chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; was twin child & devel a chicken pox like rash on hands & feet p/ vax;
she experienced "Hypertonic" in the neck area right after taking the shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes Type 1" (ongoing), notes: Diabetes Type 1. There were no concomitant medications. The following information was reported: HYPERTONIA (non-serious) with onset Jan2021, outcome "unknown", described as "she experienced "Hypertonic" in the neck area right after taking the shot".  Additional information: The patient was administered a first dose of the Pfizer Covid-19 vaccine purple cap formulation on Jan2022 and states that she experienced "Hypertonic" in the neck area right after taking the shot. Caller was asking if the patient should take a second dose of the Pfizer Covid 19 vaccine amidst the adverse reaction that happened.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Injection site on left arm became more painful as the day went on, a patch of raised skin emerged, the raised area became warm to the touch.  The next morning, the raised area had doubled in size and was hot to the touch and very red.  A surgeon I work for looked at it and determined it was cellulitis.
''My'' period was 8 days late with multiple negative pregnancy tests. ''My'' cycle usually runs 28 days like clockwork and ''my'' period was due on the 17th but did not start until the 25th making ''my'' cycle 36 day; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 18:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 17Apr2021, the patient experienced her period was 8 days late with multiple negative pregnancy tests. Her cycle usually run 28 days like clock-work and her period was due on the 17Apr2021 but did not start until the 25Apr2021 making her cycle 36 days. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. On an unknown date in Apr2021, the patient underwent pregnancy test multiple times and the results were negative. The clinical outcome of the event period was 8 days late was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
1st dose in 2019, did not receive 2nd yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient received did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The lot number and expiry date for 1st dose was not available when asked. The VAERS details were reported for 1st dose. The reporter consented to follow up.
Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who received a 0.5 ml dose of ACT-HIB (lot C5576A8 and Exp. Date 18-OCT-2019) via intramuscular route in the deltoid, on 15-Mar-2019. The ACT-HIB part was taken from PENTACEL package and 0.4 % nacl from an ACTHIB package. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE and HEPATITIS B VACCINE for Immunisation. It was an actual medication error case due to wrong technique in product usage process. It was reported that they ordered ACTHIB for a bone marrow transplant patient and received, ACTHIB from the PENTACEL package and a 0.4 % nacl from an ACTHIB package. ACTHIB from PENTACEL lot # C5576A8 exp date: 10/18/2019 NDC: 49281-545-15 0.4 % sodium Chloride from ACTHIB lot# U6178AA exp date: 3/13/2020. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
sxs appeared 3 days ago, itching, redness, warmth, and hard at the area of and around injection site
C/O "head to toe" rash 2 days post vaccination no rash/redness at site. "I had also been pulling weeds at my friends home." HX ? latex allergy Rt knee pads worn; (+) poison ivy sensitivity.
? Received chicken pox vaccine in L upper arm on 12/05/07, seen 2d later for swollen & redness of upper arm, 7cm diameter, mildly erythem circular raised area surrounding injection site.  No Rx.
This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were not reported). ON an unknown date in 2012, the patient developed shingles. No further adverse event (AE) information was provided. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-073689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073689:Daughter case
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-OCT-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 56, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Two weeks after my second shot, I developed dizziness/vertigo, not unlike what I experienced first in my 20s living in the dry climate where I lived.  It gets better with attention to hydration and good sleep.   Pretty profound initially.  It has gotten better over time, as happened in the past.
Woke in middle of night with belly pain, vomiting. She was confused and saying weird stuff that didn't make sense. Mom stated she felt warm like she had fever.
Fever, vomiting, diarrhea,  fever, abdominal pain starting 12/3/09. Admitted to Hosp on 12/10/09, discharged 12/16/09.
Have so much side effects in vaccine/tore up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Have so much side effects in vaccine/tore up) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 COMPLICATION (Have so much side effects in vaccine/tore up). At the time of the report, VACCINATION COMPLICATION (Have so much side effects in vaccine/tore up) outcome was unknown.      No concomitant medications reported.  No treatment medications reported.  It was reported that, patient had to stay home for 4 days that's 2 weeks.
This spontaneous report as received from a 61 year old male patient. The patient's medical history included ocular migraine. Past drug included unspecified drug for the treatment of ocular migraine, a year ago. On 18-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper left arm for preventative vaccine for "shingles" (dose and route not provided0. The patient stated that six hours after receiving the vaccine he began experiencing "light flashes" in his left eye, which have continued intermittently since (exact timeframe not given). The patient had reached out to the pharmacist that administered the vaccine who has referred him to speak with his primary physician and to the manufacturer. The primary physician has referred him to an optometrist. The patient has not scheduled an appointment yet. No treatment was given. No lab test was performed. The outcome of adverse event was not recovered. Additional information has been requested.
Shoulder hurts when using arm/ it is slightly sore, very little when he touches it; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it). At the time of the report, ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it) had not resolved.            Concomitant medications were not provided by the reporter. No treatment medications were reported.
On April 30 I went to see the doctor for pressure on my ears. She saw fluid and prescribed a steroid. It didn?t help. A week later she prescribed an antibiotic. That didn?t work either. I saw an ENT on 6/21/21 and he did not see fluid on my ears and recommended an mri.
The evening after the vaccine was administered I experienced severe pain in my right leg (4/10 at 7:30pm). The pain occured in the groin and knee area and mostly through the thigh. I took 1000mg of Tylenol and it helped resolve the pain. The following day (4/11) I experienced the same leg pain and continued with Tylenol which helped. Monday I had dizziness and almost fainted so I went to the ED to get examined (4/11). I have a family history of blot clotting and carry the prothrombin gene mutation so I'm aware of issues with leg pain and get evaluated. The pain has continued over the week and is now in my left leg with mild pain. Visited walk in clinic to have a follow up on 4/15 and they administered a Covid test.
Tinnitus. High Blood pressure, I?m usually low. Heart palpitations. Swollen lymph nodes. Swollen throat. Sweating. Faint. Disoriented. Passing out (4 times). Dizziness. Light headed. Blurred vision. Headache. nause. diarrhea. runny nose. sore throat. hot and cold felt like I have a fever.  Entire body warm. Fatigue. Bed ridden. Couldn?t lift my head off the pillow.
Developed hives in extremities 7 days after vaccination, then spread to neck. 3 days later with persistent receiving hives, he also developed shortness of breath, hence brought to ER.
Patient came back feeling very lightheaded, dizzy and nauseous.  She appeared very pale.  She was feeling like she was going to pass out and went to the floor.  After a few minutes she was able to stand and she rested in a recliner with her feet up.  After about 15 minutes of this with a cool cloth on her forehead she was feeling better and left the office.
cough, hx of diabetes, long term immunosuppression;  positive COVID test, pneumonia
Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventh of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
This case was reported by a physician and described the occurrence of transient visual disturbance in a 40-year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline. The subject's medical history included migraine headache. Previous vaccination included TWINRIX, GlaxoSmithKline given approximately one month prior to this event. The subject was taking no concurrent medications. On 3 April 2009 the subject received 2nd dose of TWINRIX (unknown route, left arm). On 3 April 2009, 1 hour after vaccination with TWINRIX, the subject experienced transient visual disturbances such as cloudy vision. On 3 April 2009, the events were resolved. The reporter does not know if she is going to complete the series.
1st Dose of Pfizer: 3/25 - 3.25 starting experiencing dizziness on the drive back and went to sleep - 3.26 start urinating blood - 3.27 went to  Urgent Care, did urine analysis, and got antibiotics, took for 7 days, finished all antibiotics on 4.2 - 4.2 rectal pain and went to the rectal doctor, 7prescribed antibiotics, took for 10 days - 4.10 tongue numbness started - 4.14 right eye start twitching 2nd Dose of Pfizer: 4/15 - 4/15 after shot, start to experiencing severe facial paralysis - 4/15 went to ER on that evening, ER doctor said is bell's palsy, total right facial paralysis - 4/16 lower body experiencing pain and weakness, facial paralysis 2nd day - 4/18 started acupuncture, headache and temple pain, facial paralysis 4th day - 4/19 went to see the rectal doctor again, rectal severe pain, facial paralysis 5th day - 4/20 went to see neurologist, re-confirmed Bell's Palsy, issued MRI for brain - 4/21 continued rectal pain -4/23 severe rectal pain (level 8/10), went to ER, had Morphine, had CT scan -4/26 see rectal doctor, prescribed pain medicine, but nothing can be done, told to wait it grow bigger -4/30 MRI for the brain - 5/3 Saw another neurologist,  -5/10 saw the rectal doc, did procedure in office to cut open a hole in buttock -5/11 start shortness of breath -5/12 low blood pressure, high pulse (116), rectal pain, facial paralysis continue
This spontaneous case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 25 years old female patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surround the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza virus on 09-Oct-2015 - 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected.
Cellulitis of left upper arm at vaccine site, centered darker erythema, + vesicles, + ecchymotic areas.  2-2-08 per mother, area fading and getting better.  Improving without medication.
Patient is a 29 y old female with no history of previous reaction to vaccines or medications. She was given Pfizer COVID vaccine at 12:08 pm and within approximately 2-3 minutes while sitting in discharge area she began to feel dizzy.  She was tachycardic with a HR of 140. Denied anxiety history , denied cardiac history. No itching, No SOB. Only c/o dizziness. BP was initially elevated 133/94. She was provided water, and a snack. No difficulty swallowing or breathing. She was observed for an extended period of time, and HR came down to 90's briefly, but went back up to 120-130's with complaint of dizziness when HR would accelerate. This continued for nearly an hour, with sustained HR 110-120's and BP elevations as high as 179/105 with no HX of HTN,  so EMS was called. She was transported to ER via EMS for evaluation . Accucheck per EMS was 99 and 12 lead EKG was done by EMS showing sinus tachycardia. She remained alert and oriented entire episode.
NSTEMI - Coronary artery bypass grafting x3 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to obtuse marginal and right posterior descending coronary arteries on cardiopulmonary bypass.  The patient was discharged on ASA and Toprol XL. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The age group was not provided, but was captured adult as per vaccine indication. The reporting Licensed Practical Nurse stated that she had seen multiple patients with arm soreness at the injection site after SHINGRIX and she did not had additional information.
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 12/25 COVID swab, result: detected 12/25 pt cc: cough, fatigue, fever, headache, myalgias, nausea, sore throat, exposure: unknown 12/25 CXR impression: No acute abnormality.
6 days after the first vaccine taken diarrhea started with abdominal pain each morning and lasted about 6 hours. Pain and diarrhea subsided for that day. Next morning, the pattern started over and this lasted for 6 days in a row.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-JUL-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at 8.33 Celsius Degrees for 416 hours, 9.44 Celsius Degrees for 168 hours, 15 Celsius Degrees for 56 hours, -3 Celsius Degrees 1172 hours, -1.11 Celsius Degrees for 80 hours and 8.88 for 24 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.