chrisvoncsefalvay/vaers-outcomes huggingface dataset:
break out in "huge welts" all over her body; painful sores; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date in 2009 (Batch/Lot number was not reported) as dose number unknown, single for immunisation. Medical history included allergies to Penicillin and Sulfa. The patient previously took and had an allergy to Z pack, Nitrofur, Macrodanton, Hydrochlorozide, Ciproflaxin, Viox, and Bextra. Concomitant medications were not reported. The caller was a 74-year-old female who stated that, 12 years ago (2009), she received a pneumonia shot that caused her to break out in "huge welts" all over her body. As a result of this, she stated that for the past 12 years, she has been getting "painful sores". The patient would like to know if, because of this, she would be able to receive the Pfizer BioNTech COVID-19 vaccine. She was concerned because she stated that one of the forms that she has to fill out before vaccination asks if she has ever been allergic to a different vaccination. She stated that she has spoken to several doctors and pharmacist regarding this and has gotten mixed answers on whether or not she should get the vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Initial unsolicited report received from a healthcare professional on 25 September 2014. A 28-year-old patient, with no reported illness at the time of vaccination, received an intradermal left deltoid dose of FLUZONE ID (lot number UT4982BA) on 24 September 2014. Approximately 16 hours post-vaccination, on 25 September 2014, the patient experienced swelling of her upper lip. She also complained of itching on her body, and redness and a bump at the injection site. The patient had not received intradermal influenza vaccine in the past. She was seen by a physician; treatment and laboratory testing was not reported. Outcome remained ongoing at the time of the report. Follow-up information received on 01 December 2014 from a healthcare professional. Name of the patient's responsible physician was updated. The patient did not receive any concomitant medications. She received a corrective treatment with OTC ZYRTEC and BENADRYL. History of breathing difficulties were denied. The patient had fully recovered on an unspecified date. She did not seek further care from any physician or NP. Documents held by sender: None.
On June 13 Bell's palsy was noticed in left lip area and had lasted since then with no improvement as of yet. Follow-up with doctor on June 18
13 hours after my shot I woke up with my throat and esophagus were swollen. It felt like Someone was lightly squeezing my throat. I have a chronic GERD cough, but I cough a lot more than normal. Also, I was on my period and it made my normal cramps and low back pain much much worse. My entire lower body was in extreme pain. I usually have little to no cramps and my uterus pain was excruciating.
Sweat; High fever; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to sulfa, penicillin, clindamycin and tetracycline. The patient received PEPSID AC, multivitamin (MANUFACTURER UNKNOWN), calcium D, I (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 20:00, the patient experienced high fever until 03:00 on 18Mar2021. In the night of 18Mar2021, the patients night gown was totally drenched with sweat as were her sheets. The patient did not feel normal until 22Mar2021. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event high fever was recovered on 18Mar2021 at 03:00. The clinical outcome of sweat was resolved on 22Mar2021.   Information about lot/batch number cannot be obtained. No further information expected.
10 itchy welts on inside of left arm; one large swollen mass; elevated blood pressure and heart rate; elevated blood pressure and heart rate; dizziness; disorientation; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received BNT162B2, via an unspecified route of administration, administered in arm left on 04Oct2021 (Batch/Lot Number: FF8841) at the age of 81 years old, as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), via an unspecified route of administration (right arm) from 04Oct2021 (Batch/Lot number was not reported, NDC: 70461-0121-03) to 04Oct2021, at dose 1, single [65+ 0.5ml] for an unspecified indication. Medical history included pre hypertension, "BPH" (reported as Blood pressure high), bladder cancer 15 years remission, tonsillectomy, appendectomy and gall bladder removal. No known allergies. Concomitant medication(s) included hydrochlorothiazide and terazosin, both taken for unspecified indications, start and stop dates were not reported. Other medications also included vitamins. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EL3302), administered in arm left on 10Feb2021 at 03:15 PM; second dose of BNT162B2 (Batch/Lot Number: EN6203), administered in arm left on 04Mar2021 at 03:15 PM. It was reported that adverse event After second shot included three incidents of itchy hives on inside of left leg, left arm, and back over a period of several months. No history of hives. No COVID prior vaccination and was not COVID tested post vaccination. Four days after 3rd shot (also reported as "Apr2021"), about 10 itchy welts on inside of left arm which formed into one large swollen mass and required injection of antihistamines at emergency room. This was also accompanied by elevated blood pressure and heart rate. Also, dizziness and disorientation. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events were unknown.
Patient fully vaccinated and boosted. Tested COVID-19 positive on 3/20/2022. 96-year-old healthy otherwise, presented due to complaint of shortness of breath. She stated she has been having shortness of breath over the past 1 week; no productive cough. Na 130. CXR: Patchy airspace opacities at lung bases may reflect atelectasis. Developing consolidation not excluded. O2 sat 88%; cough + fatigue. Treatment: 3L on oxygen. Decadron, Lovenox and remdesivir. Discharged home.
Approximately 10 minutes after patient was given the vaccine, she reported feeling slight lump in her throat. We brought her into the clinic room and sat her down. Never had trouble swallowing and did not have any swelling. Felt hot and bit sweaty and light headed. Reports has felt similar ways in past when had blood drawn. We laid her down and she immediately started feeling better. Mom and sister were with her. Refused ambulance or transfer to physician.  They were all comfortable her leaving on her own, after we have observed her for over 45 minutes from vaccine.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
The vaccine seems to have reactivated the post herpetic neuralgia from my ocular shingles in 2013. I had a dreadful case and suffered from intense PHN for about 3 years. It has grown much less severe during the past 2-3 years. The vaccine seems to have reactivated the PHN - not the full shingles but the pain and tingling is much much worse. I wonder if there will be a worsening of the symptoms with my second COVID vaccine. FYI -  I had 2 shingles vaccines last year, Shingrix, and had the older shingles vaccine about 4 years ago.  Do you know if taking and antiviral would be a good idea?antiviral medicines?acyclovir, valacyclovir, and famciclovir?
COVID-19; COVID-19; This is a solicited report received from a contactable consumer based on the information received by Pfizer from company (Mfr. Control No. 21K-163-4148142-00). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) (age at vaccination: 48 years old), intramuscular on 01Apr2021 as dose 1, single, then intramuscular on 01May2021 as dose 2, single for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. The patient experienced COVID-19 in 2021. The patient underwent COVID-19 Test: positive in 2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovering.   The reporter's causality for the event(s) of COVID-19 with adalimumab was no reasonable possibility.    Information on the batch/lot number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Erythema, swelling, swelling at injection site and approximately 5 inches downward.
Swollen lymph nodes in arm pits; Breast swell; Breast pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits). At the time of the report, BREAST SWELLING (Breast swell), BREAST PAIN (Breast pain) and LYMPHADENOPATHY (Swollen lymph nodes in arm pits) had not resolved.            Patient does not take concomitant medication.  Treatment information was not provided.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patients received improperly stored (Oka/Merck) VARIVAX (lot # K026385, expiration date 15-DEC-2016, lot # L001335, expiration date 13-JAN-2017, lot # L001327, expiration date 13-JAN-2017, lot# L006383, expiration date 25-FEB-2017, strength was unknown, 0.5 ml/once) subcutaneously. The patient's concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Shortly after patient received vaccination, he lost consciousness. He slumped in his char, nearly falling to the floor, but was caught by a nearby patient who noticed patient falling. Patient was assisted by staff to lie down on a cot. At that time he regained consciousness and was able to state his name. Staff attempted to check his blood pressure, but the electronic cuff was unable to measure b/p despite multiple attempts. Because of this, and persistent pallor, drowsiness and low pulse, EMS (who was standing by in the parking lot) was requested to enter the building to assess the patient. After evaluating him within the vaccination site for approximately 30 minutes, patient was transported to the hospital due to persistent low pulse and low blood pressure.
I had no adverse event after receiving my dose in November.  However, I did develop congestion, a cough, a low grade fever (100.5) on May 18 ,2002, and tested positive for Covid that day.
My daughter experienced what appeared to be a seizure/staring spell on April 15th, five days after receiving her vaccines.  The seizure lasted between one to two minutes and upon coming out of the seizure, she was upset/scared, etc.  Her vaccines were given at approximately 10:30am on the 10th of April and her seizure was at approximately 1:15pm on the 15th.  She was seen at the emergency room and a follow up EEG has been ordered, along with a follow up neurology appointment.  Both the attending ER physicians, as well as the neurologists believe she had a seizure/"spell".  In addition, she experienced a low grade fever on the 18th and 19th of April.
After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to a 10 years and a half old female patient with none medical history or drug reactions/allergies. The patient was vaccinated with the first 0.5ml dose of VARIVAX (Merck) subcutaneously (lot# was unknown) on 17-APR-2003. There were no concomitant medications. The patient had developed a case of shingles on an unspecified date after receiving the first dose vaccine. Medical assistant noted that the first dose of VARIVAX (Merck) was given by an unspecified healthcare provider at an unspecified pediatric office location. The patient contacted physician for medical attention. No treatment was given for the adverse events. The outcome of shingles was reported as recovered/resolved. Additional information is not expected.
Patient syncope when standing after immunization striking head on wall. Patient woke rapidly but had persistent complaint of headache and feeling numb all over. Also complained of chest pain occasionally - All VS - were stable - 120/74 BP immediately after.
Moderate to severe pain in the left arm for 48 hours, with headache. Two days after injection I developed Lymphadenopathy on the left and right side of my neck. Initial swelling and redness on the left side of the neck, then yellow/green color, which faded after 3-4 days. The enlarged lymph nodes have continued for 8+ weeks, mostly on the left side.
Pain, edema, erythema 3 x 4" "flu like symptoms". Fever 101.1 degrees F Dx - cellulitis.
On 9/10 I was administered my 2nd Pfizer vaccine the flu shot. I was severely sick with the symptoms of chills, muscle aches, and fatigue. The most ill I've ever been in my life. My most severe symptoms was painful nausea. I had painful nausea for 2 days in which I luckily had promethazine from a previous wisdom tooth surgery. All other symptoms subsided within 2 days except my GI symptoms. I continue to have nausea and have had 3-6 episodes of diarrhea daily and it has been 7 days since inoculation. I have been woken up several nights this week with diarrhea. This has never happened to me before in my life. There has been no change in my diet. I am a very healthy individual. I also started my cycle 10 days late with severe cramping. Bleeding has been normal. There is nothing else than can account for this change but 2 doses of the Pfizer vaccine.
the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home.  Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.
Pfizer COVID vaccine # 3 given 12/3/21, lot # 33130BA; pt presented to ED on 12/27/21 with fever, confusion and weakness; hx of cough, myalgias, weakness x 3 days; positive for COVID in ED; on O2 supplementation; given ABX, dexamethasone, remdesivir; pt did not improve; transferred to ICU where he passed away on 1/2/22
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) on or about 22-JAN-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2016, the patient was treated at an urgent care center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.
Shots recd 9-9-09 PM.  Lt. leg a little red & sore on 9-10.  On 9-11 Lt. leg red & swollen, hot to touch.  Child wouldn't walk.  Lt. leg swollen & red to knee & almost to the hip.  Taken to pmd on 9-11.  Given abx in case of abscess or cellulitis.  Told to give BENADRYL & use warm compresses.  9-13-09 TC to dad.  Child doing fine.  Much improved.  Dad will contact PMD if condition warrants.
adverse event(s): Myalgia, Grade 3; Fatigue, Grade 3; Headache, Grade 3;Shivering, Grade 3; Fever,  Grade 3 (101.5 degree F); GI (slight nausea)  treatment: 4 200mg advil and 5 hours sleep/rest  outcome: complete recovery
Hypertension: Placed on Blood Pressure medication Irregular heartbeat: Placed on Beta Blocker Potts Syndrome: Passed out two times. Now seeing a Cardiologist Restless Leg Syndrome: Now seeing a Neurologist Insomnia: Now on ambian
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 20-MAR-2017, the patient was vaccinated with an expired VARIVAX (lot # L004651, expiration date 11-FEB-2017) for prophylaxis (dose, frequency and route of administration were not reported). No adverse symptoms were reported and it was stated that the expired VARIVAX administered did not have any previous temperature excursions. No product quality complaint was involved. Additional information is not expected since the reporter had no further information to provide.
has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th August 2020, batch number 272M2, expiry date 7th December 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Pain in shoulder within one hour. Pain increased in intensity over the next 24 hours.  No sleep the night of the injection for no apparent reason.  Fever, extreme weakness, moderate to severe headache, uncontrolled, violent shivering, and severe shoulder pain by 1500 the afternoon after the injection. Per annual report- although both pneumo and influenza were included the original report, the adverse event was directly attributal to the pneumo injection.Medical record states cellulitis, sweat, myalgia. msv
SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and nausea was not reported. This report was non-serious.
Red swollen tender right arm over site of prior vaccinia immunization with cervovaginitis and 1.5 cm right axillary tender lymph node. Perulent drainage from vaccine site. (Major reaction) ; treated with z-pack.