chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shot was given at 0130pm on Jan 13. Symptoms woke me up at 0130am on Jan 14th. Chills that were not helped by putting multiple blankets and or clothes on. Unable to get up and walk, tried to put weight on legs felt like they were breaking, inflammation in the left armpit lymph nodes. noticed a small swell at the shot site that I thought was normal. But the swelling in the armpit/ node area hindered the movement of my left arm. Needed support getting to the bathroom ( I am fully capable of reaching the middle of my back and going to the bathroom by myself on a regular day) I reported similar symptoms to my primary care MD when I received the 2nd dose of Pfizer Biotech Lot EL3302 given at the hospital I work at on 1/27/2021. I did not realize I could self-report at that time otherwise I would of. I have all of those symptoms written down if they are needed. The major difference between that time and this time is that after 4 days I still currently have limited mobility in my left arm due to the swelling in the armpit/nodes. The hospitals are crazy right now and I am also trying to get a response from my primary care to see what to do next. I experienced chills for 48 hours. I then was extremely hot for 24 hours. I was groggy ( unable to focus and was abnormally very upset) and had severe pain all over my body. A migraine type of headache started on Saturday jan15th. I took Imitrex to try and relieve that. I took 2 x200mg ibuprofen w/ 1 500 mg Tylenol trying to help relieve the symptoms. It did not help much.  I honestly thought the reaction to the seconnd shot would not happen on the third shot. Because on the first shot I had no issues. I obviously was wrong.  I want to report these symptoms to try and help studies. Maybe it is because I have no Thyroid. I am not sure but this is awful and I will be refusing any future COVID vaccines this is dangerous, unfortunately.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Drug Ineffective, Covid 19 and the suspect drug cannot be excluded.
she felt bad but not that bad; severe muscle pain; fatigue; headaches; bad nausea; severe symptoms that were worse than the flu"; A spontaneous report () was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe symptoms that were worse than the flu. She had severe muscle pain, fatigue, headaches, bad nausea, she felt bad but not that bad.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first dose of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) severe symptoms that were worse than the flu. She had severe muscle pain, fatigue, headaches, bad nausea for several hours. On 27 Feb 2021, the patient experienced the event(s) she felt bad but not that bad.  Treatment details included Tylenol and something for the nausea.  Action taken with mRNA-1273 in response to the events was not reported.  On28 Feb 2021 she felt good again.
3cm x 6 cm warm, erythematous macule on Left deltoid at site of DTaP, and IPV. Suspected Vaccine Reaction vs Cellulitis.
Starting In May 1, 2021 after getting the vaccine 2nd shot My pulse started being sporadic going from 50 bpm to 30 and 40 bpm and by June 24 ,2021 went to Emergency Room with a pulse of 33 bpm and has stayed low even with med change has caused my heart to have multiple beats extra beats
Patient reported knot forming, turning red, and feeling warm to touch/ being sore until 10/06.
I received 3 shots (flu, pneumonia, shingles). My arm was severely swollen, and inflamed for four days following the shot. It had an egg-sized knot. I felt achy and lethargic through Saturday. (Shot was on Thursday).
Sibling and patient seen same day an order was given to MA and incorrect vaccines were given to patient.  Patient did receive catch up vaccines( DTap, Hib, Hep B, IPV, PCV),   but administered MMR and VZV as well.
(L) arm swollen, hot at touch. No cellulitis. Allergic reaction to whooping cough.
Patient's mom called and reported on Saturday (after the shot was given on Thursday), patient woke up with a rash on his left arm, warmth at injection site and swollen to the touch. His mom stated the rash went all over his left arm, on the chest, and on his face. She gave him benadryl for the reaction. No further action taken.
Induration, swollen, redness 8cm x 10cm right thigh. Induration 2cm x 2cm left thigh.
Vaccine recipient called stating that she was hospitalized 01/22--01/24/2018, diagnosed with encephalopathy.
We arrived on 02/10/2021 to give second doses to residents. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
Around 9:45p my face and neck broke out in hives, swelled up, was extremely itchy, and hot. Shortly after it became hard to swallow as my throat was closing. I went to Emergency Department around 10p. The doctors administered Epinephrine (via Epi Pen) and Pepcid through an IV. I was prescribed an Epi Pen as well as Claritin and Omeprazole for 14 days.
Doses were administered on below dates: 08/01/2015, 08/04/2016, 08/17/2017, 08/30/2022; No additional AE reported; During that call, she mentioned that a patient received 4 doses of GARDASIL 9.; This spontaneous report has been received from a nurse concerning a 23-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 01-AUG-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, route of administration, lot# and expiration date were not reported). On 04-AUG-2016, 17-AUG-2017 and 30-AUG-2022 the patient was vaccinated with the second, third and fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, anatomical location, route of administration, lot# and expiration date were not reported) respectively (Inappropriate schedule of product administration) (Extra dose administered). All doses were given as prophylaxis.  The patient did not experienced any side effect.
Fills joint pain,  horseness , muscle  stiffness,  cough sometimes with phlegm, sinus drainage , ringing in ears, weakness low fever
Fever up to 102.5 so far, chills, muscle aches throughout body, muscle weakness, tiredness.
Pt. states that after receiving the 1st dose of Phizer 11/30/2021, started experiencing symptoms of severe joint pain in the right elbow, severe numbness (right arm), fatigue, and joint pain throughout the body. No noted Primary visit/communications.
about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity; develop hives; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 025L21B, 031M220A and 029L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Corn products), Immunocompromised, Rheumatoid arthritis and Heart disorder (heart issue). Concomitant products included LOVASTATIN, FLUOXETINE HYDROCHLORIDE (PROZAC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives). At the time of the report, IMMUNE SYSTEM DISORDER (about a week and a half after the second booster, patient had to go off his medication because it lowers his immunity) and URTICARIA (develop hives) had not resolved.            It was reported that the patient did not experience any COVID or was tested positive.  No treatment medications was reported.
pt recvd vax; 6 days later exp fever, listless fussy;"blank stare" at times, dec appetite; rash spread over chest & back, still present p/ 5 days; fever lasted 5 days; pt was evaluated by ped, who felt illness was vax related;
Patient began to have an asthma attack after receiving  COVID vaccine. Patient given 50mg benedryl. Patient then had family member drive her to instacare to be seen.
Received shot on Friday, February 12 around 1PM.  Saturday, February 13:Approximately 30 hours after receiving shot,  8:00 pm, Saturday, Feb 13, developed stomach cramps.   Over the next 4/5 hours, diarrhea, vomiting, cramps, chills.  Felt very hot at times, but never ran a fever.  Sunday, February 14,  felt tired and weak, periodic cramps. No nausea or diarrhea.  Monday, February 15, more energy, some cramps,  By
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 12-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 27-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T002845, which have been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error). The use of a sterile diluent was reported (dose, lot number and expiration date were unknown by the reporter).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699:
LITTLE SIDE EFFECTS; This spontaneous report received from a consumer via a company representative from social media  concerned multiple patients. No past medical histories or concurrent conditions were reported. Patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. Patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that "Most of my friends n family also, had little or no side effects." (Dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, involving the same patients is linked to 20220210047 (case for dose number in series 1). This case, from the same reporter is linked to 20220216024 and 20220210428.
painful; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a male patient of unknown age who experienced that vaccine was painful, while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced that vaccine was painful (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of lab data not reported.  Final diagnosis was painful.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was unknown.  Information on the batch number was requested.  List of documents held by sender: none.
Maladministration of Bexsero SC instead of IM; Bexsero administer with a 5.8 inches needle instead of 1 inches needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 08-JUN-2023, the patient received Bexsero (subcutaneous). On 08-JUN-2023, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: Maladministration of Bexsero SC instead of IM) and wrong technique in product usage process (Verbatim: Bexsero administer with a 5.8 inches needle instead of 1 inches needle). The outcome of the intramuscular formulation administered by other route and wrong technique in product usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2023 Healthcare professional declined to have an account on Medical Information database. The reporter consented to follow up via email. The patient received the Bexsero via subcutaneous route using 5.8 inches needle instead of 1 inch's needle, which led to Intramuscular formulation administered by other route and wrong technique in product usage process.
This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ, lot # L013188, expiration date: 02-NOV-2016 (exact dose was not reported). There were no concomitant medications provided. Administered doses of vaccines experienced the temperature excursion of 31.3 degrees Fahrenheit for 22 hours, 30 minutes. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Loss appetite, Lack of thirst, Sweating, Couldn't breathe. Pt was hospitalized for 3 days.
Information has been received from a 61 year old female with iodine (IVP dye) allergy and a history of headaches while on therapy with DEMEROL and respiratory problems while on therapy with LISINOPRIL (manufacturer unknown;  WAES 0902USA03524), LIPITOR, NEURONTIN and GLUCOPHAGE who on 19-JAN-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck).  Concomitant therapy included BYETTA, MSD, GLUCOTROL, ASPIRIN, minerals (unspecified) + vitamins (unspecified) CENTRUM, AMBIEN, DIOVAN HCT, BUMEX, calcium (unspecified), OMEGA-3, vitamin E, vitamin D (unspecified), LEXAPRO and NEXIUM.  On 20-JAN-2009, after getting ZOSTAVAX, the patient experienced fever, cold, pain and did not feel good at all.  The patient was prescribed ZYRTEC for the adverse events that she got after vaccination, but her symptoms got worse.  The patient sought unspecified medical attention.  The patient was not recovered at the time of the report.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from a physician concerning a 61 year old female who on 19-JAN-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 662858/1558X).  On 20-JAN-2009 the patient experienced shortness of breath (SOB), cough and wheezing.  Chest X-ray was performed with negative result.  The patient was prescribed with MEDROL dose pack and albtuterol MD1.  At the time of this report, the patient was not recovered.  No further information is available.
Skin issues; plaque buildup; extra skin growth; scales; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8729, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), for COVID-19 immunisation. The following information was reported: SKIN DISORDER (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "Skin issues"; SKIN HYPERTROPHY (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "extra skin growth"; SKIN PLAQUE (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "plaque buildup"; SKIN EXFOLIATION (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "scales". The events "skin issues", "plaque buildup", "extra skin growth" and "scales" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin disorder, skin plaque, skin hypertrophy, skin exfoliation.   Additional information: Being treated by dermatologists as they provide immediate care. methotrexate, steroids, etc. Patient did receive other vaccine in four weeks and medications in two weeks. Patient had perfect health.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271860 same reporter/patient, different product/AE;
Patient reports getting first COVID booster around 6pm on 5/24/22. Started experiencing symptoms are 1am 5/25/22. Symptoms include: fever of 103,  severe nausea/vomiting. body aches, and chills.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On or about 24-JAN-2007, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2015, the patient was treated for herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Arm swelling, redness, dizziness and intolerable pain as per parent Arm tics , flailing arms and making noises the whole night
Within a few hours or my first Moderna, I had pain in my arm, upset stomach, a VERY sharp pain in the front of my right neck, had a rash all over my neck and chest, was dizzy, had a fever, chills and then that night my pee changed color and smelled like asparagus pee. Then, I had sharp,  intense sharp pain in my neck and blood vessels pumping and that went on and on for days and days and days. Then on the following day, I was accidentally stabbed in the face and had to go to urgent care and  my primary care doc insisted I get a TD vaccine (in my right arm this time) just a little more than 24 hours after my first Moderna shot and then I really got sick and not only had massive diarrhea, but I had a fever and rash for about a month but worst of all  I developed facial twitching on the right side of my face/eye and lip that has lasted this whole time. I have also continued to have rashes and strange nerve pains.
Shortly after receiving the vaccine patient fainted.  911 was called.  Pt recovered and parent refused to have patient transported.
Started with injection sire pain and fever. Continued to severe muscle pain in buttocks and thighs. One week later my joints were attacked and felt like red hot pokers and fatigue got so bad that I ended up in the ER on 04/27/21. The effects of the vaccines are still being  dealt with and I'm still under treatment by a Rheumatologist. It has been 7 months.
Subsequent to receiving vaccine, the pt developed a rash at the injection site. The reporter noted that Engerix B was administered to six pts, all of whom developed a rash. In some cases, the rash extended to include the arm only, or the arm, truck and face, or the whole body. The most recent information received reports the outcome of the event as resolved after one to two weeks.
8 day course of injection site pain that spread to the inner arm , right armpit and right trunk with swelling and discomfort. no sign of infection