chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint :90000180844
patient reported feeling lightheaded several hours after receiving the pneumococcal vaccine on 9/18/08 and experienced a syncopal episode with a fall upon arising from bed ---> sustained a nasal fracture and contusion to left knee and strain of LS spine
MILD HEADACHE; HYPERVENTILATION; STRESSED OUT; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced hyperventilation. On 13-APR-2021, the subject experienced stressed out. On an unspecified date, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hyperventilation, stressed out and mild headache was not reported. This report was non-serious.
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-MAY-2015, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 0 Celsius Degrees for 48 hours, at 1 Celsius Degrees for 48 hours, at -1 Celsius Degrees for 24 hours and at 9 Celsius Degrees for 72 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
20y male who presents with left facial asymmetry shortly after receiving vaccinations. Over the course of a few days developed progressive left facial droop. He noted the onset between the first round of immunizations during week 1 (Flu, IPV, MENACTRA, Tdap) and the TWINRIX vaccination 5 days later. He initially noticed that when smiling the left side of his mouth did not have the same crease as the right side did. This was apparent when looking at pictures of himself as well as looking in the mirror. He then developed loss of smile lines and nasolabial lines on the left cheek. Symptoms peaked around week 5 and are slightly improved since then. Currently he notices that the left side of his mouth doesn't open as widely as the right, he has asymmetric smile lines, and the skin fold adjacent to his nose is flattened on the left (but not as severely as it was a few weeks ago). He denies facial pain/numbness/tingling, denies difficulty talking, chewing or swallowing, denies lid lag or vision changes. Patient feels that symptoms worsened in the days after TWINRIX vaccination. He denies any illness until week 5 when he developed an URI. He denies rash or oral ulcers in the last 2 months.
On Wed, April 7, 2021, Kurtis received the first dose of Pfizer COVID vaccine. About 14 minutes after receiving the shot, he passed out while sitting on a chair and was found on the floor (5:45pm). He regained consciousness almost immediately and he stated he was dizzy and lightheaded. He also stated he only ate one spinach salad during the day and is trying to lose weight. We gave him water and a protein bar to eat. He slowly sat up on the floor, sat in a chair, and then stood. His fiance came to pick him up and drive him home. When called on 4/9, he stated that he was doing well and having no adverse reactions.
Information has been received from a physician concerning a 5 month old male who on 04-SEP-2007 was vaccinated with a dose of Rotateq (no lot number provided). There was no concomitant medication. On 12-SEP-2007 the patient experienced intussusception. On that same day, the patient was examined by a physician and taken to the ER. At the time of this report the outcome was unknown. Additional information has been requested. 10/15/07-records received from facility-for DOS 09/12/07-patient with 36 hour history of abdominal pain, vomiting and passage of currant jelly stool times 1 today, BE positive for intussusception without complete reduction. TX successful reduction by air enema.  10/22/07-office notes received, lot#u055 included. well baby visits with c/o stuffy nose and cough.
The patient was seated in the waiting area after getting the shot and after a few minutes (5-10minutes) patient lost consciousness. We approached the the patient and she is breathing  and slowly her eyes started trying to open her eyes  but she is non-verbal she is unresponsive so we called 911. 911 had us moved her and lying  the floor and followed their instructions until 911 arrived . she seems shivering , here teeth is chattering per observation
1 Booster dose administered past expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Booster dose administered past expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The vaccination coordinator reported that one of their veterans received first and second dose at facility (in contact information) but received a booster dose at their primary care doctor. The HCP (Health care professional) called to find out the viability of the booster dose that was administered past manufacturer expiration date. It was unknown by HCP when the vial was initially stored in the refrigerator and could contact facility where booster was administered. It was unknown to the HCP if the vial had undergone any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow-up includes non-significant information where reporter email address was updated.
I got a blood clot in my right lung. Symptoms started with extreme pain in side and back. Then, started up into my shoulder and neck as well. Pain became intolerable so we went to the ER. I had to be admitted overnight. I am now being treated with blood thinners for a few months.
FLUCTUATING BLOOD SUGAR; BLOOD SUGAR IS LOWER; CHILLS; TROUBLE BREATHING; BACK PAIN; PUKING; CHEST PAIN; NO APETITE; EXTREMELY TIRED; FELT LIKE CRAP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 1805031) dose was not reported, administered on 11-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced no apetite. On MAR-2021, the subject experienced felt like crap. On MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced puking. On 11-MAR-2021, the subject experienced chest pain. On 11-MAR-2021, the subject experienced trouble breathing. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fluctuating blood sugar. On 16-MAR-2021, the subject experienced blood sugar is lower. Laboratory data included: Blood sugar abnormal (NR: not provided) FLUCTUATING AND LOWER. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puking, chest pain, extremely tired, no apetite, fluctuating blood sugar, back pain, and blood sugar is lower, and the outcome of trouble breathing, chills and felt like crap was not reported. This report was non-serious.
Unsure if related but had severe chest pain/ left arm/jaw/ and back with troponin leak felt to be vaso spasm.
Pt received Moderna vaccines on 3/31/21 and 4/28/21. Pt presented to the ED with complaints of diffused fatigue and fever. On 7/3/21 pt was found to be COVID-19 positive.
w/in 24hr of vax pt devel a fever & had a very short duration sz;pt was seen in ER & cleared;
4/14/2021 at around 8AM noticed <2" red circle at the site of the injection that was warm and firm.  On 4/15/2021 2" red circle was a deeper red color at the site of the injection that was warm, firm, and slightly itchy.  On 4/16/2021 3" red circle at the site of the injection was warm, firm, and itchy..  On 4/17/2021 at 8AM 4" red circle at the site of the injection was warm and firm.
Beginning 24 hours later: Space flu like symptoms, bodyaches, night sweats, pain and pressure in front of chest, severe fatigue, malaise
Sore throat, fever 100, chills, body aches, weakness for 48 to 72 hours.
10-6-17 noticed lump on left leg where shots had been given on 9-28-17. Had cold sx and slight fever of 99.5 over the weekend. On 10-9-17 seen in office with 1.5cm round cellulitis firm indurated, non fluctuant area on left thigh slightly warm. Diagnosed with Cellulitis and treated with SULFATRIM Ped Susp given 4ml po BID for 10 days.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning another physician's patient who was vaccinated with a dose of ZOSTAVAX (Merck) on an unspecified date. Subsequently the patient might have developed neuropathy after administration of ZOSTAVAX (Merck) on an unspecified date. The reporter did not have any additional information. No further information is available.
I tested positive again on 29Apr2022; I tested positive again on 29Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: Jan2019 (unspecified if ongoing); "Known allergy: Sulfas" (unspecified if ongoing), notes: Known allergies: Sulfas. Concomitant medication(s) included: EXEMESTANE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "I tested positive again on 29Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (23Apr2022) Negative; (29Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
he has a dark circle under his eyes/within fifteen minutes of the injection had dark circles appeared under my eyes/dark circles/rings under eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Lot number: FC3181) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Brain tumor", start date: 2008 (unspecified if ongoing), notes: it busted the 3rd ventricle. Between his brain and skull filled up with blood.; "Surgery", start date: 2008 (unspecified if ongoing), notes: Verbatim: brain tumor on pituitary gland resulting in removal of gland; "Broke neck", start date: Nov2015 (unspecified if ongoing), notes: Verbatim: broke neck; "Qadruple bypass", start date: 2019 (unspecified if ongoing), notes: quadruple bypass; "stents", start date: 2020 (unspecified if ongoing), notes: 4 months after quadruple bypass surgery; "he was making too many red blood cells", start date: 2017 (unspecified if ongoing); "had difficulty walking", start date: 2017 (unspecified if ongoing); "He had to have blood removed", start date: 2017 (unspecified if ongoing); "his kidneys failed" (unspecified if ongoing), notes: kidneys failed and went to 3%. Concomitant medication(s) included: HYDROCORTISONE ACETATE; LISINOPRIL (ongoing); CLOPIDOGREL, start date: Oct2019 (ongoing); AMLODIPINE BESILATE taken for blood pressure measurement (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing); LEVOTHYROXINE SODIUM, start date: 2008 (ongoing); VITAMIN D3, start date: 2008 (ongoing); ASPIRIN (E.C.) taken for blood disorder, start date: 2019 (ongoing). Past drug history included: Testosterones, start date: 2017, reaction(s): "high blood count", notes: high testosterone levels caused the high blood count. The following information was reported: DARK CIRCLES UNDER EYES (non-serious) with onset 24Aug2021, outcome "not recovered", described as "he has a dark circle under his eyes/within fifteen minutes of the injection had dark circles appeared under my eyes/dark circles/rings under eyes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent the following laboratory tests and procedures: blood creatinine: 16. It was reported that concomitant Hydrocortisone was taken due to loss of pituitary gland, Lisinopril for has something to do with the pituitary, Clopidogrel: substitute for Plavix for keeping arteries clear, Levothyroxine: Generic for Synthroid since removal of pituitary gland and Vitamin D3 since removal of pituitary. Amlodipine and Rosuvastatin taken for a long time.  Additional Information for Other Conditions: Later the screws and plates backed out resulting in surgery with screws and plate going in from the front (neck) to stabilize his spine. He was in Hospital for a month in 2020.  No follow-up attempts are possible. No further information is expected.
Pt was unable to stand, move his hands, or talk for days.  He was a zombie.  Months later he could walk again--but now he needs to use a walker.
weird bumps on her face and neck; weird bumps on her face and neck; This is a spontaneous report from a contactable consumer or other non hcp.   A 16-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jun2021 11:00 (Batch/Lot Number: EW0181) as DOSE 2, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: SW0179 ) as DOSE 1, SINGLE for covid-19 immunisation. Patient took the second dose about 4 hours ago and now weird bumped appeared on her face. Caller wants to know if this is normal. At the time of this report event outcome was not recovered.   No follow-up attempts are possible. No further information is expected.
Fever, chills, body aches for one day.  Took only Tylenol 650mg 6 hrly.
Deltoid was cleaned and palpated, injection given with 1 inch needle. After withdrawl of needle from muscle, a small bleed occurred and ran down arm. This was cleaned then it was noticed that there was bruising and swelling underneath the injection site. The bleeding had stopped but a quarter-size bruise was under the skin. Patient was urged to ice the site and go to the doctor if it got any worse.
Chills; fever; extreme body aches; headache; fatigue; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via unspecified route of administration in the left arm on 18Mar2021 at 17:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to amoxicillin, penicillin and wheat/gluten. Concomitant medications included mesalamine (MANUFACTURER UNKNOWN) and loratadine (CLARITIN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via unspecified route of administration in left arm on 25Feb2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, at 03:00, the patient developed chills, fever, extreme body aches, headache, fatigue and nausea. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, extreme body aches, headache, fatigue and nausea was resolved in Mar2021.   No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of hive in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2011 approximately four to six weeks ago the subject received unspecified dose of ENGERIX B (unknown route). In 2011 approximately four to six weeks ago, less than one day after vaccination with ENGERIX B, the subject experienced hives on her head, arm and scalp and nausea. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported three subjects experienced events with ENGERIX B. See cases A0953067A and A0953069A for details concerning the other two subjects.
Band of redness below injection site, itchyness still  two weekd after injection. Unexplained am nose bleeds (two) since injection. About a week apart, they are easily stopped, but start while sleeping.
I experienced a painful and itchy rash on my neck, and it spread to both sides of my neck. The rash lasted for 7 to 8 days. I was prescribed Methylprednisolone 4mg cream, an over-the-counter anti-itch cream, Diphenhydramine HCI 25mg, and Tagamet. It has fully resolved.
MAB 12/30/2020 Estimated date of delivery: 7/2021 Approximately 9-10 weeks pregnant at time of injection.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported for herself. The age at vaccination was not provided. The pharmacist reported that she developed arm soreness in the arm where she had received the SHINGRIX vaccine. The pharmacist described her arm as super sore.
low grade fever; fatigue; muscle pain; booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle pain"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose".  Additional information: After receiving the booster dose, the patient experienced low grade fever, fatigue, and muscle pain. The adverse events resolved within 2 days. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
12/6/99:MMR vax given.12/14/99:Onset of T104,rash,& conjunctivitis.12/15/99:Onset of T106,hospitalized for severe dehydration and sepsis.Sepsis ruled-out in hospital;but dxed w/ viral syndrome.Tx w/ IV Rocephin.
Headache, Fever, Diarrhea, NauseaVomiting,  chills, pain in injection arm
Urticaria day after vaccines, seizures, arching of back with jerking of head and eyes to left.
Patient had redness and swelling, enough to visit her doctor. Lasted around 5 days.