chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After administering Td vaccine as ordered per protocol and while placing bandaid over site, I noted the area was visibly swelling and become reddened; area involved was approx 5 cm in diameter. Ice pack to site and MD notified. Pt monitored for 30 minutes after infection with no other adverse symptoms noted. Remained stable. Pt examined by MD and allowed to leave after visible swelling subsided. Phone call to pt next AM-pt stated no redness, mild swelling but "minor".
thought she was on her death bed; couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.; the shot area is still red; worst headache she ever had in her life; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (thought she was on her death bed), MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (thought she was on her death bed), MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 18-Apr-2021, MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life) outcome was unknown. At the time of the report, FEELING ABNORMAL (thought she was on her death bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications not provided.   This case was linked to MOD-2021-214487 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR - NNI
w/in 1/2 hr pts lt hand & face became numb w/tingling-subsided in 1 hr somewhat but tingling reamined for several days;
Infant given ROTARIX as IM injection vs oral as prescribed MA immediately reported to nurse manager & CRNP. Mother made aware detained in office until vaccine manufacturer contacted. Infant observed x 1 hr-no adverse reaction.
30 minutes after receiving injection, had sweating, lightheadedness and vomiting. Daughter had strep throat and fever since 10/8/10. "Too lightheaded to walk - is sweating though is just sitting". Directed to take TYLENOL or other OTC analgesic/bottle directions take temperature, call physician if not improved in 24/48 hrs. or immediately if condition worsens.
Tinnitus; This is a spontaneous report received from a contactable reporter (Consumer).  A 86 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route, administered in arm left, administration date 19Mar2021 12:00 (Lot number: EN6207) at the age of 86 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diagnosed several years ago. She does not take any medications and is diet controlled.; "High blood pressure" (unspecified if ongoing); "sinus infection" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for hypertension; AMLODIPINE taken for hypertension; AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID] taken for sinusitis, start date: 16Mar2021. The following information was reported: TINNITUS (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Tinnitus".  Additional information: Patient experienced 2 to 3 days after receiving the vaccine, her ears have been ringing with tinnitus. Patient was taking blood pressure medication and antibiotic for a sinus infection. This was diagnosed and prescribed prior to receiving the vaccine. She was also a Diabetic, diagnosed several years ago. She did not take any medications for this condition and was diet controlled. The patient had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Acute onset bilateral non-puritic painless purpura on buttocks Identified 38 hrs after vaccine administration. No no other lesions or petechiae identified. No associated bleeding or  significant trauma or environmental exposure to the area. Associated acute onset chest pain 28 hrs after vaccine administration  8/10 expanding pressure with radiation to back spontaneously resolved no associated shortness of breath. No physical Exertion and no anxiety and using state prior to onset. Chest pain remain intermittent three out of 10 dull pressure throughout the rest of the day.  No cause for purpura identified no treatment given besides monitoring. No acute cause for chest pain identified presume to be reflux secondary to pregnancy no additional treatment recommended besides monitoring. Pregnancy history: currently 29 weeks gestational age, Estimated due date June 16, 2021.
Moderna COVID-19 Vaccine EUA -Headache for 3 days straight -Fatigue for about 5 days -Lichen planus reaction: I have 3 spots where lichen planus flares up (mouth, ears, eyelids). 1 day after shot lichen planus flared up in my mouth; it lasted for about a week. About 3 days after shot lichen planus flared up in both ears (right ear worse than left). I'm about 2 weeks post-shot and it is still flared up pretty bad.
Twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Twitching). At the time of the report, MUSCLE TWITCHING (Twitching) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-059968 .   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received contains Initiative
Given 12/1/21, on 12/3/21 developed bumpy, itchy, raised rash below injection site.
headache, extreme fatigue, injection site warm, sore, joint aches, ears hot and achy
Neck and Face flushing.  Tachycardia with rate of 120 for 1.5 hours.
Right arm swelling from shoulder to elbow. Area is red and warm to touch. No temp.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced mood swings after receiving the vaccine.  At the time of this report the patient's outcome was unknown.  Additional information has been requested.
Patient developed inconsolable screaming for 1.5 hours. His left thigh developed mild redness and warmth to the touch.
Afebrile, with noted erythema to left deltoid area (site of vaccine) measured as 8x5cm, non pustules, pruritics.
Injection site redness; injection site swelling; delayed injection site warm; delayed injection site itching; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical history was provided by reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE WARMTH (delayed injection site warm) and INJECTION SITE PRURITUS (delayed injection site itching) 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.   No concomitant medication were provided by reporter   Reporter did not allow further contact
Information has been received from a Registered Nurse concerning a 13 year old female who on 19-SEP-2007 was vaccinated IM in the left arm with the first dose of Gardasil (Lot #655620/0171U).  About 10 minutes after she was vaccinated, the patient leaned against her mother, drew the right arm to the face, became rigid and fainted.  As the patient was laid to the floor she became alert although weak and pale.  Blood pressure was 110/62 and oxygen saturation was 100%.  The patient was monitored in the physician's office for one hour without further adverse symptoms.  The patient went to school the following day and is fully recovered.  Additional information has been requested.
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320.  Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO.  Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
Pfizer-BioNTech COVID-19 Vaccine EUA  2 hours after injection: body aches and chills (duration approx. 8hrs) 9 hours after injection: nausea and vomiting 18 hours after injection: severe heartburn, nausea, and vomiting 24 hrs after injection: nausea and all over body soreness 48 hrs after injection: mild nausea and arm pain at injection site 72 hrs after injection: no symptoms present
Severe high fevers of 104-105 the first day after shot. Today, day 3 I still run fevers if 101. Also chills, headache, extreme fatigue, lack of appetite and swollen glands.  Treated with Tylenol every 6-7 hours, cold packs on head and back of neck to reduce fever, liquids and sleep.  I feel better than day 1 and am regaining appetite but fevers returns 6-7 hours after Tylenol.   I am now on day 3. Was not able to work after shot. Urine is very orange but that might be Tylenol.
Information has been received from a physician concerning a 19 year old female who on 20-OCT-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) IM (Lot# 658560/1062U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 20-OCT-2007 the patient experienced syncope and tonic clonic movements ("slumped to the floor" and "flinching" ("seizure like")). Subsequently, the patient recovered from syncope and tonic clonic movements. The patient was placed into a chair and about 4-5 seconds later, the patient "came out of it." The patient was responsive to the nurse and other staff. Additional information has been requested.
No other AE and no PQC; HBP calling to report an adverse event for PROQUAD.  Caller states a 15 year old patient was administered their second dose of PROQUAD on 10/31/2023.  The first dose was on 10/10/2009.  No symptoms or further details provided.  No other AE and no PQC; This spontaneous report as received from an administrator and refers to a 15-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 10-OCT-2009, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided). On 31-OCT-2023 the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X011979 and expiration date 18-JUL-2024, for prophylaxis (exact dose, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event)
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 11th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Realized when entering information in state database that had given adult vaccine dose to pediatric patient.  informed attending.  spoke with infectious disease doctor. called mother.  no adverse events at this time.
Very painful shot, felt like a double jab following morning much discomfort on shot site, and stiffness and sore upper arm, shot was given on top of shoulder.
Pfizer COVID vaccine #3 given 10/22/21, lot # FF2593; pt had a positive COVID test on 5/2/21 when he was admitted to the hospital; AHRF secondary to pneumonia; presented with SOB, cough, nasal congestion; right pneumonia with effusion; ICU; ABX; thoracentesis; pt's condition worsened; placed on comfort care only and passed away in the hospital
Hot, red and swollen at the injection site. MOTRIN and ice packs used to resolve.
satellite lesions on trunks and chest since leaving smallpox site unbandaged; suspect self innoculation; referral to Dermatology Clinic
Left arm started to swell. Patient started to feel numb on side of mouth. Life squad came and pt refused to go to the hospital. Pt went home aprox 1 hr later.
Erythema, tender, indurated deltoid and bilat upper arm. Fever to 102 over 4 days.
At site of flu injection had approximately 2 1/2 inch diameter redness, swelling, soreness, hardness. Also had hives on upper torso lasting 4-5 days. Felt feverish. Took benadryl.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a five years old male patient who received a 0.5ml dose of DAPTACEL lot C5169AA, Expiration Date: 16-Mar-2019 via unknown route in the left thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines concomitantly. It was an actual medication error due to expired vaccine used. A patient received a DAPTACEL vaccine that was expired on 16-Mar-2019. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Swelling in her arm after receiving injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm after receiving injection) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her arm after receiving injection). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm after receiving injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137942 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137942:Reporter's case
Symptoms started 4/2/21. Stated as numbness and tingling in lower extremities and progressed to numbness of tongue and upper extremities along with back pain.  Patient admitted to Hospital with R/O Guillian Barre Syndrome.
patient claims symptoms started 12 hours after receiving the vaccine- she stated she had severe muscle aches, chills, skin hypersensitivity, headache, shaking, fever
Soon after appointment, developed right jaw pain, lasted through the night and into AM. Around 7PM on 02/09/17, broke out in hives on trunk/chest and back, very itchy. Gave BENADRYL which helped some, but hives returned and worsened overnight. This AM, rash was up his face. No difficulty breathing. We prescribed hydroxyzine HCl 25mg every 6 hours PRN for itching/hives.
As per the mother, 5 hours after the vaccination, he developed chest pain and difficulty in breathing; she massaged his chest and gave him tylenol . Within 30 to 45 minutes he fully recovered. All of this occured at home.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in 2018, refer case US2018GSK171374). In August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced fever, chills, general body pain and myalgia. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the chills, general body pain and myalgia were unknown. It was unknown if the reporter considered the fever, chills, general body pain and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the pharmacist who himself was the patient. The age at vaccination was not reported. Day after vaccination the patient experienced fever, chills, shivering, body aches and myalgia. The events lasted for 6 hours. The patient stated if he had experienced these symptoms after the first dose he might not had wanted to receive the second dose. The reporter was agreed to be follow up from GlaxoSmithKline.
concern of cellulitis; Redness; Pain; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 77-year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Relevant past drug history was reported as having allergy reaction with unknown drug. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "concern of cellulitis"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; PAIN (non-serious), outcome "unknown". Clinical course was as follows: Reporter stated that patient experienced "redness, duration, pain and concern of cellulitis." It was unknown if therapeutic measures were taken as a result of cellulitis, erythema, pain. It was unknown if patient received any other vaccines within 4 weeks PRIOR to or at same date as pneumococcal 20-valent conjugate vacccine (diphtheria CRM197 protein). It was also unknown if patient was taking any other medications within 2 weeks of the event's onset dates.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and etiology, the event "concern of cellulitis" is not considered related to the suspect vaccine PREVNAR 20, but rather an infectious coincidental condition. 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.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received FLUARIX TETRA for prophylaxis. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to FLUARIX TETRA. Additional information was reported as follows: The age at vaccination was not reported. The batch number and expiry date for FLUARIX was not reported. After vaccination with FLUARIX, the physician herself experienced redness at the injection site, which was a nickel-to quarter size in diameter. The patient had used shoot blocker to administer the vaccine.