chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first shot was on 02/06/2021 , the second on 03/06/2021. After the first shot, I noticed that the HGB and Retic ct abs both decreased.  Around Mar 20th, I suspected my HGB was decreasing. On March 25th, I requested a CBCD blood test.The HGB was now only 10.2.  For over the past year, my HGB had varied from 11.5 to 12.7.  Then the HGB continued to decrease to 6.9 on April 22 when a blood transfusion was ordered for the next day. A bone marrow biopsy was conducted April 14, (6 weeks after the 2nd shot) and showed CLL cells taking over the sample (see page 2 sticky note). Prior to the vaccination, the blood tests were stable. It seems the vaccination excited the CLL so now significant cancer treatment is needed.
This spontaneous reports was received from a physician and support services director and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L022795, expiration date: 05-NOV-2016; dose and route of administration were not provided). The dose of the vaccine was exposed to the following separate temperature excursion (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 8.3 degrees Fahrenheit, the second one lasting for 24 hours, with the lowest recorded temperature of 8.4 degrees Fahrenheit, the third one lasting for 24 hours, with the lowest recorded temperature of 8.1 degrees Fahrenheit, the fourth one lasting for 8 hours, with the lowest recorded temperature of 8.5 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
ONSET OF HEADACHES X7 DAYS AFTER VACCINE, HEADACHES PERSIST ON (09/17/2021)
No additional AEs/no PQCs.; HCP called in to report a temperature excursion and also reported that the vaccine, MMR- II was administered.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 01-AUG-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) lot #: U022175, expiration date: 14-JUL-2023 (exact dose, formulation, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
Fluzone Quadrivalent was inadvertently administered to a patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316262, 2019SA316263, 2019SA316286, 2019SA316289, 2019SA316290 (same reporter).  This case involves a 69 years old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  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 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.
Left upper arm pain and redness Rash left upper arm to left mid forearm  Swelling and tenderness left axilla  Swelling and tenderness left breast
Arthralgia Lightheaded, dizzy, left arm pain, radiates to left neck Narrative:
Patient education was given prior to vaccine administration. Patient refused mRNA vaccine and only wanted Janssen for a booster. After reviewing teaching given by Nursing Manager, nurse went ahead and administered the Janssen vaccine.
15x16cm area of erythema & warmth lateral mid upper lt arm;dx cellulitis lt arm secondary to Td;
Patient started feeling flushed, lightheaded about 10 minutes after vaccine. She was sweating and jittery. No swelling around throat or injection site, said the injection site was itchy after administration. Gave pt EPIPEN injection and sweating subsided, then pt complained of numbness in hands/feet, tight feeling in tongue.
11/11/99 pt wode with a rash on face that spread to arms and back. Very itchy.  Some ache in joints, red sclera on 11/16/99 and 11/17/99.  No drainage.  Saw PA at her MD's office - MMR reaction.  Tx with Zyrtec and cortisone cream.
A physician reported the occurrence of an injection site reaction in a vaccinee of unspecified gender and age who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee's medical history, concurrent conditions, and concurrent medications were not provided.  On an unspecified date in 2002, the vaccinee received an injection of Infanrix.  On the second or third day post-immunization, the vaccinee developed an injection site reaction characterized by a very large, red, inflamed spot on the injection site measuring four inches by three inches.  The injection site reaction resolved after an unspecified period of time.  The vaccinee provider considered the event to be related to Infanrix administration.  Please refer to case number A0375913A from the same source.
Dx 2/18/00 with aplastic anemia. Symptoms included increased malaise, tired, easy bruising and decreased loss of consciousness. A follow report received 6/12/2000 acknowledges receipt of signed consent form.
I had a stroke and I just had surgery. My stroke was on 8/9/2021. Well I did have a surgery, I did actually lost my speech and couldn't speak. I did have surgery on 9/23/2021. It's called the endarterectomy, the removal of plaque from corroded artery.
Information has been received from a RN concerning an adult pt (age and gender unk) with unk pertinent medical history and unk drug reactions/allergies, who, within the last week, in Feb 2006, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). In Feb 2006, the pt developed redness and swelling at the injection site. The pt's present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Terrible throat pain; Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit; Something else that did not know how to put in words; Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 15-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head). At the time of the report, OROPHARYNGEAL PAIN (Terrible throat pain), DYSGEUSIA (Taste is indescribable/mouth tasted like chemicals/ 6 month old rotten grapefruit), FEELING ABNORMAL (Something else that did not know how to put in words) and OROPHARYNGEAL DISCOMFORT (Patient felt like a metal ball lodged in the bottom of throat and moved around every time swallowed or moved head) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information were provided.  Device Date was given as 16May2022.   Reporter did not allow further contact
pt recv vax 6APR98 & devel local pain, erythema, edema extending to elbow;presented for eval @ 48hr w/sx just past peak & beginning to resolve;pred given x 2-3d;
Patient developed changes in her vision that she reported as black dots on the left side of her vision that lasted roughly 2 minutes. She said she could not see out to the left side of her eye.  This went away after 2 minutes and within 20-30 minutes she developed a severe headache and was in tears from the pain. She has no history of headaches and this has never happened before. She did not report light or sound sensitivity. She did not have any vomiting, but did not want to eat. We consulted her Optometrist and Pediatrician. I gave her Naproxen and caffeine and within 3 hours her headache resolved.
Numbness and tingling in her face; Numbness and tingling in her face; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced numbness and tingling in her face (non-serious). The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Intrauterine growth restriction of fetus without other risk factors; Pregnant Yes; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 08:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient experienced intrauterine growth restriction of fetus without other risk factors on 22Jul2021 (reported also as 4 weeks of gestation but per LMP, should be 31 weeks, for clarification). Patient's last menstrual period date was 17Dec2020. Pregnancy Due Date is 23Sep2021. No Hospitalization Prolonged. Treatment Received. The outcome of the event was unknown. Facility where the most recent COVID-19 vaccine was administered:Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event were weekly ultrasounds, possibly early delivery. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 23Jul2021.  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event intrauterine growth restriction  as the fetus was exposed to the drug. However, information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented covid-19 positive on 01/26/22 with a mix of COVID-19 pneumonia as well as bacterial pneumonia secondary to Moraxella. Pt progressed to acute on chronic hypoxic respiratory failure. This is considered a breakthrough case.
had a series of adverse events after COVID vaccination which had led to suicide; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COMPLETED SUICIDE (death), outcome "fatal", described as "had a series of adverse events after COVID vaccination which had led to suicide". The patient date of death was unknown. Reported cause of death: "had a series of adverse events after COVID vaccination which had led to suicide". Clinical course: On a routine first interaction, web based, with an HCP this morning, 09Jun2023 at 8:15 AM, they had mentioned, essentially in passing and off-topic of the conversation, that a "friend of theirs" had a series of adverse events after COVID vaccination which had led to suicide. The HCP stated that the friend had refused treatments of these adverse events. The HCP did not indicate that they wanted to formally report this event, nor did they ask for nor imply the need for any further interaction on this mention which they shared. Additionally, they did not specifically state which manufacturers vaccine had been used nor did they share any details of other medical or behavioral health issues that were occurring at that time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited available information, the causality between the reported fatal event (Completed suicide) resulting in patients death and the suspect product BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN) cannot be excluded as the reported event may have been related to patient's subjective purpose and not associated with the vaccines medicinal effect. However, on conservative basis the case is considered Related. Case will be reassessed upon receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: had a series of adverse events after COVID vaccination which had led to suicide
I received my second dose of the Moderna vaccine April 6, 2021.  The adverse reaction I experienced happened on April 28, 2021.   I was at the beach, sitting under an umbrella on a rather chilly day for 2 hours wearing shorts and a t-shirt.  Legs arms and 4x4" portion of my chest at the lower portion of my v-neck t-shirt turned pinkish from the sun after returning home.  I   have darker skin normally and tan very easily.  By that evening my chest was turning violently red and within 24 hours started to blister.  The affected area grew by the day to encompass much more skin surface than was originally suntanned.   Within a few more days blisters developed.  It was extremely painful, but I tried to go on thinking it would heal itself.  After two weeks when it was only getting worse and the pain was not subsiding I went to a dermatologist.   Was diagnosed with photo dermatitis (or a more common term-sun poisoning.)  I was prescribed a creme to apply topically and an antibiotic both for a two-week period.   It took 3 days for the meds to kick in and provide relief and the full two weeks of treatment to heal.  To this day I still have a small amount of skin discomfort where the rash was.   I have a follow up appointment with the dermatologist mid-June.   I will probably never know the answer but have to believe this adverse event is tied to the vaccine.  I have never had sun-poisoning in my life and have always tanned without incident.   I am reluctant to venture back into the sun as I suspect I have developed a sensitivity to sunlight.
urinary tract infection; 21Feb2021 tested positive for covid-19; 21Feb2021 tested positive for covid-19; had been sick and got sicker; This is a spontaneous report from a Pfizer-sponsored program  via consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 (Solution for injection, Lot number EL9262) on 26Jan2021. The patient experienced for a couple of weeks not feeling well with headaches, shortness of breath and congestion. On 21Feb2021, the patient tested positive for covid-19. Patient has been in bed and sick ever since. He has been sick for a total of over 3 weeks. Between 16Feb2021 and 22Feb2021 he had been sick and got sicker. The patient asked if it is ok to get the second dose on 09Mar2021. The events were treated with an antibiotic for a urinary tract infection. The outcome of the events was unknown. The patient was unable to make it back for the second vaccine on 17Feb2021 due to weather and power outages in his area then got the Covid virus during that time which postponed the second vaccine for the second time. They rescheduled the second dose for the following Monday, 22Feb2021. The patient underwent lab test which included COVID-19 test and the patient was tested positive for COVID-19.
IRRITABILITY; MEDICATION ERROR. Information has been received from a registered nurse concerning a healthy 12 week old female infant with no past medical history and no known drug allergies who at birth, in July 2003, was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. Subsequently, the patient received a second dose of the vaccine 2 weeks later at a physician's office. The infant was fussy for a day or two after the second injection. No further information or lot number was available at this time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Red itch bumps all over the body few at a time appeared and got better. Got better with 300 mg/day Diohenhydramine HCl tablet after two weeks
Patient developed difficulty swallowing and then difficulty speaking in July of this year. She had multiple medical visits for this and saw a neurologist for extensive workup.  In September, she developed lower extremity weakness which progressed to upper extremity weakness. Her weakness worsened, and progressed to include difficulty breathing, for which she was intubated. After intubation, the patient was diagnosed with Myasthenia Gravis. After several days of treatment with IVIG, her strength improved and she was able to be extubated.
Patient was seen in ED on 03/12/2021.  Symptoms included fatigue and weakness, she was flown out to hospital. She passed away on 03/14/2021 in hospital.
Almost immediately after the shot I became extremely thirsty well after the 20 minutes of waiting and we left I started feeling a little strange I am nauseated light-headed we were walking I just felt generally ill this was in 30 minutes within the hour I was trying to get in my bed I couldn't bend my knees it was causing me extreme pain in my joints it was very lethargic fell asleep right away just kept telling my son I did not feel well also became extremely itchy after the first 20 minutes itchy all over my body now it's been 24 hours a little more than that I am still extremely itchy very thirsty cannot get enough to drink but my nose is stuffy my joints and muscles hurt I can't seem to have enough energy to do much of anything I've been sleeping the taste in my mouth food taste weird been drinking plenty of water it almost has a metallic taste to it also feel like a numb feeling in my hands and so itchy everywhere feels like maybe a bruise where I got the shot no redness or raise bumps just itchy
1508 C/O LIPS TINGLY METALLIC TASTE MONITORED, BP 142/98 SAT 97% HR 70 1533 148/98 96% 67  1548 148/99 99% 70 1603 146/100 98% 66   Did not want Benadryl pt told family she will be driving home. encouraged to seek medical help if s/s worsen pt call for an appt with MD this week.
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. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2011, the healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by the healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.