chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of hepatitis b surface antigen positive in a 65-year-old male patient who received ENGERIX B adult for prophylaxis. On 8th June 2018, the patient received ENGERIX B adult. On 15th June 2018, 7 days after receiving ENGERIX B adult, the patient experienced hepatitis b surface antigen positive. On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown. It was unknown if the reporter considered the hepatitis b surface antigen positive to be related to ENGERIX B adult. Additional details were reported as follows: The age at vaccination was not applicable for this report. On 15th June 2018, the patient came to the emergency room for other reasons and had a Liver Function test. The patient tested positive for the Hepatitis Surface Antigen. The patient was negative prior. No additional information provided.
About 24 hours after receiving my first and only Covid vaccine injection red, measles like spots appeared randomly on my body.  My entire body literally itched from head to toe.  The itching comes in waves and is maddening at times.  My skin feels rougher overall, especially on my face.  I get the phantom sensation of spider webs on my face and hair. I didn?t get ?Covid arm? at the injection location.  This is general itching.  Some sources like the CDC sited a ?delayed skin reaction? that would last from 7 to 11 days.  I waited 16 days and saw my primary care physician.  I was given Cortisone which did little to help.  One week later I returned.  In desperation I asked my doctor to give me something for parasites in the event the shot wasn?t the problem.  I was grasping at straws.  I was given Permethrin Cream which also didn?t help.  The timing certainly points toward the Covid vaccine as the culprit. Today would have been the day of my second shot.  I am not getting that.  Some data indicated there may be a problem with allergic reaction to the Propylene Glycol in the vaccine.  I have never been allergic to that.  There are products all through my home containing propylene glycol and they have never bothered me.  I fear that somehow the vaccine has made me hypersensitive to that substance or something else now.  The sad thing is the antihistamine creams and oral medications you would treat this with all contain propylene glycol.  So you are simply stuck.  I am not getting the second Moderna injection which would have been administered today.  This whole thing is regrettable and leaves me with no sign of hope.  This has persisted for 27 days now.
While patient was waiting in observation after the vaccination, she complaint of having rash in the arm and that her body and throat were itching. She did not have Benadryl on her, that is why they injected Diphenhydramine 50mg from an emergency car since the itching on the throat gave her coughing and difficulty breathing. Patient also inhaled two pumps of Albuterol HFA. After two minutes of receiving Diphenhydramine, the itching and coughing alleviated.
Red blotchy skin, hives, blood pressure very high, trouble breathing, panic feeling, itchy everywhere to point of pain
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jul-2018, the patient received a dose of suspect PENTACEL lot C5388AA. It was an actual medication error due to expired product administered. It was unknown if patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
This report has been received from the nurse reported that VARIVAX (merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 16-SEP-2013 two patients (age and gender not reported) were administered the unsupported VARIVAX (merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003311, 1312USA003315, 1312USA003316, 1312USA003317, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Tiredness; lLttle nausea feeling; Headache; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness, pain and warm to the touch around is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth,headache, nausea, tiredness/fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22Feb2021, approximately two days prior to the onset of  events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) via intramuscular route  for prophylaxis of COVID-19 infection.  On 22Feb2021, the patient experienced the event(s) redness, pain and warm to the touch around the is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), redness, pain and warm to the touch around  is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue was unknown.
Adverse reaction; Very light headedness; Chills; Vaccination site pain; the gout flared up; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), GOUT (the gout flared up), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Jan-2021, the patient experienced GOUT (the gout flared up). On 12-Feb-2021, the patient experienced ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ADVERSE REACTION (Adverse reaction ), DIZZINESS (Very light headedness), GOUT (the gout flared up), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication was reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-029162 (Patient Link).
Shingles; COVID Arm; Swelling of Lymph Nodes; Fatigue in Arm and Leg; A spontaneous report was received from a consumer concerning a 37-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID Arm, Swelling of Lymph Nodes, Fatigue in Arm and Leg and Shingles.   The patient's medical history was not reported. Concomitant medications reported included daily vitamin and ginger 500 mg.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Jan 2021, a day after the vaccination of first dose the patient experienced COVID Arm, Swelling of Lymph Nodes in the injection arm and Fatigue in Arm and Leg. On 05 Feb 2021, the patient went to urgent care and was diagnosed with Shingles Virus (Shingles). Shingles was medically assessed as serious at urgent care.  Treatment medications for the event Shingles included Valtrex and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, COVID Arm, Swelling of Lymph Nodes and Fatigue in Arm and Leg was reported as unknown. On 05 Feb 2021, the outcome of the event shingles was not recovered/not resolved.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  The events of COVID arm, swelling of lymph nodes in the injection arm and fatigue in arm and leg are consistent with the known safety profile of the vaccine.
Red, itchy blotch (2 - 3 inches around) on injection site, appearing two days after booster injection.
Baseball sized swelling at injection site. Pt was counciled at time of injection to seek medical assistance if swelling occured. Pt chose not to. Swelling lasted 5 days. Pt did not report incident untill 11/20/2010.
Nausea, headache, body/muscle aches, extreme fatigue, fever/chills
Headache, itchy/burning eyes, especially left eye, joint aches, tired, sneezing, runny nose, large welt at the sight of the injection which itches.
At approximately 1654, patient reported slight tingling of the tongue to RN. Patient denied itchiness, rashes, hives, trouble swallowing, trouble breathing. Patient denied swelling and numbness of tongue, lips, and throat. Patient reported she had a similar reaction to her first dose of Pfizer Covid Vaccine. Patient reported she felt the same slight tingling sensation of the tongue. Patient reported her symptom started a "few hours" after her vaccination and "went away on its own". Patient reported allergies to flowers, cigarettes, rubber and petroleum-based products. Patient reported history of thalassemia and no current medications. At 1657, RN assessed patient vital signs: blood pressure 142/86 mmHg, pulse 65 beats/minute, and SpO2 99%. At 1658, RN offered diphenhydramine oral solution. Patient agreed to diphenhydramine oral solution. At 1700, RN administered 50 mg diphenhydramine oral solution. At 1705, RN reassessed patient vital signs: blood pressure 146/88 mmHg, pulse 57 beats/minute, and SpO2 99%. Patient reported "I can still feel it a little less". At 1710, RN  reassessed patient vital signs: blood pressure 138/80 mmHg, pulse 55 beats/minute, and SpO2 99%. At 1715, RN reassessed patient vital signs: blood pressure 138/88 mmHg, pulse 57 beats/minute, and SpO2 99%. Patient reported she was "getting better" and can "barely feel it". At 1729, patient reported her symptom is "gone". Patient denied tingling of tongue. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care physician, and to sign up on v-safe. At 1730, patient left facility with husband. Patient left facility with unlabored respirations and steady gait.
Approx 5 min after injection, pt fell facedown and hit his head. Did not lose consciousness. Pt's dad lifted him up, body was tight and flexed, staring, no incontinence, was laid back on exam table by dad, oriented to time place and person, c/o nausea. Episode witnessed by parents, and health care assistant. Vitals normal, BP was on the low normal.
There is a well-defined area of redness localized just inferior of vaccination injection site on the right deltoid region. It measures 3 inches in height and 3.5 inches in width. It is warm, tender, and slightly indurated with palpation. It was noticed one day after injection of Men B vaccine. Treatment involves warm compresses 2-3x a day and OTC pain reliever as needed.
ringing in left ear, same side as inoculation; ringing in left ear, Same side as inoculation; This is a spontaneous report from a contactable consumer (patient) reporting about herself. A 59-year-old non pregnant female patient (at 59-year-old) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: eP6955, Expiration date: not reported), via an unspecified route of administration, in left arm on 09Mar2021 at 14:15 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The medical history and concomitant medications were not reported. She had no history of known allergies. Prior to vaccination, she did not receive any other vaccine (in four weeks) and other medications (in two weeks). The patient experienced ringing in left ear and same side as inoculation on 09Mar2021 at 21:00. No treatment was received. Covid prior and post vaccination was No. The clinical outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & started coughing & acted as though was choking; began crying weakly & initially had sl retractions; HR was regular & lung fields clear; evaluated by MD-found to be ok-no referral needed
A nurse reported that a female older than 25 years did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The subject had no known allergies.  Her medical history included "skin problems in the past" and she was "recently"diagnosed with pompholyx.  the pt was also obese.  Concurrent medications were not reported.  The pt received injections of Engerix-B on 04/18/02, 05/23/02, and 10/24/02.  A hepatitis B titer (NOS) measured on 03/19/03 was less than 10.  The subject received her fourth and fifth injections of Engerix B on 03/27/03 and 05/15/03, respectively.  The reporter stated that the pt's lack of response to immunization may have been associated with the pt's pompholyx.
I had fever and chills the night of vaccination. Woke up with body aches in lower back and thighs, and nausea. Took two Tylenol for aches, and they have not returned since. It is now 1:00pm the following day after vaccination, and I am feeling better.
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
pt stated that about 25min p/vax exp wheezing, diff breathing, fast heart beat, & edema of the face;states took DPH & used some prescription nasal spray for asthma;dx rxn to flu vax;
3.5 cm area of erydema 36 hours after injection. Plan to hot pack. If not improving Keflex 500 mg  BD X 10 day. Area did not increase in size. Did not take antibiotic.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 92 years old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On approximately in 2012, the pt was vaccinated by a pharmacist with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, anatomical location, lot number and expiration date were not provided).  On an unknown date, the pt experienced herpes zoster and due to this event was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Patient states that she has severe pain at site of injection and swelling that starts from site of injection and extends up towards her shoulder. Instructed patient to take BENADRYL for the swelling, acetaminophen for the pain and use a cold compress (ice pack) on affected area for pain and swelling. Called patient back in the afternoon that day (at 3:20 pm) and patient said that she took BENADRYL and used cold compress and feels much better, but still has some swelling.
made me sick; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-091505), for BNT162B2. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from Feb2021 (Batch/Lot Number: 1391900; Expiration Date: 30Apr2024) to an unspecified date, at 10 mg, daily (5day pk) for uterine cancer. Medical history included hysterectomy; lung neoplasm malignant. The patient had no known allergies. Concomitant medications included ondansetron 4 mg tablet; pembrolizumab (KEYTRUDA), 100 MG/4ML VIAL; ibuprofen (MOTRIN CHILDREN) 200 mg capsule; paracetamol (TYLENOL) 325 mg tablet; promethazine hcl 12.5 mg tablet; paracetamol, tramadol hydrochloride (TRAMADOL HCL AND ACETAMINOPHEN); rosuvastatin 10 mg tablet; lisinopril 10 mg tablet; esomeprazole magnesium; levothyroxine 100 mcg capsule. The patient had a reaction to her 2nd COVID-19 VACCINE made me sick on an unspecified date. The action taken in response to the events for LENVIMA was unknown. The outcome of event was unknown.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 22-JUN-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Presented to the ER with left lower abdomen pain and shortness of breath. Recently diagnosed with COVID-19 Was given mucinex, singulair, flovent, combivent Patient insisted on going home and was discharged
Laryngal malacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngal malacia) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): 17-Dec-2020- Hypothyrodism.     MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.   On 08-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 22-May-2021. On an unknown date, the patient was diagnosed with LARYNGOMALACIA (Laryngal malacia) (seriousness criterion medically significant). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. At the time of the report, LARYNGOMALACIA (Laryngal malacia) outcome was unknown.            No concomitant and treatment medications were provided.  Company comment: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested.   This case was linked to MOD-2021-052207 (Parent-Child Link).   See case MOD-2021-052207 for details regarding the Parent case.; Sender's Comments: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested.
enlarged, very painful, itchy infraclavicular lymph nodes with shooting pain extending to the injection site and axila. Treated with Benadryl and ice.
pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The reporter reported that, the patient had pain at the injection site after receiving the first dose of the shingrix vaccine. No further details were provided. The reporter did not consented to follow up.
Weakness, SOB, unable to walk, raise arms, lift himself from bed. Slurred speech. Diag: GBS. CK 852. 11/19/08-ED record received for DOS 11/1/08-presented with C/O shortness of breath and anxious. Received flu shot on 10/18/08 and subsequently developed weakness. In the midst of a workup for Guillain-Barre syndrome. Had a lumbar puncture and was in process of having MRI when developed shortness of breath. Quinton catheter inserted. Intermittently short of breath for 4 days. Anxious affect. 1/6/09-records received for DOS 10/31-11/21/08-DC DX: Guillaine-Barre syndrome. Macrocytosis.  Received two course of plasmapheresis. Elevation of muscle enzymes. Low MCV. Generalized weakness and inability to move upper or lower extremities and difficulty breathing.  1/23/09-neurology consult 12/9/08 received-presented in October with severe weakness in legs, arms, almosty difficulty with breathing. Received plasmapheresis and IVIG.  Question of possible deterioration though much more improved at this time. Continues to C/O shortness of breath. 2/2/09-neurology consult for DOS 11/1/08-C/O increasing weakness somewhat dizzy sometightness when breathing. PE: no edema  not much muscle tenerness. Weakness in upper extremities, grip is weak, legs are much weaker and cannot life them off bed. No knee or ankle reflexes. Normal downgoing toes. Sensation is presentation no definite sensory level. Impression:generalized weakness progressively worsening. Rhabdomyolysis. Viral syndrome.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/27/2021. PATIENT FULLY VACCINATED ON 02/24/2021.