chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing/ shortness of breath; Tested positive for COVID-19; Pain; Not feeling well / very sick; Vaccine is defective; Bad headache; Fever; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021, approximately two to three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 04L20) intramuscularly for COVID-19 infection.   On unknown date, the patient experienced a bad headache, pain, fever and was still not feeling well. Patient went to emergency room and had difficulty breathing, shortness of breath and ended up receiving an infusion of casirivimab  imdevimab. Patient tested positive for COVID-19 as well. Treatment for the event included casirivimab/ imdevimab.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, bad headache, pain, fever, not feeling well, difficulty breathing/ shortness of breath, and tested positive for COVID-19, was unknown.; Reporter's Comments: A spontaneous report concerns a 65-years-old, male patient who experienced the unexpected serious event difficulty breathing/ shortness of breath bad and non-serious events of headache, pain, fever, not feeling well and tested positive for COVID-19. The events occurred approximately two to three days after administration of mRNA-1273 vaccine (Lot number 04L20). Treatment provided included casirivimab/imdevimab and outcome of the events is unknown.  Based on the known information about COVID and duration to diagnosis, it is very unlikely to be associated with the vaccine administration. The other events are temporally associated with the administration of mRNA-1273, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of the vaccine
SEVERE HEADACHES, ALONG WITH FLU SYSTOMS (dizzy, chills, vomiting, feeling very lightheaded). STILL HAVING SYMPTONS.
Extremely sore and painful arm (feels hot) below the site of administration (deltoid).  Per patient, applied cold compress the night of 8/1 and is feeling better the evening of 8/2
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 11:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 130.50 hours (also reported 17-1, 404, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
nausea; weight loss; Bad things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (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: Bnt162b2 (Dose:1), reaction(s): "Covid-19 immunization"; Bnt162b2 (Dose 2), reaction(s): "Covid-19 immunizarion". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Bad things".  Follow-up attempts completed. No further information is expected.
Vaccine administered that went under temperature excursion; Vaccine administered that went under temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 07-Jan-2021, Pfizer (Dose 2) on 28-Jan-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. Proposed desired use by date was 15-Jun-2022 afternoon. Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9 C to plus 6.4 C for 15 mins. Storage condition at the time of the excursion was Refrigerator.  Visual inspection noting any vaccine state change was thawed.  No treatment medications were reported.
Low fetal heart rate on 10/19/2009 followed by fetal death by 10/29/2009
This case was reported by an other health professional via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was GSK field representative reporting that she heard from a pharmacy employee about a patient who received her first shot of SHINGRIX at a pharmacy and thought the injection may had been into a tendon and not the deltoid muscle which led to vaccine administered at inappropriate site and also patient experienced pain at injection site. The caller reported that no other details were available. The caller was unable to provide full demographics for the reporter.
100-150 lesions of chicken pox, no pneumonia. No seizure disorder, no asthma, steroids about 1 month prior.
swelling right arm, 8 x 5 cm, treated with antibiotic for cellulitis
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
The Vaccine (VARIVAX) was repeated on 15-NOV-2019 (third dose).; No adverse effects reported; Patient was vaccinated with Varivax reconstituted with expired sterile diluent; This spontaneous report was received from a nurse and refers to an 18-year-old patient of unknown gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications, and drug reactions or allergies was provided.  On 07-OCT-2019, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form for prophylaxis (lot number R034396, has been verified to be a valid, expiration date reported and validated as 27-NOV-2020) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  On 08-OCT-2019 (reported as on the next day), it was realized that an expired sterile diluent ( lot number R022280 has been verified to be a valid, expiration date reported and validated as 06-OCT-2019) was used for the reconstitution of the varicella virus vaccine live (oka/merck)(VARIVAX) vaccine used to vaccinate the patient the prior day (expired product administered). No adverse effects were reported.  Follow-up information was received from the registered nurse on 27-DEC-2019. The patient's exact date of birth and gender were provided.  On 07-OCT-2019, at 2:30pm, the male patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously on the left arm and he also received meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) via intramuscular on the left deltoid (concomitant therapy), both as immunization.   The patient did not require any treatment for the reported events.   It was also reported that the vaccination was repeated on 15-NOV-2019 (inappropriate schedule of product administration) and that there was not any temperature excursion as a result of reading the Digital Data-logger.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient fainted shortly after administering first dose of vaccine. he was seated in a chair for observation and fell sideways, hit his head on the floor. minor bleeding on face. continued to observe patient until he felt stable again. monitored blood pressure. patient insisted on not calling for additional help
lt arm swollen & red from shoulder to fingertips, no feeling in fingers of lt hand;
About 10 minutes after patient received vaccine she states her heart was beating fast, she had a weird feeling on the left side of her neck and a metallic taste in her mouth.  Her pulse initially was 132.  Then about 5 minutes  later, at 1820, it went down to 115.  Pt states she had only eaten some yogurt and a granola bar all day.  She was reclined.  BP at 1825 was 119/74 with pulse of 85.  She was given some apple juice and water.  At 1835 she reports the feeling on the side of her neck is gone but now has a small area of numbness on the back corner of her tongue on the left side.  There is no swelling of her lips or tongue.  No facial numbness or tingling, and facial muscles are symmetrical.  Denies any lightheadedness, dizziness, chest pain, difficulty breathing or swallowing.     BP is now 113/70 with pulse of 71.    Continued to observe pt and at 1845 BP was 108/65 with pulse of  73.  She is sat upright with no lightheadedness or dizziness.  She continues to have numbness in back of tongue on left side.  1855 Contacted ER and spoke with charge nurse, and informed her the above information. She consulted with Dr.  and he stated since pt is feeling better and no worsening of symptoms she is free to go but is symptoms would return or worsening of numbness to be seen at the ER.  Patient was informed this information. She also contacted her allergist by phone. Dr. who recommended she stay for another 15 minutes and if no worsening of symptoms at that time she may go home.  At 1910 pt reports the metallic taste in mouth had lessened and she also felt like the numbness on her tongue was starting to lessen.  BP was 110/71 with pulse of 66.  Pt was discharge home with instructions of any recurrence of symptoms or worsening of numbness to be seen at the ER and she was in agreement with this.
local induration 2.5 cm diameter @ site of HBV inject-reoccurred off & on x 2-3 days; mom described as whelps;
Night sweats and chills for about 5 hours.  Probably fever.  felt hot but did not take temperature.  Mild headache.  Took Extra strength Tylenol at 3 am and was OK in the morning
Chills, muscle aches, mild headache, swollen lymph node (right side near clavical), right arm pain at site of injection
very infected with COVID-19 after receiving the first dose; very infected with COVID-19 after receiving the first dose; This is a spontaneous report received from a contactable consumer (patient's husband), reporting same events under the same suspect product for three patients.  A female patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were unknown), via an unspecified route of administration, on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that, his wife received the first dose of COVID-19 vaccine on 04Mar2021, at hospital. She was due for second dose today and wanted to know what to do, since she was "very infected" with COVID-19, after receiving the first dose. It was also reported that his wife was delicate and COVID put her on bed, but she was partially protected by the vaccine and she was recovering. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and resulted as very infected with COVID-19. The outcome of the event was recovering.  Information regarding batch/lot number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329502 same reporter/drug, different patients.
Mom came to clinic and said child began with a rash "about 2 hours before (papular rash). No SOB, wheezing or swelling of face/airway. Was given Benadryl 2cc po every 6 hours and it resolved in less than 24 hours.
Within  a few hours of the vaccine I felt tired and a little out of it.  I woke at 5:30 the next morning with a fever of 99.9 F, a headache, chills and body aches.  These symptoms continued throughout the day and were alleviated somewhat by tylenol.  I slept a large part of the day and felt better when I woke the next day, Monday.  On Monday I felt mostly normal but still had some body aches including a back ache on my left side.  I also had more injection site pain and a red rash about a half dollar in size that was tender to touch and by night time was itchy.
discomfort/soreness at injection site ten days following vaccination, after immediate injection site soreness/discomfort had subsided for over a week.
Patient fainted immediately after getting vaccine. Pt reports that he has a history of fainting with vaccinations. He was reported to be unconscious for approximately 40 seconds. He was not injured and denied any other symptoms. He was released at 1:30 pm.
Achiness; Cold sweats (no fever); Dizziness; Sick; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 08:30 (Lot number: EP6955) at the age of 38  as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number- EL3248, Administration Time- 16:00, Vaccine location- Left Arm), administration date: 03Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Achiness"; COLD SWEAT (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Cold sweats (no fever)"; DIZZINESS (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Dizziness"; ILLNESS (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Sick"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain, cold sweat, dizziness, illness, fatigue. Additional information: Patient was 38-years-old and patient age at vaccination was 38-years-old. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks or any other medications in two weeks. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient did not have any known allergies or any other medical history.  The reported seriousness of the events was non-serious. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. Patient did not have any allergies to medications, food, or other products. She was the one who received the vaccine. She got the vaccine on 24Mar2021, sick on 25Mar2021, reported on 26Mar2021. Became aware on 25Mar2021. On 25Mar2021, patient experienced Fatigue, Achiness, cold sweats (no fever), dizziness, sick. Patient did not receive any treatment for the adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.    No follow-up attempts are possible. No further information is expected.
mom states pt had inc temp 103 ax & convuls lasting approx 1hr @ 2AM 28SEP95; had been giving APAP, temp to 103 ax again about 6AM & pt had another series ax of szs; on evening of 28SEP95 temp again inc 103 & had more convuls; hx szs a/vax
A medical assistant reported the occurrence of an injection site reaction in a 7 month old male who received Infanrix. The subject's medical history and concurrent conditions were not specified. The vaccinee was taking no concurrent medications. On 11/22/01, the vaccinee received his first injection of Infanrix without adverse event. On 1/22/02, the vaccinee received an injection of Tripedia without adverse event. On 4/17/02, the vaccinee received an injection of Infanrix (547A2). On 4/19/02, he developed an injection site reaction characterized by a large lump (knot) and redness. He was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration and were ongoing as of 4/22/02.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination (Pfizer dose 1 and 2). No booster or 3rd dose received. Date of vaccination #2 was 2/27/21.
Fatigue started at 8pm on 2/17/21, ran a low grade fever overnight, chills, sweating. By 7am on 2/18/21 body aches set it. Fever, chills, sweating, and fatigue continued throughout the day. Treated with Tylenol every 6 hours. Symptoms were gone by morning of 2/20 with the exception of slight fatigue.
Headache; Nausea; I slept almost the whole day; Fever; Chills; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 02Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 02Apr2021 at 23:00, the night of the vaccination, the patient experienced fever, chills and body aches. On 03Apr2021, the patient experienced headache, nausea the next day and the patient slept almost the whole day. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, headache, nausea and the patient slept almost the whole day was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
p/vax pt taken to ER & devel throat closing, hives, facial edema;tx w/epi, oral prelone & nebulizer treatment;pt recovered & was sent home from ER;event considered medically important;
T100.2 in AM 24SEP91; afebrile @3PM; 530PM t105.5, lips blue, extremities trembling; to ER; had x-rays & blood work w/neg results; mild redness of ears & throat; rx for inc temp; left ER @730PM; t102.7 w/rx for Amoxil; 25SEP91 PT alert;
Vertigo, dizziness, nausea, vomiting within 24 hours of receiving vaccine, mostly resolved after 72 hours
Injection site became reddened, swollen and quite painful, including with movement chills lasting  approximately 10 hours