chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of exercise induced asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced exercise induced asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 34 subjects who onset exercise induced asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcome among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of VARIVAX subcutaneously, lot #: M041081, expiration date on 06-OCT-2018, lot #: M044347, expiration date on 04-NOV-2018 and lot number reported as: M044307, expiration date on 04-NOV-2018 (strength, dose number and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown. It was reported that the dose of VARIVAX M041081 was improperly stored at 14° Fahrenheit degrees for 34 minutes; the dose of VARIVAX lot number reported as: M044307 was improperly stored at 6° Fahrenheit degrees for 4 hours and 49 minutes and the dose of VARIVAX lot #M044347 was improperly stored at 6°F to 14°F (10°F-4 cycles) for 30 minutes. This excursion was detected due to a digital data logger. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1706USA010046.
pt recvd vax & exp chills, fever of 102, soreness & redness at inject site,n & v, bloody stools & pain in upper rt quadrant;
This spontaneous report as received from a pharmacist refers to approximately 78 year old female patient. Pertinent medical history and drug allergies were none. On 03-MAR-2014 the patient was vaccinated with single dose of ZOSTAVAX lot # J011337/expiry date: 13-DEC-2014, subcutaneous in the left arm. Concomitant medication was none. On 04-MAR-2014 the patient experienced redness, swelling, soreness, and itching at the injection site. On 05-MAR-2014, 3 days after onset of therapy the patient experienced numbness of both upper arms. The patient sought medical attention since she visited the pharmacy. No lab diagnostic test was performed. No treatment was rendered. It was reported that the patient was referred to her physician for evaluation. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Pt devel a fever & vomited on evening of 30MAY92; vomiting stopped 1JUN but fever persisted & was documented 100R @ office visit 4JUN92; pt was anorexic; PE unremarkable x/for doughy abdomen & some frequent water stools;
Temp 102-103 deg, approx 24 hour after injection, complained of stomach ache, headache, pain at injection site, red (swollen) rash. (no other IRI 5x's), no cough, no sick contacts).
Day of the vaccine she started to become fatigued. The next day at night she started to vomit. No noticeable pain or discomfort other than continuous vomiting. She went to school the next day however she did come home early. At day 3 post vaccine she started to have diarrhea as well. On Friday she started to feel better however continued to have diarrhea. On Saturday she was feeling back to normal. Went to a swimming class and in the late afternoon she began to vomit again and have diarrhea as well. We took her to ER and they did all the tests including COVID-19 tests and all were negative. They believe that it was due to a viral infection. The doctors did not believe it was due to the vaccine. She had IV fluids and was sent home. She has started feeling much better as of Saturday.
a patient received GARDASIL and may not have completed the series with GARDASIL; a patient received GARDASIL and may not have completed the series with GARDASIL; No additional AE reported; This spontaneous report was received from a pharmacist referring to a currently 35 years old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.         It was reported by the pharmacist that the patient may not have completed the series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (circumstance or information capable of leading to medication error and inappropriate schedule of product administration). No additional adverse event was reported.
2nd dose on 5.15.21   at 5 am     reports he has pain and swelling in left arm, more so in his left hand and digits. He was given Ibuprofen and calling medical professional
Pt recv vax on 4/5/99; 1 hr post vax pt exp fever (102), vomiting, diarrhea, red macular rash, dyspnea, exacerbation of asthma sx; tx=Ibuprofen
Patient died 72 hours after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died 72 hours after receiving the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 26-Apr-2021 The patient died on 26-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication was not provided, Treatment medication was not reported.  A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported.  Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported.  Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Died 72 hours after receiving the vaccine.
2nd dose of Hepatitis A given less than 6 months from dose 1. Did verify with a second RN but was not caught that it was given early until patient checked out.  It was brought to my attention, I immediately went to speak with parents and informed them that I had administered 2nd dose too early and that it would have to be repeated for school, 6 months from 1st dose administration. Parents verbalized understanding.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 09-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Had intense tremors and spasms from about 8pm on 9/25 until about 4am on 9/26 and then had them periodically until 9/27. Also had severe brain fog and short term memory loss from 9/27-9/28.
muscles aches; joint pain; fever; This serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 22-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-APR-2023, 1 hr after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscles aches) (serious criteria clinically significant/intervention required), joint pain (Verbatim: joint pain) (serious criteria clinically significant/intervention required) and fever (Verbatim: fever) (serious criteria clinically significant/intervention required).  On 24-APR-2023, the outcome of the muscle pain and fever were resolved. The outcome of the joint pain was not resolved.   It was unknown if the reporter considered the muscle pain, joint pain and fever to be related to Shingrix.     It was unknown if the company considered the muscle pain, joint pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023 The physician reported after administration of first dose of shingrix vaccine within 1 hour patient experienced fever, joint pain and muscles aches. Reporter stated she got over fever and muscle aches with first two days after vaccination. The patient was still suffering from joint pain and her physician asked her to see rheumatologist for the joint pain. The patient had appointment with rheumatologist on 4th October. The reporter consented to follow up.
patient got vaccine on 12.14.20  and called pharmacy on 12.17.20 to report a tennis ball size area of redness, swelling/hardness and pain at injection site
flu symptoms for a few days with minor headache, experienced a Primary Exertion Headache (16 hour duration), ongoing headaches with somedays more servere than others, using over the counter medication. Doctor proscribed additional medication after the Exertion Headache occured.
FEVER; TIRED; This spontaneous report received from a patient via a company representative 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: 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 fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and tired. This report was non-serious.
yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight; yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight; have had a sore upper arm fro 3 weeks after having shot; This non-serious case was reported by a consumer and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-MAY-2023, the patient received Shingles vaccine. In MAY-2023, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain (Verbatim: have had a sore upper arm fro 3 weeks after having shot), mobility decreased (Verbatim: yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight) and induration (Verbatim: yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight). In MAY-2023, the outcome of the pain was resolved (duration 3 weeks). The outcome of the mobility decreased and induration were not reported.   It was unknown if the reporter considered the pain, mobility decreased and induration to be related to Shingles vaccine.     It was unknown if the company considered the pain, mobility decreased and induration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-May-2023 The patient stated that some days unable to lift arm above mid high not even to her shoulder height, sore to the touch hard to lift objects even at a light weight. The reporter consented to follow-up.
From 03/04/14 I began to have shoulder pain and limited movement when raising my arm crossed in front of me.  The pain increased up until month 2.  By then I couldn't sleep on my left side, carry things on my left arm, and would wake up with pain.  After trying hot compress, cold compress, and mud patches the pain diminished some.  Now after 3 months I only have pain when I use my arm to carry or lift.
Soreness to right arm 2 hours after injection on 1/4/21 lasting 2 days. Right arm rash started on 1/11/21 - itchy, warm, muscle knot
After the second dose, within 24 hours had severe fatigue, headache, unable to function.  This lasted 2 days.  On the longer term, had daily unusual fatigue, dizziness, headaches, and a stiff neck.  Continues now in August.  On July 28, 2021 I tested positive for Covid-19 on the PCR test and was extremely ill with all Covid symptoms for 10 days.
Vomiting for 3 days, terrible splitting head ache, ear ringing, disoriented, confused.  bed ridden for 5, heard things not there unable to eat.
A non-serious, spontaneous report of vomiting was received from a Registered Nurse concerning a seven year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2008 the patient received FLUMIST. On 21-Oct-2008, the patient vomited within a couple of hours of receiving FLUMIST. The outcome for the adverse event was not reported.
Patient received the flu vaccine on 12/5/17, of note-patient has extreme anxiety and took 3 people to restrain her. The next day, the mother noticed the arm red and swollen. She made appt. on 12/6/17, picture was taken of left arm.
Two days after immunization, the site started getting red and warm. One week later site is still red and warm. It is an unraised rash about the size of a half-dollar. It no longer itches. UP to this point, patient has not taken anything for symptoms. I recommended that she notify doctor and that she should use a cool compress/ice pack if the warmth was annoying and she could use hydrocortisone cream or take Benadryl if she chose to.
Patient has history of muscular sclerosis symptoms without a confirmed diagnosis. Patient experienced muscle spasms in the days after the vaccination.
Cardiac arrest within 1 hour  Patient had the second vaccine approximately 2 pm on   Tuesday Jan 12th  He works at the extended care community and was in  good health that morning with  no  complaints.  He  waited  10-15 minutes at the  vaccine  admin site  and then   told them  he  felt  fine and was  ready to get back to work.  He  then was  found unresponsive at 3 pm within an hour of the 2nd vaccine.   EMS called immediately  worked on him 30 minutes in field then 30 minutes at ER  was able to put him on  life support  yet deemed Brain  dead  1-14-21 and pronounced dead an hour or  so later
Increase heart rate during the night when at rest. Heart rate 136BPM-144BPM.
Starting 8 hours after shot, 101 fever, chills, body aches, headache
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA323313, 2018SA323314 and 2018SA323310 (same reporter). This case involves a 14 years old female patient who was vaccinated with 0.25ml dose of FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) instead of 0.5 ml, on 21-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due vaccine underdose. It was reported that they accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVALENT instead of the 0.50mL dose. The patient had no adverse event. 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 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. List of documents held by sender: none.
Dizziness within 1 minute of administration of 2nd shot (Adacel 1st then Menactra 2nd).  Patient took off his mask --lips were white, then put head down and was unresponsive for about 15 seconds.  Came to and wanted to know what happened.   Gave patient poweraid drink, his color returned to his lips.  He stated he couldn't hear but was able to answer questions.  He sat for about 10 minutes and was feeling better.  Grandma and patient walked the store for about 15 minutes and came back to pharmacy where he stated he was feeling fine.
experiencing pain on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing pain on site of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experiencing pain on site of injection). At the time of the report, VACCINATION SITE PAIN (experiencing pain on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rosacea on my face; a new itchy spot on her arm; several "blotches"; red places on both arms and collar bone; another "spot" developed on her arm; started itching; left arm started to "Get itchy"; red puffy, welts on her right arm (2" in diameter); big round red mark ("spot") at the injection site; itchy; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), PRURITUS (a new itchy spot on her arm), ERYTHEMA (red places on both arms and collar bone) and ROSACEA (Rosacea on my face) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 47A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX, FLU VACCINE VII and PNEUMOCOCCAL VACCINE (Pneumonia Vaccine). Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 22-Feb-2021, the patient experienced PRURITUS (a new itchy spot on her arm) and ERYTHEMA (red places on both arms and collar bone). On an unknown date, the patient experienced ROSACEA (Rosacea on my face). The patient was treated with STEROIDS from 23-Feb-2021 to 01-Mar-2021 at a dose of UNK milligram. On 23-Feb-2021, PRURITUS (a new itchy spot on her arm) and ERYTHEMA (red places on both arms and collar bone) had resolved. At the time of the report, VACCINATION SITE REACTION (COVID Arm) had resolved and ROSACEA (Rosacea on my face) was resolving.            Treatment:  Ice, anti-itch powder, Aveeno anti-itch cream, Metronidazole 0.75%   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: VAERS form On 22-Jun-2021: Significant Follow up information received, new event added