chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT WAS AT COVID VACCINE POD TO RECEIVE SECOND COVID VACCINE. NURSE MISUNDERSTOOD THAT PATIENT WAS TO RECIVE DIFFERENT MANUFACTURER VACCINE AS SECOND DOSE AND GAVE IT AS SECOND DOSE. BOTH VACCINES ARE BEING ADMINISTERED AT THIS TIME DUE TO ADDITION OF PREVIOUS MANUFACTURER. SO THERE WERE FIRST AND SECOND DOSES OF OTHER MANUFACTURER SCHEDULED AND SECOND DOSES OF INTIAL MANUFACTURER.  PATIENT WAS NOTIFIED IMMEDIATELY AND TO DATE NO ADVERSE EFFECTS HAVE BEEN NOTED.
Per the Registry facility administered a single dose of Moderna vaccine on 12/30/2020. We administered a dose of Pfizer vaccine on 4/21/21 under the assumption this was the resident's first dose of COVID-19 vaccine.
Sharp left shoulder pain aggravated by lifting, movement. Pain with ADL's, decreased mobility, joint pain. joint tenderness, popping.
The pt developed a fever of 99 deg F, and a rash on torso. On 05/22/2002, temp went up to 106 deg F with rash. He was then taken to ER. On 05/23/2002, erythematous macular rash, extensive adenopathy were noted.
Approximately 15-20 minutes after vaccination patient developed weakness in her limbs.  BP and glucose were normal.  Approximately 10 minutes after the onset of symptoms the patient developed bright red rash on the face, increased breath rate, and swelling of the lips and tongue.  She was having difficulty talking due to shortness of breath and swelling in the tongue.  911 was called and epinephrine 0.3mg IM was administered as well as diphenhydramine 100mg orally.  Her rash improved fairly quickly, swelling went down a small amount.  She stated breathing still felt labored and she was feeling like her heart was racing but she was also tired (likely due to medications administered).  She was still having difficulty talking, taking short breaths between almost each word.  Paramedics arrived approximately 12 minutes after epinephrine was administered.  They attempted to walk her to the ambulance per her request, however she was unable to feel her legs.  She was placed on a stretcher and into the ambulance.  The patient stated she was given additional epinephrine in the ambulance as her condition had worsened by the time they got her in there.  She was taken to the ER and given additional diphenhydramine and was observed until approximately midnight, when she said she was discharged.  Follow up was completed the following day, and she had improved dramatically.  She was still feeling a bit weak, but no longer had any issues breathing.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 03-OCT-2014, the patient was vaccinated with an improperly stored 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously that was exposed to 20 F for 139 hours. No adverse effect was reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna, vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2022 as dose 4 (booster), single (Lot number: 069H21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "not recovered", described as "vaccine brand other: Moderna, vaccine brand: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had treatment with Paxlovid started on 13May2023 and stopped on 18May2023. known allergies: no.
I had period spotting for 5 weeks from July 4 - August 11. Then I had heavy menstrual clots for a week. This was my first period after the Covid shot.
1-2hrs p/vax given pt devel pallor & perioral cyanosis which lasted approx 1hr;
This is a spontaneous report from a contactable pharmacist. An elderly male patient who was more than 65 years, received PREVNAR 13 on 22May2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness at his whole upper arm on an unspecified date with outcome of unknown. Information on the batch number has been requested.
Severe Swelling in the arm, Redness, Fever to the touch, itchy, painful, patient had fever. As of 5pm on the following day patient still has side effects and it is not getting better yet.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a week after the 1st shot the entire arm was red and swollen, (upper half).) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (a week after the 1st shot the entire arm was red and swollen, (upper half).). At the time of the report, VACCINATION SITE ERYTHEMA (a week after the 1st shot the entire arm was red and swollen, (upper half).) outcome was unknown.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant drugs was provided. No treatment drug information was provided by the reporter. This case was linked to MOD-2021-404816, MOD-2021-404738 (Patient Link).
My mother received her fourth COVID-19 booster shot on April 22, 2022.  My mother had previously suffered hallucinations, psychoses, and paranoia among other symptoms after reviving her first two vaccines in April 2021. She had to be hospitalized for a long time and then to a nursing home. On May 16, 2022, my mother collapsed. She was found to be in Acute Renal Failure due to Acute Tubular Necrosis.  I conducted some research and learned that Acute Tubular Necrosis was occurring four weeks AFTER receiving the COVID 19 Vaccines. My mother was literally four weeks status post from receiving her fourth injection. My mother was hospitalized and started on dialysis. While in the hospital, her hemoglobin and hemocrit kept falling, requiring her to have numerous blood transfusions. Multiple tests and procedures were unable to locate the source of the bleed.  My mother was in the hospital until Tues, May 31, 2022.  She was discharged home. Within a couple hours, my mother suffered some type of stroke, which caused her to vomit and aspirate, causing respiratory distress. This then caused acute cardiac failure. My mother was deprived of oxygen for over eight minutes before they were able to resuscitate her. Unfortunately, the brain damage was too extensive and she passed away on June 9, 2022.
A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 14-year-old female. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Information has been received from a registered nurse concerning a patient who in approximately October 2005, was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes).  Subsequently the patient developed an injection site reaction.  No further details pertaining to the site reaction were available.  Unspecified medical attention was sought.  The patient subsequently recovered.  Additional information has been requested.
allergic reaction to the 1st COVID vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history included allergic to a peg from an unknown date and unknown if ongoing, it was reported that her allergist told her she was allergic to a polyethylene glycol (PEG) and she wanted to know if that PEG was in a product that she was using at home for hair dye. The patient concomitant medications were not reported. The patient experienced an allergic reaction to the 1st COVID vaccine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Neurological Symptoms started in July but I started getting seen in August. Memory Loss, Cognition Loss, Fatigue, Tingling/Pins & Needles in arms and legs, loss of hand mobility, stinging pain, muscle weakness, Trigeminal Neuralgia, brain lesions, demyelinating brain lesions.   I developed Pseudotumor Cerebri after my booster shot in February 2022. Symptoms that lead to that diagnosis are Vision issues (blurry vision, vision goes out if I touch my eyes for a few seconds), Tinnitus, Stiff neck, and significant increase in Migraines. I typically get migraine with aura once or twice a year but before my Lumbar Puncture and receiving Diamox, I was receiving that almost daily. I went to the ER and got a Migrain cocktail which knocked them out for a few days but they came back after.   I was referred to a Neurologist after I went to the ER for Trigeminal Neuralgia. Once I received a MRI, it was discovered that I had 20-30 brain lesions, some of which were demyelinating. I was sent to MS specialists but after rigorous testing it was determined that I do not have MS. I've done a ton of tests and lab work and there is still no cause found for my symptoms and lesions  My contract was terminated at my job due to my symptoms and side effects affecting my work quality. I've had to step back from working the past few months due to all of my issues and inability to remember anything, process anything  and inability to function on less than 12 hours of sleep a day.
From initial info received on 8/27/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 51 year old female pt received a dose of TD ADS ADULT, lot U1020AA, administered ID in error, in the left arm on 7/20/04. That same day, the pt developed cellulitis of the left arm at the site of injection. No treatment was required and the pt recovered from this event. From additional info received on 10/1/04, from an RN, the pt's full name, address and telephone number were provided. Reportedly, the pt did not have any illnesses at the time of vaccination. The reporter had no additional info at this time. No further info is anticipated. This case is considered closed.
Within 30-60 minutes of vaccine, patient developed swelling and redness and pruritis of left upper arm, below injection site. Mother reports that immediately after injection, patient had bleeding (more than normal). On exam 1 day later, there is a 11cm x 6.5cm indurated erythematous patch on left deltoid region, with visible injection site superior to patch. Nontender to palpation. No fluctuance. No other skin rashes/hives present. No shortness of breath, trouble swallowing, facial swelling, lip swelling, vomiting. She did have some mild abdominal pain this morning (usual type of pain for her). She has had multiple flu vaccines in the past with no reaction. No other vaccine reactions in the past. Questioning whether injection ended up subcutaneous rather than intramuscular.
A consumer report has been received. The report concerns a 14 year old, female consumer, who had been receiving FLUMIST, 0.2 milliliters, once/single administration. FLUMIST started on 09-NOV-2012. The patient experienced moderate runny nose and moderate stuffy nose, which started during Nov-2012. Swollen sub mandibular glands, three sinus/3rd sinus infection and respiratory infection. At the time of reporting the event of swollen sub mandibular glands, runny nose, stuffy nose, three sinus/3rd sinus injection and respiratory infection was ongoing. The report was considered to be non-serious.
no adverse events; improperly stored vaccine administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and drug allergies/reactions was not provided. On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, schedule, route of administration, anatomical location was not reported) of lot# R023736 having expiry date of 20-AUG-2020 for prophylaxis (product storage error). The diluent used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. No additional adverse events. The vaccine underwent a temperature excursion of -9 degree celsius to 8 degree celsius (0.9 celsius) for a duration of 15 hours and 15 minutes. The vaccine underwent a previous temperature excursion of - 14 degree celsius to -10 degree celsius (-13.04 celsius) for a duration of 45 minutes. There was no involvement of data logger. No associated product quality complaint.
p/vax pt dx w/chickenpox;pt had a few bump to break out & was not sick;
Very tired; Fever of 99.8; Occasional chills; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received the 1st dose of Shingrix. On 1st October 2021, 1 days after receiving Shingrix, the patient experienced fatigue, fever and chills. On an unknown date, the outcome of the fatigue, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever and chills to be related to Shingrix.  Additional details provided were as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received a dose of Shingrix and on the next day, the patient was very tired, had a fever of 99.8 degree F and occasional chills. The patient asked how long did the side effects last. Follow-up would not be possible as no contact details available.
On day 19 after the vaccine was given I tested them for antibodies to the virus, they both were negative for IgM and IgG.; This is a spontaneous report from a contactable Physician who reported similar events for two patients. This is the first of two reports.  An 84-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eh9899), intramuscular in left arm on 29Dec2020 10:30 at single dose for covid-19 immunisation. Medical history included hypertension, benign prostatic hyperplasia, lipids increased. Concomitant medication included asa (ASA), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), finasteride (unknown manufacturer), fish oil (unknown manufacturer), hydroxychloroquine (unknown manufacturer), furosemide (LASIX), atorvastatin (LIPITOR), lisinopril (unknown manufacturer), levothyroxine sodium (SYNTHROID), vitamin b complex (unknown manufacturer), vitamin c [ascorbic acid] (unknown manufacturer), vitamin d3 (unknown manufacturer), zinc (unknown manufacturer). On 17Jan2021, day 19 after the vaccine, the patient was tested for antibodies to the virus, and was negative for igm and igg. Test was negative also on 18Jan2021, day 20 after their vaccination, the day before his second vaccination. No treatment was performed.  The outcome of the event was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086757 same reporter/drug/event, different patient
My right arm was sore and headache. Woke up Friday morning and my right armpit was swelled up and sore to the touch, it hurt to put deodorant on.
without any residual effects experienced; the consumer was inadvertently administered 2 PNEUMVAX 23 vaccines/ the first dose was given 23-JUN-2020, and the second dose was given on 05-OCT-2020; This spontaneous report was received from a registered nurse and refers to a 68-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUN-2020, the patient was vaccinated with a 1st dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 time dose (lot # T007790 was confirmed to be valid, expiration date was reported as 03-DEC-2021) (route of administration and anatomical location were not provided) for prophylaxis. On 05-OCT-2020, the patient was inadvertently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 time dose (lot # T007790 was confirmed to be valid, expiration date was reported as 03-DEC-2021) (route of administration and anatomical location were not provided) without any residual effects experienced by the patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Continue to have a sore throat; a cold with massive amounts of mucous since injection.; tiredness; joint pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3248), dose 1 via an unspecified route of administration at left arm on 27Jan2021 07:15 as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included Lisinopril 20 mg, Atorvastatin calcium 10 mg, Sildenafil 100 mg taken for an unspecified indication. Patient did not suffer any Allergies to medications, food, or other products. Prior to vaccination patient was not diagnosed with COVID-19. Even after vaccination, patient has not tested for COVID-19. On 27Jan2021 10:00 am, the patient experienced continue to have a sore throat and a cold with massive amounts of mucous since injection. Has subsided a bit, but it continues today. Also had usual side effects (joint pain, arm pain, tiredness, etc). The outcome of the event was not recovered.   Follow-up attempts have been completed and no further information is expected.
1 1/2" DIAMETER, RED,RAISED,WARM,TENDER, ITCHY AREA ON RIGHT THIGH.
initially, chills, muscle ache, nausea; next day:  cough, shortness of breath; 5 days later diagnosed with bacterial pneumonia; two negative COVID tests
One day post vax pt experienced a 3 inch area on right thigh; bright red with small pimple like spots. Pain in arm, back, head and in ribcage area. numbness in fingers, forearm and tingling sensations.
RLE REDNESS AND SWELLING (WORSE THAN CHRONIC), FEVER, CHILLS, SHORTNESS OF AIR
a little reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little reaction to the first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder, Neurological disorder NOS and Immunocompromised.    On 02-Mar-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 VACCINATION COMPLICATION (a little reaction to the first dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a little reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant low dose steroid , antibiotic was reported.  Treatment ice cool compresses was reported.  Patient state they had the flu shot one week prior to the third dose which was given on 24-Oct-2021,in the same arm.   This case was linked to MOD-2021-373419, MOD-2021-373418 (Patient Link).
Swelling, redness, and a little itchy at injection site occurred approximately 8 days after dosing.
Pt came in 7 days after injection with redness below site of injection that wrapped almost completely around arm.
Pt received vaccine at 11:30 on 3/28/01. At 15:00, rash appeared on upper back and face. Provider was contacted and they recommended Benadryl every 4-6 hours. Rash disappeared and then re-appeared at 19:00. Contacted provider again and was told to continue Benadryl as needed and use Calamine lotion for itching. Rash still present today but provider not contacted further. No respiratory symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, macular rash, injection site warmth and injection site bruising. On an unknown date, the outcome of the injection site erythema, macular rash, injection site warmth and injection site bruising were unknown. The reporter considered the injection site erythema, macular rash, injection site warmth and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: On 21st May 2018, at 12:45 hours, the patient received SHINGRIX in the left deltoid. The patient came into the pharmacy on the date of reporting to show her arm to the reporter. The patient experienced redness and blotchiness that extended from the injection site out, taking up most of the left deltoid area. It was warm to the touch. There was bruising right at the site where the product was injected. The patient indicated that she did not know exactly when these symptoms started but she first noticed them on the day before reporting. The patient thought that the area was redder on the reporting date than it was a day before.