chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a healthcare professional on 02 October 2014. A 92-year-old female patient, whose medical history and concomitant medications were not reported had received an intramuscular dose of FLUZONE HD (batch number U5015BA, expiration date, site of vaccination and dose number was not reported) on 30 September 2014. The patient had experienced increased BP, increased BP and heart rate on 30 September 2014. The patient required emergency room or doctor visit. Laboratory investigation and corrective treatment was not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the adverse event was recovered. Documents held by sender: none.
Significant back pain, unable to get out of chair; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 10Feb2021 at 15:45(at the age of 73-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included clopidogrel bisulfate (PLAVIX) and simvastatin (MANUFACTURER UNKNOWN) taken for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 20Jan2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 12Feb2021 at 13:00, the patient experienced significant back pain and was unable to get out of chair. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant back pain and was unable to get out of chair were recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Pt recvd 1 dose of Engerix-B & 3 hrs p/receiving vax devel h/a & hot & cold flashes; tx unk;
Second Dose Administered 18 days after the First Shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Significant FU Correspondence mail - Patient stated no adverse reactions.
On 05/05/2015 my son completed his Dtap series (4 vaccinations, the final one given after my sons 4th birthday). On 05/09/2016 we went in for his 5 year check up and were told he needed yet another Dtap. I explained I did not want to give him another vaccine. The physician pulled his vaccine records from website and stated he needed another one. She made a mistake and was incorrect. His vaccine records accurately reflected his completion of this series but she vaccinated him again anyway. He did not need a 5th Dtap. As a result the recommended CDC guidelines were not followed and overdose occurred. The same week of his vaccination, two days after the injection, he started wetting the bed. He hadn't wet the bed since he was 2.5 years of age. This progressed over several weeks and also began to include weight loss and extreme thirst. He was subsequently diagnosed with Type 1 diabetes in August 2016. On the day of the vaccination his urine screen for diabetes was negative, he had no history of issues regulating his blood sugar and there is no family history. His HgbA1C on 08/17/2016 was approximately 9 indicating his sugars had been elevated for several weeks-3months prior. It is reasonable to assume a temporal relationship to his vaccine overdose and the development of this autoimmune condition.
There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-Nov-2021 Contains patient identifiers
Onset, w/in 24 hrs, of fever, abdo cramps, diarrhea, ataxic gait, spatial disorientation, bilateral babinski reflexes, vertigo; Seen by MD 12MAY; had MRI 13MAY neg for tumor, MS: cranial nerves clearly seen; dx viral synd;
Otherwise healthy, non-smoker male quickly (next day) developed myocarditis type symptoms, as well as soreness in area of injection (left gluteus). Irregular, high heart rate (130 bpm resting), low blood pressure, shortness of breath, loss of endurance and libido, and general weakness and fatigue. Conditions persist to the present in somewhat lesser forms.
33-year-old female who now presents with some chest tightness, numbness, tingling lightheadedness. The patient was having anormal morning, went to get her first dose of the COVID-19 Moderna vaccine. She got the vaccine, was observed for 20 minutes, left, then about 45 minutes after the dose she started to feel lightheaded. She had some numbness tingling over her face and hands. She felt some tightness in her chest. She felt lightheaded dizzy. She was able to drive back to where she received the vaccine. They contacted paramedics and she was transferred here. The patient denies any swelling anywhere, rash, fevers, chills, difficulty breathing. The patient does have a history of having COVID-19 in September of last yr
Dizziness, spinning world, memory issues, ringing ears, hearing loss, double vision, extreme waves of tiredness
Information has been received from a physician concerning a 22 year old female patient who in approximately 2008 ("about a year ago") was vaccinated with the first dose of GARDASIL at a different physician's office.  In approximately 2008 ("after receiving the first dose") the patient had experienced nausea and dizziness for about 24 hours post vaccination.  Subsequently, the patient recovered.  The patient sought medical attention via seeing physician.  Additional information has been requested.
Heart rate increased to the 200s, arms and legs went numb, hallucinations, and chest pain within 24 hours of both shots. I am now on a heart medication for the remainder of my life, at 23 years old.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In March 2015, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PATIENT WAS GIVEN SPIKEVAX (MODERNA COVID VACCINE) AND AS SOON AS NEEDLE WAS WITHDRAWN, PATIENT'S ARM STARTED BLEEDING AND SWELLED UP. PATIENT WAS GIVEN BANOPHEN 25MG TABLET AND MONITORED FOR 20 MINUTES TO REDUCE SWELLING. NO OTHER SIDE EFFECTS. NO  THROAT SWELLING OR HIVES. PATIENT STATED SHE FELT FINE. WILL FOLLOW UP IN THE NEXT COUPLE OF DAYS TO SEE IF SWELLING GOES DOWN OR IF ANY BRUISING OCCURS.
LMP 6/1/2021 EDD 3/8/2022 FETAL DEMISE AT 22 WEEKS AND 3 DAYS. PATIENT WILL BE UNDERGOING INDUCTION OF LABOR AT A SPECIALTY HOSPITAL.
fall from bed; sustained a bruise on the side from the fall; scalp was tender; arm soreness; extreme fatigue; dizziness; loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), CONTUSION (sustained a bruise on the side from the fall) and PAIN OF SKIN (scalp was tender) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue). On 10-Nov-2021, the patient experienced FALL (fall from bed) and CONTUSION (sustained a bruise on the side from the fall). The patient was treated with PARACETAMOL (TYNELOL) on 10-Nov-2021 for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) on 10-Nov-2021 for Pain, at a dose of UNK, one time dose. On 10-Nov-2021, DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue) had resolved. At the time of the report, CONTUSION (sustained a bruise on the side from the fall) outcome was unknown.            Concomitants of the patient includes only vitamins.  Patient also applied topicals to the bruise as treatment.   This case was linked to MOD-2021-384343, MOD-2021-384309 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non significant follow up contains no new informataion
Pt had vomiting, body aches, arms felt heavy on Saturday AM 8/5/04. Noticed hives on upper left arm Sunday AM 8/6/04. Gave pt Benadryl OTC on 8/6/04, all sxs resolved by 8/7/04 when I spoke with pt's mother.
Patient stated that originally had 2 separate red whelps below injection site that merged into 1 large whelp about 3-4 inches below injection site.  Site is hot to touch and sore
Polymyalgia rheumatica; High level of C-Reactive Protein in the blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "High level of C-Reactive Protein in the blood". The patient underwent the following laboratory tests and procedures: C-reactive protein: High level, notes: High level of C-Reactive Protein in the blood; labs: no antibodies, notes: The labs show no antibodies from the vaccine. Clinical details: The patient had the series of the vaccine plus 2 boosters. The labs showed no antibodies from the vaccine. The patient developed a condition called Polymyalga rheumatica. High level of C-Reactive Protein in the blood. When patient even received a flu shot had a flare up of the condition.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
10 days p/ receiving vax developed fever & aching. 11 days p/ vax developed red spots mainly on face & neck. T = 100.
Patient reported a sore arm with redness, swelling persisting for 3-4 days post-vaccination. She noticed a mark around the vaccination site that has persisted for 28 days now (when she presented for Dose 2) and it is red around, about the size of a half dime, and an indentation into her muscle. The indentation has not gone away.
fever 101, hot arm at injection site, rash just below injection site, shooting/stabbing pains starting in feet and going up legs, headache, tired feeling.
Severe allergic reaction requiring ER visit with epinephrine.  Had a Flu shot an Tdap at the same time. Not sure which was the cause. Hives, swelling, shortness of breath. Works in the ER, so was working when happened, quick response.
245 pc from mom stated pt had fever & was jerking a little; mom stated was @ work; told to go to ER for possible treatment unsure of tx @ ER;
Eruption of about 100 blisters on 08/14/2001, about 150 more blisters on 09/12/2001, about 25 blisters on 09/21/2001 and severe itching with no fever.
Starting 5/14 evening, I started having tingling and pins and needles in my extremities, and that same evening, I started having shortness of breath/difficulty breathing.  I was wide awake and had a very difficult time sleeping.  I woke up numerous times hot and flushed and at 1am, I could barely breathe because my heart was beating extremely fast.  I was very scared.  I couldn't even slow my breath with meditation or breathing.  I somehow finally fell back asleep after about 2 hours, even though my heart continued to beat very fast.  I woke up the next morning naturally exhausted.  I have since experienced occasional tachycardia and frequent bouts of tingling and pins and needles particularly in my extremities.  Yesterday, 6/2, I woke up with extreme pins and needles in my extremities to the point of pain and discomfort, particularly my hands/fingers but throughout my body, and they kept up all day long and well into the night, worsening into the night.  I woke up today with less pins and needles, but there are still felt in my upper limbs, particularly my left arm/hands.
pt recvd vax; diffuse morbiliform rash 10 days p/ vax;dph  & apap given
During monitoring period post initial Pfizer COVID-19 vaccine, patient experienced headache, fatigue, dizziness. VS 141/97, P-157, O2-99% RA. Patient states she did not eat anything today and drank very little fluids prior to administration of vaccine today. Patient began to experience chills, flushing placed in Trendelenburg position. VS: 132/80, HR 105, 02 99%. Patient remained in Observation area for an extended period of time. Nurse remained with her and Mom for duration of observation. After an hour, VS: 130/85, P- 105, O2 100% RA, stated headache lessened.
Member received 0.25 ml  vaccine  Patient attested to immunocompromised so should have received 0.50
A nurse reported an unidentified child who, post vax, as part of routine childhood IZ's since 1998 and subsequently, developed mercury poisoning. This event is considered "medically important". The reporter declined to provide any additional information and declined permission for follow-up investigation.
Extreme weakness-difficult to walk or stand  Muscle/body aches Headache Shaking  Nausea Chills
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored GARDASIL. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
I have been sick for about 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6955) for 1 day as dose 2, single for covid-19 immunisation. Relevant medical history included: "Primary immunodeficiency (CVID)" (unspecified if ongoing), notes: Primary immunodeficiency (CVID). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone", notes: Hydrocodone. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, product=COVID 19, brand=Pfizer,, lot number=EN6205, administration time=13:30), when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "I have been sick for about 2 weeks". Therapeutic measures were not taken as a result of illness.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected
HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER; HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER). At the time of the report, PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) had not resolved and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) outcome was unknown.            It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-628604 (Patient Link).
1 of 2 pts vax from the same vial who exp an adverse event; pt vax 15AUG94; devel urticaria immed on leg which was injected; rx w/DPH/APAP; leg became swollen; hives progressed up the body; next, day screaming a lot-seen in ER;
On 10/4 he went to the hospital for not being able to breathe, back and felt off. They did a CT scan and couldnt find anything wrong. Sent him home  On 10/19- back to ER,  confusion, couldnt breathe then released On 10/22- back to ER for confusion, not being able to speak, heart racing, staring off into space, not being able to move, unable to speak, and couldnt remember items, went into AFIB and the released On 10/29- rushed to hospital not being able to breathe. Got to hospital low oxygen level, confusion, not being able to move, speak, remember who he is, and psychosis state.
Complaint of itching and redness at vaccination site; Observed red, warm area to back of left upper arm; firmness under skin palpated in an area of 7 x 11 centimeters; redness extends another 1 centimeter beyond firmness; Evaluated by PMD today and was told she had an allergic reaction and infection at this site; given Keflex x 7 days and once-a-day antihistimine.