chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 18-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K0055881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovering" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: PCR. The clinical course was reported as follows: "she did not know she was exposed to covid but did have a ST on the day of the vaccine and she was not truthful when I asked her if she was feeling well and meeting the site requirements to be at work and then she felt worse on 23Dec2021 tested with PCR and the result was positive for COVID 19 so that is a vaccine failure and she got the booster when she should not have as she was having symptoms but denied it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out.
30-45 minutes post vax, the pt experienced episodes of vomiting times 3 lasting 15 minutes. No rash or redness noted at site or elsewhere on body. No other symptoms.
blood clots; Long-lasting menstrual cramping (greater than 8 hours & still going); heavy period; cervical discomfort/pain; fatigue; This is a spontaneous report from a non-contactable other health care professional (patient). A non pregnant 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ;  Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient had long-lasting menstrual cramping (greater than 8 hours & still going), heavy period, cervical discomfort/pain, blood clots, fatigue on an unspecified date. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Thrombosis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
pt recv flu vax,was given inadvertently instead of TB test;devel redness on forearm at inject site which became progressively worse;addl info recv:pt reported swelling & redness lasted 4-5 days;
Itchy, red, swollen rash covering most of inside upper arm between shoulder and elbow. Hot to the touch. Only small tender bump at injection site - Dr gave BENADRYL and MEDROL dosepak, expected full recovery.
Found a little pea size knot on my left clavicle/Nodule still present; got the second shot on day 38; general mild soreness; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Found a little pea size knot on my left clavicle/Nodule still present), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second shot on day 38) and MYALGIA (general mild soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MYALGIA (general mild soreness). On an unknown date, the patient experienced NODULE (Found a little pea size knot on my left clavicle/Nodule still present) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second shot on day 38). On 07-Apr-2021, MYALGIA (general mild soreness) had resolved. At the time of the report, NODULE (Found a little pea size knot on my left clavicle/Nodule still present) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second shot on day 38) outcome was unknown.            No concomitant medications reported.   No treatment information were reported.  The action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Update on AE ( Node on the clavicle has reduced in size but it was not gone) On 19-May-2021: Patient denied Email and additional information on event was added.
Pt recvd measles vax on 22AUG91 & the following day pt exp h/a which persisted for one day; No further details were provided;
About 1 minute after receiving the vaccine and receiving a bandage, the patient got up from the chair and rounded the corner to waiting area. The patient was with his mother and the mother yelled out the patient's name as he proceeded to collapse to the ground. Patient was conscious and sitting on the floor. When asked if he was "ok" and "what just happened?", the patient was giving an embarrassed laugh that he "lost his balance" and that "he was fine". Upon inspection, the patient had turned slightly pale, so I told the patient to lie down flat on the floor and I elevated his feet with a chair. Patient was asked if there was any vision or hearing changes and patient indicated there were none. Mom ran and got her son some water and some food. The patient did indicate that they had not eaten all day and when I asked, "did you have a fear of needles that you didn't share when I asked you?", the patient indicated, "I don't really think I have a fear of needles". After about 5 minutes laying on the floor, I slowly had patient sit up to a seated position on the floor and his mom proceeded to give the patient a Body Armor drink and a Snickers bar. After a few minutes seated on the floor, I help patient get to a chair and sit for another 5 minutes. After about 15 minutes in total, patient was standing and walking off normally without issue.
Excess saliva, dizzy, oxygen level dropped to 83 and pulse rate was above 150. This happened about nine (9) minutes after getting vaccine. EMT put me on oxygen and kept checking blood pressure.  Taken to Hospital ER. Di EKG and blood work. Given a steroid shot and sent home with steroid prescription and prescription for a rescue inhaler.
Contracted COVID; There was little pain the day after the arm; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Contracted COVID) and VACCINATION SITE PAIN (There was little pain the day after the arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 (Contracted COVID) and VACCINATION SITE PAIN (There was little pain the day after the arm). At the time of the report, COVID-19 (Contracted COVID) and VACCINATION SITE PAIN (There was little pain the day after the arm) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Now that I think about it, I started have discomfort in both feet around the evening time on 5/1/2021. About 2pm today, my fiance was massaging my back, I felt minimal discomfort. About 2 hours later, I begin to get chills all over. My temp is 98.4.  If I feel worst, I will sent medical attention.
swelling in her left armpit, Swollen lymph nodes; The injection site was slightly achey; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (Reference number- 00812694) and transmitted on 14-Oct-2021. This case involves a 65-year-old female patient who had swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and the injection site was slightly achey (vaccination site pain) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and coronavirus disease of 2019 (COVID-19) VACCINE. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 12-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported, formulation: solution for injection) via intramuscular route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On 13-Oct-2021 the patient developed non-serious swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and injection site was slightly achey (vaccination site pain) 1 day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and (unknown latency) COVID-19 VACCINE. It was reported "Caller has questions about possible side effects of FLUBLOK QUADRIVALENT. Caller states that she received the FLUBLOK QUADRIVALENT vaccine. The injection site is fine; slightly achey, but there is a swelling in her left armpit. She noticed the swelling about 30 hours after getting the vaccine; she believes that it is a swollen lymph node. She states that she feels fine, she is having no other side effects. She has spoken with multiple pharmacists and her doctor, who have given her different answers about whether the swollen lymph node could be related to receiving the vaccine. Caller states that her arm was really bad after receiving the Covid vaccine." No laboratory data was reported. The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymphadenopathy and vaccination site pain. At time of reporting, the outcome of the event was unknown. The reporter did not report the causality of events with FLUBLOK QIV. There will be no information available on the batch number for this case.
Patient received Moderna COVID vaccine on 4/20/21 and 5/18/21. On 1/25/22, patient admitted to our inpatient facility (med/surg unit) with  encephalopathy and COVID-19 viral syndrome. During hospitalization, patient was also found to have enterococcal bacteremia. As of today (1/27/22), patient is still admitted in the med/surg unit.
Day 1 of vaccination- sore arm axillary lymph node swelling Day 2 of vaccination- Fever 101. COVID 19 test done-  Day 3 h/a chills, fatigue no fever COVID 19 results negative
Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   Reporter did not allow further contact
got covid in december; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got covid in december) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19: Paxlovid (Last dose in the evening. Taken for 5 days Patient was again covid positive on 23-jul-2022, and this time symptoms were different congestion, cold like and tired.) from 17-Jul-2022 to 21-Jul-2022; for Product used for unknown indication: PRAVASTATIN (stopped taking and Tablet 20 mg for I believe 7 days once on meds.). Past adverse reactions to the above products included COVID-19 with Paxlovid; and No adverse event with PRAVASTATIN. Concurrent medical conditions included Asthma, Penicillin allergy and Allergy to antibiotic (erythrocin 500 mg tablets, erythrocin 500mg injection, 1 vial). Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETHASONE DIPROPIONATE for Asthma, OMEPRAZOLE, LORATADINE, VITAMIN D3 and ASCORBIC ACID, ROSA CANINA (VITAMIN C PLUS ROSE HIPS) for an unknown indication.    In November 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, the patient experienced COVID-19 (got covid in december). On 21-Dec-2022, COVID-19 (got covid in december) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2022, SARS-CoV-2 test: Negative. On 23-Jul-2022, SARS-CoV-2 test: Positive. On 17-Dec-2022, SARS-CoV-2 test: Positive. On 21-Dec-2022, SARS-CoV-2 test: Negative. On an unknown date, SARS-CoV-2 test: Positive.         Patient had received two Moderna vaccines and two boosters, from which the last dose was taken at the end of November 2022. Patient was on trip in Dec-2022 and had again got Covid. Patient had not even realized it as she thought that it was just cold. Patient had cold symptoms, she walked touring about 40 miles and ate normally. Symptoms were started on Monday 12-Dec-2022. Patient was tested positive on 17-Dec-2022 and once tested negative on 21-Dec-2022, patient just felt very tired for a couple of weeks and mentioned that it was too late to take paxlovid. Patient took Losartan potassium 25 milligram beginning of 2023 and cranberry extract 500 milligram since May-2023 and was still taking.
Patient was given the wrong vaccine. He should have gotten 0.25 mL of the infant Moderna. I mistakenly grabbed a booster dose (0.25mL) of adult Moderna. Parent of patient was informed of the mistake. Patient waited for 15 minutes in case of an allergic reaction and/or any complications. Upon leaving clinic, no symptoms reported. Educated parent of patient on reporting any concerns directly if any adverse reactions were noted.
pt recvd vax & was vomiting; fever; diarrhea & weakness;
asymptomatic- tested as part of f/u on known exposure- tested positive on binax rapid antigen test 9/9/22 has completed primary series plus 1 booster- all moderna- due for bivalent booster
Myalgia, Fever, CHILLS, ARM PAIN Narrative:  STAYED HOME FROM WORK FOR THESE SYMPTOMS
two physicians who both had second doses a month ago and both are now showing negative antibody tests; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. This consumer reported same event for two patients. This is the second of two reports.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the second dose a month ago and showed negative antibody tests on an unspecified date (reported as "now"). The reporter wanted to know if it was normal. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273876 Same reporter, product and event/Different patient
COVID infection 8/12. Was treated outpatient. Admitted 8/24/22 to a health care facility for new onset A Fib, likely secondary to COVID 19. Was also positive for COVID again here on admission. Treating her for A Fib
gen maculopapular rash w/eye conjunctivitis, t103.5;
Onset of bruising and petechiae 18 days after vaccines.  MR received from pediatrician revealing a normal well baby exam on Oct. 4,2006 where child received Proquad vax.  On 10/24/2006 child presents with petechiae all over the body as well as multiple bruises.  PE WNL on 10/26/2006 except for multiple bruises and petechiae over   Two days later, increased bruising and petechiae are noted. Admitted for IVIG-Carimune per protocol. Assessment: ITP. DX: Immune Mediated Thrombocytopenia.
Urticaria onset 11/27/02; newtropenia onset 12/8/02 (ANC 300)
Severe nausea and vomiting until 6:00 AM. Uncontrollable shivering, chills and teeth chattering. Head ache.
3 h after vaccination - flushing and itching of upper back, chest, face (esp eyelids). No palpable rash or hives, no respiratory sx
throat started closing up, lots of Phlegm + asthma like coughing/wheezing. Just like what happens when I encounter eggplant. Took Benadryl + it subsized except heart racing + itching
Extreme fatigue to the point of spending most of Friday and Saturday in bed.  Stomach cramping every time tried to eat, pain in stomach would continue after eating all day on Friday, and just during eating and shortly after eating on Saturday.  Fever of 100.8 degrees F under arm on Friday, down to 99.8 on Saturday morning, gone by Saturday afternoon.  Stomach cramps stopped by Sunday morning. Arm extremely sore where shot was given and around that area and extremely hot.  The soreness and heat around the shot area was just down to  mild Sunday morning.  Still tired on Sunday when I am writing this, but hopefully not as bad as Friday and Saturday.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot #, route unknown). No concomitant medication was reported. On an unknown date one dose of improperly stored GARDASIL was inadvertently administered to patients. No adverse events were reported. Product quality issue was not involved. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT BEGAN WITH SORE ARM ABOUT 8PM. COULD NOT MOVE ARM. ON NEXT AM PATIENT FAINTED, AND SAID FELT POORLY ALL DAY AND NEXT DAY. ON MONDAY AM 11/12/18 PATIENT CALLED AND STILL FELT ACHY.
On 04/24/2021, within one hour of the vaccination,  I had a weird feeling on my right kidney area. A bubbly feeling, like a liquid bubbly feeling, a weird feeling, and ever since I been having pain in that area. I went to see my doctor twice in regards to the pain. The 1st time was in May and then in October. She ran some labs and my BUN, creatinine, globulin, those results were abnormal. I have never had any problems with those results before. They diagnosed me as dehydrated. They asked me if I was dehydrated. I drink about a gallon of water a day. When I went back this month they are saying it is muscle related. They want me to do Physical Therapy. I want them to watch my kidney closely. I do not want to be someone who needs a new kidney down the road. On 05/23/2021- I had my period. I bled for 5 days, I was supposed to be menopausal and this happened. I have been menopausal for like 2+ years.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-JUN-2016 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (lot # L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 204 hours with the lowest recorded temperature of 33 Fahrenheit degree; the second time was 444 hours with the lowest recorded temperature of 34 Fahrenheit degree; the third time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree; the fourth time was 24 hours with the lowest recorded temperature of 21.7 Fahrenheit degree; the fifth time was 1732 hours with the lowest recorded temperature of 29 Fahrenheit degree; the sixth time was 24 hours with the lowest recorded temperature of 31 Fahrenheit degree; the seventh time was 96 hours with the highest recorded temperature of 48 Fahrenheit degree; the eighth time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Family of 4 immunizing together. all same lot all for boosters no previous reaction.  Vaccine administered with no negative results. Mother called on 26th seeking advice.  Mentioned patient had GI upset a few hours post shot (pain and diarrhea), then after 24 hours swelling and pain at injection site and some hives and rash on body.  Mother asking if utilizing antihistamines a good route. stated they had administered Singulair and Zyrtec.  I offered maybe to switch to Benedryl if they wanted to be more aggressive.  Stated that if no slowing or reversing of uticaria to contact Dr when they feel it would be necessary.  Informed mother that I would fill out VAERS on their behalf and if anything progresses to seek medical attention.
Severe headache started at 5:00 pm post vaccination. Lasted 24 hours. Moderate, lower body muscle cramping and pain started 24 hours post vaccination. Lasted five days.