chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When patient came in for her second dose of the series, she said that about a week or two after her first dose she developed hives all over her body. She said it was definitely delayed to when she received the shot but didn't remember changing anything else that would have caused it. She said that she notified the nurse at her facility about it and they gave her steroids and it went away. She was told by several health care providers to continue and get the second dose so she did so willingly.
I received 2 doses of the Covid 19 Vaccine. 4 weeks later I had a confirmed breakthrough infection of Covid 19; I received 2 doses of the Covid 19 Vaccine. 4 weeks later I had a confirmed breakthrough infection of Covid 19; This is spontaneous report received from Pfizer RXPathways. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2 doses of the covid 19 vaccine. 4 weeks later who had a confirmed breakthrough infection of covid 19 on an unspecified date with outcome of unknown.
swollen area that starts from armpit and goes to mid-trunk; swollen area that starts from armpit and goes to mid-trunk. The swelling is very painful.; swollen armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen area that starts from armpit and goes to mid-trunk), PAIN (swollen area that starts from armpit and goes to mid-trunk. The swelling is very painful.) and LYMPHADENOPATHY (swollen armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen area that starts from armpit and goes to mid-trunk), PAIN (swollen area that starts from armpit and goes to mid-trunk. The swelling is very painful.) and LYMPHADENOPATHY (swollen armpit). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING (swollen area that starts from armpit and goes to mid-trunk), PAIN (swollen area that starts from armpit and goes to mid-trunk. The swelling is very painful.) and LYMPHADENOPATHY (swollen armpit) outcome was unknown.            Concomitant medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Approximately 18 hours after vaccine noted maculopapular mildly erythematous rash over L shoulder - spread to left chest over few hours then to entire chest, R shoulder & upper back.
I started having jaw pain during the day. By evening, while I was eating it got so bad and my jar started to swell severely each time I chewed. Was pushing on my neck and made my head feel like it was going to pop. Went to urgent care and was prescribed antibiotics. Followed up with ENT. Unsure of cause and has never happened before. Was told it is a blocked salivary gland aka sialadenitis. I have never experienced this before and am convinced there is a correlation with the second dose of the vaccine.  CT scan will be scheduled to rule out a stone.
Patient presents with a potential reaction to the COVID19 vaccine. The patient was evaluated in his vehicle as a passenger. He was responsive. He presented with signs and symptoms consistent with vasovagal syncope. He was placed supine with legs elevated and given oral hydration.   Vasovagal syncope with rapid return to baseline with repositioning and hydration. Returned home with mother as the driver.
Information has been received from a medical student concerning a female patient with a drug reaction/allergy to penicillin who on unknown dates, was vaccinated with the first (lot# 666598/0786Z), second (lot# 036AA is not a valid lot for GARDASIL) and third dose (lot# 671006/1291AA) of GARDASIL (dose and route not reported), respectively. A few days after the third dose, the patient experienced seizure like activity. The medical student reported that the patient did not lose consciousness but had tonic clonic movements. At the time of the report, the patient was hospitalized. The patient did not have any adverse events after the first and the second dose of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Received MMR and PREVNAR 13 at 4pm 6/1/11. Pt. was grumpy and fussy 6/2 and 6/3 - late afternoon 6/3/11 developed clusters of white bumps surrounded by red area then progressed to full body rash. Improved with BENADRYL, CLARITIN and SINGULAIR - very painful so also MOTRIN. Resolved 6/4/11 but pt. awoke with fever of 101 degrees, vomiting and diarrhea x 24 hours.
As per hx given by mom (+) erythema/hives and swelling in day 1 and 2 after vaccine administered BENADRYL given and resolved. No rash/swelling.
Patient was given a Moderna vaccine at 16 years of age.  Based on CDC guidelines, we had the patient follow up for a second Moderna shot on 05/04/2021.
Initial misuse report received from a health care professional on 04 November 2013. A 15-month old patient was administered FLUSONE NP on August, September and November. The extra dose was administered. No adverse event was reported. List of documents held by sender: none
patient was administered an expired vaccine/ no AE;Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer via Medical Information (Reference number- 00798692) and transmitted to Sanofi on 05-Oct-2021.   This case involves a 46-year-old male patient who administered an expired IPV (VERO) [IPOL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 04-Oct-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1F972M and expiry date 03-Oct-2021] via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Caller stating that an expired dose of IPOL was administered to a patient and inquiring if there was a "grace period", the caller stated that the label was wrinkled and the date could have been misconstrued, she was wondering if the administration was valid".  Product used: Used First time product used : No Still using product : Yes.  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
The patient started to experience tinnitus within 2-3 hours of receiving the vaccine. She stated it was still continuing at 7 pm following the vaccination. The ringing had not worsened, and she stated it seemed to be improving.
This spontaneous report was received from a consumer (patient's husband) refers to the female patient of unknown age. About 7 years ago in 2007, the female patient received PNEUMOVAX23 (dose/frequency, therapy route, lot # and expiry date unspecified) to prevent disease. She experienced a red, hot, swelling, itchy and tenderness sensations on her arms, at the point of injection. Outcome of the events were unknown. Causality assessment was not provided. This is one of several reports from the same reporter (MARRS # 1503USA012500). Additional information has been requested.
Starting in the morning of 6/26: low grade fever, chills, sore joints (knees, legs and hands) severe that the patient had a hard time holding items in hands.
not reported any adverse reaction to the accidental administration of the PROQUAD vaccine at the time of the call; the error occurred due to the trays the vaccines were handled on being accidentally switched; a dose of PROQUAD that was accidently administered to the wrong patient/ one patient was given the wrong vaccine; This spontaneous report was received from an office manager referring to a 2-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 14-AUG-2023, the patient was accidently vaccinated a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (0.5 mL / two dose series, lot#: X004368, expiration date: 02-JUN-2024; strength and route of administration were not provided), which was administered to the wrong patient (wrong product administered). This vaccine was supposed to be administered to the patient's sibling, who came into the practice at the same time for routine vaccinations. The error occurred due to the trays the vaccines were handled on being accidentally switched, not due to confusion over the vaccine appearances (product selection error).  The patient involved has not reported any adverse reaction to the accidental administration of the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (no adverse event).
cough,; dizziness.; arm soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough,), DIZZINESS (dizziness.), MYALGIA (arm soreness) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (cough), DIZZINESS (dizziness), MYALGIA (arm soreness) and PYREXIA (fever). At the time of the report, COUGH (cough), DIZZINESS (dizziness.), MYALGIA (arm soreness) and PYREXIA (fever) 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 medication was not provided Treatment medication include Vitamins, Vitamin C, allergy medicine, Fish oil, Zinc, Aspirin, Advil .
Administration error. Patient received a monovalent booster dose instead of the recommended bivalent booster dose on 09/12/2022. Attempt made to contact client to inform client of need to receive a bivalent booster in 2 month. Unable to reach client at this time.
Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced injection site hyperpigmentation.  At 2 months of age, the patient received a dose on 09-Dec-2008.  After receiving PREVNAR therapy, the patient experienced a mark at the injection site.  It was noted that within minutes of receiving the injection a "brown area formed over the exact site and continued to grow to the sized of a quarter."  The parents stated that it got "bigger and bigger and there was no itching or any other symptoms occurring at the site".  The mark is demarcated and has hyperpigmentation.  Patient has not yet recovered.  No further information was provided.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old female patient who received ADACEL instead of DAPTACEL in error which was her fourth in the series. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunization; and VAQTA for Immunization. On 06-Sep-2018, the patient received a Fourth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA expiry date 16-Jun-2020 via intramuscular route in the right thigh. Needle size was 25 gauge 5/8. It was a case of actual medication error due to Wrong vaccine administered and also for inappropriate age at vaccine administration as 24-month old patient was given ADACEL. No Adverse event was occurred. 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.
This spontaneous report was received from an approximately 68 year old female patient with rosacea, neomycin allergy (causes rash) and penicillin allergy (causes rash). The medical history of the patient included eczema. On 20-MAY-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). There were no concomitant medications. On 06-JUL-2013, the patient experienced rash, burning, prickling on the arm and feeling of heat on the neck after receiving PNEUMOVAX23. The patient sought medical attention (spoke to physician). She was treated with Clobetasol (dosage unspecified). No lab tests were performed. The patient was not recovered from the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
This is a spontaneous report from a contactable other nurse (patient). A 29-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206), via an unspecified route of administration in Arm Left on 11Mar2021 at 14:45 (29-years-old at the time of vaccination) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Mar2021, the patient experienced swollen lymph nodes hours after COVID-19 vaccine, then fever and next day developed aphthous ulcers in mouth and tongue. She also developed a strep throat infection and cold sores on lower lip, it's been a week and she still have the cold sores on her lip that became infected. She hasn't been able to eat well due to the pain she was currently experiencing. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown if patient tested for COVID-19. The outcome of events was not resolved.  Follow-up attempts are needed. Information Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event bacterial pharyngitis, Lymphadenopathy, Asthenia and Pain with the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient called pharmacy at 9am and reported redness and swelling of left side of her face. She stated the swelling was worse at night.  I instructed patient to try to get medical attention.  Follow up with patient at 5pm.  She said the swelling went down and the redness also is not as obvious as it was in the morning.  She said she never had difficulty breathing when she had this reaction.  She mentioned she is aware of lots of allergy she had to other stuff as well.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99
Tdap and Varicella immunization Rxn to L arm size 7x7x7
Received PNE vaccine and Flu vaccine in (R) arm on Friday 9/20/13. Sat. night area around injection site became red. By Sunday, a large area around injection site on upper arm red, swollen and warm. Monday morning she came to the HD to be evaluated. Instructed to place cold rag on area, take TYLENOL and BENADRYL and report back if the area becomes worse.
Began to feel light headed, then lost vision. Then lost consciousness. Profuse sweating. Initial BP 70/40. This was approximately 15 minutes after symptoms started. Blood sugar was normal.
I wake with a hot large lump in my inner right forearm. It looked like an egg and hot to the touch. I did not know what it was at first. I applied heat and ice. I am in the medical field, so I thought it was a blood clot. I went into urgent care. They did not have the equipment to do an ultrasound. So, they referred me to another HCF. Once they did the ultrasound image and the referred me to the ER. They did a deep vein study and another ultrasound. They were looking for a DVT and they found it.
Fever of 103,chills,headache, malaise Red warm rash, hard to touch at injection site 2 days after injection appeared.
lost a lot of sense of taste; Sore injection arm/very slight sore arm/Sore arm was the injection arm; Mild headache and head felt full; Mild headache and head felt full; little bit of a strange feeling in her head; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: GL9262), via an unspecified route of administration in the left arm on 25Feb2021 at 09:00 (at the age of 74-year-old), dose 1, single for COVID-19 immunisation. Medical history included never had a sense of smell. Family history included never had a sense of smell. The patient never had a sense of smell, it was genetic. Stated her grandfather, herself, and her grandson never had a sense of smell. The patient did not receive any concomitant medications. The patient did not receive any additional vaccine on same date of COVID-19 vaccine. The patient did not receive other vaccines four weeks prior to COVID-19 vaccine. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. It was reported that the patient hardly had any reaction as far as feeling sick form the COVID-19 vaccine. Stated it seemed strange that she lost a lot of sense of taste. The patient reported, currently nothing tastes right. The patient could taste sweets but could not taste flavors. Tasted like her coffee was not strong enough. She made a garlic shrimp pasta and she could not taste the garlic or seasoning. Could not taste her pastrami, mustard, and sauerkraut sandwich and hardly had any flavor. The patient wanted to know if loss of taste was a side effect of the COVID-19 vaccine. The patient had had a very slight sore arm, which was not a problem at all. The sore arm was the injection arm, which was her left arm. On 26Feb2021, just the first day, the patient had a little bit of a strange feeling in her head. Had a mild headache and her head felt full. After that she was fine. It was a very little reaction. The patient did not undergo lab tests and procedures. The outcome of the events 'little bit of a strange feeling in her head' and 'mild headache and head felt full' was recovered and outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
EXTREMELY SORE ARM, SEVERE BODY ACHES AND 102 TEMPERATURE FOR 2.5 DAYS.
Sharp pain to back and abdomen that comes in cycles without warning or trigger.  Individual has difficulty getting out of bed and talking due to the pain level.
Information has been received from a health professional concerning a male in his 40s who a few years ago, in approximately 2001, was vaccinated at the appropriate schedule with two dose series of varicella virus vaccine live. In the past 6 months, the patient had an exposure and a titer was negative. Medical attention was sought. No product quality complaint was involved. No other information available at this time. Additional information has been requested.
Day 2 : slightly sore arm.  Days 3 - 7: everything was fine Days 8 - 12:  injection site was red, swollen, and mottled/bruised looking (about the size of 3 quarter coins) and was SOOOOOO ITCHY Days 13 onward: things return to normal, but injection site is still slightly itchy
12 month old received immunization on 01/28/2002, 02/04/02-Mother noticed scattered skin rash in trunk , history of URI PE-trunk-skin  positive papular, erythema scattered-confluent rash, negative mucosa, treatment-observe