chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High blood pressure if 206; Dizziness; Uncontrollably Shaking; Cold; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FH8020) at single dose via an unknown route in right arm on 29Oct2021 11:30 at 50-year-old for Covid-19 immunization.  Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included diabetes. Patient received other medications the patient received within 2 weeks of vaccination; did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included Ace inhibitors and celecoxib (CELEBREX) and experienced allergy. Patient experienced dizziness, uncontrollably shaking, cold, high blood pressure "if 206" (as reported) on 29Oct202111:30. The adverse event result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No hospitalization involved. No treatment was received. Outcome of the events was unknown.  The report was assessed as serious with seriousness criteria of life threatening.
Initial unsolicited report received from consumer on 15 September 2015. This case involves a 71-year-old female patient who was vaccinated with a first intramuscular dose of ADACEL (batch number was unknown, dose and site of administration was not reported) and also received an intramuscular dose of PREVENAR (Manufacturer Other, batch number, dose, cycle in series and site were not reported) on 3 August 2015. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. Concomitant medications were not reported. On 3 August 2015, following the vaccination, the patient experienced pain in both arms and they were locking, swelling in both arms and both arms were purple from the injection site to the elbow. The patient went to the physician and the arms were still swollen and itchy. The patient also experienced headaches and tightness in the throat and pain in ears, pain in stomach and some blood when going to the bathroom. The patient required emergency room and physician visit. Laboratory investigation and corrective treatments were not reported. The patient was recovered from the event itchy and not recovered from the other events. Upon internal review, the company decided to consider the event "some blood when going to the bathroom" serious because of important medical event bleeding. List of documents held by sender: none.
Large 2"x3" irregular circle at site of injection, bright red, swollen, feverish.  By 6/27/99 pt felt extreme fatigue bordering on exhaustion.
Narrative: Hospitalization - pt admitted on 1/9/22 for SOB. Prolonged hospital course for PNA, human metapneumovirus, COPD exacerbation. Found to be COVID-19 positive on 2/8/22 (while admitted), fully vaccinated (not boosted). Patient died on 2/15/22 of hypoxic respiratory failure.
pt ahd swelling of the tongue large enough that the mouth would not close 1 -2 hours after vaccination
Patient received the vaccine on 4/10/21 and a few days later hit his leg, which subsequently became erythematous and swollen. He went to urgent care on 4/13/21 and received a prescription for doxycycline which he stopped taking prior to resolution of symptoms due to side effects from the medication. He was prescribed clindamycin, but did not start this medication. Patient had outpatient labwork this morning which revealed an elevated SCr, for which he was sent to the ED. The patient was found to have AKI with hyperkalemia, as well as left lower extremity DVT and cellulitis. Patient is being treated with heparin and linezolid, as well as Kayexalate. The patient is being admitted to the hospital for treatment.
Patient was given the wrong dosage.  She was given a double dose of vaccine.  Patient was instantly light-headed.  She has diabetes and had not eaten.  Provider feels it was a vagal response instead of the vaccine reaction.    Patient was monitored for 1 hour until symptoms resolved.    Patient was contacted this afternoon, she is feeling much better.
Pt c/o SOB, back pain about 3-5 min after vaccine given. Pt given 50 mg Benadryl IV, 80mg depo-medrol IM, and HH Neb with xopenex.
Flu like symptoms for 24 hours after vaccine, within weeks following frequent headaches, dizzy spells, ear pressure, tinnitus. Referral to ENT appointment in Dec. Second vaccine dose in November of 2014. Flu like symptoms again following vaccine. Frequency of headaches, dizzy spells ear complaints increased. See ENT in Dec. Diagnosis of Meneire's Disease bilateral. Refered to a Neurologist specializing in balance and vestibular conditions. Diagnosed with vestibular migraines. [February 2015]. New symptoms continue to pop up extreme exhaustion, muscle aches and weakness and joint pain. Diet changes do not help initial symptoms. Amitriptyline is prescribed for migraines. In May removed from amitriptoline because of possible absent seizure activity. EEG is normal but Topamax prescribed. Dose is increased in July to 50mg at bedtime. Cognitive issues ensue and all symptoms are still present. Dose is dropped to 37.5 all symptoms still present.
This spontaneous report as received from a physician and nurse refers to a currently 18 year old male patient. No medical history provided. On 19-SEP-1994 the patient received on the 1st dose in a series of  Hepatitis B vaccinations (indication routine vaccinations). The nurse was unsure who the manufacturer of each Hepatitis B does was but initials were provided for each dose. First dose was RECOMBIVAX HB with initials MSD (lot # 1788W; exp date: 27-OCT-1996). No concomitant medications were reported. On 22-NOV-1994 the second dose was Hepatitis B virus vaccine (unspecified) (manufacturer unknown) with initials ENG (lot # 1392A2). On 23-MAY-1995 third dose RECOMBIVAX HB with initials MSD (lot # 1285A, exp date: 11-JUL-1997). The physician reports that he had titers drawn for the patient, on an unspecified date the Hepatitis B and the titers resulted negative. The physician reports that the reason for having the titer drawn for the patient was due to the patient having tattoos done on an unspecified date and the physician wanted to ensure that the patient was not exposed to Hepatitis B. Additional information has been requested.
About 2 minutes after getting shot, patient was found laying on ground passed out in front of pharmacy while his father held him.  He appeared to be passed out for about 15-20 seconds.  Pt. had pulse and was breathing. Emergency response was activated.  Pt. urinated on himself.  Pt. remained on ground after he came to for about 10 minutes just so we could make sure he was ok.  We gave him an ice pack and some water.  Pt. was evaluated by the emergency response team and did not want to be taken away in ambulance.  Checked in with patient and hour later, and father said he was doing fine.
Pt devel inject site rxn of induration and redness. Reporter indicates that of 20 employees vax, 9 exp similar rxn. Additional reports to be generated.
7 days p/vax pt devel an inj site rxn characterized by redness & swelling which extended to the elbow;pt rx w/Keflex & recovered;
she woke up with bruise filling in her armpit area; she had swelling in between her chest and armpit; feeling of bruising underneath left arm; tenderness at inject site; injection site soreness; swollen lymph nodes.; 30 pound weight loss; This is a spontaneous report from a contactable consumer reported that. A 32-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jun2021 (Batch/Lot Number: EW0173) as DOSE 1 SINGLE for covid-19 immunization(Age at vaccination 32 years). The patient past Medical history included thyroid disorder from an unknown date and unknown if ongoing , cardiac disorder from an unknown date and unknown if ongoing And there is a heartburn medication that she takes. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication from an unspecified start date and ongoing.  Caller has taken the first dose of the Pfizer COVID-19 vaccine. On 20Jun2021 the patient had injection site soreness, she woke up with bruise filling in her armpit area and she had swelling in between her chest, tenderness at injects site and armpit and feeling of bruising underneath left arm: Feels like she has been walking on crutches on 22Jun2021. From her understanding, she has swollen lymph nodes on unspecified date in Jun2021. Caller wanted to know if these have been reported as adverse events with the vaccine and she wanted to know how long they would last. Caller states her weight is 287 pounds with a 30-pound weight loss on unspecified date in Jun2021. But the injection site is not swollen or red or anything and the soreness in it is almost gone. Caller asks to be transferred to medical information. Caller asks if her symptoms are a known side effect of the vaccine and how long should she expect it to last. Is it something that should make her reconsider getting the second dose. The event outcome was  recovering for Vaccination site pain and  Vaccination site tenderness ,Not recovered for Bruise, Swelling, Bruising of arm, Swollen lymph nodes and weight decreased for Unknown,   PSCC Communication:  Report 1 of 2. PC filed. Unable to obtain full details as caller wished to be transferred to medical information to ask question. Warm transferred caller to Ana with Pfizer Medical Information, GRACE: INT-#.  Provided caller with phone number of #, option 3, with hours of 8a-8p, Monday-Friday, 9a-3p, Saturday and Sunday, prior to transfer, in the event of disconnection.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
I received the shot around 9:15 AM. Early afternoon started feeling tired and a general feeling of unwell. Went to bed around 9:00 PM. Woke up at 10:00 PM with real bad chills and headache. Got up at 1:00 AM 4/12/21 very hot and chills. Took my temp and it was 103 degrees. Felt dizzy and weak. Took two Acetaminophen and went back to bed. Got up around 4:00 AM still hot. Took temp and it was 101.6. Took two more Acetaminophen and went back to bed. Continued this type of treatment all day. Drank water and rested. All day had temp, headache, fatigue, and nausea. Went to bed at 7:00 PM after taking 2 Tylenol PM's. Upon getting up (4/14/21), took my temp 99.5 degrees. Still have slight headache and fatigue, but feeling better.
This spontaneous case was reported by an other healthcare professional, describes the occurrence of pyrexia (after taking the shot I have a fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (after taking the shot I have a fever). At the time of the report, pyrexia (after taking the shot I have a fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
burning sensation from site of inject to bend in elbow; for several wks aching, throbbing of arm from inject site to the bend in the elbow;
This case was reported by a physician (parent of the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Hepatitis A vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), and experienced not responding to therapy, vaccination error and laboratory error.  The physician reported that his daughter, who had received a Hepatitis A vaccination in the past, had an antibody test performed which showed she needed another dose.  The physician did not know which Hepatitis A vaccine had been given.  The physician wanted information on the accuracy of antibody tests, and wanted to know if additional doses were recommended after vaccination series.  The physician felt "it may have been an administration error on the administration of the vaccine or the antibody detection's testing laboratory error."  The physician was not willing to provide any information, nor did he want to be followed up with.  The physician stated that he did not have any additional information to offer.  This is one of two cases by this physician; see case A0814449A for not responding to therapy for an unknown number of subjects.
Patient reported that he had fever, swelling in the vaccination area, nausea, muscle aches, headache, redness in the entire arm.
3 cm circular area of redness and warmth with induration, 2 days post injection- Rx BACTRIM DS tab bid x 7 days, BENADRYL 25-50 mg q 6-8 hrs prn.
MMR and Varicella were combined in one injection. MMR reconstituted with one 0.5ml vial of Sterile dilutent. Added to Varicella vial to reconstitute and given as one injection. No reported adverse events from family reported as of 4/8/2019.
4 days of tachycardia resulting in cardioversion required 5/24/21.  Sinus rhythm restored 5/24
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No concurrent conditions, medical history, concomitant medications and drug allergies were reported. On 12-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number L005297, expiration date: 17-AUG-2016, albumin status HSA; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of  unknown age and gender. On 21-OCT-2013 the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (lot # H012519, expiration date 09-OCT-2013) (dose and route were not reported). Concomitant medications were not reported. No adverse symptoms reported. This case is linked to case 1311USA003267 via same reporter link. Additional information has been requested.
This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age, who was pregnant. Her last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. On 02-MAY-2016 the patient was inadvertently administered with a dose of GARDASIL 9 (lot #L043213, dose, expired date and route were unknown) (drug administration error, exposure during pregnancy). No concomitant therapy was reported. The pregnancy outcome was unknown. No adverse event was reported. Additional information has been requested.
Severe pain down arm with movement. Started several hours after the dose was administered and has continued ever since. Pain seems nerve related with a burning and tingling. The pain is aggravated by movement. Pain originates in the shoulder joint area and radiates down arm.
stomach is still in knots; hurting really bad; headache; muscle pain; joint pain; really bad chills; nausea; fever 80 something to 99.9; A spontaneous report was received from a healthcare professional concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, muscle pain, joint pain, really bad chills, nausea, hurting really bad, fever 80 something to 99.9, stomach is still in knots, she was feeling a lot better on reporting day but woke up with real queasy stomach.  The patient's medical history included sinus allergy and has a current condition of hypertension. Losartan was concomitant medications reported by patient  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 07MZVA) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced headache, muscle pain (myalgia), joint pain (arthralgia), really bad chills, nausea, hurting really bad (malaise), fever 80 something to 99.9 (pyrexia), stomach is still in knots (abdominal pain upper). On 14 Feb 2021, she  woke up with really queasy stomach (nausea).  Treatment for events included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient after 4pm appointment, went to gym to lift weights, then returned home and drank a protein drink and cherries then went to soccer practice. While at practice about 30 min patient developed itching swollen eyes, lip. Returned home where patient was given BENADRYL and taken to ER. On route throat was closing up.
pt recv vax 13JUN96 to lt arm mid-AM;pt presented 6hr later w/lt arm & hand swollen;some erythema @ inj site;subjective numbness & tingling in lt arm/hand
Pt said she had severe pain in arm and swelling for about a week but finall subsided.  It happened the next day after the injection.
Patient received Pfizer BioNtech higher than authorized dose. No side effects or symptoms. Patient was contact after 3:00 Hours and patient was completly fine with no side effects local or systemic. We called the patient again on 07/17/2021 at 12:10PM and patient reported that he is completly fine with absolutely no side effects what so ever.
Approximately 4 1/2 hours after the flu shot was administered the client called me to report severe muscular pain, so severe, he couldn't raise his left arm or lie on his left side. Denied fever.
Mom stated child's rt eye was swelling & nose congested & coughing & wheezing; Mom instructed by MD child should never have a MMR in future w/out contacting private MD;
awakened me from sleep.; arm pain; swelling; Vaccination site induration; Vaccination site pain; Restless night with pain on any movement, mostly joint-lines; headache; myalgias; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee surgery NOS (Four distant past surgeries on left knee).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INSOMNIA (awakened me from sleep.), PAIN (arm pain), SWELLING (swelling), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PAIN (Vaccination site pain), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache), MYALGIA (myalgias) and FATIGUE (fatigue). At the time of the report, INSOMNIA (awakened me from sleep.), VACCINATION SITE INDURATION (Vaccination site induration), ARTHRALGIA (Restless night with pain on any movement, mostly joint-lines), HEADACHE (headache) and MYALGIA (myalgias) outcome was unknown and PAIN (arm pain), SWELLING (swelling), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that her symptoms began 15-16 hours post vaccination. No concomitant medication was reported. The treatment information included ice and topical pain relief.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Significant follow up appended On 07-Jul-2021: Followup received on 07-JUL-2021 contain information about events reported.
patient present at office 5.16.22 for 12 months physical,  after visit Dr. noted that pt was given 2 m vaccines instead of 12 m, due to accidently pressing the button for 2 m instead of 12 m in order selection.  Dr. immediately   called mother, reassured that PCV 13 and pentacel were ok to be given at this time, will ask to return to get Hep A, so can catch up by 18 m, and MMR and Varicella could be given with next visit. Rotavirus vaccine- was given and asked mom to observe for diarrhea.
approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 22-APR-2016 the patient was vaccinated with improperly stored dose PNEUMOVAX 23 0.5 ml (lot # L010598, expiration 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion eighteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (215, 29.3); (144, 34.2); (52, 33.1); (72, 32.9); (144, 32.4); (100, 34.5); (28, 30); (24; 34.3); (104, 29.1); (48, 34.9); (48, 34.7); (24, 34.8); (104, 34); (100, 33.6); (24, 32); (24, 31.3); (163, 31.1), (56, 33.4). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt came in for Bivalent booster to which patient received. However upon follow-up review, patient had received bivalent booster 10/18/22.
On 3/10/21 patient was inadvertently given the Moderna vaccine. On 4/7/21 patient returned for second dose and it was discovered the patient was 16 years of age, vaccine was not given at this time. Provider contacted CDC at this time and spoke with NP, health specialist who informed the provider with further instructions on how to vaccinate the patient in the future. Per CDC guidelines it is recommend for the child to receive the second dose of Moderna as a off label use. The 2nd dose of the vaccine was given on 4/14/21. The patient/ parent reported no adverse reactions to the vaccine.
Sense, feeling that there is water in my ear. Constant yawning so that it may pop, however, no true water in my ear. Hearing low bass noises extra loud, muffled and resonating in my ear. Only one ear affected.
After telling medical center "I think I'm going to pass out - pt slipped to floor from her chair - Nurse found pt on floor at registration desk - arms and legs stretched out rigid with some jerking movements that lasted 30 secs or so. Pt stated her chest was hurting. She pulled herself up with assistance into a wheelchair and was taken to exam room. For vital signs and treatment see progress notes attached. Ambulance to ER. Admitted 23 hours. Discharged Dx syncope, chest pain, probable allergic reaction to vaccines, bronchial asthma, hypotension resolved.  8/22/07-records received from facility for DOS 8/8-8/9/07-DC DX: Syncope. Chest Pain. Possible allergic reaction to vaccinations (MMR, RBP, hepatitis). Bronchial asthma. Hypotension resolved. Presented to ED with history of syncope and chest pain, 5-10 minutes after vaccination developed substernal chest pain described as severe heartburn. Became short of breath, sensation she was going to pass out and finally she passed out with BP of 60/40.