chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, male patient. The patient's medical history and concurrent conditions were not reported. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Swollen and sore axillary lymph node about the size of a grape in the left arm. Onset on 01/27/2021, 8 days after vaccination. On the day of onset, I felt very fatigued, lethargic, and weak.
AFTER VACCINE ADMINISTRATION, PATIENT WENT HOME AND SLEPT BECAUSE SHE FELT REALLY TIRED. AFTER SHE WOKE UP FROM HER NAP, HER WHOLE BODY FELT STIFF.  HER LEFT ARM (INJECTION SITE) WAS RED AS A BRICK AND SWOLLEN LIKE A SIZE OF A BASEBALL.  AFTER 1 WEEK, HER UPPER LEFT ARM WAS STILL REALLY RED, BUT SWELLING HAS GONE DOWN.  PATIENT ALSO COMPLAINED OF PAIN IN THE RIGHT EAR.
allergic reaction to the patients face. inflammation around the eyes,rash, itching, redness, acute onset.
The pt developed pain, swelling and erythema at DTaP injection site approximately 12 hrs after vaccination. Treated with ibuprofen.
Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; no adverse effect; This spontaneous report was received from a medical assistant regarding a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, 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) injection lot # N022952, expiration date: 14-JUN-2020 (exact dose, strength and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK Trivalent (528). This is an initial report of a non-serious adverse event, received on 31/Oct/2014, by a 59 year old female patient/consumer. The patient received FLUBLOK Intramuscular (IM) on 21/Oct/2014 at an unknown location. The patient stated that she received her vaccine on 21/Oct/2014 and developed pain in her clavicle on the same arm as the vaccine was administered. She was seen in the emergency room on 29/Oct/2014 and later by her primary care physician (PCP) and was diagnosed with shingles. She believed she developed shingles from the flu vaccine. She was unsure of the time or date this occurred. The events required a visit to the emergency visit (no further details provided). At the time of this report, the outcome of the events was unknown. Medical history reported an allergy to eggs. There was no current illness at the time of vaccination. Laboratory and/or other relevant test results were not reported. Concomitant medications were not reported. This report was received from a consumer therefore; no medical confirmation or assessment of causality is available. Further information is unavailable at the time of this report. The Company's assessment of the causal relationship between Herpes Zoster, pain and FLUBLOK is not reasonably possibly related considering the days of onset of the events to the vaccine administration. Addendum 31 Dec 2018. Upon second medical examination of the case during internal review, a significant correction was performed on 31 Dec 2018 to change suspect product from FLUBLOK QIV (529) to suspect FLUBLOK Trivalent (528).
Initial and follow-up information has been received from a certified medical assistant concerning a 69 year old female with penicillin allergy and allergy to aspartame who on 15-SEP-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX, 0.5 ml, (lot # 661899/0519X).  It was reported that on 15-SEP-2008, the patient developed an injection site reaction.  The symptoms included pain in upper arm (grade 7), hurt to move her arm, redness, tenderness and swelling, and a possible cellulitis.  The patient went to the doctor's office and was treated with KEFLEX and ROCEPHIN.  On 19-Sep-2008, the patient recovered from the events.  Additional information is not expected.
I63.9 - Stroke (cerebrum) (CMS/HCC) R29.810 - Facial weakness
approx 5min p/vax child states head didn't feel right & pt fainted;pt was laid on the floor  & immed aroused w/ammonia inhaler;
received the Covid 19 Pfizer vaccine and passed out approximately 2 minutes after the vaccine. Was seated at the time. Physical support until patient regained consciousness approximately 30 seconds after. Assisted via wheelchair to cot to lay down and water provided. Mother with. Instructed to lay down for second dose of vaccine when receiving it. Left with mother ambulatory in stable condition approximately 30 minutes after dose administered.
ITCHING, NO PAIN, REDNESS TO INJECTION SITE 9 DAYS AFTER VACCINATION. ICE WAS PUT TO AREA. SWELLING HAS REDUCED AS OF 2/16/21
Fever, 101.3, 101.9 Chills, body ache, headache 14 hours
large left upper arm swelling induration erythema and fever localized from upper deltoid to lateral epicondyles on the lateral upper arm
temperature increased to 100 degree; nausea; dizziness; This is a spontaneous report from a Pfizer sponsored program,  from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient's first dose was in Mar2021 (reported as "3 weeks ago"), patient mentioned that after she got the vaccine her temperature increased to 100 degree, had nausea and dizziness. Patient's second dose was due on 21Apr2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness/vertigo, Headaches, Tremors/Shaking, Muscle Twitches throughout body, elevated BP for 2 days after vaccine and elevated heart rate. All have been persistent since the day of vaccine.
Headache, nausea, swelling of entire arm all within 45 minutes. Patient used ice on injection site and Benadryl 25mg.
Client reported as being anxious about the vaccine and was pale, nauseous and light headed.  02 Saturation was 98% Pulse 91 and blood pressure 118/77.  Client was released after being monitored by EMS and Dr.  Advised to seek medical attention later if needed and verbalized understanding.
Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm (reported as right and left arm) on 18Mar2021 a little after 07:00 (at the age of 43-years-old) (Batch/Lot Number: EN6208) as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing migraine since puberty, from around 13-14 years old, has been migraine free for five years; COVID-19 from Dec2020 to an unknown date. Concomitant medications included topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; rizatriptan benzoate (MAXALT) taken for headache, start and stop date were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. The patient experienced migraine on 18Mar2021 ever since she received the first dose of COVID-19 vaccine. The patient worked the night before she received her first dose of the Covid-19 vaccine, 17Mar2021 into 18Mar2021; she got the first dose of the Covid-19 vaccine the morning of 18Mar2021, came home, went to sleep, and woke up with a pounding headache around 1 PM on 18Mar2021. The patient considered the event medically significant as she had to get an MRI for it and the event required a physician office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: found white matter lesions consistent with chronic migraines which was normal for her on 07Apr2021.  Therapeutic measures were taken as a result of the migraine which included migraine medications topiramate, Butalbital-APAP-Caff and rizatriptan which were not helping; physician changed her medications to a different rescue medication which did not help. The clinical outcome of the event migraine was not recovered (reported as low level of migraine for 4 weeks).  The reporter considered the event migraine as related to the COVID-19 vaccine.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event  and the suspect vaccine BNT162B2
Patient was given 1 dose of Moderna vaccine. She is 16 years old which is a contraindication for the vaccine. Patient was called by a healthcare provider for follow up. Patient denied any adverse symptoms, only complained of sore arm. Healthcare provider explained to patient normal reactions to vaccine vs. adverse reactions.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 15-AUG-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route were not reported). No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Swollen armpit lymphnode; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm, on an unspecified date (at the age of 30-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and unspecified women's multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunisation. The patient experienced swollen armpit lymphnode on 19Feb2021 at 23:00, which was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of swollen armpit lymphnode was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Breakthrough case admission after 2 vaccines 2/5/21 no MFR no lot# ; 2/26/21 Pfizer no lot#;
Generalized seizure 12/16/99-lasted 1 1/2 minutes. No treatment needed.
felt a little bit like "fluish"; stronger reaction; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-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 INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (felt a little bit like "fluish") and PYREXIA (slight fever) outcome was unknown and VACCINATION COMPLICATION (stronger reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-339322 (Patient Link).
Same day developed rash on thighs, pt has fever and decreased appetite. Normal behavior, not bothered by rash.
02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x;  fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea  PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited
Red, itchy, edema to right upper arm on 8-11-17, was noticed by patient in the AM. Prescribed: diphenhydramine 25 mg - 1 tab every 6 hours for 5 days. Provided ice packs to apply to site.
Rash developed 6 days following Varivax. Raised, erythematous papules without vesicles. Diffuse aver all surfaces.
Mother states that three hours after receiving MMR, Kinrix, VZV immunizations, child developed pruritic urticarial rash which persists today. No fever or other symptoms. Mother applied Caladryl. I prescribed diphenhydramine today.
Patient is describing headache, related to previous COVID diagnosis, dry throat, fever at 100.8 degrees, chills and nasaea, body aches, paint at the injection site, leading to pain in hands, patient describes numbness in the left hand, which is where the injection site was.
on 16 Apr2021 my feet was numb and and some pains and saw doctor. No diagnosis was given and was told to get 2nd dose. Got 2nd dose o 17apr 2021 the next day. In May2021, went to ER because I was having chest pains and numbness in the arm. The tests showed that I did not have heart attack. Numbness and pain in body continued and went to doctor. They did a spinal tap and was diagnosed in Jun/Jul with MS.
c/o dry mouth beginning approx 1 hr p/vax; seems to have no gag reflex when eating lunch; 7PM same day began having pain hips, lower back & legs; agitated & unable to sleep w/periods of tachycardia of 15-20 mins;  diarrhea, nausea, fatigue
Acute onset of stuttering and slurring of speech with difficulty with word pronunciation.  Left sided facial numbness and left lower extremity weakness.   Facial and leg symptoms improved over several hours.  Speech difficulty is progressive improving but still not fully resolved.
On 05NOV2010, a 54 year-old male, was vaccinated with BIOTHRAX by subcutaneous route to an unknown arm. On 06NOV2010, the subject experienced swelling, pain, limited mobility of the injection site arm, and stated he was "feeling ill". At the time of the report, the events had not resolved. Additional information was received on 02DEC2010 which revealed the subject recovered well, and without lasting effects.
Later that day after the vaccine I developed a severe headache, fatigue and my arm was sore.  I took Aleve and went to bed. The headache subsided the next day.
dose of GARDASIL 9 was improperly stored on 11/18/2021 and was administered to a patient on the same day; This spontaneous report was received from a regustered nurse and refers to a patient of unknown age and gender.No information regarding the patient's concurrent condition, medical history or concomitant medications was provided. On 18-NOV-2021, 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 # T028582 and expiration date: 04-MAR-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in too high temperature of 48 degrees Fahrenheit (F) for 1 hour and 26 minutes. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA008723:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 05:41, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information was received from a consumer referring to his/her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiration date, route, dose and frequency were unknown) for prophylaxis. After 3 weeks, the patient had some severe reactions. The reported said he/she meant just saying that the adverse reactions were not real, because these reactions were so vague and could mask as the glue that most doctors dismissed them, and did not actually know which tests to run to confirm these strange symptoms. The outcome of the severe reactions was unknown. The reporter knew the reactions were from the vaccine but few doctors would go to bat for his/her. Additional information is not expected, because there is no contact details.
Large purple, red  3 x 5'' diameter. Itchy welt that is sore to touch.
pt recv vax & next AM 18AUG98 had facial swelling & fine rash on abd, T96.9;no other sx;
Patient woke up burning up. I took her to give her some medicine but would not stop crying. She then started to vomit and pass out and then seizing for about a minute. We called the paramedics and she was evaluated and dx: with a febrile seizure.
The week following my vaccination I experienced menstrual spotting, cramps, and nausea.
many reactions after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (many reactions after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (many reactions after the first dose). At the time of the report, VACCINATION COMPLICATION (many reactions after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant was not provided Treatment was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-051162, MOD-2021-119592 (E2B Linked Report).; Sender's Comments:  MOD-2021-051162:Same reporter/different patient (1st dose case) MOD-2021-119592:Same reporter/different patient (2nd dose case)
This spontaneous report was received from the patient's mother and refers to a currently 15-year-old female patient. The patient's concurrent conditions and concomitant medications were not reported. The patient's medical history included combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio (manufacturer unknown). On an unknown date, the patient was vaccinated with the first dose of M-M-R II (exact dose, route of administration, lot# and expiration date were not specified) for prophylaxis. The reporter said she had been hesitant about having her daughter get a second shot of the M-M-R II because her daughter "reacted as a baby" after getting one dose of another combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio (manufacturer unknown). It was unclear from the reporter if her daughter never got a second dose for the M-M-R II solely over the mother's concern that her daughter (as a baby) had an unspecified reaction to an unknown combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio or if the daughter possibly had some kind of unknown reaction to the first dose of the M-M-R II. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported.
reports dizziness.  denies any difficulty swallowing and/or other s/s.   at 1604, c/o difficult swallowing- transferred care to EMS.   EMS administered epi & called for transport,    1611- mother agreeable;  1616 pt. reports feeling better- symptoms resolved.
Left arm moderate pain and slight swelling; low grade fever and chills; muscle and joint paint.  Resolved within 24 hours.
muscles and joints in her left arm hurt; numbness in her fingers; muscles and joints in her left arm hurt; muscles and joints in her left arm hurt; This is a spontaneous report from a contactable nurse. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via an unspecified route of administration on 03Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date in Sep2021, patient experienced muscle and joint pain along with numbness in her fingers that feels off because of the muscles and joints in her left arm was hurt. The outcome of the event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Patient complained from a swollen arm, rash, and she had to see her doctor who prescribed her prednisone according to her.
after undergoing multiple MRIs and seeing several doctors, patient was diagnosed with Complex Regional Pain Syndrome (CRPS). patient says arm began hurting, tingling, and he can barely use his hand. the pain went down the arm and up the arm into the neck creating a bulging disc.
Expired vaccine given to 2 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 2 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Patient had no adverse event Patient received a dose from lot 058F21A five days after it was expired Treatment information was not provided
Woke up at 2 am the morning after the injection with my arm extremely sore, swollen, red, and feverish to the touch that has continued for 4 days now. I also experienced a fever for 2 days after the injection along with dizziness, weakness, fatigue, headache, body aches, vision changes, and ringing in both ears. As of today 1/12/21 I am still experiencing symptoms even while using Benadryl allergy tablets by mouth and anti-itch cream applied to the injection site.