chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt fine when I left the facility. I drove for 20 minutes to go to a store. When I got out of the car, I had difficulty breathing. It felt as though I had run a marathon. I got back in my car and went home.  The next morning when the symptoms did not decrease, I called my doctors office and they told me to go to the Emergency room. I went to emergency and after diagnosing me, they told me that I ?had a bad reaction to the vaccine. They told me to call my doctor which I did. She prescribed some breathing medications (Symbicort, Albuterol) and added more drugs as the symptoms did not decrease over time. It is now October and my shortness of breath is worse.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The concurrent condition, medical history and concomitant medication was not reported. On 24-MAY-2016, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot # L038501, Expiry: 16-AUG-2018). The vaccine was stored at 27.98 F for 1 hour and 13 minutes. There were no previous temperature excursions. There were no adverse effects. This is one of three reports received from the same reporter. Additional information has been requested.
Roughly 5 weeks after the second dose of the Pfizer\BioNTech vaccine, patient caught Covid. During the first few (3-4) days symptoms were mild and limited to shortness of breath and being easily tired. After a number of days with symptoms, patient continued feeling worse and worse. Around the 4th day of symptoms patient's face (eyes, lips, lymph nodes, throat) began to swell which prompted a visit to the ER. Once admitted, patient spent 9 days in the hospital as she moved towards a stable condition. Upon further investigation and visits with multiple specialists, a dermatologist concluded this was a case of Stevens-Johnson syndrome which may have been brought on due to vaccine (and suggested contacting CDC about this case as to his knowledge this has yet to be documented).
presented with fever of 103.3 14 hours after 2nd injection. dry heaves presented with high fever, body aches, soreness at injection site. fever fluctuating between 100.3 and 101.5 for 2 days after despite alternating tylenol and ibuprofen. day 3 and fever is still present and 100.5. other reactions minimal at this time with the exception of tiredness and sore arm.
This spontaneous report as received from a physician concerning a 12 year old (actually 28 year old) female patient. The patient had no relevant medical history, drug reactions or allergies or concomitant medications. In approximately 2003, when the patient was 12 year old, she was vaccinated with one dose of ENGERIX-B, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) followed with in the appropriate schedule by one dose of RECOMBIVAX HB for prophylaxis and routine vaccination (dose, route of administration, lot number and expiration date were not reported). In approximately 2003, with in the same day of each of the doses, the patient experienced a febrile reaction, the fever reach 103 F (39.44 C)that lasted two or three days each time. No laboratory tests were performed. The patient was treated with an unspecified antipyretic therapy and the fever resolved. The physician also mentioned that the patient did not experienced any anaphylaxis, stridor, wheezing, urticaria or arthralgia. At the time of the report, the patient had recovered.
DID NOT TAKE LAST DOSE ON TIME; This spontaneous case report (PVX2019-2828) was received from a consumer on 15-Nov-2019. It described a female consumer who "did not take last dose on time" (PT: Product dose omission). She was receiving oral Vivotif (lot number: 3003297) for typhoid fever prophylaxis.  Case report: The consumer started Vivotif on 04-Nov-2019. She reported that the last dose of Vivotif fell out of the refrigerator on either 08-Nov-2019 or 09-Nov-2019. Thus, she did not take the last dose of Vivotif on 10-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take last dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take last dose on time" was considered as not applicable.
feeling worse; dehydration; palpitation; candida; rash; kidney issue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida) and RASH (rash) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue). At the time of the report, FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue) outcome was unknown.            No
Pt received vaccine on 6/16. Reports no rxn until 6/18. Notice red bump around the injection site. Redness appeared two days later and is half-dollar size. Pt considered to sick medical attention immediately. Pt consent to take BENADRYL.
Medium size (2 cm) hives/welts appeared on his hands and feet (top and bottom).  Very itchy.  Administered 1.5 teaspoons Benadryl.  Hives subsided with Benadryl.
syncope, history of syncope due to vaccinations. monitored for 30 mins and symptoms resolved.
Information has been received from a 75 year old female consumer with no known allergies and a thyroid "condition" who on 01-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and atorvastatin calcium (LIPITOR). A few days after vaccination, on approximately 04-MAR-2007 the patient experienced a burning sensation and tingling over her entire body, and specifically her face and tongue. The patient saw a neurologist who prescribed gabapentin (NEURONTIN). The patient improved slightly however she was till experiencing these events at the time of the report. She was instructed to see an allergiest. No lab studies were performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007; 6/22/2007. Information has been received from a 75 year old female consumer with no known allergies, hyperlipidemia, a goiter, osteoporosis, and a thyroid "condition" who on 01-MAR-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, XANAX, alendronate sodium (MSD), and LIPITOR. A few days after vaccination, on approximately 04-MAR-2007 the patient experienced a burning sensation and tingling over her entire body, and specifically her face and tongue. The patient saw a neurologist who prescribed NEURONTIN. The patient improved slightly however she was till experiencing these events at the time of the report. She was instructed to see an allergist. No lab studies were performed. There was no product quality complaint involved. No further information was provided. Additional information has been received from a physician who reported that in March 2007, the patient experienced internal itching, stinging, diffuse skin itching and burning, and internal nerves pulsating since just after the vaccine was administered. The patient has persistent symptoms daily. The patient requires NEURONTIN for symptom control. At the time of the report, the patient had not recovered. Additional information has been requested.
chest tightness, wheezy feeling, trouble talking.  treated with epi and benadryl and symptoms improved.  pt monitored for 3 hours and departed. .
This non-serious initial spontaneous case, was received on 07-Sep-2017 from a pharmacist, concerning a 10-year-old child. The patient's medical history and concomitant medications were not reported. On 07-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Severe headache, 102 fever, chills, body aches  Lasted for approximately 3 days post vaccination
This is a spontaneous report from a contactable physician and other healthcare professional. A patient of unspecified age and gender received a single dose of PREVNAR 13 , on an unspecified date for pneumonia vaccination. The patient medical history and concomitant medications were not reported. On an unknown date the patient was diagnosed with fever of unknown origin, hyponatremia, elevated sedimentation rate and CRP, anemia, elevated LFTs and erythema nodosum, due to which was hospitalized. Hospital discharge summary on 01Feb2017 also stated that the patient was admitted with weakness and ataxia. A diagnosis of UTI was suspected. The outcome of all the events was unknown and patient was discharged on 01Feb2017. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the events. This case will be reassessed when additional information becomes available. 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.
couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think of words) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CR1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and LATANOPROST for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MENTAL IMPAIRMENT (couldn't think of words) (seriousness criterion medically significant), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills). On 28-Apr-2021, MENTAL IMPAIRMENT (couldn't think of words), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details was given. No treatment information was given. Patient stated two occurrences of this type of episode on 27 Apr 2021 and 28 Apr 2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
I turned away when I was given the shot because I don't like to look at needles. I could feel it went high and was in for what seemed like a long time.  Less than 3 hours later I was working at the computer with a colleague when my shoulder pain kicked in. I had no idea what it was from but it was severe. When I couldn't lift my arm to take my top off I noticed when I pulled my crew collar out the bandaid was right by my shoulder. I have lost mobility in my arm. Can' move it in many directions without a lot of pain and sometimes it goes into my forearm.  No anti-inflammatory pills whether over the counter or prescribed do anything to relieve the pain.  I spoke to someone who had the vaccine administered by the same woman and she also had an adverse reaction. - less severe than mine. I have had to stop many activities including exercise. I was hoping this would have been gone by now. I am afraid of developing a frozen shoulder. I am athletic- play tennis, etc.
Aches and pain, weakness, whole body. Pain at injection site. Up multiple times throughout night to go to the bathroom. Lethargic the whole next day.
Tested positive for COVID-19 on 03/06/23 I had a mild headache, scratchy throat, coughing with nasal congestion and upper back pain. I went into the ER and was given a back xray because of the pain. I was prescribed :Nasal Spray; Prednisone 50 mgs x five days; Solutate; cepacol lozenge and OTC Tylenol for headache and back pain. I was not prescribed Paxlovid.
Ulcers in vaginal and anal area; I am breastfeeding; I am breastfeeding; sleep deprived; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 36-year-old female patient received BNT162B2 (Batch/Lot Number: Ew0173), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 at 12:00 as DOSE 2, SINGLE (at the age of 36-year-old) for covid-19 immunisation. Medical history included rosacea, psoriasis, polycystic ovaries. Concomitant medication included nystatin (NYSTATIN) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (CALCIFEROL VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline, bnt162b2 for covid-19 immunisation. It was reported that, on 10May2021, the patient experienced ulcers in vaginal and anal area (ulcer), i am breastfeeding (off label use), (product use issue), sleep deprived (insomnia). The outcome of events was not recovered.  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021573472 Same reporter/drug, different patients/events
Janssen COVID-19 Vaccine EUA Hyperglycemia - ongoing Acute severe pancreatitis - ongoing Intestinal blockage - ongoing
Arrives in the Emergency Department with complaint that after receiving immunization today developed red blotchy rash, pain from elbow up into neck,dizziness and lightheadedness lasting hours improved after receiving Tylenol and Benadryl.  MD orders included ECG, Lab work BMP, CBCD and troponin all testing came back within normal limits. Patient discharge home diagnosis Adverse effect of vaccine.
approx 3yrs p/vax pt exp chickenpox w/over 100 lesions.
Excruciating pain in left hip, progressed to shoulders, wrist, left neck; Unable to hold/lift his phone; A spontaneous report was received from a consumer who was an 57-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone.  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 039K20/2A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient experienced excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone. The patient reported he went to emergency room (ER) but was discharged. Treatment for the events included paracetamol and ibuprofen. The patient also stated that the pain medications have not been helpful.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, excruciating pain in left hip, shoulders, wrist, left neck and unable to hold/lift his phone was considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. arm became very warm and red, a large area (approx. the size of a large spread out hand)She later developed a scab/hole at the injection site with no signs of infection.
This case was reported by a other health professional via call center representative and described the occurrence of sweating in a 61-year-old male patient who received ENGERIX B adult (batch number 5G943, expiry date 31st October 2016). Concurrent medical conditions included unknown. Concomitant products included medication unknown (Unknown). On 24th October 2014, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On an unknown date, the dose was an unknown dose. On 25th October 2014, 1 days after receiving ENGERIX B adult, the patient experienced sweating and chills. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the sweating and chills were recovered/resolved and the outcome of the fever was unknown. The reporter considered the sweating, chills and fever to be possibly related to ENGERIX B adult. Additional information received: Nurse reports a patient who experienced swelling and chills after receiving an ENGERIX-B vaccination. The patient did not take his temperature, but he did feel like he was feverish during this time. The sweating and chills would last for about 30 min and would come and go during a two day period. By the third day the symptoms had resolved. It has not yet been determined if the patient will continue the series. The patient is currently 7 days late for his second dose of ENGERIX-B.
atrial fibrillation symptoms; heart rate variance; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol succinate (Toprol).   On 12th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2020, less than a day after receiving Shingrix and flecainide and less than a day after starting Shingrix and flecainide, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant) and heart rate abnormal. The patient was treated with flecainide. On 15th June 2020, the outcome of the heart rate abnormal was recovered/resolved. On an unknown date, the outcome of the atrial fibrillation aggravated was unknown.   The reporter considered the atrial fibrillation aggravated and heart rate abnormal to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported  The patient had a history of atrial fibrillation.  The patient stated he states that on 12th June 2020, the patient took dose 1 of Shingrix and started a new medication for atrial fibrillation, flecainide. On the same day patient had heart rate variance, atrial fibrillation symptoms that lasted till 15th June 2020. The cardiologist told her the atrial fibrillation symptoms were related to receiving the vaccine. The reporter consented to HCP follow up.
Seizure.  Minor discomfort in abdomen followed by loss of consciousness, eye-rolled back in head.  Came to and light headed, woozy, hands feel light, abdomen worse but not bad. Shallow breathing. Later: symptoms lessen; feel membrane around brain, nausea, joints ok.  No fever.
Information has been received from a nurse concerning a 79 year old female patient who on 17-JAN-2011 was vaccinated with PNEUMOVAX 23 (lot # 665924/0930Z, expiration date 17-JUL-2011). Throughout the night of 17-JAN-2011 the patient experienced chilling and nausea with soreness to injection site. No treatment was given to the patient. The events lasted only for 3 or 4 hours and resolved independently. On 18-JAN-2011 the patient recovered from the adverse events. The patient did not seek medical attention. Additional information has been requested.
According to the patient on 4/26/18, he has called on 4/25/18 reported to RPH about the pain, redness, swollen and warm to touch around the injection site, which was most intense on the first day. He was advised by RPH to circle the redness site and see MD when it got bigger. Patient said the redness got bigger on 4/25/18 night and so he went to see MD on 4/26/18. Patient said MD didn't suspect of any infection but on the safe side he gave cephalexin 500 mg as a prophylaxis, which was filled and dispensed to patient on 4/26/18.
This pt is one of 4 pts who were vaccinated with two doses of varicella virus vaccine live failed to seroconvert.
Left shoulder has severe pain.  Arm could not be moved for 2 days even now the pain is awful.  I was given a c pack for 6 days and now I'm on meloxicam 15 mg.   Pain level is still at a 9-10 in the evenings.
Pt recv'd shingles vax on 5/12/10 around 4:30PM.  Shortly after pt. experienced burning in her throat.  She sat in front of pharmacy for about 10-15 min and tingling and burning went away.  She also noticed 4 or 5 nodules in her arm, very warm, red, and inflamed.
Itchy skin around the site; dry skin around the site; Itchy with dry skin around the site with a bit of redness; Warm to touch; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0128) via an unspecified route of administration in the left arm on 11May2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumothorax on both lungs at different times about 28-years ago and pollen allergy. Prior to the 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. Concomitant medications included lysine hydrochloride (L-LYSINE), cetirizine hydrochloride (WAL ZYR) and multivitamins; all for unspecified indication and start date. On 11May2021 at 15:30, the patient experienced itchy with dry skin around the site with a bit of redness and warm to touch. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy with dry skin around the site with a bit of redness and warm to touch was not resolved at the time of this report.  No follow-up attempts are needed; No further information is expected.
Fainted and then had convulsions for about 5 seconds, pale, clammy, dizzy. 6:20pm, symptoms resolved quickly. Call 911 patient refused.
Large abscess at the site of injection.  Copious amout of purulent drainage in rt arm.