chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported some left arm pain that began about 24 hours after the injection. Assuming it was a typical reaction we provided reassurance and warm compresses. He progressively then expressed that the pain was radiating down the entire arm to his fingers and that he is unable to sleep. He then appeared confused with inability to dress himself, getting lost in the house and not knowing how to get to bathroom. We checked his blood sugar and blood pressure which were at his baseline. He complained of excruciating pain that did not respond to Aleve, Indomethacin, Tramadol or local lidocaine. He described it as knifes in his arm. He did not seem weak but he had no coordination to eat with arm or button his coat. After watching this for 2 weeks with no improvement we went to the emergency room  on March 19, 2021. He is uninsured so we were really trying to avoid going in but he was only getting more confused. He was admitted and had several tests listed below without any acute causes found. He was given Gabapentin in the hospital and that  settled his pain for the first time in 2 weeks. He was discharged on March 20th as the treating doctor felt he might benefit from spinal tap but was not sure.
dizziness/she has a friend who is going through something very similar; Vision disorientation/she has a friend who is going through something very similar; ringing in her ears/she has a friend who is going through something very similar; pains in her face/she has a friend who is going through something very similar; anxiety/she has a friend who is going through something very similar; depression/she has a friend who is going through something very similar; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, vision disorientation, ringing in her ears, pains in her face, anxiety and depression. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.  F/U (PRD/SRD 25aug2021): Follow-up activities closed: Batch/lot number not available.
Got Booster on 21 Nov 2021 and broke out with severe shingles  23 Nov 2021.   Continues as 2 Feb 2022.  Still have postherpetic neuralgia,.. pain medication not working well. Off work now for 2 months going on 3 months.
6wk post vax devel blurred vision intermittent lasting 30min to 1hr each episode 3x4per mon;pruritus, devel neuro paresthesia, equilibrium distribution, joint pain, soreness;devel pityriasis rosea;
1020PM began to stare then became unresponsive;slowly recovered w/o sequela;no sz activity documented;most like a hyporesponsive incident;
I noticed a small blister like spot on my left knee area, when I got up on July 4, 2014.  It was itchy.  I put on some Benadryl cream.
Presented with AMS, resp distress, fatigue; + Covid in ED; CXR: "early developing infiltrate"; Labs: D-dimer 1.28, CRP 11.6; Ferritin 428; TX: Zithromax, maxipime, remdesivir, Vit C, Decadron, Lovenox, ; Initially on 3 LPM NC; down to room air by d/c
Arm was sore but not unbearable; was a little red; headache; nausea; fatigue,exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Panniculitis and COVID-19 on 04-Jan-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE, HYDROCODONE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore but not unbearable), ERYTHEMA (was a little red), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue,exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include half of hydrocodone.
received 3rd dose of Pfizer vaccine on 10/7/21. Reports she had generalized itching on 10/7/21 and 10/8/21. Took Benadryl 10/8/21. Symptoms resolved 10/8/21.
Headache from 6/20/21-6/24/21, Fever of 99.5-100.2, nausea, vomiting, chills, aches, arm still swollen around injection site. Symptoms were gone by 6/25/21
A non-serious, spontaneous report of should not have gotten two doses this season, in a nine year-old male patient was received from a health professional. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information received 12-Nov-2008: No reactions have been reported in the patient since vaccination.
Dizziness, lightheadedness, fever of 104 and body aches, blood pressure kept bottoming out. Participant had COVID last year and was in the hospital, they tested her and she still has a significantly high level of antibodies .  Had double pneumonia. Physician took a photo because he never saw anyone hold that high if antibodies.
No additional adverse events reported; admnistration of an adult dose of VAQTA admnistered to a 19 months old patient; This spontaneous report was received from a physician and refers to a 19 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  The physician reported that on 04-NOV-2021, the child patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter,  lot number T034003 with expiration date 28-MAR-2022 (route of administration and anatomical location were not reported) for prophylaxis (Product use issue). No additional adverse event reported.
Initial information was received on 29 October 2008 from a manufacturer whose initial reporter was a health care professional. A patient experienced an anaphylactic reaction after receiving a flu vaccine (manufacturer unknown). The lot number, route, site and date of vaccination was not reported. No further information was available. List of Documents held by Sender: None.
I had shingles even though I had a shingles shot/ Suspect vaccination failure; I had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Felt fine for 15 min waiting period. Began drive home and started to feel slight sensation on left jaw, almost like novocaine, then my heart began extreme racing and lurching, with irregular rhythm. I looked for a place to pull over-I was on the highway, but luckily it subsided after 4-5 min.
Severe pain in left shoulder to the point it's difficult to move.  At times I have numbness in my fingers. This started about 4 hours after my shot.
approximately 10 hours after the 2nd shot, I started experiencing a racing pulse, heavy beating heart, and extreme fatigue (couldn't walk across a room without stopping to catch my breath.  I also broke out in hives at both injection sites.  I elected to not go to the doctor, as in the past I've had severe reactions and have been told it's "normal", but did alert him of the adverse reactions I was experiencing.  I don't remember much of the day following the shot.  6 days after the 2nd vaccine admin, I woke up with extreme itchiness, redness, swelling and numbness in my right arm, which got worse as the day progressed.  I contacted my doctor who directed me to urgent care.  I was diagnosed with cellulitis and prescribed Clindamycin.  The doctor I saw indicated that it was most likely related to the vaccination.
I have developed a chicken pox-like blemish on the underside of the (likely) injection arm (can't remember or find a record of which arm received the dose.) It has been itchy in the same specific spot for several months. The spot is raised and usually red, and usually has a scab on it. I have an uncontrollable urge to scratch it especially when I am very warm or clothing brushes it.
An expired Pfsier Bivalent Booster 18+ was possibly administer to this patient at his visit. It is unclear if an expired or current vaccine was given at the time of administration.
information has been received from a nurse concerning a 5 year old male who on 01/11/2001 was vaccinated with the first dose 0.5ml; of varicella virus vaccine live. There was no concomitant medication. On 03/01/2005 the pt presented in the MD office with a mild case of chicken pox. He had about 35 lesions on his torso area and was afebrile. He was given Benadryl as Tx. At the time of this report the pt's present status was unknown. No product quality complaint was involved. It was reported that the mild case of chickenpox was another important medical event (OMIC). However, follow up information form the nurse indicated that on 03/01/05 the pt developed varicella  with 25-30 bumps on his torso The nurse did not consider the pt's varicella to me serious. Additonal information is expected.
multiple pulmonary emboli Eliquis 10 mg bid for one week, then 5 mg bid short of breath, chest pain started 8/27/2021 still short of breath today
Flu like symptoms - achy, headache, woozy, tired, nausea 1.5 hours about 4:00 pm next day.
Left arm at site redness, hot to touch, pain. Local reaction 10 cm x 10 cm. Referred to Dr tomorrow if no better.
Patient experienced severe headache and nausea/vomiting for 2 days after vaccination. Patient also had a rapid heart rate and pressure in the chest which prompted an emergency room visit on 3/8/19. Patient now (3/11/19) has developed hives around the injection site and still has migraine headaches from time to time.
About 2 hours after receiving the vaccine, I became very nauseated.  I than begin vomiting.  I vomited probably around 7-8 times (maybe more), and the last 2 times there was nothing left in my stomach to come up and I was just heaving.  I also had moderately severe lower abdomen cramps (just above my pelvic bone).  It felt like my insides were twisting at times, and the pain was constant cramping with moments of pretty severe twisting doubling over pain. I had chills just before the vomiting started, and felt like I had a slight fever, but because of the constant nausea/vomiting I did not take my temperature (all I have is an oral thermometer). To get the pain to stop, I had to lay down on a bed and put pressure on my stomach sides to ease the cramping. I tried taking Pepto-bismol to stop the nausea and vomiting, but immediately vomited that up too. The vomiting finally stopped after 2 times of dry heaving and nothing left to come up.  The severe lower abdomen stomach cramping calmed down around 1 or 2 am. Today I feel weak, my right arm is very sore and slightly swollen, and as of the time of this report at 2:30pm I have only eaten some saltine crackers today. My stomach still feels weak, even though the nausea, cramping, and vomiting have gone away now.
This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. The primary reporter stated that as of 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on unspecified dates, improperly stored doses of PNEUMOVAX 23 (lot # L022262, exp. date on 05-NOV-2016), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
From telephone contact received at manufact. on 08Jul2002 it was reported that a 16 month old male received a dose of Tripedia vaccine on 03Jul2002. Pt developed a large area of redness and swelling at the injection site (thigh).
pt presented approx. 25 mins after receiving Moderna vaccine in which she complained of throat tightness she remained upright and talking during event and was immediately pulled back for tx. Code team called to assess allergist on call during team who tx pt for sx at the time of event in clinic. epi pen administered in clinic, EMS called for pt transport. Pt stable upon leaving and oxygen remained 99% both before and after the administration of epi-pen.
Patient's arm was swollen. He had flu like symptoms: fever of 102, coughing up green mucas, wheezing, body aches.
Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees) up through my thighs to my hips, pretty much 24/7.  Chills, loss of apatite and some foods taste strange.  have been unable to sleep through the night because of the pain.I do think that the antibiotic did not mix with the second shot even though the medical staff cleared me at the COVID clinic that I could have the shot.
Subject in pneumococcal vaccine trial, with severe COPD, was admitted to the general medical service. Vaccination took place on 1/28/2008 and admission was on 4/7/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
One of three patients who developed urticaria w/in 30 minutes of receiving immun; Recovered;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial placed in refrigerator - 06-NOV-2021  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter
A serious event of pneumonia was reported by a Study Investigator concerning a four-year-old male subject (Pat ID# 42458400) enrolled in a post-marketed study MI-MA162.  Medical history included cough and congestion with intermittent fever for three weeks.  Concomitant vaccinations included DTaP, IPV, MMR and Hep A and were received on the same day FLUMIST was received.  The subject received FLUMIST on 29-Nov-2007.  The subject had been feeling better for a few days after his vaccinations on 29-Nov-2007, he then developed a fever of 104 degrees Fahrenheit, was vomiting and taking only sips of fluid.  On 04-Dec-2007 the subject was seen by his primary physician and diagnosed with pneumonia after a chest x-ray showed a right middle lobe infiltrate.  He was prescribed amoxicillin and sent home.  The subject's condition did not improve with continued cough, occasional post-tussive emesis, fever and worsened breathing.  He was admitted to the hospital on 06-Dec-2007 with a oxygen saturation of 91% on room air and a respiratory rate of 55.  The subject was treated with intravenous fluids, ceftriaxone, albuterol nebulizers and supplemental oxygen.  A NP swab done 05-Dec-2007 was positive for RSV. On 08-Dec-2007 the subject was discharged from the hospital and per the father he was reported as doing "fine" with an occasional cough.  The pneumonia was considered resolved on 08-Dec-2007.  No additional doses of FLUMIST were received.  The Study Investigator considered the event of pneumonia as possibly related to study drug.
Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided. Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.
Pt received the second dose of Moderna.  Pt stated experienced numb tongue, difficulty walking, weakness after the first dose. Pt talked to her PCP, PCP didn't restrict her to get the second dose.  The concern of allergic reaction was discussed with patient. Patient decided to get the second dose at 9:19 am. Pt was instructed to stay and being monitored for 30 minutes. at 9:40, Pt reported numbness of the tongue. VS was taken. BP: 153/95, HR: 62, SO2 100%. No difficulty breathing noticed. Pt was transferred to the adult health.
I had the first side effect approximately 5 hours after the injection.  I was walking and I felt some sensation of neuropathy in my left foot.  A sensation of not fully feeling my foot. I have continued to have tingling on and off in my left foot sporadically since the day of the injection. Approximately 4 months after the vaccine, I began to have joint pain in my left side which included shoulder, hip, knee and foot.  This pain was almost constant if I was sitting but did not bother me during the day while moving.  I went to the chiropractor to try and alleviate the discomfort and the treatments have helped.  I have also used Advil and Tramadol for the pain.    I have had no pain on the right side, only the left, where I had the injection in my left arm.
SEVERE PAIN; DEBILIATING CHRONIC BACK PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced severe pain, and debiliating chronic back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain and debiliating chronic back pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210627096.
Pt seen for sick visit 11/15/22, reports developing L lateral shoulder pain 6 days after flu shot with mild stiffness, pain with movement. Pain with ROM on exam, mild lateral tenderness. Some improvement w/ NSAID. ? Frozen shoulder.
got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf.  The batch number is 206a21a if I can read it from my card.
Mum called left message to call her back. Returned her call & she informed us of patient's swollen right arm and right breast. We asked if she was able to take picture & send to us. She did. Right arm & breast swollen next day 3/9/2015. We asked that she take patient to the ER at hospital.