chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dosing details, lot# and expiry date were not reported) for prophylaxis. On an unknown date post vaccination, the patients developed shingles. The outcome of shingles was unknown. The reporter did not provide the causality between shingles and ZOSTAVAX. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Information has been received from a nurse concerning a female who in February 2007, was vaccinated IM with 0.5 mL Gardasil. In February 2007, the morning after receiving Gardasil the patient experienced a stiff neck which was stiff for about a day. Additional information has been requested.
The initial spontaneous case was received on 11-Oct-2017, concerning a 76-year-old, elderly, female patient. On an unspecified date, the patient was vaccinated with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, after few days of vaccination, the patient experienced soreness and redness at injection site. The patient stated that, she would continue the flu shot. The outcome of the event was not reported. The reporter assessed this case as non-serious.
Insomnia; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Insomnia) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with MELATONIN at an unspecified dose and frequency and EMERGEN C at an unspecified dose and frequency. On 12-May-2021, INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications information were not reported  Treatment medications also include sleep aid herbal relaxing. Patient had normal sleep after sixth day of vaccination
Initial information and follow up has been received from a nurse concerning a patient who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported).  The patient received the second dose of GARDASIL (lot# not reported) 7 months after the first dose.  On 07-MAR-2008 the patient received the third dose of GARDASIL (lot# 659180/1758U) (9 1/2 months after the first dose).  Concomitant therapy included MIDRIN and INDOCIN.  The patient's outcome was not reported.  The patient has been notified of need to repeat dose #3.  Additional information has been requested.
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021.  After 8pm, started going downhill with chills and some sneezing.  Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep.  Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
101.8 - 102.2 fever; Extreme hip pain, joint pain in knees, elbows majority of day 2; Headache; This is a spontaneous report from a contactable HCP (patient).  This 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER4176), via intramuscular on the right arm, on 07Jan2021 (at 13:00) at single dose for COVID-19 immunization, administered at hospital. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via intramuscular on the right arm, on 17Dec2020 at 13:00. No other vaccine was received in four weeks. Relevant medical history included allergy to Brazil nuts and to kiwi. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D), chlorella spp., plantago ovata seed husk, spirulina spp. (COLON HEALTH) and glucosamine. On 08Jan2021 (at 10:00), the patient had fever 101.8-102.2 (from 10:00 AM until 4:00 AM following day), extreme hip pain, joint pain in knees, elbows majority of day 2 and headache. The events were assessed as non-serious. The patient was not treated for the events. Post-vaccination COVID-19 test was not done. The patient had recovered from the event in Jan2021.
The patient reported feeling lightheaded 15 minutes after the vaccine. He remained in the pharmacy for 30 minutes post vaccine time and left feeling better but tired.
Information has been received from a physician concerning an around 60 year old male patient who on approximately 11-MAY-2010, "four weeks ago", was vaccinated IM with a dose of PNEUMOVAX 23 (lot# not reported). Four weeks after PNEUMOVAX 23 injection, the patient's shoulder began to hurt and he could hardly move the arm. On 08-JUN-2010 the physician diagnosed as frozen shoulder. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
Spotting/bleeding consistently from 4/5/21. Still spotting as of 4/19/21. No full period/full flow (cycle day 1) as of yet. I wear an Ava watch that tracks my cycle, and based on the data from this month ovulation did not occur. I believe that the shot does affect cycles and fertility as I asked two of my friends that have experienced similar symptoms.
pt recvd vax; exp tearing of lt eye which progressed to facial nerve paralysis by 29oct94;tx: po steroids;
Sweaty, high blood pressure and dizzy upon standing, chest pain, jaw pain, back pain, can breathe but slightly short of breath. Suggested to go to Hospital ER.
Fever 103 at 2 mo of age 2 hours after first set of immunizations.
No adverse Effects; Improperly stored dose of GARDASIL9 was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The reporter stated that, on either 16-JUL-2019, 22-JUL-2019 or 29-JUL-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020947, expiration date 04-MAY-2021, for prophylaxis (dose, route and site of administration were unknown). No adverse effects reported. The outcome of the event was not reported.  Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit/ 9 degrees Celsius (9.12 degrees Celsius) for 3 hours and 15 minutes and below 36 degrees Fahrenheit/ 2 degrees Celsius (-13.33 degrees Celsius) for 2 minutes. There were no previous excursions reported.; Sender's Comments:  US-009507513-1909USA001880:
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This case refers to 35th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
3rd dose of Pfizer COVID vaccine given 10/29/21, #ff8839; pt fell at home and was brought to ED on 10/23/22; elevated troponin; found to be positive for COVID; heparin drip; suffered cardiac arrest; ACLS protocol; intubated; pt remained asystole and passed away in the hospital
Rash on back and abdomen; Leg got bacterial infection; Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     Concomitant products included LOSARTAN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss). The patient was treated with MUPIROCIN at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss) outcome was unknown.      Treatment medication also included antibiotics.
Vertigo; Foggy headed; Shortness of breath; Dizzy spells; Feels off balance; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FEELING ABNORMAL (Foggy headed), DYSPNOEA (Shortness of breath), DIZZINESS (Dizzy spells) and BALANCE DISORDER (Feels off balance) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M02A) for COVID-19 vaccination.     The patient's past medical history included Polio (As a child). Concomitant products included SERTRALINE for an unknown indication.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VERTIGO (Vertigo), FEELING ABNORMAL (Foggy headed), DYSPNOEA (Shortness of breath), DIZZINESS (Dizzy spells) and BALANCE DISORDER (Feels off balance). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), FEELING ABNORMAL (Foggy headed), DYSPNOEA (Shortness of breath), DIZZINESS (Dizzy spells) and BALANCE DISORDER (Feels off balance) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Additional treatment medications included jinger and Claritin which the patient did not take.
pt recv vax & exp nausea & stiffness especially in neck; No further details were provided;
Mom states patient developed red area around where vaccine was given. Area was about 3" long and 2 " wide. Mom called MD and he recommended BENADRYL - patient received 3 doses of BENADRYL over a time interval. No breathing difficulties. Patient felt fatigued after the vaccine.
patient received vaccine and into 5 minutes of waiting I noticed he began to jerk and slump down on his chair. when going over to him he was pale and drenched in sweat.  EMT arrived 10 minutes later and took him to the hospital for follow up.
if BNT162B2 was messing with Adderall or if that could be a symptom or side effects; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), via an unspecified route of administration from an unspecified date at unknown dose for attention deficit hyperactivity disorder (ADHD). Medical history included attention deficit hyperactivity disorder. The patient's concomitant medications were not reported. On 10Jan2021, patient felt like amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate was not working at all, like didn't take it and patient took amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate and it was like patient didn't know if BNT162B2 was messing with amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate or if that could be a symptom or side effects. The outcome of event was unknown.  Information on the lot/batch number has been requested.
pt called on tuesday 08/17/2021 reporting that she had redness all around the injection side and reported that it is itching
Extreme shaking chills for 2 hours followed by a fever that fluctuated between 102 and 105+ for the next 3 hours then went down to 100 to 102 for the next 2-3 hours;  heart rate extremely high, usually 72 to 75,  resting heart rate has not gone below 80 even as of today, 3 days after the shot...hopefully starting to go back to "normal;" arm where shot was injected still sore after 3 days but starting to feel better.
Patient reported and brought photographic documentation of red/swollen hands, flushing/urticaria on injected extremity and anterior chest. This occurred despite pre-medication with Tylenol/dipendhydrate
p/vax pt  had epistaxis;knee/hip pain; then epistaxis again;saw MD, had pruritic rash on back;tx w/vaseline to nose, calamine to rash;resolved;no pre hx of epistaxis;
Injection site reaction; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site reaction. Bexsero was discontinued. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. Physician Assistant reported that a patient was not completing the Bexsero vaccination series by refusing the 2nd dose due to a reaction to the 1st dose. The reporter stated that, she believed it was a injection site reaction. The reporter consented to follow up.
Hives started breaking out at approx. 7pm of 03/03/15.  03/04/15 - 8am face/eyes swelling. Symptoms continue daily. 03/24/2015 - 4pm anaphylaxis - ER visit. 03/26/2015 - 1pm anaphylaxis - on air plane. 04/28/2015 - 9pm anaphylaxis - ER visit. Have seen primary care Dr, allergist, immunologist.  25 days of prednisone starting 3/24 to 4/15 (hives/swelling/rash continued throughout treatment). Medications - Prednisone, Singulair, Atarax, Zantac, Benadryl, Epi-Pen. Hives/Swelling/Rash are currently present daily.
About a couple weeks after my second dose of the vaccine I started to have extreme itching on my scalp. I did not see anything at first and then another week later I saw a red irritated area. Then a couple days later I saw a white plaque like material. So then I saw a dermatologist and he said it was plaque psoriasis. He injected some medication behind my left ear (I do not remember what) and gave me a medicated shampoo which was a prescription. It is called ketoconazole shampoo 2% for topical application only. I continue to use it because the plaque is still there, the itching continues as well. I itch a lot during the night and I will do a follow up with a DR.
Received Vaccine on 08/11/2021 -  began having swelling in shins / ankles / feet as well as forearms and hands - skin feels "tight" on 08/23/2021.   Never have had swelling / tight skin feeling before.  No change in diet or exercise routine.  Knowledge worker with long hours of sitting, with frequent times of standing up and doing some stretching.    BP 119/76 HR 68 weight 124 height 5'4"
vaccine administered to a 15 month old. vaccine licensed for 24 month and up. No adverse reaction at this time
My arm hurt immediately, to the point that I couldn't support even carrying my purse in my right hand. I don't know if it was related to the force in which it was injected or what, but I have never had an experience like that with any past vaccines.
vaccinator gave employee pfizer instead of moderna for 2nd vaccine. Employee was monitored and no adverse reactios noted.
admitted on 3/15/2022. Patient had a recent admission for Covid-19 with a prolonged hospitalization. When she was discharged home, she required 4-6L of supplemental oxygen The patient developed worsening hypoxia and was found to be in sepsis. She was admitted to the ICU and was started on IV antibiotics and I V steroids. Patient was utilizing oxygen via nonrebreather, had increasing oxygen requirements. Patient required advancement to CPAP, and then BiPap. On 3/20/2022 she underwent endotracheal intubation for placement on mechanical ventilation, due to prolonged hypoxia and tachypnea with evident physiologic fatigue. The patient initially was oxygenating well, but became hypotensive refractory to IV fluids and vasopressors. The patient unfortunately progressed to asystole, requiring cardiopulmonary arrest on three separate events. The third event of cardiopulmonary arrest resulted in the patient unable to achieve ROSC. The patient was declared deceased at 6:29am.
Patient reports that he was sitting in chair, quite anxious, reporting that he had similar episodes in the past with fainting while aware of hypodermic needles. today, the patient reports that he felt himself beginning to pass out and lowered himself to the floor. Upon reaching the floor the patient sustained a period of unconsciousness for 10 seconds followed by 5 seconds of tonic clonic seizure activity. Patient awoke slightly confused and disoriented. Patient was completely alert and oriented about 30 seconds after event. Patient was brought back to EMS area and evaluated.  Vitals signs were assessed and patient refused further medical care and transport to hospital.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/26/2023.
5/21 (date of vaccine) patient complaining of leg aches over next few months he complained of leg numbness also (7/26/12) nerve test ordered showed severe peripheral neuropathy. Patient started to have weakness that progressed. He eventually was diagnosed with CIDP.
Fatigue, severe headache, fever, aches; took ibuprofen which helped reduce fever but only dulled the severe headaches; lasted 12-14 hours; headache continued but lessened during next 6 hours.
On 2/7/21 RIGHT  great toe developed a hang nail and 2 small blisters noted to 5th digit. 2/13/21 black/blue discoloration was noted to RIGHT foot 5th digit. 3/22/21 Dr. (surgeon) diagnosed patient with dry gangrene and trimmed the nail on RIGHT great toe.  3/25/21 RIGHT foot 5th digit amputated. 3/27/21 black discoloration noted to RIGHT foot 4th digit and RIGHT  great toe. 4/5/21 blisters noted to LEFT foot. Black discoloration noted to LEFT great toe and LEFT foot 3rd and 4th digit. After right digit was amputated patient continued to have other digits of the opposite extremity develop necrosis after several months.  Patient is currently awaiting appointment with a surgeon.
Injection stinging 5-10 sec. afterwards. L arm sore later in day 10/11/11. When got home and took shower L arm more sore and swollen below injection site. 10/12 remains very sore and today swelling aprox egg size distal to injection site. also has bad headache today. Started aprox 20:15 on 10/11/11 and continues.