chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM; No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None;Question:Was there parental vaccine exposure?Answer:No.     On 09-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM).    Patient dose details reported as: 1st dose: Moderna batch/lot number 027L20A-Administered on 12-Jan-2021  2nd dose: Moderna batch/lot number 043L20A-Administered on 09-Feb-2021 3rd dose: Moderna batch/lot number 037F21A-Administered on 06-Dec-2021  4th dose: Moderna batch/lot number 058A22A-Administered on 07-Jun-2022  On 09-Dec-2022 patient received fifth dose as additional booster dose.  No concomitant medication information was provided.  Patient didn´t report side effects.  No treatment medication were provided.
This case described the occurrence of exacerbation of arthritis and fibromyalgia in a 47 year old female who received Lyme disease vaccine recombinant OsaA (Lymerix) for prophylaxis.  This report was received from the pt and has not been verified by a physician or other healthcare professional.  The medical history reportedly included allergy to sulfa-containing medications, fibromyalgia and arthritis. Concurrent medications included naproxen (Naproxyn) and fluoxetine hydrochloride (Prozac). The pt stated that she was bitten by a tick in October 2001.  Reportedly, a physician removed the tick and recommended that she receive the first injection of Lymerix, which was administered on 10/05/01.  The pt stated that on 10/06/01, one day post-immunization, she developed swelling in her arms and pain "in her body", which she attributed to worsening of the pre-existing fibromyalgia and arthritis.  The pt stated that "the pain has never let up.  My body is deteriorating, and they tell me if the rate of acceleration does not slow, my bones will eventually fuse together."  The pt stated that due to the swelling of her arms that she experienced post-immunization the Lymerix immunization series was discontinued.  As of 08/11/03, the arm swelling had reportedly resolved.  The worsening of pre-existing fibromyalgia and arthritis was "worse".
Participant started becoming diaphoretic and pale in color at 15:00. Participant began to lose consciousness, at which point his feet were elevated. Participant was at a decreased level of consciousness with difficulty responding to his name for approximately two minutes. Participant became more diaphoretic BP 102/54, HR 42. After two minutes participant was able to respond to his name, answer what day it was and where he was at correctly. Participant was given a glass of water to drink. At 15:09, BP 104/42. At 15:29, BP 110/62 HR 48. Pt stood reported no dizziness and stated he would have a snack once returned to his desk. Participant was pink in color and stated feeling good enough to return to desk. Participant was allowed to leave at 15:37.
big knot where the shot was done; red; really hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot). At the time of the report, VACCINATION SITE MASS (big knot where the shot was done), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (really hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported. No treatment products reported.
I experienced flushing with fever and chills starting the evening of the 4th and ending on the morning of the 6th
fever; body aches.; Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.), PYREXIA (fever) and MYALGIA (body aches.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LISINOPRIL and PHENTERMINE for an unknown indication.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.). On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.), PYREXIA (fever) and MYALGIA (body aches.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   COVID-19+: Unknown. Other vaccines: No. No treatment drug information was provided.
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during  3 days
Case received from a healthcare professional on 26 September 2008 under the local reference number 08-0447. This case deals with a cluster of 5 male and female patients. Fifteen patients (staff members) had received their 1st intramuscular dose of ADACEL batch number C3027BA in the deltoid (right and left) on 23 September 2008. On 24 September 2008, i.e. the following day post-vaccination, five of the fifteen patients aged 20-50, developed local reactions described as slight swelling, swelling to 4" diameter, T 99.9 (37.C) and sore arm (X2). No diagnostic tests or lab data were preformed. All the patient received treatment symptomatically. The patient's events were not resolved at the time of the report. Follow-up information concerning six female patients was received from a health care professional on 08 December 2008. This case now refers to a specific adult female patient (age not reported). The patient had not received any additional vaccinations within four weeks of 23 September 2008. It was indicated that the patient recovered (date not provided). No additional information was reported concerning this patient. Follow-up information received 09 February 2009 from a health care professional.  ADACEL had been administered in the patient's right deltoid and the injection site swelling had been approximately one two inches (previously reported as "swelling to four inches diameter"). The patient had no illness at the time of vaccination and the symptoms resolved in seven to 10 days. No additional information was provided. Documents held by sender: None. The reporter of this case is the same as cases 2008-03923, 2008-03924, 2008-03926 and 2008-03927.
Within a few hours of receiving the vaccine she began to have severe pain in that arm. 48 hours later she still cannot move her arm without pain. Even the weight of a t-shirt or coat hurts. Acetaminophen doesn't help. Minimal redness. Some swelling.
About 1-2 days after second Pfizer shot in series, I became very sick, achy, almost went to the ER because it felt like I was having a very bad reaction that felt like a heart attack. Sore body aches and pain; feeling very weak and uncomfortable for about 3 days. In bed and slept for about 2 days straight.  Very tired and lethargic. Still have joint aches and always tired.
pt recv vax 10MAR98 & mom reported red bumps on neck;mom brought child to clinic had red whelps over body & swelling of face;sent to ER;seen in MD office given DPH;
Sick; Fever; Chills; Arm was hot; Arm was /red; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, chills, extremities hot feeling of and erythema of extremities. On an unknown date, the outcome of the sickness, fever, chills, extremities hot feeling of and erythema of extremities were unknown.   It was unknown if the reporter considered the sickness, fever, chills, extremities hot feeling of and erythema of extremities to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that patient received shingles vaccines and felt sick too,fever,chills, arm was hot and red. This case is linked to the case US2021AMR158035,reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158035:same reporter
Received Rotateq on 9/25/19 @ 1100, vomiting started @ 2330 9/26/19, vomited 2 episodes then, denies hematemesis, did not feed @ 0400 on 9/27/19, blood noted in diaper without stool @ 0400, called exchange and sent to ED, unable to reduce intussusception, surgery (reduction & appendectomy) @ 1230 9/27/19
02/06/21-Received the vaccine . 02/08/21 -(48hrs post vaccine)developed severe head ache,brain fog, muscle pain,electric sensation across hands and legs, nausea,chills,tiredness, severe fatigue. Symptoms continue to persist. 02/11/21-Continued to have severe Headache,developed muscle twitching in arms and legs.
I have not had a period in over a year, I am past menopause and exactly three days after getting vaccinated I have started bleeding, and have a period again. I know this is not normal. I also have period cramps and bloating, as I used to when I had regular periods. Being 52 and having a period again after menopause is what I want to report.  This should not be happening. This is from getting the Johnson & Johnson vaccine.
lymph node pain; severe pain in arm that vaccine was given in; dizziness; nausea; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 39-year-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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, day after vaccination, the patient experienced dizziness, nausea and fatigue and on 10Apr2021, from second day to the time of report the patient experienced lymph node pain and severe pain in arm to which vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit.  Therapeutic measures were not taken as the result of adverse events. The clinical outcome of the events dizziness, nausea and fatigue, lymph node pain and severe pain in arm were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Headache on day of vaccine.   Then was fine for 2 days.  Then 3 days later with headache, dizziness and briefly blurred vision.  By 4 days later (day of visit and report) headache is mostly gone, but intermittently returns.
Patient had severe reactions during all vaccine series. She experienced burning, aching muscle and joint pain over her whole body. Severe headaches, abdominal pain, stomach sickness and severe heart burn. On her 3rd shot, Her tongue swelled up and she could not control her saliva in her mouth. We went to the ER and the doctor did not know what was going on but diagnosed as an unknown virus. We are proceeding to investigate her abdominal pain and Gastritis, as it has not subsided and it's been a year to date.The doctors here are at a loss and diagnose it all has an unknown virus. Patient has been a very healthy girl since birth but this past year has been long and she's been feeling unwell ever since the vaccines.
Generalized erythema; After dose 2 woke day after w/same headache but it only lasted 8 to 10 hours; This is a spontaneous report from a contactable other hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (Batch/Lot Number: 1-N6201) as 2nd Dose, SINGLE DOSE for covid-19 immunisation. Medical history included sinus issues environmental 'dust mites, ash trees which came sinus issues,  exposure to sars-cov-2 from an unknown date and unknown if ongoing. The patient concomitant medication was not reported. The patient previously took first dose bnt162b2 for covid-19 immunisation and experienced Chest tightness/achiness, mild/partial loss of smell, headache, sinus discomfort (pressure, ache), Breast tenderness and patient previously took penicilline and experienced urticaria. About 5 or 80 years ago retested and not allergic any longer. The patient experienced after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours on 21Feb2021 and generalized erythema on an unspecified date. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-COV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being reported.  the patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination. The patient did not dermatological/mucosal, generalized urticaria (hives), angioedema (not hereditary), generalized pruritus with skin rash, generalized pruritus without skin rash, generalized prickle sensation, gastrointestinal, diarrhea, abdominal pain, nausea, vomiting. The patient underwent lab tests and procedures which included chest x-ray: normal, electrocardiogram: normal, sars-cov-2 test: negative on an unspecified date. The patient did not receive any treatment for the event after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours. The outcome of the events after dose 2 woke day after w/same headache but it only lasted 8 to 10 hours was reported as recovered on an unspecified date and generalized erythema was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Events:tachycardia, chest discomfort, heart palpitations, tinnitus, paresthesia (numbness, tingling, pins and needles)(head/face, neck, arm, leg, and foot), burning sensations, internal tremors/vibrations, muscle spasms, neurocognitive disorder, headaches/migraines, severe anxiety/depression, insomnia, and jaw pain. Treatment: Prednisone, Gabapentin, Cymbalta
CIN grade 2 pre cancer; first dose on 26-FEB-2018, second dose on 23-OCT-2018, and the third dose on 27-OCT-2019; This spontaneous report was received from the Pharmacist, who refers to a 24-year-old daughter.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 26-FEB-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); the second and third dose she received on the following dates respectively: 23-OCT-2018 and 27-OCT-2019 (inappropriate schedule of product administration). Outcome of the event was unknown.  On 20-OCT-2021, the patient had a Pap smear (the Papanicolaou test), that identified potential precancer [Cervical intra-epithelial neoplasia (CIN) grade 2 precancer] (cervical dysplasia), and a loop electrosurgical excision procedure (LEEP) was completed on an unknown date in March 2022 (exact date unknown by reporter). The gynecologist (OBGYN) stated the CIN grade 2 was in the glandular area, not just surface, type unknown. Pap smear tests made on an unspecified dates in June 2022 and August 2022 were negative. At the time of report the patient was Human papillomavirus (HPV) negative. No additional information provided.  The causal relationship between cervical dysplasia, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee pain (for several years) and Back pain (for several years).    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Decrease in joint pain after getting the Moderna covid19 vaccine/kneed and back pain has gone for 4 days/no night crams) outcome was unknown.            No concomitant medications were reported.  Reporter stated that they had the second booster with Moderna on the 01-Apr-2022, and that patient suffered for bad knee pain and back pain for years, and after two hours of getting the vaccine, their pain was reduced. Patient's knee and back pain had gone for 4 days. Also patient had no night crams.  No treatment medications were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-DEC-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K007262, expiry date: 25-NOV-2015 (dose, strength and frequency were not reported). No concomitant medications were reported. No adverse effects have been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information is not expected as the reporter did not wish any further contact.
Local redness, inflammation, hot to touch. Fever 100+. Treatment IV fluids and antibiotics for possible cellulitis.
7-21-08 client came in to have PPD read.  Lt. arm from elbow to about 4 inches from shoulder was red and warm.  No rash, blisters or any peeling.  Could identify injection mark.  7-24-08 redness resolved.  Sm. blister at injection site.
Started to feel fatigue with headache. Before the flu shot, I felt in great health and was able to exercise with no problem. The day after the vaccination, I started to feel under the weather and symptoms got much worse on the weekend.
Chest pain and cramping and struggling to breathe.  This began around 6:45 am.  The pain and struggling to breathe intensified.  We ended up in the ER by 7:45 am.  A chest x-ray, full blood panel and EKG was performed.  No issues were discovered.  500 mg of Tylenol was administered and within 30 mins the pain in chest diminished.  My child was extremely scared as was I and the reaction was unexpected.  The ER didn't act like it was a common occurrence in pediatric patients and nothing they had seen occur from pfizer vaccine.
12 hours after injection, got the chills before bedtime. Woke up often with arm soreness. Next day very fatigued; chills; headache; dizziness. 24-48 hours after injection moderate symptoms, lasted about 72 hours.
Patient stated her dr wanted her to get a pneumonia shot, stated she couldn't remember her last pneumonia shot. We looked at STC and IRIS no record on either. She stated it had been 10-15 years since last. Thus thought received Pneumo23.  We called dr Monday to see if she had record  of the a shot. They stated she got Prevnair 13 in 2013, thus this was her second.
Patient reported to mother that she started feeling bad at work midday. Per mother, patient c/o general achiness, fever (unknown temperature reading), HA, chilled yesterday and this morning. Took Tylenol x1.
Approx. 45 min to 1 hr after receiving imm. began sneezing uncontrollably with rash to face and restlessness "like all the energy drained out of him". No fever, no respiratory difficulty. Tx with Benadryl, and observation. Symptoms persisted x 24 hrs
Information has been received from a physician concerning an 18 year old female who on 25-JUN-2007 was vaccinated IM in her left deltoid with the first dose of Gardasil (Lot#655617/1447F).  Concomitant therapy included MENACTRA.  A few days later on approximately 27-JUN-2007 the patient experienced weakness in her left eye.  She went to an ophthalmologist who diagnosed her with uveitis.  She was treated with "high doses" (actual doses not reported) of unspecified oral steroid.  The physician reported that at the time of the report the patient was recovering from the event.  Additional information has been requested.
left arm redness, warmth, and soreness feels flush and ears ringing. Benadryl and Augmentin.
Pt states 2 days after Tetanus shot was given pt started with (L) shoulder to neck pain. This does radiate down her arm at times. No injury during this time. Feels is from the shot. Pt called our office to report this pain continues on 1/7/11. Told to use ice, rest and that symptoms should be gone in more wks.