chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Vaccine Card had Infant Pfizer as the first dose of series. I vaccinated patient with another Infant Pfizer as the second dose in the series. Patient was over age of 5 at time of second dose administration as was verified. Due to the first dose being marked as infant the decision was made to complete the series as started. After vaccination I went into the electronic records and saw that the records was contradictory to what was recorded previously on the vaccine card as the electronic records had Orange Cap Pediatric Pfizer as being recorded. It is unclear what dose the patient received previously as there are two different records of the event.   **** Patient had no immediate adverse reactions or symptoms after receiving vaccination. ****
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of GARDASIL 9 injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature between 32 degrees Fahrenheit (F) and 36 degrees Fahrenheit (F), with the lowest temperature of 33 degrees Fahrenheit (F), for unknown period of time. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000338: US-009507513-1703USA000337: US-009507513-1703USA000335: US-009507513-1702USA009503:
I end up with the flu; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case from consumer/non-healthcare professional via Digital Media.  This case involves patient (unknown age and gender) who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date, the patient had flu (influenza, non-serious) (unknown latency) following the administration of vaccine.  It was reported "Not getting it period everytime I get it I end up with the flu"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been  received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.         On 21-SEP-2020,  the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) Lot # T013539, expiration date 17-OCT-2021 for prophylaxis (dosage regimen  was not reported). The storage temperature was reported  to had been  between 6°F to 14°F, specifically at 11.7°F  for 25 minutes.            There was digital data logger involved and  no previous temperature excursion was reported.
very splotchy rash and very sore above and at injection site,  mild chills, very tired and achy
No AE; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a 4 years old patient. No medical history, concurrent condition, or concomitant therapy was reported.       On 14-JUN-2021, there was a temperature excursion on measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). This vaccine was improperly stored at the temperature of 6 F to 14 F (10 F) for 7 hours (product storage error). On the same day, the patient was vaccinated with this improper vaccine (lot # T027112, expiration date: 07-FEB-2022; dose, frequency and route were not reported) as prophylaxis. Previously, there was also temperature excursion at 6 F to 14 F (6.10 F) for 1 hour 30 minutes. The call was not because of a data logger. No adverse event was reported.
Pt sts shortly after receiving the vaccine she became lightheaded.   She passed out before she knew she was going to and as a result she fell out of her chair hitting her head.   She has a minor abrasion approx 8mm in diameter to the L forehead.  Swelling is minor as well, there does appear to be a light contusion as well.   Pt sts she has not passed out with needles or injections before.   VS: HR 110, BP 122/58, RR 14, Sats 98%.  PMSx4, skin signs normal.   Pt went to first aid area and allowed vitals.  She does have tenderness to the site of her abrasion on her forehead.  Her lightheadedness resolves and she denies all further complaints.  She does not complain of headache and does not want further treatment.   She declines further assessment, including a second set of vitals.  Risks of refusal given.  Pt notified that VAERS will be completed.  Pt instructed to follow up with her doctor.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 at  time of administration. Patient also did not call in to complain of adverse event. This is administration error without adverse event.
9/24 Patient c/o "lump in stomach", nausea Friday eve. at 6 pm. At 12 midnight he vomited and had diarrhea, total of vomiting x 4 and diarrhea x 2 throughout the night. On Saturday 9/25, he felt weak and had no appetite. By Sunday 9/26/10 he felt better. Ate at a restaurant 9/23.
No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 11-SEP-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968393 and expiration date 24-MAY-2024, for prophylaxis (exact dose, dose number and route of administration were not provided) (experienced product storage error and no adverse event). On 14-AUG-2023, the temperature excursion lasted 12 hours 20 minutes 0 second in temperature 8.9 Celsius degrees (°C). On 28-AUG-2023, the temperature excursion lasted 8 hours 20 minutes 0 seconds in temperature 9.4 Celsius degrees (°C).
Very sore arm, rash and redness at injection site. Headache, light body aches and joint pain. Tired and sleeping a lot, diarrhea with a little bit of upset stomach. Seem to have hot and cold chills but not too strong
Increasing pain in right arm.  Large swelling about 8 inches by 6 inches, raised about an inch about 5 hours after vaccination.  Took advil and benadryl and iced the site with a small ice pack wrapped in towel. Pain from elbow to shoulder.  Called office in the morning,  and the saw me just short of 24 hours after the shot.  They prescribed pepcid and steroid cream, continue with benadryl and advil. Swelling still present, plus increasing redness 24 to 36 hours after injection. On the morning of 9/10 swelling and pain has decreased  but redness is increasing, encircling my whole upper arm, approximately 6 inches top to bottom.  Pictures are available if needed
Inappropriate Schedule of Vaccine; Tiredness; Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 1st July 2018, refer linked case US2019186011).   On 2nd June 2019, the patient received the 2nd dose of Shingrix. On 2nd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced tiredness, nausea and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, nausea and dizziness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the tiredness, nausea and dizziness to be related to Shingrix.  Additional information received were as follows: Less than 5 months after receiving Shingrix, the patient experienced tiredness, nausea and dizziness. The symptoms lasted a day. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
mom stated @ 4mo visit that pt had screaming, inconsolably for hrs for 24hrs off & on p/initial vax;
The patient was given 5 vaccine at 5:10PM and I informed the patient to remain seated until I returned with a printed copy of immunization records. When I returned to the room at 5:15PM I found the patient in a seated position, her skin was very pale, and she appeared fatigued. I asked the father what happened and he stated that she momentarily passed out in her seat for no more than 10 seconds after complaining of nausea. I asked the father if she hit her head or fell to the floor and he said no. I proceeded to inform my provider who came to clear her before leaving and I gave her some orange juice to replenish her blood sugar level.
Information has been received from a physician concerning a patient's aunt who in '1950's" was vaccinated with MMR II (manufacturer unknown). Subsequently sometime in 1950's she experienced an anaphylactic reaction and was hospitalized. She was treated in the hospital, but eventually recovered. Anaphylactic reaction was considered to be immediately life-threatening and an other important medical event. The patient's father (WAES 30605USA04639) had a similar experience following vaccination with MMR II (manufacturer unknown). No further information is available.
I would wake up at around 3 to 4am with severe inner chest pain and it would take around 2 hours to calm down. I am now taking Colchicine to reduce inflammation.
Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 12Aug2021 (Lot Number: FA7484) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks prior to the administration of the suspect vaccine. The patient experienced appendicitis (caused hospitalization, medically significant) on 25Aug2021 with outcome of recovering. The event required emergency room visit. The patient was hospitalized for appendicitis from 25Aug2021 to 28Aug2021. Therapeutic measures were taken as a result of the event and included appendectomy on 25Aug 2021.   No follow-up attempts are possible. No further information is expected.
Pt developed hives at the injection site where the adhesive from the bandages were. Pt developed a macular rash that started on the thighs/groin area and spread to the rest of the body.
Red/swelling to entire thigh on right side. Warm to touch, patient very upset and crying in pain for several hours. Benadryl given to treat reaction.
This spontaneous report as received from a health professional via other company letter refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with PNEUMOVAX23 (lot # N024717, expiry date: 06-APR-2019) and PREVNAR 13 (lot # T94429, expiry date: 31-MAR-2020; T94424 and expiry date: 31-MAR-2020; lot # T62565, expiry date: 28-FEB-2020) following temperature excursion at 1.29 °C for 100 minutes. The outcome of the event was unknown.
Hyperglycemia; Injection site swelling; Injection site redness; Tenderness of the injection site; GI symptoms; Fatigue; Headache; Muscle ache; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 25th April 2019 (refer case US2019AMR131452).). Concurrent medical conditions included type i diabetes mellitus.   On 12th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. In July 2019, the patient experienced injection site tenderness, gastrointestinal symptom nos, fatigue, headache and muscle pain. On 15th July 2019, the patient experienced hyperglycemia. On 17th July 2019, the outcome of the injection site erythema and injection site tenderness were recovered/resolved. On an unknown date, the outcome of the injection site swelling and hyperglycemia were not recovered/not resolved and the outcome of the gastrointestinal symptom nos, fatigue, headache and muscle pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, gastrointestinal symptom nos, fatigue, headache, muscle pain and hyperglycemia to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on right deltoid. The lot number for Shingrix was not reported. The patient experienced multiple adverse events from both the doses of Shingrix. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced redness and swelling of the injection site of the right arm. Also, GI (gastrointestinal) symptoms, fatigue, headache, generalized muscle ache (whole body). The redness and tenderness of the injection site almost resolved at the time of reporting.  The patient noted hyperglycemia from 15th July 2019 and still ongoing, requiring her to triple her dose of her short-acting insulin. The reporter consented to follow up. In form structural field outcome for event swelling reported as RECOVERING/RESOLVING, but as per narrative section only redness and tenderness were reported as resolved. So outcome captured as per narrative.
Red at site 24 hours  Tired 24 hours  Throat sore 24 hours  Ears itch  Throat tightening  within 72 hours
Developmental delays, poor eye contact, speech delays, agitated when held occurring between 1 to 6 months after MMR. Food allergies, diarrhea, weight loss, looking through peripheral vision between 6-12 months.  Nurse follow up on 07/20/04 states: "Complete."  Per annual report-He has an official "autism" diagnosis from AGRE 2005.  He still continues to have unformed stools.  He has sensoriy processing problems.  He does not like to touch most foods, he has obsessive compulsive issue of needing to touch you last.  He is currently recieving early education services with autism consultant and speech therapist.  His speech is improving but still delayed for his age.  Mom would like more research on : "If I received vaccines as a child what if any immunity was passed to my child and now their receiving vaccines affects them.
Approximately 3 days after receiving the vaccine her arm got very red and swollen. It is still somewhat inflamed but is residing since that dose.  She did not take any ibuprofen to reduce the swelling until 3/15/2021. It is beginning to feel better.
Symptoms began in early morning hours.  Low grade fever, chills, muscle aches.  Flu like symptoms.  Injection arm was very warm and tender.  Can not lift or put any pressure on it.   I have been pushing fluids and taking ibuprofen (600mg) every 6 hours.
I get bronkidious after the Flu shots; 3 days 24/7 coughing; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media.  This case involves an unknown age patient who get bronkidious after the Flu shots (bronchitis) , 3 days 24/7 coughing (cough), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that patient get bronkidious after the Flu shots (bronchitis) , 3 days 24/7 coughing (cough) will just take you out (Unknown latency) following the administration of Influenza Vaccine.  Final diagnosis was patient get bronkidious after the Flu shots and 3 days 24/7 coughing.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for both events.  No further information was reported.
The 1st dose we had no issue with but from the day he got the 2nd dose to right now-more than 3 weeks later, he has a large reddened knot in his arm that is warm to the touch and is very painful. He had just gotten over his fear of getting injections and thanks to you nice folks there...he never wants another, and I don't blame him!! By the 2nd day, it was as big as a golf ball-and he's not a crying type kid but in my 50 years, I've never had or given an injection that has done that!! I would never have willingly done that to him-as a guinea pig for you had I known THAT YOU ALREADY KNEW THAT 79% of the boys his age were having this happen? You people suck!
Patient presented in clinic with left thigh swollen and getting worse. Patient sent to EC by NP for X-ray.
Experienced a red welt-like skin reaction on my upper left thigh and about two weeks later it had begun to spread. The welt did not itch or cause any immediate pain. Over time it became warm to the touch and the lymph node in my groin had swollen.
Itch, swollen, tenderness, and  red at vaccine site one week after vaccination was administered
first day after got fever, aches, chills one week out developed buzzing in ears. has not gone away!
Pt experienced a rash consisting of 12-14 lesions. Half were atypical with vesicles resembling chickenpox. The remainder looked like bug bites, raised red and itchy. A mild fever was noted and mild upper respiratory symptoms.
Patient complained of soreness and "cannot lift his arm up" in his left arm where he received two vaccinations - Pneumovax-23 and Fluvirin PF, intramuscularly.  Complained about the arm in the evening of the same day when he received his vaccinations.
I was asleep and my smart watch, it started clicking on my wrist and asked if I was having a heart event because it looked like I wasn't exercising. I used the watch to check my heart and it said I was in A-Fib. I went to the emergency room they confirmed I was in fact in A-fib. They gave me an amiodarone drip that did not work. They did give me a cardioversion that did work. I was given new prescriptions of amiodarone.
muscle pain/severe muscle pain; headaches; fever/occasional fever; utter exhaustion; body aches; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, headache, fever, exhaustion and general body pain. On an unknown date, the outcome of the muscle pain, headache, fever, exhaustion and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, headache, fever, exhaustion and general body pain to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got 1st dose of Shingrix 11 days ago of reporting date and still had severe muscle pain, headaches, occasional fever, utter exhaustion and body aches. The patient enquired was this normal and how many days can side effects last. The patient reported that all the above symptoms come and go and seem to get worse at night.
pericarditis 3 weeks after 2nd vaccine dose. Chest pain. HS troponin 7000. Further workup pending
axillary temp of 99.2;strong uncontrolled jerking movements in sleep;jerking movements occurred every few mins during sleep times
Per patient: After receiving his HPV vaccine he stood up, felt dizzy and fell striking his forehead on the cover of the exam table. It was not witnessed. Pt had not eaten yet that morning.
sharp pains in legs and arms- 2 days burning in the spine- 1 day -now its sore pressure in the chest with heart palpitations and shortness of breath- 2 incidents   excruciating migrane- 2nd day  burning in the arm of the vaccine shot- 2 days dry month and numb lips- 1st day pain in joints- knees and ankles - 2 days
Hot, inflamed, swollen rash and lump at injection site approximately  3" wide x 2" high
The arm she got the shot in has been real dry; The arm she got the shot in has been flaky; never had eczema before; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DRYNESS (The arm she got the shot in has been real dry), VACCINATION SITE EXFOLIATION (The arm she got the shot in has been flaky) and ECZEMA (never had eczema before) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DRYNESS (The arm she got the shot in has been real dry), VACCINATION SITE EXFOLIATION (The arm she got the shot in has been flaky) and ECZEMA (never had eczema before). At the time of the report, VACCINATION SITE DRYNESS (The arm she got the shot in has been real dry), VACCINATION SITE EXFOLIATION (The arm she got the shot in has been flaky) and ECZEMA (never had eczema before) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient was calling to see if anybody reported dry skin as a side effect. The patient reported that the arm she got the shot in had been real dry and flaky. The patient stated she never had eczema before.  No treatment information was provided by the reporter.
Slight fever, scratchy throat, running nose. COVID positive. Cough started later. They last about 2 weeks.
at 1015 L side of body had sharp pin pricks of pain, shortly after the pain L side from head to toe  feels cold. By 1030 L side of face, neck, shoulder, arm, thigh, and ankle tingles. By 1100 L side of face, neck, shoulder feels tight (like being squeezed or scrunched without relaxing). Its now 1510 and the same reaction is still there.
pt recv vax 8AUG97 & 9AUG97 26hr p/vax pt exp two sz & was hosp p/spending one noc in hosp;
pt recv vax & 4 days post vax pt devel a fever & a severe h/a;monospot test was positive;@ the time of the report, pt had recovered;