chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes (various locations). Extreme joint pain (various locations). Massive fluid retention. Low grade fever. Rash. Fatigue! Patient is a 56-year-old female. About two weeks ago she got an MMR vaccine and has not felt the best ever since but in the last few days she has noticed lymph nodes in the back of her neck being very swollen. She does admit that she has difficulty taking vaccines and she has been this way for a while. She states she always reacts strongly to them and in fact once before did have lymph node involvement with a prior vaccine although that was not an MMR vaccine. I believe it was a tetanus vaccine. She has no sore throat, no fever that she aware of. No nausea or vomiting or other symptoms mainly joint achiness and then these lymph nodes on the back of her neck somewhat associated with a little bit of a headache. Her past medical history is significant for osteoporosis, hypertension, GERD, fibromyalgia, and tobacco use. She is allergic to penicillin. Her current medicines are EVISTA per chart. Patient is a 56-year-old female that presents to the ER with complaints of left knee pain. She states that she woke up around 1:30 this morning and had pain into her left knee. She took 600 mg of ibuprofen around 2:30 and didn't have relief, so she decided to come to the ER to be evaluated. She believes this is all related to the MMR vaccine that she had on April 8th. On Monday she was with some coworkers eating lunch when she noticed that she had these lumps on the back of her head. She was then seen in clinic that next day by nurse practitioner who gave her ROCEPHIN, 1 gram IM. She states that her lymph nodes are still enlarged at the back of her head and also now into her neck. Now she has just had this sudden onset of left knee pain without knee injury. She believes they are all related and is concerned and wants to have it evaluated.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-OCT-2011, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided) and on 26-APR-2012, was inoculated with the ZOSTAVAX vaccine for the second time (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-APR-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. On or about 23-JUN-2017, the patient sought subsequent treatment from a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and excruciating pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Muscle Aches, Fever of 102.4F , cold sweats, eye pain, extreme fatigue
This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The physician stated that there had been instances where people have completed a series of hepatitis-B vaccination but did not establish protective titers and required a 4th dose. This statement was said in passing, unrelated to the original purpose of the phone call. It was unclear if this was exclusively related to ENGERIX-B or number of patients that might not have achieved a protective antibody response after 3 doses.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose number 1, single (Lot number: EN6198), in left arm, on 17Mar2021 as dose number 2, single (Lot number: EP7534), in left arm and on 19Nov2021 as dose number 3 (booster), single (Lot number: FG3527) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; FISH OIL; VITAMIN C [ASCORBIC ACID]; ZINC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) positive, notes: which was Day 9 after initial positive test; (23May2022) positive, notes: Rebound infection of Covid-19, symptoms & positive antigen tests began again on 23May2022, 4 days after Paxlovid treatment ended. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are needed. No further information is expected.
Guillain-Barre Syndrome/vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP); This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received Shingrix. On 24th December 2020, 9 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.   GSK Receipt Date: 28 Jul 2022 Reporter's Comments Plaintiff being administered the Shingrix on 15 Dec 2020.On or about 24 Dec 2020, Plaintiff started experiencing signs and symptoms of Guillain-Barre Syndrome including ascending motor paralysis in his legs and arms.On or about 7 Jan 2021, Plaintiff was diagnosed with vaccine induced acute inflammatory demyelinating polyradiculoneuropathy (AIDP), otherwise known as Guillain-Barre Syndrome.
Pain during administration. Over the next week post-vaccination the pain continued to increase into shoulder. The following week, the patient experienced a great deal of pain in right shoulder and arm making it difficult to do certain tasks. She has been seen by urgent care who prescribed prednisolone. She followed up with her PCP and now has a future appointment with orthopedics for continued pain.
Narrative:  Patient notes developing an area of pruritus under the medial side of the bandaid, just lateral to the initial injection site. The itchiness started 1 day after the vaccination/removal of bandaid and persisted for 3 days. It was not associated with rash, warmth to touch, induration, or change in color of the skin. He applied a home remedy for itchiness, which seemed to have helped a little. He notes having scratched so hard, that he caused an excoriation. Other adverse effects from the vaccine were denied. On examination, there is a small, irregular ~1x2cm area of mild hyperpigmentation over area that had been described as itchy present on his left upper medical deltoid, + blanching, no associated rash. His stated preference was to receive dose 2 in that arm. Advised to use paper tape with removal after about 5 minutes and placement perpendicular to where bandaid was.
This spontaneous report was received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (route, lot numbers and expiration dates were not provided). On an unknown date, there was incorrect product storage as multiple unspecified patients had received ZOSTAVAX that were improperly stored. No adverse event were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
PCR testing showed that she has the measles virus; This spontaneous report was received from a medical assistant referring to a 13-month-old female patient. The patient's concurrent condition included kabuki make-up syndrome, gastrostomy, milk allergy and food allergy. The patient's concomitant medication included diacoxide. The patient's historical medications and medical history were not reported.     On 21-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number w028731, expiration date 06-APR-2024, 0.5 milliliter, subcutaneous for prophylaxis.         On 21-JUN-2023, the patient experienced fever of 101 degrees that continued on the next day. On 26-JUN-2023, the patient developed rash. The HCP did a throat swab that resulted positive for measles    The outcome of measles was reported as not resolved. The causal relationship between the event and the vaccine was not reported.
Resident noted with edema to lower extremities on 1/21/23. She exhibited lethargy and was difficult to arouse
pt recvd vax;devel fever & tremors & exp imbalance & irritability; he could not walk; to md;
Site itched patient at 7pm 4/25/12. Per mother redness and swelling and heat at injection site in Left Deltoid noted the next morning about 8am 4/26/12.
Information has been received from a physician concerning a 19 year old male patient who was vaccinated with MMR II. On 15-DEC-2009 the patient developed left parotitis. She was diagnosed with mumps on 15-DEC-2009. The patient did not have a fever. Blood works were performed on 15-DEC-2009. The serum immunoglobulin M test result was < 1:10. The serum immunoglobulin G was 4.47 and the serum amylase was 71. At the time of the report, the patient's outcome was unknown. Follow up information was received from the physician. It was reported on 01-DEC-2009 the patient developed parotitis on both side. She was diagnosed with mumps on 04-DEC-2009. The patient was afebrile. The patient had swelling under both ears. Blood works were performed on 04-DEC-2009. The serum immunoglobulin M test result was < 1:10. The serum immunoglobulin G was 5.68 and the serum amylase was 322. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
As of 16SEP91 12PM mom noticed red rash on face & back; Several small red spots on chest & leg; no temp;
Itching; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching was unknown.
Information has been received from a licensed practical nurse concerning a 9-year-old white female with an allergy to amoxicillin who on 08/22/1996 was vaccinated with a first dose of Varicella virus vaccine live in the first arm. On 04/16/01, the patient developed 10-15 vesicular lesions on her trunk. On 04/17/01, the patient reported to the doctor's office and was diagnosed with chicken pox. According to licensed practical nurse, no other symptoms were noted. It was noted that the patient recovered. Additional information is not expected.
It was reported that a male pt received a Fluzone UNSP '99-'00 vaccination. Reportedly, within 24 hours, the pt developed a local reaction of redness and tenderness at the injection site. The pt also developed generalized malaise and arthralgia.
On 6/6/03, son poked wooden object into right ear, receiving abrasion to inferior aspect right canal. Placed on Tequin and Auralgan. Receive dT. Woke up 6/7/03 3:30 AM: freezing, T 101, shakiness, aching, diaphoretic, heart pounding, dizziness, headache. Lasted 3 hours. By 6/8 improved although still achy and tired. Left arm soreness.
Patient reported that she had itching and hives 24 hours after receiving 1st dose of Covid vaccine. Pt. reports taking benadryl and hives going away after unspecified time.
Full feeling in abdomen; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
March 26 - 27: 101 degree fever, chills, headache and fatigue;  March 28 - 29: headache and fatigue continued;  March 30 - 31: bedridden with nausea and diarrhea;  April 1 - 3: fatigue continues with no appetite;  April 4 - 12: severe head cold with chest congestion and continued fatigue.   Additional ongoing symptoms:  periodic episodes of losing sense of balance.
Woke up very lightheaded around 9:30, to the point of nearly passing out. Felt like I needed to sleep for several more hours before lightheadedness was gone. Point of injection is also a bit hard and swollen.
Rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash on left arm). At the time of the report, RASH (Rash on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included hydrocortisone cream twice a day
had no appetite at all/Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02May2021 11:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: DECREASED APPETITE (non-serious) with onset 03May2021, outcome "unknown", described as "had no appetite at all/Loss of appetite".  Additional information: The patient stated that the day of his second dose he felt fine. The next day, yesterday, he stated that he had no appetite at all reported, he had no hunger pangs like he usually did when he was hungry. The patient did not feel hungry at all. There was a small window where he might have felt a little hungry around dinner but that was it. The patient then stated that he still had no appetite today either and he was concerned because he did not see this side effect listed as commonly reported with the Pfizer COVID-19 vaccine. The patient denied any nausea associated with his lack of appetite. No other side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 60-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 07-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The Shingles vaccine temperature excursion was exposed and patient received unstable vaccine, which led to incorrect storage of drug. This case was 1 of 169 cases for the patient reported by same reporter. The reporter did consent to follow up. This case had been linked with US2023054677 and US2023AMR055743 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Narrative: Patient received one dose of covid vaccine. PMH of lewey body dementia, was in LTC. Patient developed stroke-like symptoms several weeks after vaccination and was transferred to outside hospital. Patient was returned to hospice where he passed. No other causes of death notated. Reporting per facility instructions.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same site, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu Shot (manufacuturer: unknown batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination the patient was down with bronchitis. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
DIFFICULTIES IN BREATHING; FELT LIKE REALLY HAD BAD CASE OF FLU; TURNED PURPLE IN THE FACE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included very sick with covid symptoms, diarrhea, and fever, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced difficulties in breathing. On 2021, the subject experienced felt like really had bad case of flu. On 2021, the subject experienced turned purple in the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulties in breathing, felt like really had bad case of flu and turned purple in the face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.
Patient experienced pain and burning as the needle was removed from the left arm. The pain has persisted and remained the same since the day of the shot. She experiences pain when lifting arm above head and behind body. She states that sometimes the pain wakes her at night. Patient following up with primary care doctor.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 22nd December 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JAN-2023 and 10-JAN-2023 Reporter's Comments: The reporter stated that vaccine was expire at time of given. The reporter stated that patient and physician were notified at the time of incident. The vaccine administration facility was the same as primary reporter. The reporter requested to have some contact to see what protocol to take or if he/she could have confirmation from the manufacturer that company was notified with this incident and what type of complications the patient may experience. The reporter consented to follow-up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.