chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache worse than a migraine; High temperature; Chills; Sore arm; Achy body; Nausea; Not able to sleep for 36 hours; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included epileptic seizure disorder. The patient had unspecified allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took unknown medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, at 00:00 the patient experienced severe headache worse than (then) a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours. The patient also reported that effects lasted 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included selfcare. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache worse than a migraine, high temperature, chills, sore arm, achy body, nausea, not able to sleep for 36 hours were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received her flu vaccine at 12:56 pm and around 7 pm, she started experiencing uncontrolled jerking of her hands and legs. She took 500 mg  tylenol and rested for a little while; she thinks she feel asleep around midnight after feeling comfortable.
Information has been received from a physician concerning a 25 year old female who in May 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. about 10 days after the vaccination her foot swelled up. Then the swelling spread to her knee and shoulder. The patient had a CAT-scan done and it revealed that she had an enlarged spleen. Unknown medical attention was sought. The patient was put on high dose of Ibuprofen (manufacturer unspecified) and the condition resolved by July. The enlarged spleen and swollen foot considered to be disabling. No product quality complaint was involved. No further information is available.
Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains primary reporter address updated.
Day 1 aches and fatigue, Day 4 stiffness in joints and red sores. On day 9, symptoms ongoing.
Swelling; Injection site pain; Fatigue; Headache; Muscle and joint pain; Muscle and joint pain; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Muscle and joint pain) in a 72-year-old female patient 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 Faint (2 episodes of falling in the night but stated that both were faint episodes.).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain). At the time of the report, SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Muscle and joint pain) and MYALGIA (Muscle and joint pain) outcome was unknown.            No concomitant medication was reported. It was reported that patient had minor side effects after her Moderna doses. Treatment information was reported as Unknown.   This case was linked to MOD-2022-572766, MOD-2022-572771 (Patient Link).   Reporter did not allow further contact
Exhausted evening of 11/9/21 & 11/10/21.  11/10/21 Night sweats all night and extreme leg and foot cramps about 6 times while sleeping.  I slept off and on for 10 hours.
Patient received her shot around 3:30pm 7/30/21. She states that she felt a sharp pain instantly at site upon injection which she stated to pharmacist who gave the shot. She states that the pain has been continuous and progressive over the past 12 hours since and is calling in at 3:30AM 7/31/21 to complain of severe pain in her arm keeping her wake. She states that there is also tingling that goes to her fingers and she feels it is affecting the use of her arm. She is concerned there is nerve issues. Patient says the pain also goes up her shoulder to her neck. This is her 2nd dose and she says the first dose she did have pain in the injection area but the onset was gradual (next day) and it was more localized. She feels that the shot was given higher up on her shoulder this time than past immunizations.
Follow-up information provided updated physician address and county where vaccine was administered.  Information regarding Hib-Titer Vaccine (haemophilus B conjugate vaccine (diphtheria crm197 protein conjugate) injection) was received from a healthcare professional regarding a 3 year old female patient who received a fourth dose on 07 Apr 2000 and developed irritability and a "localized reaction in her left arm" characterized by injection site redness, injection site "warmth to the touch" and injection site swelling. Medical History: The patient's concurrent illness included cardiac murmur functional (reporter indicated the patient was "seen by a cardiologist in June of 1999"). Product Details: Indication for Hib-Titer Vaccine was immunization. Product was administered on 07 Apr 2000. Dose regimen was 1 dose (intramuscular). Concomitant Therapy: Concomitant medications were not reported.  Event Details: On 07 Apr 2000 the patient received a fourth dose Hib-Titer and later that day developed irritability (agitation) and a "localized reaction in her left arm" (injection site reaction) characterized by injection site redness (injection site erythema), injection site "warmth to the touch" (injection site warmth) and injection site swelling (injection site swelling). The reporter indicated that the patient recovered. Related Case(s): See related case(s): HQWYE584812JAN05 (adverse event, non-expedited). No additional information was available at the time of this report.
onset of severe dizziness with rapid heartbeat and pain; extreme dizziness/onset of severe dizziness; rapid heart beat/onset of severe dizziness with rapid heartbeat; headaches daily/daily headaches since receiving the vaccine.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness/onset of severe dizziness), TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat), HEADACHE (headaches daily/daily headaches since receiving the vaccine.), FATIGUE (fatigue) and PAIN (onset of severe dizziness with rapid heartbeat and pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergies to Doxycycline, Nubaine, Codeine, Shellfish, Eggs, Milk, Soy, Beans, Salmon.), Asthma (Has gotten worse, albuterol is too strong, less in control) since 05-May-2008 and Hypertension since 18-Apr-2014. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 18-Jul-2020 to an unknown date for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, AMITRIPTYLINE for Depression and Anxiety, LISINOPRIL, SPIRONOLACTONE, DICLOFENAC and SALBUTAMOL SULFATE (PROAIR HFA) from 05-May-2008 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (extreme dizziness/onset of severe dizziness), TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat) and HEADACHE (headaches daily/daily headaches since receiving the vaccine.). On an unknown date, the patient experienced FATIGUE (fatigue). an unknown date, the patient experienced PAIN (onset of severe dizziness with rapid heartbeat and pain). The patient was treated with ALBUTEROL SULFATE for Asthma, at a dose of unknown and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) for Headache, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (extreme dizziness/onset of severe dizziness) and TACHYCARDIA (rapid heart beat/onset of severe dizziness with rapid heartbeat) had resolved. At the time of the report, HEADACHE (headaches daily/daily headaches since receiving the vaccine.) and FATIGUE (fatigue) had resolved with sequelae and PAIN (onset of severe dizziness with rapid heartbeat and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow up received. Updated Reporter details, Updated Patient's demographics and other relevant histories, Updated Suspect Product 1st dose start date, Updated and added Concomitant medications and treatment medications, Updated Vaccine facility information, Added Adverse events (Fatigue and Pain), Updated Adverse Events start and stop date, duration, outcome.
The patients fiance received his vaccine at the same time as the patient and he got lightheaded and dizzy and almost fell in the pharmacy area. The patient stood up to check on him and got lightheaded and dizzy. She was sat back in a chair and was given water and an ice pack for the back of her neck. She started to feel better than complained of tingling in her hands and her blood pressure was 91/56 mmHg. EMTs were called and took over care.  She never lost consciousness but was not able to hold a water bottle.
I started gettin sick the evening after my shot and have been very sick with covid ever since!!!  I could not go to work on Thursday because I was so sick. Sore thoart, chills, running nose, weakness, muscle soreness, queasy so on. In otherwords you gave me Covid this time. I had no reaction with the other 3 vaccines. This one has made me very ill and is not going away after 2 days. I will probably have to miss another day of work tomorrow.
Day 10 my arm became red and warm to touch and skin around injection area is itchy. No fever noted.
Information has been received from a registered nurse concerning a 22 year old female with papanicolaou smear abnormal and papilloma viral infection positive (possibly for 16 and 18) and drug reactions or allergies reported as none who on 27-JAN-2010 was vaccinated with a first dose of GARDASIL (lot # 662299/1099Y) intramuscularly. There was no concomitant medication. It was reported that after first dose of vaccine she had no adverse effects. On 29-MAR-2010 she received second dose of GARDASIL (lot # not reported). On the same night as the second dose of vaccine on 29-MAR-2010, she developed a fever, itching and a generalized rash on the abdomen, arms and neck. The rash spread, so she reported to the office on 06-APR-2010. There was no fever when she reported to the office. The physician gave her a prescription for BENADRYL 50mg three times daily for 5 days. At the time of the report on 08-APR-2010 she was recovering. There were no laboratories diagnostics studies performed. Fever, itching and generalized rash on the abdomen, arms and neck were considered to be an other important medical event by the primary reporter. Additional information has been requested.
The next morning after receiving the vaccine the site at injection was sore. The arm starting to feel really hot to touch and a hard lump at the injection site about day 3. The soreness in my arm lasted for about 3 days. Then day 10 I showed my daughter who said it was a big red circle. It maybe about 4inches.  Today day 13th it has increased in size and just as red. It is still hot. I am also been having hot flashes, but no fever when I checked my temperature. I have also had headaches, cough (yesterday). Is worried that the shot was administrator in the wrong place, I can still see the hole where the needle/injection was given as well.
I received the flu vaccine at 6 PM on 10/9/12. I woke up at 12 AM (6 hours later), with uncontrollable shivering, fever, chills, hot spells, vomiting, terrible headache that all lasted thru the next day. I experienced fatigue & muscle aches, and stiffness in my neck.
Patient reported to clinic 2 days post vaccine complaining of redness and swelling at injection site.  10cm area of redness with a 3 cm pale center on right thigh.  Area painful to touch.  Evaluated by doctor.  Patient started on Keflex 250mg/5cc 3/4 tsp tid x 10 days, OTC Benadryl 12.5mg/5cc 1/2 tsp q 4 hours.  Patient advised to return to clinic 8/4/08.
Pfizer-BioNTech COVID-19 Vaccine EUA effects: bruising of injection site about size of golf ball, 6.5 hours after itchy rash on neck persisting for over 24 hours then on and off, whole body soreness and fatigue.
Hives lower trunk, spreading Administered diphenhydramine 50mg; Zyrtec 10 mg  Discharged with diphenhydramine 50mg at bedtime and Zyrtec 10mg daily
Headache, breastfeeding and baby?s poop is extremely dark green and mucusy.
No adverse event was reported at the time ,however, an extra dose of a booster dose was administered. An administration error occurred due to vaccine mix-up.
This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 22-MAR-2015, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to seven separate temperature excursions (dates unspecified): two concerning a freezer (one lasting for 72 hours with the highest recorded temperature of 8 degrees Fahrenheit (-13.33 degrees Celsius) and the second lasting for 24 hours with the highest recorded temperature of 6 degrees Fahrenheit (-14.44 degrees Celsius) and five concerning a refrigerator (one lasting for 72 hours with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius), the second lasting for 72 hours with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), the third lasting for 248 hours with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), the fourth lasting for 112 hours with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius) and the last lasting for 72 hours with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt at school this AM. Complained of "head spinning, legs tingling, feet numb". Mom reports that pt took "new drug Midrin for headaches this AM". Mom questioning if symptoms from vaccine or drug. Instructed mom to notify MD and follow back with us. Mom voiced understanding.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 05-NOV-2012 at 08:32, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse concerning a 20 month old patient who on 15-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 669795/1381AA). The nurse mentioned that on 23-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up has been received from a registered nurse provided information that patient with hearing problems, infantile, Seborrheic Dermatitis and Flat Foot, who at 5:30 PM on 15-MAR-2012 was vaccinated with the first dose of VARIVAX (Merck) (lot# 669795/1381AA) SC into the left leg, came to clinic on 21-MAY-2012, diagnosed with viral exanthem and aphthous stomatitis. The patient returned on 23-MAY-2012 with worsened rash described as "many erythematous macules, small papules, and open vesicles with surrounding excoriation of arms, hands and legs". No scaling. Lab diagnostic test were not performed. None illness at time of vaccination. On 29-MAY-2012 the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Fever over 100 for 15 hours. Headache, Chills, body aches, nauseous
About 10 minutes, post vax, was walking in lobby and right arm had red and warm area at injection site noted. Benadryl was given. Red, warm area was the size of a half dollar. On 8/7/00, mom called and had no problems.
sore everywhere; with headaches; quite achy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy). At the time of the report, MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Pt recv vax on 11/23/98; 24 hr post vax pt exp tender & stiff knees, ankles, wrists &hands x 3 wk, weak hands
PATIENT REPORTED HIGH ADMINISTRATION IN LEFT DELTOID MUSCLE, NO LIMIT OF MOTION UNTIL A COUPLE OF WEEKS LATER AND RECEIVED PHARMACEUTICAL INTERVENTION.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old male patient who received first dose of IMOVAX RABIES (batch number, expiry date, route and site of administration was not reported) on 15 June 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were IXIARO, TWINRIX, TYPHIM VI. It was a case of actual medication error due to incomplete course of vaccination as patient received the first dose in series for IMOVAX pre-exposure vaccination but then left for a trip and did not received second or third doses in series in June 2018. It was unknown if any adverse event 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 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.