chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When it first happened, I had nothing but soreness in the arm. I was tired and aching. When I had got sick it was around the 3rd week after receiving the shot. It started with a lot of coughing, sore throat, pressure on my ears, and back aches. On 10/28/2021 I went to my doctor office. They did some test and diagnosed me with a viral infection. I was prescribed Azithromycin for 5 days. The next day I had got a fever, so my doctor prescribed a Z-Pak for 5 days, benzonatate 100mg 3xday for 10 days, and Ventolin inhalation aerosol 2xday. I am tired all the time, and I have no energy. I still have a cough, and I get short of breath really quick. I have a headache, sore back that is aching, and no appetite. I don't have a fever anymore. I was also having acid reflux, so my doctor also had prescribed Pepcid.
Four days after the Covid vaccine, Pt experienced dactylitis in his toe. This was soon followed by extreme swelling and pain in his knees. The symptoms were consistent with psoriatic arthritis which came on suddenly  and which he never had prior to the vaccine. He was already on Taltz, a medication used to treat inflammatory conditions. He had to have fluid drained from both knees and multiple steroid injections in the knees directly. Also a round of prednisone. It?s been almost 3 months and he still suffers with knee pain and trouble walking. His physician discontinued Taltz and started him on Humira. He never had a flare of plaque psoriasis. Just acute new onset arthritis directly after the covid injection. He was advised not to get the second covid vaccine injection.
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 91-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019). On 28th April 2018, the patient received SHINGRIX (intramuscular) 1 ml. On 28th April 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, sleep excessive and overdose. On 29th April 2018, the patient experienced dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching. On 30th April 2018, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the fatigue, sleep excessive, injection site erythema, injection site warmth, injection site pain and injection site itching were recovering/resolving and the outcome of the injection site swelling and overdose were unknown. The reporter considered the fatigue, sleep excessive, dizziness, injection site erythema, injection site swelling, injection site warmth, injection site pain and injection site itching to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was daughter of the patient. On 28th April 2018 (Saturday), the patient received SHINGRIX 1 ml but the dosing regimen of 0.5 ml was noted from the prescribed information, which led to an overdose. On same day, the patient experienced extremely fatigued caused her to sleep a lot. On 29th April 2018 (Sunday), the patient had redness, swelling, hotness, pain, and itching at the site. The patient also noted dizziness that began on Sunday but appeared to have resolved today. The patient had not told her doctor, but was encouraged to do so. The representative did not ask HCP information.
Patient reports getting sore and achy within hours of her vaccine, with headache, low grade fever. Called later to report she "lost the use of her arms and her head got floppy" She laid down and was fine when she woke up without any neurological deficit present in the morning. Of note, this patient has an undiagnosed neurological condition. She is in a wheelchair at baseline but stands to self-transfer.
This spontaneous report was received from a licensed practical nurse and refers to a 5 year and 8 month-old male patient. There was no information about the patient's concurrent conditions and medical history provided. On 02-AUG-2016, the patient was vaccinated with PROQUAD (lot # M006105, expiration date: 01-AUG-2017), subcutaneously for immunization. Concomitant therapies included BENADRYL. On 02-AUG-2016, the patient experienced localized injection site reaction. On an unknown date in approximately 2016, the patient experienced shingles with a rash and itching. An unspecified treatment was given for the adverse events. The healthcare professional was interested in Varicella zoster virus (VZV) analysis by polymerase chain reaction (PCR) and wanted to send viral isolates. The outcome of the events was not reported. The relatedness between the events and PROQUAD was not provided. Additional information has been requested.
Feeling of warmth on head and face at 9:00pm  on 1/19/21 Woke with fever (99.6F), shaking chills, headache at 4:00am on 1/20/21 Fever (100.6) joint pain, muscle pain at 9:00am Fever 101.0 at 1:00pm with intense headache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise. Fever 101.0 at4:00pm. Accompanied by symptoms listed above.Took 1,000mg Tylenol. Fever 101.0 at10pm. Accompanied by symptoms listed above. Took 1,000mg Tylenol. Insomnia. 1/21/21: Fever 99.0 degrees 4am. 1,000mg Tylenol.  Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/21/21: Fever resolved at 6pm.  Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/22/21: Body aches, headache, fatigue, malaise, fatigue, dizziness, nausea
On 3.13.23, Patient presented to clinic for COVID vaccination. Patient did not have a preference on which vaccine to get. This nurse removed a Moderna from the refrigerator; vaccine had been pulled from the freezer on 3.9.23, with Beyond use date of 4.8.23 based on storage conditions. This nurse did not verify the manufacturer's expiration date, which was the previous day, 3.12.23. Vaccine was administered to patient. Occurrence was reported by CDNS, and the PCM and Immunization Program nurse. The nurse reached out to the manufacturer, Moderna, and it was determined by the manufacturer that the dose would be considered valid and the patient does not need revaccination for the expired dose that was administered.
8/12-Fever 100.6, body aches, chills x1 day 8/13 itchiness day 2 to current VA RX'd hydroxyzine 25mg PRN and Chlorpheniramine 4mg PRN
Moderna Booster Patient is reporting muscle spasms and they have effected her ability to drive.  Patient is also reporting slight soreness @ injection site. Patient states that she didn't experience this with first 2 doses
Chills, shaking, body aches, nausea, headaches, fatigue.
Left supraclavicular lymphadenopathy non-painful node  bulging out of collar bone on the same side as vaccinated arm. Will follow up with pediatrician on Monday.
Boood clot in heart and deep-vein thrombosis in right leg  Diagnosed during Emergency room admission for heart pain
Elevated temp 11PM; sz; transp to hosp by ambulance; ER temp 100.8; adm for observational status; highest temp recorded 101.4; few reddened areas on skin night of 27JAN; dx'd w/chicken pox 28JAN; immediately dismissed from hosp;
Patient felt light headed, fell, and passed out a couple of seconds then woke up unaware of what happened all in under a minute. Patient was seated and treated for injuries sustained from the fall. After monitoring for 30minutes, patient states he felt fine.
Soreness of muscle noted same evening. Warm and tenderness in L biceps 70x70mm (skin above not red or erythematous).
Antibodies were 243 units which was considered low; Vitamin D numbers were higher than normal for her - 112; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Nodule. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, SARS-COV-2 ANTIBODY TEST (Antibodies were 243 units which was considered low) and VITAMIN D INCREASED (Vitamin D numbers were higher than normal for her - 112) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Blood test: 243 (Low) COVID antibodies. Her results were 243 units which was considered low.. On 06-Dec-2021, Vitamin D: 112 (High) Vitamin D numbers were higher than normal for her but she explained that she also had been taking Vitamin D for years. Her numbers were 112..         Due to antibodies were low patient had concern of taking another booster vaccine.   This case was linked to MOD-2021-415132 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 15:45 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pyrexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) at the age of 71 years 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: PYREXIA (non-serious), outcome "unknown", described as "pyrexia".  Additional information: the patient didn't get any pain after the first dose. It was only after the second dose. Caller doesn't recall patient having any severe reactions with either dose. Patient had some pyrexia, the usual things that a person gets after the first and second dose. Patient was not really sick. Thinks patient got chills and fever and it went away. Nothing that caller would think was unusual. Attempted to clarify dates regarding fever, pyrexia, and chills. Caller doesn't know when this occurred or after which dose. Caller just remembers patient saying he was going to bed because he was cold. Attempted to clarify dates of Comirnaty vaccines: Caller had her first dose in Dec2020 and second dose in Jan2021. She thinks the patient had his first dose in middle of Jan2021 and second dose in Feb2021. Caller does not have patient's record card to provide any information about patient's Comirnaty vaccines. Indication: Both caller and the patient are in the medical field. They both see patients. Patient still walks around like he was a man from Mars. A couple months later, caller has not seen patient put the Volatren on. States it's regular. Patient mentioned recently that he should see someone about the pain, which was unlike him. Caller thinks the pain must be bothering the patient significantly. Caller doesn't know if patient was having pain or if patient was frustrated. Caller decided on her own to call and report this to Pfizer. Patient had the booster dose just recently. Doesn't believe patient's pain has gotten any worse since the booster shot, but she hasn't actually asked the patient that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
09/04/21  9:00am fever aches headache 09/05/21 dull headache and fatigue most of day 09/06/21 5:00 am chest pains few hours while laying 09/07/21 3:30 am chest pain radiating to both arms while laying 09/07/21 8am called physician 10am ER 09/07/21 6pm transferred to hospital - myocarditis: high cardiac markers 09/07-08/21  Echo, enormal
1PM pt recv vax, cried-fell asleep @ 145PM, woke up screaming @ 2PM-cont crying until 8PM;fell asleep;could not be comforted;6PM taken to ER-examined-xray done on lt leg;on med APAP w/Codeine, Motrin q 6hr;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-MAR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature 0 Fahrenheit degree. The total cumulative excursion time of the second time was 920 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  5 hours after the injection, received a shock from his pacemaker/defibrillator which lasted just a few seconds - it was painful enough to make him shout and doubled over and grabbed the chair next to him. This only lasted a minute or so and then he was okay. But I think the form should also ask if you have a pacemaker/defibrillator implanted so that you are aware of this possibility happening.
For Last 14 Days outbreak DAILY of either Rash or Swollen  Hand or toe, some rash turns to iticy welts. , Gowt like on bottom of feet
On 10/21, pt called to report itching and welts all over arms and legs and neck. Pt advised to go to ED. Dr. spoke to pt on 10/27 advised pt. to come in to walk in clinic. Pt reported on 10/27/11 to walk in clinic with symptoms of mild rash resolving with BENADRYL prn.
2 weeks after first vaccine menopause reversed 13 months into menopause; cramping; pimples; regular period with heavy first day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 06Feb2021 14:15 (at the age of 57-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ropinirole and daily multivitamins taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 22Feb2021, the patient experienced 2 weeks after first vaccine menopause reversed 13 months into menopause, cramping, pimples, and regular period with heavy first day. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021. It was also reported that the patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 27Feb2021 11:00 (at the age of 57-years-old) for COVID-19 immunisation.  No follow-up attempts are possible. No further information expected.
Pt states she experienced pain and redness at the site of injection. Pt was referred to PCP for further evaluation. Pt went to urgent care and was recommended to take BENADRYL and ALEVE.
I began experiencing drowsiness; Eventually leading to minor slurred speech (like I was drunk); Body aches; Coming down with the flu; Lethargy; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 08Jun2021 at 15:30, as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Jun2021 at 11:30, the patient experienced drowsiness, eventually leading to minor slurred speech (like she was drunk), low grade fever, the patient was coming down with the flu. Over the next several hours, at the time of this report, the patient had remained in bed (came home from work) and had body aches with lethargy. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event drowsiness, minor slurred speech, body aches, coming down with the flu, lethargy and low grade fever were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dose administered after manufacture date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Moderna cannot guarantee patients received full protection against the COVID-19 Virus.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received and contains non significant information.
Patient developed pain with in the left arm a hour or two after receiving her immunizations. The sever pain is limiting mobility in that arm. She has taken Ibuprofen periodically over the last 18 hours without relief. She has been advised to use warm compresses and to see a doctor at one of the urgent care facilities in town.
p/inject returned w/lightheadedness, double vision & hand numbness; BP 160/100; hives @ site 13OCT94 inc BP 160/100- 164/80R, 144/92 L; speech still funny; induration 3" diameter lt upper arm; tx Seldane;
she felt very tired; weak for about two weeks; difficult for her to walk; she did not feel dizzy but unbalanced; she has a pacemaker and that she had a previous stroke /she is concerned about having another stroke; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: not reported), via an unspecified route of administration on 19Jan2021 20:00 as Ist dose, single for covid-19 immunisation. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing She has a pacemaker and that she had a previous stroke. The patient's concomitant medications were not reported.  The patient experienced she felt very tired, weak for about two weeks, difficult for her to walk, she did not feel dizzy but unbalanced, she has a pacemaker and that she had a previous stroke /she is concerned about having another stroke on 20Jan2021. Outcome of the events were recovering.   Information on the lot/batch number has been requested. .
Patchy vesicular and bullous rash on the legs, hands, and buttocks. Noticed the morning after the vaccine. New lesions occurring until day 5. No improvement yet day 7. No treatment.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. "About a month and a half ago", on approximately 27-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (route not reported, dose: 1 injection). Concomitant medications were not provided. The pharmacist reported that the patient mentioned that, "about a month and a half ago", on approximately 27-SEP-2014 she developed a staph infection shortly after being administered the ZOSTAVAX vaccine. The patient was treated by her primary care physician. The patient had sought medical attention from her physician. Outcome of the event was not reported. Additional information has been requested.
This spontaneous report was received from a 63 year old female patient referring to herself with diabetes mellitus, auto immune deficiency, hypertension, blood cholesterol increased and allergy to unspecified medications. On 17-DEC-2014 (reported as two weeks ago), the patient, who had auto immune deficiency, was vaccinated with one dose of ZOSTAVAX intramuscular injection, (strength, dose, frequency and lot number were not reported), during a schedule office visit. The patient was not taking concomitant therapies. The patient started that the nurse did not administered the ZOSTAVAX according to the prescribing information, because it was administered on the top of her shoulder blade, also the patient experienced injection site pain on 17-DEC-2014. The patient did not seek medical attention, no treatment was given and lab diagnostic studies were not performed. The outcome of injection site pain was reported as recovered/resolved on an unspecified date in December 2014. The relatedness between the injection site pain and therapy with ZOSTAVAX was not reported. Additional information is not expected. There is no patient or physician's contact information.
I have had a very bad cough ever since I got the vaccine. I was a little sick afterwards, congested, coughing, headache, slight loss of voice. But the cough has lingered for almost  a month now. People have compared me to an "old smoker" whenever they hear me cough.