chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/02/2021, I was doing normal routine things and I was fine through out the day, Then at 4:30 pm it felt like someone kicked me in my back, I had severe headache, neck ache and sour stomach, and no energy.  I got shivers, chills, and fever (the highest was 101, I had low grade fever for a couple of days.  I took Tylenol and 4 hours later I tried Motrin, and Tylenol arthritis and nothing helped relieve the symptoms. I slept for 3 days straight. I could not get out of bed. My headache was torture. I had nausea, I kept down fluid, I never threw up. On Monday I was very weak, I could not catch my breath. On 10/05/2021, Tuesday,  I was tested for COVID-19 test-positive.  On Wednesday, Dr. scheduled me to get antibodies and prescribed me an inhaler, Brio.  Today is my 12 day since I started having symptoms, but I feel a whole lot better and I am on my way to feeling  better.  I think I contracted COVID-19 at work,  I'm a healthcare worker,  about 2 or 3 weeks prior I had 3 or 4 patients who had COVID-19 and we did not know. I have been real careful. Thank goodness no one in my house contracted COVID-19.
11/21/2022 I started feeling cold symptoms; strong coughing especially in the evening  I went to Urgent Care and was tested for COVID-19 and was negative. 01/2023 I had the same symptoms I also had a sore throat and a low grade fever. Again I was tested COVID-19 and it was negative I was also tested for Influenza. I tested positive for Streptococcus and prescribed a course of Cefalexin
Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; was around her stepson who had COVID-19 and she herself ended up contracting COVID-19; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that friend's wife got her first shot and was around her stepson who had COVID-19 and she herself ended up contracting COVID-19 and was sick for about 3 days on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 on an unspecified date. Outcome of the events was unknown.   Information about batch/lot number has been requested.
hives; skin type reactions; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), URTICARIA (hives) and SKIN REACTION (skin type reactions) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced URTICARIA (hives) and SKIN REACTION (skin type reactions). In May 2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, URTICARIA (hives) and SKIN REACTION (skin type reactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information was not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional event herpes zoster after first dose.
Patient was given Pfizer vaccine prior to vaccinator realizing that patient had received a Tdap within the past 14 days. Patient was monitored, no adverse reactions occurred.
redness at the injection site of less than 20mm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site of less than 20mm).  The outcome of the injection site erythema was resolved (duration 48 hrs).   It was unknown if the reporter considered the injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt date: 18-SEP-2023 A pharmacist reported that a patient experienced redness at the injection site of less than 20 mm, which remained for about 48 hours post injection. The reporter agree to follow up from GSK.
Patient complained of midsternal chest pain within 15 minutes after vaccine administration.  Pain 5/10 described as sharp and tight but non radiating. BP 149/85, HR 111, SpO2 99, 911 called and transported to the hospital.
No treatment for area on my arm, I don?t remember if I had any treatment for my chronic coughing
itchy rash; Red; RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 18-Feb-2021, the patient experienced RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, RASH PRURITIC (itchy rash), VACCINATION SITE ERYTHEMA (Red) and RASH (RASH THAT IS SPREADING ALL THE BODY LIKE FOREHEAD, EAR AND ARM) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.
9-9-03 1450 Patient phoned with concern of redness, warmth at injection site.  Sore to touch.  Came by office, 7cm reddened area, warm to touch present.
Left cheek/chin,  numbness, , left arm paresthesia,, left side weakness of mouth, left tongue numbness, left sided neck numbness
Headache, Myalgia, Arthralgia, Fever, Diarrhea, redness and swelling at injection site, runny nose
L arm-swelling, red, hot, tender 1/3 length of arm upper.
Seen in office 5/30/01 with angioedema of lips, treated with Benadryl and Medrol dose pack
1hr p/vax onset of fever then frequent vomiting, diarrhea, h/a lasting about 5 days;cervical & axillary node & abd pain;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX vaccine (strength, dose, frequency, route, lot# and expiration date were unknown). The patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was unknown. Causality assessments were related.
Initial subjective fever, localized erythema, 12 centimeters by 12 centimeters.
Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had covid earlier this year in July and it wasn't as bad as what is experiencing with the shot. Covid was longer lasting then the vaccine symptoms.).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain). At the time of the report, ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain) outcome was unknown.            Concomitant medications were not reported. Treatment medication for muscle and joint pain was not reported.  Patient had Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) (Pfizer's latest covid 19 vaccine), it's the XBB 1.5 Pfizer's newest one, Lot no. HG 4432 vaccination card states received it on October 2nd, but actually received it on October 1st, 2023.  Patient had severe muscle and joint pain that night when received the vaccine. Monday morning patient started having the reaction and at 4 o'clock in the morning it woke patient up, and it was so bad. Patient had similar reactions to Moderna as well, but this was more severe. Patient stated that the side effect of the vaccine, it was very mild now. Patient took Tylenol to keep it under control, it was a lot less than it was yesterday. Patient does not feel comfortable, and it wakes patient up.
Severe heartburn and acid reflux beginning 2 days following the first vaccine; Severe heartburn and acid reflux beginning 2 days following the first vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 21-years-old) and the second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 21-years-old)) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 12:00, 2 days following the first vaccine, the patient experienced severe heartburn and acid reflux beginning and symptoms were still present but were being managed with omeprazole. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with omeprazole (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe heartburn and acid reflux beginning 2 days following the first vaccine was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
p/vax pt tops of both feet tender to step if resting; pain will come back to toes of both feet; pain is everyday; both knees hurt; ache; everyday stiffness in lt back
Red hot swollen arm. Diarrhea. Very painful - even more so compared to first dose. Went to MD and was prescribed steroids 6/29/18.
Covid-19, I tested positive for Covid 19 on July 8, 2022 I experienced a terrible cough, sore throat, fever of 100.0 and body aches, with loss of appetite & fatigue. I was prescribed PAXLOVID and was taking a prescription for the cough.
red dot size of quarter, its little bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter .  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and RETINOL ACETATE (VITAMIN A [RETINOL ACETATE]) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Cetirizine Hydrochloride as treatment
Two days after shot - had diarrhea for about 12 hours. Had second shot on 1/29/21- BioNTech COVID-19 vaccine  Lot: EL1283 Pfizer - again two days after had diarrhea and continued stomach upset for a week. Went to the doctor 2/9, had CT scan which showed my diverticulitis had flared up. The doctor wasn't certain the covid injections had caused this, but felt I should report it.
two days after vaccination with second moderna dose, pt experienced skin reactions on both arms and back of head. itching down to the flesh. the itching has continued to the current date in November  2021
No adverse effects reported; Patient received unspecified doseof ROTATEQ that was improperly stored; This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 13-AUG-2019, and 14-AUG-2019, previous temperature excursion was at the temperature of 34.7 degrees Fahrenheit (F), for 3 hours and 2 minutes.   On 27-AUG-2019 the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), per oral route, lot number S009940, expiration date 04-OCT-2020, (strength, dose and frequency were not reported) for prophylaxis.    The vaccine was stored at the temperature of 34.1 F for the time frame of 4 hours and 33 minutes. The call was because of data logger. No adverse effects were reported.
Awoke with tingling from my breast down to my toes. Went to urgent care 01/11/2016 referred to neurologist and first of three MRIs. 01/14/2016 all fingertips except thumbs began to tingle. Found three lesions in spinal column and brain areas hyperintensities.
Severe vomiting and severe diarrhea. Every 45 minutes for at least 7 hours. No treatment. Just waited to get better.
48 hours later- symptoms started with pins and needles in foot and went up entire leg. 11/13- still experiencing symptoms in foot. Patient has had this reaction before, in years prior with flu shot. Been treating with tylenol.
24 hrs p/vax had episode of faintness & pallor followed by brief apparent LOC, life squad called, normal by the time of their arrival;
Mild left arm pain; body aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2021 (Lot number: EM9809) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies. The patient's concomitant medications were not reported. Past drug history included: Advair, reaction(s): "oral ulcers", notes: Known allergies: Advair causes oral ulcers; Advair, reaction(s): "Known allergies: Advair", notes: Known allergies: Advair causes oral ulcers. The following information was reported: PAIN IN EXTREMITY (disability) with onset Feb2021, outcome "unknown", described as "Mild left arm pain"; PAIN (disability) with onset Feb2021, outcome "unknown", described as "body aches"; FATIGUE (disability) with onset Feb2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible. No further information is expected
Back ache getting progressively worse until second shot on March 3, 2021.  Then back ache progressed to back pain that would be a sharp jab to mid thoracic area.  Pain was much worse after second dose.  Paid has become less severe  by 3/17/21.  Less severe side effect has been dizziness that is mild but still persists as of 3/17/21.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown demographics. No further information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date the patient was vaccinated with ZOSTAVAX (therapy dates, dose, route was not reported) that was stored improperly. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Nausea; Fever with chills; Stuffy nose; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever with chills), NASAL CONGESTION (Stuffy nose) and MALAISE (Not feeling well) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever with chills), NASAL CONGESTION (Stuffy nose) and MALAISE (Not feeling well). At the time of the report, NAUSEA (Nausea), PYREXIA (Fever with chills), NASAL CONGESTION (Stuffy nose) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking an unspecified  arthritis medicine as concomitant medication.  Treatment taken was unknown   Reporter did not allow further contact
pt came to ED from rehab for evaluation of LE swelling and wounds are affecting ambulation; ESRD, tested positive for COVID in rehab facility and was unable to go to dialysis the morning of presenting to ED; c/o vaginal bleeding, too; tested positive in the ED for COVID; ABX given; CT showed necrotic mass, DVT, infiltrative metastatic disease; GYN Oncologist recommended DNR and hospice; pt agreed; pt moved to hospice where she passed away
Information has been received from a registered pharmacist concerning a 17 year old male with developmental delay, slight asthma condition and allergies who on Oct  19 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649989/0579P), intramuscularly. Concomitant therapy included sertraline HCL (Zoloft), cetirizine hydrochloride (Zyrtec), albuterol and Pantoprazole sodium (Protonix). On Oct 21 2005 at 2:00am the patient was admitted to the hospital. The patient was complaining of fever 104, redness, swelling and pain at injection site. he was started on IV Ancef and site of redness in arm continued to progress. Antibiotic was changed to Clindamycin IV. He did not improve so he was then given piperacillin sodium (+) tazobactam sodium (Zosyn) IV and vancomycin IV. Lab diagnostic studies performed WBC 30.8, ESR 19 and CRP 38.1. He was eventually discharged on Oct 24 2005 on oral antibiotics (name of antibiotics unknown). The patient was diagnosed with cellulitis, He had recovered. The physician reported that this patient had a softball size (pseudo abscess) that required a CAT Scan. The pharmacist considered cellulitis to be disabling. Additional information has been requested.
Extreme Vertigo about 15-20 minutes after injection. Patient rested with cold compress to forehead and back of neck
Pt developed temp 102.5F and rash at injection site the day of vaccine and mental cloudiness. Lasted 2 wks, then resolved with development of bilateral tinnitus and hearing loss that was intermittent, soreness of both his testicles intermittently and shooting pains in his anterior chest and arms localized over left precordium. Chest pains associated with dyspnea and worse in supine position. Lasted 1 hr 2-3 times daily. Not exertional. He sought care 10/17/21 due to peristent sx . Seen in ED with negative work up at that time (EKG, echo, troponin, CXR). His symptoms are gradually improving.
I received 2 shots and I still got it/ Suspected Vaccination Failure; I received 2 shots and I still got it; still got it, very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that it does not matter, he/she received 2 shots and still got them. The patient stated that it was very very painful. The patient did not had blisters and they gave lidocaine to him/her it really helped. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.