chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache; vomiting; This is a spontaneous report from a contactable nurse. A nurse reported that a 17-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization as No reaction on previous exposure to drug. The patient experienced severe headache and vomiting on 17Jun2021. The group that this patient came in with is from an under-served community and most likely these kids came from homeless shelters or a community based housing for them. So they got the COVID vaccine to protect them since they live in like a home in a group setting. Reporter would call it a mild to moderate reaction and she thought that they would of been fine without medical intervention. They were able to be okay with just calming down and that type of thing. Reporter seriousness for complaining of severe headache and vomiting was not serious. The outcome of severe headache and vomiting was recovering. The reporter did not think that the COVID vaccine necessarily caused the reactions. She thought that it was anxiety induced symptoms. The primary source reporter considered events were unrelated.  Information on Lot/Batch number was available. Additional information had been requested.
Pt developed prodrome symptoms 1 week after receiving the vaccine. Twelve days after receiving the vaccine she broke out with a shingles-type rash on her right torso. Her physician prescribed her 800 mg of acyclovir, which she began on 1/9/14. She followed up with her physician 1/15/14.
Increased pain during injection. Post injection: headache, dizziness, nausea, chest pain, abdominal and back pain, throat closing .
FEVER, CHILLS, SWOLLEN LYMPH NODES 2/5/21, 2:00 PM - 2/6/21, 3:30 AM 2 DOSES OF TYLENOL 500MG
On April 18, 2022, she was experiencing cold symptoms. She had congestion, headache, cough, shortness of breathe and trouble breathing. Local emergency hospital. They ran a COVID-19 test and she tested positive. They instructed me to have her take TYLENOL.
Within 5 min after vax child developed blotchy rash on face, chest and both legs-heels red. left leg became bright red and remained that way for approximately 10 minutes. Child alert and active in no obvious istress. Parents encouraged to have child seen.
1530-Pt in observation area in vehicle, started to honk horn for signal of distress. Pt reported tongue swelling and itching 1551-EPI pen device deployed, EMS activated 1554-2 puffs Albuterol inhaler, 4L O2 via nasal canula applied.  1603-EMS arrive. Vital signs: HR: 102, BP: 140/70, O2 SAT now at 96% on Room Air 1608-Transport to local hospital ED by EMS
Rash at injection site lasting 3 days, itchiness at injection site, body stiffness, delayed period with heavy flow and painful cramps.
This spontaneous report was received from a Certified Medical Assistant concerning a 34 year old female patient. On 12-SEP-2013, the patient was vaccinated with the first dose of VAQTA (dose, route, lot # and expiration date not reported). On 13-NOV-2013, the patient was vaccinated with the second dose of VAQTA (dose, route, lot # and expiration date not reported). No adverse reaction was reported. At the time of the report, patient's outcome was unknown. Additional information has been requested.
The patient received an undiluted 0.3ml dose of the pediatric Pfizer vaccine. An adult dose is 30 mcg and the patient is believed to have received about 42 mcg dose. The discovery was made about 5 hours after the dose was administered. At this time the patient has not answered any telephone calls so treatment and outcomes are at this time unknown.
This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015 at 12:39 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Dose 1: Tiredness and slight headache started 12 hours after the injection and only lasted for one day.   Soreness in arm and for approximately one week.  10 days later the injection I got a site reaction (hives) that was red and itchy. That lasted for a few days.  I applied a topical hydrocortisone cream and it helped.  Dose 2:  Headache and muscle aches started 12 hours after injection(s) and diminished but lingered for  about a week.  Soreness in arm and for approximately one week.  9 days later the injection I got a site reaction (hives) that was red and itchy and is still there but diminishing.  Using hydrocortisone cream.
This spontaneous report as received from nurse refers to a patient of unknown age. On an unknown date in July 2014 (2 months ago), the patient was vaccinated with ZOSTAVAX single dose, subcutaneous. The nurse reported that the patient was inadvertently vaccinated with a second dose of ZOSTAVAX on 05-SEP-2014. No adverse effects were reported. Additional information has been requested.
Tinnitus, humming like a fan or motor in Left ear.  Ongoing, constant.  Seems worse as the day progresses.  Also waking in the night and wide awake, which isn't normal.
Complained of throat swelling with no acute cardiopulmonary distress.  Given: Diphenhydramine 25mg IM, Epinephrine 0.3 mg IM, Dexamethasone 10mg IM and transported to the ED for evaluation.   Vitals stable with O2 sat 99-100% on room air.
Aching all over, in a lot of pain; fever; feel very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 12:00 as dose 3 (bivalent), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Dieabates" (unspecified if ongoing); "Known allergies: Sulfer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid 19 immunization.  The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Aching all over, in a lot of pain"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; MALAISE (non-serious), outcome "not recovered", described as "feel very sick". Therapeutic measures were not taken as a result of pain, pyrexia, malaise.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Breakthrough case after Covid vaccination, Dose #1 03/25/2021 Dose #2 04/18/2021. C/O loss of taste/smell and stuffy nose/ onset 9/10/2021
Just soreness, tiredness and little bit of headache; Just soreness, tiredness and little bit of headache; Just soreness, tiredness and little bit of headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0178) via an unspecified route of administration on 15Jun2021 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Jun2021 the patient experienced just soreness, tiredness and little bit of headache. Patient asked was there any information on magnetic effects at the injection site after receiving vaccination with the Pfizer-BioNTech COVID-19 vaccine. It had actually happened, patient stated that she can place a magnet to her arm and it sticks to the injection site. Patient has pictures and witnesses. Patient was not a young kid. Patient did not receive treatment for the adverse events. Outcome of the events just soreness, tiredness and little bit of headache was unknown.  Additional information has been requested.
5 days after shot 2 I started feeling dizzyness and disoriented. It's now day 14 and I still feel it. It's interfering with daily life
Tightening under the tongue/throat.  Red and mucus in the eyes.  Pounding chest/rapid heart beat.
Pt had a mild vaccine rx following first dose of Moderna Vaccine. Pt has seasonal allergies and takes Claritin D 24 hr every day however denies specific allergies. She denies previous vaccine reaction. Pt developed hives on her left arm where vaccine was given and stated her arm was hot and itchy. During the interview, the hives moved towards her chest, however she was unaware of these hives. Patient denies any trouble breathing, swallowing, speaking, tongue swelling, and respiratory distress. Patient was calm and not concerned at all. She was advised to wait an extra 15 minutes. She denied cold compress and Benadryl. Informed patient of v-safe as well if she was interested.  Towards the end of her 15 minutes, the hives on her chest did decrease and they became more localized to her left arm. Instructed patient to take Benadryl at home if sx persisted and to utilize cold compress. Pt agreeable with plan.
Severe site reaction requiring urgent medical care 12/1/17: treated with steroid injection & BACTRIM po, resolved in 72hrs. Fever, chills, body pain: self treated with TYLENOL.
I because confused and unsteady.  I then fell.  My husband helped me up but he knew something was wrong. He called 911 an ambulance took me to the hospital but I was transferred to another hospital.  In case I needed surgery.  It was touch and go. I was suffering a stroke. A blood clot was also found. I was in the hospital ICU for 3 days then transferred to another room. For another day.
8 days after the vaccine I had chest pain, high blood pressure, injection site became red and swollen. Hives all over my body. Having some type of allergic reactions since the vaccine currently waiting on doctor appointment with an allergist.
Influenza administered 10/10/11: child developed redness, swelling, pain and blisters to site overnight.
Was conducting IM shot in Client's left deltoid when muscle twitched. Client confirmed that his muscle did twitch and he did not voluntarily move his muscle. Stopped injection. 0.1 ml was administered into left deltoid. Client denied any pain, tingling, burning, numbness, or other sensation. Educated client that there is a chance of hitting a nerve and to reach out to his Provider if he had any concerns. Client verbalized understanding. Completed administration of IM shot in right deltoid (original dose discarded/wasted appropriately. New syringe and needle used, 0.5 ml administered in right deltoid). Client denied any pain, numbness, tingling, or other sensation.  Attempted to contact patient on 3/3/2021 at 9:14 AM to follow up. No answer. Left voicemail to return call. No return call as of 3/3/2021 4:12 PM. Will attempt to contact again within this week.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-DEC-2016 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient returned for 2nd dose and informed vaccinator that she had trouble swallowing for 2 days following the first Pfizer COVID 19 vaccine.  Patient reported that she did not have any other symptoms such as itching, swelling or scratchy throat.  patient did not receive dose 2 of the vaccine series.
Sore throat; severe untreatable headache; body aches; ear infection; sinus infection,; lethargy.; heart arrhythmia.   Pain at injection site was also an issue, however, it is understandable that this happens with most injections.  The first symptom experienced was sore throat and headache.  These started 2-3 days following the first vaccine on 9/7/21 and they continue today (9/21/21).  My headache continually got worse to the point where I have had to miss work and despite taking ibuprofen alternated with Tylenol around the clock, I have not been able to get relief.  The heart palpitations had already been an issue for which I was tested by a cardiologist earlier in the summer months of 2021.  These symptoms had improved approx a month or 6 weeks prior to receiving the vaccine, but they reoccured following the first vaccine.  On 9/20/21,  I finally decided to contact my PCP.
it was reported that a patient ( 1 of 6) received a Fluzone SV '01-02 vaccination (administration date  and site information was not provided). Sometimes after vaccination, (exact date not specified) the patient developed a local reaction at the injection site. Further information is requested. Linked cases: U2001-01225, U32001-01226, U2001227, U200101228 & U200101229
I was achy all over my body the next day.  I had a sore throat slightly, my left arm at the site of injection was extremely sore and hurt a lot when I moved, and I felt lethargic.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies and was taking no other medication in 2 weeks. She was on treatment for COVID-19 from 02May2022 to 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SWELLING AND ITCHING AT SITE INITIALLY FOR A WEEK; ROUGHLY 5 DAYS AFTER THE INJECTION I HAD HIVES FROM MY EARS TO MY HIPS (NECK, CHEST, STOMACH, BACK) FOR THE NEXT FOUR PLUS WEEKS
2 days post vax pt devel transient red patchy rash on buttock per mom; no fever; 9 days later low grade temp; temp gone @ x 3 d; 10 days & maculopapular non confluent rash, arthralgia, lymphadenopathy;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-NOV-2015 at time- 04:49, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Client received Moderna Vaccination at School Based Immunization Clinic  at 9:20AM.  Client was sent to the observation area after the shot for 30 mins due to history of severe allergy to Morphine (self reported).  At 10:05AM,  client stated to complain about a headache and feeling extremely exhausted.   Client was told by the observation team to lay head on table and team alerted PHN about client.  PHN came over to observation area to evaluate client. While PHN was talking with client, client stated she was very nervous about getting the shot, stated she didn't want to get another one, was shaking all over, said she was dizzy and them became limp.  Client was moved to the floor for evaluation.  9-1-1 was called for EMS to arrive to school clinic.  PHN took initial vitals:  B/P  158/96, Pulse 120,  Resp  44.  Client was asked to start taking slower deep breaths to help with oxygen flow.  Client started to open eyes and become more alert.  Stated again she was not going to get another COVID vaccine and that she was very nervous about getting this vaccine.  EMS arrived at 10:24AM.  Vitals were reevaluated B/P:  146/88,  Pulse: 84, Oxygen 94, Resp: 22.  Client was moved to sitting in a chair and recoperating well.  Still complained about being sleepy and headache.   Client's husband arrived to the event and when client saw husband, she started to shake and became limp again.  Client them moved to the floor again and then transferred by EMS to stretcher and transported to ER for evaluation.
I was awakened last evening with a wave of cyclic nausea.  I couldn?t vomit to relieve the discomfort.  I too a Pepcid Compleye, which lessened the issue; however, the side effect persists through today.
Swollen lips; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LIP SWELLING (Swollen lips). At the time of the report, LIP SWELLING (Swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact
Noted redness to the inside of patient's right arm with swelling compared to left arm, however, no redness at injection site (right deltoid.)  Patient states that the redness seems to be moving downward and there was swelling yesterday twice the size of her arm today.  Patient denies pain other symptoms such as breathing or swallowing difficulty.  She will use ice to the arm 3-4 times daily, and elevate as possible.  She will avoid overuse of the right arm - symptoms worsened after she went golfing yesterday.  Ibuprofen 400mg every 6 hours as needed for pain, take with food. Patient instructed to call back with questions/concerns and seek evaluation at urgent care if symptoms worsen over weekend.
I experienced a sore left arm at the site of the injection after the first dose of Moderna on 01/14/2021. After the second Moderna shot on 02/11/2021, I also had a sore left arm. On 02/12/2021, I had a slight fever, headache, and feelings of nausea. These symptoms cleared by 02/14/2021. However, on about 03/05/2021, I started having vomiting, diarrhea, and headaches. Soon after I developed a cough, extremely sore muscles with joint pain and fatigue. It was painful to walk or stand, lift my arms over head, or roll over in bed. I took over the counter pain medicines, like Tylenol and Aleve. The pain and cough lasted until July. Needed pain meds through July.
Chills, fever (100.9 F), HA. Took Tylenol 500 mg, 2 caplets
About 10 minutes after receiving the vaccine, patient's mother got my attention and stated that her daughter (the patient) was feeling nauseous. A receptacle for vomit and a bottle of water were brought out to the patient. The patient was visibly pale. When asked how she felt, she stated nauseous and a little light headed. The patient vomitted what looked like mucus into the receptacle. After she vomitted, she stated that she felt a lot better and the color returned to her face. She remained in the pharmacy for about 15 more minutes, where she stated she felt back to normal.
Upper left arm sore; at time soreness increases and thumb feels numb. Nee to take ES Tylenol 2 tabs to help relieve soreness.  Have had to get up at night to take Tylenol due to unable to sleep due to soreness.
Pain and redness and swelling at injection site. Some unspecified fever, body aches, fatigue and two days headache.
No PQC reported; VARIVAX mistakenly administered to a patient instead of PROQUAD; This spontaneous report was received from a physician assistant referring to a 4 years old male patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 11-MAR-2021, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter subcutaneously for prophylaxis (lot # T002847, expiration date 23-JAN-2022). It was supposed to be Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) that was administered but it was documented in the system that varicella virus vaccine live (Oka/Merck) (VARIVAX) was given (wrong product administered). No PQC reported (no adverse event).
Local swelling/redness/induration (extensive) started < 24 degrees after vaccine R deltoid area.
infection in her abdomen, currently taking antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) (seriousness criterion medically significant). At the time of the report, ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  The patient was treated with antibiotics for abdominal infection.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
The pt received immunizations at 1:00PM. Returned to office with grandmother at 3:30PM. Had a red rash and hives on face, neck, back, abdomen, legs. Sent to local physician and was started on Claritin and sent home. Mother stated the pt improved quickly with Claritin.