chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care provider on 13 May 2010. An 18-year-old female patient, with a history of weekend alcohol and marijuana use, had received an intramuscular left deltoid injection of MENACTRA, lot number U3341AA, and an intradermal left forearm injection of TUBERSOL, lot number C3566AB, on 11 May 2010 and when the patient returned to have PPD read, it was noticed that she developed swelling of the left eyelid, eyelid droopy, skin around eye reddened and puffiness to the left cheek and side of face. The issue with the patient's left eye was confirmed to be a sty. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 21 June 2010. The patient reported eyelid swelling beginning the day of vaccination (11 May 2010). She was seen by a physician and determined not to have a "vaccine adverse event", but instead coincidentally had a sty on her left eyelid causing swelling. She was treated with warm compresses and POLYTRIM solution. Outcome was unknown. Documents held by sender: None.
Armpit pain and swollen; Armpit pain and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 15:00 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: AXILLARY PAIN (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 06Dec2021 07:00, outcome "unknown" and all described as "Armpit pain and swollen". Therapeutic measures were not taken as a result of axillary pain, peripheral swelling.  Additional Information: Batch/lot is Unknown due to Unable to locate or read the details. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks reported as Tylenol children's gummies vitamins. Prior to vaccination, Patient was not diagnosed with COVID-19. Since the vaccination, Patient not tested for COVID-19. No known allergy was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was diagnosed with Ramsey Hunt Syndrome.  The adverse event caused a shingles outbreak in my left ear which also created facial paralysis to the left side of my face.
This is a spontaneous report based on the information received by Pfizer from Merck (manufacturer control number 00737850) from a contactable medical assistant. A female patient of unspecified age, race and ethnicity was vaccinated with one single dose of PREVNAR 13 for immunization on 13Oct2016. The patient began experiencing "redness, itching and swelling at the injection site" on an unspecified date after having received the vaccine. It was unknown if "redness, itching and swelling at the injection site" have resolved. No further information provided. The information on the lot number has been requested.
Injection given December 2 at 10:30. At 10:40 itching started on both arms. Liquid Benadryl given at facility. Itching did not let up. No hives or rash. Itching continued 2 weeks later. Saw PCP on Monday, December 13. She prescribed cetirizine HCL 10mg, famotidine 40mg, hydroxyzine HCL 25mg and prednisone 5mg dose pack (21 pills). Itching subsided for 2 to 4 hours after antihistamines but came back.
For the first day after my 2nd dose of the vaccine, I experienced a constant itching all over my body. I also felt like fire was shooting through my body randomly throughout the day.  I am not allergic to anything but felt like the itching was that of an allergic reaction.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccines with an associated reaction of pain in extremity (received in the past, refer case US2018GSK221456). On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In August 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Within 24 hours after receiving SHINGRIX, the patient's arm was sore and it lasted 2 to 2.5 days. The soreness was minor. The reporter did not consent to follow-up.
PATIENT HAD FACIAL SWELLING AND TONGUE SWELLING AT 5PM AFTER RECEIVING THE VACCINE 4:40PM, THE PATIENT NOTICED HER SYMPTOMS AND ADMINISTERED HER EPI PEN INJECTION. AROUND 5:10PM, HER SYMPTOMS HAD IMPROVED.
I had a severe allergic reaction to the vaccination I was given at Pharmacy.  I fell ill within a day and a half and did not recover for a week and a half.  My symptoms included bad headache, tiredness, physical weakness, runny nose, constant mucus drainage, persistent cough, and sore throat.  The vaccination info is Fluarix Qiv PFS 2019-2020 INJ 0.5ml (3FS25 Glaxo 06/30/20) (NDC: 58160-0896-52).
Severe body pain; migraine; fever; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 06Aug2021, the patient experienced severe body pain, migraine, fever and vomiting. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body pain, migraine, fever and vomiting were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 10-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M007762, expiration date 07-DEC-2018, dose and route were not reported). The vaccine had been stored under the temperature of 47.7 Fahrenheit degrees for 4 days 8 hours and 23 minutes. Digital date logger was involved. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
ERYTHEMA MULTIFORME MAJOR; This is a literature report for the following literature source(s).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastroesophageal reflux" (unspecified if ongoing); "Hypertension" (ongoing); "gastrostomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ERYTHEMA MULTIFORME (medically significant, life threatening), 36 hrs after the suspect product(s) administration, outcome "unknown", described as "ERYTHEMA MULTIFORME MAJOR". The patient underwent the following laboratory tests and procedures: Endoscopy: removed a 34 cm section, notes: esophageal tissue was removed from the airway; Oesophagogastroduodenoscopy: noting extensive Grade D, notes: erosive esophagitis and gastric ulcerations with friability. Therapeutic measures were taken as a result of erythema multiforme.   Clinical course: 36 hours after receiving the second Pfizer COVID-19 vaccine, she developed lip and tongue swelling, mucosal ulcerations, and respiratory distress. There was no conjunctivitis or genital involvement. She denied taking any new medications, supplements, or food that might have led to the reactions. She initially presented to an outside hospital and required intubation prior to transfer to our facility. A bedside esophagogastroduodenoscopy (EGD) was performed noting extensive Grade D erosive esophagitis and gastric ulcerations with friability. When the endoscope was removed a 34cm section of necrotic esophageal tissue was removed from the airway. Despite intravenous steroid treatment, she continued to have esophageal scarring and was unable to tolerate food by mouth. Therefore, a gastrostomy tube was placed. Since that time, she has required several recurrent EGDs for esophageal dilation due to scarring. It has now been six months from her initial injury, and unfortunately, the patient is still unable to take PO and is dependent on tube feedings.; Sender's Comments: Based on the available reported information, the causal association between the event erythema multiforme and the suspect drug BNT162B2 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.
SORENESS IN LEFT SHOULDER JOINT ABOVE THE DELTOID AREA WHERE INJECTION WAS GIVEN IM. PATIENT SAID THAT SHE FELT THE INJECTION WAS "GIVEN TOO CLOSE TO HER SHOULDER BONE, TOO HIGH UP ON MY ARM".
Patient was administered invalid 2nd dose of Pfizer vaccine (vaccine was stored 5 days beyond recommended freezing time). Pfizer was contacted and recommended that the patient receive a booster in the opposite arm. Patient can receive booster immediately and will be contacted to schedule booster dose.
Injection site swollen, sore, hard. Took allergy medicine and ibuprofen
BREAST MASS, AXILLARY, EPITROCHLEAR, INGUINAL ADENOPATHY PERSISTENT FOR 5 MONTHS FOLLOWING VACCINATION
15 yr old patient stated to feel dizziness, sweating, and palpitation 10 minutes after her second dose of Pfizer COVID vaccine. She's alert and oriented. She has no medical history. She states he got headache from the 1st dose of pfizer COVID vaccine. Assisted the patient to lay on yoga mat with legs elevated . Her VS stable: P78; BP 119/86; Res 18 and O2 saturation 98%. Cool pack applied to her forehead and back. water and salt crackers provider to the patient. She felt better after about 10 minutes on yoga mat. She went back to her chair and was observed for another 10 minutes. The patient and her father were advised to follow up with her PCP and inform her PCP about her symptom after receiving 2nd dose of vaccine with understanding.
ACUTE NON ST ELEVATION MI 4/10/2023 LEFT INTERTROCHANTERIC FEMUR FX, NDISPL INIT ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/10/2023 LEFT INTERTROCHANTERIC FEMUR FX, NDISPL INIT
Patient's right arm, the arm in which they received the FLUZONE HIGH DOSE, experienced swelling and itching. The swelling started at approximately the elbow and extended up to the shoulder joint. Discomfort started a couple hours after injection and continued to worse until late at night the same day. The next day the swelling had started to slightly improve and the itching has decreased. Since the swelling appears to be improving, no further attention appears to be needed.
She developed hives all over the leg where the Trihibit was given, within the first 24 hours of receiving he vaccine. The rash responded to Benadryl.
Patient had nausea. Provided water, crackers. Stable, released from vaccination site.
Patient felt dizzy and fainted right after immunization. Patient hit head on floor and came to quickly. Patient drank fluids and was assessed EMS.
This spontaneous case, initially received on 15-Oct-2018 from a pharmacist (initial and follow up 1 combinedly processed) concerns a 46-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56F for 8 hours following a power outage. On 14-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019] which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804548 was cross-linked to source case: 201804533 due to the same reporter. Non-significant case amendment (15-Oct-2018): The sentence 'On 14-Oct-2018, the patient was administered' was added in the product description in narrative.
Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 9 doses were administered at administration site 1. No treatment medication reported.   This case was for the 8th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Symptoms initially started with exacerbation of my ulnar neuropathy (pain, numbness of the left 4th & 5th digits) as well as chest pain. The chest pain was midline and severe enough the evening of 1/12/21 that I sought care in the ED for evaluation. Since that time, I continue to have intermittent but daily episodes of left arm and chest pain as well as intermittent left face, neck, and head pains.
cried inconsolably for 1 noc, slept 2 hrs in 2 days & 2 noc; jittery; rapid shallow resp; spit up clear liquid; eyes moved rapidly back & forth in head, t101.4 x 2 days; was given APAP; was unable to see MD;
tonic clonic sz lasting less than 5min, taken to hosp ER evaluated & d/c w/probable diagnosis febrile sz
74 year old male presented with complaints of covid 19 infection. He came to hospital as his shortness of breath was getting worse. His oxygen saturation was low with exertion at arrival in ER. His d-dimer was elevated so CT angio and lower extremity duplex was done. His shortness of breath improved on decadron. He did not require oxygen. He was discharged home.
Rash, burning/itching after vaccination and flared up again 6/18 in areas other than vaccination site in left arm and still experiencing. Apptmt with my doctor for wellness gad been scheduled for 6/29 so as of now not notified doctor
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT DID NOT REPORT ANY ADVERSE REACTION.
Mom called to report patient had seizure within 12 hours after receiving vaccines on 9-13-17. Went to the hospital and was discharged. Return the next day to the hospital and was transferred to another Hospital.
Need to be able to attach photos of patient's arms and hands.  Left arm became inflamed, colored, pustules, swollen, blackened fingers, swollen knuckles, five days after vaccine.  Three weeks later, right arm did same thing. Patient continues to live with this condition, without pain, some minor itching, but much discomfort and embarrassment for people to see arms. He has seen multiple doctors, including primary care, dermatologist, urologist, cardiac specialist, oncology doctor, been in a rehab facility for two weeks after fall and L-1 fracture, and no one knows what it is, or what caused it. Very frustrating. Suspicious of Covid vaccination. Pt stopped taking amiodarone a couple of months ago, with no change.
black eye; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28Feb2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation. Medical history included blood thinner from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS) taken for blood thinner, start and stop date were not reported. The patient was received 1st dose of the Pfizer Covid vaccine on 28Feb2021 and who was scheduled to receive second dose on 21Mar2021 was concerned about a black eye she developed 1 week ago and wants to know "was this caused by the vaccine? Caller has been seen by her HCP who has advised her to proceed with 2nd dose, but caller states ". The patient may cancel her appointment until she speaks to her doctor. Additionally, she wants to know if these symptoms have been reported before? She was on Eliquis blood thinner and was concerned about bleeding. The patient requested information for concern for potential AE from the 2nd dose of the Pfizer Covid Vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
3 year-old girl received expired third ACTHIB vaccine/ NO AE; Initial information received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center via Medical Information (reference number- 00655008).  This case involves a 3-years-old female patient who was vaccinated with an expired 0.5 mL third dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, lot number : UJ318ABA and expiry date : 18-Jun-2021 ) via an intramuscular route in left thigh(expired product administered) on 23-Jun-2021 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller wanted to know if the product was still active or should the patient be re-vaccinated.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I saw patient on 1/6/2021 for a possible vaccine reaction. She had her vaccine on Dec 31 and had arm soreness. On the evening of 1/5/2021 she had headache, chills, and during the night sweating. She woke on 1/6/2021 with itching on wrists with a red raised rash and then noted it was also on her hips when she took a shower. In office on 1/6/2021 she had erythema on wrists (she had applied Kenalog cream and states that it was no longer raised after application of the cream) and she had small dime to quarter sized hives on bilateral hips. My colleagues and I researched and found that people can get a serum illness with any vaccine so we checked labs and a UA ? it was all normal but a little protein in her UA. I spoke with patient on 1/7/2021 and she stated that her hives had spread over her buttocks the evening of 1/6/2021 but had resolved by the time she woke on 1/7/2021 and she was not having any current symptoms yesterday late afternoon when I spoke with her. She feels sluggish on 1/8/2021 but overall feels okay. No more rash. We discussed that she can return to her next shift on Monday 1/11/2021 unless she notes any other symptoms / return of symptoms she will let us know.