chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team (159558). The reporter is the patient. A 94 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 94 years, as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Feb2021, outcome "unknown", described as "the "needle hurt but it was not terrible""; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "chilly but did not have chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was sore"; NEEDLE ISSUE (non-serious) with onset 23Feb2021, described as "vaccine provider mentioned that "the needle was broken""; UNDERDOSE (non-serious) with onset 23Feb2021, described as "the patient was not sure if she got all of the dose or not".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe weakness. Unable to rise from a chair or walk by myself. Fatigue. Slight nausea.
This spontaneous report was received from a consumer refers to a male patient of 73 years with shingles on and off for the last 5 years approximately on an unknown date in 2009. The patient's symptoms included blisters that eventually went away, but left scars that were white in color. About three years ago approximately on an unknown date in 2011 the patient informed his physician that he wanted to take the ZOSTAVAX. The patient encourage his physician to write a prescription to allow him to get the ZOSTAVAX even though he already had several severe shingles outbreaks. Concomitant therapies included tramadol hydrochloride and gabapentin. Since receiving the ZOSTAVAX approximately on an unknown date in 2011, the patient was still experiencing nerve pain in his neck and jaw area. Patient sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of still experiencing nerve pain in his neck and jaw area was unknown. Causality was not provided by the reporter. Additional information has been requested.
After receiving his vaccine lineup my son, who was on track developmentally, began experiencing multiple developmental delays to include: multiple physical delays requiring physical therapy to correct and severe speech delays requiring speech therapy. He was later diagnosed with ASD.
sore arm; headache; back ache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included rectal carcinoma (started 4 years ago the port was still present.).   On 1st September 2020, the patient received Influenza vaccine Quadrivalent unspecified season. In September 2020, less than a week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, headache and back pain. On an unknown date, the outcome of the pain in arm, headache and back pain were unknown.   It was unknown if the reporter considered the pain in arm, headache and back pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine, and experienced those symptoms.  The name of the vaccine was unknown.  The patient had a history of rectal cancer 4 years ago and the port was still present and she made the comment that she may had to get her port flushed out. The reporter did not consent to follow up.
dose was administered from a vial that was more than 12 old from the first puncture.  the vial was first punctured at 9:20am on 1/25/2022 and the dose was drawn up at 1:20 pm 1/26/2022.  there were only five punctures in the vial.  we contacted the manufacturer and they said that the vial would still protect against covid, the only thing would be the sterility of the vial. they said it would be up to the provider to contact the patient if they felt sterility, was an issue.  with the low puncture count and the dose viable against covid we have not contacted the patient
Day 1 - received injectionwithin a fe minutes of administration I noticed a slight lightheadness and feeling "off"  within half hour  slight nausea began and headache began within hour muscles aches began with joint pain. Above symptoms progressively worsened by midnight was in pain and could not sleep. no fever. took tylenol and only had moderate relief. Day 2  -entire day severe muscle and joint pain - worst headache of my life, severe nausea and chills - no fever. double vision and dizzy Day 3 - same as day 2  - in evening  - around 7 pm headache lessened so that it was tolerable with  tylenol - muscle aches jopint pain the same Day 4  - headache tolerable, was able to eat.  muscle pain better but joint pain still sharp Day 5 - headache sporadic and better - fatigue and muscle pain would come and go, joint pain not as sharp, extreme fatigue Day 6 - extreme fatigue - other symptoms much better
Vaginal bleeding for 3 weeks outside of a period. Stopped for a week and resumed. Continued after second dose also. I take continuous birth control and don't usual have bleedimg.
Per patient since receiving the vaccine a month ago his arm has been sore, stiff, and he is unable to lift it normally.
Pretty painful burning at the site of injection, started immediately, and has only alleviated some in the past hour.
Delayed hypersensitive reaction. Welts on injection site, hand of injection side, and on leg opposite from injection site. Itchy, red. 12 day after second shot.
10 small 2cm in diameter measle-like rash on R forearm elbow to wrist only. Itching occurred at about one week after MMR same side. No fever at any time, saw pt 8/14/06 for Boosters. 8/11/06 Rash crusted over no other symptoms since previous note (itching resolved). 8/25/06 resolved rash.
Information has been received from a physician concerning a 41-year-old female with multiple allergies including penicillin, codeine, sulfur, aspirin, nuts and erythromycin, as well as a medical history of asthma, who on 14-AUG-2007 was vaccinated subcutaneous in the right arm with (single dose series) measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 654985/1181F). There were no illnesses at the time of vaccination. On an unspecified date, following vaccination the patient felt fatigue, tired and lazy. On 22-AUG-2007, the patient experienced diarrhea and "myalgias." On 25-AUG-2007 (over the next few days) the patient developed a rash that started on her trunk and spread to her extremities and face and then by 27-AUG-2007 the spots continued to spread. It was also reported that as of 30-AUG-2007 the spots had spread all over the patient's body. On 27-AUG-2007, the patient was referred to ID associates and was seen on 29-AUG-2007. She was scheduled to receive a follow-up visit on 05-SEP-2007. On 29-AUG-2007, the patient had a measles AB (IgM) test that was positive (320 less than 10 titer) and Lymphocytes Absolute 4464 (850-3900 cells/mcl). At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Information received on 16-OCT-2007 contained the following adverse experiences: Achy flu-like symptoms (O5-SEP-2007) with sore throat, flushed red, achy eyes and tired; as well as an upper respiratory infection (05-SEP-2007) with congestion, crusty nose and a cough. Additional information is not expected.
I had my injection on June 18. I started experiencing chills, body aches, fatigue on June 20. Yesterday morning (June 21)  I felt even worse and knew I was running a fever.  I went to see a doctor. My fever turned out to be high - 100.4 (oral) and I tested positive for Covid. I wish I didn?t take the vaccine
This spontaneous report as received from medical assistant refers to patient of unknown age. No medical history and concurrent conditions were reported. On 20-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of improperly stored product was unknown. The reporter considered incorrect product storage to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Headache, nausea, body aches, chills and fever ranging from 99 to 101 for a period of 24 hours. Ibuprofen helped with symptoms and alleviate some of the body aches.
I am the epidemiologist reporting on behalf of 92-year-old male patient. The patient received two doses of the Pfizer vaccine on 02/09/21 and 03/02/21. The patient received their third dose of the Pfizer vaccine on 10/01/21. On 10/10/21 (10 days post dose 3), the patient took a PCR test and a rapid test and was positive on both. According to contact tracing team who spoke with daughter of case, case was asymptomatic with the 3rd dose of the Pfizer vaccine. On 10/12, the case was moved to Hospice care as they are not treating the case for COVID, however, as they speaker mentioned a "heart attack." The patient died on 10/15/21 (15 days post 3rd dose). The cause of death is listed as ?Acute respiratory failure; Pneumonia due to Covid ;Covid? on the death certificate. Other significant conditions contributing to death but not resulting in underlying causes are listed as ?adult failure to thrive syndrome.? Known pre-existing conditions include cardiovascular disease.
pt recvd vax; pt exp delay in her menses; pt exp'd also tiredness & abdominal bloating;
10/05/2005 received hepatitis B vaccine (Engerix lot AHBVB168AA) on 10/03/2005. Approx 1-2 hrs later started to feel ill, headache, generalized body aches, muscle weakness, chills, fever. Temp 102.6 axillary. Patient called me about 10:40am 10/04 to tell me he was at an apt with his parents. Parents rent an apartment when visiting Patient. Patient complained of continued muscle weakness headache and fever advised him to go to medical center ED via ambulance. Patient said his father would drive him to the hospital. At Ed patient received IV fluids and blood work including blood cultures. ED Doctor felt patient symptoms were probably due to the Hepatitis B vaccine, Viral or Bacterial.
CANNOT KEEP EYES OPEN; FEEL VERY WEAK, NO STRENGTH AT ALL; LOT OF JOINT PAIN; LOT OF MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported.  The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced cannot keep eyes open. On 2021, the subject experienced feel very weak, no strength at all. On 2021, the subject experienced lot of joint pain. On 2021, the subject experienced lot of muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel very weak, no strength at all, lot of muscle pain, lot of joint pain and cannot keep eyes open was not reported. This report was non-serious.
3/17/04 hives over body lasting approximately 30 minutes. Given Benadryl and resolved. Redness and swelling at site with pain increasing; seen 3/18/04 and Benadryl given. Swelling and pain increasing right thigh; went to ER and admitted. Diagnosed with Cellulitis for 2 days. Medical records states rash, vasodilitation. msv
28FEB97 838AM pt mom called to report big red spot @ site of inj;pt can't lift lt arm;mom described red area 3" across;weak x 2 days;didn't go to school today;already taking APAP;reported to MD apply ice cont w/APAP
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On an unknown date in 2001, patient was administered with first dose of VARIVAX and on an unknown date in 2016, 2nd dose of VARIVAX was administered (lot and expiry date were not reported) subcutaneously (inappropriate schedule of drug administration). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concerns (PQC) involved. Additional information is not expected as there was no reporter consent for follow up.
Patient received GARDASIL vaccine on 1/16/13. Pt. had pos. home pregnancy test on 1/17/13 and pos. urine preg. test at clinic on 1/18/13. Had IUD remove 12/11/12. Neg. pregnancy test on 1/9/13.
Proximal (L) shoulder/deltoid pain; started w/in week of receiving flu shot.
As soon as patient received the vaccine, she noticed a flushed feeling and then her right hand was tingling. She then felt a rush of heat up her right arm into her right ear and then a subsequent tingling of the lips. She became flushed on her chest and diaphoretic.  After a dose of 10mg Benadryl and consumption of peanut butter crackers, ginger ale, and an orange, patient stated that she felt much better despite some heat in her right ear and tingling in her right thumb still.
pt recvd vax; c/o no discomfort w/ inject; no contraindications;c/o inc pain in arm on 25oct & 26oct94; unable to sleep 26oct;contacted hlth rn 27oct94 & c/o inc pain & pain when moving arm esp in shoulder area;sl puffiness in upper arm;
Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received her second Moderna Covid-19 booster shot on 03 May 2022 / Patient received expired Moderna Covid-19 vaccine for her booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 02 May 2022, the vial was initially stored in the refrigerator. The vial did not underwent any temperature excursions. After first dose the patient did not experience any other side effects or adverse reactions.The Nurse was not aware of any side effects after second dose and first booster dose.No other adverse events are reported after second booster.No treatment information was provided.
RIGORS; SEVER ARM PAIN FOR A WEEK; FELT UNWELL; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rigors, sever arm pain for a week, felt unwell, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rigors, headache, sever arm pain for a week and felt unwell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817490 and 20210817554.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever and swelling arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the swelling arm was unknown. It was unknown if the reporter considered the fever and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be in between 55 to 65 years. The patient's body temperature was recorded as 104 degree F. It was reported that half the patient's arm was swollen. The temperature went down but the arm was still swollen at the time of reporting. The patient was on vacation. The health care professionals were concerned that the patient might not get 2nd dose.
1 1/2 x 6 cm red sl. raised area around site of injection.  Treated with Keflex, Benadryl & ice.
pt rcvd vax; pt found dead in crib; tentative dx is sids;
Increase in heart rate (160), both arms became numb, vomiting, loss of consciousness. Was transferred to ER.
Covid positive test done, came back as detected; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included LISINOPRIL for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment were not provided   This case was linked to MOD-2021-008849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Email has been changed and IRD was updated
Information has been received from a nurse practitioner referring to an unknown number of patients. Between 27-APR-2015 and 30-APR-2015, the patients received improperly stored doses (unspecified in series) of (Oka/Merck) VARIVAX, lot number: K016129, expiry date: 23-SEP-16, (another lot number was reported as L001332, and expiry date: 13-JAN-2017), 0.5ml, subcutaneously. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
About 40-44 hours after vaccine, I developed hives on my chest, stomach, back, and torso. Developed numbness in right side of throat, experienced extreme headache, fatigue, and exhaustion.
Arm pain and swelling, nausea and vomiting, diarrhea, fever.
24AUG91 @ 930PM PT suddenly started having szs w/no previous signs of illness; PT taken to hospital where PT had several szs; p/2 hrs PT flown to another hospital; no further szs; normal findings x/bacteria on urine culture (UTI);
fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 3 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 13Jul2021 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE; lot number: FT9142; time of administration: 08:54 AM; anatomical site of injection: Left thigh; route of administration: Intramuscular), administration date: 07Oct2022, when the patient was 24-month-old, for COVID-19 immunization, reaction(s): "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses", "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses", "fatigue"; pentacel (DOSE 3, SINGLE; Manufacture: Sanofi; Batch/lot: WJ641AAA; Route: IM; Anatomical site of injection: Left thigh.), administration date: 14Sep2022, for Immunization; prevnar 13 (DOSE 3, SINGLE; Manufacture: Pfizer; Batch/lot: FF7356; Route: IM; Anatomical site of injection: Right thigh.), administration date: 14Sep2022, for Immunization; fluzone (DOSE 2, SINGLE; Manufacture: Sanofi; Batch/lot: WT7680MA; Route: IM; Anatomical site of injection: Left thigh.), administration date: 14Sep2022, for Immunization; Bnt162b2 (DOSE 2 (MAROON CAP), SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovered" (2022).  Additional information: It was also reported that the patient provided information regarding the reported adverse event with the use of the product and considered Pfizer product had a causal effect to the adverse event. There were no relevant tests. Not having appropriate vaccine preparation and administration summary from CDC website in front of nurse when reconstituting vaccine/not being able to draw up all vaccine doses at one time before administering to patients/nurse fulfilling regular office Responsibilities (i.e. roaming patients taking recording vitals administering routine vaccines answering/triaging phone calls etc.) as well as running COVID vaccine clinic alone. Patient was fatigued the day after receiving the 3rd and final dose of the 6th month< 5 year  COVID vaccine, however return the baseline to the next day. No change in activity with 1st and 2nd dose Vs. 3rd dose. Patient made a full recovery. Parents contacted by patients PCP and notified of vaccine error of VAERS report having been submitted and full increased likelihood of reactogenicity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201212961 same patient/drug, different dose/event;