chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever up to 102.1°F; Chills; Could not fall asleep; Shoulder pain localized around injection site; A spontaneous report was received from a consumer concerning a 30 year old male patient who received Moderna's COVID-19 vaccine and experienced insomnia, injection site pain, fever, and chills.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 29-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced shoulder pain localized around the injection site.  At night, he woke up with a fever of up to 102.1°F, chills, and could not fall back asleep. Treatment medications included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The events fever and chills were recovering/resolving. The outcome of events, insomnia and injection site pain, were considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
The day after I received the vaccine I noticed that I had rashes on my left arm. It wasn't where I received the vaccine, but it was over my left hand. The next day, the rash started to spread to my other arm. Then it spread to both of my legs. It even spread to my buttocks. There was a little of a rash on my feet as well. I went and saw my PCP and she told me that it would just go away. I would have to wait for about 4 days for that. She said maybe a week or two at the most. It's not itchy. I noticed that it was still spreading so I went back to my doctor. I asked her if it could be a blood clot. She checked my blood and everything came back normal. I was worried because I was about to receive my 2nd dose. My doctor told me to see a dermatologist. It took me 1-2 months to get an appointment so I contacted an allergist. I went and he tested me for different allergies. He tested me on one of the ingredients of the vaccine. I was advised to take warm showers and stay away from the sun. I also saw a dermatologists assistant. I was prescribed a lotion/moisturizer. I was told to take Zinc and a drink called Juven. I still have the rashes all over my body. It's very prominent after I get out of the shower. I am going to see a dermatologist on 07/01. I really hope to get answers from this doctor.
8-3-12 Frontal headache, localized reaction of erythema at injection site also itching at site. Pressure behind eyes, bilateral soreness down sides of neck tingling behind ears.
15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and chest tightness
Pontine Stroke characterized by numbness and tingling on the left side from shoulder to feet.  Put on Asprin and low sodium diet.
Patient is a 61 year old female who presents for reaction to the COVID vaccine in her left arm. She is 13 days post Moderna vaccine dose number 1. She notes the redness in her arm started 2 days ago, and was worse this morning, so nursing asked her to come in and get evaluated to rule out an infection. She states she has no pain, it is just red and looks bad.   Diagnosed with delayed localized cutaneous hypersensitivity reaction
Body Aches, extreme fatigue, increased heart rate, fever (101°F) starting at 7:15 pm 03/13/2021. Taken 1000mg acetaminophen 10:00 pm - fever increased from 99 to 101
CHILLS; DEAD TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and dead tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and dead tired. This report was non-serious.
high blood pressure:  188/110; patient felt flushed , unwell and experienced  vertigo
Vaccines administered at 1535. Patient discharged, but returned at 1555 with fine red rash from head to toe. Bilateral wheezes. BENADRYL administered, pulse ox check = 96-97%. Albuterol administered MDI, transferred to ER for further observation. Discharged to home at 1830.
Information has been received from the authors of the literature article. The aim of this study was to evaluate persistence of varicella (VZV) specific antibodies after vaccination with 1 or 2 doses of VZV vaccine (manufacturer unknown) and to identify determinants of varicella seropositivity in a large cohort of children and adolescents with PHIV and also in perinatally HIV-exposed but uninfected (PHEU) children. The Adolescent Master Protocol (AMP), a component of the Pediatric HIV/AIDS Cohort Study, is an ongoing prospective cohort study designed to evaluate long-term effects of HIV infection and antiretroviral therapy (ART) among children with PHIV. It enrolled 451 children with PHIV and 227 PHEU children aged 7-16 years from March 2007 to November 2009 at 15 sites. Participants were required to have complete medical history of ART use, plasma HIV RNA concentrations, and lymphocyte subset measurements since birth. There were 653 subjects (432 PHIV and 211 PHEU) whose birth years ranged from 1991 to 2002. Compared with PHEU subjects, more subjects with PHIV were living in poverty. At the time their specimens were obtained for testing, subjects with PHIV were older and had a lower BMI z score than PHEU subjects. Overall, fewer subjects with PHIV compared with PHEU subjects received the VZV vaccine, with 38% vs 18% unvaccinated, 26% vs 25% having received 1 dose, and 34% vs 55% having received 2 doses, respectively (P< .001). Subjects with PHIV were older than PHEU subjects at the time of their vaccine (median: 4.7 vs 1.5 years; P < .001), had a shorter interval between first and second vaccinations (median: 3.9 vs 6.1 years; P < .001), and had more documented HZ episodes (10% vs 0%; P < .001). The median interval from last vaccine dose to sample collection was longer for subjects with PHIV than PHEU subjects (4.2 vs 3.5 years: P< .05). Of the 653 subjects tested, 84 (24.8%) tested negative by wcELISA. Among those testing negative, 78 (11.9% of all subjects) then tested positive by gpELISA. Overall, 87% of the cohort was seropositive to varicella, with a seroprevalence among subjects with PHIV of 82% (95% CI, 78%-86%), significantly lower than among PHEU subjects (97%; 95% CI, 94%-99%). This case concerns of 1 patient who received >/=3 doses of VZV vaccine (manufacturer unknown) in the PHEU cohort, and was seronegative. This is one of several reports from the same literature source (linked to MARRS # 1602USA002825 and 1602USA004824). Additional information has been requested.
Had a low grade fever (99.6) for approximately 48 hours and cleared Sunday 1/31/2021. Accompanied with body aches
Patient started having itching starting at the ankles, circumfrentially, symmetrical on both legs. This continued upward the legs to the body.  Back and back of arms. treatment with anti-histamine (anti-H1) drug  and acid reducer anti-H2 famotidine
Excruciating pain beginning in feet and legs, spreading throughout entire body.; Excruciating pain beginning in feet and legs, spreading throughout entire body.; Difficulty walking; Extreme exhaustion; Difficulty sleeping; Occasional high blood pressure; Profuse sweating during sleep; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EML201) via an unspecified route of administration in the left arm on 25Feb2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included atherosclerosis and stent placement. The patient was not aware of any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), carvedilol (COREG) and clopidogrel bisulfate (PLAVIX); all taken for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Mar2021 at 12:00, the patient experienced excruciating pain beginning in feet and legs and on same day patient experienced pain spreading throughout entire body, had difficulty walking, felt extreme exhaustion, and difficulty sleeping. The patient had occasional high blood pressure, profuse sweating during sleep. The patient had ongoing and constant pain for a week currently at the time of this report and reported that vitals otherwise were normal. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events excruciating pain beginning in feet and legs, spreading throughout entire body, difficulty walking, extreme exhaustion, difficulty sleeping, occasional high blood pressure, profuse sweating during sleep was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Narrative: 72 y/o M found to have low grade fever 99.7F on 1/6/21 at 2:30am; likely attributed to administration of COVID-19 vaccine on 1/4/21 at 11:53am. Patient received APAP 650mg po q84 prn pain/fever; however, fever subsided w/o immediate administration of APAP.
Startle reflex activated at the slightest touch; vibrating or trembling limbs; inconsolable crying; inability to make & maintain eye contact.  Symptoms lasted approx. 5-6 hours.  I suspect her egg allergy is connected to the vaccination.
lower back pain; This is a Spontaneous report from a contactable consumer via a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got the first dose of covid vaccine on 29Dec2020. On Friday (01Jan2021) she experienced terrible lower back pain. She was still experiencing the lower back pain but it was getting better. She was asking if this was normal. The outcome of event was recovering.    Information on the Lot/Batch Number has been requested.
This spontaneous report as received from a health care worker via a field representative refers to her mother, a 75 year old female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # unknown) and then received a second dose of ZOSTAVAX "a year later" on an unspecified date. No untoward effects reported. The patient had since died. Healthcare worker stated that the cause of death of patient was unrelated to the ZOSTAVAX. Additional information has been requested.
7 and a half weeks after the shot I was diagnosed with Guillain Barre and was in ICU on a ventilator etc.  I was sent sent to Acute Care Rehab on July 28 and was released from there on August 5th.  I am still in Physical and Occupational therapy.
STATED SHE HAD PAIN AFTER INJ. IN ARM AT INJ. SITE.  STATES IT HAS BEEN HARD TO MOVE AND RAISE HER LEFT ARM SINCE INJECTION.  SHE HAS NOT DONE ANY TREATMENT TO RELIEVE PAIN AS IN NSAIDS, IBUPROFEN, HOT OE COLD PACKS OR EXERCISES.  SHE STATES SHE STILL HAS DIFFICULTY MOVING ARM.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint \"swooned\" when the observer was getting the timer.  He was responsive after 2 minutes.  sat upright after 5 minutes.
Bloody diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose arm left on 30Jan2021 15:00 for covid-19 immunisation.  Medical history included diabetes mellitus. Concomitant medication included sitagliptin (JANUVIA). The patient experienced bloody diarrhea on 06Feb2021. No treatment received. The outcome was recovered.  Information on the lot/batch number has been requested
pt recv vax; devel fever; inc T 103.6; had sz of >30mins duration; to hosp w/ body posturing suggestive of deteriorating neurologic state;
Patient has redness on the entire upper arm area around vaccination site that has last for over 11 days. No soreness or itchiness was reported.
SENSITIVE TO TOUCH; SWELLING UNDER ARMPIT; FOGGY FEELING IN HEAD; PAIN BELOW INJECTION SITE; FAST HEART BEAT; SHOULDER PAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 (units unspecified). On 16-MAR-2021 18:45, the subject experienced fast heart beat. On 16-MAR-2021 18:45, the subject experienced shoulder pain. On 16-MAR-2021 18:45, the subject experienced chills. On 16-MAR-2021 18:45, the subject experienced fever. On 17-MAR-2021, the subject experienced sensitive to touch. On 17-MAR-2021, the subject experienced swelling under armpit. On 17-MAR-2021, the subject experienced foggy feeling in head. On 17-MAR-2021, the subject experienced pain below injection site.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fast heart beat, fever, shoulder pain, foggy feeling in head, swelling under armpit, pain below injection site and sensitive to touch was not reported. This report was non-serious.
tongue numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue numbness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (tongue numbness). At the time of the report, HYPOAESTHESIA ORAL (tongue numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Pain in hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in hand) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A7LB or 037A7RB and 016CZLA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in hand). On 11-Apr-2021, PAIN IN EXTREMITY (Pain in hand) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications included spray for seasonal allergies.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114451 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114451:Second Dose Case
they ran a COVID test and he tested positive/mild fever; they ran a COVID test and he tested positive/mild fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as dose 1, single dose and on an unspecified date in Jan2021 (three weeks later)(Batch/Lot number was not reported) as dose 2, single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included blood thinners. The patient received first COVID vaccine on 30Dec2020 and second dose three weeks later. He resided in assisted living facility and had several co-morbidities. He fell was taken to hospital to assess for internal bleeding since he was on blood thinners. He had a mild fever so they ran a COVID test and he tested positive on an unspecified date in 2021. ED physician did X-ray and CT of lungs. Gave patients dose of doxycycline to clear up lungs. Patient home and stable. Event took place after use of product. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Left side numb Extremely head ache Shaking Involuntary muscle movements Joints are on fire and swollen Dead spots on my skin appearing.  Still appearing. Incontinence  Multiple Asthma attacks and labored breathing.
Swelling, redness 2 days. Cellulitis at 2 days.
SWELLING BELOW SITE OF INJECTION, WITH ITCHING, TIGHTNESS AND REDNESS.
2 days after vaccination pt started having ringing in the ears. it is still happening. He went to the dr (not sure which dr) and he said to have me do a VAERS form. not sure why the md did not do it
administered Pentacel reconstituted with sterile water; Initial information received on 03-Apr-2019 regarding an unsolicited valid non-serious case received from an -other healthcare professional by phone.  This case involves a 4 months old male patient who was vaccinated with 0.5 ml dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5530AA and expiry date: 04-Oct-2019) via intramuscular route in the right thigh on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13V (CRM197) (Pneumococcal Vaccine Conj 13V (CRM197)) and Rotavirus Vaccine (Rotavirus Vaccine) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 10-year-old subject of unspecified gender who was vaccinated with HEPATITIS B vaccine and later ENGERIX B, (GlaxoSmithKline) as an adult.  On an unspecified date when the subject was 10 years old, he/she completed a HEPATITIS B vaccine series.  At an unspecified time later, when that subject started working, she was tested and found to have a negative titer.  As an adult, the subject repeated the HEPATITIS B series and received ENGERIX B.  The 3rd dose of ENGERIX B was administered in 2009.  One month following administration of the 3rd dose of ENGERIX B, the subject was tested again and the titer was negative.  The subject had not responded to therapy following both series of HEPATITIS B vaccination.
1010: Informed patient feeling tired, dizzy and warm feeling to chest/neck/head: BP: 152/94; HR:80; RR:20; O2 sat:99%; remained with patient. Patient was able to hold a conversation and knew where he was at. 1015: BP:160/94;HR:72;RR:22; O2 sat:99%; patient stated he was feeling better after placed in a cot in a supine position; applied a cool, wet towel to posterior neck. Asked patient if he wanted something to eat/drink and he responded he did. Drink, cookies/snacks given to patient. Tolerated snacks/drink w/o complications 1020: BP:162/94: HR:68; RR: 24; O2 sat:99%; remained with patient, stated he was feeling better but now feeling fuzzy brained, confused and pins/needles to bilateral extremities. 1040: BP: 152/90; HR:68; RR:20; O2 sat 99%; Patient indicated he needed to go to restroom; a male staff took patient to restroom, no problems, no dizziness. This nurse did not want patient driving home so he called his wife. 1050: BP:154/88; HR:70; RR:18; O2 sat 99%; patient stated he was feeling much better and no longer had the confusion feeling or the pins/needles feeling to bilateral lower extremities. 1115: BP:148/90; HR:70; RR:16; O2 sat 99%; patient's wife showed up and he was discharged to her care. This nurse informed patient wife what had happened and she verbalized understanding. Patient ambulated out with this nurse and difficulty. Patient placed in car and he was able to place seatbelt on himself. Airway never compromised at this visit. 1920: this nurse called and left message for patient to report how he was feeling 1940: Patient called and stated he was feeling really good. Stated he had not answered because he had gone to pick up his car from the COVID-19 clinic.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT WAS GIVEN A PFIZER COVID 19 VACCINE INSTRAMUSCULARLY.  IMMEDIATELY AFTER BAND AID WAS PLACED, PATIENT APPEARED TO BE FROZEN FOR SEVERAL SECONDS AND WOULD NOT RESPOND TO MY QUESTION.  MOM ASKED QUESTION AND HELD PATIENT, AT WHICH TIME THE PATIENT COLLAPSED AND HER EYES ROLLED BACK.  SO SHE PUT IN A SUPINE POSTION AS I RAN AND CALLED 911.  PARAMEDICS ARRIVED TO THE SCENE AND MONITORED HER VITALS FOR NEARLY 30 MINUTES. THEY OFFERED TO TAKE HER TO THE HOSPITAL BUT PATIENT'S MOM DECLINED.
ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOXIA 6/7/2022 -- RECURRENCE OF SAME SYMPTOMS