chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; pain at the injection site; swelling of the arm/ swelling, pain and redness at the injection site.; redness at the injection site; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in left arm on an unspecified date at single dose for start the vaccination series for the product. Medical history included GI Issues but is not immuno-compromised from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced pain at the injection site, swelling of the arm, hives, redness at the injection site on an unspecified date. The reporter stated the customer told her that they had a patient who came in today for their second meningococcal group b rlp2086 injection, and mentioned that they had a reaction after their first injection of pain at the injection site and swelling of the arm, but the patient never called and told the doctor about it. Caller stated that the customer said the patient reported that she also had hives after that first injection and had gone to urgent care and it went away, but the doctor's office just found out about the patient's reaction today, even though it happened a year ago. The reporter went into the Package Insert to read the common side effects to the customer and it was all the same side effects that the patient had. Caller reported the patient was 16 at the time of her first injection with the side effects and the injection was placed into the patient's left arm. Caller states that the customer indicated that the patient is fine today, but the reaction the patient had a year ago to the meningococcal group b rlp2086 injection was swelling, pain and redness at the injection site. Caller stated that the customer told her that the patient has GI Issues but is not immuno-compromised. Caller stated that all she knows was that the patient is female, she was 16 at the time of the first injection and reaction, which occurred one year ago, and that injection was administered into the patient's left arm. She does not know if the patient received any other vaccines at the time of the adverse event. The outcome of event was resolved on an unspecified date. Therapeutic measures were taken as a result of hives.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included spinal operation, hepatitis C, arthritis (back arthritic issues) and spinal disorder. Previously administered products included ZEPATIER and ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he suffered from Hepatitis C for the past 48 years that damaged his liver and for a three month period of 84 days he was taking an anti-viral medication by Merck called ZEPATIER. He also had suffered with spinal issues for many years including having back surgery and back arthritic issues. The patient also reported that he has had multiple flu shots over the years (manufacture and product name unknown) and he had experienced a little muscle soreness and redness at the injection site occasionally with the flu shot. The patient described this occurrence as happening once every several years but it was rare. The patient claims that he would be slightly sore for the next day and then it would resolve. He completed his treatment by 4th March 2018. The reporter gave consent to follow up. The patient refused to provide physician permission. This case has been linked with US2018198761, reported by same reporter for the same patient.
This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On 11-MAY-2015, 27-MAY-2015, 17-AUG-2015 and 24-AUG-2015 the patients were vaccinated with improperly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # J009788 with expiration date: 17-MAR-2016). No adverse event was reported. This is one of the several reports received from the same source. Additional information has been requested.
Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc.  Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.
pt recvd vax & the following day ex muscle pains, stiff neck & abdo cramps; @ the time of the report muscle aches persisted; No further details were provided
Urticaria 3/26/04 8 pm prescribed Benadryl 1- 1 1/2 tsp with review in am per on call- doctor. 3-27-4 apt- urticaria prescribed Supportine CA- Benadryl 1 1/2 tsp every 6 hours as needed.
(L) thigh reddened warm tender - bruising at injection site. Tx: TYLENOL Q 4- 6 hours, ice call if redness worsening or fever. Spoke to mom 2 days later, no symptoms bruise still exist.
This spontaneous report as received from a healthcare worker refers to a 16 month old female patient. On 18-MAR-2013 the patient was vaccinated with ROTATEQ (lot # 0543AA, expiration date 11-MAR-2013) third dose, 2 ml, oral. The reporter stated that on 18-MAR-2013, child was administered her third dose of ROTATEQ, but the ROTATEQ was expired. No adverse effects was reported. Additional information has been requested.
Initial unsolicited report received from a nurse on 21-Sep-2015. This case involves a 6-month-old male patient who was vaccinated with second dose of PENTACEL (batch number- C4840AA, expiry date: 02-Sep-2016) in right anterolateral thigh, a dose of PREVENAR (manufacturer: Wyeth, batch number, dose and route of administration was not reported) in left anterolateral thigh and a dose of HEPATITIS B VACCINE (manufacturer: Merck, batch number, dose and route of administration was not reported) left anterolateral thigh in all on 14-Sep-2015. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions, medical history and concomitant medications were not reported. Patient had no known allergies. On 15-Sep-2015, one day after vaccination, the patient experienced injection site red and hard to touch, rash at site and rash all down right leg. Patient required ER/ Doctor Visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, no other symptoms were reported rash was still present and patient had not recovered from the events. Documents held by sender: none. Follow up information received from a physician on 09 November 2015. Lot number of Hepatitis B updated as L009155. It was reported that, patient did not receive PREVNAR (in initial report it was reported). Illness at the time of vaccination was reported as none. On 29 September 2015, patient was reevaluated and it was found that patient still had rash.
Client received the Pfizer 2nd dose COVID vaccine (lot #EW0187 and expiration date 7/15/21) at approximately 4:45pm.  Client was sitting at vaccine table waiting for registration to be completed.  At 4:50pm, student nurse notices client is struggling with mask and client looking like something was wrong.  PHN  sees  getting blood pressure cuff and walks over to client. Client reports she "feels fine" that she just had a second where she felt a few seconds of dizziness and shortness of breath that had completely resolved.  PHN was asking client history and she reports no medical conditions, no medications and no allergies to anything.  Client is alert and oriented to person, place, time and situation.  At 4:51pm client reports a few seconds of dizziness occurred again.  Client reports she only ate breakfast and was at vaccination site alone. Client reports no shortness of breath and no dizziness at the moment.  At 4:55pm vitals were taken by student nurse: blood pressure: 130/92, heart rate 91 and oxygen sat: 98%. PHN  arrived to assist with assessment.  Client reports to PHN  that she feels "like she got a sedative" and "relaxed". Client reports no chest pain, no headache, no blurred vision and no nausea. At 4:58pm heart rate is 72.  At 5pm client reports feeling "shaky". At 5:02pm client leaned forward crying.  PHN request RN to get zero gravity chair. Transfer client to chair.  Client reports "I feel like I am on drugs even though I have not been given any" or "like when you get a sedative." Then she continues to describe that "her body felt heavy, like someone was pushing down on her shoulders." Client motor and sensory intact-no tingling or numbness. PHN calls 911 at 5:03pm.  At 5:06pm vitals are blood pressure: 118/78, heart rate: 77 and oxygen: 99%.  At 5:09pm Fire department arrived and assumed care. Client AMA at 5:17pm. Fire paramedics left at 5:20pm and client states she "needs to stay a few more minutes to make sure she feels okay."  Client also described to PHN  that the feeling she had reminded her of "the medication before an epidural" but that it had passed. Client provide client with ER precautions and to follow up with provider.  At 5:28pm reports to PHN that she "feels normal and able to drive safely." Client left facility walking unassisted at 5:29PM.
Patient reported feeling  dizzy after vaccination. Patient's blood pressure was taken and trended high - it was 140s-150/80. It was high 10 minutes after vaccination. Patient was instructed to stay seated and wait under supervision for 15 more minutes. Patient was given water and BP remained high, ~140/80s. Over the entire course of observation, the patient's pulse was normal (80 BPM).
The next morning on 2/11/21, I woke up and had extreme joint pain and body stiffness. I also had brain fog. I arrived to work at 8:00 am and left by 10:00 am because, I couldn't function. It hurt to move my body and I was so out of it I couldn't even type an email. I rested the entire weekend and continued to have brain fog that eventually lifted. I then noticed my body felt heavy and I felt like my heart couldn't calm down when lying down. I noticeably felt my heart beating when laying down. I also started to notice my tonsils were enlarged and I was squeezing stones out of them and also noticed my tounge was white and dry and still have this issue with my tounge today.
Severe neck muscle pain, gastric upset, headache, sore throat, extreme fatigue, general flu like symptoms, but NO fever at this time.
Swelling and redness from injection site on Left deltoid past elbow into upper forearm. Limited range of motion of elbow. Became increasingly hotter and harder for 4 days. No treatment until night 4 when person took ADVIL and began alternating ice packs and warm, moist compresses on arm. Swelling decreased, ROM increased by Day 5 when began taking ZYRTEC and continued warm, moist compresses. Day 6 continued ZYRTEC but stopped when swelling much decreased, full ROM occurred. Injection site began itching. Day 7 went to doctor.
Fever of 102 deg. F (rectally) noted at 10pm with some redness and swelling in leg.
DIFFICULTY THINKING; SHORTNESS OF BREATH; PAINFUL BREATH; FEVER; BODY ACHES; CHILLS; EXHAUSTION; NIGHT SWEATS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 01-MAY-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021 approximately 16:00, the patient experienced fever, difficulty thinking, shortness of breath, painful breath, body aches, chills, exhaustion to the point of falling asleep in the middle of tasks and night sweats.  On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 02-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches, and the outcome of difficulty thinking, shortness of breath, painful breath, chills, exhaustion and night sweats was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210502600-Covid vaccine coad26.cov2.s-Difficulty thinking, shortness of breath, painful breath. This event(s) is considered unassessable. The event(s) 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(s).
Fatigue; Aches on his lower back, hip and ankles; Pain on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site), FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 08-Jan-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles). On 30-Dec-2020, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, FATIGUE (Fatigue) and MYALGIA (Aches on his lower back, hip and ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Rash developed underneath injection arm, near the armpit area. Rash developed approximately 48 hours after injection and caused a stinging sensation along with redness.,   Rash was about 4 inches wide. After 24 hours the rash subsided with no burning or discomfort and appeared to be clearing.  No topic creams or substances used on rash nor the injection site.
Patient was given the vaccine and his age is 17. We were under the impression 16 and older can get the vaccine. We followed the advice of the medical director to administer the vaccine. Patient had no side effects or adverse reactions reported at this time.
Severe soreness from the elbow to the shoulder, even to the back of the arm. I could not lift more than 6 inches or so from my body. Dressing and sleeping were difficult. Bruising at shot site. 4 days later and I am better but upper arm still sore for lifting arm over the head.
Patient fainted during post vaccination time. He was conscious. Pharmacist raised his Feet for few minutes, Patient's symptoms started improving in 15 minutes.
Janssen COVID-19 Vaccine EUA about 6 hours after Janssen shot I experienced a fever, body aches, chills and nausea throughout the night and through the next day.
Left upper arm pain; compromised mobility/decreased range of motion; vertigo Examined by doctor and diagnosed with tendinitis and benign paroxysmal vertigo Ordered physical therapy to begin in August 2021
Patient felt very weak, body aches, shortness of breath and was found deceased at home on 5/10/2021
hard; a swelling in her arm; warm; bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included PRAVASTATIN and VITAMINS NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm) and VACCINATION SITE MASS (bump). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard). On 21-Jan-2021, VACCINATION SITE WARMTH (warm) had resolved. At the time of the report, VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concomitant products included PRAVASTATIN and VITAMINS NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE WARMTH (warm) and VACCINATION SITE MASS (bump). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard). On 21-Jan-2021, VACCINATION SITE WARMTH (warm) had resolved. At the time of the report, VACCINATION SITE SWELLING (a swelling in her arm), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (hard) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
This report was received from a the authors a published literature article and refers to a 3 year old female patient. 09-NOV-2011 the patient's mother was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (dose, route and lot number were not reported) (MARRS case# 1304USA005178). On approximately 23-NOV-2011 (two weeks after the mother's inoculation), the patient developed chickenpox and did not attend a preschool nor was she exposed to anyone. The patient had not been otherwise exposed to zoster vaccine live (manufacturer unknown), it was likely that the source of her viral infection was her mother's inoculation two weeks earlier. The patient's mother described appears to have transmitted VZV to her daughter after inoculation following a very short course of fingolimod. Furthermore, during the first year of fingolimod treatment, she has had 2 discrete episodes of recurrent herpes zoster. These observations suggests the possibility that zoster vaccine efficacy was attenuated in patients who had received fingolimod immediately prior Ro vaccination, event a short course, and that VZV control may be diminished during treatment with fingolimod leading to recurrent zoster in some patients. A blunted immune response to vaccination to varicella would not be surprising in the setting of the administration of immunosuppressive drugs as it has been observed with influenza and pneumococcal vaccinations. It was unlikely that either her influenza infection or the corticosteroid administration for the MS relapse occurring on its heels contributed to her bouts of shingles as there was a 6 month hiatus between them and the first onset of zoster. The zoster vaccine is a live-attenuated virus (Merck strain) that was extremely safe and highly immunogenic. It reduces the risk of developing zoster by 51.3% (95% (1=44.2-57.6). It had been proposed that vaccinated individuals may shed the attenuated virus increasing the herd immunity following vaccination efforts; however, early studies by the manufacturer failed to confirm transmission of the vaccine virus in contacts. While transmission of the live attenuated varicella virus to contacts is infrequent, it has been described. The incubation period from time of exposure to VZV to the clinical expression of varicella is typically 14-15 days, precisely the time from our patient's vaccination to the development of her daughter's varicella, and transmission may occur in the absence of the rash. As our patient's 3 year old daughter had not been otherwise exposed to VZV, it is likely that the source of her viral infection was her mother's inoculation two weeks earlier. This is one of the several reports from the same source (patient's mother case # 1304USA005178). Additional information has been requested.
Patient had adverse reaction to HPV 9 she had the injection at 1:15 pm started having body aches, dizziness, faint feeling approximately 15 to 20 minutes later, throat felt scratchy.
w/in 30 mins p/vax pt became limp, unresponsive, lips were cyanotic, fever 104 & vomited x3 while being evaluated in ER: whole body shook-five tremors this lasted on & off x 1 day; fever 100 x 2 days