chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild headache; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number EH9899 and expiration date 01Mar2021), via unspecified route on 08Jan2021 at single dose for covid-19 immunization. Medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced injection site pain-minor, tiredness-moderate/fatigue, headache-mild to moderate, muscle pain-minor/muscle aches, fever-low grade, nausea-comes and goes, muscle weakness, and weak. The patient recovered from vaccination site pain on 20Dec2020, from headache after two weeks and on unknown date for the other events. On 18Dec2020 the patient experience also chills and injection site redness light pink with outcome of recovering. On 19Dec2020 the patient experienced feeling unwell-mild to moderate with outcome of recovering. The events injection site pain-minor, tiredness-moderate/fatigue, headache-mild to moderate, muscle pain-minor/muscle aches, fever-low grade, nausea-comes and goes, muscle weakness, feeling unwell-mild to moderate and weak were serious due to hospitalization. The patient took ibuprofen for fever and headache. No treatment was received for the other events. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination. On unknown date in Jan2021, after receiving the second dose, the patient experienced a mild headache and no other side effects for 1-2 days and then she felt fine. The patient did not received treatment for the adverse event. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Non-blanchable purple rash on left lower leg noted in afternoon of 5/4/16.
Patient communicated that he has anxiety. Patient received the first moderna vaccine and about a minute after stated that he was feeling light headed. He then felt very nauseous but did not vomit. He said he felt very hot inside and was sweating very profusely. We got cold water for the patient to drink and placed some cold water on a towel on the back of his head. We then checked his blood pressure 117/68 his pulse was 65. We kept an eye on him for the next 30 minutes and he opted to leave because he said he was feeling a lot better and lived very close by. Patient ate lunch by 1 pm. We took his information to follow up and counseled him to lay down and get something to eat. He was instructed to call the pharmacy if he had any concerns or questions.
On 5/26/2006 Pt presented with a 12 x 7cm area of erythema, warmth, and tenderness, surrounding injection site on left thigh. TX with Keflex 250 mgl 5 ml.
Patient stated on 10/1/11 that she thought immunizer had hit a nerve. 10/4/10 because she had significant pain and could not for instance scratch her back some pain still lingers.
patient was inadvertently given an expired dose of Pentacel, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician, other healthcare professional and consumer/non-health care professional via Medical Information (MI) (Reference number- 00830643) and transmitted to Sanofi on 27-Oct-2021.  This case involved a two-month-old (2 months and 3 days) male patient who was inadvertently given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Expired product administered].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 27-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ393AA, expiry date: 12-OCT-2021, formulation: suspension for injection) via intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse reported that a patient was inadvertently given an expired dose of Pentacel, today. She requested guidance on how to proceed."  No other adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or was to be held liable for the occurrence of this medication error.
11 days of extreme flu like symptoms.  High fever, chills, nausea,  severe body aches, loss of appetite and thirst. Turned into a lung infection.  Took antibiotics and steroids
Tested NAAT positive for COVID 8/27/21 after being fully vaccinated.
None. Vaccine was administered to 14-year old female although Heplisav-B is only approved in patients 18 years and older.
Menstrual cycle came 8 days after finished previous cycle.  Was on day 3 of period when received shot.
Woke up with abdominal pain on the right side just below the ribs. I have had two other "events" that I assumed were gallbladder attacks but the pain subsided within a few hours. With this event, after a few hours and the pain was still high, I had to be driven to the ER. Just before leaving my house I started getting tunnel vision and my arms and legs went numb. I was able to walk on my own again once reaching the hospital. As of today, 5 days later, I am still in pain. I have taken out all fatty foods and things that are bad for gallbladder issues and still no change.
VACCINATION SITE RED, VERY WARM TO THE TOUCH, PAINFUL, SLIGHTLY SWOLLEN, AREA APPROXIMATELY THE SIZE OF A BASEBALL IN CIRCUMFERENCE SYMPTOMS LASTED 3-5 DAYS NO TREATMENT GIVEN (EXACT FLU VACCINE UNKNOWN).
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 13:50 patient began to show the following symptoms: diaphoresis, paleness, weakness, dizziness, and tingling in both the hands and feet. Patient  instructed to lie down in cot. Vitals taken in supine position at 13:55 were as follows: BP: 110/70, P: 80, T: 98.2F, and RR: 24.  During this time patient stated feeling dizzy and nauseous. Patient stated he "gets this type of reaction whenever he gets a shot" He also stated having a phobia of needles. 15 minutes later at 14:10 patient sat up and vitals were taken again: BP: 130/70, P: 76, T: 98.3F, & RR: 20.  Patient stated "feeling better now." Patient instructed to go to urgent care or Emergency room if symptoms persist. Patient verbalized understanding and agreed to instruction. Patient alert and oriented and walked out of facility in stable condition.
1 day after vaccination patient developed fever 103, headache, back pain; ran fever for 6 days over 101.
Mild dizziness, felt fuzzy. BP 156/90 (pulse 64), O2 sat 98%.
lt thigh swollen, tender to palpation;erythema @ the inj site;no induration;
cold congestion; minor respiratory symptoms; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jul2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy, petroleum allergy, penicillin allergy, battery, assault in 2017, and puncture wound (2017 assault and battery under anesthesia puncture wounds to the abdomen and spine). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL XR) 20 mg from an unknown date for an unspecified indication. Four days afterwards on 27Jul2021 at 08:00, the patient experienced cold congestion and minor respiratory symptoms that have not abated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events cold congestion and minor respiratory symptoms was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up
Patient complained of headache the morning of 4/20/18, the day following the vaccination, that persisted for several hours. She described it as intense, diffuse pain. At the injection site, there was significant redness encompassing a 4-inch diameter on the left deltoid. The red rash was not raised but was warm to the touch and mildly painful to the patient.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and sex. On 10-APR-2013 date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route not provided) (lot # 0073AE, expiration date: 03-APR-2013). The reporter stated that on 10-APR-2013 the patient received an expired ZOSTAVAX, no adverse effect was reported. Additional information has been requested.
Swollen lymph nodes under arm for past 2 weeks; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset an unknown date Jan2022, outcome "recovering", described as "Swollen lymph nodes under arm for past 2 weeks". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Fevers up to 102. Coinciding with fevers he will additionally have headaches, occasional fluid with lump in his stomach that makes it more difficult to eat and generally feels unwell. Is having multiple waves of fevers throughout the day. They do seem to be responsive to ibuprofen which has been given once a day to help manage. Appetite is decreased but does seem to begin taking enough food and water. Has normal bowel movements. No changes in bladder habits. He does seem fatigued but generally is himself.
Flu shot. Not sure which one, localized but spreading redness, heat from the area, bruising, swelling and itching. We are using Motrin, benedryl, cortisone topical cream and cold packs.    Pt a severe egg allergy.
20 min. after vaccination, c/o vertigo and nausea. 30 min after vaccination, c/o itchy throat and thickening sensation of tongue. 911 called. Taken to ER. Tx with BENADRYL and given EPIPEN for future allergic reactions. Gets annual flu shot without prior reactions.
NARRATIVE: Patient received his first dose of the COVID 19 vaccine on 2/18 and subsequently developed cough and shortness of breath. Tested positive for COVID 19 on 3/10. Prior negative test on 2/8. Patient was not hospitalized; recovered and received 2nd dose on MARCH 31, 2021.
w/in 72 hrs p/vax pt exp diarrhea & vomiting; also mom reports that pt was hitting head against the wall for approx 9 hrs; required MD visit; recovered;
Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder area; overall feeling of tired
Information has been received from a registered nurse concerning a 37 year old female patient with penicillin allergy, egg allergy, asthma and borderline hypothyroidism who on an unspecified date was vaccinated a second dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). There was no concomitant medication. The nurse reported that the patient had a large baseball size bump in the deltoid region. The patient did not get the third dose because it was found that the patient had high titers after only 2 doses. At the time of the report the patient had recovered. The patient sought medical attention by a phone call. No further information is available.
Death (Pt had 1st Hep-B/5194A2/IM/RL on 7/31/01). COD as per autopsy report: Complications of acute upper and lower respiratory tract infections/sr
Pregnancy began January 13th. 4 weeks pregnant at first vaccine. 7 weeks pregnant at second vaccine. Miscarriage occurred in the week following the second vaccine. Exact date that the heartbeat stopped is not able to be determined but there was a heartbeat 3/3. I got the vaccine 3/4.
16 Year old female received a 2nd dose of Gardasil vaccination next morning she woke up with generalized body aches.
Oral irritation; Altered taste; This case was reported by a other health professional via call center representative and described the occurrence of mouth irritation in a 34-year-old male patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th September 2022, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. In September 2022, 3 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced mouth irritation and taste altered. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the mouth irritation and taste altered were recovered/resolved.   It was unknown if the reporter considered the mouth irritation and taste altered to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR187830   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The reporter stated that the patient received his first Twinrix dose on 9th Sep 2022 and three days later he experienced oral irritation and altered taste.  The reporter state that the effects were treated with Zyrtec then Benadryl and the oral irritation and altered taste resolved.  The reporter gave consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR187830.; Sender's Comments:  US-GSK-US2022AMR187830:Same reporter
A few minutes (3-5 min) after vaccine administration (just Hep A was given) she stood to do eye testing, became pale began to pass out and vomited. Had not eaten/drank that morning. No LOC. Recovered quickly with laying down.
A health professional reported the occurrence of limb swelling in a 5 year old male who received Infanrix. The subject's medical history, concurrent conditioins, and concurrent medications were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject received an injection of Infanrix. On 4/20/02, post-immunization, the subject experienced limb swelling and was seen by a physician. The event was reported to have resolved on 4/27/02. The reporter considered the event to be related to Infanrix administration.
This spontaneous report as received from a physician via company representative refers to a 60 year old elderly female patient. On 07-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose strength, route unspecified) and later the patient started to feel unwell on an unspecified date following ZOSTAVAX administration. Physician reported that the patient had unspecified lab work drawn, on an unspecified date, due to this, which showed that the patient's hemoglobin was low. The patient was then sent for additional unspecified testing on unspecified dates. The physician reported that following receipt of all testing results, the patient was diagnosed with cold agglutinin hemolysis on an unspecified date in 2015. The patient was treated with folic acid for the event reported. The outcome of cold agglutinin hemolysis is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Rash at injection site, very itchy and red.  Rash stopped 1-2 days after 3/8  Hard lump at injection site 3/15  Itchiness has continued since rash, but no rash present.
Jerking/started jerking all over; could not stand; Legs felt like rubber bands.  No strength; Chills; Very, very bad headache; Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk; Legs just buckled/legs felt like rubber bands; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), DYSKINESIA (Jerking/started jerking all over), CHILLS (Chills) and HEADACHE (Very, very bad headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills) and HEADACHE (Very, very bad headache). On 15-May-2021, the patient experienced DYSKINESIA (Jerking/started jerking all over). 15-May-2021, the patient experienced DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength). On 15-May-2021, DYSKINESIA (Jerking/started jerking all over) had resolved. On 16-May-2021, GAIT DISTURBANCE (Could not walk/when she could get up and tried to walk, she stumbled/could only walk as long as she was hanging onto something/could not stand or walk), LIMB DISCOMFORT (Legs just buckled/legs felt like rubber bands), CHILLS (Chills), HEADACHE (Very, very bad headache), DYSSTASIA (could not stand) and ASTHENIA (Legs felt like rubber bands.  No strength) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-325697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up was received.
Abrupt onset of nausea Subsequently felt faint and experienced  dry heaves / felt very warm and flushed  Placed on stretcher  BP 152/80  --- 160/96----125/82 Throat Clear Chest Clear Skin no rash / slightly diaphoretic
A protuberance around ''my'' left clavicle bone. Can move it up and down the clavicle, feels like a nodule; Not actively painful but a bit of soreness; This is a spontaneous report from a contactable pharmacist, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies (NKA). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in left arm on 31Mar2021 at 08:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 08:00, the patient experienced a protuberance around left clavicle bone, could move it up and down the clavicle, felt like a nodule, not actively painful but a bit of soreness. She noticed when showering Saturday on 24Apr2021 morning and today Monday 26Apr2021 still had it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events a protuberance around left clavicle bone and bit of soreness was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling at site of vaccine at time of injection-resolved and returned. C/O pain earlier but not current - red & hard advised to come in for eval.
Patient is currently inpatient at Hospital with atrial fibrillation. She woke up with chest pain on 3.16.21 at 4am with chest pain. She was taken by ambulance to the hospital where she was admitted. She is on heparin and has recieved an EKG, ECHO, and blood work. The medical team is evaluating next steps. Chest pain has not resided.