chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild symptoms evening of 2/3 (arm pain). Severe headache, body aches, and moderate nausea started overnight and increased in severity until early afternoon of 2/4/21.
The patient and I were discussing the recent birth of her child. She requested the J&J COVID vaccine. I administered it. Then our conversation changed to talking about school starting soon. That is when I looked at her DOB and asked her how old she was. She stated 15. I immediately informed her that she should  not have received the J&J vaccine and that I would be giving her a call in a day or two to check on her. I spoke with the patient's mother. I informed them that this was a valid dose and would not need to be repeated.
muscle body aches; Diarrhea; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the parent.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 11:27 (Lot number: ER8737) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Diagnosed when he was about 5 or 6 years old.; "Covid" (unspecified if ongoing), notes: Verbatim: Covid. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "muscle body aches"; DIARRHOEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of myalgia. Additional Information: The mother reported that her son received Pfizer Vaccine 31Mar2021. Her son was feeling good until started feeling muscle body aches. The onset of muscle body aches was probably about 00:00 or 01:00 on 01Apr2021. The patient also had diarrhea, just a little, not a lot. The patient just went 1 time and she really does not know if recovered. The patient wanted to get the vaccine because of the pandemic and that they're going through because they had covid before. The patient was in hospital for 7 days. The patient has asthma. The patient took medication, but it was nothing to do with the body aches, he was healthy, doing fine. He didn't have no body aches or nothing until yesterday. Especially if he mowed the yard or something, he got it you know. He took an inhaler. The patient did not treat the muscle aches in any way. The mother was going to give him Advil. The patient has no history of all previous immunization and has no additional administered vaccines on the same day. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no family medical history related to the adverse events. No relevant tests were done.  No follow-up attempts are possible. No further information is expected.
Approx. 25 min to 30 min post vaccination. Pt. mom called to report Temp 102.3 F oral, nausea, vomiting, and swelling at pt (L) upper arm. Pt. mom took pt. to PCP/MD office oral BENADRYL, oral ALEVE and ice pack given. RN called to F/U at approx 2hr after pt. no s & s N & V resting and some swelling in (L) arm.
Severe swelling & pain in both legs & feet. Treated with BACTRIM DS & LASIX. Taken off work 1 day. Onset of symptoms 24 hrs after receiving vaccine.
This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on 24th April 2019). On 6th December 2021, the patient received the 2nd dose of Shingles vaccine. On 6th December 2021, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked if he/she needed to get another dose. The follow-up would not possible as no contact details were available.
pt rcvd vax; 4 to 5 hrs after vax, pt devel severe pain, soreness & small swollen area at injection site;
Left Arm hurts; Very weak; Trouble Walking; Slept for 12 hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Dec-2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Left Arm hurts), ASTHENIA (Very weak), GAIT DISTURBANCE (Trouble Walking), HYPERSOMNIA (Slept for 12 hours) and FATIGUE (Fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, SARS-CoV-2 test: positive (Positive) She had a positive PCR Test and Covid-19 in Dec-2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.    This case was linked to IN-MODERNATX, INC.-MOD-2021-064921 (E2B Linked Report). This case was linked to MOD-2021-171345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021: Patient reported that she got her second shot on 27-Feb-2021 and was feeling very tired and weak after that. She was provided with Moderna phone number to report any further information. On 06-Aug-2021: Follow-up document was received and had significant information. Updated medical history, event start date, Lab data, event outcome to recovered/resolved; Sender's Comments:  IN-MODERNATX, INC.-MOD-2021-064921:Mother case
NASAL CONGESTION, DRY COUGH, HEADACHE, LETHARGIC
She had like hyperthyroid in the hospital; her body incredibly weak she couldn't get up; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Lot number: ER8731) at the age of 38 years 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, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (hospitalization, medically significant), outcome "unknown", described as "She had like hyperthyroid in the hospital"; ASTHENIA (non-serious), outcome "unknown", described as "her body incredibly weak she couldn't get up".; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  HYPERTHYROIDISM  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200404920 same reporter/drug/event, different patients
Patient went home after vaccination. Patient took Nyquil with Benadryl at home. Felt mouth numbness and came back to vaccine Pod. Patient evaluated by Resident. Symptoms improved. Vital signs taken.
Pneumonia - ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Information has been received from a licensed practical nurse concerning a female patient who was vaccinated with a first dose of Gardasil. Concomitant therapy given on the same day included a dose of Varivax and a dose of Tdap on the same day. It was reported that Gardasil was the last in that series of vaccines the patient received. Subsequently, the patient fainted. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 12 year old female patient with a history of vaginal birth (no complication) who on 09-FEB-2007 at 09:54 was vaccinated IM into the right deltoid with a first dose of GARDASIL (Lot# 654389/0961F). Concomitant therapy given on the same day included a dose of VARIVAX and a dose of Tdap (unspecified) on the same day. It was reported that GARDASIL was the last in that series of vaccines the patient received. After immunization at 09:54, the patient stated the last shot on the right arm was painful. The patient turned pale, went back and hit her head to the wall. The patient stiffened, made some gurgling noise and had her eyes open. It was reported that the patient had a brief episode of fainting on the exam table. It lasted 1-2 seconds. The patient recovered spontaneously. Once the patient came around the patient asked "what happened?" Laboratory diagnostic studies included a "neuro" check. It was reported that the patient was alert to her name, place and was responding appropriately to questions. The patient's vital signs included a blood pressure measurement of 90/60 and a heart rate of 90. The physician was notified, water was offered and tolerated well. The physician examined the patient. The patient walked out of the room without any difficulty. The physician presumed the experience was transient vasovagal episode. The patient was offered an appointment to return to the clinic only if the patient was up to it. At the time of this report, the patient's outcome to the vasovagal episode, turned pale and painful right arm was unknown, however, the patient recovered from fainted. No product quality complaint was involved. Additional information is not expected.
Patient called back the day after (6/11/19) to report that he had gone to the doctor for severe arm pain with decreased mobility in his left arm/shoulder. Patient reported that he had seen his physician already on the morning of 6/11/19 and was being referred to Sports Medicine for follow up.
Passed out right after the last shot. Unconscious for a very short period - less than 5 seconds. BP=116/65 mmHg, T 98.1 degrees F, HR=67 bpm, RR=13 cycles.
1/24/21 woke with body ache, nasal congestion, headache 1/25/21 same symptoms plus sore throat and fatigue 1/26/21 all of the above symptoms plus loss of taste and smell 1/27/21 all of the above 1/28/21 all of the above  No fever at any time
Fever, chills, aches, fatigue for 24 hours, fatigue and aches for 48 hours
two family members that had injuries from the Pfizer covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INJURY (non-serious), outcome "unknown", described as "two family members that had injuries from the Pfizer covid 19".   The lot number for bnt162b2 was not provided and will be requested during follow up.
WHEN I WAS GETTING INJECTION RIGHT UPPER ARM I FELT NUMBNESS AND TINGLING GOING ALL THE WAY DOWN MY ARM TO FINGERS, LIKE A BOLT OF ELECTRICITY, I STILL HAVE PAIN FROM SHOULDER TO ELBOW AND SOMETIMES DOWN TO FINGERS ACHES AND THROBS WAKES ME UP AT NIGHT SOMETIMES OR WHEN I REACH FOR SOMETHING WITH RIGHT HAND I HAVE PAIN.
Patient informed us of swelling and redness the following day. Went to MD and started antibiotics. Did not improve so pt was hospitalized for IV antibiotics. Left arm only.
Upper arm tenderness radiating to neck and shoulder-difficulty lifting arm past elbow level for 4 days-hurts to lay on that side with pain when lifting.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with incorrectly stored doses of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a four-years old male patient who was vaccinated once with a 0.5 ml fifth dose of PENTACEL (lot number: C5553AB; expiry date: 02-Nov-2019) via intramuscular route in the Left thigh on 29-Oct-2018 instead of getting vaccinated with QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Wrong vaccine administered and extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. 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.
Patient seen in ER - given 50mg diphenhydramine PO. Patient reported feeling of throat closure and chest tightness. Later that evening patient developed fever, chills, body aches. Symptoms: feeling of throat closure, SOB, fever, chills, body aches. Treatment drugs used: 1 - Diphenhydramine Dose: 50 - Units: MG - Freq: Once - Route: PO.
Technician placed needle into appropriate vaccine site on patients left deltoid. He went to plunge the dose into patient arm however, the syringe was empty. He removed the syringe from patient's arm. Explained to patient the clean, new, needle that was placed into his arm contained no vaccine. He did not have any air injected into arm. Technician alerted pharmacist, who had pre-drawn doses set aside. She stated that the syringe was taken out of the wrapper and was placed in the mix of syringes that were pre-drawn with the proper dosage of vaccine. Patient wanted to proceed with the 0.3ml of Covid Pfizer into the same left arm. Patient is well and happy to have received the correct dosage.
an hour after getting the vaccine I started getting sicker and sicker. Severe body aches. I called the pharmacist and he told me to take some ibuprofen. A day and half later. I could not sleep stand walk.
Immediately after the vaccine was given in the right thigh, the patient developed a hive around the injection site measuring 11 x 7 cm at its largest. He was given BENADRYL and TYLENOL in the clinic. When he left 1 hour later, the hive was decreasing in size.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patient had been adminsitered doses of improperly stored PNEUMOVAX23 lot # K007262, expiration date reported as 25-NOV-2015 (dose, route and site of administration wer enot reported). No adverse effects were reported. This is one of several reports  from the same reporter. Additional informatino has been requested.
on injection site itchy; on injection site red; on injection site warm to the touch; on injection site rash; on injection site rash getting bigger; on injection site hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash) and VACCINATION SITE RASH (on injection site rash getting bigger) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Narcolepsy, Cirrhosis of liver, Squamous cell carcinoma and Melanoma (Left arm). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Narcolepsy, FUROSEMIDE, PREDNISONE, SPIRONOLACTONE and PREGABALIN (LYRICA) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard). At the time of the report, VACCINATION SITE PRURITUS (on injection site itchy), VACCINATION SITE ERYTHEMA (on injection site red), VACCINATION SITE WARMTH (on injection site warm to the touch), VACCINATION SITE RASH (on injection site rash), VACCINATION SITE RASH (on injection site rash getting bigger) and VACCINATION SITE MASS (on injection site hard) outcome was unknown.            No treatment details reported.
Face swollen, face pruritic gone - maculo papular rash. Itchy pink eyes. BENADRYL given by uncle. Gave prednisone 40 mg, ATARAX symptoms (Epipen for emergency only). We saw after.
improperly stored VARIVAX administration.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.     On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T012551, expiration date 10-APR-2022 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).     The vaccine was stored in a temperature of  6 degree Fahrenheit (°F) to 14°F (11.8°F) for 31 hours as recorded by a data logger. There was no previous temperature excursion reported.
Patient was given 2 HD flu shots (one dose on 9/19/22 and second dose on 10/1/22).
Received vaccination on 3/31/09:  TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm.  On 1 April 09 pt noted a 3" circle of redness and swelling around the AVA injection site.  His pain was a 3-4/10.  He thought he might have a slight fever and that his lymph nodes on the left side of his neck were swollen.  The pt went to MSC on 4/2/09.  His temp was recorded as 100.1.  He continued with redness and swelling around the injection site left arm and complained of generalized joint pain (esp his hips) and a low grade headache.  He was prescribed MOTRIN and TYLENOL #3.  On 4/3/09 his joint pain was improved, but the pain in his left arm was worse as was the redness and swelling.  He was prescribed KEFLEX 500mg qid.  Today the pt's pain level is a 2/10, there is decreased swelling and redness at the site.  The pt states for the last 48 hours he has had intermittent left shoulder pain followed by a "cold numb feeling in his arm and left hand (all digits).  These symptoms can last for several minutes to one hour.  The pt was prescribed PREDNISONE 60mg X5 days with a 10mg taper per day.  On 04/9/09 the pt was reexamined.  He had no more left shoulder pain or left hand numbness.  The left arm swelling was completely resolved as was 90% of the erythema.  Symptoms: Pain, Numbness, Erythema, Edema @ injection site 50-120mm, Pain.
doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna; doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna). At the time of the report, PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
1006:  received vaccine 1022: 15 min observation complete - no difficulties 1034;  lightheaded "wash" in my head lasting < 30seconds (as though standing too quickly) along w/ fleeting nausea then "light" numbness of face.  Uncertain if subsequent tachycardia and hand tremors were from the initial lightheadedness and numbness or additional side effects.  I was driving my car, alone and became nervous. 11:30 25mcg benadryl capsule taken ~13:00 numbness of face resolved.