chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had vaccination at 1521, at 1541 pt felt tingling on tongue, itching to chest and neck, and redness to chest and neck. rn monitored, resp clear. tingling to tongue resolved prior to medication administration. administered Benadryl at 1555 continued to monitor. symptoms subsided and pt declined driver, felt safe leaving. left at 1645 with no other complaints.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 72 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 (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, patient had covid-19 infection. On 13-SEP-2021, she tested positive via rapid test (unknown whether it was Polymerase chain reaction or Antigen) (suspected clinical vaccination failure). On 15-SEP-2021, she received an infusion. On 16-SEP-2021, She checked her pulse oximetry and it showed that her oxygen levels were 85%. On 17-SEP-2021, she presented to the hospital and was admitted. She was hospitalized for 7 days. She did not require mechanical ventilation but was on oxygen and all kinds of treatments. She was discharged home on 23-SEP-2021. She was fine but had to recover at home for a month after the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000207717, 90000207751. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20211240687.; Sender's Comments: V0- 20211240427-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211240427-Covid-19 vaccine ad26.cov2.s-Covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown. The reporter considered the injection site erythema and injection site itching to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. A few days before reporting date, the reporting pharmacist gave the patient a dose of SHINGRIX and the patient experienced a large, red and itchy spot around the injection site. The reporter planned to contact the patient to inquire if the patient still had the adverse events. The reporter requested to speak with an Medical Science Liaison (MSL), which was met. The reporter agreed to follow up from GlaxoSmithKline.
SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not in the age group for blood clots. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Imaging procedure (NR: not provided) no Sinus blood clots were found. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949951.
Started having a period after not having one for 4 months.  Tightness, slight pain in groin on right side.  3 small bruises in a line on right leg.
It makes me sick/ Full blown sick; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via social media.  This case involves patient (unknown age and gender) who had sick/ full blown sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "it makes me sick/ full blown sick" (illness) (unknown latency) following the administration of vaccine.  It was reported "Not me! It makes me sick. Patient Full blown sick. Why would I do that?"  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Information has been received from a nurse concerning a 71 year old male (this conflict to previous report which was female) with coronary artery disease, hypertension, depression, type 2 diabetes mellutis and allergies to clams and crab who in October-2008 (previous report was in April 2008), was vaccinated with ZOSTAVAX (duration and dose not reported). There was no rash at the site of injection or elsewhere within 42 days of the vaccination. Subsequently on 16-OCT-2008 (previous report was on 15-OCT-2008) the patient was diagnosed with shingles, he was noted to have 7 vesicles with clear discharge on the T8-T9 dermatomes neck and head. The patient experienced pain which was rated 8/10 (with 0 being the least and 10 being the most). The patient had no recent exposure to chickenpox or herpes zoster. At the time of report the patient had not recovered and he remained on Acyclovir. The patient sought medical attention. Additional information has been requested.
Initial report received from a health care professional on 17 November 2011. A female patient (age not reported) received an intramuscular injection (site not reported) of FLUZONE, sanofi pasteur Inc. lot number UT450AA, on an unknown date in October 2011. On an unknown date, the patient developed pain in the injection site, numbness and tingling in the arm for 5-7 days. The outcome was reported as unknown. Documents held by sender: None.
Initial information received on 19 August 2009 from another manufacturer whose initial reporter was a health care professional. A male patient received an influenza vaccine (manufacturer not known) over 20 years ago. Following administration the patient developed Guillain Barre Syndrome. No further information was provided. List of documents held by sender: none.
Developed rash on Friday - a couple of spots on chest, spread to back and then arms. Begin as vesicle, very small and then becomes red rash. Congestion noted on Friday - Nasal congestion and cough.
pain and burning sensation in neck, left shoulder blade, arm, hand, fingers, it mimicked the pain/route of my injury C6 &C7 work injury, pain and soreness at injection site, very tired and generally not feeling well.  I have felt worse with each dose and the booster was the worst.  I have not felt myself since
Headache, CoughWheeze, arm pain, body aches (unspecified), weak, fatigue Narrative:
Patient described bruise on left arm that was adminstered both Fluzone high dose and Prevnar and still has mark as of 11/2/2015.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on 04-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient experienced local reaction: looks like bee sting, raised red dot, sore, systemic reaction: sore throat, headache he, feel tired and cough. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Pt states size of softball then decreased in size to size of hardball over a week.  Still lump seeking treatment.
pain at injection site (5 on 0-10 scale) for first 48 hours. no swelling. Headache at hour 6 (5 on 0-10 scale).  ibuprofen 400 mg P.O. overall tiredness for first 48 hours
I experienced fever, chills, muscle pain and fatigue. Took 3 doses of ibuprofen over a span of about 18 hours. Symptoms just went away about 36 hours after I received the vaccine.
Patient reported reaction once she arrived to clinic on 9/21/22 for dose #2. She stated she noticed soreness, swelling, itching and warm to touch. She sought no medical treatment, but did take Tylenol and rubbed Benadryl cream on the site to help with the itching.
high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml; high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 7-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), UPPER RESPIRATORY TRACT INFECTION (medically significant), outcome "unknown" and all described as "high incidence of upper respiratory infections/IgG antibody levels and the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: 0.3 ug/ml, notes: the following serotypes (3, 5, and 14) were less than 0.3 mcg/ml.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between lack of effect (upper respiratory tract infection serotype 3,5,14) with PREVNAR 13 can not be fully excluded.
Rash/hives appeared 12-24 hrs after vaccination. Treated with antihistamines.
On 15 June started to develop headache and malaise.  On 16 June went to ER for 8/10 headache, vomiting, malaise, myalgias, fatigue, and slurred speech; head CT normal.  Was treated with toradol, Fioricet and phenergan.  On 17 June, headache improving to 4/10 with meds.  NO evidence of encephalitis.
received the flu shot at the end of September and then 9 days later she received another dose with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old female patient who received the Influenza Quadrival A-B Vaccine [Fluzone Qiv] at the end of September and then 9 days later she received another dose 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 Covid-19 Vaccine (Covid-19 Vaccine) for Immunisation.  On 22-Sep-2023, the patient received 0.5 ml (Dose 1) of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT8091NA) (Expiry date: 30-Jun-2023) (Strength: Standard) (Frequency:  Once) via intramuscular route in the left deltoid for immunisation. On 06-Oct-2023, she also received Dose 2 of the same vaccine (lot number: UT8144KA) (Expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization.  On 06-Oct-2023, patient received the Influenza Quadrival A-B Vaccine at the end of september and then 9 days later she received another dose with no reported adverse event (extra dose administered) (latency: 14 days).  It was reported, Practice manager calling regarding FLUZONE QIV NP. Caller stated that they had a patient who received the flu shot at the end of September and then 9 days later she received another dose. Caller stated that the Patient did not present any AEs. Caller would like to know if there is any information regarding patients receiving a second dose of the Flu vaccine. The practice manager reported that the error occurred due to the child was visiting the clinic to only get the COVID vaccine due to having the flu vaccine already; that on that day of 06Oct2023, the prescriber deleted the flu order on their end but the system end of the nurse who was giving he vaccine did not see the deleted order; that the nurse did verify with the parent that the child was to get the flu and COVID vaccine; that at this time when asking the parent about what the vaccines the child was screaming; that the parent said yes and the child got the COVID vaccine and then another Fluzone Quadrivalent Np dose.   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.
Pt is nonverbally autistic. When reconciling the vaccine form, pharmacist helped fill in questionnaire. When guardian stated that he met criteria for booster dose for Pfizer dose, pharmacist misread date of birth as 2002 and not 2005. Pt is 16.
Pt reports the following reactions that started 24 hrs after receiving the 1st dose: Heart racing; Facial flushing; skin tenderness; bilateral jaw pain; soreness at the injection site
1 day post dose she had nausea stomach upset sore arm. 10/18/21--patient developed Hives on arm and torso.
Burning; hot; Pain; A spontaneous report was received from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning(Injection site pain), hot(Injection site warmth ), pain(Pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (batch number: 029120A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Mar 2021, the patient experienced the event(s) burning, hot, pain.  Treatment details included Ice pack, heating pad, Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event(s), burning, hot, pain was unknown.
Skin on face, neck and back broken out. Blister on one finger. Stuffy sinuses.
I was awaken by a fast heart beat, that made me completely fearful and then I developed diarrhea.  I took 2 (two) Bayer aspirins, waited  2 hours and took 2 more aspirins.  Later, I took Tylenol for pain.  I'm still experiencing a little tightness.
Due to past Moderna 2nd shot reaction was on stretcher for shot. No reaction after 30 minutes. After 45 minutes scalp numbness occurred.  After an hour scalp, head, side face and eye area was numb and tingly. Slight headache. This continued for 6 hours and began to subside. 8 hours after shot no longer had numbness.  Fatigue, muscle aches and pain began after 12 hours from shit and lasted 24 hours total. All symptoms gone after 24 hours.
Symptoms began in mid-May.  Aphasia, swollen lymph nodes in neck and right foot, severe lethargy (noticed and commented on by family and co-workers).  Mammogram (routine) in August shows swollen lymph nodes in upper right chest area.  September 2021 brief intermittent dizzy spells, with jolts down arms - near constant some days, other days no spells.
Patient felt dizzy and blacked-out five minutes after receiving the influenza vaccine.  His mother was standing beside him and was able to catch him and prevent him from falling.  His extremities were diaphoretic. Blood pressures were 108/80 (left arm, seating) and 110/78 (left arm, supine).  Emergency service arrived but patient recovered and did not require hospitalization.  Patient was advised to take Benadryl 12.5mg every 4 to 6 hours if he developed a rash.
Pt received Hep B #2 at our office on 10/3/12. Retrd to office 10/8/12 with red swollen arm  and tender lymph node in axilla (L) side. Had same reaction 03/12 after receiving Hep B #1.
BLURRED VISION; BODY ACHES; FEVER; MUSCLE ACHES; TIREDNESS; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-MAY-2021 17:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-MAY-2021, she had injection site soreness (described as soreness around where she got the shot), then was okay during the day and night and had no immediate reaction. She also felt tired. She had usual side effects but on 11-MAY-2021, was experiencing blurred vision at the report time. On 11-MAY-2021, she started with fever. There was no measurement of fever but had all symptoms of fever, body aches and muscle aches. She had to do some work and did not rest then started with blurry vision. She had heard that it was a more dangerous side effect. She also did not have her vaccination card on hand and could not share the lot number or expiry of the vaccine. She indicated she would find it and call back. The caller was asking for advice on how to manage the blurred vision. She was advised during the call to seek the attention of a health care provider. She indicated that she had already contacted a pharmacy and was told to contact the vaccination provider. She was not able to obtain help. She did not know any providers in the area as she was a visitor.  The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from blurred vision, and the outcome of body aches, injection site soreness, fever, muscle aches and tiredness was not reported. This report was not serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
The day after receiving the vaccine I had enlarged lymph nodes on the same side as I received the vaccine. I went to see my PCP, he told me they should go away two weeks later they were still there, he did an ultrasound and found that the swelling was still there. He sent me to see an ENT. He looked at the lump by using a camera through my nose down my throat he told me it was nothing to come back in three weeks. I was not happy with this answer, I went back to my PCP who referred me to another doctor who told me I should have come to see him sooner. The mass has gotten larger and continues to grow, I ended up in the emergency room I have been told I have stage four cancer.
pt recv vax 3NOV94; approx 2 wk later 16NOV exp generalized urticaria; not seen by MD (reported to MD by grandparent); environmental factors r/o; hives lasted approx 5 days; pt recovered; h/o hives in the past w/Duricef;
I felt a tinge in my left bottom molar when the shot was injected. Later on in the evening my tooth started hurting. I think it?s related to the shot.
This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. First time caller got second covax and for 12 days the patient had a headache and weakness on left side slowly fading. She stated she saw 2 HCP and they said nothing was wrong with her. She was asking if this was normal to feel this way after the vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.