chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included hypertension, depression, allergy to cat dander ( sneezing, watering eyes), no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced dryness of mouth (drug allergy) when treated with codeine. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced right and left arm soreness two to three days after the shot. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced redness at injection site. On 10-JUN-2021, the subject experienced bleeding spots under the skin on right arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding spots under the skin on right arm, headache, right and left arm soreness two to three days after the shot and redness at injection site was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 1984, the patient had a bad reaction to a flu vaccine. The patient stated that, she almost died.
Narrative:  DIARRHEA CHILL FEVER HEADACHE MUSCLE PAIN FATIGUE Patient reports taking Ibuprofen. Did not seek medical attention.
From time to time she feels pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (From time to time she feels pain in her arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l20a) for COVID-19 vaccination.     No medical history was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (From time to time she feels pain in her arm). At the time of the report, PAIN IN EXTREMITY (From time to time she feels pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30-MAY-2021 . No new information
Adacel was given subq. into the abdomen of the patient by mistake.  Doctor grabbed the wrong syringe--thought it was Lidocaine injectable to numb up his abdomen for mole removal. Pt had no complaints after given or when he left the clinic on completion of procedure
First injection of J&J caused immediate intense pain down left arm and across neck and I know 2 other people who had same response.  Second injection only had sore arm afterward.  I got first injection in March 2021.  In October 2021 I started with extreme fatigue and legs weak, cramping and twitching.  Not sure if this is related to injection or another medical cause for which I sought treatment by Dr who has ordered an MRI of my brain and I'm seeing a neurologist in April.
Anorexia weight loss, unexplained crying persists (now 5 days after vaccine). Limp stiffness w/in 2 days after immunization. Fever x 1 day after shots resolved.
Patient said that a couple of days after the vaccination his arm started itching at the site of injection. It has not gotten better for almost 1 month. His arm itches at site, he itches it, scratches off the scab and it scabs over again. The process repeats. Patient's doctor told his to use hydrocortisone for the itching but result of this is unknown at this time.
This spontaneous report as received from a Registered Nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 27-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R011806, expiration date 23-APR-2020, for prophylaxis (dose and route were not reported). The temperature involved was (-7C) for 28 hours. Previous temperature excursion was not reported and a data logger was involved.
This spontaneous report was received from a 61 year old female patient regarding herself. The patient has concurrent condition of gastrointestinal disease. The patient is allergic to BACTRIM and most narcotics. On 25-FEB-2016 the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported). She explained that she did not have blisters or any rash at the injection site, but has been experiencing other adverse reactions. Approximately on an unknown date in 2016, the patient experienced unspecified tingling in the right arm (the same arm in which the patient was vaccinated). She also experienced a low grade fever for four days approximately on an unknown date in 2016 since the injection. On two unspecified nights approximately in 2016, the patient was awakened by a terrible itching on the bottom of unspecified foot that felt like bugs crawling on it. On 07-MAR-2016, the area near the injection site felt like someone hit her in the arm, but it was not swollen. The patient did not seek medical attention. No lab tests were performed and the patient was not treated. The patient reported still having the low grade fever and tingling on the day of report. The outcome of other events were unknown. Causality assessment was not reported. Additional information has been requested.
Painful diarrhea and nausea started within hours of taking the vaccine and has been ongoing for the past 10 days.  On 3/14, dizziness and lightheadedness started and continues.  Have contacted doctor and went to urgent care.  COVID test and Flu test = negative.   EKG administered for heaviness in chest.  Received medication for dizziness, but no other meds recommended.  Misery continues
SLEEPY; UNEXPECTED BENEFIT (SHOT HELPED, MADE HIM CALM, MADE HIM FEEL SAFE IN HIS BODY, FELT GREAT, NOW TALKING IN COMPLETE  SENTENCES AND NO GRAND MAL AND NO DROP SEIZURES); TIRED; This spontaneous report received from a parent concerned a 4 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: landau-klefner seizures, autism, hyperactive, celiac disease, non-smoker, non-alcoholic, and peanut allergy, and other pre-existing medical conditions included: Patient was allergic to lots of stuff and had epipen. Patient had no drug abuse or illicit drug usage. The patient was previously treated with measles vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 19-SEP-2021) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On an unspecified date, the patient experienced sleepy, unexpected benefit (shot helped, made him calm, made him feel safe in his body, felt great, now talking in complete sentences and no grand mal and no drop seizures), and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, and tired, and the outcome of unexpected benefit (shot helped, made him calm, made him feel safe in his body, felt great, now talking in complete sentences and no grand mal and no drop seizures) was not reported. This report was non-serious.
Covid19 breakthrough.  1st vaccine received on 02/24/2021.  72 y/o PMHx of HTN presents to ED with 2 day complaint of CP, SOB, upper abdominal pain, Back pain and fatigue.  Pt O2 sat on room air 92%.   Placed on O2 at 2L NC, afebrile and CT Chest with diffuse bronchial wall thickening. Pt started on low dose steroids and Remdesivir.
Severe erythema and pain localized at injection site.  Treated with Tylenol & children's Benadryl.
Myalgias, arthralgias, bone pain, and testicular pain for 10 days Fever, chills, malaise, and intermittent profuse sweating  for 7 days Loss of sense of taste and smell persistent to present Fatigue and intermittent dyspnea, persistent  to present Hyperglycemia for 2 weeks Low grade constant headache and mental fogginess for 10 days Sensation of burning on inspiration  inside of oral cavity for 10 days Intermittent urinary retention x 2 weeks
Pt felt faint while sitting in her chair after receiving vaccine, she lowered herself to the floor and elevated her legs. No LOC. Vital signs obtained and WNL as recorded. Rested in supine position and sipped fluids. She felt better and was able to sit up, then stand and ambulate freely without difficulty. Left for home with mom after 30 minutes of observation.
Immunization given 9/20/2018. Hives started 3am 9/24/18, Erythema multiforme 5am 9/25/18. Seen in ER, given IFV, IV solumedrol, pepcid, 50mg prednisone. 9/26/18 8am seen in office, ongoing erythema multiforme, now with oral mucosal involvement, myalgias and arthralgias. Transferred to tertiary care center for ongoing management.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed shingles on an unspecified date in Apr2021, within 48 hours after the COVID-19 vaccine. The patient wanted to know if should get her second dose on Monday. It was also reported that the patient is in severe agony and pain on an unspecified date in Apr2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fatigue; Pain, Painful blister; Migraine; Painful blister around his left eye; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles before on left side of body).   On 18th October 2021, the patient received the 1st dose of Shingrix. On 19th October 2021, 1 days after receiving Shingrix, the patient experienced fatigue, pain, migraine and blister. In October 2021, the outcome of the fatigue, pain and migraine were recovered/resolved. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, pain, migraine and blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter received the Shingris vaccine and in the following afternoon, he began to experience fatigue, pain, migraine and noticed a painful blister around his left eye.  The patient confirmed that the fatigue, pain and migraine had resolved since then in October 2021.  But the blister around his eye had not gone away and he was concerned because he had gotten shingles before and it was also on his left side of the body. The representative gave him medical advice disclaimer.  The patient was going to visit his health care professional (ophthalmologist) on the day of reporting to discuss as he was very concerned the event might affect his eyes.  The reporter consented to follow up and gave permission to contact health care professional.
Acute stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the right arm on 23Mar2021 at 13:00 (at the age of 50-years-old) as a single dose, for COVID-19 immunisation. Medical history included hypothyroidism, celiac disease, and asthma. The patient did not have any known allergies. The concomitant medication included levothyroxine sodium (SYNTHROID) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the right arm on 02Mar2021 at 13:00 (at the age of 50-years-old) as a single dose, for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 12:00 (two days after vaccine), the patient experienced acute stomach pain that lasted for several hours. The patient did not receive any treatment for the reported event. The adverse events resulted in emergency room/department or urgent care visit. The clinical outcome of the event acute stomach pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Difficulty breathing, swollen and painful right knee, left fingers swollen and painful, right ankle painful.
Patient developed severe swelling, erythema and induration to right arm from top of deltoid to right above elbow. Developed knotting to entire arm, still present 3 days later.  Note: Larger than expected amount of blood oozed from needle site right after administration.
sweating and nausea nausea persisted throughout the morning but has subsided mostly by  11:00AM
REDNESS AND SWELLING AT SITE 2 DAYS AFTER INJECTION. PERSISTED X 48 HRS. DIZZINESS BEGAN 4/19/08 AND PERSISTED FOR 4 DAYS. NEURO EXAM WNL ON 4/20/08.
Pt. seen 8/22/17; 11 days post vaccination Lt arm swollen at MMR site on 8/12 red wheel with urticaria. Rash continued to spread to all extremities and trunk. Probable delayed hypersensitivity to the MMR.
This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A 53-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at an single dose on an unspecified date for immunisation, guaifenesin via an unspecified route of administration from an unspecified date to an unspecified date for cough/cold /allergy, trazodone hydrochloride via an unspecified route of administration from an unspecified date to an unspecified date as antidepressant. The patient medical history and concomitant medications were not reported. The patient experienced allergy to trazodone HCl, PREVNAR 13, guaifenesin on an unspecified date with outcome of unknown.
had really bad headache; he was in bed all day, no energy; no energy.still lacking energy; still having blurriness; throwing up all night (vomiting) after second dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VISION BLURRED (still having blurriness), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No current or past medical history was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VISION BLURRED (still having blurriness), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache). On 09-Apr-2021, BEDRIDDEN (he was in bed all day, no energy), ASTHENIA (no energy.still lacking energy), VOMITING (throwing up all night (vomiting) after second dose) and HEADACHE (had really bad headache) had resolved. At the time of the report, VISION BLURRED (still having blurriness) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter   This case was linked to MOD21-080147, MOD21-080185 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up attempt in 22-Apr-2021 in there the reporter mention about the 2nd dose and add so many events like really bad headache, he was in bed all day, no energy, blurriness and lacking energy.The patients have recovered from the events  "he was throwing up all night".; Sender's Comments:  MOD21-080147:1st dose MOD21-080185:wife's case
Narrative: Verbal report received via phone conversation in reference to other concerns. Client reports that he has bilateral feet tingling/soreness/numbness in  feet since vaccine rec'd. Client reports that he visited a medical facility and clot was ruled out, but he remains concerned. Reports known diabetes and neuropathy, but also reports that these issues did not exist until after vaccination.
Difficulty breathing and chest pain for several hours- went to Dr following week-sent to hospital ER- admittedfor 3 days-with multiple blood tests, EKG's and cardio cath done- diagnosis was Myocarditis/Pericarditis. Had MRI on Hearth done 5/18/2021 follow up with cardiologist 6/1/2021
Pt vaccinated with HIB/MMR; 1 week after, developed fever to 103 - was jittery for 24 hrs & screamed for 12 hrs. Poss Encephalitis reaction.
Tinnitus - high pitch in B ears, worse on L.  Does not affect overall hearing however, more obvious in evening when there's less background noise.
Full body pain (muscles, joints, skin, ears, eyes, gums) began around 9:00 pm on 9/9/21 and increased in severity over the next 24 hours. By the morning of 9/10/21, a fever of 103 degrees accompanied the severe body pain. Cried from the pain. Needed assistance to get out of bed. Pain and fever gradually lessened throughout the day on 9/11/21 and into 9/12/22.
Woke up with a big lump, pain, tenderness, skin in red and warm to touch
Child had seizure on 10/10.  First seizure in lifetime.  Was seen and evaluated in ED and sent home.  On the next day, developed again seizure activity.  Admitted to the hospital.  MRI of head normal.  She was started on antiepileptic medication.
This case was reported by a consumer via call center representative and described the occurrence of back pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back surgery (3 surgeries in 2017). On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced generalized pruritus. On 24th July 2018, the patient experienced back pain, fever and chills. The patient was treated with ibuprofen, TYLENOL and prednisone. On an unknown date, the outcome of the back pain was recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the generalized pruritus and chills were not recovered/not resolved. It was unknown if the reporter considered the back pain, fever, generalized pruritus and chills to be related to SHINGRIX. Additional information was received as follows: Later that afternoon of the vaccination day, the patient experienced severe back pain and it was unlike any back pain she had ever experienced. The patient stated that the morning after she received the vaccine, she experienced a low-grade fever, that was a little higher than 100 degree F and also experienced chills. The patient also reported that experiencing a fiery itch that was primarily in her back but she felt all over her body. The patient could not recall what day the fiery itch started and she was taking TYLENOL, ibuprofen and prednisone to treat the symptoms.
pt recv vax 16DEC96 & 18DEC96 pt exp a varicella rash all over body consisting of papulovesicular lesions;pt was seen in MD office 19DEC97 @ which time the dx of varicella was made;
Pt felt dizzy/nauseous after 1st dose of HPV. Pt given ice pack to back of neck, had him lie down. Given juice and crackers. BP and HR taken MD assessed patient before leaving office.
Per phone call with child's mother; mom states since vaccine was given, child had fever, vomiting, rash on his back and on his eye lids; that night she took child to ER. Was told to give Benadryl by mouth; child saw PCP on Monday 02/22/10 at clinic; mom states child had decrease appetite and feet hurt was told by PCP possible reaction to H1N1 the child had received at school on Friday.
Pt felt dizzy post vaccine,  Vital signs were BP 117/66, Po2 98%, Pulse 106and finger stick 101. Patient was observed by medical staff as per protocol.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 03-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
1 day after receiving the 2nd-month immunizations, patient stopped breathing and became cyanotic and hyporesponsive as per mother, who rubbed the baby on his, lasting for about 20 to 30 sec. Baby had a secong similar episode lasting 20 sec and also found some sputum. These episodes were not related to feeding or the presence of other symptoms. Baby has a history of formula intolerance, currently on Alimentum. Baby is a FT, born by R C/S, no complications at birth or during gestation. Maternal history of cocaine use, currently in a rehab program with brother and patient. On Peds ER, baby was afebrile, not hypoxic. Full sepsis w/u was done. Patient has been asymptomatic during hospital course. Urine Culture was found to be positive with Enterobacter cloacae, however. Renal US has found a duplicated L collector system. Further studies will be done as an outpatient. Unknown whether described hyporesponsive, cyaotic episodes are related to vaccination or UTI.