chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I think the second time it is like some Arm Pain; This is a spontaneous report from a contactable consumer (patient himself).   A 29-year-old male patient received 2nd dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection), via intramuscular route of administration, administered in arm right on 03Jun2021 (Lot number: EW0180) (at the age of 29-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Batch/Lot Number: EW0179), via intramuscular route of administration, administered in arm right on 10May2021 as 1st dose, single dose for covid-19 immunisation and experienced left me with some type of hardness on my skin, muscle ache, tiredness and arm pain. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine because patient was really skeptical about vaccine. The patient confirmed that he had taken both the shots. On an unspecified date, the patient reported that "I think the second time it is like some Arm Pain". He thought he had doubt after seeing all this stuff all over the news and talk this hard stuff and potentially putting the life in danger. He did not receive any treatment for the events, he just rested. At the time of reporting, the outcome of the event was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "AFIB" (unspecified if ongoing). Patient had no Known allergies. Concomitant medication(s) included: DABIGATRAN; PRADAXA (Other medication in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) high; SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid (Lot number: Fw6344) from 01Oct2022 to 06Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
General malaise and feeling feverish, but no fever. Fairly Severe pain at the injection site. Rash below the injection site that is raised, red, itchy, painful to the touch and seems to be getting larger each day.
No treatment indicated. Well child check on 01/29/16. PROQUAD, influenza, DTaP, Polio given. Over the weekend father observed painless redness and swelling of the PROQUAD injection site. No distant rash, hives, itching, pain, fever. On 2/1/15 3 cm approximately 1.25" painless indurated central wheal surrounded by malar erythema at lateral aspect of left upper thigh. Minor local cutaneous skin reaction to PROQUAD vaccine. Lungs clear throughout with normal work of breathing.
Swelling on arm; Redness on arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 27th April 2019, the patient received Shingrix (subcutaneous). On 27th April 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, the patient's husband was a doctor and was adamant that, the patient received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter was from different pharmacy location in same town, who was notified of patient's events. The reporter was familiar with pharmacist who signed off on vaccination and believes that pharmacist knew what he was doing. This case was 1 of the 2 linked case. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered or resolved with sequel).
Delayed Arm soreness; Arm warm to the touch; Delayed Arm redness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (Delayed Arm redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch) and VACCINATION SITE ERYTHEMA (Delayed Arm redness). At the time of the report, PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (Delayed Arm redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous case, initially received on 09-Nov-2016, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Past medical history included a severe latex allergy. Drug history included AFLURIA (reaction: no issues). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a rash on her nose and forehead (outcome: unknown). Reporter comments: The reporter considered the event as non-serious.
Pt stated that after vaccine she felt dizziness. Pt stated that after being assessed & sitting in ambulance she felt better and signed release. Refused transport.
Patient received vaccine at 12:10pm used a 23G 1" needle. Patient came over to talk after sitting for 15 minutes and stated that her injection site hurt. Injection site was checked. Patient had minor bleeding and reported having ibuprofen Wednesday. Band-aid was changed and bleeding had stopped. Patient called back around 5pm and stated that her arm was numb. Recommended patient follow up with her PCP or reach out to urgent care.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 19-JUN-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
12/23/2020-RECEIVED VACCINE AT 9:52 AM.  REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020  CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE  8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE,  WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS.  ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020.  DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER  WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. Caller stated that she had her Pfizer COVID-19 vaccine second dose today, and has a question. She says she get migraines, usually one week out of a month, and had a bad headache the last two days which she had this morning. She said she was not saying it was from the injection, but she would like to know if she was allowed to take Tylenol or her migraine medicine since she got the second dose of the vaccine today. She says she just wanted to know if she can take Tylenol, she doesn't know if the headache was from this, she had one and it went away for the last day and a half, and now she has one again. She said she took Tylenol last night, and took Tylenol again this morning and the headache went away, now she wanted to know if she can take Tylenol for it since she has a headache again. Caller wanted to know how long it usually take for the symptom to go away. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (experienced no adverse event after 1st dose). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of to be related to BEXSERO. Additional details were provided as follows: The patient was 18 or 19 years old. The reporter reported that no vaccines were administered at same visit as BEXSERO. The patient experienced injection site pain, redness and swelling. Followed over the period of hours, the patient experienced nausea and felt weak in legs. The patient was going for the follow up visit with doctor.
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
Patient complaining of large, red, whelp on Right Thigh, and went to Urgent Care Center and recieved antibiotics at that time on 10/06/2011.  The patient went back to Urgent Care Center 10/11/2011 was informed to continue prescribed antibiotics and also gave the patient Ora Pred.
Never had varicella, but developed disseminated cutaneous zoster in February 2007. Rash resolved on Acyclovir, as did fever.  07/11/2007 MR record rec'd including D/C summary of hospitalization of 2/25-28/2007 for a disseminated zoster infection.  Child developed "bug bite" appearing rash which was itchy and burned. Initially thought to be a contact dermatitis however did not respond to steroids or antihistamines. Exam by consulting MD noted vesicles appearing in the mid portion of rash, thought to be disseminated zoster covering several dermatomes.  Then tx'd with Acyclovir and Benadryl.  Office F/U 3/5/07: rash resolving.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Within the 15min of COVID-19 Moderna vaccine given, patient came to pharmacy counter and reported to pharmacist on duty. Patient then became lightheaded and had to be caught by pharmacist before being lowered to the floor. Patient never lost consciencousness, but did need several minutes laying on the ground before he felt okay to get up. Was sitting in a chair when EMS arrived. They checked him and gave the okay for vitals.
pt recv vax & exp pain @ inj site;tx w/compresses & non-steroidal anti-inflammatory agents w/o relief;pain was worsening @ the date of report;
Case number PHEH2015US003131, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 18 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 26 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error.
The injection site was red and started itching around 7:30 p.m. on 4/12/21 until 4/14/21.  I used cortisone ointment.  It was also hot on the night of 4/13/21.  My tonsils were swollen when I woke up at 2:40 a.m. on 4/14/21 and I am hopeful this is not related to the injection.  My tonsils are still red and swollen.  I am using saltwater and one initial peroxide rinse.  I previously reported an apparent allergic reaction to the shot on the date of injection.  I received the shot around 9:30 a.m. and by 11:00 a.m. my tongue felt numb and my throat felt like it was closing in but was not sore.  I was extremely sweaty and my heart felt like it was pounding.  These symptoms passed within two hours.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX23 (lot # K009107, 21-JAN-2016, K010523, expiry date K019502). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash, hives, upper lip swelling on chest. nothing on injection site. did not report right away. waited until after a surgery. Did not seek medical attention at the time of rash
Child was brought in for a booster of the bivalent vaccine. The monovalent vaccine was accidentally administered.
ACUTE NON ST ELEVATION MI  4/12/2022 -- RECURRENCE OF SAME SYMPTOMS
6 days after receiving DTaP, IVP and MMR, pt had an erythematous raised rash on left thigh. No pain.
started menstral flow early. light for three days. I wasnt due for 3 weeks.
2:30pm  Nausea / emesis shaking headache BP 110/78 sent to ER Home and feeling was hot seen at ER. was taking to long.
Numbness on the left side of the face; body ache; general malaise; Soreness in the left arm; This is a spontaneous report from a contactable consumer or other non health care professional. A 33-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 17:00 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included oocyte harvest and was undergoing egg retrieval 4 weeks prior. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, ferrous fumarate, folic acid, retinol (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]), fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness on the left side of the face, body ache, general malaise, soreness in the left arm (non-serious) on 05May2021 17:30. This events lasted for 24 hours. On an unknown date in May2021 the events recovered.  Follow-up attempts completed. No further information expected.
The patient is scared of needles and was nervous. About 5 minutes after the shot was given, she walked up to the drop off window and reported she was feeling dizzy. The pharmacy tech and I advised her to sit down. She looks disoriented. She didn't seem to have understood any of our words.  Before we were able to guide her to a chair, she fainted and fell. we helped her lie on her back. She was able to breath, her eyes shut. we immediately called 911. She woke up in about less than 1 minute. The EMS checked her and she declined. She was able to ride home with a family member.
Starting about 6-7 days after injection, injection site was itchy and developed about a 2 inch red ring around injection site. Itching has gone but red ring is slowly fading
Moderna Covid-19 Vaccine EUA  Received vaccine and 15-20 minutes later (just after leaving pharmacy) started to feel very nauseous. My face started tingling/prickling and my heart was racing and my throat felt moderately tight but I could still breathe fine. Symptoms continued for 2 hours before I returned to speak with the pharmacist. She recommended I take Benadryl to counter reaction and watch symptoms. Symptoms subsided after taking Benadryl.
NEXT DAY AFTER VACCINE HER INJECTION SITES WERE RED AND SPREADING DOWN HER ARM, HOT AND SWOLLEN LIKE A RED SUNBURN. HER SPOUSE RECOMMEND SHE SEE A DOCTOR. DOCTOR DIAGNOSIS WAS CELLULITIST. RECOMMENDED COLD PRESS  500 MG CEPHALEXIN, 200 MG MOTRIN . DOCTOR ORDERED TO RETURNED IF IT HAD NOT CLEARED AFTER 4-5 DAYS.  DATE OF VISIT ON 4/18/2022 UURGENT CARE DR.
some deep muscle pain at injection site after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose). At the time of the report, VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: f/u received on 16-jun-2021, No new information reported.
Patient received smallpox vaccination on left shoulder approximately two weeks before presenting.  On the morning of March 6, 2012 he noted a papular rash on his chest, abdomen, neck and back.  No rash on arms or hands.  Prior to the rash he had typical symptoms associated with smallpox vaccination: axillary lymph node tenderness, intermittent fevers and malaise.  Considering mild presentation will defer treatment at this time. Will continue to follow.  (Comments provided by Doctor).
patient received the liquid component only of the vaccine, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient who vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was inappropriately reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that the patient received the liquid component only of the vaccine.  It was unknown whether the patient had any adverse reactions.  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 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.  Information on the batch number was requested.
palpitations; the injection area is in pain and is inflamed and red; arm has been super irritated in the injection area; the injection area is in pain and is inflamed and red; the injection area is in pain and is inflamed and red; tachycardia; episodes of fatigue; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red) and FATIGUE (episodes of fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced FATIGUE (episodes of fatigue). On 02-May-2021, the patient experienced TACHYCARDIA (tachycardia). On 09-May-2021, the patient experienced VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red). On 14-May-2021, the patient experienced PALPITATIONS (palpitations). At the time of the report, TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), FATIGUE (episodes of fatigue), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as ibuprofen.