chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first shot did turn red at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0171) at the age of 66 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "recovered", described as "The first shot did turn red at the injection site".  No follow-up attempts are possible. No further information is expected.  Additional Context: Patient is calling about the Pfizer COVID shot that she got. She got her second dose on 11May2021. She did have two of the side effects that have been reported to Pfizer already. She had swelling and redness that covered almost all of the front part of her upper arm not just at the injection site on her left arm. It was everywhere. Yesterday, it finally started going down. The redness has gone away. She was told she was supposed to call Pfizer and let them know. She got the vaccine on a Tuesday, and on Wednesday night is when she first noticed it. She did not have a prescribing doctor. She just went to (withheld) on (withheld). She went to see the pharmacist after the swelling and redness lasted Wednesday, Thursday, Friday. She just popped in last Friday. She showed up, and the pharmacist's eyes got big like woah. He took a picture of it . She told him it had been there since Wednesday night. He said to call and report it, and to take Ibuprofen and Ice it. It started Wednesday at night. It didn't stat improving until the 18May2021. It looked like a bad sunburn on one arm. Her first vaccine was 19Apr2021 with lot number EW0171 on left arm. She doesn't take any other medication. She did take the ibuprofen for the swelling. The first shot did turn red at the injection site but not all over her whole arm like the second one. It was red and lasted a couple of days and went away. This one went days and days. It covered almost her whole upper arm. If she has to get a booster in a year or so should she get the Pfizer one?
a nurse administered Quadracel to a 6 month-old child instead of the intended 3rd dose of DTaP and IPV; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (frequency once) lot C5635AA (expiry date: 18-Jun-2021) via intramuscular route in the left thigh (reported as left VL) on 19-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; PNEUMOCOCCAL VACCINE POLYSACCH (PNEUMOVAX 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It is an actual medication error case due to wrong vaccine administered. It was reported that the Quadracel was vaccinated to a six month-old child instead of the intended 3rd dose of DTaP and IPV.  It was reported that the patient had no adverse event.  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.  List of documents held by sender: none.
18 to twenty days after VARIVAX #1, pt developed 5-6 lesions which look varicelliform. No other symptoms.
Patient reported headache, nausea, and injection site pain with both doses in the series. With the second dose given on 3-25-19 she reported severe pain in her left arm pit area and reported this to her physician. Patient had been applying heat for 6 hours prior to reporting. Instructed to use ice and TYLENOL or ibuprofen for relief. Symptoms resolved after 3 days.
For last 5 weeks, since 50 minutes after my 2nd shot, I have had a disturbed digestive system ? from moderately inflamed to violently ill. ER visit CT scan displayed colitis. Stool samples negative. Course of Cipro and metronizadole have not eradicated problem. Further investigation underway with gastroenterologist.   For two weeks after my 2nd shot, my left hand developed arthritis (which I do not have) and fingers were noticeably colder than in right hand. Exactly two weeks after the shot, the pain and cold fingers disappeared.
5 hrs post vaccination pt experienced, chills, sweats, fever 102 degrees - dry heaving. 8-10 - after treatment with analgesics - fever decreased to 99.8. 24 hr complete resolution of adverse symptoms.
itchy red dots all over body starting about 24 hours after the shot. Symptoms are improving but still having some today
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same lot number). This case involves a patient of unknown age and gender, who was vaccinated with a dose of Fluzone Quadrivalent batch number: UI669AA, expiry date: 30-JUN-2017 (dose, dose in series, form, site and frequency of administration were not reported) via intramuscularly on an unknown date (also reported as over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On unspecified date (also reported as "over the past month"), following vaccination, the patient experienced arm aches and warm to touch swollen. Lab data was not reported. The patient did not receive any corrective treatment. The outcome of the events was reported as unknown. Follow-up information received from a Physician on 28 November 2016. This case involves a 42 years old female patient. List of documents held by sender: none.
Rash with puritis started 7/19/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middle some as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. Some have faded. Client also received Tetnus Diptheria at local hospital on 6/15/07 for an injury. Does not appear that he received gamma globulin at that time.
Information has been received from a physician concerning a 6-year-old female who on an unspecified date was vaccinated with an injection of varicella virus vaccine live (Oka/Merck) (lot number not provided). Subsequently, on an unspecified date, the patient developed cellulitis (location unspecified) which became infected and the child had to go to the emergency room. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Injection Site soreness,  chills and fever about 12 hours after receiving Vaccine, slight headache the following morning .
I first started having issues with my right shoulder, possibly in April, just discomfort and I couldn't raise my arm up. Then in May, about the 21st. It started in my right groin area with pain and aching. It didn't radiate but I also felt it in parts of my lower leg, it was hard for me to bend down or stoop, or raise my right leg. It was painful when I sat down, and difficult standing back up from a sitting position. That's when we were riding in the car, it was very uncomfortable, even sitting on pillows to try to help. I called my family doctor and got a prescription for meloxicam 15mg. I was taking that and I also took some Tylenol extra strength, alternating between the two. I was travelling at the time, and that was until we got home. I was able to get in to actually see my doctor. I saw one about my shoulder discomfort, who prescribed prednisone pack- that took care of my shoulder and lower extremities for about 4 days. Then I went back and saw the Nurse Practitioner and she did X-Rays and told me I had arthritis and possibly need a hip replacement and prescribed specific exercises. This came as a total shock to me because I have never had anything like this before. A few days after that, I ended up seeing my actual Doctor and got a cortisone injection in my hip and that helped until today (07/12/22) and its starting to bother me again.
Client stated she was having sever pain on her right arm, that she could not move arm and arm was swollen. Pain was going up to her neck.
Received FLUMIST on 10/8. Woke the following morning with urticarial rash on face and chest. Seen in ED, treated with Prednisone and BENADRYL.
Information has been received from a certified medical assistant concerning a 64 year old female who was vaccinated IM with a dose of PNEUMOVAX. Subsequently the patient experienced a severe cellulitis of the upper arm that included her arm pit. There was no medical intervention, hospitalization or further intervention. The patient did not die, the patient has not recovered but is recovering. Additional information has been requested.
Patient reports pain in the arm in which the influenza vaccine was administered. She went to the general practitioner and did not feel relief with the prescribed medications. He is going to a physiatrist and is awaiting an MRI study.
1 wk after administration: Redness, swelling, warm/hot to touch, tender to touch, very mild itching Seen in ER treated for cellulitis/rash  Sent home with 7 days course of antibiotics and antihistamines.   Improvements seen after 1 full day of antibiotics.
ANAPHYLACTIC REACTION THE EVENING VACCINE WAS RECEIVED: DIFFICULTY BREATHING, FEVER, DROWSINESS, DISORIENTATION. 7 DAYS LATER: FEVER, PLAQUE PSORIASIS, RASH, BURNING/ITCHING SKIN, FEVER
Felt like I had a heavy pressure on my chest and felt like my ribs were broken. Hurt to breathe. Messaged doctor and said it was possible I had been sick at the time of booster
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Pt experienced a fever of 101-102 with redness at injection site. Symptoms started 4 hours post vax and continued for 2 days. Pt then experienced hives all over with intense itching, lasting 5 days.
he cried so he never finished the series; he cried so he never finished the series; This case was reported by a consumer via call center representative and described the occurrence of crying in a infant male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   Co-suspect products included DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine and the 2nd dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine and not applicable after receiving DTP vaccine, the patient experienced crying and incomplete course of vaccination. On an unknown date, the outcome of the crying was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the crying to be related to DTP vaccine.  Additional information was provided as follows: This case was reported by patient's mother. The age at vaccination was not reported. Till the time of reporting, the patient did not receive 2nd dose of DTP vaccine, which led to incomplete course of vaccination. The patient cried when he was baby, after receiving DTP vaccine so he never finished the series. This case is linked with US2020036876, reported by same reporter for same patient.
This spontaneous report was received form a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or drug allergies were not reported. On 24-APR-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX injection (dose and anatomical location were not reported) lot number: L009206; expiration date 17-MAR-2017, for prophylaxis. The vaccine was reconstituted with a sterile diluent (manufacturer unknown) injection that was not expired and had no previous temperature excursions (lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
2nd,  NOTE; Caller Stated the 1st shot he developed a HA  4pm ( 1pm had shot) Called asking what to do for the signs and symptoms.  PC advised treat symptoms with OTC Medications, Consult His Local Pharmacy and or PCP. Call back  PRN
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In November 2021, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the activities of daily living impaired was recovered/resolved. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to Shingles vaccine. Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine on last Monday of reporting date. The patient stated, the shot dropped him/her off and was in bed for 4 days. The patient's arm was still sore. Consent to follow up was possible as contact details were not available.
Ulcerative Colitis; This literature-study case was reported in a literature article and describes the occurrence of COLITIS ULCERATIVE (Ulcerative Colitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Sigmoid hemicolectomy. Concurrent medical conditions included Diverticulitis (Patient had a history of diverticulitis requiring sigmoid colectomy).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLITIS ULCERATIVE (Ulcerative Colitis) (seriousness criterion medically significant). The patient was treated with BUDESONIDE at an unspecified dose and frequency and MESALAMINE at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (Ulcerative Colitis) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: abnormal (abnormal) Colonoscopy showed friable mucosa and a loss of vascular markings. On an unknown date, Histology: abnormal (abnormal) histology was consistent with ulcerative colitis (UC).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COLITIS ULCERATIVE (Ulcerative Colitis) to be related.    Concomitant product use was not provided by the reporter.    Company comment:  This literature case concerns a 66-year-old female patient, with history of diverticulitis and sigmoid colectomy, who experienced the serious (medically significant) unexpected event of COLITIS ULCERATIVE. The event occurred approximately 1 week after receiving the first dose of mRNA-1273. The rechallenge is positive since the event reoccur after the second dose. Diagnosis was confirmed with colonoscopy and histology. Patient was treated with budesonide and mesalamine and symptoms resolved. Patient's history of diverticulitis and sigmoid colectomy remains as a confounder. The benefit-risk relation of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-399731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Followup received by safety on 03-Dec-2021 included an Email, contains new information: Author added; Sender's Comments: This literature case concerns a 66-year-old female patient, with history of diverticulitis and sigmoid colectomy, who experienced the serious (medically significant) unexpected event of COLITIS ULCERATIVE. The event occurred approximately 1 week after receiving the first dose of mRNA-1273. The rechallenge is positive since the event reoccur after the second dose. Diagnosis was confirmed with colonoscopy and histology. Patient was treated with budesonide and mesalamine and symptoms resolved. Patient's history of diverticulitis and sigmoid colectomy remains as a confounder. The benefit-risk relation of mRNA-1273 is not affected by this report.
Left upper arm swelling/redness to elbow. Mildly warm. Treated with Augmentin 600mg BID x 10 days.
Her "arm blew up" /  (injection) arm was hard; Her "arm blew up" /  (injection) arm was / swollen; Her "arm blew up" /  (injection) arm was / painful; She ran a fever; "felt yucky" for 2 days; This case was reported by a consumer and described the occurrence of induration in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 episodes of shingles many years ago) and chickenpox. Concurrent medical conditions included aids (immunocompromised).   On 10th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than 2 weeks after receiving Shingrix, the patient experienced induration, swelling arm, pain in arm, fever and feeling abnormal. On an unknown date, the outcome of the induration, swelling arm, pain in arm, fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the induration, swelling arm, pain in arm, fever and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient indicated that her arm blew up. The reporter asked her to elaborate on that and she indicated that the (injection) arm was hard, swollen and painful. She also stated that she ran a fever. She indicated that she "felt yucky" for 2 days. The reporter consented to follow up. This case is linked to the case US2021AMR014110, reported for the same patient. This case is linked to the case US2021013450, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter.
Aches Fatigue Chills Fever of 99-100 Dull Headache  Upset Stomach   Took ibuprofen which helped and slept.  Stomach unsettled for a few days.
After administration of Tdap & MCV4 adolescent continued to talk and state he was fine. Administrator turned to document injection site and client fainted and fell on carpeted clinic floor, first to his knees and then fell further to the floor on his right side causing a nickel sized raised area on right forehead near hairline. No open wounds found. First Aid provided along with vital signs. Client denied any pain or discomfort. Client stated he had not eaten or drank anything all day. Parent verbalized understaning of the S/S of concussion and to take client to ER if S/S occured. After 15 mins client left in custody of father. Ambulatory without assistance in a normal gait. Next day client's father was called and no adverse effects were reported.
INCORRECT PRODUCT STORAGE; ADMINISTERED PATIENT USING AN EXPIRED VACCINE AND IMPROPERLY STORED VIAL OF THE J AND J  COVID-19 VACCINE; This spontaneous report received from a physician concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administered patient using an expired vaccine and improperly stored vial of the j and j covid-19 vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered patient using an expired vaccine and improperly stored vial of the j and j covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558475, 20220558498, 20220558469 and 20220558482. This report was associated with product quality complaint: 90000233203.
Reaction started around 2pm on 10/24/12 with sore throat and cough with chest tightness and congestion.  Noticeable increase in muscle aches and headache by 5p. First noted extremely red eyes around 7p. Chills (without fever) began around 8p. Treated headache and muscle aches with 400 mg ibuprofen and bed rest starting at 8p.  Sore throat, muscle aches and redness in eyes was significantly reduced by 6am the following morning (10/25/12). However, both upper eyelids were swollen upon waking. Swelling was gone by 9a on 10/25/12. Headache and slight cough lingered until the morning of 10/26/12.