chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I feel weak; I throw up two times; Dizzy; Headache; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection; Lot number not reported) via unspecified route of administration on 09Feb2021 (at age of 66-years-old) as dose1, single for Covid-19 immunisation. Medical history and concomitant medication were not reported. On 10Feb2021 (1 day after vaccination), patient was dizzy and had headache. On 11Feb2021 (2 days after vaccination), patient throw up two times. On 12Feb2021 (3 days after vaccination) patient feel weak. Consumer stated that he got his first shot this past Tuesday(09Feb2021) and was fine, don't have any side effects or anything and everything was fine. Wednesday(10Feb2021) woke up and was dizzy for weeks and have slight headache. So, Wednesday passes he ate regular dinner and Wednesday night threw up two times and today Thursday saw the same problem. Patient was dizzy, feel weak and a slight headache. He drunk five glasses of the water, 1 tea and a bottle of nutrients nos (ENSURE). It was like a vitamin thing that was taken, a drink that taken and then took cracker. This seems like patient threw up at 1 o'clock last night and 3 o'clock. So, have not thrown up since then but still feeling very dizzy, that goes hanging around with him. The outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Pt recv vax on 1/6/98; on same day pt exp crying inconsolably, fever (99-101F).
Pt. has some diarrhea occasionally; This is a spontaneous report from a Pfizer Sponsored Program Optum Xeljanz Program. This contactable consumer (Other Health Professional) reported that a 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number and expiration date: Unknown), via an unspecified route of administration on an unknown date as unknown dose, single dose for COVID-19 immunization and started receiving tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, Lot number and expiration date: Unknown), at 11 mg via an unspecified route of administration from 01Mar2021 and unknown date for an unknown indication. Medical history and concomitant medications were not reported. Patient reported that doctor instructed her to take one week off from the medication before the COVID Vaccine, and one week after she gets the COVID-19 vaccine. Patient had some diarrhea occasionally, but Imodium helped. The outcome of event was unknown.  Information about the lot/batch number has been requested.
SHOT WAS ADMINISTERED EARLIER THAN RECOMMEDNDE TIME: NO ADVERSE ISSUES, SIGNS/SYMPTOMS NOTED AT THIS TIME....
Diagnosed with Pulmonary sarcoidosis. Symptoms began within 10 minutes of receiving the moderna vaccine.  Symptoms include extreme chest tightness, shortness of breath, multiple swollen lymph nodes and pain localized around the swollen nodes. Swollen nodes include under the collar bone, in the chest, underarms, spleen and liver. Symptoms are still present after almost 5 months.
Itching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (Itching all over her body). At the time of the report, PRURITUS (Itching all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications provided. No relevant treatment information provided.
Arm swelling, hot to touch, and soreness within 12 hours after. Soreness and warmth at injection site continued for 10 days.  24 hours after injection, numbness and tingling started and still hasn't resolved 2 weeks after injection. Decreased strength in right arm, pain and discomfort comes and goes through day and night. Arm will go numb for up to an hour  making it hard to grasp items, write, type, ect. Took Tylenol and Benadryl every evening, applied ice , stretching and movement to work muscle.   Appears that vaccine was given too low instead of 2 in from shoulder, given  6 in from shoulder by pharmacist
extreme fatigue, headache, muscle aches, very sore arm, low-grade fever and chills
Varicella infection.  Follow up on 04/21/04: Reporter does not give any more new information.
Moderna 12/30/20 and 1/26/21. Positive on 1/4>
that I got the first modern vaccine and it gave me a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (that I got the first modern vaccine and it gave me a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (that I got the first modern vaccine and it gave me a fever). At the time of the report, PYREXIA (that I got the first modern vaccine and it gave me a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Patient had a vasovagal response in observation area 3 minutes after receiving 1st dose of Moderna vaccine. He informed field ops employee he did not feel well and she called on the nurse staff. The patient fell to the ground assisted by his girlfriend. The observation nurse and charge nurse assessed the patient for injuries and patient was conscous and alert and oriented X4  He said he did not hit his head or any other part of his body during his fall. Vitals were taken at 2:10PM B/P 90/79 HR 54 Temp. 94.9 Resp. 16. O2 98%. Patient said he was feeling nervous before his vaccinaion and "did not like shots". Vitals were repeated before patient was sat up in chair at 2:15PM B/P 123/80 HR 58 and charge nurse walked with patient outside to sit and get fresh air . Patient said he "felt much better" and  B/P was repeated B/P 139/71 HR 62 at 2:23PM . Patient left without further incident shortly after with his girlfriend with steady gait and without further interventions.
Large local reaction (6-7cm) area of warmth/ erythema beginning 2nd day and lasting 4 days. Nontender. Only cool compresses applied.
12hr p/vax had extreme body aching & flushed feeling that lasted 8 hr then fine;48hr p/vax devel welts around inj site;
The diluent used for the Yellow Fever Vaccine had expired on 6/21.  Have attempted to reach patient  regarding the need for second valid dose of Yellow Fever Vaccine 28 days after last dose.  Will  continue to attempt to contact him once he returns from his trip.,
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline).  The subject's medical history included allergic rhinitis.  Concurrent medical conditions included autism, delayed speaking and developmental delay. Previous and/or concurrent vaccination included PedvaxHIB; Merck; unknown given on 6 August 2004 and 5 October 2004; Prevnar, unspecified; Wyeth Labs; unknown given on 6 August 2004, 5 October 2004 and 17 December 2004.  On 6 August 2004 at 15:15, 5 October 2004 at 14:00 and 17 December 2004 the subject received 1st dose, 2nd dose and 3rd dose of Pediarix (.5 ml, unknown).  On 28 April 2008, at an unspecified time after vaccination with Pediarix, the subject experienced decreased therapeutic response.  The subject was playing in a sharps container and stuck herself with a contaminated needle.  Relevant test results included hepatitis B antibody level was 5 (unprotected level).  The healthcare professional considered the events were clinically significant (or requiring intervention).  At the time of reporting, the outcome of the events was unspecified.  The healthcare professional considered the events were probably related to vaccination with Pediarix.
Reported some swelling noted after a flu shot, BENADRYL taken. Decrease. Reports feels better able to speak breath without difficulty.
Information has been received from a medical assistant concerning a 23 year old female with a history of dysmenorrhoea and no known drug allergy who on 02-JUL-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #657737/0522U). Concomitant therapy included YASMIN. On 04-JUL-2007 the patient experienced fever and fatigue. It was reported by the medical assistant that the patient was instructed to call the physician's office if experiencing any injection site pain. The patient did not report injection site pain. There were no other symptoms noted. The patient did not seek medical attention. On approximately 07-JUL-2007 the patient recovered. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On 26-AUG-2016, the patient was vaccinated with PROQUAD lot # L044056, expiry date 02-MAY-2017, and M-M-R II lot# K016154, expiry date 24-SEP-2016, both 0.5 ml, subcutaneous (overdose). No adverse effect was reported. There were no Product Quality Complaint (PQC) involved. Additional information has been requested.
approx 8 days p/vax pt devel rash on legs, arms, neck, cheeks (fine, red rash) along w/fever to 102.4; rash & fever lasted approx 4 days w/spontaneous resolution;
Temperature 99.2; injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Oct2021 09:00 (Lot number: FC3183) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lower and upper back pain" (unspecified if ongoing), notes: Lower and upper back pain; "Lower and upper back pinched nerves" (unspecified if ongoing), notes: Lower and upper back pinched nerves; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA, administration date 30Sep2021; TRAMADOL; TYLENOL; LIDOCAINE; BIOFREEZE PAIN RELIEVING. Past drug history included: Iodine, reaction(s): "known allergies: Intravenous iodine", notes: known allergies: Intravenous iodine; Levitra, reaction(s): "known allergies: Levitra", notes: known allergies: Levitra; Plaquenil, reaction(s): "known allergies: plaquenil", notes: known allergies: plaquenil. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL3302, Administration time: 01:00, Vaccine location: Left arm), administration date: 16Jan2021, when the patient was 78 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: EM9810, Administration time: 01:00, Vaccine location: Left arm), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "Temperature 99.2"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021 08:00, outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, vaccination site pain.  Additional information: The patient had received other vaccine in four weeks with influenza. The patient had other medications in 2 weeks with tramadol, tylenol, lidocaine patch, boiofreeze. The patient had treatment with tylenol for adverse events temperature 99.2 and injection site pain. Patient had covid prior vaccination and had covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Tingling headache sensation in afternoon on left scalp. Arm pain which traveled to neck and upper back spine. Next am severe stiffness and moderate pain with movement and weakness in arm.   Day 2 sweaty, tired and feeling like getting sick. Slight nausea. Day 3 more energy but army neck and upper back pain and stiffness  continued with upper arm weakness. Day 4 less pain and stiffness. Day 5 pains and stiffness better.
I experienced a rash on the back of my leg with tiny blisters which turned out to be shingles.
COVID ARM. Developed a circular rash and swollen bump around the injection site that lasted a week.
After the 2nd dose there was some fatigue and fever and 2 days at 5PM I was having dinner and I was itchy rash from my neck to my feet, blotchy, itchy and it was everywhere. Huge pink patches that almost became blistery and went to primary care a few days later. After 3 days I called for an appointment. I was referred to an allergist after 6-8 weeks by then it stopped before.
Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted about 10 minutes after the last shot, falling off the table. ? L.O.C for about 3 minutes.
Tenderness; Redness; Muscle aches; Edema at injection site; Patient under 65 received Fluad QIV; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04831) and concerned a 31-year-old, female patient.   The patient concurrent conditions included polycystic ovary syndrome (PCOS). The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date, after receiving Fluad Quadrivalent, the patient experienced muscle aches, redness, tenderness, edema at injection site. The patient used Ibuprofen as treatment medication.   At the time of initial reporting on 05-Nov-2020, the outcome of the events was not reported.  The case was assessed as non-serious.  This case is linked to cases 202004845, 202006068, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006091, 202006092, 202006095, 202006097, 202006098, (the same reporter).  Company comment: The patient experienced tenderness, erythema, myalgia and vaccination site swelling on an unspecified date after administration of Fluad Quadrivalent. Causality is unassessable for tenderness, erythema and myalgia (unclarified chronology) and possibly related for vaccination site swelling (anatomically plausible). Patient under 65 received Fluad QIV - Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: The patient experienced tenderness, erythema, myalgia and vaccination site swelling on an unspecified date after administration of Fluad Quadrivalent. Causality is unassessable for tenderness, erythema and myalgia (unclarified chronology) and possibly related for vaccination site swelling (anatomically plausible). Patient under 65 received Fluad QIV - Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
I don't have a lot of information other than tested positive for covid on         2-10-23                at      a local hospital lab                          and deceased 2-23-23
SORENESS AT INJECTION  SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced soreness at Injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness at Injection site was not reported. This report was non-serious.
Information has been received from a physician concerning a patient who was vaccinated once SC with a 0.5ml dose of varicella virus vaccine live. On 5/20/2005 the patient came into the physicians office with a breakthrough case of varicella. No other information regarding the adverse event was provided. There was no product quality complaint reported. Additional information has been requested.
Patient received Janssen Covid-19 vaccine 4/13/21. She stated that she is worried about the delta variant of Covid-19 and received Pfizer Covid-19 vaccine 07/23/2021.
feeling ill; tested positive for COVID; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves male patient (age not reported) who experienced feeling ill (malaise) and tested positive for (Covid-19) , while he received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious feeling ill (malaise) and tested positive for (Covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Started with a headache and sore arm at injection site. Then pain moved on down the same arm, increasing as it manifested in other arm, legs, shoulders. Aspirin only vaguely quieted it enough so I could sleep intermittently.
This spontaneous report was received from a Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot/batch # L048456, expiry date 25-MAY-2017 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effect were reported. There were no product quality Concerns (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a 18-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included ADACEL (non-gsk); Sanofi Pasteur; unknown; unknown given on 7 May 2012. There were no concurrent medications. On 7 May 2012 at 09:56 the subject received 1st dose of HAVRIX (.5 ml, unknown, left arm). On 7 May 2012, 24 minutes after vaccination with HAVRIX, the subject experienced arm numbness and numbness spread. The numbness started in his upper left deltoid extending down to the left proximal elbow. the subject was very nervous about getting injections. At the time of reporting the arm numbness and numbness spread were unresolved. Follow-up information was received on 29 May 2012 via healthcare professional who reported the events resolved on 23 May 2012. The reporting healthcare professional attributed the events to erroneous administration and the subject "was very anxious about receiving vaccines."
Child received 2 PROQUAD vaccines on the same day and same time. No adverse effects noted at time.
patient inadvertently received an expired dose of TENIVAC with no reported adverse event; Initial information was received on 20-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17-year-old male patient who inadvertently received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment(s) and family history were not provided. The patient's past vaccination(s) included DIPHTHERIA TETANUS ACELLULAR PERTUSSIS on 12-FEB-2021. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 20-Apr-2021, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA, expiry date-19-Apr-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (on the same day).  At the time of report, no adverse event was reported.  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.
Initial report was received from a health care professional on 03 January 2011 via a search of the scientific literature. A 68-year-old male patient developed neurologic complications after he had received Influenza vaccine (manufacturer unknown, lot number and date of administration not reported). Two weeks post vaccination, the patient experienced paresthesias of the upper and lower extremities and was diagnosed with acute idiopathic demyelinating polyradiculopathy (Guillian-Barre Syndrome). He received intravenous gammaglobulin therapy as corrective treatment with marked improvement. Outcome was not reported. The reporter for this case is the same as for case number 2011-00042. Documents held by sender: None.
I found out I was pregnant between dose 1 and 2 of the vaccines. I received dose 1 on 12/23/21 and had a positive pregnancy test on 1/2/21. I had my 2nd dose on 1/13 at 5w6 days based on LMP. I had my first prenatal visit on 2/10/21 at which time US showed twin gestation but neither fetus had a heartbeat.