chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 57-year-old male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th November 2018, 9 days after receiving SHINGRIX, the patient experienced swelling, pruritus, lip swelling and lip pruritus. On an unknown date, the outcome of the swelling, pruritus, lip swelling and lip pruritus were not recovered/not resolved. It was unknown if the reporter considered the swelling, pruritus, lip swelling and lip pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and itching at various sites on his body (including the lips) which were ongoing till the time of reporting. The symptoms began approximately one week prior to 22nd November 2018.
Information has been received from a physician via a company representative referring to a 15 year old female patient. Information about concurrent condition, concomitant medication, medical history and reactions/allergies was unknown. In November 2017, the patient was vaccinated with GARDASIL 9 (route, batch/lot number and expiration date were not provided) for routine vaccination. On an unknown date in February 2018, the patient was ''admitted in the hospital with pancreatitis". The outcome of the event was unknown. The causality between the events and GARDASIL 9 was not provided. Upon internal review, pancreatitis was determined to be medically significant.
Cough, shortness of breath, pleuritic chest pain. -Spo2  94%. Temp: 98.7F. Treatment: Quarantine
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored PNEUMOVAX 23 lot# M005286 with expiry date: 08-OCT-2017 and Lot# M018766 with expiry date: 15-OCT-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Hospitalization for COVID-19 on dates 12/26/2022-12/29/2022. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Interstitial cystitis patient. Very bad flare up; Interstitial cystitis patient. Very bad flare up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; TYLENOL WITH CODEINE NO. 3; BENADRYL. Past drug history included: Zithromax, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Batch/lot number: E13246, Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Batch/lot number: EL9263, Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FC3184, Dose Number: 3), for COVID-19 immunization. The following information was reported: CYSTITIS INTERSTITIAL (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 07Jun2022 at 16:00, outcome "not recovered" and all described as "Interstitial cystitis patient. Very bad flare up". Therapeutic measures were not taken as a result of cystitis interstitial, condition aggravated.  No follow-up attempts are possible. No further information is expected.
Pt received injection,  immediately became dizzy, mildly anxious.   Dizziness lasted, 5-6 minutes and resolved without any intervention.  Pt monitored for 30 minutes, ambulated out of clinic independently.
Swollen lymph node, left armpit and fever - treated with ibuprofen - improved condition
63 year old male patient was admitted to the hospital 9/13/2021 for Covid-19 pneumonia after full vaccination with Johnson and Johnson vaccine in April of 2021.
Information has been received from an RN concerning a 77 year old Caucasian female pt with an allergy to penicillin who on 4/10/02 was vaccinated IM in the left deltoid, with a dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, the pt experienced injection site pain, swelling, itching and redness and the site was hot to the touch. It was reported that the symptoms were almost like a cellulitis and went down to the elbow. The pt was afebrile. The nurse reported that the experiences were severe and Benadryl was needed to be given to the pt. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent and did not have a problem. At the time of this report, the outcome of the events was unknown. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow-up information received from a physician reported that on 4/10/02, the pt was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 4/10/02, the pt developed erythema, edema and pain and was treated with over the counter Benadryl and warm compresses. The outcome of the events was not reported. No further information is expected. The nurse also reported that following vaccination with pneumococcal vaccine 23 polyvalent, 2 other female pts experienced injection site pain, swelling, itching, redness and warmth (WAES 0204USA01568 and 0204USA02064) and a 3rd pt experienced pain, swelling and redness (WAES 0204USA02065).
PT CAN'T DRIVE AND SAYS FEELS WORSE THAN HE HAS EVER FELT BEFORE AND HE IS IN A LOT OF PAIN
Came to clinic on 9/13/08 with c/o redness to eyes, visual disturbance, eye pain that was progressively getting worse. He was sent to ER on that date. Seen on follow up on 9/22/08, per MD report, patient was diagnosed with iritis by Ophthalmologist on 9/13/08. Given Sulfacet/Pred solution at that visit. Subsequent visit on the 22nd reports that iritis may have been associated with smallpox/anthrax vaccinations. Is now being referred to Neurology to assess to rule out a vascular event as a result of his immunizations.
Raynauds developed in third digit of the right hand. Tip was completely numb and white. Resolved after 20 minutes in hot water. No history of raynauds. Also headache and nausea and body aches.
This case was reported by a consumer (the subject) and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had never previously received a flu shot. Concurrent medications included VIVANCE. On 30 September 2010 at 18:15 the subject received a dose of FLULAVAL (unknown route, left arm). On 30 September 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness. On 01 October 2010, the subject experienced breast engorgement, impression of swollen breast, soreness breast, sore arm and soreness armpit. The subject reported left breast soreness, including her left arm underside and left armpit. The events began with a feeling of breast engorgement and swelling. At the time of reporting the outcome of the breast engorgement and impression of swollen breast was unspecified. The injection site redness resolved on 01 October 2010, and the other events were improved, but not resolved.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Approximately three minutes after receiving the HPV and Hep A  vaccines the patient was in a standing position and had blood running down his arm. As I was cleaning patient's arm he fell forward into my arms. He did not lose consciousness during the incident. Another nurse and his mother assisted in helping him ambulate to the treatment table. His vital signs were taken at 205 PM,  BP 103/63 and HR 76. He was also given an ice pack to place on his head and some juice. The patient reported only having cereal with milk after being asked if he had eaten anything. After drinking the juice the patient reported feeling better and had no reports of dizziness and was able to ambulate by himself  with his mother and family friend out of the clinic at 2:16 PM
1st dose 2018, can't remember getting the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th April 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The reporter was the patient. The patient could not remember if he received his second dose. He had nothing else to report. Additional Supportive Information: Till the time of reporting, it was unknown if the patient received his second dose which led to incomplete course of vaccination. This case was conservatively kept valid with event incomplete course of vaccination, clarification has been raised.
Approximately 2 months after my booster shot (dose 3) I experienced the following symptoms: Twenty-five cent piece-sized rash (it was flaky and scaly), itchiness. I saw my doctor about it and was prescribed with cortisone cream but I haven't gone to get one as of now yet.
9 year received Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Dtap vaccine (around 6 years of age) and Td vaccine (dose received in august 2022 at 8 years of age).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 year received Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 26-APR-2023 A nurse called in to ask for information about a 9 year old patient who received Boostrix vaccine.  The health care practitioner mentioned that patient received a Dtap at around 6 years of age and last August at 8 years of age patient got a Td vaccine. The health care practitioner asked why Boostrix could not be used in persons younger than 10 years of age. The reporter declined sharing information about the patient and the vaccine given lot number, expiry date. The reporter consented to follow up. The 9 year old patient who received Boostrix vaccine, which led to Inappropriate age at vaccine administration.
Arm has been hurting every since she received the injection. Her arm has been sore for almost 4 months and if she moves it a certain way it is increasingly painful. Received a steroid injection in Oct 2021 and it did not help it at all.
24 hours after the 2nd dose I became ill with heavy chills, temp of 100.2, joint and muscle pain, fatigue, hard, hot swollen, itchy left deltoid at the injection site, fatigue, headache and focus issues including light headedness affecting ability to walk. Symptoms lasted 24 hour with lingering fatigue, body aches and minor light headedness. 24 hours after injection I took ibuprofen and Benadryl. Applied cool compresses to the injection site.
Patient received Moderna COVID 19 vaccine EUA. Patient reported to nurse that she was "feeling weird" along with chest tightness at 10:30 am. Patient placed on non-rebreather and oxygen a 100% wide open. Vitals taken every minutes. EMS called at 10:36 am. Patient declined EMS. Patient monitored for one hours. Patient left clinic with her daughter.
Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 01-JUL-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169: US-009507513-1611USA010737.
Rash developed Lt deltoid (at injection site) and Rd side face, neck on 12/13/09. Rash has gradually worsened. Rash is red, raised, papules.
Mom took baby to ER at 20:40 because of crying, eye swollen and vomited. Possibly a reaction to shots given earlier. Fever to 100F; per mom on 11/10/2000.
Patient was given 2nd dose of Pfizer covid 5-11yrs 1/30/23 the vaccine was not diluted, as a result patient received a higher than recommended dose.  The covering provider & the parents of the patient were alerted as soon as the error was discovered. Per CDC guidelines the parent was advised of increased risk of of local and systemic adverse reaction due to the higher dose given. Patient will not have to be revaccinated.
On 19APR91 had fever 101 & mom gave APAP about 6PM @ 1030PM fever was 103 & stayed 103 all night; Seen by MD w/no visible signs of illness & was playing & eating w/temp 102; Developed rash on the back of her neck;
Pt reported that he was vaccinated with Shingrix # 2 on 27 May. Approx on 6 Jun while doing yard work he noticed a rash that started on his finger, then his wrist, inner bicep, legs, buttock and then on his left side going towards navel. Did have a few lesions on his eyebrow and neck area. Lesions described as vesicles and papules with some crusting and itching. All lesions were healing except area on abd in which new lesions were appearing. He states he is otherwise well. He went to an doctor on 18 Jun and was told that it appeared to be a contact dermatitis. HZV was doubtful. Was given a Medrol dos pak and an antihistamine. If area did not clear would consider culture/bx. Pt reports area is clearing. No new lesions appearing. Did not take photos of the rash and pt reports that he reported the reaction to GSK and that he thinks they filed a VAERS.  Symptoms: RASH&OTH NONSPEC SKIN ERUPTIO
c/o dizziness without other symptoms whatsoever.   TX - mask removal / airflow to car;  seat reclined x 8 mins.  seat to up right position after return of dizziness - able to stand without dizziness.   Drove off observation lot after 25 mins. total time.
On 10/12/00 the child was hospitalized for pneumococcal sepsis. A blood culture was obtained on 10/12/00 yielded the presence of streptococcus pneumoniae. The child recovered and was discharged seven days later. This case has been determined to be a duplicate of report HQ2678324OCT2000. A physician reported that a 4 month old male received his first dose of Prevnar, Hib-Titer, Acel-immune, IPV (manufact unknown), and his second dose of Recombivax-HB(MSD) vaccines on 21-Aug-2000.
Staff member described being ill and in bed for 3 days and also described having 'sporadic nose bleeds' during this time.  No further information reported and staff member has returned to work.
On 09/14/1999 pt was vaccinated with the first dose of varicella virus vaccine live in the left leg. On 09/22/1999 the pt experienced a few sparse red/pink spots, a few vesicles on the neck and trunk area. The pt was diagnosed with a mild case of varicella. On 09/28/1999 the pt continued to break out with vesicles on the face. Physician noted 35-40 spots altogether. Pt had no prior exposure to varicella.
Sedation, Myalgia, Arthralgia & Diarrhea Narrative:
REDNESS, FLU LIKE SYMPTOMS, WANTING TO DRINK FLUIDS STARTING THE EVENING OF THE DAY OF VACCINE ADMINISTRATION.
Patient stated on Saturday a.m. (9-12-15) she was sick at her stomach. She noticed arm being red, rash and swollen, red and warm to touch. Patient was in office today for blood work.
About 12:30pm on the 4/26 I was feeling nauseous and my energy level went from a ten down to a three. By 06:00-07:00pm my head and chest were hurting and my arm felt like it was going to fall off.  I could not lift my head from my pillow. The symptoms the first 3 days were very severe. On 4/29 my primary physician did a telephone call with me, they told me I may have the flu. The physician called me back and told me to go get a COVID 19 test done. The doctors were calling and checking in on me. My COVID test results were negative. I had a chest xray. By the 7th day I started to feel a little better. By the 10th day I was able to eat soup. My arm pain lasted for 20 days after my vaccine. My feet and ankles are swollen to this day.
I received the vaccine on Wednesday. On Friday I was tired but by Friday afternoon I had a fever, was congested, sneezing, exhausted and had a headache. These symptoms worsened through Saturday and Sunday and I also had a sore throat, joint pain and stayed in bed on Saturday and Sunday. Monday I still had a fever, congestion, sneezing and fatigue. Tuesday I am still fatigued, have congestion and brain fog.
Reports full immune response Reports full immune response to vaccine on 01/28/2021. On 02/05/2021 reported that the left ear was swollen, itchy arms, hives down legs and back.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 6th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses were give. The 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot  number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:master case
Pleuritic chest pain, emesis, shortness of breath, palpitations,  epigastric pain - albuterol with improved shortness of breath f/u 6/23 all symptoms resolved except epigastric pain
Several hours after vaccine was given, had arm pain/numbness, intermittent dizziness. Chest pain, shortness of breath, anxiety.
LEG PAIN; LEGS FELT REALLY HEAVY LIKE NUMB; NAUSEA; HEADACHE; RASH; This spontaneous case (PVX2019-779) was received from non-healthcare professional on 01-Apr-2019. It describes a 52-year-old female consumer who experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the last dose of Vivotif on 26-Mar-2019 and on the same day, she experienced nausea, headaches, rash, leg pain and numbness. She felt better on 01-Apr-2019 from the events. The rash did not spread, but her legs felt heavy like numb over the weekend.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events "leg pain" and "legs felt really heavy like numb". However, she was recovering with the event's "nausea", "headache", and "rash".  Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case.
Some pain at injection site in the 3 days following shot.  Pain mostly gone after that until two days ago. Now quite painful, making it difficult to sleep or function normally. I can't think of anything I did that would have caused the pain otherwise.
Round red and warm rash, itchy 9.5 x 8 cm, and swelling.
PATIENT ONSET OF COVID SYMTOMS WAS 8/2/21, AND TESTED POSITIVE TO COVID ON 8/11/21