chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with GARDASIL vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within in a moment of being vaccinated. Medical attention was sought, in the office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of GARDSIL vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of GARDASILL vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
Information has been received from a physician concerning an 8 year old male who on 11Jul2000 was vaccinated with a varicella virus vaccine live. On 26Dec2003 the pt was diagnosed with shingles. The pt sought unspecified medical attention. It was noted that the pt was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
11/16/2022 sore throat and a headache. 11/17 tele visit with doctor. Doctor prescribed PAXLOVID. Tested with an at home COVID-19 test, positive. Once PAXLOVID started, symptoms diminished to being not noticed. 11/22 after PAXLOVID I continued to test positive on at home COVID-19 test. 11/24th I tested negative. Symptom free since 11/17.
My son is 2 years old an can talk full sentences clear as day. Very smart. He is out of the blue stuttering BAD for the first time an can barley talk an say a sentence. It?s very very bad. I?m  very concerned and want to know what to do.  He has never had a problem with speech before. He was fine before the shots
Patient developed an urticarial rash 48 hours after H1N1 injection. This has persisted until present.
arm swollen, warm to touch, intermittent fever, nausea, arm aching, local redness;
pt c/o tender lump rt deltoid area over area where vax administered; swelling is 1x1 cm nodule w/mild tenderness to palpation; tx Advil, warm compresses;
tired; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 93FR9, expiry date 29th April 2022) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix and was tired. The reporter consented to follow up. For tolerance of 2nd dose refer cases US2020203956.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203956:Same reporter
Ten minutes after the injection I felt flushed & hot, 20 minutes  after the injection I started to feel itchy.  Within an hour I had asthma symptoms and used an albuterol inhaler.  Within 6 hours I noticed my throat feeling tight?like there?s something in it.  I have been taking benedryl 50mg every 4-6 hours.
Pt reports pruritic circular rash to area just below injection site 9 days following shot.  Areas subsequently erupted on bilaterral digits of both hands, and toes of both feet.  Vesicles are noted on initial eruption.  Pt has used trimacinalone cream 1% with temporary relief.  Evaluation by MD here at clinic resulted in additional antifungal cream.  Pt denies any other symptoms at this time.
Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless, was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb, had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th.
Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 13Feb2021 at 10:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Thyroid problem. Concomitant medication included: Synthroid 88mcg, Synthroid 75mcg, Ibandronate. On 13Feb2021 at 5:00PM, the patient reported that her arm was sore for a day. The clinical outcome of the event arm sore was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Vomiting, shaking, sweating, unfocused eyes, eyes rolling towards back of head, stomachache. Possible low grade fever.
Lupus; Raynaud's disease; Rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On or about 08-SEP-2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at  her local Pharmacy as recommended for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, pt. vaccination the pt, was treated by providers for rash, Raynaud's disease and Lupus(Systemic lupus erythematosus)( dates unspecified date). As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment.   As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages. The outcome of the events was unknown.  Causality for the events were considered related to zoster vaccine live (ZOSTAVAX) vaccine   Upon internal review Lupus(Systemic lupus erythematosus) was considered were considered to be medically significant.
I got the shot and was fine until I went to sleep. I woke up at around 1:00 am really thirsty and then i was hallucinating like I was on drugs or something. It wasn't major hallucination but everything was distorted and kinda spinning.
supraclavicular lymphadenopathy; tenderness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613, patient was not pregnant at the time of vaccination), via an unspecified route of administration in the right arm on 12Apr2021 at 16:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were reported as none. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 17:00, the patient experienced supraclavicular lymphadenopathy and tenderness on right side and after noticing tenderness on neck right below right ear/jaw area, the patient was unsure if it started prior to this date or not. The adverse events supraclavicular lymphadenopathy and tenderness resulted in doctor visit. Therapeutic measures were taken as a result of supraclavicular lymphadenopathy and tenderness. The clinical outcome of the events supraclavicular lymphadenopathy and tenderness was not resolved.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: per DOB and event onset date, update age as 51, Historical Vaccine age is updated, vaccine facility information captured, Concomitant medications were not reported" update to "Concomitant medications were reported as none", 1st dose vaccine location was Left arm, captured wrongly in narrative, updated
This spontaneous report was received from a medical assistant and refers to a 38-year-old patient. No information regarding the patient's medical history, concurrent conditiond and concomitant medications was provided. On 13-DEC-2017, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administralion, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.; Sender's Comments: US-009507513-1712USA006863:
The patient's entire upper arm and the (L) side of chest was swollen after receiving the vaccine.
Vaccine may have been stored under conditions that departed from the manufacturer's recommended specifications. The manufacturer deemed the vaccine not to be viable. No harm was caused; however, patient may not receive the optimum benefit of the vaccine.
Thought she was dying; tremendous pain; headache; nausea; couldn't stand up; pain in the left side of her chest and shot up through her left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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 No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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 No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
1.  These symptoms occurred after my 2nd COVID vaccine:  A bad headache several hours after the 2nd vaccine. Headaches in places I don't get a headache, such as the top of my head (I can feel the exact spot), forehead, both temples, behind my eyes, back of my head.  Sometimes the headaches last 5 minutes or less (top of my head),  other times it could last several hours if located at the back of my head or at temples.  This is still occurring since my vaccination on 3/17/21.  I take an Advil liquid gel for the more intense headaches, which does help. 2.  Tinnitus since the 2nd vaccine dose.  It is still occurring all day and night, despite drastic cutback on caffeine (as of 4/2) and vitamins/supplements (4/20).
high fever 103, rash;end of 1st wk dec platelet count beginning of 2nd week;easy bruising, resulted in bleeding disorder treated by hosp & Gamma globulin infusion;
Patient is complaining of constant pain in her arm since receiving the vaccine. She went to her dr and had some tests done (xray) and the md office told her they did not find anything wrong that could be causing the pain. Patient still has pain and wants to know what she can do so that she can get help to get rid of the pain and get better.
auditory hallucination; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 28Dec2020 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. The patient had taken other medications in two weeks. No other vaccine in four weeks was taken. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Facility type vaccine was hospital. The patient experienced auditory hallucination on 29Dec2020 with outcome of recovered.  No treatment was received for the event.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event auditory hallucination cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Initial pregnancy report received from a healthcare professional on 29 July 2013. A 30-year-old female patient had received first dose of ADACEL vaccine (lot number: U4646AA, expiry date 28 November 2015, anatomical site of administration was not reported) intramuscularly on 29 July 2013. The patient's health during pregnancy, and risk factors (e.g. Alcohol), tobacco or recreational drugs) were reported as "NA". The patient's last menstrual period date was 24 December 2012 and the expected date of delivery was reported as 30 September 2013. At the time of this report, the patient had not experience any adverse event. List of documents held by the sender: none.
Sore arm 36 hours later, muscle aches, joint aches, headache  I only wanted to report these because I had Covid in October 2020 and had this response on my second dose of the vaccine.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 89 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2013, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
12 HOURS AFTER SHOT EXTREME TREMORS / SHAKINESS / CHILLS  LASTED 3 DAYS                                                                                                             /
I was very sleepy, hard to keep eyes open. I slept it off and felt better then next day. Most days pain is 5-6/10 but with medication it can be as low as 4/10. Sharp pains in legs cause falls. About 4 falls, worse in the morning. When standing after sitting for a prolonged period or in the morning getting out of bed is when pain is at its worst.
10 minutes after the vaccination, she began clearing her throat, within 30 minutes began coughing, which led to chest tightness.  Was evaluated in the ER and admitted for observation. Given: Prednisone 40mg po, Benadryl 25mg po Duoneb x 3 and Pepcid 20mg
ongoing cough and feeling unwell, chills, fatigue, fever, headaches Pneumonia due to COVID-19 virus  Increase fluids. Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed.
Report coughing, chest congestion,  nasal congestion, HA, chills  and fatigue began day 4 post vaccination. Treatment: PCP tested for COVID-19, Tylenol. Outcome: Waiting on results of PCR test, no improvement of symptoms. Does not interfere with ADLs.
Blood pressure went up and remained higher than normal for several hours even though I was resting. Felt faint/dizzy. Had a twinge of pain in my jaw and my face felt slightly numb on that side (left).
Right arm was hot, red, numb, it also had a small soft lump, Also some facial swelling with a headache. Jan10, arm is much better swelling, redness, lump have gone down considerably. She did not go to her doctor. All resolved on its own.
Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received a 0.25ml dose instead of a 0.5ml dose of the Moderna Covid-19 bivalent vaccine.).    No concomitant medications were reported.  No other adverse events were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727279:Master Case
Total and complete lethargy.  And it hasn't gotten much better since. I couldn't function for the first 2 weeks after.  About the 2nd or third day, I woke up with stopped-up ears and dizziness, that didn't go away so I went to Urgent care. That doctor said my ears look clear but said I had Vertigo and gave me a prescription for Prednisone and one for Meclizine. I finished the Prednisone but only feel about 11% better.  I already had an appointment with my Family doctor on 10/03/2019, for a medication and he's sending me to an ENTon Oct 22, 2019.   I don't know what's going on but  I'm miserable. I'm also not sure if was the vaccines. But it all started AFTER I had them.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and shivers. On an unknown date, the outcome of the pain, erythema and shivers were unknown. It was unknown if the reporter considered the pain, erythema and shivers to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had stated side effects red, painful about circumference of a tennis ball, shivers, etc. The patient was reluctant to take the second dose of SHINGRIX, and the patient asked if she did receive it, then what she could expect. The patient was not looking forward to more of the same. The patient said that her husband did not have any problem.
No adverse events; a patient was administered an improperly stored PEDVAXHIB; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.  On 23-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R036176 and  expiration date 08-OCT-2019)  (dose, frequency and route of administration were not provided) as prophylaxis (product storage error).  The vaccines were exposed to temperature above 47 degrees Fahrenheit/9 degree Celsius (11.3 degree Celsius) for 9 hours and 55 minutes and the data logger was involved. No previous excursions were reported. No adverse events were reported.
Pain in lower right abdomen began on 8/28/21. It started as a dull throbbing pain and became more pronounced over the ensuing weeks and months.  Pain also consists of a burning sensation in lower right abdomen (near the the throbbing pain) and lower right back.  Pain and symptoms continue to this day. Cardio exercise 3x/week for 10 minutes with HIIT has not helped. Taking Sulfasalazine 500 mg 3x/day from 11/19/21-12/10/21 didn't help. Taking 2000 mg daily of Saccharomyces cerevisiae var. boulardii starting on 12/11/21 has not helped. Please note: The above 3 courses of action were taken after the 10/28/21 medical tests indicated in Item 1 (Medical tests).