chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The booster before my leg swelled up from my mid-calf down to my foot. I went to urgent care to get it checked.  There was no blockage of a blood clot. It subsided after being but on an antihistamine and Lasix. It was gone in 4 to 5 days I took Benadryl with this most recent dose to offset, this was on 10/06/2022 Lot# GH9693 Pfizer-Bivalent. The reaction was the same but not as severe. It down my leg between the knee and ankle. It was slight swelling, I reported to the doctor, and he told me take the medication I had before on the last dose. It helped and within 48 hours it was back down to normal size.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patients medical history was not reported. On an unknown date, the unspecified patients were vaccinated with 7 doses of ROTATEQ (dose and frequency were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for ROTATEQ. This case is linked to 1409USA012424 and 1409USA014917 (same reporter link). Additional information has been requested.
My throat felt like it was closing up and I was nervous going to sleep at night on both doses. I'm sorry for taking so long to report, but I do want it on record that once those vaccinations 'took' or finished through my system, the symptoms subsided. But it was scary, I'm not sure why I decided to get the second dose based on that reaction.
03/10/2023 I had a headache, sore throat, cough, runny nose and malaise x 3 days 03/10/2023 I reached out to the local clinic and was prescribed a 5-day course of PAXLOVID.
Generalized tonic clonic seizure on 4/15/2021.  Follow up neuro exam and EEG were normal.
Patient called to say she was having a reaction to the COVID vaccine that she received Thursday.  She reported that her arm where she received the injection was red, swollen, and itching very bad.  It started the same day as the injection. She already takes 3 Benadryl a day and says she cannot apply ice to the area because "ice makes her hurt."  I advised her to increase the amount of Benadryl she was taking and that she could use a topical steroid to the area.  I also advised that it should go away on its own but to follow up with her doctor if she has any further issues.
Moderate swelling of left deltoid with mild erythema tender to touch palpation hypopigmented area to upper arms
pt recvd vax;grandma called & state pt had taken a bottle;was burped & pt got still,then began to tremble;eyes rolled back;lips & tongue turned blue; took to MD;felt had not seizured but had choked;
Got the vaccine, and yesterday 3/24/21 somewhere around 3:30 he started feeling weak, tried to walk and  had weakness.  By 6:30 he could not get up.  He was on the floor as he slid off the bed and could not push himself up on his arms, and got worse and worse.  He went up to bed, and his son had to come over and help him into bed as he was not even able to lift his legs to get into bed.   Then at 3:00 AM this morning he could start walking again.  Now this morning he is a little wobbly and otherwise getting better.  He did take 2 Tylenol.  No soreness around the injection site, just the extreme weakness.
HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On mar-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Case number PHEH2015US002316, is an initial spontaneous report received from a physician on 30 Jan 2015. This report refers to a 45 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with Influenza vaccine INN (manufacturer and batch number unknown) on 30 Sep 2014 and also received FLUVIRIN (batch number: 135014) intramuscular on 02 Jan 2015. No adverse event was reported. No further information was provided.
About 5 minutes after administering Jassesn COVID 19 vaccine the patient began to lose consciousness and rested his head on the table. The patient was then assisted down to the floor.  Within 2 minutes the patient was alert and oriented, 911 was activated. PT reported dizziness. Patient asked about medical history which entail WPW, and no medications. EMS assessed and took vital signs. PT refused to go to the hospital. Patient monitored for an additional 30 minutes, and escorted downstairs.
Sore arm, sore muscles along side of injection. Stomach pains and fatigue.
On the morning after the first vaccine dose (6am) , I experienced an ear pain for about an hour in my left ear. This pain ceased for the day and there was no other pain in the ear.   Beginning the evening about 30 hours after the shot, I experienced a severe, sharp and consistent pain on the right side of my neck.  Starting at my right thyroid gland  - which was not notably enlarged.  After about 15 minutes, the pain  extended up into my jaw line and right ear.  This pain has been consistent since Monday, 8.30 at 10pm.  It is worse and more noticeable in the evening.   On the left side, the ear pain has returned as well, but there is no pain in the jaw.   The pain is consistent, not throbbing. More pressure at times and sharper as it gets more intense in the evenings.
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, nurse. This case involves a 18 years old female patient who received the imovax first two injections on time but is late for her next injection, while she received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 29-May-2018, the patient received 0.5 ml single dose of suspect RABIES (HDC) VACCINE (M14921M) and received another 0.5 ml single dose on 05-Jun-2018 (M14921M). It was a case of actual medication error due to Drug dose administration interval too long. No symptoms occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports that the day following her second Pfizer Covid vaccine she started having menstrual bleeding that lasted 3 months.  Her previous menstrual cycle had been 9 months prior to this .
Temporal, periorbital HA, constant w/ varying degrees of intensity. ALEVE and TYLENOL taken w/o improvement. 12/08/15: MD appointment.
This spontaneous report was received from the registered nurse regarding a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
pt recvd 1st dose of Hep B vax on 3FEB92 & while vax was being administered pt exp a stinging pain @ site of inject;
On April 8, 2021, around 7pm I began to experience body aches, fatigue, and loss of appetite. By 8pm I began to experience chills along with continue body aches, fatigue, and loss of appetite. At 11pm that night, I was awaken as my heart was pounding very hard. I was still experiencing the body aches, fatigue, chills, and loss of appetite. This continued all through the night into the next day. April 9, 2021.   On April 10, 2021, the body aches and chills subsided however I continued to feel fatigue, loss of appetite and I could still feel my heart beating hard. These symptoms continued through Tuesday April April 14, 2021 when I went to see the doctor.  I started to get my appetite back later that week after my doctor appointment however I continue to feel heart palpitations and fatigue. I went for a follow up doctor appointment on April 21, 2021.
Dose listed in Item 4 is the first dose.  The second dose was administerered on 2/09/21, also Pfizer, Lot #EL9264, same hospital.    Within a month after receiving the second shot I developed constipation which was unusual for me.   I began to take stool softeners and Senna products but they did not resolves the problem. In May and June my discomfort increased and on July 7th I had a CT scan that revealed inflammatory diverticulitis with the first signs of peritonitis.  I was admitted for an overnight stay and treated with intravenous antibiotics, followed by oral antibiotics after returning home.
Moderna COVID-19 Vaccine EUA Burning immediately after injection. The following morning noticed a small red raised area immediately below the injection site that was warm to the touch and very tender. The area grew larger over the course of a couple days. At around day 5 post vaccine, the area began to itch. At day 8, it is still red, warm to touch and itchy. No treatment has been used.
This spontaneous report as received from a 68 years old female patient with no drug allergy, high cholesterol and high blood pressure refers to herself. The patient was vaccinated with ZOSTAVAX (lot#unknown) and PNEUMOVAX 23 (lot# unknown) concomitantly in the same arm on 17-SEP-2012. Concomitant medications included ZETIA, levothyroxine sodium and losartan potassium. On 17-SEP-2012 the patient experienced her arm was swollen and hard. The reporter mentioned her arm was painful and difficult to move. BENADRYL was reported as treatment information. The patient sought medical attention by spoken with pharmacist and no lab information for the event. The outcome was reported as recovered on an unknown date. Additional information has been requested.
As vaccine was being given the child pulled away and the technician retracted the needle so patient had  needle stick twice
Patient Fainted approximately five minutes after vaccination. Patient was waiting in post vaccination observation area. He fell from the chair and was discovered face down. After rolling patient to his side, the pharmacist tapped patient back until he was responsive. After hydrating and staying on the floor for 5 minutes, patient fully recovered and spent another 10 minutes in a chair with arms until he insisted on leaving.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was received as follows: This case was reported by a Pharmacy Intern. The age at vaccination was not reported. The patient received SHINGRIX about 2 months ago from the date of reporting. The patient experienced redness and soreness at the injection site. On an unknown date, the patient recovered from the symptoms. The patient did not want to receive the 2nd dose. The reporter did not have the patient details.
Heart palpitations; congestion; Hard time breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable 66-year-old- male patient (consumer) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 26Apr2021 11:30 (at the age of 66 years) (Lot Number: EW0169) as dose 2, single for covid-19 immunisation. Medical history included ongoing blood cholesterol (He has had about a year). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to adverse events was none. The patient's concomitant medications were not reported. Patient historical vaccine included, on 05Apr2021 at 11:30 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right (Lot Number: EW0150) as dose 1, single for covid-19 immunisation and experienced heart palpitations, hard time breathing. Warm transfer from (name withheld) from Pfizer. Transfer agent provided zip code as (withheld) Later caller verified zip code as correct. Transfer agent stated that the caller had side effects after getting the Pfizer Covid-19 vaccine. He had heart palpitations, congestion and a hard time breathing. Caller said that he was congested and he never had this before. He said it was hard to breathe. When caller was asked when he had the vaccine, he said about 2 months ago. Facility: Caller stated he got the shot at the University of (name withheld) when they were handing them out. It was a drive-thru clinic. Caller did not have an address or phone number to provide. Events: Caller stated that the events happened after the first shot all at the same time. Then he said the congestion was after the second shot. The congestion was persisting. Caller said that he couldnt remember if the hard time breathing happened after both shots, but it is still happening. It is persisting. When he was up and walking around, it was happening on and off. Caller clarified that the congestion and hard time breathing were related to each other. Relevant Tests was none.  Communication: Advised caller that this safety report would be submitted and then he might be contacted. Advised caller that he might receive something in the mail. The outcome of the events was not resolved.  Follow-up attempts are needed. Further information is expected.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
pt recvd vax 16APR93 & tc from dad 930AM 19APR93 pt had total body rash red blotchy sl raised; no scratching noted; fussy when ate baby food;
Potential allergic reaction - epinephrine administered  PT had seizure activity at 11:45am, within 30 minutes after administration of first COVID vaccine (Moderna)  Epinephrine (0.3mg) administered by provider  at 11:47am PT had audible and palpable pulse, approximately 180 bpm that declined to 107 at time of arrival of the fire/ambulance department, respirations and heart rate did not cease during event  PT in postictal state after seizure however able to dictate to Fire Department his name, date of birth and his last seizure which he states was "a month ago"  Patient was transported to Hospital in stable condition Fire Department
With both boosters I had a high fever in the evening after the vaccine along with severe bodily shaking.  I went to bed and then had severe, shooting pains from either side of my neck up either side of my head which went o for about two weeks.  Then, I had terrible pain in my back between my spine and right shoulder blade which then ran down from my shoulder to sever pain around my right elbow and tingles and sort of numbness down the outside of my forearm to the outside of my hand down to my little finger.  I've also developed tinnitus.  The tingling and tinnitus lasts to this day.  I told my previous Dr. she had me get an MRI at Immaging in June of 2022.  But didn't report anything. She just prescribed about 5 different drugs which did no more than an Advil.  She also prescribed a visit to a neurosurgeon and pain management specalist, which scared me.  I got treatment briefly from an accupunturist and chiropractor and then Physical Therapy.  Those helped alleviate some of the acute pain, but I still have tingling in my arm, some neck pain and tinnitus.
Pt called 1/4/11 after vaccine given on 1/3/11. He c/o pain, swelling, & redness by inj site radiating to armpit. 1/5/11 pt was tx via an urgent care w/pain meds and KEFLEX for infection. Another pt in our clinic reported similar reaction after have PNEUMOVAX w/same lot #.
A healthy 36-year-old female with a history of Grave's Disease. Four days after my second dose of the PFIZER COVID-19 vaccine, my right temple vein was visibly bulging and I experienced a right temple headache. Shortly after, I started having paresthesia and pain in my arms and legs and occasionally face. In addition to the headache and paresthesia, I had multiple episodes of tachycardia and high blood pressure. The headache and paresthesia lasted nearly 3 months. I was admitted to the ER multiple times. Developed superficial thrombophlebitis in ER on the right arm from IV catheter. All scans (CT, MRI w/ and w/o contract, ZIO monitor, Cervical MRI, chest x-ray, etc.) and blood work were normal with the exception of elevated Anti-DS DNA. Multiple visits with General Practitioner, cardiologist, and neurologist with no diagnosis. Most symptoms resolved three months following vaccination but arm pain persists.
Itching, sensitive to touch. Broke out in rash within 1 hr. of receiving vaccine. Break-out of shingles lesions within 6 hrs.
24 hours after receiving the shot.  I had normal reaction, 3 days of fatigue and not feeling well.  After the 3 days started to feel much better.  Than 9 days after I began to feel dizziness and light headedness.  This reaction is still continuing today.  I have been seen by my PCP and he insists its anxiety.  I have also been seen by PT to help relieve dizziness symptoms with no changes.  In doing research I have found that this type of reaction can happen to regular flu vaccine.
Sedation & Myalgia Narrative: Developed significant fatigue and myalgias about 12 hours after shot, lasted about 12-18 hours. Missed work x 1 day. No known prior covid infection
Patient c/o feeling lightheaded and dizzy during observation period.  Was noted to be diaphoretic.  He was placed on a stretcher.  His HR was noted to be in 40s and BPs low about 70's systolic.  He was monitored for an additional 45 minutes.  His BP recovered but his HR remained in the 40s.  His physical symptoms resolved.  He declined transport via EMS to the ED and was transported home in the company of his wife.    Upon follow up call on 5/28/21, he reported being back at baseline.  PCP follow up was arranged for him and happened on 5/29/21 at Health Clinic.  EKG showed a HR of 50 with an incomplete Right bundle branch block.  No further intervention was done.
Patient received doses of vaccines after a temperature excursion; No adverse effect were reported; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history.   On unknown date, the patient was vaccinated with a dose after a temperature excursion (product storage error ) of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R033660, expiration date 20-NOV-2020, and R029517, expiration date 14-OCT-2020 for prophylaxis (strength, dosage, route of administration, and anatomical site were not reported). Therefore, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dosage, route of administration, anatomical site, lot number and expiration date were not reported). No adverse effects were reported. Administered doses of both vaccines experienced the temperature excursion of 35.9 degrees Fahrenheit (F) for 5 hours 54 minutes. Data logger was involved. There were no previous excursions reported.  This is one of three several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005428: US-009507513-1905USA005429:
The injection was administered in the Left deltoid area. Two days later I experienced tingling pain in the middle finger of my left hand.  It has progressively gotten worse, to where the pain is sevier, and wakes me up in the middle of the night.  By rubbing the hand for a several minutes, pain may completely go away, or subside to bearable.  Is this GBS?
Pain and soreness in arm and shoulder Limited range of motion Limited weight-bearing ability Still ongoing at current date (11 weeks later)
Adverse effect of vaccines and biolg substances, sequela on 2016-04-15.
The injection itself was quite painful, my arm was sore after the injection but became very uncomfortable by bedtime. Today  the pain is more substantial, raising and lowering my arm is difficult.  This is the first vaccine that has been really painfu during and after.
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 01 December 2013 the subject received a dose of FLULAVAL TETRA (unknown). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Received first dose Pfizer COVID vaccine on 3/05/21 and the second dose Pfizer COVID vaccine on 3/26/21. Patient stated that approximately an hour after his second dose he felt light headed for about 3-4 hours. RN sent a medical consult to the Vaccination Operations leads. Vaccination Operations Lead approved Pfizer booster dose. RN educated patient on worsening signs and symptoms of COVID vaccine and when to seek EMS, urgent care or emergency department. Patient left vaccination site at 1643 unassisted and with a steady gait.
Dizziness, Headache, Myalgia, Tachycardia, Fever, chills, night sweats, severe fatigue Narrative:
Information has been received from a nurse practitioner concerning a pt (age and gender not reported) with an unk medical history and unk allergies who on an unspecified date was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed cellulitis as a result of the vaccination. It was reported that the pt recovered from cellulitis on an unspecified date. The reporter felt that the pt's cellulitis was related to therapy with pneumococcal 23v polysaccharide vaccine. There was no product quality complaint involved. Additional information has been requested.