chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really bad cold; Congestion; sore throat; Fever; Chills; Body aches; Joint aches/joint pain; tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (Fever) in a female patient of an unknown age 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain). At the time of the report, TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) She had great high numbers of antibodies.         No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-392232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received on 24-NOV-2021. Events (Sore throat and Congestion) added. Outcome of events(Tinnitus, fever, chills, body aches, joint pain, sore throat and congestion) updated from unknown to recovered/resolved. On 24-Nov-2021: Follow up received on 24-NOV-2021 and does not contain any new information; Sender's Comments: Non-serious Case
This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 1st December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain, headache and tiredness. On an unknown date, the outcome of the injection site pain, headache and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, headache and tiredness to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient did not had problems with the 1st dose but felt side effects from the second dose received last night and experienced Injection site pain, headache and tired. The patient enquired how long should a person feel side effects from the Shingrix vaccine. Follow-up would not be possible as no contact details available.
Information has been received from a registered nurse concerning a 45 month old male with a history of eczema and allergic reactions who on 07/08/1998 was vaccinated with the first dose of varicella vaccine SC in the left arm. Concomitant therapy that day included the first dose of MMR vaccine SC in the right arm. There was no illness at the time of vaccination. In the afternoon/evening of 05/08/2001 the pt 'broke out in a rash, started under arms, few scattered pox on back and groin area." The pt was seen in physician's office on 05/09/2001 with a temp of 97.6 deg. F. There were  a few papule vesicular lesions on upper trunk, anterior and posterior, more on right side and were "somewhat itchy." It was discussed that the pt be treated with Benadryl. On 05/29/2001 the mother reported that the child continued to break out slowly. There were a few new lesions each day. They reportedly pimpled, scabbed over and then went away. There were two pox on the face and the others had resolved. It was reported that the pt recovered. It was also noted that the pt and his siblings did not have any previous adverse events following prior vaccinations. No further info is expected.
9 Days Post Dose 1 - red spots on arm out of shower warm to touch non itchy. Went away after 30 min  On and off dizziness,  tingling on skin, skinwriting and redness  3 Days Post Dose 2 - Heaviness in body, tingling all over body, burning sensation in face, inner thighs arms. Burning sensation affects different parts of body at different times. Neuropathy-like condition. 3.5 weeks post second dose still occurring.
Information has been received from a nurse practitioner, concerning to "couple of youngsters", who were vaccinated with the second dose of VARIVAX vaccine (Merck). The patient experienced itching and large swelling after the second dose of VARIVAX vaccine (Merck). The patient sought medical attention. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow-up information has been received from a Licensed Practical Nurse, concerning a 12 year old female patient, who was vaccinated with VARIVAX vaccine (Merck) (Lot # 660671/0430X). The patient experienced itching and large swelling after the second dose of VARIVAX vaccine (Merck). Subsequently, the patient recovered. Additional information is expected.
Received vaccine at 5:00 pm on Tuesday. By 9:00 am the next day symptoms included severe shaking chills, aches and pains in extremities and chest to the point that it felt like burning, headache going up the side of my head, fever, and dizziness when I got out of bed to the point where I felt like I was going to faint. Symptoms somewhat relieved by taking 600 mg of Ibuprofen. Fever and reduced symptoms lasted until Thursday night. By Friday morning, afebrile and very reduced symptoms. Injection site is reddened, slightly swollen, and itching--somewhat relieved by applying Cortisone cream.
Patient reported local pain and minor swelling (larger than a quarter) at site of injection, she then developed a rash on the abdomen and back from just below the breast down to pubic area.  Rash was improving significantly by day 3.  The patient also reports having a migraine after the injection lasting several hours the afternoon after getting the vaccine.
Experienced intermittent chills, gen. aching, slight rhinitis; Approx 50 cent - sized area of swollen, tender redness at injection site. Gradually all symptoms resolved. By 8/1/10 only small pink spot at injection site and non-tender and afebrile.
After 2nd shot in series had chills, headache and body aches as expected.  About 2 days later stiffness and burning pain in neck and shoulders started along with nausea that came and went for a couple of days.  Was exacerbated by exercise. It is now 3 weeks later and the pain is everyday and does not go away. It is really a debilitating type of nerve pain.  NSAIDs help a little, but only dull it.  After the first shot, I had this same pain occur for only a day and a half and then it disappeared.  It did return for another day about 2.5 weeks after first dose, but was gone by the date that I received the 2nd dose.  It feels as though this will never go away.
arm at the injection site was painful, still tender; arm at the injection site was red; hives on her face and collar bone; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and GARDASIL for prophylaxis.   On 31st May 2022, the patient received the 1st dose of Bexsero .5 ml, Bexsero Pre-Filled Syringe Device and GARDASIL. On 1st June 2022, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain and injection site erythema. In June 2022, the patient experienced hives. On an unknown date, the outcome of the injection site pain, injection site erythema and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The patient received Bexsero on right arm and Gardasil on left arm. The patient's mother stated that the day after her daughter got the 1st dose of Bexsero, her daughter's arm at the injection site was painful and red. The injection site was still tender and slightly red but was improving.   On 2nd June 2022, about 36 hours after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Gardasil, the patient started to get hives on her face and collar bone. The hives would fade and then come back. The patient currently had some hives on her face.  The reporter didn't have the lot number or expiration date for the Bexsero.  It was unknown if the reporter considered the injection site pain, injection site erythema and hives to be related to Gardasil. Consented to follow up was granted.
It was swollen, had tenderness; I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.; Felt a bit tired; It was swollen, had tenderness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (It was swollen, had tenderness), INJECTION SITE SWELLING (It was swollen, had tenderness), VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.) and FATIGUE (Felt a bit tired) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 30-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (It was swollen, had tenderness). On an unknown date, the patient experienced INJECTION SITE SWELLING (It was swollen, had tenderness). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.). an unknown date, the patient experienced FATIGUE (Felt a bit tired). The patient was treated with ZINC OXIDE at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (It was swollen, had tenderness) and INJECTION SITE SWELLING (It was swollen, had tenderness) had not resolved and VACCINATION SITE ERYTHEMA (I got a red large circular spot measuring about 4-4.5 inches diameter on my arm/Close to the injection site it was a deep red color.) and FATIGUE (Felt a bit tired) outcome was unknown.            Concomitant medication was not provided. Two days after administration on her left arm, patient got a red large circular spot measuring about 4-4.5 inches diameter on arm. It was swollen and had tenderness. Close to the injection site it was a deep red color. Patient also felt a bit tired. She used over the counter cream to bring down the swelling. Sudo cream (zinc oxide) was currently being used. It was slowly going away.
My tinnitus loudness has tripled. It was barely noticeable before the shot, now it is very noticeable; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FL3180), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included Prone to panic attacks, anxiety, tinnitus. Tinnitus loudness has tripled. It was barely noticeable before the shot.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam.  The patient experienced "my tinnitus loudness has tripled. it was barely noticeable before the shot, now it is very noticeable" in Aug2021.  Facility where the most recent COVID-19 vaccine was administered pharmacy or drug Store. The case was non serious as it did not meet any of the seriousness criteria. No treatment was given for the event. The event did not cause hospitalization Prolongation. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Rash on injection site of 2 inches, maybe a bit more. Described as a big bump and redness. Also with smaller bumps on rash. Starting to itch and painful to the touch.
Phone call from patient 06/09/2003 reporting after getting shot 06/06, she has had fever 99.3 to 100.3 since.  Reports being achy, dizzy to upset stomach.  Also reports swelling in hands and feet.  No problems at injection site.  06/10/2003: took some Vioxx per md prescribed and okay now.
I felt dizzy, nauseous, massive headache, it felt like my brain was swelling. hips and joints where so sore. dehydrated. i was exhausted all day and night. these symptoms lasted up untill today.
A non-serious spontaneous report of laryngitis, chest pain, sore throat and wheezing has been received from a physician concerning a 45-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Oct-2009, the patient received H1N1, Intranasal, for unknown indication. Immediately after receiving the vaccine, the patient developed a sore throat and her voice became hoarse. The patient also experienced wheezing, chest pain and the patient vocal cords look like patient has laryngitis. The outcome of laryngitis was not resolved, however outcome of chest pain, sore throat and wheezing was resolved.
pt start to fill weak after 5 minutes of vaccine. his face was so pale. got tired, and dizzey , sweat. shaking a little bit. pharmacist was monitore him and call 911. after arriving they measure bp and bs. he started feeling better. they left, he stayed for 10 more minutes. after he felt ok he left. pt does't want to go to hospital or emergency department.
CARDIAC EPISODE, heart attack; had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure; HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED; This serious case was reported by a nurse via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced heart attack (Verbatim: CARDIAC EPISODE, heart attack) (serious criteria hospitalization and GSK medically significant), vaccination failure (Verbatim: had VACCINE AND HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: HAD A HORRIFIC OUTBREAK, SHINGLES FOLLOWED). The outcome of the heart attack and shingles were not reported and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the heart attack, vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 and 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she had vaccine and then later heart attack (cardiac episode) and that left him/her hospitalization and horrific initial outbreak and lasting days . The patient was a retired nurse and had not a clue how horrible shingles truly were until he/she experienced first hand. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt was fed morning p/vax & when mom checked on pt was found to not be breathing;autopsy=SIDS
Patient presented to ED on 3/16/21 with cough and shortness of breath. He was found to be COVID-19 positive on 3/16/21 at PCP office. Was treated and admitted from 3/16/21 to 3/20/21. Returned to ED on 3/21/21 following a syncope and collapse episode at home that results in a head wound and suturing.  Presented to ED on 3/24/21 with hypoxia and was transferred to medical facility where he was admitted from 3/24/21 to 4/1/21.
just some bruise; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date in Dec2020 as dose 1, single; second dose (Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported to experience just some bruise. 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.
9 days after vaccination patient still with C/O pain in arm at site of injection at times making it difficult to us or lift.
Rash Rt and Lf deltoid where injections were give. Red rash face and antecubial area, treatment with Zyrtec 10mg and Amcinolone 0.025 9/9/02/ Called pt no answer left message. Allergic reaction to immunizations.
Red rash on trunk, shoulder blades, inside elbows, on inner thighs and calves, upper arms.
extreme joint (or nerve) pain in sacro/iliac,neck & shoulders; very stiff neck on left side (the side injection was given); extreme joint (or nerve) pain in sacro/iliac,neck & shoulders; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (sulfites), Gluten intolerance, Galactose intolerance, Fructose intolerance and Drug allergy (Sulfa). Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone replacement therapy, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for Supplementation therapy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache). On 01-Mar-2021, NEURALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders), MUSCULOSKELETAL STIFFNESS (very stiff neck on left side (the side injection was given)), ARTHRALGIA (extreme joint (or nerve) pain in sacro/iliac,neck & shoulders) and HEADACHE (Slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Acidophilous taken orally as general supplement and Lutein taken orally as preventative was reported.  No treatment information was reported.   This case was linked to MOD-2021-220687 (Patient Link).
Fluzone given 0.5mL, age appropriate dose 0.25mL.
Severe body aches (from head to toe) for 24 hours, fatigue for two days
Severe pain & swelling of joints; sx appeared suddenly could not write or care for children or even move;
chest heaviness, pressure and complained of mild SOB. Rescue was called and she refused transport. Symptoms resolved within 20 minutes or so. No allergic reactions were noted
sore throat; Fatigue; fever; injection site soreness; This is a spontaneous report from a contactable other HCP (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via uknown route of administration, on 06Jan2021 at 11:15 AM (at the age of 38 years old) as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history included anxiety and depression. The patient has known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021 evening, the patient experienced injection site soreness at 6:30 PM, fatigue and fever at 7:30 PM. Fatigue and fever were gone by morning. Injection site soreness faded every day. On 08Jan2021, the patient experienced sore throat. No treatment was received for the events injection site soreness, fatigue, fever and sore throat. The outcome of the events injection site soreness, fatigue, fever and sore throat was recovering. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had been tested for COVID-19 via COVID test Nasal Swab on 08Jan2021 with pending result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash, burn sensation, progressed to rash, blister under arm on arms on chest. His personal dr diagnosed that he has shingles, and prescribed acyclovir 800mg 5x day and tramadol for pain 1 bid.
Left arm issues pinching sensation, palpatation and left side of head tension. Hard to breathe and chest pain.
Pt was given wrong vaccinations. Child received MMR and VZV at 6 months of age.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: The size that the patient described was width not quite the size of a bologne, but the length is the size of bologne. It has been getting bigger and bigger with each day. Advised to contact PCP and pt was seen by her PCP and was given steroid pack.