chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; stomach pain; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 11:45 as dose 4 (booster), single (Lot number: FL3197) at the age of 56 years intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: AZELASTINE; QNASL; PEPCID [FAMOTIDINE]. Past drug history included: Sulfa, reaction(s): "Known allergies: sulfa drugs", notes: Known allergies: sulfa drugs; Clindamycin, reaction(s): "Known allergies: clindamycin", notes: Known allergies: clindamycin. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19May2022 at 06:00, outcome "recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset 19May2022 at 06:00, outcome "recovered", described as "stomach pain"; FATIGUE (non-serious) with onset 19May2022 at 06:00, outcome "recovered", described as "tired". Therapeutic measures were not taken as a result of headache, abdominal pain upper, fatigue.
p/vax pt had rxn when get home-pt can't see, can't hear, numb all over;
This spontaneous report as received from a treating pharmacist via a company representative refers to multiple, unspecified patients, during the past three days, had received ZOSTAVAX (Lot# unspecified) single dose injection (dose and location unspecified), and returned to the pharmacy within three days post-vaccination, with symptoms of "cellulitis" at the injection site and surrounding areas. The patient did not reintroduce the therapy, the patient had sought medical attention via contact pharmacist. At the time of report, the outcome of the event was unknown. Follow up information has been received from a pharmacy manager refers to a 63 year old female patient. On 13-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (No lot number available, no expiration date available) (dose and route not reported). The pharmacy manager confirmed that the adverse event of injection cellulitis did occur 3 days after receiving the vaccination approximately on 16-NOV-2013. Treatment: Primary care physician prescribed KEFLEX to the patient, Pharmacy manager stated that this patient recovered and did not need to be admitted to a hospital for further treatment. This is one of several reports received from the same reporter. It was linked to MARRS# 1312USA010651, and MARRS#1401USA005670. Additional information has been requested.
Swollen lymph nodes under the arm that received the second dose of the vaccine.  Swelling began about two days after the shot and lasted about 7 days. Over those 7 days, the swelling diminished until it disappeared. Mild pain was present when the swelling first appeared. After four days, there was pain only when the lymph nodes were pressed.
Pain in eyes, burst blood vessels in eyes, eyes have become sensitive to wind, soreness in eyes.
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified.
Seasonal flu vaccine given approx 10:30 am. At about 9:30 pm patient experienced chest pain, pounding feeling in her chest and the feeling her throat was closing. This lasted about 1 hour. She woke 1 time during the night feeling the same and states she felt it again in the morning for a short while.
Patient with reported (per mother) large amount of redness/swelling starting with spot on top of thigh where IM injection was given (Kinrix). Started about 2 hours after administration of vaccine and redness/swelling/heat spread to the remainder of the leg beyond the normal swelling/redness. Patient also developed limping and impaired walking due to swelling and pain. Patient also developed very loose stools for a couple of days after vaccination as well.
I started to experience shortness of breath while walking around 5:30pm and then felt heart palpitations. My heart rate was checked periodically and it was very high, the highest being 145. My blood pressure was also high. I was taken to the hospital where I was given two bags of fluid to hydrate me. Multiple tests were done but overall there was no treatment provided to me.
5 - 10 MINUTES AFTER SHOT ADMINISTRATION PATIENT BECAME PALE AND COMPLAINED OF PAIN IN UPPER RIGHT CHEST. DEVELOPED NAUSEA, VOMITING, AND DRY MOUTH. I ADMINISTERED 25 MG DIPHENHYDRAMINE LIQUID BY ORAL ROUTE. MOM DIDN'T WANT TO STAY FOR MONITORING AGAINST OUR ADVISE. COUNSELED MOM TO WATCH FOR ANY SYMPTOMS OF PROGRESSING ALLERGY INCLUDING TINGLING IN THE LIPS, TONGUE, MOUTH, TROUBLE BREATHING, HIVES, OR ANYTHING ELSE OF CONCERN. I ADVISED THEM TO TAKE PATIENT TO ER IF ANYTHING CHANGED. ON 8/11/2021 I FOLLOWED UP WITH PATIENT WHO WAS DOING WELL. MOM STATED SYMPTOMS HAD SUBSIDED. THE DIPHENHYDRAMINE MADE HER TIRED.
patient informed us on 11/12 (41 days after flu shot administered) that her arm was sore and had been sore since the day she got the flu shot
Received Zoster immunization on 9/30/11.  On 10/5/11 started off with nausea and decreased appetite.  Then developed burning pain on right chest followed by erythema of the same area.  The next day developed small vesicles that grew day by day all in a dermatomal distribution, consistent with Zoster.
Heart rate went over 120 BPM and it's called tachycardia- felt my heart is not beating properly Chills Fatigue Admitted me in the hospital-a day/one night The doctors said my heart is perfect condition and what happened may be a result of the booster shot or other unknown causes.
On 2/28 around 6pm. I started feeling some flu like symptoms start. Mild headache, fatigue, chills, slight runny nose, mild sore throat. My left eye suddenly felt awful. I told my husband my eye is stuck (open). It was very scary and I felt like I had to hold my hand against it tightly. Meanwhile my right eye just wanted to stay closed, so then I couldn?t see at all. My husband guided me into the kitchen and I tried to flush my eye with water to see if that would help whatever was going on with my eye lid. My husband gently rubbed the skin above my eye. He couldn?t see my  eye lid at all. All that was visible to him was the tip of my eyelashes. He was able to grab the tip of my eyelash and release my eyelid. It was very uncomfortable and scary.  After the eyelid was released the eye was very sore . I called the nurse line and they recommended I be seen within 24 hours. I saw the doctor this morning not related at all to the vaccination facility. She said it sounded like an ocular muscle spasm. She said she didn?t see anything in the vaccine literature about this type of response but recommended I report it in case it?s a rare response.  I have never had that happen before and I hope to never have it happen again.
Pt given Moderna vaccine 040B21A and states that her throat felt tight. Pt tongue not swollen. Pt denies any difficulty swallowing or breathing. Pt monitored and states she is feeling better. Pt vitals as noted. Pt monitored with out treatment. Pt to return home with family to monitor her condition. She was instructed to call EMERGENCY if symptoms progressed or if she changed her mind 11:01 127/99 p74 r16 11:09 130/74 p 70 r 16 11:21 116/86 p 69 16 11:25 pt given 10ML of 25mg Benadryl PO elixir 11:29 138/82 p 74 r 16 11:41 112/73 p74 r 16
No additional adverse events reported; a 12 month old patient received an extra dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 12 month old female patient. No information regarding her medical history, drug reactions/allergies or concomitant therapies were was provided.  On 02-AUG-2021, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, lot # U002538, expiration date 24-JUL-2022 (exact dose and route of administration were not provided), for prophylaxis. On 16-AUG-2021, the patient was vaccinated with an extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 1 dose, lot # T035409, expiration date 14-APR-2022 (exact dose and route of administration were not provided), for prophylaxis. The patient did not experience any adverse event. She did not have any fever.
Red blotches on both arms. Hot injection site. Swollen tongue/numbness. Pins & needles in (L) gums & ear & throat. Signs after about 10 min BENADRYL after 20 minutes.
Patient described that they started feeling extremely cold with shivers, yet their skin felt like it was burning. Stated they did not have fever, hives or trouble breathing.  Felt this way 9/27/19 and 9/28/2019
broke a hip; pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: on COPD medication; "anxiety" (ongoing), notes: on anti anxiety medication; "blood pressure" (ongoing), notes: on blood pressure medication. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. Vaccination history included: bnt162b2 (DOSE 2, SINGLE), administration date: 06Apr2021, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, Expiry date: 31Jul2021), for COVID-19 immunisation. The following information was reported: HIP FRACTURE (hospitalization, medically significant) with onset 2023, outcome "unknown", described as "broke a hip"; PNEUMONIA (hospitalization) with onset 2023, outcome "unknown". The patient was hospitalized for hip fracture, pneumonia (start date: 10Nov2023). Therapeutic measures were taken as a result of hip fracture. Clinical course: Caller asked if being in the hospital should he take the fourth dose of the vaccine. Caller said he has COPD, he has been in the hospital twice and broke a hip a month a half ago. Caller currently in hospital for pneumonia, that he had about a week before being admitted to hospital, the symptoms were not as bad. Carries oximeter, his numbers just crashed, went way down. Clarified, he was admitted to hospital 10Nov2023. Had hip surgery about a month and a half ago, they put his hip back together. Patient was currently on COPD medication, anti anxiety medication, blood pressure medication. Prior vaccination included flu shot and pneumonia shot.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300372632 same reporter/patient, different dose/event;
ADR as described by patient: I experienced normal injection soreness for about 36 hours. There was no redness or swelling at the injection site, just soreness in the upper arm.  After that, I felt completely fine without any soreness or flu-like symptoms. My injection arm was completely back to normal without the slightest after effect from the injection.  On Sat., Jan 16 ? 8 days after the injection ? I woke up with a hard, red, swollen, warm lump at the injection site, the size of an avocado. The next day it was a larger red area, not quite as hard or warm, but still uncomfortable. It is now Jan 20 and the area is no longer red, but still a little swollen and sore.
Red patch inferior to injection site at left arm that is warm to touch. Decline any other symptoms of fever, chills, feeling ill/weak, no shortness of breath, eating fine.
Information has been received on 07OCT2003 from an elementary school licensed practical nurse concerning an approximately 7 year old male who on 22APR1998 was vaccinated with varicella virus vaccine live. Subsequently, "within the last month,"the patient developed chicken pox. The pt sought unspecified medical attention.  It was also reported that five other children also developed chicken pox through WAES 0310USA01248). Additional information has been requested.
Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for almost 3 weeks now.
This spontaneous report was received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse practitioner informed that since 24-OCT-2014 the patients were vaccinated with improperly stored of VARIVAX (Merck) injection (lot number, expiration date, dosage and route were not reported). No adverse effected were noted. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 28-JUL-2016, the patient was inadvertently vaccinated with an improperly dose of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017)(concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted. A product quality complaint (PQC) was not involved. This is one of several received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
Death Narrative:  Death on 01/25/2021. 2nd dose administered 19 days prior to severe event. Patient had diagnosis of malignant pulmonary process with a terminal prognosis. There are no indications that death was related to the vaccine.
THE NEXT MORNING AFTER PATIENT GOT MODERNA VACCINE HE HAS NUMBNESS ON BOTH OF HIS HAND. WHOLE LEFT HAND HAS NUMBNESS AND IN THE RIGHT HAND HE HAS NUMBNESS FROM FINGERS TO HALF WAY TO PALM
Vaccine was accidentally given outside of the 6 hour expiration date after the vial was opened.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 12/27/2022. I had a runny nose and sneezing. I also had leg cramps. I had a prescription for PAXLOVID.
meningo-encephalitis & acute cerebellar ataxia over several days & starting around 6/20/99, requiring adm to hosp on 6/24/99 x 3 days for observation & neurologic/infectious disease consultation;
This spontaneous report was received from a nurse and refers to a 16 year old female patient. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. In JUN-2017, (about 2 weeks ago at the time of reporting), the patient was vaccinated with both GARDASIL 9 (dose, frequency, route, site of administration and lot # were not reported) for prophylaxis and TRUMENBA (other suspect therapy). The nurse reported that the patient had received both the GARDASIL 9 and TRUMENBA vaccines simultaneously about 2 weeks ago and experienced injection site pain and nausea immediately after receiving the two vaccinations. Within the last two weeks, the patient also experienced "brain fog"  for one week after receiving both the GARDASIL 9 and TRUMENBA vaccines. The outcomes of injection site pain, nausea and brain fog was unknown. Causality assessment was not provided.  Additional information is not expected, as no contact details were provided.
Patient was seen at 0830. Reviewed what vaccines were going to be given and possible side effects. Patient was extremely anxious prior to shots being administered and was hyperventilating. Shots administered at approx. 0850. Pt felt nauseous and sat down. Patient became pale and vomited about an ounce, clear in color. After patient rested longer. The patient laid down on the bed with legs up. Vital signs were taken, doctor and nurse in room evaluating patient. Vital signs were stable. After 15 min of observation patient was advised to stay in clinic a complete 30 min. Patient went with guardian and attended appointment. No other signs or symptoms of reaction to vaccine occurred.
8:30-9am Kindergarten student received TIV flu shot. 11:00 Complained of nausea/vomiting .  11:15 Temp 99 Pulse 88 R= 24. Mother notified. I took student home at 11:45 Instructed to TC MD if symptoms persist.
Upon administration of vaccine, pt experienced light headedness and profuse sweating, called 911 within 2 minutes, paramedics arrived, took pt blood pressure, pulse and sugar, all within normal range, within minutes pt began feeling better, paramedics asked if pt wanted to go to ER, pt refused, pt was able to get up on her own strength and walk out, I followed up with pt later in the afternoon, pt states all was well.
Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain
severe burning sensation in mid-section (abdomen & hip area); severe burning sensation in mid-section (abdomen & hip area); discomfort eases; stay in bed; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in abdomen in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included burning sensation, discomfort and bedridden. The patient had a Family History of shingles. Previously administered products included Tamoxifen with an associated reaction of burning sensation (received from 1996 to 1997), Fosamax with an associated reaction of discomfort (discontinued on an unknown date), Actonel with an associated reaction of discomfort (discontinued on an unknown date) and bisphosphonates with an associated reaction of discomfort (discontinued on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation in abdomen, burning hip, discomfort and bedridden. On an unknown date, the outcome of the burning sensation in abdomen, burning hip, discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the burning sensation in abdomen, burning hip, discomfort and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a negative reaction to the 1st shot and had some concerns.  The patient experienced severe burning sensation in the mid-section (abdomen and hip area) which lasted for several days. During that time, the patient became very uncomfortable and had to stay in bed until discomfort eases.  The patient did not considered these events as side effect because the patient reacted similarly to several other drugs and medications received in past.  The patient asked to the primary care physician regarding to have 2nd shot. They both had concerns of having the same effects or possibly worse and lasting longer.  The patient was very aware of the pain of Shingles, since several family members have had Shingles and the patient would like to avoid that experience. Therefore, the patient asked that only 1 Shingrix shot reduce the odds of having Shingles or was the 2nd shot essential to be effective.  The patient would going to receive 2nd shingrix shot shortly.
Severe headache, shaking, and chills;  also, nausea, tiredness, insomnia, and generally feeling cold when not having chills.  Symptoms started Friday evening (day of injection) and persisted the following day (Saturday). Felt a little bit better on Sunday.  Monday much better.
Patient received Tdap vaccine at 14 6/7 weeks estimated gestational age with a viable pregnancy. Returned at 18 5/7 weeks with a fetal demise diagnosed. Head diameter consistent with 14 week sized fetus.
DIZZINESS; SWEATING BULLETS IN A COOL ROOM, LIKE HAD JUST CLIMBED OUT OF A POOL; BEEFY BODY ACHES; SORE ARM AS THE TECH POKED HUMERUS WITH THE NEEDLE; HEADACHES JUST SHY OF MIGRAINE-STRENGTH; LOW GRADE FEVER; VERY LOW GRADE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, headaches just shy of migraine-strength, low grade fever, and very low grade nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating bullets in a cool room, like had just climbed out of a pool, beefy body aches, sore arm as the tech poked humerus with the needle, low grade fever, and very low grade nausea, and the outcome of headaches just shy of migraine-strength was not reported. This report was non-serious.
A pharmacist reported that a 28 year old male received Pnu-Imune 23 and Hib-Titer vaccines on 10/1/00. The next day, he developed a severe headache and a fever of 102F. He also developed soreness at the injection site. On 10/3/00, the injection site reaction included a 6" X 3" area of warmth, redness and induration. The fever and headache resolved in 2 days.
Pt reported initial injection site soreness after administration on 10/23/10. 24 hrs later on 10/24/10 - noted redness, warmth & swelling of (R) arm extending from mid upper arm to mid forearm. Pt. given KEFLEX to cover for cellulitis.
Patient reported to the pharmacy one week after receiving the immunization stating that he had experienced severe pain in his shoulder and neck area that started shortly after receipt of the immunization and is still currently continuing.
Pt presented for travel evaluation on June 5th and received the yellow fever and typhoid vaccine. The following day she noted a small blister in the area the yellow fever vaccine was administered and some pain.  Over the following days multiple vesicles developed and some coalesced into larger blistered. No significant erythema, warmth or fevers.  She went to the ER 5 days after the vaccine was given and in the ER the blistered were drained and the overlying skin was removed.  The following day she noted hyperpigmented lesions around the area of the denuded skin which has increased in size. Last night after running she noted that the hyperpigmented skin has started to blister. The fluid in the blistered always appeared serosangenous. She still remains afebrile, no significant erythema or purulent drainage.
pt recv vax 23OCT95 & 5APR97 pt devel a chickenpox rash w/approx 100 lesions & some itching;