chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18 hours post vaccine- severe muscle/joint pain and fatigue 28 hours post vaccine- several episodes of severe vertigo, nausea and vomiting  By March 18th- muscle symptoms and fatigue have resolved. Severe vertigo episodes have  stopped with only mild dizziness when moving my eyes and looking at computer screen, but I was able to work.   Called my doctor  and she recommended Dramamine. March 19th continued improvement with slight dizziness when watching computer screen. March 20 th. Felt great and I thought it had resolved but severe vertigo episode occurred when lying down. Lasted 20 seconds.
Slept for 2 days, had to be awakened to feed, fussy irritable mild fever with Tylenol given x1 with good response. Mother noticed rubbing of head and face and lost ability to console oneself and lost ability to suck thumb. Feels cry is more high pitched and not vocalizing as much as before vaccine.
Vaccines -> few hrs later child seemed more fussy than NL but nursed well. Mother provided dose of TYLENOL. Shortly after, child had "pale lips" but was breathing normally. ? slightly lethargic. Child taken to ER for eval.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 04-DEC-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L014458 and an expiration date of 11-FEB-2017 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Cellulitis; A spontaneous report was received from a consumer concerning a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and cellulitis.  The patient's medical history was included lymphedema in her legs. Concomitant product use was not provided.  On 19 Jan 2021, prior to the onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient was hospitalized on 01 Feb 2021 for cellulitis. Treatment for the events included intravenous antibiotics, which the patient reported were antibacterial medications. The patient was switched to oral antibiotics but remained hospitalized.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Hot flashes; Case reference number US-BN-2021-002122 is a spontaneous case report initially received from a physician via Agency (reference number: USBAV21-0372) on 23-Jul-2021 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in 2019, the patient was vaccinated with RabAvert (inactivated rabies virus; batch number: not provided), at unknown dose or route of administration and for unknown indication.   On an unspecified date, an unknown amount of time after the vaccination, the patient experienced hot flashes.  At the time of this report, the patient had not recovered from the event.  The reporter assessed the event as non-serious. The reporter did not provide causality assessment.    No further information was provided.; Reporter's Comments: Hot flush is not listed for RabAvert per Agency Information. Reportedly, the patient experienced reported event after receiving suspect vaccine. The exact timeline was not reported. At the time of the report the patient did not recover yet. No information regarding concomitant and co-suspect medication and medical history were provided. Due to lack of information causality between suspect product and reported event cannot be excluded and is assessed as possibly related. The case is considered as non-serious.; Sender's Comments: Hot flush is not listed for RabAvert per Agency Information. Reportedly, the patient experienced reported event after receiving suspect vaccine. The exact timeline was not reported. At the time of the report the patient did not recover yet. No information regarding concomitant and co-suspect medication and medical history were provided. Due to lack of information causality between suspect product and reported event cannot be excluded and is assessed as possibly related. The case is considered as non-serious.
Patient complained of fatigue and sore throat. Was diagnosed with mono on 09-19-16 by doctor.
Case number PHEH2014US020583 is an initial spontaneous report from the pharmacist received on 09 OCT 2014. This report refers to a 72-year-old male patient. On 08 OCT 2014, he was inadvertently vaccinated with an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 14554P) instead of FLUZONE high dose (influenza vaccine, other manufacturer). No adverse event reported following this medication error (wrong vaccine administered).
c/o swelling of face, trouble swallowing;mom took to ER & DPH given, solumedrol, methyl pred acetate given;pt sent home w/DPH & given pepcid IV in ER;
Burning eyes, head pressure. BP 136/86, P 78 at 15:10 BP 130/86, P 72 a2 15:20  Patient monitored and currently reports to feel better. Instructed to follow up with PCP as soon as possible.
Skin rash & swelling 6x7 cm. Requires BENADRYL one tsp q 6 hours PRN.
1 of 2 pt vaxed w/Tetramune/MMR on 19OCT93 3Pm exp 4 hrs of persistent crying (from 4AM to 8AM) on 20OCT93; no fever of other sx occurred; not seen by MD; pt recoverd;
Triggered 3-1/2 + week long migraine. Pain intensity at times 9/10. Neurologist put me on extended prednisone taper to help break cycle.
No additional AE reported; pediatric patient (16 years old) was administered an adult dose of VAQTA.; This spontaneous report was received from a health care professional (HCP) referring to a 16-year-old patient of unknown gender ( reported as pediatric patient). The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 27-SEP-2022, the patient received an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 U/mL, 1 milliliter, lot # U036184 and expiration date on 02-MAR-2023, administered for prophylaxis (dose number and route of administration were not provided) (Incorrect dose administered).  No adverse event was reported.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Moderna COVID-19 Vaccine EUA Fever of 102.2, swollen face and eyes, cold sweats, diarrhea, and confusion. Lasted from the night I got the second dose (5/27) until today (5/29).
fear damaged heart lining Myocarditis and/or Pericarditis; fear damaged heart lining Myocarditis and/or Pericarditis; shortness of breath; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2; Lot No: Unknown.), administration date: Mar2021, for COVID-19 Immunization; Covid-19 (Dose 1; Lot No: Unknown; Brand= Unknown), administration date: Feb2021, for covid-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: PERICARDITIS (medically significant), MYOCARDITIS (medically significant) all with onset Nov2021, outcome "unknown" and all described as "fear damaged heart lining Myocarditis and/or Pericarditis"; IMMUNISATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "Dose Number : 3"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath". The patient reported, shortness of breath, which I fear damaged heart lining myocarditis and/or pericarditis after mRNA COVID-19 vaccination. Therapeutic measures were not taken as a result of pericarditis, myocarditis, dyspnoea. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
RIGHT THIGHAS RED,HOT, &SWOLLEN MOM WAS TOLD TO APPLY COLD PADS TO THE AREA CHILD WAS WAS SEEN AT ER  AND PRESCRIBED CEPHALEXIN
Sudden onset severe nausea and vomiting 1 hour after receiving shot. Called 911 after 90 mins of severe vomiting. Eval. by ER--Tx with IV's and antiemetics Went home with several hours. No additional. Tx nec. Er feels probably not   to flu shot.
This case was reported by a consumer and described the occurrence of gluten intolerance in a patient who received Flu vaccine. Previously administered products included flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced gluten intolerance (serious criteria GSK medically significant). On an unknown date, the outcome of the gluten intolerance was unknown. It was unknown if the reporter considered the gluten intolerance to be related to Flu vaccine. Additional details were provided as follow: An employee at a hospital received flu vaccinations through the hospital and was diagnosed with gluten intolerance. This is one of the three cases reported by the same reporter for the same vaccine.
Pneumonia confirmed via chest X-ray. Started 2 weeks from second dose of vaccine. Patient has history of aspiration so unsure if related. Patient also just started school, could have picked up other illness. Started with congestion and coughing on 8/21, progressed into more substantial congestion and ear drainage. on 8/23 patient had fever 100.6 with chills and aches. Oxygen required at 1.5L for majority of night to keep sats above 90.  Started azithromycin, prednisolone, xopenex q4, and ciprodex ear drops on 8/22. Saw doctor on 8/23 and had chest X-ray. X-ray confirms pneumonia.
Patient received 1st dose of VARIVAX and 6 days later came to our office with classic chicken pox. I unroofed one of the lesions and culture was (positive) for varicella. There was an outbreak of varicella at her daycare with 2 other kids diagnosed in same week.
Loss of 5 week embryo, which had been PGS-tested without any genetic abnormalities and transferred via IVF on April 14, 2021. Have had one successful pregnancy in past and four other miscarriages, though this is first through IVF with PGS testing.
Periodic (approx 5 - 7 weeks) swelling and inflammation of joints. The areas most commonly effected are fingers, toes, wrists, ankles, back of hands, tops and bottom of feet. Outbreaks last approximately 2 weeks
Case number PHEH2014US025363, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 62 years old patient of unknown gender. Past medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # M003436, 07-SEP-2017, L024122, 30-DEC-2016, M001152, 15-JUL-2017. No adverse effects were reported. Temperature of 2.8 degree Centigrade for 6 hours 46 minutes and it was administered, previously there was no temperature excursion. This is one of the 3 reported received from the same reporter. Additional information has been requested.
Pt in office with twin sib gave two PENTACEL instead of one PENTACEL and one VARIVAX which was due to pt.
Fever - 106 19JAN91; 20JAN91 102; puffy face; vomited x1.
Mother called 04/20/2005, late morning states she noticed pt left arm Upper is swollen the size of a baseball, warm to touch, no fever, no soreness, just noticed around 10:00AM Pt is acting fine, no c/o, playing as usual. Advised mom to monitor pt. Use cold pack and Tylenol PRN, mom called DR office and Peferred providers who offered some advice to mom.
Sever headache, upset stomach, full body muscle pain, nail pain, kidney pain, fever, full body joint pain.
Felt lightheaded and had headache that started about 20 min post injection. Got progressively worse. Began having chest pain around 11am. Took a dose of Benadryl. Did not subside. Went to ER and was given "something for anxiety".
I HAD AN APPOINTMENT FOR ALLERGY TESTING AND MY BLOOD PRESSURE WAS HIGH, THEY ASKED IF I WAS ON MEDICINE. I HAVE NEVER HAD HIGH BLOOD PRESSURE IN MY LIFE, I HAD TO GO TO THE ER AND THEY DID A CARDIAC WORK UP ON ME.
This spontaneous report was received from a registered nurse referring to a 5-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Received ZOSTAVAX on 7-20-10. Per pt on Wednesday left arm become swollen and red, hot to touch and painful. Thursday temp 100.1 and on Friday c/o fatigue. Better by weekend. But today still c/o being very tired.
Pt came in with warm, swollen left arm. she stated all week (2 days since the shot).
Received the final 2nd Pfizer vaccine shot 4 days prior. I came down with severe red, hot, itchy skin that wouldn't stop. I went to the ER and they gave me some atarax, xanax, and another drug to try and relieve the symptoms. They stated I was having an allergic reaction and that I would never be able to take the vaccine again.
At approximately 1655 hours a 40 y/o WF c/o to Np a that she was having difficult breathing and feeling sweaty. NP  immediately evaluated patient with assistant for the EMs.  Benadryl 50mg ordered, Iv NS started and call 911. At approximately 1724 hours ambulance arrived and evaluated patient. After evaluation client was transported to hospital @1730 hours
Information has been received from a medical assistant concerning a 14 year old female patient with no known drug allergies or pertinent medical history who on 29-JUL-2010 was vaccinated im with a 0.5 ml first dose of GARDASIL (lot number 665607/1333Y, expiration date June 2012). There was no concomitant medication. The medical assistant reported that the patient fainted immediately after the administration of GARDASIL, on 29-JUL-2010. The patient recovered completely after a few minutes without requiring medical treatment. No laboratory tests were performed. The patient sought unspecified medical attention. Follow up information was received and indicated that there was no adverse reaction seen "yet" as reported. Additional information is not expected.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a 2 year old male patient who received a first dose of Prevnar on 10/25/01, at 4 months of age. On the same day the child received a second dose of diphtheria/tetanus toxoids/acellular pertussis vaccine, IPOL. and haemophilus B conjugate. In May 2004, at 2 years of age, the child was diagnosed with autism. Relevant medical history was not provided. indication for Prevnar was immunization. Product was administered on 10/25/01. Dose regimen was 1 dose (IM). Additional suspect medication included hepatitis B vaccine, diphtheria/tetanus toxoids/acellular pertussis, IPOL, haemophilus B conjugate vaccine, MMR, and Varivax. Concomitant medications were not reported. On 10/25/01, at 4 months of age, the patient received a dose of Prevnar. In May 2004, at 2 years of age, the child was diagnosed with autism. The reporter stated, he had the symptoms well before then. The reporter also indicated as of 2/23/05, the patient had not recovered. No additional information was available at the time of this report.
Headache; Fatigue; by evening Mild injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (by evening Mild injection site pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Pre-existing health condition).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (by evening Mild injection site pain). On 15-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (by evening Mild injection site pain), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. Not Provided          The patient was not on any routinely medications.    The patient was wondering whether she should take Tylenol or any over the counter pain medicine to help relieve her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-077846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077846:First dose
This spontaneous report has been received from an other health professional refers to a patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 667269/1163A, Exp Date 10-DEC-2011) on 19-JUL-2012. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Several days after noticed a light red, blotchy, itchy rash on inside of both calves, and inside top of thighs. Shortly after noticed same rash on top of forearms and a little on biceps. It is still on arms two weeks later though fading and not as itchy and almost gone on legs. Today, 2/21/2021 have a swollen and tender lump under left armpit ( lymph node).
This literature marketed report as received from a other health professional refers to a 21 year old female patient with asthma. This is case 2 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (Manufacturer unknown). The patient received both the vaccines in opposite arms. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization) presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 20.7K/microliter, ESR 92mm/hr, Maximum temperature 103.2 degree F and CRP 20mg/dl. The patient was admitted to the hospital, but did not receive antibiotics in hospital and post discharge from the hospital. The patient received the 2 vaccines in opposite arms, developed local erythema and edema at the site of the Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The arm where the influenza vaccine (manufacturer unknown) was placed was normal. This suggested that the local reaction experienced by the patients who received the Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and influenza vaccine (manufacturer unknown) in the same arm was due to the Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) vaccine rather than the influenza vaccine. The patient sought care within 2-3 day of vaccination. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leukocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008574, 1405USA007995, 1405USA008575 and 1405USA008576 (same reporter link).