chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Patient complains of severe joint/muscle in all over body but especially hip. He said it was helped by ice pack and tylenol. I lasted 5 days and then resolved. He stated it was so bad on Friday, 6/28, that he had trouble walking. He also experienced fever, chills and all over body shaking.
elevated heart rate; This is a spontaneous report from a contactable female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced elevated heart rate. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. Therapeutic measures were taken as a result of elevated heart rate with Benadryl. Inquiring if she should take the second vaccine. The clinical outcome of event was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Vasovagal syncope. Patient felt lightheaded. Pt drank water and ate snack and returned to baseline after about 30 minutes.
Pain in left deltoid that limits range of motion x 2 weeks. Pain persists despite 600mg ibuprofen TID.
10 year old received the 12+ presentation of the pfizer bivalent vaccine. Pt tolerated injection well and did not have any adverse reaction.
Patient called 9-26-18 after receiving both the FLUZONE HD and PNEUMOVAX 23 immunizations on 9-24-18. Complained about left arm hurting and red. He came into the pharmacy where I looked at this reaction. The injection site looked fine, but down the inside aspect of his left arm and down around the outer aspect of his elbow was all red. I called his physician and they immediately took him in for an appointment. They prescribed Bactrim DS q12h for 7 days.
fatigue; flu like symptoms; This is a spontaneous report from a contactable nurse via Pfizer sales representative.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue and flu like symptoms on an unspecified date with outcome of unknown. The patient  had to call in sick for days.  That information on the Lot/batch number has been requested.
spread everyday, it spread around her arm; itchy; around the shot started to get hard; around the shot started to get red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (spread everyday, it spread around her arm), PRURITUS (itchy), INJECTION SITE INDURATION (around the shot started to get hard) and INJECTION SITE ERYTHEMA (around the shot started to get red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-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 ERYTHEMA (spread everyday, it spread around her arm), PRURITUS (itchy), INJECTION SITE INDURATION (around the shot started to get hard) and INJECTION SITE ERYTHEMA (around the shot started to get red). At the time of the report, ERYTHEMA (spread everyday, it spread around her arm), PRURITUS (itchy), INJECTION SITE INDURATION (around the shot started to get hard) and INJECTION SITE ERYTHEMA (around the shot started to get red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
large local rxn consistent w/SC administration;also may have had prev tetanus shot less than 5yr ago;
pt recv vax 25MAY95 & 6hr p/vax pt devel high fever,nausea,vomiting,abd cramps which was consistent w/flu-like sx;pt recovered w/in 24 to 36hr
Client is experiencing  redness and  swelling with vessicles  on the Left thigh.  Pt was treated with Benadryl and Antibiotics.
No additional AE; patient was given a dose of VAXNEUVANCE after the dose was stored improperly; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 02-MAY-2023, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection, 0.5 milliliter, lot #W027275, expiration date: 09-JUL-2024, was underwent a temperature excursion of 34 degree Fahrenheit (F) for 7 hours. No previous temperature excursion.   On 03-MAY-2023, the improperly stored vaccines was administered to patient for prophylaxis (route of administration was not provided) (product storage error). No additional adverse events (AEs).
This spontaneous case, initially received on 21-Nov-2016, was reported by a health professional and concerns a(n) adult unk patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from Oct-2016 to Oct-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Significant pain that lasted 2 weeks or longer at the injection site (outcome: Not recovered/ Not resolved). Follow-up information received 13-Dec-2016: The patient did not receive any other concomitant vaccination on the same arm. The patient was recommended to rest arm and use ice or heat if needed for pain. The patient experienced no other associated symptoms. The outcome was reported as complete recovery. All doses were administered by a RN (registered nurse) or a Certified Medical Assistant who is also a paramedic. Both have been administering flu vaccines for years. A 22 gauge 1 inch or 1.5 inch needle was used. The RN is certain that the dose was administered correctly in the deltoid muscle of the arm as trained. Case correction 23-Feb-2017: Follow-up information received on 13-Dec-2016 missing the following information: QA investigation results (final assessment): Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
shivering jaw clenched; experienced 2-3 hours of chest pain severe heart burn; felt nauseated sick to stomach; running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever; fatigue; Headache; migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Treatment received: Steroids) in November 2020.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever). In August 2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of took 4 total that morning; CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 14-Aug-2021, BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) had resolved. On 17-Aug-2021, MIGRAINE (migraine), NAUSEA (felt nauseated sick to stomach) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Body temperature: 103 degrees f (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitants were reported.   Patient stated that Tried to have crackers and bread to settle stomach, went to lay back down took more ibuprofen took 4 total that morning. Slept until 10:30-11AM. Could not drink water, nauseated. Patient had COVID-19 last year in November2020 and said that  symptoms from 1st dose was similar to COVID-19 she had except for the nausea. Patient was in bed the most of the day. Patient woke up 3pm tried to eat soup broth and experienced 2-3 hours of chest pain ,severe heart burn.
About two hours after getting Covid vaccine (Moderna) (around 4 pm), she started having pressure in head and ears, which caused mild headache. Her eyes looked red without fever or chill. Otherwise, she did not have any other symptoms. The symptoms got worse on the two following days (Saturday and Sunday). She came to our pharmacy to report the adverse effects at 5:25 PM on Sunday (3/7/2021), and according to her report, Sunday was the worst. She took Tylenol for the past two days (Friday and Saturday) without improvement. We instructed her to take ibuprofen and to see her doctor on the day after (Monday 3/8/2021). We followed up with her on Monday, and she said her symptoms got improved with a tablet of ibuprofen.
The day after my second Shingrix vaccine I was very lethargic, body aches  and a slight fever.  Not able to do usual daily routine.   Symptoms lasted most of the day.  The next day I felt fine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of VAQTA (route, dose lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Having a flushed feeling in face and shoulders; Mild rash on face and shoulders/very fine bumps all over those; Mild sunburn; Feeling itchiness and burning; Feeling itchiness and burning; Think it might just be the crazy amount of pollen in the air; The first two days after the shot had mild chills and soreness in right arm; The first two days after the shot had mild chills and soreness in right arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm right on 24Mar2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the first two days after the shot had mild chills and soreness in right arm. On 06Apr2021, the patient started having a flushed feeling in face and shoulders and now a mild rash on face and shoulders. When it started it felt like a mild sunburn but did not have any signs of sunburn. She can now see very fine bumps all over those areas and had been feeling itchiness and burning. On an unknown date in Apr2021, the patient thought it might just be the crazy amount of pollen in the air, but never experienced any allergy symptoms that affected skin like this and can't think of any other reasons other than possibly the pollen or the vaccine, that's the only reason she felt the need to report. The adverse events did not result in a visit to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events mild chills and soreness in right arm, pollen allergy, mild sunburn, feeling itchiness and burning, mild rash on face and shoulders/very fine bumps all over those and having a flushed feeling in face and shoulders was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented yesterday 11/28/17 to pharmacy to pick up a pain Rx for her arm. She came to consult and informed me that she has been having very bad pain in her arm since getting her flu shot. I asked about previous conditions or any injuries or unusual activity since. Patient stated nothing out of ordinary. She stated that the pain has been waking her up at night and that it is both sharp and dull pain. She has not yet been to see a MD. Advised her to get it looked at. I asked if she could show me where the injection was given. She stated it was very high up on her arm. There is no visible redness or swelling on her arm now. I informed patient it may be due to some injection going into bursa.
Had fever after vaccine on 1st day to max of 103.5F, Had several brief episodes of eyes dilations arms and legs jerking for few seconds, then getting limp and then crying.  Was seen in ER that might with normel exam and ono episodes while there.  Has not had any episodes exception that 1st day, currently healthy infant with normal exam and normal growth.
A medical assistant reported the occurrence of injection site cellulitis in a 5-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the Centers for Disease Control and Prevention (CDC). The pt's medical history, concurrent conditions and concurrent medications were not reported. The pt experienced no adverse events following previous immunizations. On 03/19/2003 the pt received her 5th injection of Infanrix (lot DTPA541E9. On the same date the pt received injections of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles, mumps and rubella virus vaccine (MMR II, Merck). Initially, the reporter stated that the subject developed injection site edema and blisters on 03/20/2003. On follow-up, she indicated that the reaction began on 03/18/2003. However, the follow-up information still reported date of immunization as 03/19/2003. The pt was seen by the physician. A diagnosis of injection site cellulitis was made. The reporting medical assistant considered the injection site cellulitis to be related to Infanrix administration. The most recent information was received on 04/09/2003. As of 04/01/2003, the outcome of the injection site cellulitis was unknown. Comment: This is one of two subjects who experienced injection site cellulitis after receiving Infanrix lot DTPA541E9. For the report of the other subject, please see report A0401522A.
Approx 8-10 hours after receiving influenza vaccine, experienced pain in the shoulder, neck and severe headache.
A week after vaccine developed pain in left side, high blood pressure, numbness in left foot, hands, leg, blood test shows anemia, heart rate was 145, referred to a neurologist.
tiredness after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th December 2020, 8 hrs after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced tiredness. The reporter did not consent to follow up.
Site: Pain at Injection Site-Severe, Additional Details: Unable to lift arm due to pain.  States pain is improving.  Will follow up with patient in 3-5 days
Narrative:  Transported patient to the emergency department via wheelchair for high bp, dry mouth, swelling sensation on right deltoid (covid vaccine site), and light headedness after receiving 2nd covid booster (Pfizer). Charge nurse and nurse manager made aware. Transported patient in stable condition. Not in any type of distress. Report given to RN at 1018am. NO further questions/concerns at this moment.
Moderna vaccine was administered - reported by patient  I95.9 HYPOTENSION 7/1/2021 HYDRONEPHROSIS
On 2/24/12 at 10:00 am Pt was given vaccines on 2/22/12. Was given a call at the clinic that pt's arm was hurting to lift red, swollen, and painful. I had the pt come into be seen by another physician here at the clinic. Pt was evaluated and placed on clindamycin.
Had a Heart attack July 2 2022. Now I am no longer able to work and support my family and now I'm in danger of be coming homeless.
This spontaneous case reported by a physician, describes the occurrence of vaccination site discomfort (local discomfort) in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included hypertension since Sep 1, 2017. Concomitant products included telmisartan from Sep 1, 2017 to an unknown date for hypertension. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site discomfort (local discomfort). At the time of the report, vaccination site discomfort (local discomfort) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or treatment information. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-080656 (patient link).
Parent does not feel reaction was related to vaccine. Every time patient has fever, she gets seizures, with or without vaccine. Patient had fever/seizure evening after vaccine. Parent stated this has happened after previous vaccines also.
Fever, chills, muscle aches, headache, fatigue, nausea, dizziness, pain in arm (injection site).
Came into clinic hives on face, upper chest and knee area. Benadryl PO given.
Information has been received from a health professional concerning a 12 month old Laotian female, w/ no medical history, no known illness at the time of vaccination and NKDA, who on 03/21/01 was vaccinated with the first dose of varicella virus vaccine live, administered SC, in the left thigh. Concomitant therapy, on an unspecified date, included the first dose of MMRII and the second dose of hepatitis b vaccine recombinant (yeast) (manufacturer unknown). Three days post-vaccination, on 03/24/2001 (previously reported as 03/26/2001), the mother called the doctor's office to report that the child had 50 itchy lesions over her body. The pt had no fever and was not seen in the office at that time. The pt was reported to have chicken pox. According to the reporter, the child's mother was unaware of exposure to the virus and questioned vaccine relationship. The lesions resolved w/out treatment required. At the pt's 15 month physical, the physician noted a pox scar under the left eye. It was also reported that the pt tolerated the viral symptoms well with full recovery. No further information is available.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: EW0187) at the age of 51 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: Has had for years; "Asthma" (ongoing), notes: Diagnosed within the last 5 years; "Sjogren's syndrome" (ongoing), notes: Diagnosed around the same as Rheumatoid arthritis, may have been about 7 years ago.; "COPD" (ongoing), notes: Diagnosed within the last 5 years. Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "muscle weakness". No follow-up attempts are possible. No further information is expected.
Patient received her first dose of SHINGRIX on 3/27/18. Pharmacist went through normal immunization process of cleaning hands, gathering supplies, donning gloves, discussing potential side effects including pain and redness at injection site, cleansing vaccination location, and administering the vaccine. Patient called the pharmacy 3/31/18 with concerns of the injection site being painful, red, and warm. The pharmacist on duty recommended for the patient to monitor the site, use ice to help reduce redness and warmth, and if things got worse or she developed a temperature that she should seek medical attention. Pharmacist called patient on 5/31/18 to notify her that she's due for second dose and patient shared concerns of continued discomfort -- she's been experiencing a dull aching pain at the injection site since receiving the shot 2 months ago. Pharmacist contacted GSK to inquire (longest duration of pain reported in clinical study of 41 days) and passed this information along to the patient. Patient will consider this information and decide whether or not she receives the second dose. Pharmacist did mention that the CDC recommends completing the series even if side effects occurred (other than allergic reaction).