chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker - Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored RECOMVIBAX HB (reported by CMA as RECOMBIVAX), MMR II (Reference MARRS # 1510USA006844), GARDAIL (reported by CMA as GARDASIL (HPV-4)), and PNEUMOVAX 23. Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered doses: GARDASIL (Lot number K016966, expiration date 10MAY2017) (Reference MARRS # 1510USA009473.) and PNEUMOVAX 23 (lot number 1005563 (as reported), expiration date 03NOV2016). [Lot number 1005563 is an invalid lot number for PNEUMOVAX 23] (Reference MARRS # 1510USA009474.) The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from the same source.
Headache, fatigue, muscle pain, joint pain, soreness at injection site, swollen lymph nodes on injection arm
Symptoms began roughly 15 hours from the injection with severe headache and body aches.  That continued to progress to include a 102 fever, aggressive chills, nausia, no appetite and muscle weakness.  The symptoms continued, especially the muscle weakness, to the point that by the afternoon of the 12th, I was unable to get up from a chair or navigate stairs on my own.  I was really unable to sleep.  By the afternoon of the 13th, the muscle weakness subsided to the point that I could get out of a chair and navigate on my own, not well, but on my own.  Symtoms continued to decline by the afternoon of the 14th.  Symptoms continued to improve by the afternoon of the 14th that I could return to computer work.
Information has been received from a registered nurse concerning a 15 month old male with no known medical history or allergies who on 06-Aug-2004 at 11:00 a.m. was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 645575/0436N). There was no concomitant medication. There was no illness at the time of vaccination. On 11-Aug-2004 the patient developed a few "blister-like" lesions at the injection site. On 18-Aug-2004 the patient's mom reported apparent mild onset varicella. On 21-Aug-2004 no further lesions were noted; all have dried and the patient recovered.  No further information is available.  OMIC
Jaw pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Jaw pain). At the time of the report, PAIN IN JAW (Jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Pt complained of dizziness, instructed to put head down. 1:45 child stood up walked to hall with Mom & said I'm tired, pt assisted to floor by RN, skin warm/dry, alert, complained of dizziness. Pt B/P 80/40.
Suspected vaccination failure; Had them in 2018; NOT so painful; Itches too; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got when the patient's kids wer little).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. In 2018, after receiving Shingles vaccine, the patient got shingles. The patient stated that, shingles vaccine helped him/her a lot. Shingles was not so painful but still painful and itched too. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Began getting Migraines more frequently after receiving the Booster vaccine. Dr. prescribed migraine medicine to alleviate the migraine pain. Breakthrough COVID case - 09/20/2021.
-FLU LIKE symptoms Fever, upset stomach headache for 36 hours -injection site soreness for 1 week, Black and Blue as well
pt didn't feel well after vaccines given. nervous, sweaty, had high blood pressure. was monitored for 20 minutes, water given. no medication intervention necessary.
temperature excursion involving punctured IPOL that was administered post excursion; due to being administered post excursion; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adolescent male patient who reported temperature excursion involving punctured ipol that was administered post excursion and due to being administered post excursion while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Aug-2022, the patient received a  0.5 ml 1X dose of suspect IPV (VERO) (lot V1A121M; expiry date: 15-feb-2024) via intramuscular route in the deltoid nos (Deltoid (Caller did not know which arm)) for prophylactic vaccination..  On an unknown date the patient reported temperature excursion involving punctured ipol that was administered post excursion (product storage error) and On 08-AUG-2022, the patient reported due to being administered post excursion (poor quality product administered) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event product storage error and was Unknown for the event poor quality product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Cellulitis left arm,  fever, body aches, chills, ?feels like I have covid again?, headache. Fatigue, lethargy, All sympotoms x 3-4 days,
ON THE 11TH PATIENT RAN LOW GRADE TEMPS AND WAS GROUCHY WHICH IS NORMAL FOR HER AFTER A SHOT, THEN  ON THE 13TH SHE WAS RUNNING A 104 TEMP AND TOOK TO PHYSICIAN ON THE NEXT MORNING. PHYSICIAN SAID IT WAS A VIRUS AND SENT HER HOME AFTER A CBC WAS DRAWN. ON THE 14TH SHE STOPPED EATING ON THE 15 SHE WAS LETHARGIC AND WOULDNT EAT OR DRINK ANYTHING. SHE WOULD CONTINUE TO RUN A 102-104 TEMP AND DIDN'T GET OUT OF BED. TOOK TO ER 2 TIMES AND PHYSICIAN 2 TIMES. FINALLY SHE WAS ADMITTED ON THE 17TH. ON THE 18TH SHE WAS LIMP AND WAS FLOWN TO HOSPITAL VIA HELICOPTER WHERE THEY PUT A TUBE FEEDING DOWN HER NOSE, SHE WAS KEPT UNTIL 21ST. THE PHYSICIAN SAID SHE HAD VASCULITIS DUE TO THE  MMR VACCINE. Information from discharge summary states post vaccine syndrome. msv Information from Medical record states rhinitis. msv
This spontaneous report as received from Registered Nurse refers to a 11 month old female patient. The patient received her first dose of VAQTA on 07-DEC-2010 and a second dose of VAQTA on 14-JUN-2011. No adverse symptoms reported. Additional information has been requested.
Well I was having chest pains and dizziness and extreme fatigue and weakness. I went to the ER and then had a follow up with my DR, then went to a cardiologist as well. I was put on heart medications. I was in the ER for ten hours originally though, they gave a lot of tests that I cannot even recall. I do not remember anything else really.
On 12/21/2002, a cystoscopy was done with "clear" results, and a weekly series of 3 planned instillations of maintenance BCG was started on 01/21/2003, at 10 am (only one instillation was given).  On the following morning, the patient's wife called to report, since 5 pm of 01/21/2003 (7 hours after instillation), the patient had been experiencing chills, fever of 102.5 degrees F, and was so weak, when he arose from sitting, he fell and hit his head, sustaining a bruise.  He went to bed, where his symptoms persisted, and also urinary urgency and "leakage" (urinary incontinence), and difficulty eating.  Two days later, the fever was beginning to resolve; the patient was able to eat a normal breakfast, and was beginning to feel better.
Neuropathy: nerve pain in both legs and arms (first 3-4 weeks) tingling in fingers, intermittent hand numbness lasting about 30 seconds (first 2 weeks) Muscle Pain: stabbing pains in backs of legs, armpits, and along spine (first 2 weeks) Multiple Joint Pain:  joint pain without swelling in knees, ankles, wrists, neck (started in ankles and knees, neck pain started after 6 weeks)
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-APR-2017, the patient was treated by a physician at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Fever 101 ? Chills ? Muscle ache and headache ? Flu-like symptoms  SKIN HURT. It hurt to wear clothes and to lie down on the bed. I had to urinate frequently a teaspoon or so but it was painful enough to wake me up.
Vaccination was received on Wednesday afternoon. That Friday night at 11pm I felt tingling around my mouth. I developed nausea and lightheadedness/dizziness at about 12:00 am and the tingling became severe itching that spread gradually to the rest of my body without any visible rash, from my scalp down to my knees, slightly less severe on my feet and soles, and lasted some 36 hours. I visited an emergency center Saturday morning due to extreme discomfort and received a steroid injection and hydroxyzine HCl tablets. Itching continued through the rest of the day and gradually diminished, ending by Sunday mid afternoon.
A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started during Oct-2013. The patient experienced fever which started on 18-Oct-2013. The outcome of the event of fever is unknown. The report was considered to be non-serious.
54 hours of continued  fever (as high as 101.5), fatigue, chills
Patient received a 3rd dose of Moderna. 1st dose on 2/9/21, 2nd dose on 5/12/21, and 3rd dose on 6/17/21.
Fever; Body chills; Body aches; Headache; Nausea; Dose 1 date: 03Mar2021, Dose 2 date: 24Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 24Apr2021 at 12:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 03Mar2021 at 16:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 05:00, the next day, the patient experienced fever, body chills, body aches, headache, and nausea which lasted two days after shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 fever, body chills, body aches, headache and nausea was recovered on 26Apr2021.   No follow-up attempts are needed. No further information is expected.
A non-serious, spontaneous report of secondary transmission and influenza A has been received from a consumer concerning a five-month-old, breastfed female patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age. The patient's medical history and concomitant medications were not provided. The patient's mother received FLUMIST on 12-Oct-2009. The patient did not receive FLUMIST. The patient was in close contact with her breastfeeding mother (MEDI-0009075) who received FLUMIST. On the night of 13-Oct-2009, the infant developed flu-like symptoms of fever, congestion, cough, sneezing, and runny nose. On 14-Oct-2009, she was taken to the doctor and tested positive for Influenza A. the infant also vomited after returning from the doctor's office. The mother stated that the infant is a stay at home baby and she does not think the infant could have gotten the virus from anywhere else but her since she got the live vaccine. The event of Influenza A was on going at the time of the report. Required follow-up attempts have been performed, requested information unable to be obtained. 22-Feb-2010.
Little vague ache in our shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine Quadrivalent (received yearly for over 30 years).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. After receiving Influenza vaccine, the patient had a little vague ache in her shoulder. The patient had been getting the vaccine yearly for over 30 years. The patient was schoolteacher and during that time, she never had the flu. This was 1 of 14 linked cases reported by the same reporter. This case was linked with case US2020AMR196973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR196983:Husband's case Season 2015-2016 US-GLAXOSMITHKLINE-US2020AMR196984:Husband's case Season 2016-2017 US-GLAXOSMITHKLINE-US2020AMR196973:Husband's case season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196985:Husband's case Season 2017-2018 US-GLAXOSMITHKLINE-US2020AMR196987:Husband's case Season 2019-2020 US-GLAXOSMITHKLINE-US2020AMR196982:Husband's case season 2014-2015 US-GLAXOSMITHKLINE-US2020AMR196986:Husband's case Season 2018-2019 US-GLAXOSMITHKLINE-US2020AMR196967:Season 2014-2015 US-GLAXOSMITHKLINE-US2020AMR196968:Season 2015-2016 US-GLAXOSMITHKLINE-US2020AMR196969:Season 2016-2017 US-GLAXOSMITHKLINE-US2020AMR196970:Season 2017-2018 US-GLAXOSMITHKLINE-US2020AMR196971:Season 2018-2019 US-GLAXOSMITHKLINE-US2020AMR196972:Season 2019-2020 US-GLAXOSMITHKLINE-US2020AMR196967:Season 2020-2021 US-GLAXOSMITHKLINE-US2020AMR196971:Season 2020-2021
vaccines being in transit too long as vaccines were sent on 26Aug2023, and it should have been at the office, yesterday (28Aug2023), vaccines already being administered with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 21-month-old female patient who experienced vaccines being in transit too long as vaccines were sent on 26aug2023, and it should have been at the office, yesterday (28aug2023), vaccines already being administered with no reported adverse event while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Aug-2023, the vaccines being in transit too long as vaccines were sent, and it should have been at the office, yesterday (28aug2023).  On 29-Aug-2023, the patient received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine Suspension for injection in pre-filled syringe (lot: UT8040KA, expiration date: 30-Jun-2024) via intramuscular route in unknown administration site for flu prevention (Antiviral prophylaxis) & Immunization with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.   Additional information was received on 08-Sep-2023 from Other health professional. Case has become non valid to valid. Patient information added, clinical course updated and text amended accordingly.
cold like sx-took OTC cold med per MD;chest congested, sl temp, SOB, coughing up alot of phlem;
New and worsened reaction to food allergy/intolerance. After 20 years of small bites, I have  built some immunity to certain foods. Since I received my vaccine I have had strong reactions to foods I usually tolerate with mild oral itching in very small portions. The first increased reaction was around 2 weeks after my first shot.  About 2 hours after eating a very small portion of avocado, I woke up with a start with extreme tightness of my chest and gasping for air. I caught my breath after a few seconds then projectile vomited. Treated with 50mg Benadryl and returned to sleep after 45 minutes. I have never had any respiratory symptoms with a food allergy reactions. About 2 weeks after my second shot I accidentally ate a few bites of tomato which has not been a problem for over 10 years. After vomiting in my car and pulling off the road I saw my cervical lymph nodes were swollen to about 1.5 inches in diameter. I have never seen any thing like it. My airway was clear. I took 25mg of Benadryl, waited for 30 minutes, then drove home. I had a similar experience 3 weeks after my second shot with a fresh/homemade pickle that apparently was too raw. Vomiting with mildly swollen cervical lymph nodes treated with 25 mg Benadryl
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (just received the second shot and arm is a little numb) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (just received the second shot and arm is a little numb). At the time of the report, hypoesthesia (just received the second shot and arm is a little numb) outcome: unknown. No concomitant medication or treatment information reported.
COVID; This spontaneous report received from a consumer via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced covid. The action taken with covid-19 vaccine  was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with product quality complaint:
Patient experienced an injection-site reaction following immunization administration. She reported pain and swelling in her right arm that radiated down to the right hand. A cold pack was given to the patient and one dose of Diphenhydramine 25 mg solution was given by mouth. A couple minutes after the Diphenhydramine was administered, she reported that her face felt "weird" but she denied any shortness of breath, throat swelling, or any other S/S of anaphylaxis. She was monitored for about 30 minutes following the adverse reaction, and after about 10-15 minutes following Diphenhydramine administration, she said that she was feeling a lot better. We let her know that she is free to stay at the pharmacy as long as she would like, but she said that she wanted to leave and that she felt fine to leave and to drive herself home.