chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a growth on my inside of my right big toe; I called it a tumor; Intravenous in the arm/Inappropriate route of vaccination; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ3268) intravenous, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "Smoke cigarettes" (not ongoing), notes: I was smoking 2 packs of Marlboros a day. Concomitant medication(s) included: MECLIZINE [MECLOZINE]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EN6200), for COVID-19 immunisation, reaction(s): "Intravenous in arm/Inappropriate route of vaccination"; Bnt162b2 (DOSE 2, SINGLE, Batch/lot number: FJ8157), for COVID-19 immunisation, reaction(s): "Intravenous in arm/Inappropriate route of vaccination"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Intravenous in the arm/Inappropriate route of vaccination". The following information was reported: NEOPLASM (non-serious), outcome "unknown", described as "Had a growth on my inside of my right big toe; I called it a tumor"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Intravenous in the arm/Inappropriate route of vaccination".  Additional information: Patient had discovered a plant that when a proper catalyst was used it made a compound, a new compound that, one, it stopped the desire to smoke cigarettes and tobacco, it took the desire away completely. Patient used it topically. A new compound that did certain things, it definitely stopped the desire to smoke cigarettes 3 to 5 days. Patient was smoking 2 packs of Marlboros a day and tried to quit and didn't and then made some inquires and found this wonderful plant. Patient called it the leaf of life but that not what the withheld call it. Patient had all 3 shots and booster and it worked, Patient had a wonderful experience. There was only one time somebody stuck the needle in patient's arm to near the bone but otherwise the vaccine was great. The third dose LOT was FJ875 patient could not tell the last number was 1 or 7. Patient had 4th Pfizer shot (COVID 19 Vaccine) also. The 4th one that was listed on the other one was G looked like J3268. The first two doses were given at patient's residence. The third and fourth in the withheld. The two of them on the withheld.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263549 Same Patient/Product, Different Dose/Event (Dose 1);US-PFIZER INC-202300263551 Same Patient/Product, Different Dose/Event (Dose 3);US-PFIZER INC-202300263550 Same Patient/Product, Different Dose/Event (Dose 2);
According to school nurse, child has red, swollen, hot area on (L) arm size 11 cm x 11 cm. Spoke with father on 3/3/17, reports unsure when arm reaction began went to ER today. Was advised to put warm cloth.
After about a week of receiving the above COVID booster shot and Flue shot, blood sugar levels starting rising and have been extremely difficult to remain at desired levels, despite no changes in diet, exercise, etc.  Condition still exists.
Left upper arm swelling, warth, redness, pain, blister at injection site (unsure of time of onset/time entered because had to put something to proceed in computer).
Patient called this afternoon to report decreased oxygen levels after agency.   Patient reports to have COPD and remains on oxygen. He reports after the administration his oxygen levels will dip as low as to 70 percent when oxygen is removed. Upon speaking to the patient he did admit to feeling bad several days before the administration in which he had a physician's office visit due to complaints of chest pain. The patient said the physician preformed x-rays and EKG to evaluate his symptoms. All test reported no abnormal findings. The physician changed his breathing medication and added steroid therapy for a few days to help him recover. This apt occurred on Tuesday 23rd. The administration occurred on Friday 26th. The patient said they experienced the "trouble breathing" during the weekend. He contacted his physician again on Monday the 1st and reported the vaccine had made him worse. Unfortunately he contacted them at 4:15 in the after before the office closed and they told him to report to the ER if he was in discomfort. He called me today the report the issue at 4:30ish. I was able to reach out to his pulmonary physician to confirm his therapy and previous apt and complaints.  They instructed me to tell the patient to make an appointment if needed.   The patient does not fill medication here. On the vaccination form he denied feeling unwell as well as denied the use of steroid therapy.
By 7:00 PM patient was acting erratically. She was unable to operate a phone or TV. She was wandering into other people's homes. She did not remember where her home was or what her family members looked like. Dr. drew blood and plans an MRI. He prescribed Donepezil and Trazadone.
Began with a very painful arm which I could not use, especially for reaching. It has been almost 8 months, still painful, but not as bad as earlier. In a day or so began to get a shingles or chicken pox type breakout on left arm. The red bumps like went down my arm then spread to other parts, abdomen, right arm, legs. It is now on my feet and toes, and between my toes. Itches like crazy.
a 2nd dose of both was administered after a week; 2nd dose Boostrix received after expiry date; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2022) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT) and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 21st November 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 21st November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered and expired vaccine used. On an unknown date, the outcome of the extra dose administered and expired vaccine used were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The reporter called to reported a maladministration of a dose of Flulavsal and Boostrix to a patient, with the first dose given 1 week ago. The reporter gave information for the Boostrix vaccine but not the Flulaval vaccine and also information about the patient. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient received an extra dose of expired Boostrix and Flulaval, which led to extra dose administered and expired vaccine used.
Stroke, weakness on left side of the body, in rehab now. Too soon to tell if patient will regain use of left side.
8/18/2021 client received an expired dose of Moderna. rml 10/4/2021 3:29 pm called patient, is unavailable, left message to return call. rml 10/18/2021 11:12 am called patient, is unavailable, left message to return call.  10/18/2021 2:15 pm Message on vaccine portal. rml 12/23/2021 2 :04pm Message sent via vaccine portal to call Public Health Office before next COVID-19 vaccine. Note left to give client a full dose of Moderna at the next vaccination visit. rml
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Developed scattered blisters over torso/legs on evening of administration. After exercise, rash resolved partially. Treated with Atarax 25 mg PO, RC cream.
No adverse effects; A patient received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant refers to a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/allergies and concomitant medications were not reported. On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005874 and expiration date 31-OCT-2020 (strength, dose and route not reported) for prophylaxis (product storage error). The storage temperature of vaccine included 33.8 Fahrenheit (F) for the time frame of 4 hours and 5 minutes. There was no previous temperature excursion. The call was made because of data logger. No adverse effects reported. No product quality complaint (PQC) present.
Severe dizziness, nausea, headache, arm pain, extreme fatigue, fever and body aching. Lasted all day. Finally abated in evening but could not eat without stomach upset. I had Covid-19 in March, 2020.  There were no tests available in my area and I was too sick to go anywhere.  I have experienced "long hauler" symptoms ever since including daily headaches, brain fog, fatigue and general malaise.
Patient received vaccine at 2:00 PM on 6/23/2010. At 3:00 PM, parent reported patient had emesis, fever, headache, and a stiff neck. Parent reported a fever up to 104 degrees F that evening. Symptoms continued through the next day and resolved by 6/25/2010.
redness; rash; Injection site swelling; lip tingling; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 2 days after receiving Shingrix, the patient experienced injection site swelling, tingling lips and rash. On an unknown date, the patient experienced erythema. On an unknown date, the outcome of the injection site swelling, tingling lips, erythema and rash were unknown.   It was unknown if the reporter considered the injection site swelling, tingling lips, erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix last week, and two days later she developed the following symptoms lip tingling; injection site swelling, redness, and rash.  The reporter consented to follow up. The reporter declined to provide date of birth.  The vaccine was administered elsewhere.; Sender's Comments: Medical assistant reported that a patient received her first dose of Shingrix last week, and two days later she developed the following symptoms: lip tingling; injection site swelling, redness, and rash. Consented to follow up.Call Notes:Reporter declined to provide DOB. Vaccine was administered elsewhere, so the lot # was not available.
punctured IPOL was administered post excursion with no reported adverse event; highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient and it was reported highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes and punctured IPV (VERO) [IPOL] was administered post excursion 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, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) both for Immunisation.  On 21-Mar-2023, IPV (VERO) [IPOL] underwent temperature excursion and it was reported that highest temperature reached 52.5 F and the total excursion lasted 1 hour 30 minutes with no reported adverse event (product storage error) (latency: unknown).  On an unknown date, the patient received 0.5 mL of punctured IPV (VERO) Suspension for injection (batch/lot number: V1B902M; V1B902M, expiry date: 02-Jun-2024, 02-Jun-2024; strength: standard; frequency: once) via intramuscular route in the deltoid NOS for immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that, the vaccines were moved to a back up fridge while the fridge was being cleaned. The caller stated that the excursion occurred in the fridge that the products are normally stored in. The punctured IPOL was administered to four patients post excursion.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Inconsolable crying, Exaggerated Startle Reflex, followed by high-pitched crying repeating every 2 min, worsening of reflux for 4 days following vaccinations.
Woke up with mild headache the morning of 9/8/23.  She began with elevated HR up to 170 that day.  Had mild chest tightness and lightheadedness also.  Had a temp up to 99.7.  Had back pain also.  Continued with back pain, elevated HR and chest tightness on 9/9/23.
was a little achy; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included amlodipine besilate (NORVASC), metoprolol tartrate (manufacturer unknown), and spironolactone (manufacturer unknown) all taken for an unspecified indication and start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as first dose, single dose for COVID-19 immunisation. After receiving the first dose of BNT162B2, patient experienced sore arm on an unspecified date. After receiving the second dose of BNT162B2, the patient was a little achy on an unspecified date. Patient took a warm bath as a result of being a little achy. The outcome of event was unknown. Causality was assessed as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Quarter size swollen painful hard lump just below injection site. Continued to increase in size. Pain and redness on area. By next morning swollen size was 6 inches by 3 inches. At 7:00 PM 1/28/2017, upper arm from top of shoulder down to 3 inches above elbow, and 5 inches across. Hot to the touch, swelling, redness, extreme pain.
This 55 year old male presents for Reaction to vaccine. Had SHINGRIX last week. Fever 104 that night. Then on weekend felt achy, cough, flu like symptoms,- sore thoat, and bloody nose from coughing so hard. Coughing yesterday. Started on DAYQUIL yesterday. Patient had full work up and workup was negative for cold/flu.
"lifted some heavy stuff and "tweaked his lower back"; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back") in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu vaccine (Route:IM) in 2021 and J&J. Past adverse reactions to the above products included Fall with Flu vaccine; and No adverse event with J&J. Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back"). On 08-Apr-2022, MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back") had resolved.            No treatment medications was reported.   This case was linked to MOD-2022-539697 (Patient Link).
: Thigh: R leg 21'' L leg 23'', Calf: equal bilaterally. L leg pain and swelling. Started after receiving the Janssen COVID vaccine on Thursday. The pain started as bilateral and then resolved. It returned on Monday in her left leg, starting in her anterior thigh and radiating down her leg. States that her leg began swelling today and had increased pain. Denies redness and heat to her leg. Pain is worse with ambulation. She states that it does not feel like the sciatica that she experienced in the past. Patellar reflexes equal bilaterally. Denies chest pain, shortness of breath. Admits to headache that has been present for a number of days and is resolving. Denis light and noise sensitivity. Neuro exam WNL.
Patient reported itchiness at injection site, arm, and back. Patient administered Benadryl 25mg. Patient vitals remained WNL. Patient reported symptoms diminished 10 minutes after Benadryl taken.  Patient observed for 30 minutes. Patient PCP notified with permission of patient.
Case number PHEH2011US00881 is an initial spontaneous report received from a consumer on 01 August 2011. This report refers to a patient of unknown age group and gender. This patient was vaccinated with MENVEO vaccine (batch number: unknown) intramuscularly on an unknown date. After vaccination the patient experienced fever. No further information was available.
There were no indication or bumps prior to 06/06/2021. Then on 06/06/2021- I noticed a raised bump above my collar bone. I went to my PCP, he ordered an ultrasound. He said it was suspicious of lymphoma, I had a excisional biopsy at the site of the bump, they took out a whole lymph node and determined it was Hodgkin's Lymphoma. And a PET scan after that determined it was stage 2 unfavorable. It was unfavorable because the size of the mass was over 10 cm. I went to 3 different oncologist and got their opinion on what treatment I should take. I preceded with and started treatment on 07/17/2021, and I go every 2 weeks. Disability yes, risk to my heart and lungs from the aggressive chemo meds.
No side effects; Patient given PROQUAD and VARIVAX at the same time; This spontaneous report was received from a registered nurse, referring to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-AUG-2023, the patient was given at the same time measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, dose, route, anatomical location, lot #, and expiry date were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, lot #, expiry date, and route of administration were not provided); both administered one time for prophylaxis (overdose). No side effects were reported.
Information has been received from a registered nurse concerning a 13 year old female who on 25-OCT-2007 was vaccinated with the first dose of GARDASIL (lot no. 659435/1265U).  On 01-JUL-2008 the patient was vaccinated with the second dose of GARDASIL (lot no. 660387/1967U).  On the same day, the patient became pale and stiff after receiving the second dose.  The patient was also non responsive and the symptoms lasted for 30-45 seconds.  The patient was recovered.  The patient sought unspecified medical attention in office.  Additional information has been requested.
devel varicella lesions-chest, back, scalp;dx made per office visit;vax given 10OCT95;
Fever up to 101 for two days. Muscle aches and cramps, stiffness, night sweats, chills , headache, loss of appetite . Dizziness within 15 min of shots vitals checked ok. Runny nose after day 3
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035885, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fever, chills, bad headache.  Just rested, symptoms lasted about 24 hours.  Was worse than any flu I can remember though.
A large, irregular shaped, raised red lump appeared at site of injection. About 1/2 the size of the palm of my hand. It became itchy the following day. It lasted about 4 days. No treatment.