chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm soreness; left armpit lymph nodes swollen; arm tenderness; I developed paralyzing pain in the lower back on the left side; I still have pain in the lower back on the left side and armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization, reaction(s): "left armpit lymph nodes swollen", "left arm soreness". The following information was reported: BACK PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "I developed paralyzing pain in the lower back on the left side"; AXILLARY PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "I still have pain in the lower back on the left side and armpit"; TENDERNESS (non-serious) with onset 27Nov2022, outcome "not recovered", described as "arm tenderness"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2022, outcome "not recovered", described as "left arm soreness"; LYMPHADENOPATHY (non-serious) with onset 27Nov2022, outcome "unknown", described as "left armpit lymph nodes swollen".  Additional information: 25Nov2022 evening received booster left arm. 27Nov2022 in addition to left arm soreness and left armpit lymph nodes swollen (Happened with previous vaccines for Covid), the patient developed paralyzing pain in the lower back on the left side, this never occurred previously. Today the patient still has pain in the lower back on the left side and armpit and arm tenderness. No other medications or underlying conditions. This was a self-report. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Within one hour, the pt developed generalized itching and a welt on the injection site, elbow, and each leg. She was treated with oral Benadryl and recovered.
had first one, going through Shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (level of pain once before back in the early 60's).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine and going through shingles now. The patient reported that he/she could only remember going through this level of pain once before back in the early 60's. The patient reported that hopefully on the downhill of this thing. The patient reported that as soon as he/she was cleared, he/she would getting that second shot. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Leg is weak; Knee goes out and she tips over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Leg is weak"; JOINT DISLOCATION (non-serious), outcome "unknown", described as "Knee goes out and she tips over".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Debilitating pain in left arm, exceeding that of a broken limb.  101*F fever, chills, sweat spells, body ache, headache, mental fog, upset stomach.   I've never felt more sick in my life.  Would have gone to ER however my wife suffered the same vaccination reaction (was vaccinated at the same time/location) and was unable to drive.
No adverse event Patient received expired Moderna dose Exp. Date: 10/13/2021 Date Administered: 10/14/2021
RN administered the orange 5-11 year old  dose rather than the 12 year+ dose
Sore muscles and joints, headache, red face, difficulty sleeping - no redness or swelling to injection site.
Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced; Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose 2, single (Lot number: EW0180) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "nerve pain in my left arm", start date: Jan2021 (unspecified if ongoing), notes: Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior. Concomitant medication(s) included: CLARITINE; ACIPHEX; SINGULAIR; LIPITOR; VITAMIN D2. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW-0187, Location of injection: Arm Left, Manufacturer: Pfizer), administration date: 22May2021, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: NEURALGIA (non-serious), DISEASE RECURRENCE (non-serious) all with onset 14Jun2021, outcome "recovered" and all described as "Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced". The event "reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neuralgia, disease recurrence.  Additional information: Reoccurrence of nerve pain in his left arm from an incident that occurred 6 months prior. The prior issue was resolved via physical Therapy. He had no issues for several months. After the second dose of the COVID 19 vaccine the nerve pain resurfaced. He had the injection in his left arm. He had to go through PT to resolve the pain. No other vaccine in four weeks. No covid prior vaccination.
PT had MMR vax on 1/13/03 and on 2/4/03 noticed swelling to left side of jaw-line to left cheek. Area involved was an ache without pain. No discoloration. Low grade fever of 99.2 deg F on 2/4/03. Saw MD that night, who confirmed mild reaction to MMR vax. On 12/02 titers for measles & mumps were negative for antibodies.
Mosquito bite redness, which has now progressed to elbow worsen's with agitation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation). At the time of the report, VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a pharmacist referring to three patients of unknown age and gender. On unknown dates the patients was vaccinated with improper stored ZOSTAVAX (lot # reported as L017138, expiration date 13-AUG-2016, dose and route were not reported). The vaccine was exposed to 20F for 8 hours. No adverse effects were reported. Additional information has been requested.
On 11/08/2001 the patient's mother noticed redness, swelling and warmness. The patient was seen by the Dr on 11/09/2001 and diagnosed with erythema and swelling of the left upper thigh. The patient was treated with Motrin and Benadryl.
pt recvd vax;began to scream & fussy w/in 2 hrs;by 8 hrs uncontrollable screaming x 2 hrs;apap given;was pale,dec appetite;not fine for 2 days w/ poor sleep; fussy & poor intake;
6 days, post vax, pt developed a high fever for 3 days and then a rash on body only. 8 days, post vax, pt had 1 small patch of tiny blister-like rash on stomach. The day after vaccines, the pt's eyes oozed green goo, but felt it might be related to a cold. (Never seen anything like it).
This case was reported by a consumer via call center representative and described the occurrence of aura in a 57-year-old female patient who received BOOSTRIX for prophylaxis. Co-suspect products included LAMICTAL unknown for epilepsy. Concurrent medical conditions included epilepsy. Concomitant products included CLARITIN, IMODIUM and ZOCOR. On 25th May 2018, the patient received BOOSTRIX .5 ml. On an unknown date, the patient started LAMICTAL (oral) 500 mg once daily (500 mg daily). On 25th May 2018, 9 hrs after receiving BOOSTRIX and unknown after starting LAMICTAL, the patient experienced aura. LAMICTAL was continued with no change. On an unknown date, the outcome of the aura was recovered/resolved. The reporter considered the aura to be almost certainly related to BOOSTRIX and LAMICTAL. Additional information was received as follows: The patient had surgery to had piece of brain removed for epilepsy treatment. The patient was using multivitamin and PROTONIX as concomitant product. The patient stated that she had a history of epilepsy and states that she had not any seizure activity in 34 years. Nine hours after receiving the vaccine, the patient stated that she had aura and she had it again about 2 hours after first experience. The patient panicked because she usually gets aura prior to having a seizure. The patient did not experienced, however, had a seizure, but rather it was a chemical reaction. The patient had the product information (PI) and stated that read the ingredients, but asks if thiomersal was one of the ingredients in BOOSTRIX. The patient stated that thiomersal was known to cause seizures. The patient informed that she could not find any mention of thiomersal in the PI but suggested that she had her health care professional (HCP) call our medical information department. The call center representative mentioned that the patient uses LAMICTAL as preventative treatment for her epilepsy so it was listed as a suspect product. The patient did not feel that the LAMICTAL was what caused her symptoms. The patient's primary care physician was aware of her symptoms.
patient inadvertently received Tdap and MENACTRA that was meant for older sibling. Therefore get MENACTRA and Tdap earlier than usual schedule
Pt recvd vax & began to exp a serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular diseases, & been non-diagnostic;
Large swelling, redness, itching below injection site. Swelling lasted 24 hours, redness and itching lasted a week. Area was about a 5 circle.
This spontaneous report as received from a medical assistant refers to a 26 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-SEP-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 dose, lot # N003697, expiration date 13-MAR-2018 (route of administration was not reported) instead of the scheduled one dose of VARIVAX. Concomitant therapies included sterile diluent. No adverse effects were reported. The outcome of wrong drug administered was unknown.
On 01/31/2021 that night her arm started to itch a lot looked down at it saw that it was a large hive with with small bumps on her right arm. Most of the welts was on her fingers stated that they hurt so bad she couldn't move and then they started to spread on her left hand. On the 5th of February went to see an allergist showed them her rash they told her that they didn't know anything about it. On February 12th stated she could barely make a fist with her right hand and couldn't move it. Called her physician doctor and went in to see her that afternoon and recommended a steroid which was a day course of prednisone. Took the first pill at Friday night on the 12th almost all her hives were gone; the itching had stop; and she could move her hand completely .
Runny nose, temperature, headache, fatigue; and I passed it to my nine year old cat, who is very sick.
Within just a few minutes patient(nurse) leaned back in chair and appeared to pass out(while seated the entire time)- came to in just a few seconds and was confused and slightly upset and began sweating.  WE fanned pt and got her a bottle of cold water, wet paper towel  and cold pack for her neck. (pt also requested a Sprite and saltine crackers while waiting on her ride-which we provided to her)  Two  associates stayed in the booth with pt until 10:56 when she felt better (then just one associate stayed with her) and was just waiting on her ride to pick her up.  Pt blood pressure was 107/65 with pulse rate 65.  Pt was refused ambulance multiple times.  Pt left feeling better with her ride around            11:20.   Called pt around 1:21 pm and she stated that she was doing her homework and felt better but was still experiencing slight nausea off and on >
Patient received influenza vaccine 10/7/2010.  Patient has not had problems with prior influenza vaccines.  He presented to the ER on 10/14/2010 for gradual LUE numbness and weakness after receiving the shot.  Patient is still being monitored for this reaction as it has not subsided.  Differential from MD include:  ulnar neuropathy after influenza immunization question of adverse reaction to influenza vs technique vs idiopathic reaction.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (FEVER, COUGH, BODY ACHE AND CHILLS); DIZZINESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, (dose number in series was 1), 01 total, administered on 10-JUN-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced suspected covid-19 infection as had fever, cough, body ache and chills (suspected clinical vaccination failure). on the same day, laboratory data included: Covid-19 virus test (home test) which resulted positive. On DEC-2021, the patient experienced dizziness (dose number in series was 1). He also stated that no other issues after receiving vaccine on 10-JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (fever, cough, body ache and chills), and dizziness, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209085.; Sender's Comments: V0:20211259381 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Treatment information was not provided by reporter.   This case was linked to MOD-2021-225634 (Patient Link).
4 year old patient rec'd Fluzone High Dose, no treatment necessary, no adverse reaction.
Information has been received from a nurse concerning a 12 year old female patient with a history of a premature atrial contraction who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 661046/0381X). There was no concomitant medication. On 22-SEP-2209 the patient's mother called 911 and the patient was taken to the Emergency Room (ER) and diagnosed with syncope and sinusitis. The mother believed it was due to the vaccine; however the nurse did not think that it was. There as an about two month's delay, almost a three month between the injection and the syncope. The patient received AUGMENTIN. At the time of the report, the patient was doing well. Additional information has been requested.
pt recv vax 12JUN95 & 20JUN pt exp t102 & episode of sz; pt was hospitalized for observation; upon hospitalization dx w/OM & URI; given Ibuprofen, Amoxil & APAP;
Pt recvd 1st dose vax; same day exp h/a; later exp joint pains, rash, hives; felt tired, exp itching; sx abated w/o treatment
Case number PHEH2015US019326, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO, batch number: M14097, expiry date: 31 Dec 2015) on 18 Jun 2015 and vaccine administered was stored in 34.0 degrees Fahrenheit and 50.2 degree Fahrenheit for 48-120 hours. No adverse event was reported following this maladministration. Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient's details (height and weight) were provided. MENVEO batch number was changed to M14070; the vaccine was administered intramuscularly on the right deltoid.
Too young. Mom reports child did better with the second dose of the Moderna than the first dose. Child's mom startes her child started experiencing symptoms a few hours after receiving the vaccine; the evening after receiving the vaccine - she received her vaccine in the afternoon somtime. Symptoms included; body aches and tiredness. Denies any fever or chills. Mom reports that by the next afternoon her child was feeling normal.
This initial serious spontaneous case, was received via company on 20-Jul-2017, reported by other health professional (nurse) concerning a female patient of unknown age. This initial serious spontaneous case, was received on 20-Jul-2017, reported by other health professional and concerns a female patient of unknown age. The patient's concomitant medication included MDV (dosage unspecified) with unknown preservative, taken, since an unspecified date. On an unspecified date in 2001 or 2002 (as reported) in the afternoon, the patient (nurse) was administered with influenza virus vaccine polyvalent (dose, route of administration, anatomical location, batch number, trade name, manufacturer was not reported). On the same day, in the late evening, after administration of INN Flu Vaccine Seasonal, the patient experienced rash allergic reaction (as reported) which required a visit to the emergency room. On an unknown date, the patient recovered from the event.
Given on Friday, 5/11/12. States that by the next day there was a blister at the vaccination site. It has been sore. Today, Monday, 5/14/12 the blister is gone but there is reddened skin there with yellow scabbing. It still is sore.
Severe joint pain and gastrointestinal upset (like an IBS attack). Joint pain lasted for two weeks, abdominal pain is still going on.
Acute exacerbation of CHF (congestive heart failure). ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
after administration of the vaccine, I realized this was her first vaccination of covid and she should have received the monovalent instead of the bivalent vaccine.  Currently no adverse reactions to the medication
CHILLS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non smoker, non alcohol user, mold allergy, cat allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced injection site pain. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 07-APR-2021, and injection site pain on 06-APR-2021. This report was non-serious.
Information has been received from a RN concerning a 12 yr old male with no allergies or medical history who on 04Jun98 was vaccinated with a dose of varicella virus vaccine live. On 27Feb06, the pt developed a rash on his back, chest and legs for three days. He was seen in the physician's office on 01Mar05. The physician noted that he had 50 to 100 lesions and was diagnosed with varicella. A product quality complaint was not involved. Additional information has been requested. It was reported that the pt's brother has a similar reaction after therapy with varicella virus vaccine live (WAES0602USA04848). It was also noted that the patient's brother was diagnosed with chickenpox about 10 years prior to the patient's outbreak.