chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had difficulty breathing and numbness of throat.  treatment benadryl, Epipen, and 911 called ambulance took to hospital
1 yearold given Kinrix; fourth dose for DTaP and IPV series; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTAP vaccine  (received 1st dose 19th April 2021), DTAP vaccine (received 2nd dose on 25th June 2021), DTAP vaccine (received 3rd dose on 15th September 2021), IPV vaccine (received 1st dose on 19th April 2021), IPV vaccine (received 2nd dose on 25th June 2021) and IPV vaccine (received 3rd dose on 15th September 2021).   On 28th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The staff member at pediatrician office stated that the patient was accidentally given the fourth dose of Kinrix early, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  The reporter consented to follow up via email. Note: It was unknown if the patient received DTAP vaccine and IPV vaccine as separate dosage, it was coded separately considering received on same day.
Fever early morning around 99.4F, 99.5F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever early morning around 99.4F, 99.5F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 15-Mar-2021 to 31-Mar-2021. Concomitant products included ASA for Clot blood.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever early morning around 99.4F, 99.5F). At the time of the report, PYREXIA (Fever early morning around 99.4F, 99.5F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications also include some other medications. No treatment medications reported.
fever of 100.2 degrees Fahrenheit; Body aches; cough with phlegm; sore throat; pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in shoulder), PRODUCTIVE COUGH (cough with phlegm), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever of 100.2 degrees Fahrenheit) and PAIN (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002AZIA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, INSULIN, METFORMIN, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VENLAFAXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FAMOTIDINE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ARTHRALGIA (pain in shoulder). On 19-Mar-2021, the patient experienced PRODUCTIVE COUGH (cough with phlegm) and OROPHARYNGEAL PAIN (sore throat). On 20-Mar-2021, the patient experienced PAIN (Body aches). On 21-Mar-2021, the patient experienced PYREXIA (fever of 100.2 degrees Fahrenheit). On 17-Mar-2021, ARTHRALGIA (pain in shoulder) had resolved. At the time of the report, PRODUCTIVE COUGH (cough with phlegm), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever of 100.2 degrees Fahrenheit) and PAIN (Body aches) 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.   No treatment details reported.
this was given  outside of the approved date range (12+) by a relief pharmacist-----no adverse events were reported by the parents as of today 10/30/23.
Hives to opposite arm; redness to injection site; Itching; This is a spontaneous report from a contactable pharmacist.  A 33-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiry date not reported), intramuscular in 30Dec2020 09:00 at a single dose in the left arm as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient had no COVID prior vaccination and patient was not tested for COVID post vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 09:15, the patient experienced hives to opposite arm and redness to injection site, and itching. Started within 20 minutes, patient taken to the emergency room/department or urgent care for evaluation and medications. As treatment, patient received diphenhydramine, famotidine, prednisone in response to the events reported. The events reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the events hives to opposite arm and redness to injection site, and itching was unknown.
multiple sclerosis; Headache; prevented him to sleep; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age (reported as 67, unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient is a veteran and got the first dose of the COVID vaccine on Friday (unspecified date) and he had a strong headache that have prevented him to sleep and he could not think straight because of the pain. Patient's wife also reported that patient has multiple sclerosis and would like to know what they can do about his headache. Outcome of the events was unknown.  Information on Lot/batch number has been requested.
Migraine, fever and nausea (7-1-16) (Sat-Sun) 24 hrs after injection.
Full flu symptoms - chils sweats, fever, fever dreams, ache, headache, nausea and vomitting
Tightness on left-side of chest and under left armpit; shortness of breath.
Patient called the pharmacy at 4:10pm stating that she had a large (4 inch to 5inch) red mark on the back of her arm where she got the zosta shot 2 days ago. She said it was mildly itchy and that was how she discovered it. I told her to take benadryl tonight and every 4 to 6 hours until tomorrow at noon (she knows it will make her drowsy). If the mark does not lessen or go away, she will make an appt with her PCP or go to urgent care to see if something else can be done.
Slight edema and induration at injection site measuring 1.5cm x 1.0 cm. Resolved with ice and Ibuprofen.
Weakness, tingling in L arm given script for PREDNISONE and following up w/neurologist
swollen arm; Hot arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) in a 30-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-010219 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) in a 30-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and SKIN WARM (Hot arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-010219 (Patient Link).
Here with mother. Was seen in office on 5/17 for 9 month checkup. Received IPV and Hep B. Next day started with hives. This morning hives worse with eyes swollen shut. No problems breathing. No illnesses prior to 9 month checkup. No new foods.
Swelling of lymph nodes; Pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Mar2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for an unknown indication and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced swelling of lymph nodes and pain. The patient did not receive any treatment for the event. On an unknown date, the patient underwent Nasal swab and the result was unknown. Since the vaccination, the patient had tested for COVID-19. The clinical outcome of the event swelling of lymph nodes and pain was recovered on unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Temp to 100.6 Rectal. No redness or soreness at site of inj.
Headache, NauseaVomiting, Palpitations, light headed, no sleep, Narrative:
pt recv vax 11NOV97 & same day a few hr p/vax pt exp joint pain & swelling, devel a fever & a pins & needles sensation;pt hosp;pain in lt leg from knee to foot;pain in rt leg from hip to foot;
Patient began running a 104-105 fever on 5/16 and then had a seizure on 5/16 which required a trip to the ER. The ER physician states that he had a seizure and after being monitored, patient was sent home. On Sunday 5/18 the boy was still running high temperatures (103-104) and started breaking out in a rash from head to toe.
pt recv vax 19FEB97 & 20FEB97 pt exp a fever of 101, sore throat, head congestion, & nausea;pt was treated w/APAP & fluid;
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported that an 81-year-old male patient of other ethnicity received on 11Sep2015 12:00 a single dose of PREVNAR 13 in the right arm and FLUZONE in the right arm intramuscular since he got the flu shot annually. Concomitant medications were not reported. Medical history included ongoing diabetes since 2013 and ongoing cellulitis (right leg). It was reported that the patient had the hand really swollen (Sep2015) for which he was hospitalized. The patient was in hospital from 17Sep2015 to 30Sep2015. It was also reported that on unspecified date in 2015, he had not strength in his arm and his hand was hurting. The patient went to the urgent care and then admitted to the emergency in order to perform an x-ray to his hand. The reporter specified that the patient was admitted to the hospital for his hand. Additionally, it was stated that when the reporter visited her husband at the hospital, she found him with a breathing apparatus for the oxygen. A physician explained her that the patient was having some breathing difficulties and that the patient's hand had been x-rayed. The patient received a breathing treatment, while laying flat, and the patient inhaled something in his lungs that caused a pneumonia. The patient was breathing alright prior to going in to the hospital. Actually, the patient did not have the body strength he had before, both arms and the patient himself were weak. His hand was still swollen. He had no bowel control, he could not speak plainly, he was non-responsive and sleeping all of the time. Laboratory data included blood sugar at 110 (highest value) on an unspecified date, X-ray of left hand on 17Sep2015 with unknown results and blood work (Sep2015) that showed great values, WBC improved. A treatment for the event hand really swolled was provided. Outcome was not recovered.
high fever within 24 hrs and flu-like symptoms, now 3 days after vaccine fever is gone but has a flat red rash at injection site that is very sore and hard to touch
1. Winging of right scapular secondary to right long thoracic neuropathy of demyelinating type 5/16/07. 2. Weakness left leg - atrophy same time period. 3. Right foot tremor 5/31/07 ----> resolved 6/11/07.
Peripheral neuropathy in legs and wrists/hands. Nerve pain and fatigue that worsens as the day goes on and makes it difficult and painful to stand and walk.  The we?ve pain has worsened from April until now (September), but I am now on Cymbalta for the nerve pain. Doctors were unable to come up with a diagnosis to explain the sudden nerve pain.
Information has been received from a pharmacist concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. In approximately 2014, ("reported as three years ago") the patient was vaccinated with one dose of ZOSTAVAX for prophylaxis (route of administration, lot number, expiration date, dosage number and anatomical location were not provided). On an unknown date, the patient experienced itching and redness of skin (no site specified), needle-like pain (no site specified), blurry, itchy eyes and headache. The patient also stated that she was generally feeling sick. It was also reported that on approximately 2014 ("reported as over the past three years") the patient experienced liver function test increased (unknown by the patient how much did it increased). Furthermore, it was unknown if the patient had received a treatment for the mentioned events. The outcome of itching and redness of skin, needle-like pain, blurry, itchy eyes, headache, generally feeling sick, and liver function test increased was unknown. The patient stated that she went to see her doctor and he did not think that ZOSTAVAX had anything to do with the events. Additional information is not expected as there was no consent to contact reporter.
She said her head was spinning; Ringing in her right ear; She felt nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "She said her head was spinning"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "Ringing in her right ear"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "She felt nauseous".  Additional information: The patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last week. Afterwards, she said she felt nauseous, she said her head was spinning, and there was ringing in her right ear. She wanted to know if this was a common reaction with the vaccine. The patient also said her daughter did a research on the internet and saw that tinnitus was one of the side effects of the vaccine. The patient did not wanted to provide her physician's information. The patient was offered a warm transfer, but patient declined. The patient was responded from the attached SRD, CONS-what are the risks of the vaccine (v6.0). The patient was told that there was no information about tinnitus or ringing in the ears associated with the Pfizer-BioNTech Covid-19 Vaccine. The patient was also referred to her HCP for further guidance, and told her that Pfizer cannot give any advice or treatment recommendations for individual patients.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
01jul90 pt vax 2nd hepta B. pt next menstrual period should have occured approx 1 week following vax.  it did not occur until last week of jul.  menses were characterized by many large clots and old blood.
FEVER (103'F), ONSET DAY OF ADMINISTRATION, CONT TO PRESENT (4+ DAYS); ALTE ON DAY 3 OF FEVER  7/4/08 Reviewed PCP medical records which included hospital medical records of 6/21-6/22/2008. FINAL DX: fever, apneic episode s/p vaccinations Records reveal patient experienced fever & reduced oral intake since vaccinations. No further seizures in hospital.  D/C to home w/referral to neuro as outpatient.
approx 5PM last evening became irritable, cried fell asleep for 1 1/2 hr awoke screaming high pitched cry, very irritable, limp; awake most of noc; temp 99.5 ax 2AM & 98.5 ax 930M; APAP given every 4 hrs;
On 1/27/14 patient woke up with a rash on his left leg that is slightly itchy, but not burning or painful. He described the rash as large hives.
Neuropathic pain in both legs; Bi-lateral leg pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "did not tolerate", notes: the patient did not tolerate gabapentin. The following information was reported: NEURALGIA (non-serious), outcome "unknown", described as "Neuropathic pain in both legs"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Bi-lateral leg pain".  Additional information: The patient had Bi-lateral leg pain within 1-2 days of her 1st Pfizer COVID vaccine. Pain persisted. Reporter mentioned that it sounded like the patient might be experiencing neuropathic pain in both legs. The patient had a history of diabetes and spinal stenosis. It was a female patient 83 years of age. Reporter mentioned that the patient did not tolerate gabapentin, reporter was not sure if this was used previous to the patients 1st vaccine for COVID. The doctor did not share the patients initials. Company representative told to reporter that." I would report this and he was ok if someone reached out to him for more specifics". Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two months later, I experience horrible cough, low grade temperature and low grade headache. I did a PCR and covid test and both were negative. I have recovered now.
Starting in June 2022, I started to developing rashes on my forehead. The rashes increasing to other parts of my face and neck. I started to develop also skin problems on my hands as well. I also developed muscle weakness, particularly on my legs and my upper extremities, my neck and shoulders. I had medical imaging studies due to my symptoms. My diagnoses was dermatitis. My symptoms are improving but I have not recovered.
Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very nauseous; shaky; cold then hot; This is a spontaneous report from a contactable Other HCP (patient).   A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:15 (Lot Number: EN6201) (at the age of 46) as single dose for covid-19 immunisation. No other vaccine was received in four weeks. No covid prior vaccination, no covid tested post vaccination. No known allergies. Medical history included fibromyalgia, chronic fatigue syndrome, depression, anxiety, I have no spleen either. Concomitant medications included melatonin, duloxetine, bupropion. The patient experienced dizzy on 13Feb2021 03:00, very swollen and very painful lymph nodes on 13Feb2021 03:00, very swollen and very painful lymph nodes in armpit of arm that received the vaccine on 13Feb2021 03:00, very nauseous on 13Feb2021 03:00, shaky on 13Feb2021 03:00, cold then hot on 13Feb2021 03:00. The outcome was not recovered.    No follow-up attempts are possible. No further information is expected
This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dose unit, lot number and frequently unknown) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
On 8.23.21 approximately mid morning patient presented with a clear runny nose and red eyes. Pt does not have allergies, so a Covid rapid test was obtained with a positive result.
Swelling, hurting, rash on my muscle of arm. Couldn't move arm on Friday eve. Oct 2. 2009
Administered Tdap instead of DTaP to a 26 month old child. Age of patient at time of event: 26 months.
Patient was administered first dose of COVID19 (Moderna) vaccine. Within 5 minutes of administration, patient complained of feeling faint, dizzy, weak. She stated her heart was pounding very fast and it felt like it was going to come out of her chest. Patient also complained of headache and stated she felt very nervous. Blood pressure was taken and patient had it elevated (171/96). Pharmacist was with patient until paramedics arrived. Paramedics measured patient's oxygen level, took her pulse, took her blood pressure and monitored her heart. Patient declined to be taken to the hospital.