chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Janssen vaccination in our shot room and was able to walk to the waiting area without assistance or complaint of feeling ill.  Within 5 minutes the patient passed out as he tried to move to a chair closer to his father.  He fell to the floor and lost consciousness.  He almost immediately regained consciousness, however, was very confused and disoriented for a short time.  911 was called.  I stayed with the patient, gave him water, and made sure he stayed on the floor until EMS arrived.  They checked the patient out and concluded that he was ok to leave with his father.  A trip to the hospital was not necessary.  The patient has a small cut behind his left ear, but otherwise was ok.
almost like on top of my hand loses feeling; hand is partially.. like a numbness, tingling or needles sensation; hand is partially.. like a numbness, tingling or needles sensation/hands felt like pins and needles; She could still feel pain in her forearm; injection site pain; the pain was going down her elbow; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number; unknown), via an unspecified route of administration on 05Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Apr2021 patient received the covid vaccine two days ago. The first day, she felt injection site pain. She felt it from her arm down to her forearm, elbow area. Her arm feels better today. The injection site feels better today. She woke up today and her hand was partially.. like a numbness, tingling or needles sensation, almost like on top of her hand loses feeling. Since she has woken up, her hands feel like she has been sitting on them. Clarified that her hands felt like pins and needles. She felt this on her wrist and hands. She kept moving her hands around, sticking them up in the air, and making a ball with her hands. She would say it was about a 25 percent loss. She could still feel pain in her forearm, which was weird to her. The injection site feels much better. She was concerned about the nerve issue. She was asking if this was a reported side effect. The outcome of the event injection site pain was recovering and unknown for other events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Initially I had a sever sore arm that advanced into my neck muscles. I had a severe headache and blurred vision. Six days later I developed small joint pain in both thumbs.  I then developed abdominal pain and diarrhea on day 7.
Throat and chest tightening, as was all warm and flushed feeling in throat and chest
Pt. had syncopal event after administration of 4 vaccines (see below).  Was caught before fell to floor, was sat on chair, as soon as sat, her eyes opened she was fully conscious (alert & oriented).  Stated felt "dizzy" and "weak".  Had not eaten in several hours gave her candy  and water.  Observed for 20 min., was fine stated felt better:  Went home with mother.
Started to experience tightness in both feet.  Foot Doctor sent me for a nerve conduction test where neuropathy of both feet was confirmed.  I never had an issue with this and was told I'm one of the 3-4% that has the problem for no know reason.  Still have it and according to both doctors, unlikely it will improve or go away.
10Nov2022 in late afternoon, I had a sore throat and a lot of fatigue. I took a home test and it was positive. That night I called the doctor and got PAXLOVID and felt better.
hematoma at site shot - started that evening - progressed over a week to the size of a "plate"; no further following by patient
Patient received Hep A #1 1/9/06. Mother called 1/12/06 to report bruising on shins, forehead, arms. Injection site purple. Tiny dots on chest, face, tip of tongue. Mother reports bright green "poop" for 2 days prior to Hep A IZ. 1/17/06, mother reports reaction not related to Hep A IZ per MD.
Went on line and found out people were getting the same symptoms I had and it said to take Benedril.(Antihistamine). I have Zyrtec on hand so started taking that and it stopped the itching.  As of today I still have a couple of bumps on my wrist that still itch but have quit the Zyrtec after 3 days
Started within six (6) hours of the shot along came...Fever (100.4) with aching muscles & joints for 26 hours...after temperature returned to normal I was able to sleep the next night.
Menveo administered intradermally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo (intradermal). On 16th August 2022, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The reporter reported that menveo administered to a patient intradermally. The reporter consented to follow up. Additional supportive information: The patient received menveo intradermally instead of intramuscularly which led to incorrect route of administration.
Patient received a duplicate dose of influenza vaccine. Previous dose given on 9/14/2023
16:00 legs tingling-sharp pain in neck and rad. down Rt arm (inj given in Lt arm). Both hands tingling - approx 16:30 throat tight scratchy.
Developed a high pitch noise in my left ear two days after receiving the first dose of Moderna.
10/15/12 - received vaccine. 10/16/12 0645- Fainting episode occurred, where pt. fell face first to floor, hitting face - nose, decreased BP, decreased pulse, throat tightness. Pt taken to E.R. per ambulance. BENADRYL, TYLENOL given. Sent home, hives developing, tightness in throat remained until 10/18/12 A.M. F/U with family physician 10/18/12 2:30 p.m. BENADRYL et TYLENOL taken x 2 around clock.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-APR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-FEB-2017, the patient was treated at an Internal Medicine office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
numbness in my arms, legs, and feet; Nerves felt like burning in arms and legs, and tongue; tingling; Nerves felt like burning in arms and legs, and tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue). At the time of the report, HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not specified.  Treatment medication were given by doctor.
During 15 minute monitoring- this RN performed her routine check. The patient had approximately 12 minutes remaining on his timer, indicating that he had received his vaccine in the last 3-4 minutes. He stated that he was feeling lightheaded. This RN and clinic staff secured the vehicle- shutting off the truck and removing the keys. We reclined his seat back and applied a cold compress on his forehead. At this time, the patient presented with diaphoresis and increased pallor. O2 sat 98% on RA, B/P 130/60, pulse 118. Had patient drink approximately 240 cc of cold water. Patient driving his company truck. Employer notified. Employer to send staff to drive the patient and the truck back to his home/work siteContinued to monitor patient for the next 30 minutes. At the end of monitoring- color had returned to his face, diaphoresis had ceased, and he stated the he felt "much better".  Patient assisted to the passenger side of the vehicle with assist x 2. Gait steady. Patient drank an additional 240 cc of cold water. Patient encourage to continue to hydrate, and to contact his physician with any concerns- 911 with any emergent concerns.
Vaccine received at 13:30 on February 25.  At 16:45 arm became very sore.  By 21:00 there was a slight fever.  At 06:00 on February 26 I got out of bed to go to the bathroom.  Felt weak and lightheaded.  Tried to return to bed but fainted after a few steps.  Regained consciousness very quickly after hitting the floor.  Weakness and lightheadedness diminished over the next few hours.  Moderate fever also subsided.  Gradually resumed normal activities by midday.
STARTED WITH NECK PAIN, WHICH GRADUALLY MOVED TO HER RIGH ARM. PATIENT COMPLIANED OF DIFFICULTY MOVING HER ARM BUT HER ARM LOOKED NORMAL WHEN I CHECKED. NO SWELLING, INFLAMMATION OR REDNESS.
Flu shot was given in left arm on Saturday 9/29/18 and a few hours later mom noticed the left arm was becoming swollen, warm to touch, and red. Symptoms have persisted since then.
After Dose 1: Severe pain at injection site (L arm) and muscular pain into trapezius muscle area--lasting for 2 days--resolving without intervention. After Dose 2: Severe pain at injection site (L arm), severe fatigue, whole body aches, low grade fever of 100.7--rest, fluids and ibuprofen---resolving in 24 hours
a swollen lower lip; White color; The swelling went down under the chin; bumpy; swollen flesh below the lower lip; spills some liquid on the side while she talks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy) and LIP SWELLING (swollen flesh below the lower lip) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included GLIPIZIDE, SITAGLIPTIN, HYDROCHLOROTHIAZIDE, VALSARTAN, PROBIOTICS NOS and ALPHA-AMYLASE SWINE PANCREAS, CELLULASE, LIPASE, PROTEASE NOS (DIGESTIVE ENZYME) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include PreserVision Eye Vitamin.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up information received on 10-Jul-2021 contains no new information.
3-4 days after injection, patient developed a 1 cm nodule right upper arm at site of injection.
patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines) in an adult male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines). At the time of the report, COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-674607 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674607:wife case
Pt states that his pulse is over 90 and that he has been in pain since he had the vaccination.
NauseaVomiting Tingling lips the day of vaccine, nausea near  vomiting the next day Narrative:
Tingling in feet & legs, progressed to hands and arms in two days, Became worse second week.  Tingling/vibrations increased & progressed to pulses in thighs, up to bladder, burning cold numb spots on arms and legs, difficult breathing-tight chest, increased heart rate at times.  Worst first four weeks, lessened weeks five & six.  Ongoing -Currently has leveled to feet legs, arms, hands.  Seeing neurologist and have not yet had nerve conductivity test.
One month after second shot: tingling in arms/hands and legs/feet, muscle weakness, joint pain
temperature excursion that exceeded the stability data with No adverse event; administered to patients post excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old and unknown gender patient who was administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] post excursion with no adverse event and temperature excursion that exceeded the stability data with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 23-Sep-2022, the patient received suspect influenza quadrival A-B multidose vaccine preserved at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 23-Sep-2022 there was temperature excursion that exceeded the stability data with no adverse event (product storage error) and administered to patients post excursion with no adverse event (poor quality product administered) same day latency following the administration of influenza quadrival A-B multidose vaccine preserved.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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.
Received flu vaccine 10-27-14. Awoke with pruritic rash 10-28-14. Concentrated in (L) axillae, antecubital fossa and under breast. Treated with topical antifungal and steroid without relief. Then antibiotics and oral steroid.
I started feeling unwell on Thursday evening. I had fever, tunny nose, cough, chills, loss of taste and smell. I got tested for COVID on Friday and it came back positive. I felt pretty bad on Saturday. On Monday I received the monoclonal infusion and I felt better after that. On 09/20/2021 I tested negative. They recommended Theraflu and other over the counter medications.
In addition to the expected soreness in site of injection, there was tiredness on day 2 and some redness on day 3 on left deltoid. However, on day 8, there was a marked increase in redness, swelling, and itching similar to hives on the left deltoid.  After applying 2.5% cortisone cream (prescription I had on hand) and taking Ibuprofen and Tylenol for swelling and discomfort, the symptoms subsided over the next 3 to 5 days. On day 13 there is still occasional itching.
Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
The vaccine was administered on Wednesday 3/7/2018. On Friday she experienced a generalized rash on arms and chest. Today is Monday 3/12/18 and the rash has not improved. She states that she has used topical Hydrocortisone without improvement. Today she'll try ALLEGRA, ZYRTEC or CLARITIN. The patient was instructed to notify her prescriber.
Started feeling a strong needle like pain in the left ear. Pain later extended to top left of head and along left side of neck. Strong pain even from brushing hair when applied to top of left side of scalp. Feeling of pressure being applied to the top of left side of head. During the first day, I felt fatigued and had difficulty focusing.  The pain continued for about 2 days, until I took Tylenol I did feel the pain subside.
Recipient had very brief; <5 second loss of consciousness from vasovagal syncope within about one minute of vaccination at her vaccination seat while seated. She self-recovered quickly and without issues. She quickly came to consciousness worried about her phone having fell and was awake, alert, oriented to person, place, time, date. We advised she lay down and elevated her legs to help with recovery and she was provided water and instructed to take slow deep breaths and relax. Recipient and family reported she had not had much food or fluids. Family reported patient experienced anxiety from patient's father's feelings about receiving the vaccine. Within 10 minutes patient sat up and proceeded to wait an additional 15 minutes in observation and went home without issues.
1 of 2 pts who devel inject site react; pt devel large inject site react of tenderness & swelling; not seen by MD; treatment included APAP & alcohol compresses;