chrisvoncsefalvay/vaers-outcomes huggingface dataset:
where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose; where she got vaccinated is still red and it hurts; headaches; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A., 037K20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (where she got vaccinated is still red and it hurts/ still has redness in her upper arm where she got third dose), VACCINATION SITE PAIN (where she got vaccinated is still red and it hurts), HEADACHE (headaches) and FATIGUE (feel tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information provided includes that the vaccination site arm is red and hurts. Patient also reported that he had Headache for first two days and then kind of went away.
Bell's palsy (left face); This is a spontaneous report from a contactable nurse (patient). A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 58 years old) (Lot Number: ER8737, unknown expiration) as 2nd dose, single for COVID-19 immunization.  Medical history and concomitant medications reported as none.  The patient also received first dose of BNT162B2 in left arm on 18Mar2021 (at the age of 58 years old; Lot number: EP6955, unknown expiration) for COVID-19 immunization. The patient experienced Bell's palsy (left face) on 05May2021, 3 weeks following second dose. The patient confirmed that she never had it before. The patient received valacyclovir and prednisone as treatment for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not yet recovered from the event.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Bell's palsy and the use of BNT162B2 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt stated within 30 mins. of receiving flu vaccine she was on her way home when she experienced tightness in her chest. She also experienced throat tightness and was hoarse. She had wheals on her arms and neck, No treatment got better on its own by this morning, advised to see MD.
Developed epigastric & rt upper quad pain. sx worsened & eventually became debilitating. ON 3MAR89 pt rec'd 2nd dose of vax sx recurred. Another gastroenterologist found her liver funct studies to be abnormal.
Tenderness and swelling at injection site. Then a blister and serious bruising three (3) inches below injection site three days after injection. Cleaned area with alcohol and bicitracin.
Pain in arm, couldn't move arm, chills, felt groggy and out of it for 2 days. Took Tramadol and it did not help.
Patient was supposed to be given COVID Moderna Booster shot at 6 months post COVID series. The booster shot was administered 4 months post COVID series. Patient currently asymptomatic and to come back in for a follow up appointment because of this.
other symptoms as well; fainted twice within the first hour; Initial information was received on 31-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an adult female patient who fainted twice within the first hour (syncope) and had other symptoms as well (unevaluable event) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Information of concomitant medications was not reported.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 14-Aug-2020 the patient developed a serious event reported as fainted twice within the first hour (syncope) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On an unknown date the patient, developed non-serious other symptoms as well (unevaluable event) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Also, it was reported that sometimes that happens.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of this report, the outcome of both the events was unknown.  Information on lot/batch number was requested for this case.; Sender's Comments: This case concerns an adult female patient who had syncope and unevaluable event after vaccination with  FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccines for the event syncope. The time to onset is unknown for the event unevaluable event. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Arm, back and head aches - tightness in chest and cough that evening, still felt achy the next day
I had a severe shingles outbreak which I believe wasrelated to Pfi zer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. Inaddition, I had severe headaches for several days. I'm 38 and I've never had shingles before (although I likelyhad chickenpox in my childhood). An urgent care nurse prescribed me Acyclovir 800MG tablets 5 times a dayand TRIAMCINOLONE 0.1% cream 2-4 times a day. Now 2 weeks later the rash looks much better however Istill feel annoying burning.
Breakthrough COVID infection 6/7/2022. Intubated 6/7/2022
Patient said she was swollen on the site of the Pneumovax injection.  She also said she passed out at 5:30am on 10-8-2020 which she feels is related to her vaccination
Generalized, pruritic rash developed one day post flu shot. Rx'd with Benadryl, Prednisone. Underlying hx of pruritis and rash, but was in remission prior to vaccination.
Patient received vaccine 11/7/2014. She threw up at 2:00 am 11/8/2014. She noticed a bump with redness and swelling below injection site on 11/14/2014. She came to after hours care 11/15/2014 and was treated with AUGMENTIN. Acc by one of her daughters for F/U S/P AH visit 2 days ago. She is currently treated for cellulitis at the site of PREVNAR injection she had 10 days ago. She developed bump at site of the injection w redness and swelling below the injection site that spread down her (L) arm one week after the injection. She took 4 pills of AUGMENTIN so far, and the redness is getting better, but it the swelling is going down to just above her elbow. She threw up at 2 AM last week on Monday, but then OK since then. She has no fever and been eating OK since then.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose. Vial was initially stored in the refrigerator was on 04-Jun-2022. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
At 15:00, the pt had a sore left arm associated with hot and cold chills, headache and nausea. At 17:00, he was seen in the ER with a temperature of 100.3F.
Within 5 minutes of injection,  i became light headed, flushed in the face and hand, and hot/sweaty.  These were mild/moderate symptoms and came and went for about 1 hour,  decreasing in severity from the time of injection.  They were the worst within the first 20 minutes post injection.    I consulted with Dr. prior to my vaccination due to my mast cell disorder; he said to take 2 Zyrtec  an hour prior to injection - which i did.  I still had the above reaction.  Also had pain at injection site for approx 48 hours
Late Saturday I noticed my lip dropping to the right and by morning my right eye was dropping. On the way to theER my eye felt like it had sand in it and I had to hold my hand over it and my mouth and lips felt like I had a shot of novicane and it was hard to pronounce certain words. I have  to eat small things because it is difficult puttinng food in my mouth and I can not feel the food in my mouth on the right side and if food gets over there it gets  between my gums and my cheek,  to drink I  have to position a straw in my mouth on a certain point  and some goes back down in the straw.
A day after receiving flu shot, the patients had swelling of the face from top of head that gradually worked down, she also had itching all over body. She has been taking BENADRYL for 1 week to help calm down reaction.
p/vax  pt had 1/2 vision in lt eye-corrected later in day;had flu like sx for about3 weeks;felt better 8/15/99 (h/a, nausea, fatigue, low grade fever);rt hip had a lot of pain during 3wk;
Received Tdap and Meningococcal vaccines in LUE on 10/28/14. When dad picked him up from school the next day LUE was red, swollen, warm and 7/10 tender to touch from shoulder to elbow. No constitutional symptoms. Dad with hx of reaction to Tdap as well.
Severe pain all over body with heat to the body. Turning red and hives on arms. Believe left arm was injection site. Feelings is throat swelling and labored breathing and odd chest discomfort not previously experienced with typical asthma trigger or flare. Shooting pains and skin irritation symptoms lasted throughout the week. I went to ER where I was brushed off after calling Dr. . I think I may have been treated with Dexamethasone eventually but relied on asthma meds to maintain breathing. I felt every effort was made to conceal and not address my reaction unfortunately. I?d never been treated like this with other adverse reactions to previous pharmaceuticals. I?ve not received further vaccination after this due to unknown and struggling to recover or understand how or why this happened.
Vasovagal syncope episode occurred right after receiving the Pfizer COVID-19 vaccine injection, patient became pallor, not diaphoretic, no c/o CP nor SOB, patient felt dizzy, HR in the50's, BP 78/50, glucose = 91, pt given water and OJ. After fluids pulse was stronger, bounding in the 60's, color improved, patient was still feeling faint, taken to cardiac intervention area to lay down, patient refused to go to ER, RRT paged and came to pod - escorted patient to lay down. Of note the patient only had 1 egg for breakfast.  Patient continued to be pale, starting shaking and was escorted to the ED for IV fluids and monitoring.
Erythema to left thigh 3cm, mild induration, slightly warm to touch.
hives all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over his body) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B4A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-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 URTICARIA (hives all over his body). At the time of the report, URTICARIA (hives all over his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: TCR added
From telephone contact with reporting physician ,it was stated that a 22 year old male patient received a JE-Vax vaccination on 07/27/01. That same day, the same patient developed tingling in upper lip, cheek and hands.
Took first VIVOTIF on Monday morning 11/5/18. Took at 7 AM on empty stomach with cold water and didn't eat for over an hour. Began experiencing nausea at 1 PM. Vomited 1 time and diarrhea 2 times between 3 and 5 pm. No side effects next day. Nausea only on Wednesday after 2nd pill, consumed very little food. Thursday no side effects. Friday took 3rd pill - nausea began around noon and worsened throughout afternoon. Diarrhea 2 times early evening. Saturday (no pill) experienced diarrhea 6 plus times late morning to early afternoon. Sunday took last pill - no side effects. On days with side effects ate only CHEERIOS, noodle soup, saltines, bananas, and ginger ale.
Patient experienced a seizure on 28MAR2021. The treating physician did not relate the seizure to the vaccine and provided patient with permission to get 2nd COVID vaccine. The patient reports she also had low blood sugar the same day as the seizure and was relating the seizure to possible low blood sugar. The patient denies history of seizures. The patient reports she has a history of low blood sugar and has implemented a new diet to try to control the low blood sugar.
Case number PHEH2012US018046 is an initial spontaneous report received from a healthcare professional on 07 Sep 2012. This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: M11082) intramuscularly on unspecified dates. The reporter stated that this batch of MENVEO reached 34 F for one hour on 23 Aug 2012 before reconstitution and were subsequently administered. It was also reported that MENVEO was not frozen after temperature excursion. No other information was available.
Patient received vaccine with routine 4 mo WCC 4/8/21. Pt vomiting 4/12/21. Seen in walk in. 4//13/21 seen at Pediatrics for vomiting 4/15/21 seen at Pediatrics for vomiting and transferred to ER for projectile vomiting, concern for intususception 4/15/21 abdominal ultrasound concerning for intususception, admitted to pediatric floor 4/15/21 IR procedure to reduce intussceuption. Patient currently admitted
Patient inadvertently received FLUAD for patients over 65 instead of FLUCELVAX for patients under 65.  On the day she received the vaccine, she was just having a little soreness in the arm where she received the injection, as expected. The next day, she came into the pharmacy complaining of shortness of breath and feeling extremely lethargic. She appeared to be doing okay at that time and did not need further medical attention but was advised to see a doctor immediately if her symptoms worsened. She has not responded to any follow-up phone calls since that time.
Monovalent Vaccine given after deauthorization of booster dose on 08/31/2022.
Received Heplisav-B While Pregnant; Initial Report Received on 15-Feb-2023.  A pharmacist reported that a 37-year-old pregnant patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while in her third trimester.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  The patient's last menstrual period, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On 13-Feb-2023 (in her third trimester), the patient received a dose of HEPLISAV-B vaccine (Lot # 941054, expiration date 23-Nov-2024, NDC # 43528-003-05) intramuscularly in the left arm from a pharmacist. No adverse effects were experienced by the patient.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Could not lift arm from side, pain affected sleep (amount and duration). X-ray revealed no fractures, separation. After 7 days no improvement received cortisone shot, one day later pain much better and could raise arm 90 degrees from body.
This spontaneous report as received from a nurse refers to an 11 months 20 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information has been received from a pharmacist concerning an 85 year old female patient with sulfonamide allergy who on 07-SEP-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665708/0651Z). The pharmacist reported that the patient in a long-term care facility received the PNEUMOVAX 23, and subsequently, on 09-SEP-2010 the patient developed an unspecified cellulitis surrounding the injection site that required treatment with unspecified antibiotics. It was unknown whether this was the patient's first dose of PNEUMOVAX 23. At the time of the report, the patient had not recovered. The patient's unspecified cellulitis surrounding the injection site was considered to be an other important medical event by the pharmacist. This is one of several reports from the same source. The pharmacist requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Warmth at the site of injection; Reddness expanding to inner arm; Redness at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE WARMTH (Warmth at the site of injection), VACCINATION SITE PRURITUS (Itching at the injection site) and ERYTHEMA (Reddness expanding to inner arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included RA (medication taken every week of Tuesday 26JAN2021) and Diabetes. Concomitant products included METFORMIN and GLYBURIDE for Diabetes, METHOTREXATE from 26-Jan-2021 to an unknown date for RA.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itching at the injection site). On 21-Jan-2021, the patient experienced ERYTHEMA (Reddness expanding to inner arm). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE WARMTH (Warmth at the site of injection), VACCINATION SITE PRURITUS (Itching at the injection site) and ERYTHEMA (Reddness expanding to inner arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I was out shopping with my daughter at an interior mall. The lightning was very subtle. I walked into a department store where it was extremely bright. I experienced some flashing light in my left eye. It was consistent. It would come and go for a few seconds. It lasted thought out that day. At night I experienced something floating in my visual field. I went to the ophthalmologist. He checked me carefully. He said he did not see any retinal detachment. I've had slight flashing since then. Very rare flashing and floaters in my left eye. I have a follow up in December. I got my flu vaccine and my first shingles shot after receiving the third dose.