chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tightness in chest; occasional double vision; light-headed; very low energy; itchy skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 13:00 (Lot number: 330308D) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number= 33030Bd, Administration time= 03:30 PM, Vaccine location= Right arm), administration date: 14Dec2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 06Jan2022, outcome "unknown", described as "Tightness in chest"; DIPLOPIA (non-serious) with onset 06Jan2022, outcome "unknown", described as "occasional double vision"; DIZZINESS (non-serious) with onset 06Jan2022, outcome "unknown", described as "light-headed"; ASTHENIA (non-serious) with onset 06Jan2022, outcome "unknown", described as "very low energy"; PRURITUS (non-serious) with onset 06Jan2022, outcome "unknown", described as "itchy skin". The events "tightness in chest", "occasional double vision", "light-headed", "very low energy" and "itchy skin" were evaluated at the physician office visit.  Additional information: The patient did receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
The patient had pericarditis that was treated with Colchicine with symptoms that resolved by 08/24/2021
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 98th out of 100 adult male patients described by the reporter. Concomitant Medication use information was not provided by reporter. Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Severe sinus infection resistant to steroids and antibiotics. After further testing I have been give preliminary diagnosis of Trigeminal Neuralgia. I get adverse allergic reactions to everything now, which seems to trigger the TN massive face pain on left side
This was his second vaccine ever in his life. Again, hypotonic/hyporesponsive event right after the vaccine: he could not stand up. His eyes did not get bloodshot as they did with the dtap, however his speech got progressively worse. He stutters at the end of words, not all the time, sometimes more, sometimes less. Nonetheless, this is a progressive neurological problem and I am concerned. He never did this prior to vaccines in all of his years of speech therapy, he actually graduated from speech therapy in July 2021.  Also he complains very frequently that his back is cold. Nowhere else on his body is cold, only his back (which is part of the neurological system). He never complained of this prior to vaccination. His pediatrician referred us to a pediatric neurologist, we are waiting to be seen next month.
Large indurated hot to touch 7cm x 3cm size erythematous swelling over L arm; no blisters or vesicles.
Moderna 0.5ml administered IM for booster instead of 0.25ml.
sore arm; felt faint/dizzy; Feeling hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 24th July 2019, the patient experienced felt faint and feeling hot. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the felt faint and feeling hot were recovered/resolved.   It was unknown if the reporter considered the injection site pain, felt faint and feeling hot to be related to Shingrix.  Additional details were provided as follows: The reporter is husband of the patient. The patient received Shingrix and experienced soreness at the injection site. Next day, she felt faint, dizzy and hot, She had to sit down in a chair under a fan and the symptoms resolved after 10 minutes. The reporter consented for follow up. This case has been linked with US2019134723, for same reporter.
Preparing to administer a flu vaccine with Fluzone high dose lot # UJ716AB. When taking off the cap to the needle the glass vial snapped in half. A new fluzone vaccine was given to the patient with same lot# and expiration with no problems.
No additional AEs were reported; The patient received the first dose of VARIVAX on 11/13/2008. The patient was supposed received second VARIVAX  on 5/31/2022 but instead received SHINGRIX.; The patient received the first dose of VARIVAX on 11/13/2008. The patient was supposed received second VARIVAX  on 5/31/2022 but instead received SHINGRIX.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 13-NOV-2008, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route of administration, lot#, and expiration date were not reported), for prophylaxis. The patient was supposed to receive the second varicella virus vaccine live (Oka/Merck) (VARIVAX) dose on 31-MAY-2022, but instead received varicella zoster vaccine rge (CHO) (SHINGRIX) (, dose, route of administration, lot#, expiration date, and indication were not reported). No additional adverse events (AEs) were reported. No further information provided.
Patient reported sensation of throat closure and palpitations. Patient has history of A-fib and stroke. Patient given 50 mg of benadryl IM and improved until stable and discharged from facility.
Wife called stating patient could not use his legs well this morning. Stated he is normally up moving and out of the house. He had to get him a walker this morning to move around. He was fine yesterday evening and last night. He woke up this morning with decreases mobility in both his legs. He did this with the last vaccine 08/2021 also, but last time was worse than this time. His wife thinks he will be better tomorrow. I explained to wife he should not take any more COVID-19 vaccines. When asked about adverse reactions with any previous doses before administration yesterday, patient and wife both declined. Explained to wife that him not being able to use his legs with last vaccine in 08/2021 would have been an adverse reaction and should have also been reported. Wife states she forgot until this morning. Encouraged wife to have patient seen by PCP and to call 911 if symptoms persist or worsen. His wife voiced understanding.
body aches, chills, headache, fatigue, night sweats, loss of appetite, severe pain, hallucination, talking in sleep, cough
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot #, expiration date, dose, route unspecified). On an unknown date the patient experienced thyroid disease. The outcome of thyroid disease was unknown. This is one of several reports received from same source. Additional information has been requested.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients. No treatment information was provided.
Woke up in the middle of the night to hallucinations of flapping wings of birds/proceeded to see black birds taking over the hallway and laundry room; fever; aches; terrible sweating; non stop nausea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 20Apr2021 10:00, as 1st dose, single dose, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient previously took loratadine (LORTAB) and amoxicillin and experienced allergy to both. Concomitant medications were not specified (reported as "other medications the patient received within 2 weeks of vaccination: Yes"). On 11May2021 at 02:00 AM, the patient woke up in the middle of the night to hallucinations of flapping wings of birds. She proceeded to see black birds taking over the hallway and laundry room. They had bright blue spots on their wings. The patient's son reassured her that nothing was in their home and he had to close all doors. This was on top of the fever, aches, terrible sweating and non-stop nausea. No treatment was given for the events. The 2nd dose of COVID-19 vaccine was administered on 11May2021 at 10:00 AM ((lot number unknown) in the left arm. The patient underwent COVID-19 nasal swab: negative on an unspecified date (since the vaccination). The patient was recovering from the events.  Information on the lot/batch number has been requested.
Began experiencing chills, fatigue, generalized body aches and weakness, nasal and sinus congestion, and headaches.
Pt given Imovax rabies on 9-JUN-90 c/o sore arm. 17-JUN-90 pt. had fever & abd tenderness.  Family member states worsened.  While traveling w/husband pt. began to vomit blood. Taken to ER & admittedto intensive care. Pt had a cardiac arrest
Immediately he had a headache associated with dizziness and the headache persisted.  He was known to be unstable on his feet with muscle weakness.  Other complaints include shortness of breath, confusion, decreased appetite.  O2 saturation  dropped from 90% to 80% on room air.  He complained of low back pain and weakness and heart rate of 115.
Client reported feeling weak and unable to feel her body. Afterwards client began to fall backwards onto the exam table and was limp for approx. 2-3 seconds. Monitored and applied cool compress to forehead and neck.
crying that could not be stopped & that lasted more than 3 hrs; fever of 102; consulted MD who recommended treatment w/APAP;
Moderna 2/24/21, 3/26/21, 12/15/21. Positive on 4/13/22
Very bad pain in injection arm, culls and sweats, sharp pain in right kidney area on and off.
pt recv vax 29AUG96 & w/in 15min of vax pt exp pain in arm which spread up the arm & included the back & leg;pt felt numbness in leg which lasted about 2hr;all events resolved the same day w/o tx;
Information has been received from a consumer concerning her 16 year old grand daughter (patient) who on 08-JUN-2007 was vaccinated with a first dose of GARDASIL 0.5 mL and on 04-AUG-2007 was vaccinated with a second dose of GARDASIL.  There was no concomitant medication.  On approximately 08-JUN-2007 ("shortly after first dose") the patient experienced flu like symptoms.  She did not have much energy and a little rash.  After the second dose, the patient experienced headaches, a rash.  She broke out in "huge" blisters all over her back.  In September 2007, the patient recovered.  Third dose was never given.  The patient sought unspecified medical attention.  No further information is available.
ON 3/5/2009 PATIENT CAME IN COMPLAINING OF LEFT UPPER ARM SWELING AND REDNESS AROUND THE SITE OF SHOTS.  EXAM 4CMX5CM AREA OF REDNESS, WARMTH AND TENDERNESS. DX)CELLULITIS, PRESCRIBED: AUGMENTIN AND BENADRYL.  RESOLVED ON 3/19/2009.
Received vaccine (MMR) on Wed 3/21/07. Came into health department on Mon 3/26/07, left arm with large red area, warm to touch. Measures 120 by 100. Also c/o fever the next day, self resolved. Advised to ice area and return to health department for follow-up in 2 days.
Fluzone high dose and it leaked between the syringe / no AE; Fluzone high dose and it leaked between the syringe / no AE; injection the medication leaked over the patient's arm / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 82 years old patient who received 0.5 ml vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  lot UJ241AB (Expiry date Apr-2020) via intramuscular route in the right deltoid on 18-sep-2019.  It was case of syringe leak, vaccine underdose and Exposure via skin contact.  It was reported that prefilled syringes in the box were fine and this was the last one so she threw the leaking syringe and the box away after the infection therefore has limited information. States as she was giving the injection the medication leaked over the patient's arm.  At the time of reporting no adverse reaction was reported.  List of documents held by sender: none.
01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the 30 mins observation period before returning to work, then took ibuprofen for the headache. About an hour later post nasal drip started, lasted about 2-3 hours or so. Around 4-5pm headache returned, left arm soreness increased (felt like the arm was swung on by a bat), persisted all night. Took ibuprofen around 11 pm before going to bed. 01/21/2021: Woken up at 5 am with a headache and joints were sore especially my troubled joints (knees and lower back). Generalized fatigue experienced as well. Took Ibuprofen at 08:20 for the headache, joint soreness and fatigue still present.
p/vax post immun titers (measured on jun24/1998) compared to pre-immun titers were not different for serotypes 3, 7F, 9N and 14
I woke up with the symptoms. It started with a cold sore sensation. I had 5 clusters when I woke up with symptoms. I treated those symptoms with acyclovir. I also took an albuterol inhaler and generic ADVAIR consistently for my symptoms. I started taking them when my child came down with it. On January 09 and 10th I started having tightness in my chest, I tracked my oxygen level and it got down to 94%. It increasingly got worse. On the 12th I woke up and my breathing issues were on the upswing. I'm 98% recovered from the symptoms. I still have decreased wind capacity. I get more winded when I am working out. I scheduled PCR test for my family so that we could track when everyone contracted COVID-19.
pt recvd vax & 4 hrs later started screaming; legs turned beet red & tender to touch; to er via ambulance, then to after hrs facility; examined & released;
I contracted COVID-19. When I first developed the symptoms on day one, I felt very tired and hyper. I felt crabby and very warm. On day 2, I felt like I had a head cold. I felt like I was in a fog. I would feel warm and then cold. That was when I took a COVID-19 test and tested positive. I spoke to my doctor and she prescribed me PAXLOVID.
Symptoms of fatigue, body aches , sore throat and dry cough  developed  14 days after a second booster shot.  A home Covid test was done  6 days later (i.e. 20 days after second booster) and was positive.  A second Covid test was done at urgent care  the same day and was positive.  Urgent care referred to local hospital clinic for monoclonal antibody injection  which was administered 10  days after onset of symptoms
Initial information was received on 01 December 2008 from a consumer. A 59 year old female patient with an allergy to penicillin received an injection of IMOVAX in August 2008 (lot number, route, and site of administration was not reported). The patient stated that she had hair loss in September 2008. The patient reported that she had the rabies vaccine series at age 12 and did not experience any reactions. She saw her doctor and thyroid testing was completed (date and results were not provided). The patient is scheduled to see a dermatologist on 09 December 2008. The recovery status was not reported. Follow-up information received on 12 February 2009 from a health care professional. On 02 September 2008 the patient received a rabies vaccine (manufacturer not reported, lot number 942320) administered in the left deltoid, rabies immunoglobin serum (lot number B1145-4 and B1123-4) administered in the bilateral glutterals and right thigh. The patient received IMOVAX on the following dates: 05 September 2008 (lot number B0182-2) right buttock intramuscularly, 09 September 2008 (lot number B0182) left deltoid intramuscularly, 16 September 2008 (lot number B0182) right buttock intramuscularly, and 30 September 2008 (lot number B0182-2) right buttock intramuscularly. The patient received  these vaccines after being bitten by a bat (date not provided). On 19 November 2008, the patient went to the doctor's and had a thyroid test completed, results were Ft4 1.17 and TSH 1.220. The date of event onset was unknown. An etiology was not determined. Recovery status was not known. List of Documents held by Sender: None.
I had vaccination on 10/25/2022. By mid-November 2022 I started to have extreme throbbing headaches into the temple and eye region and up the neck. I had a car accident in 01/2022. I have had various vaccinations in 2022 to include flu MMR Shingles and Hepatitis B. I am referred to neurology and prescribed medication that did not work for the headaches. I am being sent for a contrast MRI on 04/10/2023. I am also being prescribed an anti-seizure medication to start after the upcoming MRI.
Pt may have been given tetanus instead of PPD in (Left ID Forearm. 10mm rxn 05/23/2005. 06/06/2005 still has residual looking rash. No tx given.
26JAN97 began w/vesicles;no fever no cough;27JAN98 presented in office w/ 8 pink residual papules & 2 small vesicles on face;8-10 raised pink papules on chest w/2 vesicles;exposure to varicella 2wk prior;
This spontaneous report was received from a physician referring to a 15 year old patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unspecified date in May 2014 (also reported as "4 years ago on an unspecified date"), the patient was vaccinated with a dose of GARDASIL (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 21-MAY-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N019104 with expiration date: 03-FEB-2020 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects. No further information provided.