chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented to the vaccination site on 08/08/2022. The client reported that she received two doses of Pfizer: Dose one, on 04/20/2021, Lot # EW0164 and Dose two, on 5/11/2021, Lot # EW0168.  After the second dose of Pfizer COVID vaccine on 05/11/2022, client reports having an unusually stronger reaction to a new cat in her home which belonged to her roommate. Client reports having previous medical history of mild allergies to cats, in addition to dust/dirt, and weather changes. As per client,  a typical reaction to cats include: some mild fatigue, localized pruritus on skin when in contact to cat?s hair, mild itchy nose and congestion, never having to take any medication for her cat allergies since childhood. On the day of the second dose of Pfizer, client left the clinic after observation reporting having no reactions until after about two hours when she arrived to her apartment. She sat on the living room sofa where the cat had been lying down for the day and she immediately started to feel stronger SOB/ fatigue while walking and going upstairs, pruritus on arms, and 4/10 headache for about one hour, no other symptoms were reported. RN submitted a medical consult, as per site lead request, via text message to Dr. on provided number at 12:54 PM and phone call follow up at 1:21 PM requesting to proceed with the COVID vaccine. Per Dr., approval to proceed with Pfizer Booster 1 dose COVID vaccine was obtained from medical consult. Client received COVID vaccine Pfizer Booster 1, Lot#FP7135 on 08/08/2022. The client did not report any symptoms during the 30-minute observation period. RN and another RN educated client on possible adverse reactions, when to seek medical care and to register with V-Safe. The client left the vaccination site at 1400 (2:00 PM) no signs of acute distress were shown or reported by client. No symptoms reported per client. Client appears well, alert, oriented x4, talkative, smiling, and ambulated out of the clinic
On Friday, November 12, 2021 the PT came to clinic for a Covid-19 Pfizer vaccine. Client stated to ancillary staff during check-in process that he was vaccinated with one dose of Cansino Covid-19 vaccine on May 5, 2021 in Mexico with proof of vaccination. At this time Cansino Covid-19 vaccine is not a vaccine approved by the WHO. Submitted a medical consult to Vaccine Operations who confirmed with Dr that client was approved to receive the Pfizer vaccine as his first dose as it has been more than 28 days since receiving the one dose of non-FDA-authorized Covid-19 Cansino vaccine. Client has no history of allergies or previous adverse reactions to other vaccines. Client was to be a 15 minute wait in the Observation Area. Client received his Covid-19 Pfizer vaccine (LOT #: FF8839) at approximately 2:21 PM in his left arm. Client was educated by RN  on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 2:45 PM.
Child developed swelling and redness around the area of the injection site. Erythema was 6 inch around site. Also had some difficulties with breathing.
Headache, Myalgia, Arthralgia, CERVICALGIA, FATIGUE Narrative:
Expired dose was given by accident; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 02-JAN-2023) for prophylaxis.   On 19-APR-2023, the patient received the 1st dose of Engerix B. On 19-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose was given by accident). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 A physician wanted to know how to proceed further. Information about the patient and vaccine were given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient accidently expired dose of Engerix B, which led to expired vaccine used.
24 hrs after injections administered severe pain from injection site (L) deltoid down "entire" (L) arm to wrist and hand. Inability to lift or turn on flex arm over slightly - "excruciating" pain 3 days - then ER visit. W/Lidocaine patches and Ibuprofen ordered. Pain in (L) shoulder still 10/18/17.
General achiness; Pain at Injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache). At the time of the report, PAIN (General achiness), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medication details has provided as patient was receiving migraine tablets and allergic medication not specially mentioned the class of drugs; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. The medical assistant reported that, on an unkonwn date of 2014, unknown number of patients were vaccinated with a dose of PROQUAD (Merck) (lot#, dose/frequency and route not reported) which had been improperly stored in March 2014. No adverse effects reported. This is one of two reports (MARRS# 1404USA005034 and 1404USA006997) from the same source. Additional information has been requested.
Received H1N1 vaccine 10/23/09, contracted shingles 10/31/09
03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain  lasting entire day and into evening, difficultly moving
syncopal episode immediately after injection.  patient quickly recovered and felt fine after about 15 seconds.  no nausea, vomiting.
8/20/2021 I started feeling the symptoms of fatigue, and I thought my allergies were going on. No, Sunday I started feeling worse got a cough and still more fatigued and felt just yucky. I lost my taste on 8/26/2021 but I could still smell. I took cold Tylenol. I went to the pharmacy and had a COVID test done and results came back positive on 8/26/2021. On 8/27/2021 I had a virtual visit with my doctor, the doctor wanted me to get an infusion but no appointments were available. She prescribed a cough medicine for me to take. I did not have a fever. She did recommend that I take zinc and so I did start to take that.
Patient felt dizzy and fainted after receiving second dose of Pediatric Pfizer Vaccine.  She rested for about 15 minutes before she stopped feeling dizzy.
Sweating at night; This spontaneous case was reported by a nurse and describes the occurrence of NIGHT SWEATS (Sweating at night) 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 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 NIGHT SWEATS (Sweating at night). At the time of the report, NIGHT SWEATS (Sweating at night) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.   This case was linked to MOD-2022-478534 (Patient Link).   Reporter did not allow further contact
Persistent itching all over body that comes and goes all day and night(because I wake up with scratches from me itching in my sleep)
12/4/2022 I spent all night throwing up with an upset stomach and nauseous. I could not keep water down. I had been switched from lisinopril to lisinopril with hydroxychloroquine. I went to the urgent care on 12/5/2022. I was given a shot and a prescription to stop the vomiting at home and the vomiting did stop. I was tested for COVID which was positive. I was also tested for the Flu which was negative. I was given a prescription for PAXLOVID which I began taking that day. I stopped taking the lisinopril with hydroxychloroquine because of the diuretic and went back to the lisinopril. I slowly got better and began taking the lisinopril with hydroxychloroquine again. 12/22/22 I suffered a stroke. I called the paramedics and was taken to the hospital. My sodium was at 122 because of the lisinopril with hydroxychloroquine I was taking. I spent 4 days in the hospital while they tried to get my sodium back in line. Chest x-ray, Echocardiogram, EKG's were normal, CT of the brain and MRI of the brain which revealed the stroke, on 12/23/22. I had bloodwork every 6 hours and IV. I was released from hospital with different prescriptions, atorvastatin, lisinopril and aspirin 325. I had a couple of repeat visits to the emergency room because my daughter saw some stroke symptoms. I had CT and MRI of head on 12/30/22. bloodwork each time. I had Tee scan on 1/5/23 which was negative. I started wearing a 30 day monitor on 1/7923 which was normal. On 1/10/23 I had a scan with contrast and it showed a blockage in my carotid artery. My hemoglobin was very high, and I was referred to a Hematologist on 1/11/23. He suspected polycythemia vera. I had a lot of bloodwork which came back positive for the gene that causes polycythemia vera so I was diagnosed. My atorvastatin was stopped and I was switched to a lower dose aspirin. 1/27/23 I had a bone marrow biopsy. It did not contradict my diagnosis and did not show additional abnormalities. I had switched from the lisinopril to losartan which elevated the potassium, so was switched to amlodipine. I was given hydroxy urea for four days. I have been back and forth to the Hematologist and started the hydroxy urea again. I had a follow up with my Cardiologist who wanted me to get the blood issues under control before looking at the blockage. I saw a Nephrologist and was switched to nifedipine and took me off the amlodipine. I see the Hematologist on 3/29/23. Planning to have a stent on April 6, 2023.
Paralyzed for over 10 minutes at 3:00 AM. while lying on back. Then diarrhea for 4 days. Weakness and tired for same period of time.
Patient woke up on day 2 with a swollen shoulder that was warm, itchy, and painful.  Pain was radiating.  She was counseled to apply ice to the site, and to contact her primary care provider.
Got shingles shot on 19th of May. About May 23rd I started getting small red bumps on my skin, by Jun 1st I had large red blotches in many places plus all the small red bumps. It is now Jun 22nd and they are just starting to leave. They did not hurt, but they were uncomfortable.
headache which lasted a day Tiredness which lasted two days itchy, red rash on injection site arm , not sure of duration since it appeared on 2/16 but grew to current size of 3-4? on 2/17
Had the injection 3/21/2021 at 2:30.  On 3/22/2021, the next morning after the injection had nausea, flu-like symptoms, and slept all day.  Took two advil and one tylenol at 6:30 am, 2:00 pm and again at 10 pm.   On 3/23/2021, woke up 7 am in the morning and felt fine.
Mom called office 6/30 to report redness/swelling on L thigh at vaccine injection site. Pt examined by ARNP. Large area (approximately 10 cm x 12 cm) of soft edema and blanchable erythema L anteromedial thigh. No tenderness or induration. TX with antihistamine and cool compress.
This spontaneous report as received from a nurse refers to a female child "under 2 years old". Concurrent conditions and medical history were not reported. The patient received three doses of ROTATEQ (oral; lot number, dose, frequency not reported) however the reporter did not have dates of vaccination at a time of a call. On unknown date, the patient was hospitalized for three days due to unknown reason. The reporter stated that the patient was seen for follow up appointment approximately in April 2015 (reported as "last month") and "was doing great" (recovering/resolving). The causality assessment was not reported. This is one of several reports from the same source. Additional information has been requested.
At injection site, itchy, red, warm to touch, 3 1/2" x 2" patch. Not resolving after 3 days - counseled to take TYLENOL/MOTRIN and ice. If gets worse, seek medical attention.
1. Patient received vaccine in her (R) deltoid (Non-documented). 2. 4 days after vaccination, patient (who is an ortho surgeon) developed severe (R) shoulder pain with decreased AROM. 3. Continued symptoms of (R) shoulder bursitis/rotation cuff tendinitis at this time. 4. Awaiting MRI of shoulder. PT stated.
No symptoms or additional adverse effects reported; unspecified dose in PROQUAD immunization series were administered after being improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022914, expiration date 19-JAN-2021 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis. Diluent was properly stored.  Administered dose of vaccine was exposed to the temperature excursion of -14.06 degrees Celsius for 10 minutes. There were previous temperature excursions, -14.28 degrees Celsius for 55 minutes, -13.72 degrees Celsius for 55 minutes and -12.92 degrees Celsius for 5 hours on unknown dates. Digital Data Logger was involved. No symptoms or additional adverse effects were reported.
it is sore; Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large; This spontaneous case was reported by a patient and describes the occurrence of PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     It was reported that patient do not had any allergies (medications, food and other products). Patient had COVID + test or diagnosis in Apr-2022. Patient did not had acute and chronic illnesses at the time of vaccination.  .  Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL for Blood pressure high, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 09-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large). At the time of the report, PAIN (it is sore) and VACCINATION SITE INFLAMMATION (Her right shoulder is very inflamed, the glands under the right arm and side of her body and under the arm are inflamed. This is massive and large) had not resolved.            It was reported that patient had received the flu shot the same day on the other shoulder.   Dose Number: 1, Date administered: 08-Jul-2021, Lot number: 045B21A.  Dose Number: 2, Date administered: 17-Sep-2021, Lot number: 046C21A.  Dose Number: 3, Date administered: 14-May-2022, Lot number: 056A22A.  AE did not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Patient had never experienced a similar event in the past.  It was reported that patient symptoms were ongoing.  No treatment information provided.   This case was linked to MOD-2022-657528 (Patient Link).
Fever 103-104 degrees F lasting 24 hours, low grade fever 3 days after; would not eat except breastmilk for 3 days, extremely irritable for 4 days.
This case was reported by a nurse via call center representative and described the occurrence of herpes simplex antibody positive in a 51-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK214221). In September 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced herpes simplex antibody positive. On an unknown date, the patient experienced fever, chills, induration, swelling, erythema and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the herpes simplex antibody positive, fever, chills, induration, swelling and erythema were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the herpes simplex antibody positive, fever, chills, induration, swelling, erythema and injection site pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse for herself. The patient had a worse reaction after the 2nd dose of SHINGRIX than 1st dose. The patient had fever, chills, large induration, swelling, redness diameter of about 4 inches. The patient experienced a false positive Elisa IGg HSV2 result following SHINGRIX. In 2015, the patient was tested negative and in October 2018, resulted positive. The patient did not have a partner for 5 years. As the patient was tested every 2 years due to her job. She forgot she had received vaccine, or she would have waited to test her yearly tests exposure risk. The patient thought this might had given a false positive test result. She called the lab and they said they use Elisa. The gynecologist referred the patient to ID to question this. He did not have the answer. The 2nd dose was worse in every aspect. The fever lasted longer. The pain was occurring till the reporting time. Lot and expiration date was not available. Lab Comments: In October 2018, the patient resulted Elisa IGg HSV2 false positive.
The vaccines KINRIX and IPV here administered to a one year old female. Called resources to check on any reactions and informed mother and  she was educated on S/S to be aware of, she verbalized understanding. The error was due to the PHN not reading the vaccine label properly.
Arm pain after vaccination #1; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown if the patient had been tested for COVID-19, since the vaccination. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced arm pain after vaccination #1. It was unknown if the patient  had received any treatment for the event arm pain after vaccination #1. The clinical outcome of the event arm pain after vaccination #1 was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mom notices large 15 x 15 cm red induction at site of IPV and DTaP on 11/25/05
high pitched screaming-would cry for 2 hrs, stop for 15 mins and cont to cry for another 2 hrs; fever 101; leg swelled;;
He started dramatically limping on his leg... didn't think too much of it until a few hours later we noticed his thigh was twice the size as his other, very warm to the touch, had a rash, and very red, splotchy and itchy.
Patient received 1st dose of Pfizer vaccine on 2/19/21. On 7/16/21, patient accidentally received one dose of Moderna vaccine. Patient had no adverse reaction to the vaccine after 15 minutes of monitoring. Patient is a transgender individual, in the process of transitioning to female.
Pt was lying in crib in usual state of health. She cried out and when the mother arrived in the room she was limp non-responsive and with perioral cyanosis. This lasted a few minutes and resolved spontaneously.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reported that on an unknown date and time after 02-FEB-2015, unspecified number of patients were inadvertently vaccinated with VAQTA (unspecified dose and route) lot # K007791, expiry date 22-AUG-2016 (also reported as 22-MAY-2016) and lot # K018182, expiry date 12-FEB-2017. On an unspecified date, the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. reported itchness on (L) side of chest ~ 15 minutes after inj. Redness size of grapefruit noted on (L) side of chest. Benadryl 25mg po x one cap. given at 9:20 am 10:40am T.C. w/pt. slight HA - x 30 -45 mins. 0 OTC needed. 0 (R) side itching - started but @ 10:40 AM no more itching. Feeling sleepy from Benadryl. 1/15/2021 - 4:25pm tc with patient who reports "she is ok" and feels her normal self now.
Facial motor tic developed about 1 wk after receiving intranasal flu vaccine. Same reaction may have occurred last year after intranasal vaccine but was not reported & resolved spontaneously. Last years dose given 10/13/2010 FLUMIST lot 501019P.