chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was feeling sick after the end of November and then about a week later I was feeling like I was over the sickness and better, but it came back. I was having a fever; body aches and chills along with a cough that is still linger today. I was also so tired and exhausted during all of this and slept a lot more than I normally do. I was on a trip and the hotel had an urgent care, so I went there, and they tested me for COVID-19 and Influenza. I was negative for COVID but positive for Influenza A. Even though I was past the time frame for TAMIFLU, but the provider did set me a prescription for that. I do not think that the medication helped but it gave me peace of mind to try it. I started feeling better on about the 8 or 9th which was right before I flew home from my trip.
About 4 hours following the immunizations the patient was seen having a seizure lasting about a minute. No fever noted prior to the seizure, though he did have a fever following the seizure. Some cyanosis during the seizure so was taken to the ED where he was diagnosed with febrile seizure, though it is uncertain if fever was the cause of the seizure. Was seen again in clinic the following day for follow up and did have a little fever, but was otherwise doing very well.
Temperature 100.4 day after MMR. Tingling and pain in arms, legs and weakness and neuropathy.
Patient developed vesicular lesions at area of injection that developed within 24 hours. Lesions faded over a week and discoloration remains on arm.
This case was reported by a pharmacist and described the occurrence of injection site induration in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced injection site induration and injection site redness. The subject received ENGERIX B and experienced red induration at the injection site. At the time of the report no other details were provided. At the time of reporting the injection site induration and injection site redness were unresolved. The pharmacist reported another adverse event with ENGERIX B, see case A0848454A.
BLISTERS IN THE MOUTH; SWELLING IN GUMS; MALAISE; HEADACHE; LOWGRADE FEVER; EYE STRAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAY-2021, the subject experienced eye strain. On 16-MAY-2021, the subject experienced malaise. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced low grade fever. On 19-MAY-2021, the subject experienced blisters in the mouth. On 19-MAY-2021, the subject experienced swelling in gums. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, eye strain, malaise, low grade fever, blisters in the mouth, and swelling in gums. This report was non-serious.
received his 2nd dose of Shingrix, 30-DEC-2019 in his left arm as a subcutaneous injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2019 as a intramuscular injection in his left arm).   On 30-DEC-2019, the patient received the 2nd dose of Shingrix (subcutaneous, left arm). On 30-DEC-2019, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received his 2nd dose of Shingrix, 30-DEC-2019 in his left arm as a subcutaneous injection). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The case was reported by patient's wife. The consent to follow up with healthcare professional was not asked as the patient was not on the phone. The reporter reported that the patient received his 2nd dose of Shingrix in his left arm as a subcutaneous injection rather than intramuscularly, which led to intramuscular formulation administered by other route. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023089237:Same reporter
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 25-Feb-2021, the patient experienced HEADACHE (Severe headaches). On 02-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Severe headaches) and FATIGUE (Tiredness) outcome was unknown. No concomitant medications were reported. Treatment details included Tylenol. This case was linked to MOD-2021-064625. Reporter did not allow further contact.
After 7 hours I noticed a rash all over my body. At this time I have bumps all over. I will be going to visit a doctor if the rash gets worse and does not improve within 24hrs of the 1st dose.
Vasovagal Syncope began within minutes of vaccine administration. Patient felt dizzy, hearing muffled, blood pressure and heart rate increased and patient began to faint. Patient was laid on table with feet elevated and monitored. Event lasted approximately 15 minutes.
Symptoms from vaccine are paresthesia and numbness in face, arms and legs.  The first several weeks also included rapid heart rate.  I have seen my primary care doctor and a neurologist.  EMG and NCS tests were normal.  Both brain and cervical spine MRI's were normal.  It has been 10 weeks since vaccination and symptoms are still present.
Hospitalization: 1/11/2023 - 1/16/2023 (5 days) Presentation to the ED:  COVID + date: 1/11/2023 Treatment: no indication for therapy.  Discharge to: Home.  Moderna 029L20A 1/21/2021 Moderna 001A21A 2/22/2021 Moderna 053E21A 8/18/2021 Moderna 045L21A 2/17/2022 Pfizer Bivalent GJ2524  9/17/2022
client had some generalized itching to extremities and also to circum-oral area with some redness and slight swelling noted approximately 20 minutes after vaccination.  Denied shortness of breath or chest pain.  vital signs stable.  The client was transported to the local hospital as a precaution for further evaluation.  No emergency treatment rendered on scene.
The day after I got my third dose the Pfizer dose I had shortness of breath and a strange feeling in my heart area my chest I thought maybe I had caught Covid when I went and got my booster shot it lasted for about four days very noticeable very concerning did not go to the doctor I don?t have a primary care right now I?m going to a new primary care in April in the last week or two when I exert myself I was doing some yardwork I have shortness of breath and when I got the third dose I had no energy at all for the first week after none minus energy.
I was admitted to the hospital on 11/4/2022, for a collapsed lung and I had to stay there for 4 days. About 3 days before, I had slight chest pain, and my rib cage was hurting bad. They had to re-inflate my lung. I was diagnosed with Right Partial Spontaneous Pneumothorax. This normally occurs in smoker's and I haven't ever smoked.
15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stated she had trouble breathing. RN's in observation area ran to the car. Patient tachypnic and couldn't talk, slightly pale with no signs of cyanosis. 911 called immediately and epi pen, 0.3mg administered at 1621. Patient layed down in the back of her car until ambulance arrived. BP stable, no pulse-ox available, respirations 66 bpm. Patient awake and alert, still unable to talk, lips pink, diaphoretic. Care turned over to Paramedics on site. No h/o allergies or anaphylactic reactions. H/O anxiety and on Prozac.
Patient was given pediatric dose of Hep A instead of adult dose of Hep A.
By January 2022 I had lost 80% lung capacity and was unable to walk without shortness of breath.  Massive amounts of phlegm/snot, coughing, dizziness, and fatigue.
Stuffy and runny nose, sneezing, watery eyes, tired. Since July 3 to July 5.
I looked it up online and it has been described as "Covid Arm" - 5 days after getting the injection - I noticed "itchiness" at the injection site.  Since then a Red, Hard and Warm circle of redness has progressively increased over time.  Today (8 days after the shot) - I feel "itchy" and will be taking Benedryl as I am quite "uncomfortable".  No fever, muscle aches, etc.  Just "uncomfortable and itchy"
Patient complained of throat itching and swelling, along with tongue swelling a few minutes after the vaccination.  Took 2 doses of 0.3 Epi at clinic and with EMS.  Patient transported to ER.  Upon arrival, symptoms resolved and patient had no other co's or distress with  V/S being stable.  Patient given prednisone, diphenhydramine and famotidine orally as a precaution, and discharged from the ER.
chills; headache; nausea; sweating; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, headache, nausea, sweating, muscle and joint pain shortly after vaccine in Jan2021 with outcome of unknown. Was treatment received for the adverse event: unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, has the patient been tested for COVID-19: Unknown. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
mom states several hrs p/shots were given pt became very fretful & started running inc temp of 104; pt was given APAP but only brought temp down to 102; pt was taken to ER & seen by MD & was given tepid sponge baths & pedioprofen;
I am currently nursing and after both doses I developed a clogged milk duct roughly 24 hours later. With continued nursing and pumping the duct did get relief
Patient had injection site pain at around 10:30AM on 10/5.  She felt warm later on that night, but she didn't take her temperature.  She took Tylenol and slept.  She felt better the next day.
severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute.  Dr. primary rehab doctor. Neurologists consultants.
This spontaneous report was received from a consumer who was patient's friend refers to the female patient of unknown age. On an unknown date the patient was administered with ZOSTAVAX by an injection in her hip, which was other than indicated for injection of the vaccine. Outcome of the event was unknown. No side effects were mentioned. No product quality complaint (PQC) was involved. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
About an hour after receiving flu vaccine large, painful pimple-like hives started appearing all over my face and neck.  I also had a rather large, painful bump in the muscle just above the elbow in my right upper forearm. This bump persisted for approximately 18 hours.  Before taking the vaccine I did ask if having taken my allergy medications, Singular and Hydroxyzine (Atarax), beforehand would be a problem and was told that it would not be.  Some of the hives on my neck disappeared after taking 3 hyrdoxyzine (anti-hive medication) later in the day, but as of 10/16/07 at 9:27AM I still have lots of large, red, soar bumps all over my cheeks and neck. I also have a backache and headache.  The bump in upper forearm had disappeared overnight.  Could all of this be a reaction between the Singulair and the influenza vaccine? Singulair is an asthma medication as well as an allergy medication.  Needless to say, I will never take the flu vaccine again.
VERY SLEEPY/SLEEPING WHILE DRIVING,DOZED OFF AT WORK; MUSCLE CRAMP/PAIN IN HER RIGHT SIDE,ON HER RIGHT CALF; BACK(SEVERE SHARP PAIN)/BURNING SENSATION; FATIGUE(WAS NOT ABLE TO GET OUT OF BED); CHEST PAIN ON THE LEFT SIDE; FATIGUE (VERY SLEEPY); This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, cholesterol, and smoker, and other pre-existing medical conditions included patient had no drug allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070,  expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 at is right arm  for prophylactic vaccination. No concomitant medications were reported. On 01-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 13-MAR-2021, the subject experienced fatigue (very sleepy). On 18-MAR-2021, the subject experienced chest pain on the left side. On an unspecified date, the subject experienced very sleepy/sleeping while driving, dozed off at work, muscle cramp/pain in her right side, on her right calf, back (severe sharp pain) /burning sensation, and fatigue (was not able to get out of bed). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on the left side on 18-MAR-2021, and had not recovered from fatigue (very sleepy), fatigue(was not able to get out of bed), very sleepy/sleeping while driving, dozed off at work, muscle cramp/pain in her right side,  on her right calf, and back(severe sharp pain)/burning sensation. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022).    No concomitant medication was reported.   Patient received half dose.  The vial was initially stored in the refrigerator was on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.
warm, redness, itching, tenderness on left arm at the injection site 7 days after 1st dose of vaccine. no other symptoms previously except arm pain the fist two days after vaccine.
SARS-CoV+SARS-CoV-2 Ag Resp Ql IA.rapid performed on 7/20/21 at 22:25. Test came back positive. Case investigation interview with patient has not been performed as of the time of this note.
Localized redness, induration, and mild pain at site of injection 24-48h post injection.  No fever, chills, adenopathy or signs/symptoms of anyphylaxis.  Induration measured 10cm.  Symptoms controlled with OTC antihistamines and analgesics.
This spontaneous report as received from a physician and office manager via Company Representative refers to a patient of unknown age and gender. In approximately June 2014, reported as a month ago, the patient was vaccinated with (Oka/Merck) VARIVAX injection, 1 single shot instead of ZOSTAVAX (dose, route and lot # not reported). The patient did not seek any medical attention. It was reported that therapy with (Oka/Merck) VARIVAX was continued. The patient's outcome was not reported. Additional information has been requested.
17  yr 8 month  teen received Flublok intended for 18 year olds. Immunization was given by a nurse at our facility. No adverse reactions were reported. Both patient and mother were informed.
redness, soreness, swelling @ 3rd site;noticeable spot still @ 1st site;
I am immunocompromised with no spleen.  It was removed in 2008. I was diagnosed with Crohn's disease in 2002.  It has been in remission for 18+ years. Within two weeks of the 2nd COVID vaccine I went into a severe Crohn's flare.
Localized redness/pain in left deltoid (site of injection), area approximately 3 inches in diameter per mother's report.
Pfizer shot given to person under 12 years of age by Nurse. No adverse event at this time.  Talk with mother and patient is  doing fine.
On 03/27/2000, the pt developed an injection site rash consisting of 2 - 3 dots. The pt sought unspecified medical attention and according to follow-up information, from the physician, has recovered. No further information is available.
No additional AE reported; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from an "healthcare professional" and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #W017570, expiration date: 29-NOV-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 0 hours, 30 minutes and 0 seconds, with previous excursion of 6 F up to 14 F (9.1F) for 1 hour 6 minutes and 0 seconds.
Seen in office today (1/22/2021). Patient with local ecchymosis, erythema, and warmth around injection site. Patient also complained of joint pain and mild headache. Recommended Benadryl 25-50 mg every 8hrs as needed, hydrocortisone cream, and cool compresses. Parameter of erythema marked with pain. Will treat with Augment if redness worsens.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-MAY-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M022408, expiration date 02-MAY-2018. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT) lot # M013219, expiration date 15-NOV-2018. There was no temperature excursion. No adverse effect was reported.
This spontaneous report was received from Medical Assistant concerning an unidentified patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine, it was not specified if it was GARDASIL (Lot #, dose, route and frequency not reported), or GARDASIL 9 (Lot #, dose, route and frequency were not reported). Concomitant therapies were not provided. On an unknown date, the patient experienced cervix carcinoma after receiving the vaccine. At the time of the report, the outcome of cervix carcinoma was unknown. Upon internal review cervix carcinoma was determined to be an other important medical event. Additional information has been requested.
The patient received improperly stored vaccine; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.  On 30-SEP-2019, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot number S007770; expiration date 24-JUL-2020; 1 dose; route unknown) for prophylaxis (Product storage error).   Temperature was 1.4 Celsius. Time frame was 20 minutes. Previous temperature excursion was 10.5 Celsius for 56 minutes. The call was because of a data logger.
Call made to pt reg her message stating approx 2 hours after pt received H1N1 vaccine, yesterday 12/20/09, pt developed rash all over body. No report of difficulty breathing, no noted edema. Rash is bright red and raised. Denies pruritis. C/o pain on bottom of feet only. Pt cont w/rash today, is doing well. Parents sent to pt to gym where he has been going daily while on holiday school break. Parents gave BENADRYL last PM and this AM. Rash conts today, is slightly better. Mom instructed to make sure gym aware of rash and possible reason for rash. Child must be monitored. Mom verbalizes understanding and states gym is aware and will call her/911 if needed.