chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Contracted COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Contracted COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Contracted COVID-19). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Contracted COVID-19), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant and treatment medications were reported. No further information and no additional adverse events reported.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. Patient received Tozinameran vaccine as the booster dose of the COVID-19 vaccination schedule. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-648378, US-MODERNATX, INC.-MOD-2022-648363 (E2B Linked Report).; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 (AESI). Vaccination dates were not provided, latency cannot be assessed. Patient received Tozinameran vaccine as the booster dose of the COVID-19 vaccination schedule. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-648378:Father's case US-MODERNATX, INC.-MOD-2022-648363:Reporter's case
death D69.6 - Thrombocytopenia, unspecified N93.9 - Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF BREATH
Patient stated after she sat down she began to hear ringing in her ears and had tunnel vision; didn't remember after that; medic and this nurse ran to patient where she was laying face down. Patient began to come around and skin was pale and clammy to the touch. VS taken: HR: 82; BP: 140/70/ O2 Sat RA; 78%. Patient was speaking coherently after she woke up, was out for about 25 seconds. Patient stated she had a hx of fainting w/labs or shots. Placed cool, wet towels behind neck, forehead and lower back - patient stated it helped her feel better. VS retaken: BP: 134/66; HR: 77; O2 Sat RA: 98%. Patient sat up in a wheelchair and began to have color to face and feeling less clammy. EMT sat with patient until she was feeling better. Patient was joking and  stated she felt embarrassed. Patient discharged to home.  This nurse contacted her after clinic, she stated she was doing well and would be seeing us again for her 2nd Moderna dose. This nurse encouraged her to notify the next vaccinator of her hx of fainiting - She stated she would. Patient appreciative for call.
devel h/a, vomiting & fever 2 days p/vax; physical exam revealed a stiff neck; admitted to r/o menigitis;
Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA164901 and 2018SA175612. This case involves adult female patient who experienced purple rash on her thigh, more tired and urine changed color, while she received vaccine FLUBLOK QIV. It was also reported that in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. It was reported that years ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicy, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack.States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. In 2015, the patient received a first dose of suspect FLUBLOK QIV lot number not reported in unknown administration site. In 2015, the patient developed a non-serious purple rash on her thigh, more tired and urine changed color (chromaturia) few months later administration of FLUBLOK QIV. The reporter reported that purple rash it could have been an immunological rash. Other relevant tests included No lab data Final diagnosis was urine changed color, more tired and purple rash on her thigh. An unknown corrective treatment was received. The patient outcome is reported as Unknown for purple rash on her thigh, more tired and urine changed color. List of documents held by sender: none.
Patient experienced hives after receiving vaccines. Patient was seen by Dr after event and prescribed ORAPRED 15 mg/6 ml PO qd x 3 days advised to also take ALLEGRA 1 tsp daily.
Morning after immunization, pt presented with very swollen, red, hot, full upper arm (L). She went to primary Dr, got Doxycycline 100, then that night, reaction spread. So went to ER and prescribed KEFLEX 500. Doing better.
I had general malaise, felt lethargic, fever of 106F, congestion, coughing, nasal congestion felt like I had a common cold. I used a home COVID-19 test that did come back positive. I called a known healthcare provider to let her know that I had tested positive for COVID-19, we discussed my symptoms. She is a doctor and works in the office with my doctor, they discussed my symptoms, my doctor called in a prescription of Paxlovid. I took the Paxlovid immediately as prescribed. I had a good recovery.
Patient came to health office to show me site of varicella vaccine; she stated symptoms started in the afternoon of 6/2 with a red spot, soreness, itching, burning. The spot then grew larger. What I observed on the AM of today, 6/3/10 was a raised, red area, 7 cm X 7 cm, looking like hives, hot to the touch. No pustules, open area or drainage present. Client complains of burning soreness and slight itching.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2016, the patient received a dose of flu vaccine from the year of reporting date. The patient's arm became swollen after receiving the Flu vaccine. The reporter was unaware of the brand name. The reporter declined to provide the further details. This case is one of the three cases reported by the same reporter.
flu like symptoms; Fever; vomiting; Diarrhea; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 07Apr2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 09Apr2021 at 13:15, the patient experienced flu like symptoms with fever, vomiting, diarrhoea, chills, aches and fatigue about 52 hours after the second savior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events flu like symptoms with fever, vomiting, diarrhoea, chills, aches and fatigue were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Started experiencing Hives 2-3 weeks post vaccination.  The hives come with skin irritation (i.e. scratching, brushing, scraping). They were all over my body and are still occurring. I'm also experiencing Dermatographia. I have chronic pruritus (itchiness) with the hives.
sore arm at injection site; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Oct2021, outcome "unknown", described as "sore arm at injection site"; CHILLS (non-serious) with onset 22Oct2021, outcome "unknown", described as "chills".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
INITIALLY FEVER, ACHES, HEADACHES,HOT FLUSHES, NAUSEA, DIARRHEA, AND UPPER ABDOMINAL STOMACH PAIN WITH DIGESTIVE COMPACITIY DIMINISHED. LASTED ABOUT 1 WEEK, THEN FOR ADDITIONAL 10 DAYS AND STILL CONTINUING, I HAVE HAD HOT FLASHES, TINGINLING IN MY HEAD WITH TIGHTNESS, INCREASE HEART RATE, AND BLOOD PRESSURE, AND WAKING UP EVERY NIGHT AT 3 AM IN THE MORNING WITH BAD NIGHT SWEATS MOST OF THE TIME. NONE OF THIS EXISTED BEFORE THE SECOND PFIZER VACCINE. I AM 55 AND IN MENOPAUSE , BUT WAS TOTALLY CONTROLLED WITH NATURAL PROGESTERONE SUPPLEMENTATION. THE WORST IS THE RACY HEART, AND JITTERINESS , WITH HEADACHES.
1 shot - body shaking , fever 2 shot - no reaction  2nd vaccine was not available several months  Got shingles - 7-12-2019
SLIPPED OUT OF BED AND COULDN'T GET UP OFF FLOOR; This spontaneous report received from a consumer concerned a White, Not Hispanic/Latino female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 09-MAR-2021 10:00 am to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021 20:00 pm , the patient experienced slipped out of bed and couldn't get up off floor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slipped out of bed and couldn't get up off floor on 09-MAR-2021. This report was non-serious
My COVID-19 symptoms started on 11/23/2022 in the morning with sneezing which continued till evening. On 11/24/2022 in the morning I had low grade fever, headache, fatigue, runny nose, severe sore throat, body aches, loss of appetite and chest congestions. I didn't think that I had COVID-19 infection but on the 11/27/2022 I tested with a home COVID-19 test which was positive. I realized that my symptoms were getting worse so that's when I decided to take the home COVID-19 test. The same day I went to the urgent care they also tested me for COVID-19 and FLU. My COVID-19 test was positive and FLU was negative. The urgent care advised me to take TYLENOL or take over the counter sore throat medication. I took TYLENOL for at least 6 days and I also took lozenges with zinc in it. I did recover from COVID-19 infection but I get easily tired. My legs would hurt even if I sit down or lay down. This is something new I am experiencing after COVID-19 infection.
Abdominal pain, vomiting, erythema distal to injection site. Vital signs WNL. Benadryl 25 mg given. Monitored x 20 minutes. Symptoms resolved.
Patient came by pharmacy 12/19/15 and said arms still hurts from shot and inquired what needs to do.
cronic headache after 10-15 minutes after the injection...next day headache, lightheadedness and body agitation. These symptoms have NOT GONE AWAY TO DATE!
No adverse reaction. The patient was suppose to get a Boostrix vaccine and instead received a Infanrix vaccine
p/vax pt had an anaphylactic rxn-pallor, sl cyanosis, sweating, cold & clammy extremities, bradycardia; cont breathing normally;mouth to mouth breaths given & pt started crying in a few minutes;911 had been called; 100% 02 by mask;
Fever, chills, headache, and over all body aches starting approximately 12 hours after injection lasting approximately 24 hours
Mom reports she got her vaccine, she had given her Tylenol 30-45 minutes before vaccine which is a normal practice for where she is from. She was called in for the vaccine, mom is pregnant and getting her third booster, and daughter getting her first dose. They both had COVID in February of 2022.  The nurse gave mom hers first, and then they gave the daughter hers. They waited for the 15 minutes following the vaccine, and they went home.  There were no symptoms of high fever, no difficulty breathing and no swelling.  At 5:30 PM she received a call from the nurse and with the supervisor notifying them that she received 0.2 ml without dilution of the vaccine.  Mom has spoken with the CDC and perhaps it was an overdose of the vaccine, and they gave her our phone # to call and report this. Mom is 27 weeks pregnant and nervous about the notification.  Daughter has no further symptoms, but called her pediatrician and told her to get documentation of the incident.
Information has been received from a registered nurse concerning a 17 year old female with a penicillin allergy who on 13-DEC-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #658560/1062U). There was no concomitant medication. On 14-DEC-2007 the patient developed oral herpes. She initially experienced a fever and then later developed blister-like lesions in the inside of her mouth. She also experienced a sore throat and nausea. She was treated with acyclovir. There was no laboratory or diagnostic tests performed. The patient was in for an office visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
lymphadenopathy; had swollen spleen; night sweats; slight fever; This is a spontaneous report from a contactable consumer (patient's brother-in-law). An unknown age of male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) on unspecified date for covid-19 immunisation. On an unspecified date the patient experienced lymphadenopathy, swollen spleen, night sweats and slight fever. The reporter reported that the patient's brother-in-law received the Pfizer covid vaccine second dose. He's been in and out of the hospital for about a month now, this is the 3rd time. They were thinking throughout this time it could by lymphoma. They did a biopsy and was negative. There are doctors that said all along it wasn't lymphoma. Now they are back to thinking it was the vaccine. The patient wanted to know about the 0.8% of lymphadenopathy. The outcome of the events was unknown.  Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer included: Reporter details were added.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from  a physician concerning an approximately 12 year old female with no medical history or allergy who on 11-SEP-1997 was vaccinated with VARIVAX (Oka/Merck) (lot# not reported)0. There was no concomitant medication. Subsequently the patient's "varicella titer" was less than "0.90" after having 2 doses of VARIVAVX (Oka/Merck). No adverse effect reported. The patient was seen by the physician. Additional information has been requested.
Twitching in right shoulder area, twitching in right butt area,    or another word to use is TREMORS.  ITS BEEN ABOUT A WEEK NOW.
Left arm is sore 2 weeks after injection, OTC Advil not helping, denies redness, swelling or warm skin.  Advised to increase ibuprofen to 400 mg every 6-8 hrs with food, apply heat to area 3 -4 times a day 20 minutes.
This is to report an inadvertent 3rd dose of Pfizer covid-19 vaccine.
pt recvd vax & was cold & clammy; t 97.2; c/o headache & tired feeling; skin color pale;
a little bit of tiredness; some arm pain from the first dose; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in upper left arm on 30May2021 15:45 at the age of 41-year-old as dose 1, single for covid-19 immunisation. Patient felt lightheaded two weeks (may2021) before the vaccination and he went to a heart doctor and the doctor said he needed to adjust his body so they did  blood work and everything. The patient's other medical history and concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no vaccines administered on same date with the Pfizer vaccine. The patient had some arm pain from the first dose and a little bit of tiredness which result in physician office visit. Patient did not visit emergency room. The outcome of the event was recovered on Jun2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Per mother, patient experienced an all over body rash 2 1/2 hours after vaccination of VZV and Hepatitis A on 07/14/2009.  Denied fever.  Denied itching.  Mom treated at home with OTC Benadryl x2 doses on 07/15/2009.  Treatment with Prednisone 5mg TID x5 days.  OTC Calamine Topical Lotion as needed.  Decrease sun exposure.  To see MD if does not improve.
pt recv vax 26NOV26; subsequently devel vesicular rash (50 lesions) on trunk, arms & face, accompanied by low grade fever, lethargy, h/a, & dec appetite;mom denies contact w/known chicken pox carrier;
Fever> 102, large area of redness and heat to administration site, with nausea
A patient that developed neck swelling 1-2 hours after receiving the first dose of the Pfizer Covid 19 Vaccine; Experienced injection site redness & pain; Experienced injection site redness & pain; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route administered, on an unspecified date, as Dose 1 single, for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient developed neck swelling 1-2 hours after receiving the first dose of the Pfizer COVID 19 Vaccine and the symptom lasted for about 2 days. On an unspecified date, the patient also experienced injection site redness and pain. Caller asking if the patient should receive the second dose of the Pfizer COVID 19 Vaccine or not. The outcome of all events was unknown.  Information on lot/batch number has been requested.
The pt noticed pain and redness at the injection site that started small and by 3 days after the vaccination the redness was "about the size of a fist"
Patient states she developed the COVID arm rash on day 2 following her first dose of Pfizer vaccine. The rash was about the size of an orange around the area where her immunization was given. It was warm to the touch and felt like there was a lump under her skin.
Fever of 105.5; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. The patient received other medication(unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient also took acetyl salicylic acid, ascorbic acid(ASPIRIN) and ibuprofen sodium(IBUPROFEN) on unknown dates and experienced allergy. 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 vaccination. On 10Apr2021 at 01:00, the patient experienced fever of 105.5. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 10Apr2021, the patient underwent body temperature test and the result was 105.5(unit unspecified). The clinical outcome of the event fever of 105.5 was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complains of swelling & redness at site, with fever 101' started day after administration, cleared up after 2-3 days, reported by phone to nurse
Patient felt pain in her throat and very cold. Pale and very pale around her lips as well. Vomited once, complaint of abdominal pain. She was given two teaspoons of BENADRYL. Patient was sent to hospital, she was prescribed with BENADRYL and PRENOLE 15mg. Dr thought it was an allergic reaction to the vaccine. Patient was discharged from ER.
MOC stated noticed hives about 10-15min p/vax;it was on pt hands, neck & trunk area;later lips started to swell;mom spoke w/MD instructed usage of DPH which didn't stop the hives & swelling but didn't make it any worse;