chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of  PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Low-grade fever, fatigue, general achiness, especially in leg/hips joints -- these symptoms started late morning the day after receiving the injection, and were gone the following day. Red swollen area below injection site, kind of itchy, but not really a rash -- this symptom started about the same time as the others, but is still there now (2 days after receiving injection).
Bruising at injection site, pain in entire upper arm where injection given, pain in shoulder joint, headache.
Received flu vaccine 12/8. On 12/10 developed fever and seizures. Sepsis work up negative, head CT negative. Dx: complex febrile seizures. 3/3/09-records received-on 12/10/08 2 episodes brief stiffness and eyes rolling back during fever of 103.7. 12/11/08-additional episodes of stiffness and eyes rolling back.
The register nurse informed that on 17-AUG-2015, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route were not reported), lot # L002424, expiration date 23-APR-2016, which was reconstituted with improperly stored sterile water diluent, lot# K018540, expiration date: 27-AUG-2017. Concomitant therapy was not reported. No adverse events were not reported. This is one of several reports received from the same reporter. Lot # K018540, has been verified to be a valid lot number for sterile water diluent. Additional information has been requested.
Patient complained of leg, arm and hand edema 2 hours after vaccine given.  Also complained of feeling tired, lethargic and generalized weakness x 2 days.
This spontaneous report was received from a mother refers to her 13 year old son (who is also the patient). On an unknown date in JUN-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in AUG-2012, the patient was vaccinated with secod dose of GARDASIL, (lot number, expiry date and route was not reported). The patient was yet to receive the third dose of the vaccine and it was well beyond the time frame for dosing listed in the Pl and no side effects was reported. This is one of the two reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-JUL-2013, 0.5 ml, once, intramuscularly) for vaccination. In October 2013 the patient experienced pain from shoulder to wrist. There was ice treatment given for the event. No lab diagnostics studies performed. The patient sought medical attention via spoke to the pharmacist. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 30-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
The injection did sting, but didn't think anything about it. For the first 30 minutes I did seem to be fine, so I was released, but my shoulder was not looked at. It was itching some. About an hour later I started getting a headache, some nasal congestion and a sore throat. I took a couple of Tylenol  and went to bed early. Day 2 I felt sluggish and achy and my stomach was bothering me some. Day three my chilling was worse, but after Tylenol I began feeling better around 6:00 pm. The rest of the week I felt sleepy and achy. My shoulder was feeling sore. I am the type of person that tries to push through  when I feel bad because I live a very busy life. On day 5 I finally looked at my left. It had a large red area beginning at the injection site. I got a tape measure and found it was 10 inches long and 3 inches wide. Today is day 6. I have finally admitted I feel bad and will rest a few days. I am wondering if I should skip taking the 2nd vaccination? . I am also taking some 60mgjAllegra on ce a day.
ITCHING AT SITE OF INJECTION; OOZING AT SITE OF INJECTION; EXCESSIVE SLEEP; HIGH BLOOD PRESSURE; DIZZINESS; HEADACHE; NUMBNESS OF FACE AND ARM; NAUSEA; This spontaneous report received from a consumer concerned a 35 year old female. 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, and batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing at site of injection.  On OCT-2021, the patient experienced excessive sleep. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced numbness of face and arm. On OCT-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, itching at site of injection, oozing at site of injection, high blood pressure, dizziness, and nausea, and the outcome of numbness of face and arm and excessive sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014251.
Approx 18 hours after vaccination lightheadedness and dizziness. Almost passed out. Had to stay in bed for about 2 hours until reaction subsided.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 05-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R018735, expiration date 06-APR-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA008566: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Rare cases of young male adults with symptoms of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) in an adult male patient 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 CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had intermittent temperature excursion to temperature of - 14 Celsius degrees to -10 Celsius degrees (maximus -9.5 Celsius degrees) for 38 hours and 30 minutes.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (lot #T009929, expiration date 16-SEP-2021; route of administration not provided) for prophylaxis (it was also reported that the lot # S031882 expiration date 07-APR-2021 was involved, but no information of administration was provided) (product storage error). There were no previous excursions reported. The digital data logger was involved.
Information has been received from a physician concerning a pt who was vaccinated with 1 dose of MMRII. Subsequently, the pt experienced negative titer to measles and mumps. The pt sought unspecified medical attention. Additional info has been requested.
Trouble sleeping; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Indication: Asthma; This spontaneous report was received from a pharmacist referring to a 58-year-old male patient. His concurrent conditions included asthma and drug hypersensitivity. His historical drug included penicillin. His drug reactions/allergies included allergy to penicillin. Concomitant medications included unspecified asthma medications.  On 09-OCT-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (lot # R009162 and expiration date: 06-JAN-2020) intramuscularly in the left arm for asthma (product use in unapproved indication). On the same day (also reported as later that night), the patient had troubled sleeping (poor quality sleep) due to pain and swelling in left bicep muscle and the left side of his chest wall causing decreased limb mobility (pain in extremity, peripheral swelling, musculoskeletal chest pain, swelling and injected limb mobility decreased). The patient sought medical attention and was prescribed Benedryl on 10-OCT-2019 with a follow-up on 11-OCT-2019 if he has not improved. No lab diagnostics/studies were performed. The outcome of poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity was reported as not recovered/not resolved. Outcome of product use in unapproved indication was unknown. Causality assessment of the events poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity were not provided. No product quality complaint (PQC) was involved.
Complex Febrile Seizure. 102 sudden onset. No illness. CT scan. All labs neg. 24 hour hosp obs. Infant fine since with no other fever. No sick contacts.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's medical history included headaches and arthritis with none drug reactions and allergies. On 09-DEC-2011 the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, dose schedule, route, lot number and expiration date were not reported). Concomitant therapies included methotrexate (manufacturer unknown) maintenance dose. In approximately June 2014 (reported as approximately three weeks ago) the patient experienced shingles on her forehead area and pain, and the patient stated that she was not immunosuppressed. The reporter stated that the patient consulted an emergency room physician who diagnosed the condition. The patient was prescribed with ACYCLOVIR on 18-JUN-2014. On an unknown date in 2014 the patient consulted her ophthalmologist, who prescribed an unspecified medication (not GABAPENTIN) for the pain that the patient was experiencing during her shingles outbreak. Performed laboratory diagnostic studies were unspecified. The outcome of shingles and pain was reported as recovering. The pharmacist did not believe that the patient was still experiencing fluid-filled vesicles. Additional information has been requested.
She got her vaccine, the injection was very painful, and about 2 hours she was not able to move her arm without horrible Charlie horse type pain.  About 5:00 PM she took Tylenol when she got home.  She put ice on it, which makes it ache badly and put heat on it through the night and also has continued to take the Tylenol.    Her arm aches real bad and her hand is tingling as well.  Nothing alleviates the pain.  The Tylenol takes the edge off.  The pain runs into her collar bone and up into her neck as well, and is wondering if it got in a nerve, which is what is acts like.    She got the 1st vaccine about a year ago, but does not remember having any difficulties from that one other than achiness and not feeling well for a couple of days, nothing like this.
Body ache; Fever; Swelling at injection site; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced general body pain, fever, injection site swelling and injection site erythema. On an unknown date, the outcome of the general body pain, fever, injection site swelling and injection site erythema were resolved with sequelae.   It was unknown if the reporter considered the general body pain, fever, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced body ache, fever, swelling and redness at injection site. The reporter stated that, the patient had recovered. No further details were provided.
Acquired hep A-severely ill (age 14). Developed gall bladder disease, acalulus, GERD (age 15). Surgical removal of gall bladder (age 15). Told by MD hepatitis could return with pals. liver problems.
Patient reported that she received her 1st motor in a vaccination on June 2nd, and then the 2nd vaccination on July 2nd.  Patient states that she started having symptoms of significant weakness and lethargy 3 days after her 2nd vaccination. Patient came to the hospital with acute encephalopathy.  Symptoms associated with generalized weakness, especially profound weakness in the bilateral lower extremity.  Patient reported difficulty with ambulation. Patient also noted to have initial findings of pneumonia-which is treated with IV antibiotics. Multiple specialties evaluate the patient. Workup included lumbar punctures.  Abnormal values noted-including elevation in Neuron specific Enolase (NSESF) initially elevated at 53 and then repeat value was elevated at 58.   Other organic medical cause was ruled out, and elevation in abnormal levels resulting in acute encephalopathy is thought to be secondary to murder in a vaccination.  Per the medical service and including specialists: Interpretation of abnormal CSF fluids from 07/20 and 7/22 of NSESF (with an otherwise negative Neuro Work up)  - suggests that this could be secondary to the 2nd Moderna vaccination received on July 2, 2021.
6x8 macular rash right thigh (vastus lateralis area) without tenderness.
Severe local reaction on 11/09/04. Went to ER on day after vaccine. Complained of left arm swelling with itching on left arm and warmth.
pt recvd vax & exp swollen area at inject site; approx 3 days after inject swollen area 3 cm below vax site;
Reports feeling dizziness, unable to focus, voice hoarseness, trembling,  O2 15L by nonresreather mask then nasal O2 at 2L/min.
Headache, Myalgia, Fever, Fever 101.6 ay 8:00PM, Fatigue-Fever and fatigue lasted the longest-5 days Narrative:  Did not feel well with the fever and fatigue.
Pt. states that after receiving the 3rd dose of Moderna 12/23/2021, started experiencing symptoms that evening of both sides of the throat swelling (Lymphnoids), fatigued, weakness, chills, and severe headache. Severe pain (tearing sensation) in the right arm from shoulder down and around the injection site. Dry heaving, ringing in both ears, both legs from the knees down pain, dizziness, difficulty walking (contractions in the back), stiffness throughout the back area, confusion, (low-grade) fever, difficulty sleeping, numbness, tingling sensation in the lower extremities, and severe dehydration. Symptoms have subsided within  72hrs after vaccination. Primary visit 02/16/2022 with recommendations of reporting.
according to mom pt w/fever x 3 days w/unk exact numerical temp grade;fever apparently occurred the day p/vax given @ 10AM;
Sore arm, tunny nose, cough with copious mucous, shortness of breath, low grade fever, extreme fatigue, dizziness, nausea
Patient's arms and torso tensed up within 20 seconds of injection, uncontrolled twitching for approximately 15 seconds. During this time he did not respond to his name. Once twitching stopped, pt. complained of fatigue and weakness.
Started with a fever then parents noted his body shaking/choking, eyes rolled to side lasted 2-3 minutes. Face changed pale color with circumoral cyanosis. Vomited x1 during seizure.
Left upper arm at injection site pink; site measures 38x45mm. No discomfort. Slight raised.
5 min after vaccine, had "body tightness", lightheaded, clammy, dizzy, and slight shortness of breath. Did have a seafood allergy.   BP 110/62 SPO2 99 P 69  Ate breakfast
Dizziness, Palpitations, Shortness of Breath, Numbness and Tingling, Reduced Functional Aerobic Capacity, Fogginess and Confusion, Fatigue  Started bronchodilator inhaler for reactive airway disease (diagnosed 08/2021) Started Florinef for orthostatic hypotension (08/2021)  Started noticing fatigue and decreased physical activity around mid July. Was sent to the ER on 08/03/2021 due to oxygen levels dropping to low 90s on walking (evaluated at clinic) Symptoms progressively worsening over August. Was sent to ER on 08/27/2021. Admitted for 3 days
Developed hives on both arms and shortness of breath.  NP administered 25 mg benadryl IM, Offered 911 but patient refused.  Transferred from the vaccine to Medical department and seen by physician for evaluation.  Prednisone 40 mg administered along with albuterol treatment.  Stabilized and discharged
Pt felt dizzy 10 minutes after receiving the vaccine and had some vision impairment.  Vitals taken and were WNL and orange juice given to pt.  Pt discharged 20 minutes after incident and was back to baseline.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patient were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a male patient of unknown age, reporting on himself. Information on patient's medical history, concurrent conditions or concomitant therapies was not reported. In approximately 2015 (reported as "two years ago"), the patient was vaccinated with RECOMBIVAX (dose number, lot number and expiration date were not provided) for prophylaxis, and also received a dose of VAQTA (dose number, lot number and expiration date were not provided) for prevention of hepatitis A. On an unknown date, after the vaccinations, the patient had bloodwork done and the results were "non-reactive to Hepatitis A". The outcome of the patient's Hepatitis A antibody negative was not reported. The patient did not assess a causal relationship between the patient's Hepatitis A antibody negative and the vaccination with RECOMBIVAX and VAQTA.