chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 by 3 inch skin discoloration , similar to a skin burn; Extreme soreness; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; Scab has started to peel, showing pinkish skin color & dry; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 18:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies Latex" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FK9895, Anatomical location: , Arm Left), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 301458A, Anatomical location: , Arm Left), administration date: 29Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EN6206, Anatomical location: , Arm Left), administration date: 03Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EN 9581, Anatomical location: , Arm Left), administration date: 10Feb2021, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "2 by 3 inch skin discoloration , similar to a skin burn"; PAIN (non-serious) with onset 26Sep2022 at 08:00, outcome "recovering", described as "Extreme soreness"; SKIN EXFOLIATION (non-serious), ERYTHEMA (non-serious), DRY SKIN (non-serious) all with onset 26Sep2022 at 08:00, outcome "recovering" and all described as "Scab has started to peel, showing pinkish skin color & dry". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin discolouration, pain, skin exfoliation, erythema, dry skin.  Additional information: The patient did not receive other vaccine in four weeks. Treatment included steroid cream & Zyrtec for reported events. The patient was not diagnosed with COVID prior to vaccination. Post vaccination, the patient was tested COVID.  Follow-up attempts are completed. No further information is expected.
Sore scratchy irritation in throat and an irritated larynx (voice box) following the administration of the second dose of the  Pfizer vaccine. Saw an ENT doctor on 5/27/2021 and was diagnosed with Laryngopharyngeal reflux for the first time.
Hive near the injection site; Hive near the injection site; This is a spontaneous report received from a Pfizer Sponsored Program Covax US Support. A contactable male consumer (Patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 06Mar2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date single for covid-19 immunization. On an unspecified date the patient experienced Hive near the injection site and sides of his torso after the second dose. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Severe fatigue All over achiness Joint/muscle pain hands and feet Knot formed on right forefinger joint Diagnosed with inflammatory arthritis April 10 - Dr  Saw rheumatologist July 26 Hydroxychloroquin - began experiencing severe depression, paranoia, confusion, on top of debilitating fatigue Off of hydroxychloroquin August 5 Pain and fatigue continued - returned to  Dr; 28 September; asked him to handle arthritis; prescribed methotrexate; began taking super conservatively - reached therapeutic level October 30 Lasted for 6+ months
do not feel well; a lot of muscle aches; a lot of pain; extreme tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "do not feel well"; MYALGIA (non-serious), outcome "not recovered", described as "a lot of muscle aches"; PAIN (non-serious), outcome "not recovered", described as "a lot of pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 09 December 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 18-month-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3591AA received on 02 June 2010, lot number C3591AA received on 30 July 2010 and lot number C3668AA on 30 September 2010 (route and site of administration not reported). The subject developed cold-like symptoms on 18 October 2011, approximately 1 year after the last dose. On 07 November 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 15 November 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 15 November 2011. The subject was not hospitalized. At the time of final contact on 28 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Feeling of going to pass out; PVC's; PVC's; Shaking feeling internally from neck down to ankles; Sweating; palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (lot number: FK5730), via an unspecified route of administration at site of right arm at 10:15 on 17Dec2020 at single dose for immunisation. Medical history included Chronic migraine. Occasional PAC/PVC's. Concomitant medication included clonidine (strength: 0.02 mg). Within about 5 minutes of receiving the vaccine, the patient experienced shaking feeling internally from neck down to ankles, sweating, feeling of going to pass out. Some palpitations and PVC's. Shaking Symptoms lasted approx 4 hours. The patient visited emergency due to events. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 17Dec2020.
This spontaneous report was received from a licensed visiting nurse, referring to multiple unspecified patients of unknown age and gender. The medical history and concurrent conditions of the patients were not reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # J011272, expiration date 21-APR-2016 and lot # K006117, expiration date 14-JAN-2017 (dose, route and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of two cases received from the same reporter (linked case MARRS # 1509USA012606). Additional information has been requested.
NO ADVERSE EVENTS, PATIENT RECIEVED FLUZONE HD INSTEAD OF FLUBLOK, PHARMACIST NOTICED AFTER PATIENT LEFT THE PHARMACY, NO SIDE EFFECTS WERE REPORTED
3:40pm BP 149/105, HR 110, O2 sat 99% - Complained of feeling nauseated. Was monitored for approx. 1 hour and 20 mins. Cardiac monitor was NSR to ST. She would state she was feeling better, then complain of waves of nausea and feeling like her heart was racing. Her husband came to be by her side. She remained alert and oriented the whole time. Resp. were unlabored. She did state she felt like she was going to pass out. A code green was called. She had dry heaves, She was taken to the Emergency Department treated and discharged from there.  VS 4:00pm 148/103, 103, O2sat 98%, 4:20pm 146/105, 84, R 10, O2sat 99%, 4:40pm 157/113, 107, O2sat100%, 4:48pm HR 122, R23, O2 sat 99%, 5:05pm 161/104 90, 16, O2sat 100%. She was sent to Care Spot Urgent care on 1/7/21 due to having a headache and feeling like BP was elevated. She was referred to Cardiologist. She has appt. with Cardiologist on 1/13/21.
Neuropathyin legas and feet; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). The patient was treated with gabapentin. On an unknown date, the outcome of the peripheral neuropathy was not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Feb-2023 Reporter's comment: The patient self-reported this case. The patient was now experiencing neuropathy in his legs and feet. The was being treated with Gabapentin. Reporter did not consent to follow up.
Nausea  Chills Fatigue I slept for 16 hours and woke feeling fine.
This spontaneous report as received from a 65 year old female consumer reporting on herself with drug reaction or allergies to MOTRIN, allergies (unspecified) and high blood pressure. On 05-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, 1 time vaccine, subcutaneously (dose, lot number not reported). No other co-suspects were reported. Concomitant medications included metoprolol tartrate 25 (unit not reported) 2 times daily, CRESTOR, PROTONIX, "Virtec" for allergy and fluticasone propionate. On 05-NOV-2012, since the vaccination was given the patient experienced following side effects: headaches, redness at the injection site on her left arm, swelling, a lump and pain at the injection site. No treatment was given for the adverse events. The patient had not seen a physician. At the time of the report the patient's outcome was unknown. The relatedness for the adverse events was not reported for ZOSTAVAX. Additional information has been requested.
Blistering, itchy red arm x 2 d.  Arm developed erythema shortly after a live, zoster vaccine was administered in the area 2 d ago.  Blistering developed yesterday, erythema has been spreading.  Low fever yesterday and today.
Came to ER and was seen by Dr who noted: Complaints of abdominal pain History of Present Illness: ongoing for 4 days. Intermittent issues with nausea for 2 weeks. No vomiting nor diarrhea. Patient went to urgent care and got Zofran which helped some, but didn't resolve symptoms. For the past day they've been worse. Reports pain as intermittent cramping and feels more severe when it comes, then it goes away. Patient states that it's "different spots" when she gets it. Denies other symptoms. Has an IUD. Non-smoker, former vaping, drinks, no drugs. CT of abdomen and pelvis was negative.  Went to urgent care on 7/5/21 with complaints of nausea x 2 months, also suicidal ideations  Admitted on 9/29/21 for biliary colic. Surgery by Dr. who diagnosed patient with biliary dyskinesia. Procedure performed was cholecystectomy lap robotic.
No further AE details; TE vaccine; This spontaneous report was received from a pharmacist and refers to a 12-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 09-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 5 milliliter once, lot # W025273 and expiration date 10-AUG-2024 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 70 degree fahrenheit  for 9 minutes on 02-MAR-2023; no previous temperature excursions were reported.  No adverse symptoms were reported.; Sender's Comments:  US-009507513-2306USA008333:
pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn't. Nurse asked her to see the injection site. When she took off her sweatshirt, stating she felt on fire, the site and her arms were extremely red. She was asked to remove her mask and we discovered her lips and area around her nose was starting to swell. At that time she stated that her tongue felt "weird".  Assessing the situation, the nurse administered an Epi-pen while I dialed 911 and gave information. Epi-pen very helpful, to the point she "wished we hadn't called the ambulance" . Once the EMTs arrived, they assessed her and after some time, had her sign a release form since she declined attention. Pt was informed that she would not be allowed to finish her shift and was asked if someone could come get her. The daughter was on her way. The nurse and I sat with her, watching to make sure she didn't have a rebound reaction which she did not in the hour + we were with her. Daughter arrived, took instruction from the nurse and took her home.
Pfizer BioNTech COVID-19 Vaccine EUA: Vaccine Administration Error - Dose administered past beyond-use date. Patient received Pfizer Vaccines on 5/14/2021, 6/4/2021, and 1/17/2022. The vaccine that was administered on 1/17/2022 was past the beyond-use date.
Within 30 minutes, the pt developed blood blisters in his throat and returned to the center where he was immunized. He was instructed to see a physician. He had completed a course of antibiotics for a throat infection approximately 2 weeks prior to immunization.
Cellulitis (L) arm - erythema, tenderness. Treatment Clindamycin 300mg TID x 7 days.
Large local reaction to the anthrax vaccine despite getting the IM injection.  Swelling from shoulder to elbow.  Previous injections with swelling to the wrist
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, fatigue Narrative:
left eye twitches heavy and painful mensural cycle and as of August I have not had a period but I still experience the strong painful cramps during the time is should be on my period
Tachycardia and chest heaviness started about 25 min after receiving vaccine, Taken to ED for observation, EKG. "Jittery & restless"- given Xanax. Observation for 1.25 hours-symptoms resolved and d/c home.   Following day had body aches, fatigue, and fever up to 103.5. No further tachycardia. Took Tylenol and Advil. All symptoms completely resolved within 24 hours.
Moderna COVID-19 Vaccine  sore throat, earaches, headaches, slight cough, extreme aches in hips, knees, lower right leg and ankle, lower back, sinus aches, runny nose, mood swings
Covid shot made her sick; This is a spontaneous report from a contactable consumer via Pfizer from (manufacturer control number. This case was split from master case 2021435665 for BNT162B2. A 56-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated covid shot made her sick on an unspecified date. The outcome was unknown.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.
Right arm was sore very soon after shot, it was also painful to move completely around as it should. Into the evening I began to feel fatigued, and my muscles and joints started to ache. Into the night I began to get alternating chills/sweats and pain intensified in muscles and joints. I slept some, then woke up in terrible pain in wet clothes from the fever sweats. I took 800mg ibuprofen and slowly paced the hall like I was in labor until it kicked in. I was able to go back to bed, slept more. The next morning I was still very achey and feverish. Took another 800mg ibuprofen. Laid on couch and slept a lot! Continued chills & sweats throughout the day. Aches continued and right arm was swollen and painful. Diarrhea began 24-36 hours after shot. Continued to rest throughout evening. No appetite at all, just sipped on water.  Aches, pains continued into the night, but fever started to break. Nausea set it, along with headaches. Took another 800mg ibuprofen. Slept some more, but was restless. Woke up on third day and vomitted twice in the morning. Aches and pains subsided, fever wore off, but I was wiped out for a good 4-5 days. This was a much stronger reaction than the first dose, and I was not expecting to feel so terrible. My husband asked me a couple times if I needed to go to hospital the first night after shot. It was pretty rough.
Pt received her first COVID19 Moderna vaccine, during administration the pt reported feeling one quick palpitation and a cooling sensation in her chest. Pt reported the palpitation resolved but the cooling sensation in her chest continued and was not getting better. BP 149/92, 141/97 HR 104, 94  O2sat 99%. Pt was evaluated by Trinity EMS. Pt signed refusal for transport to the ED.
Vomiting and diarrhea for 8 hours. Weakness and headache with feeling of cold and feverish until about 3 pm. (No one else in family got sick).  Also got a rash around the injection site starting on 02/03/2014.
Sore, swollen, red upper arm, extending outward from injection site, developed 2/17/21, following a couple days of feeling extremely fatigued.  Arm still sore, but swelling seems to be decreasing; the area is still noticeably discolored in an oval shape covering the deltoid region.  No treatment, monitoring only.  PCP is out of the country and office closed.
Client fainted after leaving the clinic area.  He had received MMR, Menactra, and a TB test.  He was already conscious when I reached him. A witness said he fainted and his his head on a door.  He was pale, and sweating. No injury noted to his head.  Applied ice to his head and took his vital signs.  911 called.
Information has been received from a licensed visiting nurse concerning a patient who since January 2005, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Between 1/1/2005 and 6/29/2005, the patient developed a moderate to severe breakthrough case. The patient has fully recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pemphigus vulgaris; she developed blisters on her mouth that would come and ago.; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable reporter (patient's daughter) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection Batch/Lot Number: Not Provided) via an unspecified route of administration on 14Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. After her second dose on an unspecified date in 2021 patient developed blisters on her mouth that would come and go. A few months later it came back and it covered her head to toe in blisters. She was diagnosed with Pemphigus vulgaris on an unspecified date in Sep2021. On an unspecified date in Sep2021, patient underwent a lab test in which she was diagnosed with Pemphigus vulgaris. Reporter also added that their other family members also developing blisters. The outcome of the events was unknown.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101246991 same reporter/product, different patient / event.
1) 4 days following second dose, calf pain developed that did not resolve. After 2 weeks of unresolved calf pain a distal DVT in the right leg was detected by ultrasound at the ED. 2) Within a few days following the second dose, sudden onset hearing loss was detected in the left ear. Accompanied by tinnitus, and aura fullness. There was no vertigo or dizziness episodes
redness around the injection site that went from the inside of the arm down to the elbow; It was also itching; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first 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) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching). The patient was treated with LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site that went from the inside of the arm down to the elbow) and VACCINATION SITE PRURITUS (It was also itching) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.