chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Medium
the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown.  Information on lot/batch number has been requested.
Covid Vaccine was punctured at approximately 9 am on 8/25/21 to be administered to a patient that presented to the pharmacy.  The vial was then left at room temperature for approximately 5 hours.  The patient reported above then presented to the pharmacy for a Covid vaccine.  The vial that had been left at room temperature was then used to administer the Covid vaccine to the patient reported above.  The vaccine may only be left at room temperature for max of 2 hours.
My Chemical numbers have been off the charts since receiving the vaccine.  I have never had a liver problem or high numbers.  Since then, I get nauseous easily and feel as though I am going to pass out.  This week I have felt weak in the body..  I had an EKG, Eco cardiogram and ultrasound of the liver and those were fine.  We are still trying to figure out why my liver, BUN/ Cratinine, AST, ALT and Alkaline Phosphatase numbers are as horrible as they are.  The only thing that changes was the injection.
Inflammation at the injection site; Warmness at the injection site; Redness at the injection site; Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: On 04-JUN-2021 Folllow up was received and patient denied further Follow up; Sender'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.
Fever 100.5, injection site arm sore to touch, headache, "feels yucky"
has some redness going around the arm of injection site; injection site which feels hot to the touch; Headache; Chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (low grade fever), VACCINATION SITE ERYTHEMA (has some redness going around the arm of injection site), VACCINATION SITE WARMTH (injection site which feels hot to the touch) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Allergy (Allergy to Keflex) and Drug allergy (allergic to sulfa). Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) for COPD, METOPROLOL, CETIRIZINE, COENZYME Q10 [UBIDECARENONE], SIMVASTATIN, CIMETIDINE and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (low grade fever). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (has some redness going around the arm of injection site), VACCINATION SITE WARMTH (injection site which feels hot to the touch) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (low grade fever) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE ERYTHEMA (has some redness going around the arm of injection site) and VACCINATION SITE WARMTH (injection site which feels hot to the touch) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has self-medicated with Tylenol for two nights. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Pt c/o pain, mother noted redness, warm to touch, low grade temp - 99.9. On 6/27/13 came in office with increase pain, redness (20 mm) and warm to touch. Orders for Tylenol- with alternate of Motrin and Benadryl 12.5 mg prn.
Seizure activity 3-4 hrs after receiving vaccine on 5/5/09, seen in ER - Head CT and CBC WNL, admitted to Hosp. Plans for o/c 5/7/09 - Temp in ER 100.2  5/14/09 MR received for ER visit 5/5-6/2009 with DX:  Febrile seizure s/p vaccination. Pt presented after 2 episodes of tonic-clonic jerking lasting ~5 minutes with foaming at the mouth initially, the 2nd lasting 1-2 minutes. Pt had been acting funny since immunizations.  T=102'F in ER where pt had a 3rd seizure. Post-ictal after. No further seizures. D/C for outpt f/u. Additional ICD9 codes: 780.31 Febrile convulsions.
Information has been received from a registered medical assistant concerning a 7 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004380: US-009507513-1706USA004382: US-009507513-1706USA004383:
Patient was accidently given 0.3 ml of the undiluted vaccine.  Patient has been monitored since then for any adverse effects.  Patient complains of soreness at injection site and 'feeling tired'.  No other symptoms.  Encouraged oral fluids.  Vital signs stable
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 60 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0186) at the age of 60 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "beside her left ankle that she injured that has a plate in it and she is now disabled" (unspecified if ongoing), notes: beside her left ankle that she injured that has a plate in it and she is now disabled. The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "her left arm felt like a water balloon"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes". Additional information: 60 year old, 165 pound weighing female who is in very good health, beside her left ankle that she injured that has a plate in it and she is now disabled. She considers herself a healthy girl and only takes a stupid cholesterol pill. She is not a person who does this. She received her first dose of the Pfizer Covid-19 Vaccine. She was normal, she experienced no other side effect than her left arm felt like a water balloon, but that went away after 4 days. But in turn, she began to experience hot flashes. A good amount of them during the day. They did start at night, when one would come on she would rip her clothes off and check her temperature, but this was all coming from her inside. She added that they have subsided but do continue. She has never had a hysterectomy. No follow-up attempts are possible. No further information is expected.
Information has been received through a pregnancy registry from a 37 year old female consumer with no allergies and no medical history who on 12/2/02 was vaccinated with a dose of varicella virus vaccine live (lot # not reported). There were no concomitant medications. It was noted that she had her last period on 11/28/02 and that she is presently pregnant. Unspecified mediacl attention was sought. Follow up information indicated that an ultrasound performed on 1/21/03 showed S=D+FH and an amniocentisis performed on 3/28/03 showed fetal demise - no amnio performed. The patient had 2 previous pregnancies with 2 full term births. No birth defects occurred in any previous pregnancy. No stillbirth or miscarriage occurred in any previous pregnancy. There was no local reaction at the vaccination site and no varicella or herpes zoster symptoms post vaccination. It was noted that the mother has a spontaneous abortion 17 weeks her LMP. The products of conception were examined and the fetus was normal. No other medications was used during this pregnancy. No feature of congenital varicella zoster syndrome was noted on the fetus. No further information is expected.
Chills, then sweats.  Those 2 then alternated.  Temp 103.4 orally. Dizziness, headache.  Mild injection site pain
Initial report received from a consumer's parent on 17 January 2011. A 5-month old male infant received on 13 January 2011 in the AM a left thigh intramuscular injection of PENTACEL, sanofi pasteur lot number not reported, an oral dose of Rotavirus, manufacturer and lot number not reported, and a dose of PREVNAR, Wyeth lot number not reported. The patient had no medical history, took no concomitant medications and had no illness at the time of vaccination. On 13 January 2011 at 10 PM, the patient began crying uncontrollably for 4.5 hours and at times he would tense up his body like he had gas pains. The patient's temperature was 102 axillary and he was given TYLENOL by his mother. The patient had a knot at the left thigh injection site about the size of a dime. The next morning (AM), the child remained fussy and wanted to be held a lot but was not crying. The outcome was reported as recovered. Documents held by sender: None.
Runny nose, stuffy nose, myalgias, sore throat 12-41 hrs after immunos. Hives (urticaria) 201 hrs after immunization. Treatment: BENADRYL & ZYRTEC.
Severe body ache- 36 hours. Joint aches- 36 hours. Severe chills- 12 hours. Fever 101.0- 12 hours.
I had no adverse reaction with atorvastatin, calcium or, gabapentin. I have extreme pain and rash from "PREVNAR 13" continuous pain since December 17, 2015.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with the first, second and third doses of GARDASIL (route, lot # and expiration dates were not provided). The patient received three doses of GARDASIL on unspecified dates, with each dose having been administered one year apart. These doses of GARDASIL were administered years ago. The registered nurse did not think that the patient experienced any adverse effects. The nurse stated that it was just the way that the patient wanted it done. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
7JUL92 persistent irritable high pitched cry for 2-3 hrs duration; occurred several hrs p/vax; otherwise no adverse reactions, no seizures, no fever;
Pt experienced hives on the palms of hands, soles of the feet and elbows. Pt is being treated with antihistamines.
sore arm for a couple days; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient for himself. The patient received Shingrix and had a sore arm for a couple days in the right arm. The reporter consented to follow up and granted permission for safety to follow up with consumer, as well as with pharmacist who administered the vaccine.  This case linked with US2021025175, US2021AMR025675 and US2021AMR025778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025175:same reporter US-GLAXOSMITHKLINE-US2021AMR025675:same reporter US-GLAXOSMITHKLINE-US2021AMR025778:
Day of vaccine: very sore arm. Next day: sore arm worsened and swelling. Overall body aches, low fever, headache, nausea,tiredness. Stayed home from work.  Felt better the next day.
Arm hurt that afternoon. 2 days after shot developed dry flab/skin (R) lateral arm with brownish dry flaky patches also. No inflammation or itching.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date in 2017, the patient was vaccinated with an expired dose of VAQTA (expiry date 28-APR-2017, dose, lot #, site and route of administration were not provided). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who on 07-DEC-2009 was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23, subcutaneously. On the same day the patient developed an area of induration at the injection site of the abdomen. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information is not expected.
Arm had a 6inch by 4 inch red spot at injection site. Pt stated warm to touch.
I received the J&J vaccine 4 months after I recovered from COVID-19. Within 10 minutes of receiving the vaccine, I became dizzy and developed mild stomach cramps, both of which lasted 4 hours. Later that day, I experienced uncontrollable shivering, body aches, and felt like I was burning up. The next day, I experienced extreme exhaustion, mild stomach cramps, shivering, body aches, and a headache, which lasted for three days total, improving each day. On days 4-6, I  had pain in my lower abdomen and loose stools.
Information has been received from a physician referring to a 47 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date as a child, the patient was vaccinated with M-M-R II series (strength, dose, frequency, route, lot # and expiration date were unspecified). On an unknown date, the patient had unspecified titers drawn for school and the results for measles came back as low. The patient had an unspecified autoimmune disease that was diagnosed on an unspecified date. The causal relationship between M-M-R II and the events was unknown. Upon internal review, autoimmune disease was determined to be medically significant. Additional information has been requested.
pt reports at 4pm had tingling in her lips which progressed to throat feeling itchy.  She had no SOB, no cough, no other symptoms.  She was given 25mg oral Benadryl and 650mg Tylenol.  At 430 she was sent to ER for observation.  She reports in ER she received not medication.  Was discharged after a few hours of observation.  Today reports no symptoms of this type
Right upper arm painful immediately after injection (seemed too high up on arm near shoulder), then redness and pain to hand. Redness spreading. Vaccine site too high. RN supervisor called and will do education - unsure if rxn from vaccine or poor placement.
Dizziness, Headache, Fever, malaise, painful eyelids Narrative:  Other Relevant History:
At the time of administration of the first does of Moderna vaccine, I was 6 weeks pregnant.  I had confirmed pregnancy with home positive test and missed period. I had an estimated due date of 9/24/2021.  This was my 4th pregnancy. I have had two uncomplicated pregnancies to term. In September 2020 experienced a chemical pregnancy with early pregnancy loss at 5 weeks.  The first 24 hours after 1st dose of vaccine I experienced extreme arm soreness in the arm that was vaccinated,  causing  headache and unable to sleep. After 24 hours I felt "normal". 2 weeks and 3 days following the first dose of Moderna, I  had a miscarriage. On the night of 2/15/21 I lost the pregnancy with vaginal bleeding, bright red  blood, passing tissue, clots/ sac. I had an uneventful pregnancy up to that point, feeling well as I had with prior pregnancies.
The day after my first shot I seemed to develop nerve damage in right foot.  I went 11 days in severe pain and half my foot was numb.  Doctor said nerve damage but no idea of cause.  It?s been over 3 weeks now and pain is minimal but 1/4 of foot is still numb.  Was going to get 2nd shot today and realized the pain started the day after I got my first shot.
I received the three shots of the product GARDASIL when I was 13 by my primary care doctor. I was a virgin and didn't have any sexual contact with anyone. At age of 23 I was diagnosed with HPV and supposedly I had received the correct dosage with all the proper steps. Now I am scared for my life and what could happen.
Received shot, later  got shingles/Suspected vaccination failure; Got shingles, mild and short lived; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received Shingles vaccine later got shingles and because of the vaccine the shingles was mild and short lived. The reporter thought that the event might had been related to product/device use. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The suspect product was capture conservatively as Shingles vaccine as per reported description. The follow up would not possible as no contact details were available.