chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An adult was exposed to granddaughter who recv vax 18MAR97 & the adult exp secondary transmission;11JUN97 exp shingles on back & stomach which were blistering & weeping; Information has been received from the relative of an adult male with a history of prostate cancer, an 'altered immune status in that he does frequently get sick,' and no history of shingles who was exposed to his granddaughter who was vaccinated with one dose of varicella vaccine on March 18, 1997. Subsequently, the patient experienced secondary transmission. On June 10, 1997 (also reported as June 11, 1997), the patient experienced shingles on his back and stomach which were 'blistering and weeping." Additional information was received from a physician which indicated that on June 12, 1997, the patient went to the physician's office and was diagnosed with herpes zoster. The patient was treated with valacyclovir HCl (Valtrex). The physician reported a "stormy course" for the patient, however, the lesions had healed by June 30, 1997. The reporter also noted that the patient did have some post herpetic neuralgia. The physician reported that he was unaware of the questionable immune status on the patient. His granddaughter experienced rash after vaccination with a dose of varicella vaccine (WAES #97061242).
Given Pneumonvax Immunization on 2-25-09. Pt c/o swelling, warm, rash 3 inches in diameter at injection site. Felt feverish but did not take temp. Same symptoms on 2-26-09 but decreased from 2-25-09. Denies difficulty breathing or dhortness of breath or wheezing. Diagnosed with Cellulitis and placed on Cephalexin and Benadryl.
upper thigh erythematous w/edema;c/o pruritis & burning;dx vax rxn w/cellulitis? tx Keflex;
1/28/05 PM: ascending redness left elbow then from fingertips. 2/8/05 Increasing pain down lower back to thoracic spine. 2/8/05 Admitted to hospital; afebrile. MRI brain negative, C-spine x-ray negative, T-spine  x-ray negative, C-reactive protein 0.8.   03/01/05 Hospital Discharge summary for 2/8-2/14/2005. FINAL DX:  Likely Guillain -Barre syndrome; findings significant for Discharge summary states perioral weakness, persisting pain in back, loss of deep tendon reflexes with progressive lower extremity weakness.  Neuro consult done.  She had improvement with IVIG therapy and was discharged home after 5 days' therapy.         Follow up 7/27/05: Per phone call from RN on 7/20/05: Patient no longer has numbness or weakness (her presenting symptoms). She is back at work, full duty, and is no longer receiving physical therapy. Patient apparently was treated with IVIG. Her physician ordered lab tests (immune markers) and according to the patient, one of the immune markers is still low. Her physician will continue to monitor. The patient was experiencing a lot of flu-like symptoms, but has had none for the past 3 to 4 weeks.
Patient stated he had right chest discomfort but denied pain; no ther symptoms; relieved after rest for 10 minutes
Morning of 10/17/20 patient experienced severe pain in right shoulder and could not bear to move her right arm. Condition became progressively worse in the ensuing days with severe joint pain in both shoulders, arms, fingers, hips and knees. By 10/26/20 patient could not move from her bed and was in agony 24/7. Dr. prescribed 4 MG tabs of Methylprednisolone which did not have any effect. Dr. met the patient on 10/28/20 and ordered a blood test. The results showed inflammation due to the flu vaccine. On 11/3/20 patient's condition became chronic and Dr. ordered her to go to E.R. She was admitted to Hospital and was diagnosed with polyarthralgia due to the flu vaccine. Dr prescribed Prednisone 60 MG tabs. To date they have had no effect
very tired; head started to hurt a lot; my arm hurt; migraine pain; My arm hurt a little bit that; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt a little bit that), FATIGUE (very tired), HEADACHE (head started to hurt a lot), PAIN IN EXTREMITY (my arm hurt) and MIGRAINE (migraine pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMOXICILLIN and CABERGOLINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt a little bit that). On an unknown date, the patient experienced FATIGUE (very tired), HEADACHE (head started to hurt a lot), PAIN IN EXTREMITY (my arm hurt) and MIGRAINE (migraine pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 17-Mar-2021, PAIN IN EXTREMITY (My arm hurt a little bit that) had resolved. At the time of the report, FATIGUE (very tired), HEADACHE (head started to hurt a lot), PAIN IN EXTREMITY (my arm hurt) and MIGRAINE (migraine pain) outcome was unknown. Not Provided      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.   This case was linked to MOD21-065785 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information; Sender's Comments:  MOD21-065785:
MMRV (Proquad) was inadvertently administered with Varivax during the same office visit this morning. So far, the mother reports of no side effects on the child.
This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506.
Client came to the facility to receive her 1st dose of the Covid19 Moderna vaccine. RN vaccinated the client in the left arm at 1424 with the Covid19 Moderna vaccine (Lot# 069H21A). However, RN inadvertently administered the incorrect dosage to the client. She administered a booster dose of 0.25 mL instead of a full dose of 0.5 mL. The error was discovered by RN while she was returning a participant form to the room, she noted that she had circled 1st Dose on the form specifically for Boosters. RN then notified Lead RN, immediately. Lead RN, spoke with RN and determined the client had only received 50% of the full dose required for dose 1 of the Covid19 Moderna series. After consulting, Clinical Nurse Lead, it was determined the client would need to return to the facility to receive another 0.25 mL injection of the Covid19 Moderna vaccine as soon as possible. Lead RN, called the client at 17:04 and left a message and attempted to call again at 1715. At 1819 the client's spouse, called  back. Lead RN, explained hat the client would need to return as soon as possible, then a medical consult with the County MD would dictate the amount of vaccine that the client would receive to be fully vaccinated. Client's spouse stated "I will bring my wife in first thing in the morning at 10:30 AM to be re-vaccinated". On 12/16/2021 at 10:30 the client had returned. Lead RN then called Clinical Nurse Lead to elevate case to MD, per the MD recommendation the client was to receive an addition 0.25 mL dose of Moderna to complete the first dose series. The client was taken to RN vaccination station, and RN administered 0.25 mL of the Covid19 Moderna vaccine (Lot# 069H21A) into the client's right arm at approximately 11:00 AM. Client was calm and well post vaccination. Afterward, the client was directed to the observation area to sit for 15 minutes. No issues were noted.
Fever, chills, extreme body aches, fatigue Narrative: Reported that 48 hours post vaccine had fever, chills, extreme body aches, fatigue, and bed ridden
Information has been received from a company representative and the patient's older sister referring to a 12 years old female patient. the patient had no previous history of seizures. the patient's concurrent condition and concomitant therapy were unknown. In the morning of 11-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, dose number, lot #, expiration date and route not reported) in her left arm. The patient also received another unspecified vaccination. On 11-AUG-2016 around 13:15, the company representative witnessed the adverse event. the patient fell and started seizing. There were no adults around so the representative put the patient on her side and turned the patient's head. the patient's whole body was seizing and she was drooling. 911 was called. the patient began recovering before the medics arrived. The patient was able to communicate and breath normally. When medics arrived, they put the patient in the "squad". It was unknown where they took the patient, what treatments the patient might have been given or if she fully recovered. It was unknown if the laboratory test was performed. the causality between GARDASIL 9 and the events was not reported. Additional information has been requested.
I was breastfeeding when I received both doses of the vaccine. After each dose I developed about a day and a half of fatigue, chills, and body aches (enough to be in bed all day), followed the next day by extreme clogged milk ducts (about five total, starting on the side of the injection but spreading to both breasts within hours, verified by hospital nurse lactation consultation), followed by mastitis.
2day p/recv vax pt had 102-103f fever & was very very cranky, wouldn't eat or drink; 7/30 p/having fever pt had spots; saw MD & said it was chickenpox, they formed blisters, faded away next day; 8/2 still cranky, broke out w/ lacy mottled r
She just had a little bit of a sore arm, very slightly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vaccine for immunisation, reaction(s): "seizures"; Vaccine for immunisation, reaction(s): "loss of muscle control". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She just had a little bit of a sore arm, very slightly".  Additional information: the reporter assessed the event as non-serious. It was reported as she had seizures with vaccines as a child and was hospitalized and had loss of muscle control so she never gets pneumonia vaccines and flu vaccines. They were not aware what shots she was given that caused such a severe reaction but just know that it was vaccines. When this one came out she was really afraid to get it. They had a doctor and ER tech to wait with her because they knew she could have complications, but she never did. They said that the original (Covid vaccine) was just as good as the new one at fighting. The patient had a lot of drug allergy issues to anything. They were cautious with whatever they gave her. There was only one antibiotic she could take. It was reported as her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. She declined providing their information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287002 same reporter/product/AE, different patient;US-PFIZER INC-202201287001 same reporter/product/AE, different patient;
RASH, HEAT AND SWELLING OF A 3 TO 4 INCH DIAMETER AREA WITH A HARD LUMP DEVELOPING UNDER THE EXACT INJECTION SITE ABOUT ONE INCH IN DIAMETER. THE AFFECTED AREA WAS SEVERELY ITCHY AND PAINFUL TO THE TOUCH. ON THE FIRST DAY 1/12/18 A FEVER OCCURED. THE PHARMACIST RECOMMENDED THAT SHE TAKE BENADRYL AND USE HYDROCORTISONE CREAM. SHE ROUTINELY TOOK BENADRYL EVERY 6 HOURS OR SO FOR THE FIRST 7 DAYS. ON TUESDAY 1/16/18 OR SO THE PATIENT SHOWED THE ARM TO THE VACCINATING PHARMACIST AND WAS TOLD TO TAKE BENEDRYL. ON FRIDAY 1/19/18 SHE RETURNED CONCERNED AS THE PAIN AND ITCHING WAS INTENSE. SHE WENT TO THE WALK-IN CLINIC IN TOWN AND WAS TURNED TO THE HOSPITAL EMERGENCY ROOM BUT DECLINED TO GO AS SHE WAS PREVIOUSLY ADVISED THAT SHE WAS NOT HAVING AN EMERGENCY.
The patient stated that her arm was immediately sore and became progressivley more sore that evening and next day.  On the 3rd day, she stated that her arm was very sore, red and hot to the touch.  She took Tylenol to releive the pain and it helped.
Welts on face, arms, and abdomen. Patient was given .2 of Epi, she waited in office for 20 minutes and was sent home with Benadryl.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Patient started experiencing nausea and vomiting per his appointment on 03/30/2021 since the day after vaccination.  From the 03/30/2021 appointment, he continued to have more symptoms such as loss of appetite, fatigue, weakness, incontinence... Patient came in to see his provider on 06/07/2021 and informed him of his tremors, involuntary movements and jerking.
mom recv vax who was breast-feeding;child exp malaise the day following mom's vax;
Chills, headache, fatigue symptoms from 9 am to 6:30 pm when I slept.
This spontaneous report as received from a Licensed Practical Nurse refers to a multiple unspecified patients, who on an unknown dates were vaccinated with a dose of PEDVAXHIB (dose and route were not reported) (Lot K015462, exp 10-JUL-2017) that had experienced temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
abscesses in the left groin; Hidradenitis suppurativa flare in the Groin area and the Rear End area; abscesses in the left arm pit; sore arm; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3991430-00). A contactable consumer (patient) reported that a 66-year-old male patient received bnt162b2, intramuscular on 15Apr2021 (Batch/Lot number was not reported) as dose 1, single at the age of 66-year-old, intramuscular on 21May2021 (Batch/Lot number was not reported) as dose 2, single at the age of 66-year-old, both for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe Hidradenitis suppurativa. The patient's medical history and concomitant medications were not reported. The patient experienced abscesses in the left groin in May2021 with outcome of recovered in May2021, hidradenitis suppurativa flare in the groin area and the rear end area in May2021 with outcome of recovering, abscesses in the left arm pit in May2021 with outcome of recovered in Jun2021, sore arm in 2021 with outcome of unknown. The action taken in response to the events for adalimumab was unknown. Therapeutic measures were taken as a result of all events. The patient was treated with Cortisone. The case was reported as non-serious.    Causality for Humira (Adalimumab): The reporter's causality for the events of hidradenitis suppurativa flare in the groin area and the rare end area, abscesses in the left groin, abscesses in the left arm pit and sore arm was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of hidradenitis suppurativa flare in the groin area and the rare end area, abscesses in the left groin, abscesses in the left arm pit and sore arm was not related.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known mechanism of action of the drugs, the events of groin abscess, hidradenitis, subcutaneous abscess, pain in extremity are assessed as not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Polymyalgia Rheumatica; Fatigue; joint pain; tingling in feet/tingling 6 inches about ankle; Numbness in feet/Numbness 6 inches about ankle; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation (occurred 2 years ago from the date of reporting). Previously administered products included Shingrix (1st dose received 3/4 months before receiving 2nd dose on an date unknown).   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), fatigue, joint pain, tingling and numbness. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica was not recovered/not resolved and the outcome of the fatigue, joint pain and tingling were recovered/resolved and the outcome of the numbness was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica, fatigue, joint pain, tingling and numbness to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. Within 2 weeks of receiving the 2nd dose, the patient felt numbness and tingling in his feet and 6 inches above his ankle. The patient had knee surgery which occurred 2 years before the date of reporting and that the adverse events that he experienced were not due to the surgery. The patient had joint pain and fatigue that got worse and was referred to his rheumatologist. The patient was prescribed Prednisone for polymyalgia rheumatica and was now weaning off from this medication. The reporter declined to give further information and demographic information for his sister. The reporter consented to follow up. The case had been linked with US2021216680, reported by same reporter for patient's sister.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216680:same reporter
Rubella titer low on 5/22/06. Recommended MMR x 1. Consented to MMR and received 1 dose on 5/24/06. On 6/6/06, presented with c/o swollen neck glands x 1 week with mild rash. States she saw her primary care provider who sent her for a CT scan of neck and lab work.
Generalized weakness in arms and legs, Tingling in feet; Fever, Nausea 10/17/08-records received-office note for 8/25/08-C/O dizzy, headache weakness and tired, feeling acutely ill, arm swelled. Saw physician stated it was reaction to vaccine.Still feeling tired but able to go to school.
States that had a spike in blood glucose of 210 on 09/17around 2000.  States had not ever experience that high of a reading in the past. States that on morning of9/18, began with edema and pain to lt. foot and ankle that continued and progressed to being hot to touch for 24 hrs  and only began improving 9/20 and still 'dealing with' today, 9/21/22
DISCOMFORT IN LEGS AND ARMS GOES UPTO ELBOW AND ARMPIT/IN THIGH OF THE LEFT LEG; TINGLING/ NUMBNESS IN LEG/ARM/IN THE FINGERS; PAIN IN NECK; WHOLE WEEK SLEEPINESS; PAIN IN LEFT ARM; DISCOMFORT IN ARMS; TIREDNESS; PAIN IN HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the subject experienced discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg. On 15-MAY-2021, the subject experienced tingling/ numbness in leg/arm/in the fingers. On 15-MAY-2021, the subject experienced pain in neck. On 15-MAY-2021, the subject experienced whole week sleepiness. On 15-MAY-2021, the subject experienced pain in left arm. On 15-MAY-2021, the subject experienced discomfort in arms. On 15-MAY-2021, the subject experienced tiredness. On 15-MAY-2021, the subject experienced pain in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain in neck, pain in left arm, and pain in head on MAY-2021, and the outcome of discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg, tiredness, whole week sleepiness, tingling/ numbness in leg/arm/in the fingers and discomfort in arms was not reported. This report was non-serious.
mom states began fever several hrs p/vax APAP was given q 4 hrs; fever went as high as 105.8 & pt was taken to hosp;