chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. In February 2017 (reported as "one month ago"), the patient was vaccinated with a dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. In February 2017, immediately after being administered the GARDASIL 9, the patient experienced redness and pain at the injection site. The patient sought medical attention and reported the symptoms of redness and pain at the injection site to his/her doctor on 22-MAR-2017. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The reporter did not provide the causality assessment between the events and GARDASIL 9. Additional information has been requested.
Patient received IMOVAX (Rabies), 1st of 3 dose series. Injection was given in left deltoid. Approx. 30 seconds post injection, patient fainted. Revived within 15 seconds. Patient experienced nausea about 30 min later. Patient sent to plant physician - sent home.
allergic reaction that she had after the first dose; Hives; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date as 1st DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction of hives after the first dose, which lasted for more than 6 weeks. The patient mentioned she called the hotline for medical assistance and is awaiting a call back. Clinical outcome of the events allergic reaction of hives was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
continuous vaginal bleeding/spotting; continuous mensural cycle. I have been bleeding between periods. My 2nd cycle since the vaccine started 9/22/2021 and I have been bleeding since then.
Symptoms started at 3:00 pm yesterday felt weak, had trouble breathing, dizziness, headache.
Local reaction to varicella shot. Hot, red, swollen about 7.5 cm round with a 3 cm square in middle.
pt recvd vax; 16 days later had scattered blisters on body;was irritable; had itching; 5 days later all blisters had scabbed;
Dry cough; body ache; chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (slight fever), PAIN (body ache) and COUGH (Dry cough) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (slight fever), PAIN (body ache) and COUGH (Dry cough). At the time of the report, CHILLS (chills), PYREXIA (slight fever), PAIN (body ache) and COUGH (Dry cough) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
No additional adverse events; on 17-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reaction, or allergies was not provided.  On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, frequency, route of administration, and anatomical location were not reported; lot number S028925, expiration date 16-SEP-2021) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  On 17-JUL-2020, the vaccine was stored in a temperatures of 6 degrees Fahrenheit (F) to 14 F (9.0 F) for 1 hour, from 15 F to 46 F (45.9 F) for 10 hours and 30 minutes; and starting at 10:07 pm, in a temperature from -47 F to 77 F (77 F) for 15 hours. On 18-JUL-2020, starting at 2:52 pm, the vaccine was stored in a temperature of -78 F/26 degrees Celsius or warmer (79.5 F) for 32 hours. There was no previous temperature excursion. The temperature excursions were not call because of a data logger. No additional adverse events were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA007875: US-009507513-2007USA007982: US-009507513-2007USA008008: US-009507513-2007USA008263:
Client received dose 1 of the COVID19 Pfizer vaccine at 15:43. After receiving the injection, the client and her mother went to the observation area to sit for 15 minutes.  At 15:57 the client?s mother alerted EMT that the client was feeling a little dizzy and lightheaded.  EMT alerted Lead RN who went to assess the client.  The client refused transfer into the anti-gravity chair and her mother agreed she was OK in the standard chair.  At 16:04, EMT took the client?s vitals (BP: 122/92, HR: 94 & SPO2: 98%).  The client and her mother did not know what the client?s normal blood pressure was.  That said, the client declined being short of breath, difficulty breathing, and chest pain.  The client also communicated to Lead RN that she ate and drank before coming to get vaccinated, and was pretty anxious because she doesn?t like needles, but overall felt OK, just a little dizzy.  The client and her mother confirmed that the client does not have any underlying health conditions and takes no medications.  The client indicated to Lead RN that she was starting to feel better.  Lead RN requested the client and her mother sit for an additional 15 minutes for observation and they agreed.  At 16:19 EMT took the client?s vitals (BP: 120/74, HR: 87 & SPO2: 100).  The client stated she ?now feels totally fine.?  She also explained that she had anxiety about receiving an injection and was just really tired.  Lead RN observed that the client?s skin was very fair and asked the client?s mother if her skin tone looked normal, not pale.  The client?s mother stated that the client did look pale before and looked much better now, ?back to normal.?  Lead RN educated the client and her mother on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  Lead RN observed the client and her mother leave the observation area at 16:22.  The client was walking with a steady gait.
On Sunday, 11/3 stated with dizziness, lighthead throughout the day, nausea. On 11/5 Tuesday again with the same symptoms. Could not stand, shortness of breath, dizzy and nausea.
Patient had an extreme vasovagal reaction,. Nausea, Vomiting, dizziness, drowsiness and fainted. He never lost his pulse but was extremely pale and weak. We called 911 and they took him to hospital because his hemodynamics were off, patient was fully alert upon transfer to hospital
Thirteen days after I received this dose of the Janssen  COVID vaccine my Automated Internal Cardiac Defibrillator fired twice as I was experiencing ventricular fibrillation. This was not a new condition to me (hence the AICD) but it was the first time being shocked in over 2.5 years, and I have not been shocked since then. The labs run that day show no electrolyte imbalance nor any other common cause that might explain why I was shocked.  I know the Janssen vaccine may cause myocarditis, a common symptom of which is cardiac arrhythmias. I did ask my electrophysiology cardiologist before my vaccination if it was safe for me to do so, and he agreed the risk was worth it. I did not think at the time I was shocked that it might be vaccine-related. I have since asked my EP cardiologist several times if there was any data gathered that might answer the question of whether or not I had myocarditis on June 11, 2021. No one will answer that question.
1054 - Began administration of vaccinations. Administered in this order: Menactra, Vaqta, Trumemba, and Gardasil 9. Father also present in the clinic room. 1055 - Client became limp and lost consciousness about 5 seconds after administration of Gardasil 9. Client regained consciousness after 4 seconds and was alert x 4. Client removed mask in order to breathe easier. RN noticed when masked removed client's lips were pale. RN remained at client's side. Water and graham crackers provided to the client. Client stated never having fainted before after vaccine administration; father commented that client's mother has a history of fainting with immunization. Client stated having breakfast this morning. Client stated feeling fine. RN had client wait in clinic for 15 minutes. Client denied any problems after wait, stated feels fine. Client's lip color pink. Client left clinic escorted by father.
injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, less than 6 months after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient had redness, swelling and heat at the injection site. At the time of reporting the patient told to continue Benadryl and Ibuprofen. The reporter did not agree to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Four hours after the shot my heart raced, I was terribly cold, and I grew very, very weak. The racing heart and severe cold lasted 12 hours; the severe weakness, 3 days.
The glands in her neck are swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (The glands in her neck are swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (The glands in her neck are swelling). At the time of the report, LYMPHADENOPATHY (The glands in her neck are swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
(L) UE (shoulder) pain. Vaccine was given high on shoulder. Had immediate discomfort. Now have ongoing joint pain.
I woke the next day and I wasn't feeling well. When I went to shower, I felt like someone knocked me in the arm with a fist. It was swollen for about 24 hours. I feel fine but not 100%. My BP is good but it slightly elevated on the next morning.
Developed fever with chills and itching for both upper arms then rash development same night of vaccines given. Then that night/next day developed redness/edema/warmth/tenderness of both upper arms as well. Seen 12/12/16 in clinic, still with rash and redness but improving per mother, no treatment. No further fevers after night of 12/9/16.
The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2003USA009717: US-009507513-2004USA001737: US-009507513-2004USA001738: US-009507513-2004USA001739:
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown dates, the patients were vaccinated with the third dose of RECOMBIVAX HB injection (strength, dose schedule, route, lot# and expiration date were not provided) for prophylaxis, outside of the recommended time frame. No adverse effect were reported. Additional information has been requested.
Suddenly felt dizziness and chills and passed out for a minute. When woke up, my arms were numb.
Exactly 2 weeks after flu shot patient had a hacking cough, bad head cold, some fever, a few days later patient developed mump like swelling on left side of face and neck. Weakness. Could not get out of bed, tearing eyes.
31MAR95 sounds as if pt throwing up found  to be salivating, eyes rolled back, body jerking, color blue; last approx 3-4 mins; transported to hsp; t104.7; given Pedia-profen, temp comes down; released @ 0320
rash on his leg; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: rash on his leg). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The case was reported by patient's wife. The reporter stated that her husband got his vaccine a couple of years ago. He just got a rash on his leg. That's it. Everyone she believed reacts different to it. The follow up would not possible, as no contact, details were available. This case has been linked with case US2023AMR067497 reported by same reporter; Sender's Comments:  US-GSK-US2023AMR067497:same reporter
Temp elevation, vomiting; Treatment: DPH, Phenergan, APAP chewables;
Patient tested positive for COVID-19 last week.  States he feels so weak he is unable to walk.
pt recv vax 14JUL95 & 11SEP96 pt exp a varicella-like rash w/15 vesicles;
(Sore arm, redness, swollen, hard, hot), joint/muscle achiness. Severe low grade temp 100.5; headache; sensitive to touch all over body; minor nausea.
menstrual cycle changed; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151), via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none.  Concomitant medication was not reported.  The patient did not have any history of past drug therapy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021 at 07:00, the patient believed that the vaccine changed menstrual cycle. The patients period began about a week earlier than expected, about 24 days after previous period ended. The patient did not experience any other additional symptoms. The clinical outcome of the event menstrual cycle changed was unknown.   No follow-up attempts are needed. No further information is expected.
lips began to tingle and numb; lips began to tingle and numb; spiked a fever 2 degrees over my normal; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 08Mar2021 at 15:15 as dose 1, single for COVID-19 immunisation. Medical history included T2 diabetic, hypertension and had known allergies to sulfa drugs. Concomitant medications included ramipril and tadalafil, taken for an unspecified indication, start and stop date were not reported (medications received in two weeks). No other vaccine received in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. On 11Mar2021 at 12:00, 3 days after injection, lips began to tingle and numb, like after Novocaine wears off. Now 12 hours later (as reported), still not right. Also spiked a fever 2 degrees over his normal about six hours into the event. The patient did not receive treatment for the reported events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pulmonary embolism on 4/3, treated in ER with Eliquis
1215am: Chills, weakness, fatigue, muscle pain at site of injection and in legs, especially ankles 3am: burning up 7am: headache, nausea, weakness Most of day on 3/20 and still feeling today 3/21: slight headache and nausea
Client received 2nd dose Pfizer vaccine at Center. 4 hours later at approximately 1:20, client was shopping at store and started experiencing difficulty breathing, "throat closing." Client went to pharmacy with symptoms. pharmacist administered Benadryl at 1:22 pm and Epi-Pen at 1:23 pm. Ambulance called. Client stated she started feeling better after medication administered. Client declined going to ER via ambulance. Called client 3/16/21 and client reports she thinks she was having anxiety.
Headache, Myalgia, Fever, C/O chills,fatigue, injection site reddness,swollen and warm to touch. Told to follow up with primary care physician if promblem persists NarrativeL
Patient reports having a sore arm at site of injection 1/14/2011. States he developed chills, fatigue, and progressive muscle weakness on 1/15/2011. States symptoms have continued to present date 2/1/2011.
time of injection, arm was painless, injection itself was painless. Noticeable swelling with no pain the  night of injection. one day later (today) arm pain/soreness increasing and very painful. Fatigue set in 4/7/2021 morning after injection, and still feel fatigued 4/7 night (now at time of writing)
Itching at injection site radiating down to forearm, itching at right lower side 1125- Benadryl 12.5mg x2 chewable tablets given 1150- client reports less itching, cleared by site lead
By 11:00 PM on the day of the vaccine booster, I was awakened with severe body pain, headache, chills, fever (101.6 - my "normal temp" is 97.6 - 98 ), I had nausea earlier in the evening. I contacted my primary on-call physician to ask if I could take Tylenol and was told yes.  The body aches and fever subsided within two hours. Around 1:00 AM I started to have awful feelings of insect biting on my legs, arms and torso. This was the worse of all symptoms. The on-call physician called me around 6:00 AM and I told her about this new side effect. She said it sounded like an allergic reaction and I should take Benadryl. I didn't have any Benadryl and had to wait until noon to get the medication. There was no relief from the Benadryl.  I began taking Ibuprofen (600 mg) and felt some relief. Also, sitting in a warm bath helped. Today (Nov 5) is 10 days post the Moderna Booster. I am still feeling the symptom, but it is somewhat better... I tried to contact CDC to see if anyone else had reported this effect and the CDC was not helpful.
Soreness at injection site; fever; chills; Soreness at injection site, fever, chills, hopfatigue and weakness; weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 (at the age of 68 years) (Batch/Lot Number: EM9809) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy. The patient was not pregnant at the time of vaccination. Medical history included Possible Parkinson's Disease in process of being determined from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to brand triple antibiotic ointment. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 04Mar2021, the patient experienced Soreness at injection site, fever, chills, fatigue, and weakness. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering at the time of vaccination. No follow-up attempts are possible. No further information is expected.