chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis; Throat swelled almost shut; Rash on head; Hardness in the middle of the chest; Lost voice for 2 days; A spontaneous report was received from a consumer concerning a 74 year old female patient, who experienced anaphylaxis (anaphylactic reaction), throat swelled almost shut (pharyngeal swelling), rash on head (rash), hardness in the middle of the chest (chest discomfort) and lost voice (aphonia).  The patient's medical history included allergy to red dye, and drug allergy to sulfa, statins, and codeine. Product known to have been used by the patient, within two weeks prior to the events, included   lisinopril, vitamin D3, apixaban, and drug reported as biltiaverm cd (not found).  On 13 Mar 2021, approximately 1 day prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number:036A21A) for prophylaxis of COVID-19 infection.   On 14 Mar 2021, the patient experienced anaphylaxis, her throat swelled almost shut, rash on head, hardness in the middle of chest and lost voice for 2 days. She reported that her symptoms subsided after taking 3-4 Benadryl 4 hours apart, except her voice. The patient stated that she will not be taking 2nd dose of the vaccine.  Treatment information mentioned Benadryl.  Lab tests were not provided.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome for the events of anaphylaxis (anaphylactic reaction), throat swelled almost shut (pharyngeal swelling), rash on head (rash), hardness in the middle of the chest (chest discomfort) and lost voice (aphonia) was considered as recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Saturday evening patient noticed red itchy area on her right cheek (face) feels like getting more intense.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) 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.   On 1st March 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 01-MAR-2023 Reporter's Comments: The reporter enquired if the patient should be revaccinated. The reporter was unable to provide any patient details The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero vaccine, which had led to expired vaccine used.
10 days after 1st dose, and every evening/night since the date of injection a red itchy patch forms at the injection site.  Symptoms go away during the day in most cases, and then returns in the evening
After the 1st vaccine I did not have any hot flashes for a 2 week period.  This is highly unusual as I'm going through menopause.  After the second vaccine on April 26, 2021 I have had zero hot flashes.   Zero hot flashes - since taking the second shot while I'm in the middle of menopause and have been dealing with this for 2 years. Body is sensitive to cold I do not have the stamina I had prior to the shot.  I find that I'm sleeping more than usual.
Edema and erythema in right thigh. Red papules scattered throughout body. - likely normal VARIVAX reaction.
We got COVID after both vaccines December/January this may 31th.  Please advise; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise). At the time of the report, COVID-19 (We got COVID after both vaccines December/January this may 31th.  Please advise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided by the reporter. No lab data was provided by the reporter   Reporter did not allow further contact
This is a spontaneous report received from a contactable consumer or other non-HCP. An 82-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at the age of 82, single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient reported malaise/not feeling well, fatigue/it has made her more tired and listlessness/really fatigued and listless; all with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient.  A 46-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 left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization.   Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well.  The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Fever and body aches beginning around 5pm, 7 hours after the vaccine. Nausea hit at 10pm and lasted until the next morning. I threw up 4 times throughout the night. I have red splotches all over my face from broken blood vessels I think. They are all around my eyes, but also on the rest of my face and neck. Fever of 100.4. Had a headache and was shaky all night. The next two days I have been fatigued.
May 2008, my daughter started to experience bilateral leg weakness, bilateral arm weakness.  She required care as of 6/14/08 and was hospitalized by her neurologist on 6/30/08 for a complete neuro work-up.  She had numbness and tingling in all 4 extremities. Still hospitalized. 8/25/08-records received for DOS 6/30-7/4/08-DC DX: Ataxia. Seen in ED 6/16/08-C/O paresthesia started 1 week ago includes tingling. In ED on 6/18/08 with C/O numbness to arms and legs. In ED on 6/27/08 with C/O paresthesia and numbness to entire body Presented with 2 week history of weakness in upper extremities and motor weakness. Medical history is consistent with anxiety and stress. PE: bilateral upper extremity motor weakness 3/5. Transferrred to rehabilitation facility. 1/25/2010 Follow up: She continues to get symptoms from her transverse melytis from last year, thank God, not as sever but that may be because she is taking ReBit med, injection 3 x a week.
nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) was resolving.            No relevant concomitant medications were reported. Treatment information not provided.
Woke with: Blood Clots in my left arm at injection pt and lower arm, wrist, hand. Blood Clots in my left leg, mainly calf, lower leg, ankle, some in thigh. Larger, more numerically present than in past from antihistamines. None present before Vax, allergen-free diet prevents usually.
Sporadic display of rash/hives all over body. Red, itchy bumps.
of lymphadenopathy occurred in the arm and neck region (in axillary, left axillary, left para clavicular, left supra clavicular, bilateral cervical, or unspecified lymph nodes).; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "of lymphadenopathy occurred in the arm and neck region (in axillary, left axillary, left para clavicular, left supra clavicular, bilateral cervical, or unspecified lymph nodes).".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After my first and second vaccine. I had the same reaction. 1 vaccine 5 days later. Extreme high BP no got go to 240 over 140 pulse 100. Extreme anxiety. Pain and tightness in chest and left arm. 2 vaccine systems were 14 days after vaccine. Same results. Took 36 plus hours for bp to return to normal
On evening of 10/6/13 had a headache, Rt. ear felt plugged. On 10/8/13 arrived about 5:30 pm to ER to have ear checked, feeling more nausea and dizzy. On 10/9/13 woke up with full facial paralyses of Rt. side. Went back to Dr. on 10/9/13. Full Bell's Palsy Rt. side face.
Pt recvd vax in NOV91 & w/in 15 mins of vax devel wheezing & c/o chest tightness; treated w/meds; episodes presisted for approx 6 wks; APR92 recvd 3rd dose; In SEP92 lab eval revealed anti-HBs less than 0.1;
FROZEN PRODUCT HAD BEEN ADMINISTERED TO A BUNCH OF PATIENTS (PRODUCT ADMINISTRATION ERROR); ADMINISTRATION ERROR INVOLVING VACCINE ACCIDENTALLY FROZEN UPON RECEIPT FROM  MANUFACTURER AND VACCINE WAS PLACED IN THE FREEZER FOR APPROXIMATELY 4.5 HOURS (INCORRECT PRODUCT STORAGE); This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced frozen product had been administered to a bunch of subjects (product administration error). On APR-2021, the subject experienced administration error involving vaccine accidentally frozen upon receipt from manufacturer and vaccine was placed in the freezer for approximately 4.5 hours (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error involving vaccine accidentally frozen upon receipt from manufacturer and vaccine was placed in the freezer for approximately 4.5 hours (incorrect product storage) and frozen product had been administered to a bunch of patients (product administration error) was not reported. This report was non-serious.
Patient/patient's wife reported reaction as "inflammation"  and lack of energy/stamina with things such as climbing stairs, difficulty with normal activities that require exertion.  Reports that normally he is active, fit and healthy, and that he has been having issues since the day after his second shot.  Was treated by urgent care with prescriptions for azithromycin and prednisone filled 6/12/21, saying Dr. at urgent care was thinking possible pneumonia, but treatment did not help per Gregory's wife.  This was reported to pharmacy today 7/19/21.  Wife reports that he is still not improved.
Diagnosed with myocarditis and pericarditis - Hospitalized from 10/23/21 to 11/3/21 and inpatient rehabilitation from 11/3/21 to 11/11/21.  Treatment with antibiotics and anti-inflammatory drugs.
Red, swollen, 10 x 10 cm tender patch on left upper arm at vaccine site
Headache, Myalgia, ErythemaMultiform, NauseaVomiting, Fatigue, Pain, Chills, Swollen Glands Narrative:
This spontaneous report was received from a health care worker who was a certified medical assistant regarding a patient of unknown age and gender. Patient demographics were not provided. Information on concurrent condition, medical history and drug allergies were not reported. On 25-JAN-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # K007157, expiry date- 12-NOV-2015, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) filed. Additional information has been requested.
TUMOR; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tumor was not reported. This report was non-serious.
I immediately had pain at the injection site, it did bleed enough to fill a bandaid and over the next two days was very sore and painful and red. The next morning I had a lot of swelling severe heat radiating from the injection site, severe redness and pain. this lasted until Saturday when it appeared to have ben gone, no more redness, nothing.  The following Tuesday morning  January 12th when I woke up I had a terrible headache, body aches sore throat, by noon, I had an itch on my arm where the vaccine was given and discovered severe swelling, itchiness, redness and extreme heat coming off the site all worse than the prior week. I went to urgent care that evening after work and was given prednisone, antibiotics and was told to also take Benadryl. The diagnosis was cellulitis and was also rapid tested for covid which was negative. Physician found me wheezing,  slightly enlarged lymp nodes, a stuffy nose and I was told to get retested if the symptoms don't improve. I have no headache today but am very groggy still and have a sore throat. The arm is still red, still warm and still has little blisters in the center which is new. I am taking meds as prescribed.
. Immediately after receiving the covid vaccine on November18, patient's stereotypical behavior increased per mother's report. School noted this as well. 48 hours after the vaccine, while at a restaurant, patient appeared to not feel well and slumped forward, but maintained consciousness. He held his hands to his head and was crying in apparent distress (presumably suffering from a headache). This lasted approximately5-6 minutes and no specific treatment was provided. He appeared 'OK' later that day. He went to sleep with his Bi-PAP, as was his routine. Sometime after falling asleep at 10pm, his watch alerted his parents. They arrived to the room but did not appreciate convulsive activity. Father states he 'looked like a deer in the headlights', but was aware and answered his parents questions as per his typical. (The watch has alerted only one other time when patient was exercising). He has had no other suspicious events. However, his anxiety overall is increased.
Case became diaphoretic,naseous and pale 5 minutes after vaccine administration Vital signs stable through recovery period 113/79 pulse 57 resp 16 Case recovered after 30 minutes of resting and laying flat. At fruit snacks and drank water.
Slight headache beginning evening of vaccination. Progressed to  fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum.  Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
Arm soreness from time of shot to present (4 days), took Advil.  Chills first night of vaccine.  Tiredness, fever, flu like feeling day after injection.  Slept all day.
runny nose; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005m21A, 005m21a and 005m21A) for COVID-19 prophylaxis.     The patient had no drug allergy. The patient had previously received a COVID-19 Vaccine.  Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL, AMLODIPINE, HYDROXYCHLOROQUINE and OMEPRAZOLE for an unknown indication.   On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022 at 5:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2022, Body temperature: patient had temperature.         Concomitant medication active drug substances included Atenolol, Amlodipine, Hydroxychloroquine and Omeprazole.  No treatment medications were reported.  The patient had temperature on 12-Aug-2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
PT WAS GIVEN FULL DOSE MODERNA FOR HIS BOOSTER DOSE. NO C/O ANY S/E AT THIS TIME
Patient is a 10 year old male with history of RSR' EKG, followed by peds cardiology (asymptomatic), presenting with chief complaint of chest pain.  Occurred this evening around 1830, patient was playing, started to feel left sided chest pain, lasted few minutes then resolved.  No shortness of breath, no cough, no fever, no rashes, no recent illness.  Patient did get his covid vaccine 2/11/22.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 04-SEP-2013 the patient was vaccinated subcutaneously with an expired 0.65 ml dose of ZOSTAVAX lot # 672428/1599AA (exp. date 13-JAN-2013). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Severe Allergic reactions in urticaria and through out the body including throat swelling. Continued allergic reaction everyday until medication. Medication used - 60mg Steriod 2 dose X 2 days, Citrizine bid ongoing; Pepsid bid ongoing.
L hand tingling and numbness. URI symptoms. 2PM developed L abd pain radiating to hand. In AM, numbness/tingling L hand and L headache. Seen in ER.
pt recvd vax 1OCT92 & exp wheezing 2OCT92-coughing prior to vax; MD on 5OCT92; RSV @ 3mos;
The first dose has caused my RA and narcolepsy to flare severely. I had been doing great for quite some time. I was unable to get book an appointment until June, so I haven't seen my rheumatologist regarding yet.  I have agonizing muscle pain all over my body. I've never experienced it so disseminated nor so painful. My joints are giving a lot of trouble too, including joints that have been good for years. I checked the disability box below because I can barely function currently.
After 17 minutes, patient started feeling really cold and shivering. She requested a blanket and socks which we got for her. We also called EMS and they took her to the hospital for evaluation
Patient stated a week after the vaccine her arm presented with swelling, redness, and warm to the touch. Patient decribed as a cellulitis
Pt recv vax on 3/3/98; on 3/5/98 pt exp elevated liver function tests; tx=retroviral meds
Left arm hurt like hell for 3 days could not use it, raise it and throbbed from shoulder to elbow , couldn?t sleep without pain medication
13OCT94 sudden onset w/chills of 6-7hrs duration followed w/sweating for about 1hr; total duration approx 8hrs; pt recovered;