chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a heart condition who also received the Pfizer Covid-19 vaccine; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported on behalf of her husband and her sister in law. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Caller called on behalf of her husband who is due to get the second dose on 06May2021. Caller's husband received the first dose of the Pfizer Covid-19 vaccine on 15Apr2021 and will have an emergency on 06May2021 so she wants to know if her husband can take the second dose earlier than the given schedule and Caller's sister-in law had a heart condition who also received the Pfizer Covid-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse, and refers to an 18 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unknown date, the patient inadvertently received an unspecified first dose of adult formulation of VAQTA (Unknown Lot#/ Exp date), instead of a pediatric dose. No adverse effects were reported.
Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL5738)on 26Dec2020 at single dose into right arm for COVID-19 immunization.  Medical history was none.  Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid . She was tested negative on 03Jan2021 and 04Jan2021 (both via COVID-19 PCR tests). She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. Patient stated that other than having positive tests for COVID she has had no symptoms. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077994 same patient, different dose
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; The patients have not reported any adverse reactions; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (The patients have not reported any adverse reactions) 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 (The patients have not reported any adverse reactions) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    This case is for 5th patient out of 16 patients. Concomitant product use was not provided by the reporter. Patient received additional booster. It has been reported that 26 patients received bivalent vaccines from 2 different Bivalent lot numbers on 09-Jan-2023 they were lot numbers: 061F22A and AS7170B. For all 26 patients vaccine cards lot number has been written as AS7170B.  For 16 patients Vaccination Cards reflected the wrong lot numbers. Additionally, it has been reported that all patients received the correct vaccine and bivalent dose and the error only involved in documentation. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:master case
This spontaneous report as received from a pharmacist (also reported to be a registered nurse) refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 07-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (which had a lot # L022262 and an expiration date of 05-NOV-2016; however, the dose, dosage number, anatomical location and route of administration were unknown). No concomitant therapies were reported. Despite being vaccinated with an expired dose, the patient developed no adverse effects and no product quality complaint was involved. Additional information has been requested.
pt received 1st dose, reported felt like passing out and stood up from the chair.   Patient fell backward, hit a door, and landed on the floor.  Momentary loss of consciousness (about 5-10 seconds) but recovered quickly.  Pt was unaware he fall initially. Initial BP standing was low, was sweaty, skin was flush.  After laying down BP 124/90. O2 set 98%. HR = 69.  Provided water and rest.  Review of system by physician shows no neuro deficit, and deemed to have recovered 40 minutes post fall.
2 - 3 facial hives. Swollen lower lip. Approximately 90 minutes after injection. Took BENADRYL 25 mg.
30 minutes after vaccine experienced hot flashes,  heart flutters, shortness of breath and increased heart rate, dizziness, confusion. 15 hours after vaccine begin having chest pain,  continued increased heart rate, headache. Went to the emergency room with chest pain, shortness of breath, heart rate 133 and blood pressure 169/93. 48 hours after vaccine had low grade temp, dizziness and pain at injection site. 72 hours after vaccine pain at injection site.
Reaction at injection site. Large hive, 6 inches by 3 inches. Hot, stinging, burning, itching, swelling.
Pt reported as soon as she felt the jab of injection, she began to feel lightheaded and dizzy. Observation staff aided pt. to wheelchair and moved pt. to quiet room. Pt. started to complain of hot and clammy feeling on her forehead. Pt. drank a juice and began to feel better. 30 minutes from vaccine pt. stated she felt all the way better. Pt. exited with husband. Vital signs normal.
This medically confirmed spontaneous report (initial receipt 06-MAR-2012) concerns a 34 year old female patient with a medical history of asthma. She was also a smoker and had allergies to penicillins, latex and adhesive bandage. The patient was concomitantly taking asthma medications. On 01-MAR-2012, the patient received a flu vaccine (manufacturer unspecified). On the same day the patient also received a 0.5 mL dose of co-suspect medication PNEUMOVAX 23 (batch 1489AA, exp 05/2012) intramuscularly at an unspecified site. On 02-Mar-2012, the day after vaccination, the patient reported redness at the injection site (unspecified site). On 03-Mar-2012, the patient had nausea and emesis. On 04-Mar-2012, the patient went to the local ER (emergency room) with pain, swelling, redness and heat which went down to her unspecified arm to her elbow. She was diagnosed with cellulitis. Treatment included steroids, unspecified antibiotics and pain medication. The patient still has pain and redness but the event is somewhat resolving. Reporter comment: The patient has missed work due to significant disability or incapacity. The patient required intervention to prevent serious criteria (went to ER).
Left Rotator Cuff Hurt; Unable to lift up her left arm; Swollen Lips; Swollen Face; Fever 100.8 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm), LIP SWELLING (Swollen Lips), FACE OEDEMA (Swollen Face) and PYREXIA (Fever 100.8 F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic angioedema.    On 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm), LIP SWELLING (Swollen Lips), FACE OEDEMA (Swollen Face) and PYREXIA (Fever 100.8 F). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) ongoing since an unknown date for Face oedema, Lip swelling, Limb discomfort and Pain, at an unspecified dose and frequency. On 19-Jan-2021, LIP SWELLING (Swollen Lips) and FACE OEDEMA (Swollen Face) had resolved. On 24-Jan-2021, PAIN (Left Rotator Cuff Hurt), LIMB DISCOMFORT (Unable to lift up her left arm) and PYREXIA (Fever 100.8 F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
firm nodules; slightly tender on the right upper lip and left upper lip which formed within the first day of injection; Massaging the area made the nodules inflamed and "pus" filled; Massaging the area made the nodules inflamed and "pus" filled; Prednisone taper helped the swelling resolve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-022222-4565.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid (RESTYLANE KYSSE), since 03Feb2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2), administration date: May2021, for COVID-19 immunization. The following information was reported: NODULE (non-serious), outcome "not recovered", described as "firm nodules"; LIP PAIN (non-serious), outcome "unknown", described as "slightly tender on the right upper lip and left upper lip which formed within the first day of injection"; INFLAMMATION (non-serious), PUSTULE (non-serious), outcome "unknown" and all described as "Massaging the area made the nodules inflamed and pus filled"; SWELLING (non-serious), outcome "recovered", described as "Prednisone taper helped the swelling resolve". The action taken for hyaluronic acid was unknown. Therapeutic measures were taken as a result of nodule, lip pain, inflammation, pustule, swelling. Additional information: Patient received Restylane Kysse on 03Feb2022 reported firm nodules, slightly tender on the right upper lip and left upper lip which formed within the first day of injection; Massaging the area made the nodules inflamed and pus filled. Prednisone taper helped the swelling resolve. Nodules are unresolved. COVID vaccine received Apr2021, May2021 and booster Oct2021.  No follow-up attempts are possible. No further information is expected.
Horrible reaction to 2nd dose; Soaking wet with sweat; Very constipated after 2nd dose; Sneezing for the past 2-3 days; Upset stomach; Sore arm; Sleeping a lot since 2nd dose; Headache; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days) and ABDOMINAL DISCOMFORT (Upset stomach) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and 027c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose). At the time of the report, ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose) outcome was unknown.            The reporter was calling on behalf of their son who received both shots of the Moderna vaccine. The patient post receiving their second dose of vaccine experienced horrible reactions. The reporter said the patient had fevers and was soaking wet with sweat. The patient also had sore arms.  Reportedly, the patient was a brittle diabetic. The reporter states that the patient has been sleeping a lot and also had a headache, upset stomach and was very constipated after the 2nd dose. The reporter also mentioned that the patient has been sneezing for the past 2-3 days.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148969 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148969:Husbands case
Vaccinated on 05/22/21.  On 06/10 patient woke up with unusually painful menstruated cramps.  She proceeded to stand up and passed out hitting her head on wall.  She went to er required stitches.  Had full blood workout, ct scan , ekg, and chest X-ray. No abnormalities noted. Likely  she passed out due to the pain reaction.    Subsequent first day of. On July 27. Woke up with severe cramps and felt like passing out. Previous to first vaccination she had never had cramps this severe. Nor had never passed out her second vaccination was on June 16, 2021.
Tongue  felt a little swollen then had trouble with the swallowing motion. Had to force a swallow
The vaccination was administered into my shoulder joint and NOT into my arm muscle. The pain was immediate and I have lost significant range of motion on that side. The joint also is extremely painful and I have lost the ability to use my left arm as fully as normal.  I have sought medical attention via an orthopedist, who put me on steroids, which did not help. All anti-inflamatories has been ineffective. I have since begun physical therapy for treatment, and have yet to experience any relief. Therapy is scheduled to continue at minimum twice/week for at least a month. I will be getting an MRI of the area soon.  Diagnoses as of 4/21 (follow-up pending): bursitis, rotator cuff tendonitis, and adhesive capsulitis. As of today, this has been going on for 39 days, with no sign of improvement/relief.
Arm got tingly, pins and needles right after the vaccine, then it went away, pt reports she took Benadryl at that time. Then 13 days  later, the entire arm blew up and got welty, with hives, rash, red hot and swollen, pt was treated with prednisone.  Pt reports she was able to receive her 2nd dose and booster, her MD provided her with prednisone to take before and after the vaccines.
MENACTRA was given as the diluent for ACTHIB instead of normal 0.4% sodium chloride diluent. No patient related adverse events were documented from this visit.
pt states about 3 days after taking vax he started having severe lower back pains that lasted about 4 days.  On 3/15/2021 he went to ER in because his heart was racing.  His heart rate went from 64 to 176.  He was treated as if he was having a heart attack or stroke.  Labs showed he had not had a heart attack.  He was admitted for AFIB and irregular heart beat and stayed for 4 days.  Pt was discharged to FU w/PCP and Cardiologist.  Appt w/ Cardiologist is on 3/26/2021.  On 3/24/21 Pt still has a heart rate of 102.
THROAT TIGHTNESS; GRIP STRENGTH DECREASED; INJECTION SITE PAIN; ASTHENIA; MYALGIA. Information has been received from a nurse concerning a 37 year old white female with no reported allergies or medical history who on 09OCT2003 was vaccinated in the right deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 646157/0529N). There was no illness at the time of vaccination. The reporter indicated that the patient had tightness in the throat that lasted a few seconds. She also had soreness at the injection site and deltoid muscle which she still has even through the injection was six weeks ago. She also reported difficulty gripping things in the right arm, which is the arm in which she received the vaccination. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow-up information was received from the nurse which indicated that on 09-OCT-2003 the patient experienced a momentary tightness sensation to the throat immediately after the shot was given. The patient complained of weakness and an inability to grasp items with the right arm for one month following injection. No diagnostic laboratory tests were performed. The patient subsequently recovered from the tightness in her throat, right arm weakness and difficulty gripping things in the right arm. It was noted that the patient had no adverse events following prior vaccination. Additional information has been requested. Follow up 03/16/05: Additionla follow up received from the registered nurse reported that the patient is not fully recovered. The weakness to her right arm is improved, and she still continues to have aching in the right shoulder which was reported as "more in the joint" than in the muscle. Additional information has been requested.
About a few minutes after vaccine administration (Tdap, Menactra and Hep A), pt noted to be pale. Pt given water and candy. About 10 minutes after giving vaccine, she said she didn't feel well, put her head on her hands then suddenly stiffened up, head extended, eyes rolled backwards with stiffening of arms and legs, mild circumoral cyanosis lasted 5 seconds. Pt regained consciousness. BP 90/62, Pulse Ox = 98%, 911 called. Transferred to ER. Patient already slightly apprehensive prior to vaccination.
After two weeks I still have SOB, sever headache , and lethargy.  The chest tightness and sob with exertion is becoming worse day by day. I did Covid test since I start having sob and that was negative.
PATIENT FELT LIGHT HEADED, DIZZY AND NAUSEATED AND HIS FACE WAS PALE.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 22-APR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Experience mild chest pain within the hour of injection (ache and tightness in the lower heart)
Not necessarily an AE, but rather "normal, expected" side effects I wanted to report. 6:00AM 2/11/2021: Nausea, headache, pain at injection site/left arm. lasted all day; 5:00PM 2/11/2021: Headache, Chills, Achy muscles and joints, pain at injection site/left arm; 1:00 PM 2/13/2021: Slight Aches, pain at injection site/left arm(improved).
Both arms red and tender localized at injection site. Left arm with mild induration at injection site. Per patient redness and tenderness were resolving compared to site condition the first two days post vaccination. No concerns of skin infection at this time; per patient local and similar reactions happened before with other vaccines including prior doses of Pfizer covid19.
Client had reaction to Varicella vaccine about 2 minutes after injection SQ to right right arm. Area around injection site at site itself became inflamed with central edema. Mother was asked to stay for 30 minutes but refused. Client was alert and oriented X3 and walked out with mother.
I started feeling very cold and then started shaking uncountable. Then had severe body ache. Then I started having a fever of 103. Then I felt severe nausea for every five minutes for about 4 or 5 hours. Took an anti-nausea pill. The next morning, I still had a high fever. Then around 5 that day the fever went away.
This spontaneous report as received from a Nurse Practitioner refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. "Three years ago" (2014) the patient was vaccinated with ZOSTAVAX, (lot#, route and dosage not specified) for prophylaxis.  The Nurse Practitioner reported that "recently" (onset date not specified) the patient developed shingles. The patient was seen by the Nurse Practitioner and was prescribed an antiviral medication (NOS) for treatment. The outcome of shingles was unknown. Additional information has been requested.
Case previously recorded as MA2009-4274. Initial case report received from a non health care professional on 13 NOV 2009, A 5 year-old female patient was inadvertently vaccinated with 0.5 mL of FLUVIRIN (batch no. 101326P) i.m on 13 NOV 2009. No adverse events were reported. Reference no: NA09-008207. Follow-up information received on 25 NOV 2009: The patient was 20-months (date of birth: 06MAR 2008) of age, not 5 years initially reported.