chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Polio; Not eating; Noticeably feeling bad; feeling lousy; Croupy cough; Went to bed right after and he has been in bed ever since; Muscle pains; This serious, initial spontaneous safety report from Country was received by Novavax on 08-NOV-2023 from a consumer via the contact center.  A male of 27 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 5 on the right side on 01-NOV-2023 at 4:30 PM at a pharmacy.  The following medical history was reported: Hypertension, Hypersensitivity to Accutane (isotretinoin), Haldol (haloperidol), and cephalosporins, and previous vaccinations with Pfizer COVID-19 vaccination (tozinameran), primary series, on 20-MAR-2021 (unknown which primary series dose was administered on this date) and on an unspecified date, first booster on 09-APR-2021 and second booster on 23-OCT-2021.  The following concomitant medications were reported: levothyroxine, olanzapine, benztropine, lithium carbonate, and "listerol".  On 04-NOV-2023 around 4 PM, 2 days 7 hrs 30 minutes after vaccination, the individual experienced noticeably feeling bad (PT: Feeling abnormal). He didn't want to eat (PT: Decreased appetite). He went straight to bed and had been there ever since (PT: Unevaluable event), and had continued to eat. On an unspecified day in NOV-2023, after vaccination, the individual had muscle pains (PT: Myalgia) and thought he might have polio (PT: Poliomyelitis) (Serious: Medically Significant), and had a croupy cough (PT: Cough) he thought was weird. He went to an urgent care on 06-NOV-2023, in which the doctor listened to his heart (115 beats/minute), and tested him for Influenza A & B, for which he was negative. He took a rapid COVID-19 test at home, and that was negative. The clinical impression of the doctor was that the symptoms were side effects of the Novavax COVID-19 Vaccine.  Relevant lab tests included: Influenza A virus test (Result: negative; 06-NOV-2023), Influenza B virus test (Result: negative; 06-NOV-2023), SARS-CoV-2 test (Result: negative; 06-NOV-2023) and Heart rate (Result:115 heart beats per minute; 06-NOV-2023).  At the time of reporting, the event outcomes of Feeling abnormal, Cough, and Myalgia were not recovered/not resolved, and event outcomes of Poliomyelitis, Decreased appetite and Unevaluable event were unknown.  Lot number was requested but unknown.; Sender's Comments: This 27 year-old male experienced: Poliomyelitis, Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Poliomyelitis was assessed as serious. The events Decreased appetite, Unevaluable event, Feeling abnormal, Cough and Myalgia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Moderna COVID-19 vaccine EUA Took tylenol 15 min after injection. Started with a headache around 3pm followed by extreme tiredness and nausea. Took tylenol and went to sleep around 4pm and woke up around 6pm. Woke up with bad headache and was sensitive to light and sound. Had a low grade fever.  Went back to sleep at 7pm and woke up on and off all night with extreme body aches (pain in my back), headache, nausea, and pain in my arm. Got up to go to the bathroom around 2am and felt lightheaded so I sat down. Then got nauseous and started vomiting. Started sweating profusely. Slept on and off with the same symptoms until 8am. Took my temp and it was 101.7. Extreme headache went away but was left with slight headache, body aches, pain in arm, slight nausea, and fever. Slept on and off most of the morning. Took ibuprofen around 1pm. Helped with body aches and reduced fever. Took a nap from 2pm-4pm and woke up feeling a bit better. Slight headache, arm pain, and slight nausea still for remainder of day. Woke up on June 18th with arm pain and redness and swelling at injection site.
Per pt, she states that about 20 minutes, post vax, she had onset of pain (severe) to left arm which lasted through the night. Pain subsided by the AM, the next day (10/30/01). No pain today. Also had slight swelling which has subsided since she started using warm packs.
just a little sick for about 24 hours.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles vaccine and little sick for about 24hrs. The reporter stated if one had chicken pox as a child, the virus was in and could come out again later as shingles.  If one was lucky enough to be vaccinated for chicken pox the he/she did not have to be worried about shingles. This case linked with US2020AMR223617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223617:same reporter
About 11:00a.m. on may 30,1981 After steping on a nail with my foot,I called family doctor and was told to come in for Tetanus shot. I was seen about 11:30 A.M. and was given tetanus shot on right arm. During the same visit I complained of pain from a bump on right wrist. It was a gangling cyst. The doctor aspirated it and while driving home about 12:20 p.m. I began to have hives, breathing became hard, chest was tight and started to black out. I called the doctor right away and told to return right away. While driving back I was seeing black, throat was swollen, blue lips and hives over hands head and feet. I was taken in right away and given Benadryl, adrenaline and cortazone. The hives went away but the doctor noticed me rubbing my right knee. He said it was a side affect. I began to have headaches, neck, shoulder and right arm painful spasms.
Rash around vaccination site about a week after injection. Didn?t seem to absorb for about a week and pooled around bruise from pushing on hard on site after injection (from nurse that administered vaccine). But after massaged it in/warm compresses rash 2 days later. Rash on other areas of body including arm/face.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 23-NOV-2015 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # 1000448 and exp. 08-MAR-2016). No concomitant medications were reported. Pharmacist reported that an unspecified patient was given an improperly stored dose of ZOSTAVAX, on 23-NOV-2015 and then on 24-NOV-2015 the patient called the pharmacy to say he "felt achy" for an unspecified duration of time. Later on 25-NOV-2015 pharmacist called and provided the lot # for the suspect. The outcome of the event felt achy was unknown. Causality assessment for the event was not reported. Additional information has been requested.
Information has been received from a physician concerning a female with no known allergies or pertinent medical history who was vaccinated IM with the third dose of GARDASIL vaccine. The physician reported that a patient developed psoriasis after she received her third dose of GARDASIL. No lab diagnostics were performed. Unspecified medical attention was sought. there was no product quality complaint. No further information is available.
My main concern: About 17-18 days after the second covid vaccine(pfizer) shot in my right arm, I got a big purplish  bruise on the same arm(not at the vaccine site), and a big floater in the right eye.  The eye doctor diagnosed corneal tear and bursted blood vessel in the right eye. He treated it with the laser surgery.  It took 3-4 months for the floater to slowly reduce in size, but still not gone completely even after more than 4 months of the surgery.  The purpulish bruise went way in a few days and converted into a rash at the bruise site.  Later more rash and some hives started on the same arm, shoulder, neck and left arm. It took a few days to go away completely. No personal or fam history for corneal tear.
Chills; Heaviness with breathing; Extreme sweating; body aches and pain; felt like organs was being shifted and squeezed.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DYSPNOEA (Heaviness with breathing), HYPERHIDROSIS (Extreme sweating), MYALGIA (body aches and pain) and FEELING ABNORMAL (felt like organs was being shifted and squeezed.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Chills), DYSPNOEA (Heaviness with breathing), HYPERHIDROSIS (Extreme sweating), MYALGIA (body aches and pain) and FEELING ABNORMAL (felt like organs was being shifted and squeezed.). At the time of the report, CHILLS (Chills), DYSPNOEA (Heaviness with breathing), HYPERHIDROSIS (Extreme sweating), MYALGIA (body aches and pain) and FEELING ABNORMAL (felt like organs was being shifted and squeezed.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
(A) Patient presented to office on the afternoon of 2/09/11 with swelling/erythema & pruritus (nontender). (Patient demonstrated limp only when asked about his thigh). Treatment (1) Hydroxyzine (10mg/5ml) 8 ml PO Q8hrs prn itch (2) BACTRIM suspension 1 1/2 tsp (7.5 ml) PO BID x 7d (B) At follow up visit on 02/10/11, erythema spreading inferiorly & had receded laterally (still pruritic). Patient able to walk/play w/o discomfort. On 2/10/11, patient verbally said that (L) thigh hurt, but demonstrated normal walking, playing, sitting on his knees playing with sides of stroller, etc. Has 2/14/11 appt. scheduled.
Patient was given a Fluzone HD injection into Left Deltoid on 9/24/2020 through an Inject-Safe barrier bandage. At that time patient was instructed to take off bandage when bleeding stopped in about 10-15 minutes. Patient left bandage on for approximately 24 hours. When she took the bandage off, there was a 'burn-like' mark on her arm where the film had contacted her skin. Patient brought this to my attention on 10/6/2020. I spoke with the manufacturer of the Inject-Safe barrier and they felt that it was a reaction to the Fluzone HD injection because the circular area was where the film was not where the adhesive was.
Red and itchy rash around injection site, noticed morning of Feb 12th, as of Feb 15th is still present.
After temperature excursion of 82 degrees F for 4 hours, vaccine should have been discarded.  Vaccine was administered to patient.
I contracted Covid19 while on vacation on a tour. I was tested at a pharmacy and was positive. I quarantined at the hotel for 7 days. Symptoms, headache, red eyes, congestion and mild cough.
Last 2 years I received the pnuemonia vaccine and then got pneumonia twice; Last 2 years I received the pnuemonia vaccine and then got pneumonia twice; This is spontaneous report from a contactable consumer.   A (age 79, unit unknown) male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  In the last 2 years he received the pnuemonia vaccine on an unspecified date and then he got pneumonia twice on an unspecified date. Therefore, the patient did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months. The outcome of the event was of unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Resident received one of 4 doses that came out of a 10 dose vial.  Reported to VAERS via phone and the representative asked that I report through this reporting tool.
This spontaneous report as received from a healthcare worker refers to a 12-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date reported as 08-APR-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from Licensed Practical Nurse refers to unspecified number of patient's of unknown demographics. No current condition was reported. No historical medication was reported, On 01-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported). Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. All products had been administered. No adverse effects reported by any patients. Nurse was compiling lot and expiration date information and would call back for further evaluation. No PQC was involved. The outcome of excursion of 6 F since 01-JUN-2013 and products were not stored in an overall average support range of -58 degree F and 5 degree F was unknown. No other information was provided. This case is linked to MARRS # 1412USA010657 and MARRS # 1412USA010658 via same reporter link. Additional information has been requested.
1hr p/shots pt cried nonstop for approx 8-8 1/2 hr; nothing consoled pt; t102, rt leg red et knot et warm; APAP given-cool compresses on rt leg; next day pt was hoarse but was active et nl unless touching legs;
Feel numbness on lower lip since December of 2021; Also feel pain on right shoulder especially during night; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13May2021 at 13:00 (Lot number: unknown) at the age of 58 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Administration time: 12:30; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 21Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 01Dec2021 at 00:00, outcome "not recovered", described as "Feel numbness on lower lip since December of 2021"; ARTHRALGIA (non-serious) with onset 01Dec2021 at 00:00, outcome "not recovered", described as "Also feel pain on right shoulder especially during night". Therapeutic measures were not taken as a result of hypoaesthesia oral and arthralgia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Initial unsolicited report received from a consumer on 02 Aug 2016. This case involves a 65 year old female patient who was vaccinated with a first, second and third doses of Imovax (batch number, expiration date, route and site of administration were not reported for all the doses) on 27 Jun 2016, 30 Jun 2016 and 04 Jul 2016 respectively. Patient was also given a fourth dose of RABAVERT (manufacturer: Novartis, batch number: 587011a, expiration date, route of administration were not reported) in right deltoid on 11 Jul 2016 in early afternoon. Illness at time of vaccination was reported as celiac disease, pre-existing physician diagnosed allergies birth defects, medical conditions included gluten allergy and hypertension. Concomitant medications included Amlodipine and amitriptyline. On 11 Jul 2016, by evening, 14 days following the first dose of Imovax vaccination and few hours after RABAVERT, patient developed hives/welts on chest and neck that were very itchy. On 19 Jul 2016, 22 days after Imovax and eight days after RABAVERT, patient noted dark red raised lesions bilaterally on lower legs. Patient required emergency room visit and also saw dermatologist. Serum testing for rabies titers was done, biopsy of leg lesions was performed (results not reported). Patient was treated with prednisone and famotidine and was prescribed a "steroid cream". The outcome of the events was reported as not recovered. The dermatologist believed that the patient had a reaction to RABAVERT. List of documents held by sender: none.
Pt received vaccine on 8/25/14. Reported to another location 8/28/14 with large red, hot area around the injection site. From injection down to elbow. 4.5 inches wide.
Severe headache, moderate-severe upper body muscle pain, nasal congestion and sneezing
Feverish, body shaking, cold sweat, nausea, dizziness, headache  from late afternoon throughout night, tiredness.
Rash macular rash over head and trunk accompanied by irritability, rash resolved over 2 days, when seen by pediatrician it was completely resolved.
pt reports h/a, fever, body aches x 3 days following inject; report completed because of patient reported sx;
This spontaneous report as received from a physician via field representative refers to a 60 year old male patient. On 22-OCT-2012 the patient was vaccinated with ZOSTAVAX vial of lot # J005849 and expiry date 17-AUG-2014, dose and route unknown, for shingles vaccination. On same day, the patient experienced redness, itchiness, swelling and rash around the injection site after receiving ZOSTAVAX. The outcome of events was unknown The patient was given BENADRYL (dosage unspecified) and DURICEF 500mg (frequency unspecified) to treat the events. The patient had sought medical attention by seeing the physician. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches after second shot, started within an hour after shot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headaches after second shot, started within an hour after shot.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Apr-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headaches after second shot, started within an hour after shot.) outcome was unknown. She had headache everyday since getting the dose. Concomitant medication included Thyroid everyday.
FIRST DOSE I WAS DIZZY  BUT AFTER THE SECOND DOSE I WAS DIZZY AND NOW I HAVE HAD A RASH SINCE THE LAST DOSE AND YES I WENT TO THE ER AND THEY DIDNT DO NOTHING AND THEN I WENT TO MY PRIMARY AND HE GAVE ME SOME MEDICINE TO SEE IF IT WILL WORK TO CLEAR IT UP
Fever of 104 (digital tympanic) 10pm night of shots, vomited X 1, shaky but no seizure, rapid breathing. Mom started giving Tylenol 0.8ml every 4 hours. Fever ran 101 the next day. Child was irritable, restless x 1.5 days after onset of fever, then was back to normal behavior. Prevnar withheld per MD on 9/29/08, requested report to VAERS.
Vaccine administered on 1/30/20. Patient began having swelling on injection site ((R) deltoid) on 1/31/20. Reported to Clinic on 2/1/20. Swelling, Erythematous & tenderness noted to injection site. Doxycycline 100mg 2 times Daily given.
pt recv vax; mom noted redness & hives bilaterally on upper legs; resolved by 5pm;
paralyzed feeding tube, pitch tube; This is a spontaneous report from a contactable consumer. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, batch/lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced paralyzed feeding tube, pitch tube (paralysis). The reporter reported that, paralyzed, feeding tube, pitch tube. Pfizer said it was anxiety and tried to have her committed to a mental hospital and Pfizer is censoring her story. Pfizer destroyed her and her family, this is destroying our country and our children. The patient had Bell's Palsy from another vaccine. Out come of the event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Vaginal bleeding after first dose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration, administered in Arm Left on 01May2021 13:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing Other medical history: Thyroid. Concomitant medications included modafinil (MODAFINIL) duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took indomethacin [indometacin] and experienced drug hypersensitivity, zoloft and experienced drug hypersensitivity. On 04May2021, the patient experienced vaginal bleeding after first dose. Outcome of events was recovered on unspecified date of 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Winged Scapula Immune Mediated Brachial Plexopathy    (also known as Parsonage Turner Syndrome)
Client was fully vaccinated with Moderna vaccine for Covid on January 4 and February 3, 2021.  On July 21, client developed Covid symptoms (mild) : runny nose.  He was tested with PCR on 7/23 and the result was positive.  Lives with wife and son who are not vaccinated and were positive for Covid several days before client.  Reported as a case of breakthrough Covid in a fully vaccinated person.
Short term side effects:  fatigue, achy, dizziness. Experiencing heart palpitations