chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling really very bad all day and last night; Injection site is just a little painful; Tiredness; Head is about to burst open; Muscle pain; Chills; Joint pain; Feeling unwell; Headache; Body is sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration, administered in right arm on 01Mar2021 at 11:00 AM (at the age of 71-years-old) as single dose for covid-19 immunisation. Patient's medical history included blood pressure high and high cholesterol from an unknown date and unknown if ongoing. Patient stated that Consumer It has probably been 5 years ago or couple of years ago, she did not remember exactly. The patient's concomitant medications included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for blood pressure high, atorvastatin calcium tablets (ATORVASTATIN CALCIUM) taken for blood cholesterol increased and vitamins however start and stop date were not reported. Patient stated that she started taking Triamterene HCTZ from maybe like 5 years or something. On an unspecified date, the patient feeling really very bad all day and last night and experienced Injection site is just a little painful, tiredness, head is about to burst open, muscle pain, chills, Joint pain, feeling unwell, headache and body is sore. Patient stated that she was not had a fever and the injection site is not swelling or red and she don't feel nauseous, and my lymph nodes are not swollen. It was reported that patient started having those symptoms last night, late last night. Therapeutic measures were taken as a result of all the events. Patient stated that she took a tylenol this morning, just one Tylenol 500 mg, she hasn't taken anything else. Patient inquired that she wants to know what she need to take and how to proceed further and also inquired as if she can take more Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated w/TTOX arm swollen w/area of induration approx size of soft ball.
Report 20010037371 describes sensitivity to alcohol (itching) in a 56 year old female who received Engerix-B for prophylaxis of hepatitis B. The vaccinee has no known drug allergies. Reportedly, she has no medical history and no concomitant medications. In approximately 1996, the vaccinee received her third IM left deltoid dose of Engerix-B. Subsequently, she developed a sensitivity to alcohol. Within seconds after having an alcoholic drink she experienced generalized itching. additionally, she is a nonresponder. As of 02/08/2001, the outcome of the events is ongoing.
Hives, itching, swelling, coughing. BENADRYL-1, epinephrine, DEPO MEDROL, dexamethasone, ZANTAC, ATIVAN.
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender and race received, on an unknown date PREVNAR 13 single dose, for immunization. The patient previously, on an unspecified date, received PNEUMOVAX for immunization and experienced cellulitis.  Relevant medical history and concomitant medications were unknown.  On an unspecified date, few days after the vaccination with pneumococcal 13-val conj vac (dipht crm197 protein), the patient developed cellulitis. Clinical outcome of the event was unknown at time of this report.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Bad muscle pain in arm for 2 days, cold chills, fever and body aches with low grade fever.
Headache, Body Aches, Chills, Fever, Lethargy - Approx. 48 hours duration
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right 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 had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.Treatment for COVID-19, Treatment start date: 08Dec2022, Treatment stop date: 12Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt received bexsero and menactra by MA with another supervising. Pt moved from exam table to chair, sitting next to mother. Brother received vaccines. Patient asked for water, MA brought it to her in the doorway. Everyone was standing. Patient took a sip of water and stumbled. MA guided the patient to the floor and called for help. I, PA-C, assessed the patient. She was pale and diaphoretic. She was adequately profused and breathing. Pt states she has had previous episodes of vasovagal syncope following injections. She also states she did not eat breakfast this morning. After about 4 minutes, patient was able to stand and was asked to wait in the waiting room. She was given tea and offered food. Her BG was 109. Patient was allowed to leave after 15 minutes in the waiting room recovering.
This is a spontaneous report from a contactable Other Health care professional (patient) reported herself. A 54-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was unknown), via an unspecified route of administration on 13Apr2021 09:00 left arm as single dose for covid-19 immunisation. Medical history included covid-19 (prior to the vaccination). Allergies to medications, food, or other products: no. Concomitant medication included melatonin. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID. The patient experienced fever, Chills, headache, Nausea, Diarrhea and Fatigue on 14Apr2021 10:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021. Patient did not receive any treatment for the events. The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Back and hip pain, muscle weakness progressively getting more severe through Tuesday, 2/23; headache and disorientation 2/23-2/24; muscle weakness and general lower back tightness is persisting. No measurable fever.
pain radiating from site of inj down arm & into back/shoulder blade area;tingling & numbness radiating from site of inj down arm;all sx lasted 2-3 days;
Information has been received on 06-JAN-2017 from a medical assistant regarding a 40 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that the patient, currently 52 years old, stated that she received ZOSTAVAX, (lot number and expiration not reported) reported as "zoster vaccine" for prophylaxis when she was 40 years old on an unspecified date (approximately 2005) at an unspecified medical facility. No adverse effects reported. No further information was reported. Additional information has been requested.
My wife contracted COVID-19, and we isolated as best we could following recommendations and guidelines. However, 6 days later on 02/01/2023, I myself tested positive for COVID-19. I decided to test because I started experiencing sinus congestion and head cold symptoms. I contacted my doctor via telehealth appointment and was prescribed Paxlovid for recovery. The prescription worked very well; within four doses, it kind of kicked my symptoms away instantly. I would say I've made a full recovery from my breakthrough case.
Chills, headache, serious shivering continued for several hours.  Body aches, chills, and very painful vaccination site lasted for over 24 hours, followed by persistent cough, congestion, some fever, and weakness through present time (11/15/2013).
Pt. felt achy flu like symptoms, hot flashes dizzy, nausea and arm soreness.
Pt vax /w Hepatitis B vaccine. Within 2 weeks of vax pt was hospitalized /w pericarditis. Additional info has been requested.
just been having heartburn and not sure if its the vaccine or not.also concerned about the lot number because when I called Pfizer they said that serial number/lot number is not in their database .I told them I got it at cvs and  told me to go back to pharmacy to get the lot number.the number  was on the vial and was shown the vial.they were still using the same lot number on my  card.
Greater than 35 days without 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.   Reporter did not allow further contact
Patient was administered three incorrect vaccines: Hep A, PCV 13, and VZV. Parent was advised to monitor patient for fever through out the night and to come the next day to see pediatrician for observation. No signs of adverse reaction noted by pediatrician or reported by mother.
Pt with 2nd pfizer vaccine on 30 Apr, (1st dose on 09 apr), reported to clinic to see PCM on 05 may with approximately 7 dizzispells per day and near syncope episodes + fatigue for nearly a week. Orthostatics were check and normal. PCM referred pt to neurology. Neuro perfromed a series of EEGs. Neuro referred pt for polypharmacy eval due to multiple meds associated with sx + cardiology. Both cardio and neuro believe sx most likely associated with med regimen as results of tests were insignificant of findings. Pt came to see myself on 25 Jun where we d/c'd lyrica (lose dose of 25mg daily daily  since 11 Mar 2021 and tizanidine taking since jul 2020). Pt first noted resolutions of sx on 07 jul. but on 22 jul pt notes dizzispells still present but every other day. Made one more adjustment with alfuzosin, which pt started on 25 May, changed to tamsulosin, without change to sx. Medicinal wise, the covid 19 pfizer vaccine is the only other medication introduced around the pt reported sx. Pt states that i was the only provider who inquired about vaccinations around the time that sx started and encounters with other provides, vaccination was not inquired about.
missed dose; rash around the eyes and the mouth; it is itchy; At first it was just red above the eyelid; At first it was just red around the mouth; rash around the eyes; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes). On 02-Nov-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) on 02-Nov-2021 for Adverse reaction, at an unspecified dose and frequency. On 02-Nov-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included supplements.  Rash was not painful. At first it was just red, not even itchy (above the eyelid and around the mouth). Then it started to feel itchy. This morning it became worse because yesterday patient didn't take antihistamine. Second shot was scheduled for the 02Nov2021. Pharmacist said that they could not give patient the shot because she had an allergy.  Treatment medication was not provided by the reporter.
Got both doses, now feels like shingles/Suspected vaccination failure; Feels like a case of shingles is starting; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2022, the patient received the 2nd dose of Shingrix. On 2nd February 2022, the patient received the 1st dose of Shingrix. In October 2022, between 4 and 6 months after receiving Shingrix and between 7 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received Shingrix vaccine. The reporter stated that the patient had been experiencing pain for the past month and so it felt like a case of shingles was starting. The reporter wanted to know if patient could get the third dose. The reporter reported that the patient did not received the third dose. The reporter did not provided further details. The reporter did consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. As per narrative patient had pain for past month was considered as October 2022 conservatively.
joint pain all over her body that was real bad/her arms, she could not raise her arms/her feet hurt, everything, all her joints in her body hurt; one lymph node is swollen; It's been misery; feels tired; her knees started hurting real bad; she couldn't make a fist, she couldn't do anything with her fingers.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9265, Expiration Date: unknown), via an unspecified route of administration, on 03-FEB-2021 at single dose for Covid-19 immunization. The patient medical history included Arthritis, allergic to ACE. Concomitant medication was not reported. She went 03Feb to get her first shot, her first COVID shot and she thinks it started Monday. She had arthritis in her knees and her knees started hurting real bad but she didn't think much of it then all of a sudden, everything started going, her arms, she could not raise her arms she couldn't make a fist. She couldn't do anything with her fingers. Her lymph node swelled and it made her throat hurt and her feet hurt, everything, all her joints in her body hurt. That was when she knew it wasn't arthritis when it was her shoulders and arms she knew she does not have arthritis there and it took her a while to figure it out. She felt bad and her husband was concerned about her and she told him maybe its the COVID shot and he didn't think it would be that, he thought it was just her arthritis and she got her paper out from the first shot and it listed joint pain, she had the joint pain, tiredness, and swollen gland. later it was relaxed a little. It was a whole week for her, she has a hard enough time with regular arthritis. It almost froze  her, it almost made her feel frozen. She was up all night she couldn't sleep, she was miserable she was up and down, up and down. She was cat napping, she would fall asleep and then it would wake her up. They haven't changed any meds and she didn't have any problem. Nothing was new it was not any medications that she has taken. She confirms that her lymph node in her neck was swollen and it made her throat hurt when she swallows, that was gone down now. It was starting to go away it is not all the way gone but she can live with it now. The outcome of event was recovering.  Description of complaint: The patient reported her experience after the Pfizer COVID 19 vaccine. She reported that she had join pain all over. She says her doctor's office was closed because the doctor was under quarantine. She definitely would've gone to see him to  beg him to give her something for pain because Aspirin was not doing it. No further information provided. Product strength and count size dispensed was not provided.
Patient received first Pfizer vaccine on 4/28/21 and received a first dose Moderna vaccine today, 5/18/21.
Pain, reddness, swelling in right leg, below the knee, when I got up in the morning.  Symptoms continued over the weekend. Called Dr. on Monday, April 5, 2021 and got an appointment for the following day.  Dr.  diagnosed it as phlibitis and sent me for an ultr sound. Prescribed Xarelto 15 mg twice a day for 21 days, then decrease to 20 mg  daily.
Moderna COVID-19 Vaccine EUA  sensation on my tongue like I have gotten soap in my mouth, started after receiving the vaccine and continuous as of today, 3/4/21
I had pain in all of my joints, muscle pain, neck pain, and my eyes swelled up.
fever of 102 degrees; This case was reported by a consumer and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (For tolerance after 1st dose refer case US2020AMR018108.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was unknown.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd Dose of Shingrix vaccine and experienced fever of 102 degrees F. The reporter did not consent to follow up. This case has been linked with US2020AMR018108, reported by same reporter.      Lab Comments: On an unknown date lab test was performed
expired acthib was given to a consumer with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 8 months old male patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix), pneumococcal vaccine 13v (pneumococcal 13 valent vaccine) and influenza vaccine (influenza) for prophylactic vaccination.  On 30-Oct-2023, the patient received a 0.5 ml, (once) dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ836AA, expiry date: 28-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunisation and expired acthib was given to a consumer with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
9 days after vaccine, i woke up with arm being sore and when looking at the vaccine 2 inch area, it was reddened and sore and warmer to touch that other areas
Pt noticed hot at nare that occurred after FLUMIST and increased in the 2-3 days following intranal flu immunization.
In admin immunization for pre-placement policy to employees in high risk areas of work, employee c/o having jt aches 2nd to completing Recombivax vax series. Con't to c/o of constant jt pain, recalls jt pain beginning /w vax on 1Jul90
Pt became light headed, diaphoretic and confused and had a near syncopal episode approximately 5 minutes after vaccine administration. Pt states history of passing out post injections/blood work.  Pt vitals evaluated and Pt refused transport to ED.
Had pain in R arm that night...All muscles were painful in A m. following shot. Cried out with movement. Became bedridden because of the terrific pain to get her up. Eventually developed bedsore due to this, which became infected. Died on May 14, 2016.
Feverish chills, joint aches, headache, no appetite, lethargic/sleepy.