history of confusion for the prior 24 hours. He was admitted for further evaluation regarding his mental status. Upon admission, patient tested positive for COVID-19, however, he had tested positive in October of 2020 also. Patient had received the first COVID-19 vaccine dose 2 days prior to admission, displayed no hypoxic symptoms. MRI of brain revealed a small area that could possibly be an acute infarction of right occipital lobe. His mental status improved during his admission, and he was discharged on 2/16/2021 with some intermittent confusion. Doctor recommended he still receive his second COVID-19 vaccination on time.
I received the vaccine on 1/7/21 and the next morning (1/8/21) I woke up with a fever of 100.5, a headache, and nausea.
Patient is experiencing symptoms of Medial epicondylitis since receiving the first dose of the COVID-19 vaccine. Patient relates to having a sharp, constant pain that has been present since receiving the first COVID-19 vaccine.
Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient received booster dose vaccine past it's beyond use date of 06 Jan 2022 and does not reported any other adverse events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received, contains non significant information. On 07-Feb-2022: Follow up received, contact information updated.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitations) and CHEST PAIN (Chest Pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Jun-2021, the patient experienced PALPITATIONS (Heart Palpitations) (seriousness criterion hospitalization) and CHEST PAIN (Chest Pain) (seriousness criteria hospitalization). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. On 01-June-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, PALPITATIONS (Heart Palpitations), CHEST PAIN (Chest Pain) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company Comment: Based on the 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.; Sender's Comments: Based on the 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.
Severe back pain starting 2 weeks after vaccine and still going on for 2 weeks.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (at the age of 54-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took Penicillin and experienced Known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 03:00 PM (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient was not covid tested post vaccination. On 11Apr2021, at 04:00 PM, the patient had severe back pain starting 2 weeks after vaccine and still going on for 2 weeks. The patient not required treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash 2 weeks after vaccination. red/erythematous, itching. Tx: OTC antihistamine and cold compresses. Outlined area to monitor progression
This consentaneous report as received from a pharmacist refers to a 60 year old female patient with psoriasis and no drug reactions or allergies. On 21-JUL-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, in the arm, lot # J014810, expiration date: 21-FEB-2015). None concomitant medications were reported. On 21-JUL-2014 the patient developed redness, swelling, pain and itching on her arm at the injection site after receiving ZOSTAVAX. The area of swelling and redness was reported to be 8 cm in diameter. The patient had an appointment with an unspecified dermatologist related to her history of psoriasis (scheduled prior to receiving ZOSTAVAX) who looked at her ZOSTAVAX injection site during that appointment. The patient also came back to the pharmacy to show the pharmacist her arm. There was no treatment given for the adverse event. There was none lab diagnostics studies performed. The outcome of reported adverse events was reported as not recovered. The relatedness between reported adverse events and ZOSTAVAX was not reported.  Additional information has been requested.
Racing heart that continued on and off for over a week; longest it lasted was several hours; feeling of shortness of breath with racing heart; sporadic chest pain that has been on going since vaccination
Confusion, Dizziness, Headache, Fever, NauseaVomiting,  increased fatigue, increased muscle aches, hot sweat, chills Narrative:
This spontaneous report was received from a nurse and refers to a currently 9 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 15-MAY-2008, the patient was vaccinated with M-M-R II injection (lot#, expiration date, dose and route of administration were not reported). Information about the patient's concomitant therapies was not provided. On an unknown date, the serological testing was positive for mumps and rubella but negative for measles. The outcome of the event and the causality between the M-M-R II and the event were not reported. Product quality complaint was not involved. Additional information has been requested.
Fever on 7/12/00, rash all over from thighs to top of thighs to top of head on 7/14/00. Mother called PCP who told her it was measles and suggested Tylenol for fever and isolation for 48 hours. Fever abated on 7/14/00 and rash clearing on 7/17/00. Child is almost recovered.
Patient experienced localized itching, redness & heat at the injection site, pins and needle type pain & loss of sensation in the lower extremity within 20 min of administration.  Patient denied N&V, SOB, difficulty breathing, headache, dizziness, hives, facial/tongue swelling, light headiness, or clammy skin.  Vitals taken at 5 minute intervals include BP 121/62; 109/61; 113/62, HR 79,70, 65, 02 98, 98, 99.  Patient given 10mg cetirizine upon presentation of symptoms.  Patient returned to baseline ~ 20 minutes after administration of cetirizine.  Released with return precautions ~45 min post administration.