chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist concerning a 73 year old female patient. Medical history and concurrent conditions were not reported. On 25-AUG-2014, the patient was vaccinated with a second dose of ZOSTAVAX (lot number and expiration date were not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. Pharmacist reported that the patient was vaccinated with two doses of ZOSTAVAX. Patient received the first dose of ZOSTAVAX on an unknown date (reported as a couple of years ago). And the second dose of ZOSTAVAX was administered on 25-AUG-2014. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a  62 year old female patient with no pertinent medical history and no drug reactions or allergies. On 17-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007773, expiration date 01-MAY-2015) in the left deltoid area (dose and route not reported). Concomitant therapies included losartan potassium (manufacturer unknown), vitamin D, VENTOLIN and metoprolol. On 17-SEP-2014, within hours after receiving the injection, the patient experienced swelling the size of a baseball pain, heat and redness at the PNEUMOVAX 23 injection site on her left deltoid. The patient returned to the office the same day and received 25mg BENADRYL intramuscularly (IM) and a prescription for prednisone to address the symptoms. No lab diagnostics studies were performed. The patient recovered from injection site pain and swelling. The outcome of injection site heat and redness was reported as recovering as it was reported: "A call was placed to the patient a few days later and the swelling and pain was gone and she was feeling better". The physician did not want to use the remaining PNEUMOVAX 23 vaccine with this lot number in her office and requested a time sensitive lot check. This is one of several reports from the same source. Additional information has been requested.
At 6pm on 11-30-05 mother reports her child was taking a nap and the mother heard a strange sound in her child's room. Mother reports child was shaking all over with her eyes rolled back. Her color reported to be pale and cyanotic lips. Mother had her father take them to ER. The child kept breathing during the convulsion and her temp. was 102 degrees. the child aroused with mother holding.
Foot pain, burning, gait problem, serious vision changes, headaches, fluctuating BP, hair loss, ANCA vasculitis, neuropathy, near fainting, dizzyness, dry hair/skin/nails, night sweats, heart palpitations, ears ringing, incontinence, fatigue, nerve twitching, muscle spasms/fascilations, diminished smell/taste, brain fog
Within 5-10 min of receiving vaccines. Pt developed significant warm tense erythematous reaction from knees to feet. Also 2 urticarial lesions on arms. Reaction was symmetrical on both legs. Oral Benadryl was administered and reaction gradually resolved.
Noted to be sitting forward with head in hands, and stated she felt "tired, like I'm going to pass out" about 5 minutes after receiving injection.  Reports feeling lightheaded and dizzy.  Denies pain, HA, SOB, dyspnea, itching, swelling of face/mouth/throat, nausea.  Has not eaten today. Was nervous about getting second dose d/t does not like needles and has been receiving weekly injections of PCN recently.   11:37:  BP /80, P 82, R 16, SpO2 97%.  No respiratory distress, swelling of face, mouth, neck.  No rash or hives.  Declines to lie down.  11:39:  Given water, juice and crackers, taking without difficulty. 11:42:  Feeling "better", dizziness resolved, still lightheaded.  States "I'm really hungry." Continuing to eat snack.   11:46:  Finished snack (8 oz juice, two pkgs graham crackers).  Reports fatigue, dizziness and lightheadedness resolved.   11:48:  Standing and walking without lightheadedeness or dizziness.  Feels well and ready to go home.  Has friend with her who can drive. 11:49: Discharged home in stable condition with routine post-vaccine instructions and instruction to eat full meal when she gets home.  Escorted to POV by RN.
Initial and follow-up information has been received from a physician concerning a 16 year old female patient who on 25-AUG-2008, also reported as about a month ago, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number and site not reported). On 25-AUG-2008, the patient fainted and experienced dizzy and vaso vagal at the office after getting GARDASIL. The patient stayed at the office for a little while for monitoring and was released soon after. No lab diagnostic studies were performed. The patient recovered on the same date as injection date. Additional information is not expected.
Body temperature of 101F/Fever almost 101; Headache; Shivering/Chills; Body aches; Joint aches; Stomach aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6202), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 65-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included blood pressure high. Concomitant medication included irbesartan taken for blood pressure high. In Mar2021 (almost 2 weeks after the vaccination), the patient experienced headache, shivering/chills, body temperature of 101F/fever almost 101, body aches, joint aches, and stomach aches. The patient had taking Tylenol to keep the fever down so it's better. The outcome of the event fever was recovering while the outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
pt recv vax 10JUL98 & same day pt exp stomach pain that has been ongoing;2mo later dx w/juvenile rheumatoid arthritis w/poss juvenile dermatomyositis;pt lost 20 lbs;treated w/med;pt was not hosp;
Approximately 3 hr post vaccination pt called to report "feels like someone grabbing my chin", "lips tingle" and then "nauseous" - pt went to urgent care given epi, BENADRYL, loratadine, prednisone.
This spontaneous report was received from a nurse regarding a male patient of unknown age. There was no information on medical history and drug reactions or allergies. On 06-FEB-2014, the patient was administered with first dose of GARDASIL intramuscular injection, dose 0.5 ml (millilitre) intramuscularly (anatomical location not reported) and second dose on 08-APR-2014 and the third dose on an unknown date on 2014 earlier than recommended in the prescribing information on 11-JUL-2014. No adverse events was reported. There was no product quality complaint involved. Additional information has been requested.
slight sore arm; Lethargic; Headache; some tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight sore arm), FATIGUE (some tiredness), LETHARGY (Lethargic) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (some tiredness). On 17-Feb-2021, the patient experienced LETHARGY (Lethargic) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore arm). At the time of the report, PAIN IN EXTREMITY (slight sore arm), FATIGUE (some tiredness), LETHARGY (Lethargic) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that he was taking Lopressor and cholesterol medicine as concomitant medications. Treatment information was not provided.    This case was linked to MOD-2021-030281, MOD-2021-030281 (Patient Link).
acute drug eruption; rash, cranky, mild impetago to be considered allergic to hep B vax
Disoriented after the first shot; Metal taste in mouth ,bitter taste in mouth after first shot; Not been able to eat after first shot; Not been able to swallow after first shot; Throws up after eating and drinking after the first shot; Redness on the injection site after the first shot; Itching injection site after the first shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: TETANUS VACCINE TOXOID (Reaction to Tetanus shot so they watched her for 1 hour after each vaccination.). Past adverse reactions to the above products included No adverse event with TETANUS VACCINE TOXOID.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot), VOMITING (Throws up after eating and drinking after the first shot), VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) and VACCINATION SITE PRURITUS (Itching injection site after the first shot). On 28-Sep-2021, VACCINATION SITE PRURITUS (Itching injection site after the first shot) had resolved. At the time of the report, DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-360579 (Patient Link).
He has no side effects that we know of, but he notified us after getting the J&J vaccine that he previously had both rounds of the Pfizer vaccine. completed already.
Patient called on 1/9 with complains of local bruise and pain at injection site. She was told to make appointment if these symptoms worsened. She was seen on 1/24, 2/2, and 2/10 for other medical issues but continued to mention soreness at the injection site. No other associated complaints or findings.
No additional adverse events; administered doses of improperly stored VARIVAX; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 08-AUG-2022, the patient was vaccinated with 1 dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039948, expiration date: 16-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine was stored at a temperature between 6 to 14 Fahrenheit degrees (F) for 6 hours and 15 minutes, and between 14 F to 46 F (15.2 F) for 1 hour and 30 minutes. There was no other previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2208USA004566:
patient received the 1st dose of vaccination on 12/30/2020 and then received the second dose on 01/07/2021
Patient received additional 0.5 mL flu vaccine. Had already completed initial series this year. Flu vaccine 0.5 mL given 9/6/23, 10/10/23 and extra unwarranted dose on 11/2/23. No current complaints from patient.
Pt reported feeling like she has elevated BP prior to vaccination. Complaining of dizziness, lightheartedness this morning Vital signs pre-vaccine: BP 166/77, HR 68, O2" 96% Given 8 oz water  Vitals 10 minutes later: BP 138/66, HR 66, O2 96%, BG 132 Pt left RUHS 30 minutes after vaccine administration
I started having clogged head, ear and head pressure, chest felt tight, fever, and cough on 01/19/2022. As the days went by I felt worse and worse and my temperature on day 4th when I tested positive 01/22/2022 was 101 but then it averaged between 101-102 for the next four days and that was taking Tylenol. On 01/22/2022 I decided to go to Urgent Care they did listen to my lungs and they said it did sound like I had Pneumonia so they prescribed Amoxicillin,  Prednisone, and an Inhaler Ventolin for 3 weeks. I started to get better but it took a few days but I stayed sick and my cough became more productive but it took about 5 weeks before I felt completely better.
shingles; 2nd Dose to be given past 35 days time frame; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose to be given past 35 days time frame) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose to be given past 35 days time frame). At the time of the report, HERPES ZOSTER (shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Dose to be given past 35 days time frame) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
L arm erythematous patch, warmth and tenderness, grew to 10 x 10 cm then slowly improving. Had fever day after immunization. Still has rash but improving
p/vax recvd pt took a short nap woke up crying & cont screaming for 2 1/2 hrs; lt leg began to turn red & leg swelled 1 1/2 times; temp 103; mom called MD & was told to give DPH & APAP, applied warm pack to leg; fever & fussiness cont;
Mother states in morning she noticed child had a "chicken pox" looking rash on both legs, arms and his chin. No fever or itching.
Headache, joint and muscle aches, sore injection site. Mild the day of, increased to moderate the next day.
Mother and child in clinic on 8/17/00. Mother states that 1 day, post vax, child broke out in raised rash over arms, legs and trunk. Rash is still present on 8/17/00. Mother did not report to PMD. Pt went to PMD on 8/17/00 for evaluation.
Patient stated the vaccine injection hurt more than usual. She noticed nerve pain in her right arm that has lasted several months. She went to her doctor and received a Rx for ibuprofen. She stated her perception of the administration was higher on the arm than she typically receives.
anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter did report a patient had an anaphylactic reaction to the Pfizer BioNTech Covid vaccine. The event was serious for being medical significant. The outcome of event was unknown.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded
Started with some pain in the left arm, not too bad, around 6:30 PM.  By 7:40-ish PM (we were on a video call with friends starting at 7:30) the pain became so bad sitting up because the weight of my arm made it feel so much worse.   After the call, I started shaking uncontrollably. I was trying to eat some soup and was shaking the bowl so much but I didn't spill it.  By 9 PM I was upstairs lying on my right side and balancing the left arm and that felt better. But any motion was excruciating.  I broke my arm when I was 6th grade and was on morphine for 48 hrs prior to it being set, this felt worse than that (but memory is ... inaccurate).  By 10 my wife measured my temperature at 101. I am on meloxicam 15 mg.  So was reluctant to take anything else but I took two Advil and was able to sleep a little.  The pain continued throughout the night, I could hardly rest. I had strange nightmares.  Early morning I took my usual meds at about 4-something AM, psyllium husks, fish body oil, Vit. D, Vit B, SloMag, Allegra and Meloxicam.  Prior to the meds my stomach was already feeling weird. I struggled a bit with nausea. I ate some granola, yogurt and milk and felt uncomfortable but did not throw up.  My arm still hurt but seemed to be getting better. My temperature runs low, normally (97.something) and I felt hot at 99 so I took two Excedrine migraine tablets.  After that I slept solidly for 4 hours and woke up feeling much better.  It is now 5 PM the next day and the pain is much less.
Within 1 hour, she had trouble breathing and was wheezing. Fever of 100*, full body rash (small pin pricks from head to toe), bloody stool.
Body aches developed after vaccination on 8/31/16. On 9/1/16 patient had some occasional brief, right sided back pains that had occurred a few times. Urine had a dark appearance. Dark appearing urine continued to 9/3/16 when she was evaluated in urgent care. Patient continued to have the brief episodes of back pain as well. Lab work and urinary tract ultrasound was completed. Blood in urine.
Three hours after the injection my left arm was really sore, and I started to lose mobility. I never regained full mobility, and had my second injection also in the left arm on March 4th (Moderna). A large oblong red patch appeared, and a large knot in the upper forearm, after the first injection, and has never gone away. I went to see Dr. on February 25th, and he said it should go away, to do finger walks up the wall. I still have severe pain and have gotten two massages on the left arm, and have now started physical therapy at Hospital to try and regain mobility. PT started a week ago, and today is my third session, however still very painful and limited motion.
This case was reported by a physician and described the occurrence of low temperature in a 20-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included acne and depression. The subject had no adverse events following receipt of previous immunizations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included LEXAPRO, RETIN A and BENADRYL. The subject received no other immunizations on the date of receipt of FLULAVAL. On 19 October 2008 at 9:00 am, the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 October 2008 at 6:00 pm, 9 hours after vaccination with FLULAVAL, the subject experienced low temperature, chills, muscle pain, rash, nausea, vomiting and itching. At the time of reporting the events were improved. The physician considered the events were possible related to vaccination with FLULAVAL. The physician reported that the subject is his daughter that is a nursing student. The physician reported that his daughter's temperature was as low as 95.0 degrees Fahrenheit.
3 days after vaccination, patient had pain around the left shoulder with numbness extending from (L) shoulder upto elbow and extending to (L) scapular area; no weakness, DTR - normal. Sensory/Parasthesia to fine and touch.
My waist down numb; Mouth swollen; Fever; Dizzy; Nauseous; Many panic attacks; Have no strength on my legs or coordination; Have no strength on my legs or coordination; This is a spontaneous report from a contactable consumer (patient). This 47-year-old non-pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm left on 02Oct2021 at 11:30 AM (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. There were no concomitant medications. The patient previously took amoxicillin and experienced allergy. On 03Oct2021 12:00 AM, the patient reported that her waist down numb, mouth swollen, had fever, dizzy, nauseous and many panic attacks; all of this 2nd day after shot. The patient still had no strength on my legs or coordination. Events resulted in emergency room/department or urgent care visit, and with 3 days hospitalization. Treatment received for events including MRI CAT scan and blood work, both with unknown results on unspecified date. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. Outcome of events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Swelling, started size of baseball then covered entire upper arm to swell. Patient sought treatment and was given oral steroids & antibiotics.
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: ROSUVASTATIN; METOPROLOL; EZETIMIBE; LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), 13 days 7 hrs after the suspect product(s) administration, outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given for the treatment of Covid-19 treatment. Device timestamp was reported 12May2022.  Additional Information: treatment start date was 27Apr2022 and treatment stop date was 01May2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.