chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Pt c/o flushing/sweating and dizziness 3mins after vaccination.  Vitals significant for bradycardia.  @13:08 BP 100/58, HR 39, RR 12, SPO2 99% -- > @ 13:12 83/40, 41, 100% -- > @13:22 87/43, 50, 100% -- > @13:23 107/67, 61, 100%. 911 Called at 13:15 and paramedics arrived 13:20.  At 15:15 pt elected to leave vaccination site .  form signed.  Pt driven home.  Unknown PMH or current medications."
I came in from outside and sat down and all of a sudden I couldn't tell what year it was. My husband suggested that I check my blood pressure and it was elevated. I went to the ER and had a CT scan and a chest x-ray, no damage was seen. I was sent home because they assumed it was a TIA. I saw my doctor the next day for observation.
When I went to bed the night after the shot (0.25ml booster) I was unable to sleep. When I would get up to urinate I would think hours had passed but it would only be about a half hour according to the clock. The next day I kept making the same time misestimates, for instance at 10:00 AM I thought it was 1 PM. I kept making misestimates of time until the early evening when I finally got up.  During this period I was unable to maintain any clear or consistent thought, it was as if I had a heavy case of the flu. My thoughts kept going in a circle.  I did not experience time distortion or the other symptoms after the first two shots.
L deltoid and shoulder area swelling, warmth, and achy.  Recommed to use Benadryl and Tylenol.
No adverse reaction. Used a pediatric Needle to administer instead of adult needle. We need to reimonize We are going to readminister the vaccine with proper needle
Post vax, the pt's arm was swollen, painful, and red, low grade temperature. Pt given Claritin and Avaloxx.
Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine.  3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity.  3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that "it's nothing." 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired.  4:55 PM: Patient was transported to the emergency department for further evaluation.
A few months after, a development of macular edema in 1 eye that never existed before.
swelling and itching at injection site Narrative:  Per nursing report: "1st dose of Moderna on 1-26-21. C/o swelling, redness and itching to site of injection this week about Tuesday [2/2]. States feels worse."  Other Relevant History:
Unconsolable crying started and continued until 18:30 on 07/23/2003.  Mother treated patient with Tylenol.  No other treatment prescribed after being seen by physician.  No other significant findings by physician.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old male patient who received Influenza vaccine for prophylaxis. Previously administered products included Typhoid vaccine (years before reporting date). Concomitant products included Albuterol, oxygen and SYMBICORT. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional information received as follows: The age at vaccination was not reported. The patient stated that he had gotten the flu vaccine (unknown manufacturer) and he had came down with the flu. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown. On 4th October 2018, the patient received flu vaccine. It was unknown if the suspect was the same dose, clarification has been requested for the same. The patient did not have any additional details regarding the flu vaccine. This has been linked to the case reported by the same reporter for the same patient received pharma product INCRUSE ELLIPTA.
pt received a dose of moderna past the 6 hours expiration puncture window. we offered 2nd dose again per cdc guidance.
Pt presented to vaccination site and requested Janssen COVID vaccine booster dose. Patient received Pfizer 1st dose on 3/26/21 and Pfizer 2nd dose 4/14/21. RN 1 educated patient on health risks of Janssen COVID vaccine. Patient verbalized understanding and requested Janssen COVID vaccine booster dose. RN 1 submitted a medical consult via Patient presented to vaccination site and requested Janssen COVID-19 vaccine booster dose. Patient received Pfizer 1st dose on 3/26/21 and Pfizer 2nd dose 4/14/21. RN 1 educated patient on health risks of Janssen COVID-19 vaccine. Patient verbalized understanding and requested Janssen COVID-19 vaccine booster dose. RN 1 submitted a medical consult via collaboration app to clinical project coordinators requesting to proceed with Janssen COVID-19 vaccine. Clinical project coordinator RN 2 elevated request to medical consult team. MD 1 from medical consult team approved request for Janssen COVID-19 vaccine booster dose. On 3/21/21, patient received Janssen COVID-19 vaccine (lot 1855191) booster dose at 1359. EMT 1 educated patient on signs and symptoms of adverse reactions, when to seek emergency care, and to register on v-safe. At approximately 1415, patient left facility with unlabored respirations and steady gait. to Clinical Project Coordinators requesting to proceed with Janssen COVID vaccine. Clinical Project Coordinator RN 2 elevated request to medical consult team. MD 1 from medical consult team approved request for Janssen COVID vaccine booster dose. On 3/21/21, patient received Janssen COVID vaccine (LOT# 1855191) booster dose at 1359. EMT 1 educated patient on signs and symptoms of adverse reactions, when to seek emergency care, and to register on V-Safe. At approximately 1415, patient left facility with unlabored respirations and steady gait.
One day after receiving the second dose of Moderna vaccine (specifically, 32 hours after receiving it), my left upper arm started to feel uncomfortable. I found a rash of approximately 2 1/2" x 4 1/2" had developed on the arm.  The area is slightly warm and extremely itchy.
woke up in a pool of sweat; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 10:15 (Lot number: EN6207) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure/Blood Pressure" (ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension (ongoing); NIFEDIPINE taken for hypertension (ongoing); CLONIDINE taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "recovering", described as "sore arm"; NIGHT SWEATS (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "woke up in a pool of sweat".  Additional information: Patient did not receive additional vaccines on same date of the Pfizer suspect. Patient had no history of previous immunization with Pfizer vaccine as suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said that she got the vaccine in the morning and her arm got sore later in the evening. She said that something happened in the middle of the night, around 3-4am on 22Mar2021, she said that she woke up in a pool of sweat and never had that before. She takes something to sleep and for her to wake up was unusual. She did not feel warm or like she had a fever, and the heat was not on. It was a lot of sweat and she was concerned about this. She said that she did not typically get sweaty. She said that she was hoping her body was fighting things and it was just because of that. She does not sleep in a warm room at all. She also said that her arm was still sore today, but it was better than last night. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
threw up a number of times too; her stomach or belly is hugely distended and that she was also in distress; her stomach or belly is hugely distended and that she was also in distress; very bad diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: ABDOMINAL DISTENSION (non-serious), EMOTIONAL DISTRESS (non-serious) all with onset Sep2021, outcome "unknown" and all described as "her stomach or belly is hugely distended and that she was also in distress"; VOMITING (non-serious) with onset Sep2021, outcome "unknown", described as "threw up a number of times too"; DIARRHOEA (non-serious) with onset Sep2021, outcome "unknown", described as "very bad diarrhea".  Additional information: Patient received her booster dose on Sep2021 (at the age of 80 years old) and reported that the night she got the shot, her stomach or belly is hugely distended and that she was also in distress. patient added that she had a very bad diarrhea and that she threw up a number of times too. patient is asking if anyone has reported this experience since she is contemplating on getting her 2nd booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a female consumer who was vaccinated in her arm on an unspecified date with a 0.65 milliliter dose of ZOSTAVAX (Oka/Merck).  Subsequently the patient developed a "red mark" on her arm at the injection site.  It was unspecified if medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.
10 cm x 5 cm red/warm/welpy area at injection site. Pt seen in office 5-11-11, started on BACTRIM & BENADRYL.
Heavy Periods two and half weeks apart. 1st one was very heavy and second one has been five days of painful cramping so far. Very unusual for my cycle.   Also had flu like symptoms the day after my second shot for about 24 hours, but I was expecting that.  I was not expecting issues with menstruation. I have heard antidotal stories from other women that they experienced heavy and painful menstruation after the shot. Women really should be told this is a side effect if it is so they don't think something is "wrong" and so that they can be prepared.
STARTED TO HAVE SEIZURES; HEALTH STARTED TO GET WORST; This spontaneous report received from a consumer from social media via company representative concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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 received the vaccine and started to have seizures, and health started to get worst. It was reported as, "After my son in law received the J and J vaccine he started to have seizures and his health started to get worst" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started to have seizures and health started to get worst was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220231770-covid-19 vaccine ad26.cov2.s-started to have seizures. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Eight year old female pedatric patient was given a full 0.3mL adult pfizer dose instead of the 0.2mL pediatric dose in error. No adverse events to report at this time. Per call to the pfizer medical information line the dose is not to be repeated and patient will still be eligible for the 2nd pediatric dose in 21 days.
Mother took her son to get 3 months shot & checkup which consisted of HEP B and POLIO shot which was given at the time.  After leaving mother recv'd a call about 6 hrs later that her son had been given an HPV vax.
1.Experienced 2 menstrual cycles on the months that the first and second vaccine doses were administrated.
Cyst behind left knee has gotten more painful; arthritis pain became worse, had back pain, and an increased in difficulty with walking; She couldn't walk, and she had to walk with a cane.; back pain; She has arthritis, and she noticed her leg was getting swollen.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jun2021 13:30 at 66-years-old (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunisation. Medical history included ongoing Asthma (She has had asthma for maybe 39 years), ongoing Diabetes mellitus (She has had diabetes for a year and a half), Breast cancer from Jul2014, ongoing Depression (It started 37 years ago), Knee surgery from Jan2017, arthritis, cyst. Concomitant medication not reported. It was reported that patient had pneumonia vaccine in early Jun.  She previously had a shot for Polio. The caller has arthritis, and she discovered that she had a cyst behind her left knee. She had her first Covid Vaccine and it has gotten more painful. She wanted to know how the second shot will affect her knee with the cyst. She is due to get her second vaccine today (09Jul2021). Cyst behind left knee has gotten more painful: She doesn't know how long she has had the cyst. She has arthritis, and she noticed her leg was getting swollen. It was just very painful the last few weeks she thought. She couldn't take the pain. The pain got worse after the vaccine. She couldn't walk, and she had to walk with a cane. She managed to get an appointment yesterday with her knee doctor. the pain became so bad that she scheduled an appointment with her Orthopedic doctor and was able to see her HCP on 08Jul2021. HCP noted that her left calf was swollen and ordered an MRI; the HCP found a cyst, not a blood clot per Caller. After her first dose her arthritis pain became worse, had back pain, and an increased in difficulty with walking. States that she starting using a cane and she has never used a cane before. She had a CBC, RBC, WBC, cholesterol, and other things she can't recall right now. The outcome of the event cyst behind left knee has gotten more painful was not recovered, while other events was unknown.
Got sick with flu like systems. Did not get better. Got Covid test on Tuesday of next week and tested positive.  Was not sick before the shot.
Onset 6/5/03 of generalized dizziness and flu-like symptoms with mild congestion and fever. Pt states symptoms persisted x 3 weeks.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in right arm and in Apr2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2022 at 16:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Mar2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included from 23Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.80.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
PT in observation unit for 5mins then started to complain of l arm numbness . Bilateral hand grip denies dizziness and blurred vision. PT had pre anxiety prior to getting vaccine. PT observed  or an additional 15mins.
I did not feel ok starting Wednesday , symptoms increased daily with Saturday being the worst.  Tired, feeling warm Friday and Saturday, exhaustion increasing Wednesday until Saturday, the worst day being Saturday, and headaches.  I felt more flu  like symptoms on Wednesday and Thursday and not so noticable on Friday and Saturday.  About 8/9 pm on Saturday I felt fine, like you snapped your fingers and all the side effects were gone.
This spontaneous report as received from healthcare worker refers to a 4 year old female patient. Patient's concurrent conditions were not reported. Other relevant medical history included vaccination in 2011 with PROQUAD (manufacturer unknown) and (Oka/Merck) VARIVAX with no incidents. On 08-SEP-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (dose and route unspecified) (lot number: K007800 with expiry date 29-NOV-2015) in the leg for prevention. Concomitant medications were not reported. Within 24 hours (also reported as 08-SEP-2014) of injection with (Oka-Merck) PROQUAD, the patient developed red area at the injection side on leg. The patient's mother reported that the area continued to get larger. On 10-SEP-2014 (reported as 2 days after injection), the patient experienced fever of 101 (units not provided). The patient sought medical attention by visiting physician on 29-SEP-2014. The injection site red area measured 2x3 centimeters on the leg. It was scaly and blistered. The patient was treated with topical corticosteroid (also reported as no treatment was given for the adverse events). The outcome of the event fever was recovered/resolved on an unknown date. The outcome of the other events was reported as not recovered/not resolved. The causality of th events with (Oka-Merck) PROQUAD was not reported. Additional information has been requested.
Fever, myalgias, HA and rash starting on day of FluMist administration.