chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very hot; indurated; itched; Red; huge, great big, rash; Saw an HCP 2 days ago who attributed her vision changes to optical neuritis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dry eyes. Concomitant products included POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS) for Dry eyes.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) (seriousness criteria disability and medically significant). On 30-Apr-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash). At the time of the report, OPTIC NEURITIS (Saw an HCP 2 days ago who attributed her vision changes to optical neuritis) had not resolved and VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (indurated), VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (huge, great big, rash) outcome was unknown.            Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-128857 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Local reaction at injeciton site started with bumps about 4 days after. Increased in size with redness, swelling or induration. No fevers or pain.
Fever in arm surrounding injection site. Rash spread throughout body over a 48 hour period. Deep bruising and pain at injection site and approx. 4" around it.  On 12/13/2010 I started Benadryl 2 each at 9:00 a.m. and continued it for 3 days until rash disappeared by 12/15/2010.  The red circle around injection site stayed for 3 weeks and bruising was still yellow and tender after 4 weeks.
Tenderness of entire upper arm, arm fatigue. Body Fever over 101 onset 24 hours after vaccine checked via ear, area larger then adult palm that is red, swollen, painful and 2 degrees hotter then rest of body temp.
Bell's palsy on 2013-06-18, clinician comment: presented 2 weeks after Tdap with right ear pain, then developed Bell's palsy one day later.
2 days vaccination with localized erythema at injection site.  25x13cm, resolved in 72 hours.
On October 3, the patient went to the pharmacy and got her flu shot.  A few weeks later, she realized she had limited movement in her arm because of pain.  She spoke with a friend who is a Physician?s Assistant and she said it sounded like Sirva.  The Patient visited her PCP, who prescribed prednisone, and also recommended the patient see an Orthopedic if the medication didn?t help.  The Patient saw an Orthopedic in November who  recommended physical therapy which was started last week. The patient mentioned on November 19th that her arm does seem to be getting a little better.
headaches; fever; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 57-years, on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had headaches and fever as side effects of the vaccine. By Wednesday (17Mar2021) she had a fever for 1 night and it broke that evening. She didn't take anything and let it ride it out. Until Thursday night (18Mar2021); everything was fine. Side effects which was mentioned and not overly ill. The outcome of the events was resolved in 18Mar2021.  Information on the lot/batch number has been requested.
pt awake in AM w/hives in clusters over lt leg below knee w/urticaria t101; 10Am spread to lt thigh seen by MD put on DPH; dx due to allergic react to MMR; 12N stills spreading-some on rt calf & lt arm;
pt said her arm hurt immediately after taking the vax and she experienced strange pains in random spots.  She got home and was very dizzy.  She was stiff and achy.  Today she woke up feeling wiped out, very fatigued.  She has a slight fever, chills and pains.  She has taken 2 Bayer aspirin.
Information has been received from an epidemiologist concerning a female pediatric patient who was vaccinated with MMR. Subsequently, the patient developed mumps. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Patient received second Tdap vaccination on 2/13/2020 at our clinic but had already received another Tdap at a outside hospital on 09/09/2019.   Patient was informed yesterday about this and was advised to monitor her left arm injection site for swelling or redness and to monitor for fever or other concerns.  She was feeling well the day of her visit on 2/13/2020.
Per provider notes: Received Moderna vaccine dose #1 here at the clinic. Shortly afterwards she developed chest pain and I was called to evaluate her. Here with her aunt who provides history: pt with epilepsy, last seizure 1 week ago. Does have history of seizures after vaccines in the past and also after contrast medium. Usual prodrome of chest pain prior to seizure. Seizures are typically managed at home unless there are features that are out of the ordinary, then goes to ER. No history of any heart or lung problems.  In speaking to pt directly, she complains of strong pain in her chest and also feels lightheaded. A little difficulty breathing with the chest pain. No throat irritation or swelling. "
Patient was given HPV and Flu vaccines at approximately 10:00 a.m. mom refused to wait the 20 minutes and signed the waiver and walked to check out and patient was standing there and passed out. He did not hit his head. Pt was assessed by Dr and LPN. B/p was 130/74 and HR was 104. Pt was sat in a chair to monitor cool compresses were applied, then pt was taken to exam room to lie on a bed. B/P was 118/68 and HR was 78 prior to leaving. Left with no visible injuries or ill effects.
pain is generalized all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate and ibuprofen.   On 05-JUN-2023, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. On 06-JUN-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: pain is generalized all over his body). The patient was treated with non-drug therapy (Cold Pack). The outcome of the general body pain was not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUN-2023. The reporter was the consumer who received his second dose of Shingrix (left deltoid) on 5 June 2023.   The consumer gave himself an injection of Methotrexate in his right leg on 4 June 2023 the day before getting the Shingrix vaccine.  The consumer stated that he had been taking Methotrexate for 4 years to treat Rheumatoid Arthritis.  Consumer reported pain the day 6 June 2023 after getting the Shingrix vaccine.  The reporter stated the pain was generalized all over his body and stated the pain gets worsen at night.  The consumer was currently taking Ibuprofen 3 times a day and applying cold packs to painful areas. The reporter consented to follow up. Consent to follow up with healthcare professional was obtained.
Arm soreness; Felt "crappy"; Fatigued; Flu-like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, malaise and fatigue. On an unknown date, the outcome of the pain in arm and malaise were unknown and the outcome of the influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced arm  soreness that lasted a few days and the patient also felt crappy, which she described as fatigued and also experienced flu-like symptoms for 2 days.  The patient did not want to receive the 2nd dose of Shingrix, and the patient was already late for the 2nd dose but possibly would not receive it at all. The reporter did not consent to follow-up.
Inflamed, red, warm to touch upper arm, deltoid are with 50/50 mm red area. Temp 98.1.
The patient had already received a dose of Influenza vaccine on 10/09/2023. The team failed to check the system and vaccinated her again on 10/25/2023.
mom states pt suffered a sz 16hr p/vax;eyes rolled back & seemed to jerk & turn gray;sz disorder uncertain underlying etiology w/t99.2 R;
4/9/2022 Developed Bells Palsy - right side facial paralysis the day after receiving the Pfizer booster 4/8/2022. Lasted for a little over a month.
Pt reports GI symptoms (nausea, vomitting), tingling in fingers, fever. Pt believes she has developed Guillian Barre.
scattered red-based vesicular & excoriated lesion on trunk w/a few on the limbs & one on the lt palm, soles & rt medial thigh;post vaccine 31DEC98 itchy lump on rt medial thigh;5JAN99 h/a & first of many scattered itchy red blisters;
Slight paresthesia of fingertips 12/30 Aching and weakness in legs 01/01 Increase weakness in legs and hospitalized 01/06  01/28/05 Pt states he had hx of a headache and lethargy early in December.  Wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December,'but I didn't get it', and back pain on 12/17 which went down his leg 'like sciatica'. Pt continues with out pt therapyand finds fatigue most difficult part of recovery.  02/16/05 Discharge summary received for 1/6-1/13/2005 FINAL DX: Guillain-Barre syndrome & spinal headache, improved.  Time line is FluMist vax on 12/29/04, developed leg pain, weakness and numbness starting 01/01/05. He was evaluated in PMP on 01/06/05 and admitted w suspected onset of GBS.  Exam revealed deceased reflexes and increased CSF protein. Was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 01/13/05 w/outpatient rehab & Neuro f/u.
Patient received Pfizer vaccine began to feel unwell states he was having heart palpations & tachycardia . transported to ED, patient has a history of SVT, he currently takes atenolol occasionally for hypertension. Patient did not have wheezing, rash, itching, was chest pain free.   Atenolol given B/P  improved and he was discharged.
No adverse event reported by patient.  We received communication from home office that although vaccine had expired (we were using the beyond use date from when we received product) that revaccination was not necessary.
Wheezing and redness of face shortly after vaccines given.  Treatment - Epi-Pen, Benadryl, Prednisone.
To initial reaction, then on 4/10 had flu like symptoms and neck, shoulder, and hip joint pain but gone by 4/17.  Then started again on 4/22 through 4/27, but gone again then started again 5/1 to 5/3.  On 5/1 while rubbing shoulders noticed hard lump on left upper arm (where I was injected with shingles vaccine) then by 5/3 gone and the lump almost gone. On 5/7 started to get sore throat, had bubbles in throat and again infection, but then almost clear on morning of 5/8, but still flu symptoms and small lump.  On 5/8 the physician was able to feel the small lump where I was vaccinated and see throat infection.  Physician ordered antibiotics and currently running blood tests - based on above asked me to file report.
Child had received a vaccine on 11/30/2009 according the the state registry.  The clinic was not notified.
Narrative: COVID infection following COVID vaccine series 01/13, Pfizer, dose #1 02/03, Pfizer, dose #2 08/05 pt cc: chills, cough, fatigue, fever, rhinorrhea, dyspnea exposure; unknown 08/06 - 08/18 symptoms continue 08/16 COVID swab, result: detected 08/16 SARS-COV-2 LINEAGE AY.4 08/16 SARS-COV-2 CLADE 21A DELTA
A patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-AUG-2021, the patient was vaccinated with one dose improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U009262 (rHA) and expiration date 19-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -3.3 degree celsius (°C) for 4 hours 52 minutes; no previous temperature excursions were reported.
flu-like symptoms; tingling pain; running nose; cough; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q4h. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.   This case was linked to MOD-2021-254052 (Patient Link).
Patient received second dose of COVID-19 Pfizer Pediatric dose today. Patient felt dizzy/light headed and fell to the floor during the 15 minute waiting time after the vaccine to monitor for allergic reaction(s). Patient was alert at time of adverse event. 911 was called and patient was taken to hospital
8-19-2014 at 8:30am mom noticed redness and swelling to injection sites and warmth to area as well. Later that night redness was increasing in size with same previous symptoms mom brought patient to clinic where patient was diagnosed with cellulitis and was started on antibiotics (clindamycin).
Information has been received from a physician concerning a 60 year old female consumer who on 20-MAR-2008 was vaccinated with 1 dose of ZOSTAVAX.  The next day (21-MAR-2008) the patient presented with a little raised rash at the injection site.  Unspecified medical attention was sought.  At the time of the report the patent had not recovered.  There was no product quality complaint involved.  Follow-up information has been received from a registered nurse concerning this 61 year old (also reported as 60 year old) female consumer with sulfonamide and erythromycin allergies who on 19-MAR-2008 at 07:53 was vaccinated SQ in the left arm with a first dose of ZOSTAVAX (lot # "1857U").  There was no illness at the time of vaccination.  Subsequently, on 21-MAR-2008 the patient developed 5-6 cm erythema around the injection site and a group of vesicles right at the injection site.  On an unspecified date the patient recovered.  Additional information is not expected.
Brief LOC with nausea, feeling warm, tingling to hands, dizzy, Resolved with rest and po fluids
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever 101-104 ongoing 8 days after vaccine; rigors; fatigue; This is a spontaneous report received from a contactable consumer (patient, self-reported).  A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730 and expiry dates were not reported), via unspecified route of administration in left arm on 25Mar2021 at 02:30 PM, as single dose for COVID-19 immunization. The patient's medical history includes occasional migraine and remote pneumonia. The concomitant medication included Multivitamin and Vitamin D. It reported that, on 26Mar2021 the patient experienced Fever 101-104 ongoing 8 days after vaccine, rigors and fatigue. The patient underwent lab test 24 hours post vaccine that was COVID test negative, also negative COVID Ab, increased inflammatory markers CRP, ESR, Ddimer, abnormal CBC and large platelets, mild hemolyzed blood in urine with otherwise negative UA, blood cultures x 2 negative. Vaccination facility: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 (Nasal Swab) and after the vaccination the patient been tested for COVID-19. The patient received ongoing tx with antipyretics, monitoring ongoing as corrective treatment for the adverse event. The outcome of the patient's event drug ineffective and COVID-19 was unknown and other events (fever, rigors, and fatigue) were not recovered.   Follow-up (02Apr2021): This is a follow-up spontaneous report received from a contactable physician. This physician reported for her son (Patient). The non-significant information updated.  Additional information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.
Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin); high fever; shaking chills; tachycardia; pleuritic chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: VASCULAR HEADACHE (non-serious), outcome "recovered with sequelae", described as "Worst persistent headache of my lifeHeadache felt like vasculitis (vascular origin)"; PYREXIA (non-serious), outcome "recovered with sequelae", described as "high fever"; CHILLS (non-serious), outcome "recovered with sequelae", described as "shaking chills"; TACHYCARDIA (non-serious), outcome "recovered with sequelae"; PLEURITIC PAIN (non-serious), outcome "recovered with sequelae", described as "pleuritic chest pain". The events "worst persistent headache of my lifeheadache felt like vasculitis (vascular origin)", "high fever", "shaking chills", "tachycardia" and "pleuritic chest pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vascular headache, pyrexia, chills, tachycardia, pleuritic pain.  Additional information: Worst persistent headache of her life that started within several hours of the vaccination, proceeded by high fever and shaking chills. Headache felt like vasculitis (vascular origin), unremitting and unresponsive to usual abortive medical management (acetaminophen, NSAIDs, migraine meds, etc.) with persistent tachycardia and pleuritic chest pain. Patient did not receive  other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300280974 same patient, different vaccine dose/event;
Patient received Fluvirin prefilled syringe (NDC 66521-0118-02) on 10/2/15.  On 10/6/15 she experienced fever, aches (legs and back), coughing, fatigue.  Patient stated symptoms resolved on 10/10/15.
bilateral rash/itching on ear lobes, rash/itching/swelling suborbital region, diffuse rash on forehead. bump on right side cervical region.
16 year old twins received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067052 (Patient Link).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.