chrisvoncsefalvay/vaers-outcomes huggingface dataset:
get a strain of pneumonia; get a strain of pneumonia; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient).    A 79 years old male patient reported that he received both types of vaccines, pneumococcal vaccine polysacch 23v (PNEUMOVAX) in 2010, and pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in 2015, both at single dose, for immunization. He did not need to have either again per his primary care physician. Relevant medical history and concomitant medications were not reported. On an unspecified date, he did get a strain of pneumonia. Clinical outcome of the adverse event was unknown at time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacy technician who referred to a 65 years old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in 2017 (reported as 31-OCT-2017 or 15-NOV-2017), the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly, lot # N013521, expiration date 23-JAN-2019 (dose was not reported) for prophylaxis. On 17-NOV-2017, the patient came to the pharmacist in pharmacy and reported that she experienced "redness and swelling down the unspecified arm that she received the PNEUMOVAX 23 in". No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The reporter requested a lot check for lot# N013521 of PNEUMOVAX 23.; Sender's Comments:  US-009507513-1711USA007967:
Patient also got her COVID Pfizer 4/22/2021 (LOT ER8732) and 5/13/2021 (LOT EW0183), the 5/13 shot caused her lips to get swollen for about 12 hours.  Timeline of events after 10/27/2021 Influenza and MENVEO vaccine:  10/27/2021 - Patient had had some wrist pain since June but the pain had gotten worse in late October, so we scheduled an appointment at her primary care physician. Dr. thought the wrist pain was caused by excessive use of hands (playing instrument, typing, cell phone etc. Pt got her influenza and MENVEO booster while at the doctor's office. 10/28/2021 - Pt did not feel quite well and asked to be picked up from school early. 10/29/2021 - Major headache in the afternoon, however, ibuprofen helped. 10/31/2021 - Fever started 38c+ (Fever lasted 10/31-11/10, came down after being admitted to the hospital) 11/3/2021 - First visit to Urgent care - Dr. diagnosed with viral infection "That should run its course". 11/5/2021 - AM hours at the ER due to severe wrist pain, fever, body aches. 11/5/2021 - PM office visit with the primary care doctor who orders more lab work to be done.  Symptoms continue and worsens. 11/6/2021 - UTI detected and new x-rays and misdiagnosis of Pneumonia - antibiotics + penicillin was started. 11/5-11/8/2021 - A lot of blood work was done. 11/9/2021 - PM Based on the bloodwork results and white cell count (and other values) dropping to alarming levels, Primary care doctors arranged hospitalization for more testing to be done. 11/9-11/13/2021 - Pt was at the Children Hospital with the care of specialist Dr. and Dr. 11/10/2021 - Pt was diagnosed with LUPUS and IV treatments were started. 11/13/2021 - Pt was able to go home. 11/24/2021 - Kidney Biopsy at Children Hospital.
Body is Shivering; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body is Shivering) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced CHILLS (Body is Shivering). At the time of the report, CHILLS (Body is Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown. As per client, MI error in DOB capture as --1-JAN-1900
Information has been received from a consumer and a physician concerning a 15 month old male with no known allergies and  no past medical history who on 11/16/2001 at 12:15pm was vaccinated with the first dose of varicella vaccine SC in the right thigh and MMR. The child had no illness at the time of vaccination. Concomitant therapy included POLY VI FLOR Drops. On 11/23/2001, the child was noted to have developed swelling of lymph nodes on the right side of the groin On 12/03/2001, the child underwent blood work. Abnormal results include: lymphocyte count 65%, neutrophil count 20%, and mean corpuscular hemoglobin concentration 35.1g/dL. After inspection of the area on 12/06/2001, the swollen areas looked larger than before. At the time of this report, the swollen lymph nodes were still present. No further info is expected.
BODY HURTS; NOT FEELING WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1), unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on 29-DEC-2021 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 patient experienced body hurts, and not feeling well (dose number in series 2). The patient wanted to know the nearest test facility and if he was positive for Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurts and not feeling well was not reported. This report was non-serious.
arm swollen; itchy; painful arm at the site of injection; feeling tired; I would say its like bad but it is irritating; I felt like I am sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Oct2021 (Lot number: EW0178) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "arm swollen"; PRURITUS (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "itchy"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2021 22:00, outcome "not recovered", described as "painful arm at the site of injection"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "feeling tired"; SKIN IRRITATION (non-serious) with onset Oct2021, outcome "unknown", described as "I would say its like bad but it is irritating"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "I felt like I am sick". Therapeutic measures were not taken as a result of peripheral swelling, pruritus, vaccination site pain, fatigue, skin irritation, illness.  Additional information: This female consumer reports receiving her very first injection of the Pfizer covid-19 vaccine yesterday and she was experiencing swollen, itchy, and painful arm at the site of injection. She was also feeling tired.  Follow-up (25Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 33-year-old female consumer reported for herself that: She received her very first injection of the Pfizer covid-19 vaccine yesterday and at the site of injection on her arm, she was experiencing swelling, itchiness and pain. She said that its hurts and also she mention that she was felling tired. Concomitant medication included: Nebulizer. Event started like last night around 10'o clock, she got shot yesterday. Its her first and she felt like she was sick. She said its like bad but it was irritating. Treatment for adverse event was not received as she didn't know what to take.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
The day after vaccine was given I broke out in hives. They didn't really bother me or itch really bad, but enough to concern me. On upper body/ lasted 3-4 days.
Body aches, lethargy, chills, fever 100.7, nausea, injection site soreness.
1 adult Patient received a bivalent dose Moderna COVID19 vaccine 0.25ml as a first dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (1 adult Patient received a bivalent dose Moderna COVID19 vaccine 0.25ml as a first dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (1 adult Patient received a bivalent dose Moderna COVID19 vaccine 0.25ml as a first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1 adult Patient received a bivalent dose Moderna COVID19 vaccine 0.25ml as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (1 adult Patient received a bivalent dose Moderna COVID19 vaccine 0.25ml as a first dose).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
2nd dose administered after a year; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date over a year ago).   On 3rd January 2023, the patient received the 2nd dose of Shingrix. On 3rd January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The pharmacist reported that 2nd dose of Shingrix was given over a year after the first dose (no date available). No other information was available. The reporter did not consent to follow up.  Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Patient passed out about 1 minute after shot, she did convulse slightly but regained consciousness after 10-15 seconds.
This spontaneous report as received from a other health professional (Licensed Practical Nurse) refers to a unspecified number of patient of unknown age. Current conditions and medical history was not reported. On an unknown date approximately in 2014, the patients were vaccinated with VAQTA injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 11-SEP-2014, first excursion of VAQTA occurred and the doses of VAQTA which were exposed to a supported temperature excursion (maximum temperature of 60 Fahrenheit (F) for a maximum of 19.5 hours) and (58F for 34 hours and 35F for 17 days) have been administered to unspecified patients. As per company stability assessment data, VAQTA would not be adversely affected by this specific temperature excursion. No adverse effects have been observed or reported. Outcome of the events was not reported. Product quality complaint was not reported. No additional information was provided. Additional information has been requested.
Chest pressure & palpitations, entire body feeling sore/fatigue since getting vaccine and continued over the course of months since getting shot!
About 1 week after getting the second vax shot my ears started ringing loudly, my head was dizzy (all the time), occasional chest pressure and heart skipping/fluttering, headaches, groggy, tired, and constant brain fog where I can't think, make a decision, or work.
Patient felt lightheaded after receiving vaccination, upon standing, lightheaded ness increased. She sat down and we propped up her feet and gave her water. She then began to tremor and her arms were twitching. Her eyes rolled back in her head and she was unresponsive to questions, but breathing was normal. With fanning and cold compress she recovered and EMS did not need to be called. The time of vaccination to recovery was about 5 minutes total.
infection at injection site; This is a spontaneous report from a contactable consumer or other non hcp. A adult female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date  as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was unknown that whether patient was pregnant (at the time of vaccination) and whether the patient diagnosed with COVID-19 prior to vaccination. It was unknown that since the vaccination whether the patient had been tested for COVID-19. The patient experienced infection at injection site on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Woke on 10/28/00 4:50 am with bad headache , high fever, vomiting, went to ER at 6:56 am Started on antibiotics.
Administered Menveo not properly reconstituted; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   On 15th August 2022, the patient received Menveo. On 15th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: Health Care Provider reported that the patient received a Menveo vaccination that was not properly reconstituted as they used a non approved diluent.   The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Menveo that was not properly reconstituted as they used a non approved diluent, which led to Wrong solution used in drug reconstitution.
had COVID mid September before received booster shot.  chest and backpain 12/24/2021.  Hopitalized 12/26/201 - 12/27/2021 with inflammation around the heart, diagnosed with pericarditis.  Hospitalized again 1/6-1-7/2022 with chest pains, same diagnoses. Taking heart med for 90 days and then I will be reevaluated to see long term affects or effects.
This spontaneous report as received from a patient's wife refers to a male patient of unknown age. On an unknown date (reported as a few years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). On an unknown date (reported as soon after vaccination with ZOSTAVAX), the patient developed a mild case of the "shingles". The patient was treated with antibiotics (not specified) and fully recovered on an unknown date. The relatedness between ZOSTAVAX and shingles was not reported. Additional information is not expected.
No additional AE reported; temperautre excursion 1C; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-NOV-2021, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # T031202, expiration date 14-JUN-2022, dose of 0.5 milliliter (formulation, strength, anatomical location and route of administration were not reported) for prophylaxis (product storage error). There was no other adverse event. The temperature excursion was reported as 1 degree Celsius (C) for 40 minutes. There was no other excursion reported. The outcome was unknown. ; Sender's Comments:  US-009507513-2111USA006649:
I got the 2nd vaccine on 3/24/2021 and around 6/1/2021 I got 2 fever blisters on my bottom lip.  The fever blisters lasted for 4 to 5 days then it went away.
Day after vaccine: fever, chills, muscle aches, headache, nausea and fatigue. Two days after vaccine: Axillary LAD and tenderness.
103.4 fever, lethargy, diarrhea for 2 days. Rash over chest and back for over a week followed by eczema.
This case was reported by a pharmacist and described the occurrence of arthralgia in a 19 year old female patient who received hepatitis B vaccine recombinant. The reporter is the parent of the patient. The patient's past medical history was notable for psoriatic arthritis and asthma. Concurrent medications included Dovonax, Ultravate, Salbutamol, and Sulphasalazine. On 4/21/04, the patient received the third dose of Engerix B (lot ENG5401A2). On the same day, the patient also received the third dose of hepatitis A vaccine inactivated (lot VHA776C6), and injections of poliomyelitis virus vaccine, and Yellow fever vaccine. Approximately six days post-immunization, on 4/27/04, the patient experienced arthralgia and swelling. The reporter stated that, the pain began in second toe of the left foot. After one week, the pain spread to the third and fourth toes of the right foot. The reporter stated that her daughter was unable to walk due to the excruciating pain. The reporter considered the events to be disabling and to require intervention. The patient was seen at a physician's office. On an unspecified date in May 2004, laboratory analyses revealed elevated white blood cells. The patient was treated with cephalexin, prednisone, sulfasalazine, ibuprofen, and naproxen. (She did not take naproxen and ibuprofen at the same time). The patient developed a dermatological reaction to Sufasalazine. Therapy with Sulphasalazine was discontinued. At time of reporting, the patient continued on non-steroidal anti-inflammatory drugs. The events were ongoing at the time of follow up. The toe pain was somewhat relieved with NSAIDS. The reporting pharmacist considered the events to probably be related to vaccination with Engerix B and Havrix.
Varicella vaccine breakthrough. Had approximately 15 lesions, no fever. Diagnosed 2-23-07 with varicella.
BLOOD IN STOOL; FREQUENT URINATION; PAIN IN STOMACH; This spontaneous report received from a consumer concerned a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had no existing medical conditions and the patient was not taking any medications at the time of vaccination or at report time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient started experiencing adverse symptoms of frequent urination, blood in stool, and pain in stomach. He reached out to medical staff to run further testing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frequent urination, blood in stool and pain in stomach was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210616825-COVID-19 VACCINE AD26.COV2.S- Blood in stool. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Several hours after getting my shot I developed a rapid onset, severe Herpes outbreak; Several hours after getting my shot I developed a rapid onset, severe Herpes outbreak; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient (not Pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 16:00 (Lot Number: en6201, at age of 67 years old) as single dose for COVID-19 immunisation. The patient medical history include: Herpes Simplex 2 for several decades. Concomitant medications included simvastatin and valacyclovir (reported as valcyclovir) for Herpes Simplex. The patient previously took morphine and experienced Allergies, tetracycline and experienced Allergies. The patient had Herpes Simplex 2 for several decades. It was well controlled with a low daily dose of valcyclovir. Several hours after getting shot the patient developed a rapid onset, severe Herpes outbreak on 07Apr2021 08:00 PM (reported as 07Mar2021). The patient took the "outbreak dose" of Valcyclovir, but it didn't calm the sx. The outbreak lasted for about a week. It's the worst case the patient ever had, both in severity and duration. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
Narrative:  myalgias/fevers/abnormal cxr / ct requiring outside hospital admission for 3 days