chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown.  No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event
Arm pain, fever, chills, entire body itch, fatigue, headache; treated with 500mg acetaminophen caplet approx  18 hours after injection, and 25mg diphenhydramine tablet (28 hours after injection). Chills, fever, itch went away, headache, fatigue went away after 42 hrs post injection. Arm pain resolved after 72 hours post injection.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 17-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# not reported), subcutaneous. On an unspecified date in June the patient experienced that her left arm was red at injection site. Patient stated that the redness was now dissipating on an unspecified date. The outcome of her arm was red at injection site was red at injection site was reported as recovering/resolving. No treatment was given. It was not specified if the patient sought medical attention. Additional information has been requested.
Both after 2nd shot:  Minor: Rash at injection site. Small fever for about 1 1/2 days. Tired for 2 days.  Mild, but concerning: A couple of days after shot, I felt pain in my chest (peck muscles).  Usually I noticed it when I leaned forward or backwards. Was so mild, I didn't go in to see anyone. Was a bit worried, but thought (hoped) it was a pulled muscle - even though I didn't do anything to pull a muscle.  Pain went a way after a couple of days. Weeks later, I saw a doctor somewhere that talked about myocarditis.  He described symptoms of the mild forms of it similar to what I experienced. I was suddenly concerned that maybe that is what I had. I am in a group that I think is technically allowed to have a booster after 6 months, but now I think I may wait until more data is out, since if I did have Myocardities, I am concerned a 3rd dose could have a more severe reaction.
Vaccinated pt admitted to inpatient facility with positive covid test results. No information available concerning vaccination including manufacturer, date, etc. Vaccination  status was reported by patient.
I had vaccination on 08/31/2022. I started to experience COVID-19 symptoms to include 11/2022 tired dry cough and fever of 102.5. I tested COVID-19 Positive on 11/26/202. I was unable to take the Paxlovid due to drug interactions. I was unable to get a different medication.
pain at site along with major swelling around injection site "golf ball sized egg at injection site"/Swelling did not show up until later in the week after the shot was given; pain at site along with major swelling around injection site "golf ball sized egg at injection site"/Swelling did not show up until later in the week after the shot was given; This is a spontaneous report from a contactable other health professional via Pfizer Sales Representative.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced pain at site along with major swelling around injection site "golf ball sized egg at injection site"/swelling did not show up until later in the week after the shot was given on an unspecified date with outcome of unknown.
Dizziness Pt. stated slighte dizziness and burning feeling inside her arms and chest and in  her body. But not in her feet like first dose. Narrative:  Gave patient 25mg IM Benadryl in Lt. Deltoid at approx. 0807am and at 08:21 am stated chest less burning feeling. Pt. was transferred after 40mins to her dept. with assist of RN via wheelchair and another  assist.
Pt recvd vax 1DEC92 & exp severe burning @ the time of the inject; devel a sore upper arm w/painful lump which was the size of a fifty cents piece @ the inject site;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
After receiving both the pfizer bivalent and flu vaccines patient stated that she was having trouble breathing and swallowing. She stated that she she took benadryl about 30 minutes before she got her vaccines due to the fact that she has a lot of allergies and sometimes she reacts to vaccines. She said that a few minutes after the getting the vaccines, her right arm (flu shot arm) started to tingle, she felt like her throat was closing and it was difficult to breath. She took another dose of benadryl that only helped a little. On her way home she stated that her symptoms got worse and was taken to the ER. She received more benadryl and some steroids.
Received shots on 7/5/05, started on 7/6/05 having diarrhea and vomited x 1, some diarrhea today 7/7/05. Fever 99F-100F and also pulling at ears. Grandmother trying to get her into doctor for appt. Grandmother states that pt is keeping pedialyte down and has not had any vomiting.
PATIENT REFERED HEADACHE AFTER VACCINATION. B/P: 130/80 WAS GIVEN 2 ASA (325MG EACH) AFTER 15 MINUTES B/P WAS STILL 130/80 (PATIENT REFERED HX OF B/P OF 110/70) PATIENT REFUSED TO STAY IN OBSERVATION AND LEFT AGAINST MEDICAL ADVICE.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA088989 and 2019SA089331 (same reporter). This case involves a 19 months old male patient (second patient) who received an expired 0.5 ml single dose DAPTACEL vaccine on 24-Mar-2019 (lot C517AA, expiry date 23-Mar-2019 via intramuscular route). The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13; and HEPATITIS B VACCINE on 24-Mar-2019. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Site: Pain at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium
I have had chills. Even though the shot was given in my arm the pain has moved into my right shoulder blade and up the side of my neck.
The first shot i became sick about 8 hours after injection for about 24 hours. After the second shot I was sick and running a fever for about 48 hours. Within two months after receiving the second shot I started to notice I could not remember things. I told my PCP Dr. but he did not seem concerned. I lead singing in our little church and I began singing parts of songs but forgetting the last verses. I would set down and did NOT realize what I had until done my wife told me. That was very embarassing. I kept complaining to Dr. until he finally sent me to a Neurologist who sent me for a MRI of my brain. It showed I had two strokes. I was supervisor of a (withheld) laboratory but had to gave up my job. I was insrtucted by the CDC to fill out this form.
Patient experienced after second covid shot had a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Patient experienced after second covid shot had a headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.  No Medical History information was reported.  In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (Patient experienced after second covid shot had a headache). In 2021, HEADACHE (Patient experienced after second covid shot had a headache) had resolved.   Patient had colonoscopy on 11-Jan-2022 and results were unknown. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt had a fever & sz approx 12hr post vax;pt rehydrated & had to be intubated;transferred to hosp; EEG & MRI done results pending;
patient received 3 doses of Ipol as a baby, but never received the fourth dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and consumer/non-health care professional via Global Medical Information (Reference number- 00727955) and transmitted to Sanofi on 17-Aug-2021.  This case involved 15-year-old female patient received 3 doses of IPV (VERO) [IPOL] as a baby, but never received the fourth dose (incomplete course of vaccination)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received 3 doses of suspect IPV (VERO) as a baby (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination but never received the fourth dose (incomplete course of vaccination)  It was reported that,"Now, should she receive a single dose? Start the series over? or, because of her age, no dose is necessary"?   This was an actual medication error due to incomplete course of vaccination (latency: same day)  At the time of reporting, no adverse event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient's mother reports patient had an allergic reaction to pfizer vaccine. Pt was going to therapy session and noted hives all over face and body. Pt was very itchy and had some difficulty breathing, mother took to immediate care who then referred to ED. Pt was stabilized and given steroids and now has epi-pen.
This case was reported by a pharmacist via call center representative and described the occurrence of serum sickness in a 66-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 24th June 2018, the patient received SHINGRIX (subcutaneous). In June 2018, 3 days after receiving SHINGRIX, the patient experienced serum sickness. On 24th June 2018, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The patient was treated with prednisone. On an unknown date, the outcome of the serum sickness was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. The reporter considered the serum sickness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX subcutaneously in the triceps muscle instead of intramuscular route in deltoid region, which led to. Three days after receiving SHINGRIX, the patient visited her doctor and was diagnosed with serum sickness and prescribed prednisone.
PATIENT RECEIVED A SECOND DOSE OF FLUZONE HD (11/01/2023 AND 11/15/2023)
Three weeks later getting fainting spells, light headed, dizzy, left arm numbness and tingling, vertigo.
Large joint pain. My wrist and hand was painful. It got so bad that I could not lay on my sides. I had to get steroid shots for the pain. I had headaches as well. They ran X-ray on my joints, that came back with fluid on my joints. They diagnosed me with arthritis.
Patient given 5-11 yr vaccine instead of 12 yr+ vaccine. No adverse reactions according to patient. Was told would need repeat booster since dose would be considered invalid.
Breakthrough case admission after 3 vaccines Moderna 4/21/21 Lot# 025B21A;  Moderna 5/21/21 Lot# 043b21A;  mOderna 12/21/21 Lot# 039F21A
left arm redness and swelling.  Fever between 101-103 degrees Fahrenheit, headache, congestion, fatigue, shortness of breath.,
PATIENT WAS OUT OF TOWN AND HAD RASH ON ABDOMEN AND BACK, PATIENT CAME BACK AFTER ONE YEAR AND SHE COMPLAINS OF NERVE PAIN, PATIENT WENT TO REGULAR PHYSICAIN AND THEY TOLD HER IT'S NOT SHINGLES BUT SHE STILL HAS RASH AND PAIN.
Blistering lesions at injection site and subsequent redness and swelling spreading from this site and development of pain in shoulder joint adjacent to injection site.  Treatment is involving methylprednisolone oral taper and valacyclovir for 7 days.
Patient was accidentally given two doses of COVID booster. One in left arm and one in right arm.
Swelling, pain, high fever due to mistake. My daughter was given vaccinations by mistake twice.
I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.
Patient received Pfizer COVID-19 Vaccine to right deltoid at 0906. Patient was in observation area of the clinic, when RN received called from Pharmacist at 0930 with patient who had complaints of tingling to her mouth and throat. RN responded and Epinephrine 1mL was administered per protocol at 0934 to right vastus lateralis. Patient's initial vital sign assessment was: 1st blood pressure 149/93, 2nd blood pressure 139/85; heart rate was 70, O2 was 96% on room air. Patient airway was clear. RN stayed with patient to monitor and patient's PCP came to check on patient as well. Patient then report symptoms improving and was medically stable. PCP agreed to keep patient in the clinic longer for further observation to prevent ED visit.  At 0955 patient started to complain of right arm involuntary twitching intermittently, noting it started about 1 minute ago. Pt unable to grasp RN hand; however patient was able to grasp with left hand and pushed down with her right and left leg with out any concerns. Patient denies any respiratory complaints and continues to be responsive. Patient did endorse this reaction occurred one other time after taking Reglan. RN called for provider assessment. Two doctors came to assess patient to rule out stroke. Patient was able to hold both arms above head showing muscle strength and tone.     Doctor's direction was to bring patient to the ED for further observation. Patient was transferred to a wheelchair with minimal 1 person assistance. 2 RNs brought patient to the ED via wheelchair. Upon getting to the 2nd floor patient began to have gross twitching to bilateral arms and was still responsive. Shortly after the patient began to have full body gross twitching. One RN assisted with prevention of fall from wheelchair, while other RN called code blue, patient began minimally responding (able to open eyes on command, but unable to tell name) and was brought down to the ED with the code team.
I received vaccination #2 on Tuesday Feb. 9. On Thursday Feb 11, I woke with swelling, pain, redness on my upper arm and it felt like a hot knife at injection site. Ibuprofen & acetaminophen helped to decrease these symptoms during the day.  When I woke on Friday Feb 12, the same symptoms persisted and were more intense than the previous day. The swollen area was larger, the redness was brighter and larger area, pain was increased and it was difficult to bend my arm at the elbow because the skin felt tight due to swelling. I continued ibuprofen & acetaminophen which helped lessen the  symptoms. The symptoms gradually decreased in intensity as I continued this course through today Sunday Feb. 14.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 40-year-old male patient 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 VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, chills Narrative:
Allergies: Pneumococcal Vaccines/Drug Allergies: Pneumovax; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report regards an event part of the medical history of the patient. A currently 73-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer), at single dose and pneumococcal vaccine polysacch 23v (PNEUMOVAX), both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history included allergy to Sulfa Drugs and latex. Concomitant medications were not reported. The patient experienced allergies: pneumococcal vaccines/drug allergies: pneumovax on an unspecified date with outcome of unknown.   Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein)  in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein)  has submitted the same report to the regulatory authorities.