chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Body ache, body pain; There is like a big knot at the injection site of the vaccine; Very large and protruding thats rock hard. Swelling of the injection site; Headache; Thinking that the vaccination did not go through the muscle and its like in the upper level of muscle, and thats why there is a knot and its really huge he mentioned; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer-sponsored program Support. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Jun2021 14:05 as dose 2, single for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included citalopram (CITALOPRAM); atorvastatin (ATORVASTATIN); omeprazole (OMEPRAZOLE); colecalciferol (VITAMIN D SUPPORT)- all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization and reported as product used for unknown indication. No other medical condition reported. No other vaccine taken 4 weeks prior to Pfizer Covid 19 Vaccine. On 26Jun2021, the patient experienced nausea, body ache, body pain, there is like a big knot at the injection site of the vaccine; very large and protruding thats rock hard. swelling of the injection site, headache, and on 25Jun2021 thinking that the vaccination did not go through the muscle and its like in the upper level of muscle, and thats why there is a knot and its really huge he mentioned. Consumer stated that he don't remember the first dose exact appointment and Lot numbers as he don't have his vaccination card right now as his wife had it, she is not home yet. No, not right now she put it in the purse at the store. Patient didn't get any symptoms until this morning and wanted to know if he would be doing like a warm compress or hot compress, he mean cold compress or if he can take the Ibuprofen. And also was there any concern like if there could be an allergic reaction. Outcome of the events was not resolved.  Information about lot/batch number has been requested.
he had severe back ache; This is a spontaneous report received from a contactable Consumer via medical information team. A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Apr2021 as DOSE 1, single dose for covid-19 immunisation. The patient's relevant medical history includes felt like the skin on his stomach was on fire on 01Apr2021. Concomitant medications were not reported. Vaccination history included: Herpes zoster (he had a first set of shingle shots and last fall he had another set.), for shingle. It was reported that, patient felt like the skin on his stomach was on fire on 01Apr2021. He talked to a doctor and stated that was concerned about having shingles. On 07Apr2021, the patient had experienced severe back ache. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & devel t103 R 2-3 hrs p/vax; pt given APAP; 3AM 12MAR93 t105.7 R resp rapid but no dyspnea; by 5AM devel cough; pt put in luke warm water for 30 mins; temp down to 103; thruout day on 12MAR93; temp is staying around 103.5 R
experiencing a bad sore and swollen throat; experiencing a bad sore and swollen throat; general feeling of sickness; My throat does not seem to be as bad today as it has been but I still feel lousy; This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable male consumer (patient) reported for himself that:  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced experiencing a bad sore and swollen throat, general feeling of sickness, and throat does not seem to be as bad, as it has been but still felled lousy on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test and streptococcus test Both the tests were Negative. At the time of reporting, the outcome of the events were unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt had an episode of vomiting with associated flushing/sweating and dizziness. Vitals: 14:52 114/71, 80, 22, O2 100% on RA, 96.8F -- > 14:55 100/61, 72, 20, O2 100% on RA -- > 15:02 116/80, 85, 100% on RA, 18 Pt given cold compresses and placed in T-Berg position x 30mins.  Pt given water. Pt stable and released from the vaccination site, accompanied by significant other.
Information has been received from a nurse concerning a patient who on 10-July-2008 was vaccinated subcutaneously with a dose of VARIVAX (Merck). Five days after the vaccination, on 15-July-2008 the patient developed a mild case of hives. At the time of the report, the patient was recovering from hives. Unspecified medical attention was sought. Additional information has been requested.
On 12/15/10 mom noted red, firm bump where he received vaccine seen in office 12/17/10 approximately 1cm firm eryth nodule (R) mid/lateral thigh. Tx with KEFLEX x 7d & mupirocin.
Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic.  Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head.  The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267.  Pupils were slow to react.  Skin was flushed and red.  Dr. was notified and assessed the employee.  At 1558, the Dr.  ordered Benadryl 50mg IM.  This was given to employee in Left Deltoid IM at 1558 by RN.  At 1559, patient complained of heache, chest tightness, being cold.  At 1606, O2 sat was 99% on RA; B/P was 126/90.  He reported that his headache was going away at that time and that the chest tightness was going away as well.  Headache at that time was a 4/5 on pain scale.  Recommended that he be checked at the ER.  Between 1620-1625, first responders on site.  At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.
Patient spiked a fever.  Patient was 100.7 orally when we started at 1430 and then at recheck 1438 patient's temp was 103.1 orally.
I had itching skin all over my body. It was hives all over my body. The hives appeared on Dec 4th. I took the allergy medication over the counter. What I took was Benadryl and Allegra. The hives are still here and haven't went away. They are still on my body and they are still itching.
Patient received first dose of Moderna Covid Vaccine on 12/28/2020, second dose on 01/27/2021. Treated on 01/31/2021 for abdominal pain and nausea, appendicitis. Patient admitted and taken in for appendectomy.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.  The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021. No treatment medications were reported.
flu-like symptoms; difficulty breathing; fever; This is a spontaneous report from a contactable other health care professional. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 26Mar2021 (at the age of 83-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included ongoing breast cancer. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation and experienced cold, swollen neck lymph nodes and fatigue. On an unspecified date in Mar2021, the patient had flu-like symptoms, difficulty breathing, and fever. On an unspecified date in Mar2021, the patient recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, bloody diarrhea, joint swelling and pain--diagnosed with inflammatory arthritis secondary to SHINGRIX vaccine and treated with steroids.
Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED.  Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis.  Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis.  Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.
Received intranasal vaccine-4 hrs later began to get a headache and chest discomfort as well as achy all over. Fever 102-103. Headache became severe. Aches all over, fatigued, vomiting. Has not been around ill people-no one in household ill. Her rapid test for Influenza was negative for A and B.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves elderly patient (age and gender not reported), who was vaccinated with an expired dose of FLUZONE HIGH DOSE (expiry date: 29-May-2018) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by sender: none.
I had the first vaccine 12/22, no side effects at all.  After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs.  The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes.  I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
Headache, Arthralgia, Fever, fatigue, chills Narrative:  Other Relevant History:
About 8-10 weeks following 2nd dose of Moderna Covid-19 vaccine, symptoms started with right ear fullness, continuous tinnitus in right ear and bilateral hearing loss.
After 60 Days of receiving 1 Dose of Moderna, I suffered from persistent headaches from April 2021 through June. After having headaches, it leads to having trouble breathing at night before I selpt. I then suffered a panic attack in the month of June 2021. My whole body got extremely hot and had an increase in breathing. My lymph nodes started having stabbing pains around my neck and arm pits. I went to the ER to get examined due to an increase in pain under my neck on my lympnodes. ER said after doing a MRI of my neck and X-Rays of my chest that I was fine and sent me home. I then carried on and visited with my Doctor back at home and tryed to follow up with her after event. I expressed my symptoms of stabbing feeling in chest and increase of issues or swelling in my head. She scheduled me for post covid longhaulers and I am currently seeking medical treatment or evaluations on case.
Information has been received from a nurse and a nurse practitioner concerning a 14 year old female patient with no pertinent medical history and no allergies who on 26-JUN-2008 was vaccinated with GARDASIL 0.5 ml IM in the deltoid.  There was no concomitant medication.  On 26-JUN-2008 evening or 1-2 days later, the patient experienced a mild fever that came and went, headaches, pressure on the head and eye and eye pain.  On 02-JUL-2008 the patient developed a barky cough.  The patient's mild fever that came and went and headaches and pressure on the head and eye and eye pain and barky cough persisted.  The patient sought medical attention.  Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Additional Details: Woman with the patient stated he reported not feeling well. She stated his skin tone turned white and he went limp. She called out to pharmacy staff stating he was having a seizure. Patient regained consciousness about 30 seconds later.
Four days later (feb. 12th 2021) had a very uncomfortable atrial fibrillation episode.  This hadn't happened to me since the July 4th weekend.  Yesterday, March 30, 2021, I had an even more serious atrial fibrillation episode.  My heart hasn't felt "right" since that first Moderna injection on Feb. 8, 2021.  I didn't have any of the more commonly listed side effects, but I've begun to wonder if the vaccine has somehow taxed my heart to the point that atrial fibrillation is easily brought about.
Dizziness reports numbness and tingling in arms. rigors.  Narrative: seen in clinic directly during immediate AE-believes to be anxiety/panic attack.
mom reports pt recvd vax 10AM on 3MAR93 & by 5PM pt was extremely irritable w/t103.9 R; taken to ER & treated w/Advil mom reports pt lt leg was very red & swollen & broke w/rash; t103 to 104;
Vertigo & nystagmus pathognomonic for benign paroxysmal positional vertigo.  * went to bed * wore a sleeping mask, which lessened the spinning sensation * slept for ~12 hours  Am keeping hydrated & am eating. Vertigo is beginning to resolve 18 hours after onset.
Subsequent to receiving first and second doses of varicella virus vaccine live the pt presented to physicians office with fever, malaise and rash which had developed three days earlier. The pt had greater than 100 vesicles on his body and new crops of lesions were developing. Pt was diagnosed with chickenpox and treated with acyclovir.
Fatigue; chills; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 29Sep2023 as dose number unknown, single. The following information was reported: FATIGUE (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering"; CHILLS (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 06Oct2023 at 16:00, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of fatigue, chills, decreased appetite. Additional information: no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
positive for HSV 2; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex type ii in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than 3 weeks after receiving Shingrix, the patient experienced herpes simplex type ii. On an unknown date, the outcome of the herpes simplex type ii was unknown.   It was unknown if the reporter considered the herpes simplex type ii to be related to Shingrix.  Additional information was provided as follows: The patient received dose one of Shingrix, formulation unknown, on 28th February 2021. The patient had routine bloodwork done and requested an STD (sexually transmitted diseases) test. The test came back positive for HSV 2 (herpes simplex virus type II). The reporter did not consent to follow-up.
Pain, redness, warmth & swelling at injection site. All still present 48 hours post injection.
No additional adverse effect reported; expired PROQUAD (Ext date 8/8/2020) was inadvertently administered to a patient; This spontaneous report was received from a nurse rand refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 19-AUG-2020, the patient inadvertently received an expired measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection, lot # S003865, expiry date 08-AUG-2020, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
My mensural cycle began the same day that I received the vaccine. My period was extended to last a total of two weeks. At the injection site, a large red welt appeared and was consistently present for a total of two weeks. Being in the sun, irritated the welt and would turn it bright red and itchy.  The welt would come and go for an entire month following the injection. For the first five days following the injection, my left middle finger acted as if it was jammed on and off. The finger ached and hurt and I was unable to bend said finger.  I had a low grade fever for a couple days following the injection.   One month after the injection, I formed an outer ear infection in my left ear and minor scrapes were not healing as they did in the past. Scrapes and cuts began taking weeks to heal instead of days. The ear infection lasted one week before I asked for antibiotic drops. The day that I received antibiotics, my ear infection spread to the right ear, and lasted another week. Both ear infections lasted approximately one week each. Also a month after my injection, my facial acne increased substantially and I began feeling lethargic with light throat irritations such as coughing and flem.   Due to these reactions to the first Moderna injection, I elected to not receive the second injection.   Five weeks after my injection, on 23 Apr 21, I received my TDAP booster and PPV23, one in each arm. I have never had reactions to vaccines prior to the Moderna injection; but now, for the first two days after the booster injections, I could not raise my arms due to severe pain and muscle aches at the injection sites. I felt weak and lethargic as well as experienced lightheadedness and rushes of blood pressure changes on 24 Apr 21. Currently on 25 Apr 21, I am still experiencing moderate injection site pains and feel lethargic.
Patient inadvertently received vaccine after published expiration date. Moderna Vaccine analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event  This is administrative error without adverse event.
Dermatographia, hives with pressure. Benadryl. Still happening two weeks later
30 seconds p/vax pt c/o warm @ site (site nl);10 seconds later warm all over;5sec later dizzy complaint then stamped against wall, unresponsive & brief tonic activity;looks like vasovagal; event;
Information has been received from a health care professinal concerning a 71 year old white female pt who on 10/12/99 was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent, IM in the right arm. That same day, the pt experienced swelling, redness and soreness of the entire upper arm, as well as a fever. She sought unspecified medical attention and was treated with ice packs. The pt subsequently, recovered. It was reported that the pt had no adverse experience following the initial dose of pneumococcal vaccine 23 polyvalent administered in March, 1993. No further information is available.
Received Pfizer vaccines on 1/27/21, 2/17/21, 10/21/21, 5/12/22; tested positive for COVID by PCR on 5/19/22; admitted to hospital ICU on 5/19/22 d/t pneumonia d/t COVID19. PMH of COPD/asthma, heart failure, pulmonary HTN.