chrisvoncsefalvay/vaers-outcomes huggingface dataset:
onset of his hives 2 months ago: started in his legs and went up to the rest of the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body). At the time of the report, URTICARIA (onset of his hives 2 months ago: started in his legs and went up to the rest of the body) outcome was unknown.            Concomitant medication of the patient was about 7 or 8 of them (not specified).  The patient ad no treatment for the symptoms. The patient would visit his doctor in coming days because a friend that had the same, told him it was hives and that their doctor prescribed them prednisone.   This case was linked to MOD-2022-437658 (Patient Link).
Information has been received from a 62 year old female who "3 weeks ago" on approximately 31-MAR-2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. "Three days after" she was given the zoster vaccine live (Oka/Merck), on approximately 03-APR-2008, the patient had a rash on both collar bones and spoke to a nurse for medical attention. "Two weeks later'" on approximately 17-APR-2008, she had a rash on her thighs. The patient reported she put a band-aid on the rash and had a reaction to the band-aid she always used. She stated she never had rashes from the band-aid and never had rashes in general before. Subsequently, the patient recovered from the rash on both collar bones and rash on her thighs. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the patient. She reported that the physician "did not see the rash", she only reported it over the phone. Additional information is not expected.
Symptoms described as "COVID Arm". Injection site is red, raised, and hot to the touch. Rest of arm cold.
Reactivation of shingles 8 days after Covid-19 vaccine #3.  10 day treatment with Valacyclovir 1 gram, TID. Shingles resolved. Same thing happened after Covid-19 vaccine #2 Feb. 2021. Also, I experienced extreme hair loss after Covid Vaccine #2 and #3. Hair loss began to resolve by the time of Dose 3 and hair loss is starting all over again after dose #3.
Starting April 1 of 2021, I had numbness from nipple line down (decreased sensation not full paralysis) more so on the right side of my body than the left. It lasted for 2 weeks. I was able to see a NP at my primary care doctor's office on 04/08/2021 and they did blood work and scheduled me for an MRI. My first MRI done was 04/19/2021 and they saw lesions and sent me to neurology. I saw the neurologist on 08/03/2021 and they started working me up for MS. At this time, they do not have any definite answer. I had a second MRI done on 08/26/2021 which showed some lesions present and the one that he thought caused the event was not present. However, he felt like some of the other lesions had progressed so they are continuing to do tests. They just did a lumbar puncture at the end of 03/2022. I will follow back up with the neurologist at the end of 04/2022. He is unsure if its related to a one and done event or something else.
While being observed in waiting area, patient reported that she felt as if she was going to pass out.  Patient was then lowered to the ground by 2 medics in which patient  briefly passed out.  Patient was taken to medic area where she informed that she ofter has syncopal episodes.
Pt refers to pain in the area of injection since Monday 6/18/18 presenting inflammation, hot to touch.
Random pain on side of left breast. Stabbing at times then goes away; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 at 12:30 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Mild HTN. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 12:30, outcome "unknown", described as "Dose received: 3"; BREAST PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Random pain on side of left breast. Stabbing at times then goes away". The event "Random pain on side of left breast. Stabbing at times then goes away" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether any therapeutic measures were taken as a result of the event Breast pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. About 2 weeks after booster started with random pain on side of left breast. Stabbing at times then goes away. No lumps or other breast changes noted. Appointment to see gynecologist and had mammogram. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) for Blood cholesterol abnormal, LOSARTAN for Blood pressure high, DILTIAZEM HYDROCHLORIDE (MATZIM LA) for Hypertension, METFORMIN for Type 2 diabetes mellitus.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VERTIGO (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after), DIZZINESS (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) and BLOOD PRESSURE FLUCTUATION (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after). At the time of the report, VERTIGO (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after), DIZZINESS (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) and BLOOD PRESSURE FLUCTUATION (vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after) outcome was unknown.      Other medication include Sinteroid.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
I came home after my 15 min wait time. I got in the shower,  I felt my face burning (no  water or soap on my face). When I got out of the shower, and I looked in the mirror and I saw my face was red and bumps were on my entire cheeks and started to go down to my chin, and nose,  all the way to my neck, under my chin. It felt like my face was on fire. I then called Urgent Care. I sent pictures to her, she advised I took Benadryl. I took another picture and it was getting worse. I  was completely exhausted and was very sleepy. I took 50mg of Benadryl , and Urgent Care instructed me to take 10mg of decatron, with the Benadryl and when I woke up 4 hours later,  I looked and my face was red, but had significantly improved. I had some bumps still but the redness had subsided.  When I woke up about 4 the last time,  there was just bumps. The next two days later every thing was completely resolved
patient reports fevers, malaise and headaches since receiving her first shot on 3/30/21.   Tolerated the first shot on 3/9/21
I immediately had an achy left arm, at the injection site, which worsened as the evening came.  At 8:00 p.m., approximately 7.5 hours after receiving the vaccine I began to feel fatigue and just "not right".  I awoke at 2:30 a.m. feeling hot, with indigestion.  Then I developed chills and was very cold, and slept little.  At 7:30 a.m. I checked my temperature and had a low grade fever of  99.5 degrees F.  At 8:12 a.m. I still feel chilled and rather nauseated.  I'm sure I'll be ok, and I'm grateful for the vaccination.
Pt received Pfizer vaccine x2 doses. Pt admitted for COVID on 8/12/21 and being currently treated with remdesivir and dexamethasone
To ER on 1/2/03 after blacking out in car-mom was driving-ER ordered blood panel-wnl. Saw PMD on 1/3/03-"nothing obvious going on." 1/8/03 blacked out in room while talking on phone. Taken to health center. More blood work done-wnl. EEG on 1/13-not conclusive. Reordered EEG done on 1/24/03 wnl. Will see neurologist-appt pending. Has had many episodes of feeling faint/weak. MRI on 1/21/03 also normal. Mom reports pt's father left home within past year. Mom in process of moving our of family home of 10 yrs due to toxic mold.
Severe Head/Neck ache Body Aches Fever  (101 - 102) Hard Chills Nausea All Fingers were cold to the touch and severely aching (felt as though they were frost bitten) Fatigue
Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 13-SEP-2013, the patient was vaccinated with an expired 0.5 ml, subcutaneous dose of VARIVAX (Merck) (lot number 1244AA, expiration date 01-AUG-2013). No adverse effect reported. This is one of several reports from the same source (MARRS #1309USA012898). Additional information has been requested.
Received DTaP 07/16/2002, hives occurred next day. Swelling noted on 2nd day post immunization eyes swollen, difficulty with breathing, taken to ER MD stated to give Benadryl. GND gave him shot.
Received my first dose of Pfizer BioNTech on October 7, 2021 and missed my expected period (10/13-10/18) completely. I got my period today 11/8/21 after missing the full month of October. I have on time, consistent, and accurate periods until receiving the vaccine and I believe this is something that needs to be discussed and acknowledged instead of brushing it off to the public like always.
12/8/21 pt admitted to the local Hospital with right humerus fracture after a fall; surgery done; 12/28/21 pt tested positive for COVID; placed on BiPAP and eventually required intubation; pt coded, ROSC after 15 minutes; transferred to another hospital in multisystem organ failure with AKI, refractory shock, shock liver, AHRF, severe metabolic acidosis; pt coded again, ROSC after 3 mins; pt status then changed to DNR; went into asystole and passed away in the hospital
Patients come after 6 months for their 2nd doses; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced incomplete course of vaccination (Verbatim: Patients come after 6 months for their 2nd doses). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The reporter would like information around the 2nd doses Shingrix data outside of the 2 to 6 months interval. The patients were coming back after 6 months for their 2nd doses of Shingrix and the nursing team wants to know  if the series must be re-started. The vaccine administration facility was the same as primary reporter. No additional information available and unknown if follow up was permissible. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Two days post first covid dose I developed Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: Not reported), via an unspecified route in the left arm on 02Mar2021 at 13:30, as a single dose for covid-19 immunization. Medical history included polycythemia vera and prostate cancer. No known allergies have been mentioned. Concomitant medications included telmisartan, carvedilol, hydroxyurea and levetiracetam (Keppra). Historical vaccine included shingrix vaccine series in 2018. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, patient has not tested positive for covid. After vaccination, patient has not been tested for covid. On 04Mar2021 at 10:00, two days post first covid dose, patient experienced Shingles. Patient received unknown treatment for the event. The clinical outcome of the event was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient had routine lab work done due to an upcoming endoscopy she is to have for her dysphagia.  She was found to have a potassium 2.2 and so was directed to the ER.  Patient's magnesium level is normal.  Today her potassium level is 2.3.  Patient states this happened to her in the past and it is all related to her diarrhea.  Her diarrhea in turn is related to use of naloxone which she takes for her alcohol cravings.  Patient has been sober for 2 years now.  Patient has received 40 mg p.o. potassium so far, she is currently receiving another 40 mEq via IV.  EKG with no significant changes.  Patient is also COVID positive but did not have any clinical signs or symptoms of active disease. Discharged on 11/19/21
PT developed fever and myalgias 5 days subsequent to vax. 7 day post vax developed papular trunkal eruption. Rash waxed and waxes over next 10 days w/few vesicles. All symptoms stopped on 21st day when scab fell off.
On 6/16/00 the pt received HepB #1 and the Meningococcal Vaccination in preparation for college entrance. On 7/17/00 the pt suffered a seizure and has been exempt to further Hep B vaccinations and influenza vaccinations since. Past medical history reviewed with patient. The pt reports and the medical records indicated that on 7/17/00 the pt woke with a headache. She took ADVIL without relief. She then took a nap. Her mother noted the pt to be confused with some involuntary movements of her face when she awoke. She decided to take her to the hospital. On the way, the pt had a generalized tonic-clonic seizure without tongue biting or urinary incontinence which lasted for 45 seconds. In the ER she was awake but confused and disoriented. She was afebrile. The pt had no history of headaches, head injury, febrile illness, history of alcohol or drug abuse or FH of seizure disorder. According to the medical record the pt had a CT of the brain which was negative; an MRI of the brain which was negative and an EEG which showed a mild degree of dysrhythmia with a mild degree of intermittent generalized slowing. She was treated with anticonvulsants for 18 months and was tapered without further seizures. The pt has had "stress induced" migraine headaches since that time which she treats with rest with relief of her symptoms. The pt had a Td on 12/1/08 without adverse event. Per the patient she had a Hepatitis B titer drawn 1/07 for employment as a contractor which was negative. 2/10/09-records received for DOS 7/17/-7/18/00-DC DX: Generalized seizure possibly due to comples partial seizure, etiology could not be detected. Woke disoriented and nonfocusing then noncommunicative staring. Generalized seizure and completely unresponsive. Postictal upon arrival  to ED.
drooping in face; slurred speech; left arm clumsy; This is a spontaneous report from a contactable consumer received via Pfizer sales representative. This consumer reported the same events under the same suspect product for three patients. This is one of three reports. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced (left side) drooping in face, slurred speech and left arm clumsy. Outcome of events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606004 Same reporter, drug and events; different patient;US-PFIZER INC-2021606117 Same reporter, drug and events; different patient
Reaction occurs since 6 months of age: Parents presented with their 2 year old daughter to discuss concerns about recurrent nodules to bilateral legs following routine vaccinations and ROCEPHIN. They advised she has a history of developing large nodules to all injection sites on bilateral thighs/hips since receipt of 6 month old vaccinations. Nodules will form immediately and increase in size over the next few weeks or can begin a week later and grow. Nodules are described as firm, non-tender, non red, non itchy from pea size to oval shaped1x2x5 cm shaped. Warm baths/heat to area's does help resolve the reaction for some nodules while others persist for weeks. She has has 2-3 nodules develop pimple like white heads that popped with clear drainage. One area to left upper outer thigh did turn red and drained puss resolving with use of antibiotics. Mom advised she has noted nodules in areas not vaccinated at. Mom advised she had no fevers, fussiness or other systemic reactions other than the site reactions following vaccinations. Parents advise they have spoken with several other providers on this issue before referred to Agency. Symptoms: Local swelling, mass &lump,head(R220). HCP notes: 17 month old F who has developed subcutaneous nodules to both thigh after receiving vaccines. Mother states that the nodules do not appear to be painful. Denies developing nodule in areas where she did not receive vaccine. She got her 15 month shots since last seeing me and has a small nodule to the area with no overlying reds or increased warmth to touch. Reviews of her lab work showed a low IgA level with a normal IgG and IgM. Labs to evaluate complement system (IgA/IgG/IgM, AH50, ANA, CH50, Vit D, CBC, Chem panel) were within normal range. DHR test was not c/w Chronic Granulomatous disease. She had an order place for an ultrasound but has not had that done as of yet. 2/23/2016 US thigh: Impression: Findings as above most consistent with post injection hematomas. No skin induration or discomfort to specifically suggest a superimposed infection. Subcutaneous masses to anterior right and left thighs.
got a different pneumococcal pneumonia strain; got a different pneumococcal pneumonia strain; This is a spontaneous report received from non-contactable reporter (Nurse) from a sales representative.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 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 (hospitalization, medically significant), PNEUMONIA PNEUMOCOCCAL (hospitalization, medically significant), outcome "recovering" and all described as "got a different pneumococcal pneumonia strain".  Clinical course: the patient got Prevnar 13 and got very sick, he ended at the hospital. Reporter thought that baby got a different pneumococcal pneumonia strain. Patient was doing better now. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative serotype results and vaccination schedule are needed for full medical assessment.
Pain in arm; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30(at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021 at 00:00, the patient experienced arm pain, headache and 100 degree fever. The patient did not receive any treatment for the adverse events. On 13Apr2021, the patient underwent body temperature test and the result was 100 degree(units unspecified). The clinical outcome of the event arm pain, headache and 100 degree fever were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Upon completion of the immunization the injection site began bleeding excessively.  I applied pressure to the site with sterile cotton balls until the bleeding slowly subsided and applied new bandages over the site to control any further bleeding.  The patient was an associate here at the store she said she was having no ill effects from the bleeding or the immunization and felt fine to return to work. I advised her to return to the pharmacy before leaving at the end of her shift (which she did approximately 3 hours after the immunization was completed) and I re-cleaned the area following all universal safety procedures and applied a new bandage.  There was no further bleeding at this time nor was the area inflamed or discolored.
ANTI-HBS ANTIBODY NEGATIVE; WHITE BLOOD CELL COUNT DECREASED. Information has been received from a registered nurse concerning a 42 year old white female non smoker with no known allergies who on 05-NOV-1998, 08-DEC-1998, 07-JUN-1999 and 13-MAY-2003 at 09:00 was vaccinated intramuscularly in the left arm with a first, second, third and a fourth booster dose of hepatitis B virus vaccne rHBsAg (yeast), (lot number 624329/1225E and 623395/0429M), respectively. There was no illness at the time of vaccination. In May, 2003, "routine labwork" revealed the patient had a negative titer, also reported as "no immune titer" and a "low WBC count". Additional information is requested.