chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
This spontaneous report as received from a nurse 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 an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
This spontaneous report as received from an officer manager via a company representative refers an 18 year old male patient. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 only 6 weeks after they received the 2nd dose (unspecified date) (drug use for unapproved schedule), intramuscularly, for prophylaxis (dose, lot number and expiration date were not reported). No adverse event was reported and there was not PQC reported. Additional information is not expected because there was no consent to contact physician.
4 hrs p/vax pt awoke from a nap & cried unconsolably for 4 hrs;
Really Big Headache; This is a spontaneous report from a contactable other health professional. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot is unknown: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunization. Medical history included Covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. No known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced really big headache on 17Feb2021. Event did not result in Emergency Room Visit or Physician Office Visit. No treatment received for the adverse event. The event was considered non-serious per reporter. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Pfizer 4/20/21, 5/11/21. Moderna 9/17/22. Positive on 1/18/23
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm), SWELLING (swelling 5.5cm x 4cm), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE INDURATION (Hard) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm) and VACCINATION SITE INDURATION (Hard). On 01-Feb-2021, the patient experienced SWELLING (swelling 5.5cm x 4cm) and VACCINATION SITE PRURITUS (very itchy). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm), SWELLING (swelling 5.5cm x 4cm), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE ERYTHEMA (redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
Chills (felt colder); Reaction was slower fatigue; Headache; Disorientation; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), CHILLS (Chills (felt colder)), FATIGUE (Reaction was slower fatigue) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISORIENTATION (Disorientation). On 03-Mar-2021, the patient experienced CHILLS (Chills (felt colder)), FATIGUE (Reaction was slower fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) on 06-Mar-2021 at a dose of UNK dosage form. On 07-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, DISORIENTATION (Disorientation), CHILLS (Chills (felt colder)) and FATIGUE (Reaction was slower fatigue) had not resolved.            No concomitant product information were provided.   This case was linked to MOD-2021-037379 (Patient Link).
Breakthrough COVID-19 case: I lost my sense of taste and smell and that prompted me to get tested for COVID-19. I went to urgent care to do a PCR test. My test came back on 12/20/2021 positive. I did stay home from work for 10 days. I experienced fatigue. I did test negative before going back to work. About a week after I went back to work, I started to really feel lethargic and have body aches. I also had a difficult time breathing. I started taking my blood pressure multiple times a day. My blood pressure was starting to increase, and I would experience heart arrhythmia. I did have a tele-visit with the nurse and was advised to stay home for another two weeks. I did eventually go back to work, but when I come home I just go to bed. I am now experiencing brain fog. I really have to concentrate to remember things. I now have a new doctor and she has ordered a stress test to monitor the arrhythmia and ensure there is no damage to my heart.
Patient received first dose moderna at 9:30am. About 9:40-9:45am she started to feel itchiness on her arms and spread to her throat. She started to become red and swollen in different areas (throat and legs). I asked patient if she is experiencing shortness of breath while retrieving box of Epi-pen. I asked for patient consent and 1 dose of Epi was given. Patient refused call to the emergency number and EMS call. Patient then took two dose of her albuterol inhaler. After a few minutes she was fine. Redness, swelling and itching went down and patient left 10 minutes later after feeling better.  Patient was heading to work in hospital and followed up 30 minutes later that she was still ok.
No additional AE reported; A patient was given an extra dose of PNEUMOVAX 23; This spontaneous report has been received from a nurse regarding a 22-years-old male patient. Patient's drug reactions and allergies and concomitant medication were unknown by reporter. His pertinent medical history included splenectomy.  On 16-MAR-2023, the patient was vaccinated with a dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), injection, administered as prophylaxis, (strength, dose, and route of administration were not provided; lot number W007035 was validated as a valid number; expiration date were established as 20-OCT-2023). On 16-MAR-2023, the patient was vaccinated with an extra dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (extra dose administered). No additional adverse event was reported.
There were no signs or symptoms of an adverse event, therefore no treatment was given.  The dose was given earlier than it should have been, at three weeks out from the second dose, rather than eight weeks.
New onset Tinnitus, Fatigue and Vertigo that is now chronic since Vaccination. New onset of intermittent  confusion and "Brain Fog" that is now chronic since vaccination. Considerably more general GI discomfort since last year.
Patient had numbness, itching, tingling in left face.  Given Benadryl 25mg, Pepcid 40mg po.  symptoms responded rapidly.  No complaints of GI, respiratory, cardiovascular symptoms.   Observed almost an hour and a half.
Information has been received from a 69 year old female with sulfonamide allergy ("a rash from sulfa in the 1970's") and a history of sarcoidosis who has been vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) twice. The patient still got pneumonia every year, which would "last for about a couple of months" and she had to be in the hospital for a week each time she got pneumonia. This is one of two reports concerning the same patient. Additional information has been requested. Patient has been hospitalized at hospital on various occasions for pneumonia.
Low grade fever, aches, headache for about 20 hours   Not sure where to record but I did have Covid in December of 2020 and my first dose of the vaccine was given around 100 days after my positive Covid test.
11/05/22 presents to ED for "fatigue". PMHx of ". fib on Eliquis, HTN, HLD, CKD, kidney stones, hypothyroidism"
Information has been received from a physician concerning an "approximately 12 or 13 month old" male child with egg allergy, "very allergic and atopic" who "approximately a month or two ago" was vaccinated SQ with a quarter dose (0.125ml) of a first dose of MMR II (Merck). Subsequently the patient broke out in hives. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient was treated with BENADRYL and recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a registered nurse concerning a 12 year old female patient with no known allergies and sickle cell anemia who 10-JUL-2008 was vaccinated with first dose of GARDASIL. On 18-DEC-2008 the patient was vaccinated with 0.5ml of her second dose of GARDASIL (lot# 66174/0650X) intramuscularly. Concomitant therapy included influenza virus vaccine and pneumococcal 23v polysaccharide vaccine. On the same day, 18-DEC-2008, the patient developed painful local injection site reaction after vaccination. The reaction consisted of warm, tender and swelling around two inches at the injection site. The patient went to the emergency room and later relased. As of 19-DEC-2008, the patient was recovering.Additional information has been requested. Follow up information has been received from a health professional concerning a 12 year old female patient who at the time of vaccination had bilateral otitis media who on 18-DEC-2008 was vaccinated 0.5 ml of her second dose of GARDASIL (Lot # 661764/0650X) intramuscularly. concomtiant vaccines administered on 18-DEC-2008 included FLUZONE (Lot# U2840AA) and PNEUMONVAX 23 (lot # 0090U). On 18-DEC-2008 the patient developed severe pain on left arm, warthm and swelling at the injection site (Size left upper arm 9.5 inches, right upper arm 7.5 inches). The patient was prescribed with oral BENADRYL at the ER. The patient recovered two or three days later on approximately 20-DEC-2008. No further information is available.
hard and tight pressure on the right side of my chest; pressure also on my right back; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2021 17:00 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient had no known allergies. The patient had no other medical history. Concomitant medication(s) included: ZYTREC; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer-Biontech,, prev dose brand unknown=False,, prev dose lot number=EW0168,, prev dose lot unknown=False,, prev dose administration date=04May2021,, prev dose dose number=2), administration date: 04May2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer-Biontech,, prev dose brand unknown=False,, prev dose lot number=ER8731,, prev dose lot unknown=False,, prev dose administration date=13Apr2021, prev dose dose number=1), administration date: 13Apr2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 17:00, outcome "unknown", described as "Booster"; CHEST DISCOMFORT (non-serious) with onset 23Dec2021, outcome "recovering", described as "hard and tight pressure on the right side of my chest"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 23Dec2021, outcome "recovering", described as "pressure also on my right back". The events "hard and tight pressure on the right side of my chest" and "pressure also on my right back" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest discomfort, musculoskeletal discomfort.  No follow-up attempts are possible. No further information is expected.
Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.
Seen in office on 8/16/01 and Mom reported at that time that on 8/8/01 from approximately 2 PM to 4:20 PM pt had temperature of 98.3 to 101 F. Baby was screaming then became a zombie. Flaccid, staring, pale but no cyanosis. Responded to Tylenol within 30 minutes.
Activation/exacerbation of autoimmune process resulting in exertional dyspnea, generalized subcutaneous edema/lymphedema and pain. Sxs were minimal after the first dose, barely noticeable, but were progressively more prominent with the subsequent 2 doses.
On that morning I woke up with a droop in my mouth on the right side of my face. My face continues to droop and feel weak as I go into work. I wasn't able to open my mouth and close my eye all the way. I did a video conference with a doctor and she suspected it was bells palsy. Since I had a headache she wanted me to go to an ER to make sure I wasn't having a stroke. I went to the ER on 9/14/2021 and they ran a stroke test on me. The doctor said it wasn't a stroke but diagnosed me with bells palsy. I was prescribed prednisone, doxycycline, and valacyclovir.
persistent muscle aches and fatigue; fatigue; proximal right thigh" pain is persistent; This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2019, 2 days after receiving Shingrix, the patient experienced muscle pain (serious criteria clinically significant/intervention required), fatigue and pain in thigh. The patient was treated with ibuprofen, hydrocodone and prednisone. On an unknown date, the outcome of the muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the muscle pain, fatigue and pain in thigh to be related to Shingrix.  Additional information was provided as follows: The patient developed persistent muscle aches and fatigue. The patient's proximal right thigh pain was persistent. The patient was treated with ibuprofen at bed time and hydrocodone at bed time for pain. A treatment with prednisone was started, that physician stated, provided relief until 14th February 2020, when the pain re-occurred and persisted till the time of reporting. The reporter consented to follow up. Emergency visit required.
Long period with heavy bleeding with blood clots.  This has never happened before in my entire life.
Pt recvd MMR on 25JUN90; 2 days later pt devel fever & achiness; Pt recovered from exp;
COMPLAINED OF SWELLING WHERE INJECTED AND ARMPIT THAT ALSO WENT TO RIBS AND BREAST (STARTED MONDAY 9/27/21) - RIBS SWELLING DECREASED ON OWN - HOWEVER SWELLING DID NOT GO DOWN IN ARM OR ARMPIT, NO TREATMENT AS OF YET
Fever as high as 103F that persisted for about 6 days after the second dose. Fever currently is 100.3F
had their first vaccine on 26Jan2021; She tested positive 31Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of 2 reports. A 28 years female patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 26Jan2021,as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. Reporter stated that she aged 28, and boyfriend, aged 23 had got Pfizer Covid vaccine three weeks ago, and then he tested positive on 28Jan2021. She tested positive on 31Jan2021. Patient stated her boyfriend was getting sick with it right before the vaccine but they did not know. He is no longer experiencing side effects and she is. Reporter stated that they both have an appointment scheduled for the 2nd vaccine and is wondering if it is okay to get it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (10Feb2021): This is a follow-up spontaneous report from a contactable consumer.
VACCINE STORED IN TEMPERATURE EXCURSION; EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the patient experienced expired product administered. On an unspecified date, the patient experienced vaccine stored in temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired product administered and vaccine stored in temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916965, 20210915719, 20210916300, 20210916129, 20210916465, 20210916498, 20210916455, 20210916715, 20210917160, 20210915646, 20210916697, 20210915731, 20210916520, 20210915852, 20210916312, 20210916228, 20210915661, 20210916415, 20210916401, 20210916584, 20210916811, 20210915748, 20210915623, 20210916768, 20210916849, 20210916907, 20210916910, 20210916959, 20210917074, 20210917163, 20210913164, 20210916553, 20210917515, 20210917226, 20210916658, 20210917500 and 20210918425.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Patient developed a site of injection inflammation which is red, hot to touch and welt approx 2 inches in diameter she reported initiate SX on 5/16/07, and still has SZ even after 7 days.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unspecified dates since 11-MAR-2015, an unspecified number of patients were vaccinated with doses of ZOSTAVAX, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored exposing to temperatures outside of the recommended range. No adverse effects were reported or observed and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
I felt uneasy the first night but no clear symptoms on November 8, 2022.  The next day I had a dry cough, chills and a lot of nasal drip.  I took home COVID-19 test and it was positive.  I took another COVID-19 the next day and it was also positive.  I consulted with my doctor and received Paxlovid.  The following day I had muscle aches, and this made it difficult to sleep.  The fourth day I had a tendon pain from my mid leg to my foot and I was having trouble walking.  This pain lasted for about 4 days.  These symptoms have disappeared, but I now have pain my arm that is lingering.
VACCINE-RELATED BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned multiple patients of unknown ethnicity and race. No past medical history or concurrent conditions were reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 38 people had confirmed cases of the vaccine-related blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine-related blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009193.; Sender's Comments: V0: 20211010279- Covid-19 vaccine ad26.cov2.s-Vaccine-related blood clot. 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.