chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No side effect reported; Per the nurse a patient was given an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patients pertinent medical history, concomitant therapies, drug reactions, or allergies was provided.  On 17-DEC-2020, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S005856, expiration date 03-DEC-2020 (strength, dose and route of administration were not provided) for prophylaxis. No side effects were reported. The reporter asked if they needed to revaccinate the patient or not. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Yes; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 3 months ago in July 2012 (lot#, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. In 2012 the patient experienced an injection site reaction that looked like "a raised pimple with a dot in the middle". The entire affected area was about 7 or 8 mm wide. There was no pain at the site. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient had not contacted her physician about the event, she had visited a pharmacy. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for PNEUMOVAX 23. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a 29 year old female patient with amoxicillin allergy and TOPAMAX allergy. No medical history was reported. On 27-APR-2012 12:40 PM, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # 672962/0025AE, expiry: 18-OCT-2013) intramuscularly in the left arm. No concomitant medication was reported. On 27-APR-2012 03:00 PM, the patient experienced significant pain after receiving PNEUMOVAX23 consisting of severe muscle pain with minor use of left arm and event minor use of forearm. The outcome of severe muscle pain with minor use of left arm and event minor use of forearm was reported as recovered on 28-APR-2012. Additional information is not expected.
didn't received the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jun-2021 and was forwarded to Moderna on 30-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In september or October 2020 and fully recovered.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that 3 weeks after first dose vaccination patient suffered an accident and spent last 5 months away from home.  No concomitant medications were provided.
Headache HEADACHE X1 DAY, SORE ARM X 2 DAYS Narrative
10MIN AFTER INJECTION DONOR BECAME HOT, NAUSEOUS, DIZZY,LIGHTHEADED, FLUSHED CLAMMY, EYES BLURRY. TAKEN TO OFFICE. PLACED ON TABLE. EXTREMITIES  ELEVATED, FANNED. NO BREATHING DIFFICULTY, NO RASH. NAUSEA RESOLVED. TOLERATED 12OZ POWERADE. IN OFFICE  EPISODE LASTED 40MIN.  DR NOTIFIED OF EVENT.
Patient came in 11 days after vaccine was administered with an 8cm x 4cm raised, red, slightly warm to the touch localized skin reaction. Had a two small blisters in the center and a vesicular like rash elsewhere in the area of rash. This was her first dose of varicella.
fatigued for one day (the next day); After my second dose, my left arm was sore for two days (the day of the jab and the next day); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:30 (Lot number: EL3247) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose covid-19 vaccine captured as historical vaccine, Lot number: EL3247, Time: 10:00 AM, Location: Left arm, Event: my left arm was sore for three days, Event outcome: Recovered), administration date: 03Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Left arm was sore". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (Mar2021), described as "After my second dose, my left arm was sore for two days (the day of the jab and the next day)"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "fatigued for one day (the next day)". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  No follow-up attempts are possible. No further information is expected.
MEDICATION INJECTED IN GLUTEAL REGION INSTEAD OF DELTOID. NO REACTIONS REPORTED PER PATIENT.
Redness, tender, warm arm; body aches, headache. Ibuprofen 250mg 2 tabs taken once
Recovered from COVID-19 in December 2020. After receiving the vaccine the morning of 5/8/2021,  about 7pm that night my arm became very sore at the injection site. About 9pm I began feeling severe chills which lasted through the night and overnight. Along with chills I had fever of 102, headache, muscle aches, fatigue which lasted until late afternoon on Sunday 5/9/2021.
Mother of pt reports numbness/tingling on both feet, jaw stiffness, left abdominal pain, and knees/legs pain. Symptoms started 1-2 days after receiving the shots. Pt had previously received Meningococcal MCV4 on 25 Jan 2017 at another location.
Patient reported swelling, pain, redness, and hot to touch at site of injection. Started to notice affect about one hour vaccine was given. She also reported having a fever--feeling hot and sweating. Patient hasn't gone to see a doctor. She was advised by pharmacist to take TYLENOL or Ibuprofen, place ice compress on area and to also take BENADRYL to help with symptoms. Patient advised that if swelling and redness begin to spread further and/or no improvement in the morning, then to head to a clinic.
Mom spoke to provider had fever last eve 102 & vomited x1 today. Afebrile now
The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022; no adverse event; Patient received expired full dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022).    No concomitant medications was reported. It was reported that 8 adult patients received the vaccine (7 Adult boosters and 1 adult full dose) on 01-Aug-2022. This case contains information for the 1 adult full dose of total 8 adult patients described by the reporter. The vial was initially stored in the refrigerator was thawed on 29JUL2022 and kept in the refrigerator. The vial did not vial undergo any temperature excursions. No treatment drug details was reported.
Patient reports redness at injection site starting the day after the vaccination.  Reported to pharmacy 4 days later and redness was about 2-3 inches in diameter and had "moved south" on her arm from the day prior as she had made a mark with a pen and circled the redness the day prior and the redness had expanded beyond the pen mark more towards her elbow slightly.  Was a little warm to the touch. recommended she see her primary care in case there was slight infection.  She did end up going to urgent care where the doctor gave her hydrocortisone topical ointment thinking it was mostly a localized allergic type reaction/irritation.
Patient reported an allergic reaction including hives and redness occurring 2 hours after receiving the vaccine. Patient reported face swelling, throat tightness, and slight difficulty of breathing later that same evening. Patient self treated with benadryl  and her symptoms resolved.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old male patient who received SHINGRIX (batch number 7N227 ?, expiry date 21st February 2021) for prophylaxis. On 9th July 2018, the patient received the 2nd dose of SHINGRIX. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced flu like symptoms after the 2nd dose of SHINGRIX. No symptoms were reported for 1st dose of SHINGRIX.
Left arm first day swelled  & got warm at injection site.  Second day it seemed better , third day it really swelled, got red from shoulder down to elbow & itches.  Using benedryl cream for itching & using ice packs on arm,
Information has been received from a registered nurse concerning a female patient with an allergy to sulfur medications who in 2002 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in 2002, last year of vaccination, the patient developed a minor flare up of cellulitis. It was reported that the office was right on top of the reaction and it turned out fine. It was also reported that they thought it was interesting that this patient had an allergy to sulfur and wondered if this may have had anything to do with the reactions. It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed cellulitis. Additional information has been requested.
Nausea, Fever, Chills, Headache, body aches, injection site tenderness
swelling, redness rt arm; minimal discomfort, myalgia, malaise, ?fever;
This spontaneous prospective pregnancy report as received from a 26 year old female consumer refers to herself. The patient had no pertinent medical history and no known drug reactions or allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL intramuscular (dose and frequency were not reported) (Lot # was not reported). On an unspecified date, the patient received the second dose of GARDASIL intramuscular (dose and frequency were not reported) (Lot # was not reported). There was no concomitant medication reported. On 21-APR-2014, the patient discovered she was pregnant (onset date was reported as 10-APR-2014). The patient's last menstrual period (LMP) and estimated delivery date (EDD) was not known. No adverse effect was reported. No lab diagnostic studies were performed. The patient's outcome of vaccine exposure during pregnancy was unknown. Additional information has been requested.
Information has been received from a pharmacist referring to a 78 year old female patient. Concurrent condition and medical history were not reported. On 13-AUG-2015 ("yesterday"), the patient was administered with a dose of expired ZOSTAVAX (lot # K000325, expiration date 27-FEB-2015 0.65 ml) subcutaneously on left arm. This is one of several reports received from the same reporter. Additional information has been requested.
Received a Menveo dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 12th October 2022, the patient received Menveo. On 12th October 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired Menveo vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Admit 3/2. Vaccine 1/15, 2/9. COVID+ 2/12, DCd to NH, returned for AMS, PNA. Treated w/abx, DCd back to NH.
Dizziness, cold, clammy and temperature fluctuations,  nausea, mild headache, fatigue
Mom says pt developed severe swelling in right leg, below the knee, extending to the hip. Sunday she noticed red blotches approx. 3" long and 3" in circumference.
Beginning 18 hours after injection: slight fever, extreme fatigue, extreme head pressure, burning eyes, mild full-body muscle aches, injection site swelling and severe pain. Symptoms lasted 24 hours.
Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body aches
pt devel redness, swelling of entire upper arm for 1wk p/vax;
her lips turned a blueish tint and were tingling; her lips turned a blueish tint and were tingling; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Pharmacist. A female patient (age:70, unit: not reported) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced her lips turned a blueish tint and were tingling. It was reported that a female patient around the age of 70 had her lips turned a blueish tint and were tingling, after the receipt of the first dose of the Pfizer-BioNTech COVID-19 vaccine. The reporter explained that the patient consulted with a doctor who prescribed Benadryl and her symptoms went away and further added that she was told not to receive the second dose of the vaccine. The reporter wanted to confirm if the lips turning blue was sufficient to warrant the contraindication to the second dose. The reported also asked if the patient should get the second dose of the vaccine if that was what happened. The patient received treatment for the events with Benadryl. The reporter assessed events as non serious. The outcome of the events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained
Low grade fever day 1 & 2 TDAP given. Face arms chest turn red approx 10 min after injection & itching began. Took approx 7 BENADRYL 25mg between 1400 & 2100. Continued itching, no redness following day with redness approx 4-5", hot at site of injection. 3rd day minor itching inj site hot & red approx 2".
2-3 days after the first injection, I developed a blood clot in my lower right leg.
4/5/21 Pfizer EW0150 3/15/21 Pfizer EN6207 Admitted to ICU with COVID 5/25/22. History of kidney transplant 2010.
Urinated throughout the night; This spontaneous case was reported by a consumer and describes the occurrence of NOCTURIA (Urinated throughout the night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NOCTURIA (Urinated throughout the night). At the time of the report, NOCTURIA (Urinated throughout the night) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. Patient stated that she had taken  some Ibuprofen couple of hours before the shot. Now, she is worried that action might affect the efficacy of the vaccine.   This case was linked to MOD-2021-254015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Added Reporter email id and updated Patient initials and Added anatomical route
Moderna COVID-19 vaccine EUA  Red, hard bump/knot raised , circle form , Warm to touch  Lasts about 3 days
FELT DIZZY POST FLU SHOT AND SAW FLASHING LIGHTS AND HAD A HEADACHE- WOKE UP NEXT DAY BLIND IN BOTH EYES- SAW OPTHAM. AND RETINA SPEC. - OCULAR MIGRAINE-DIAGNOSIS OF SARCOID AND POSTERIOR VITREOUS DETACHMENT WITH DAMAGE TO THE RETINA LEFT EYE-RIGHT EYE WAS SYMPATHETIC AND WAS BLIND FOR A COUPLE OF DAYS-LEFT EYE IS STARTING TO STABILIZE BUT VISION CHANGED TO 20/100 AND WAS 20/50 A YEAR AGO WHEN SEEN BY REGULAR VISIT-TREATMENT WILL BE RETINA SURGERY AFTER 6 MONTHS IF NOT HEALED OR STABILIZED.
This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and  palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.
Redness, itching, warm and painful (Pharmacist recommended Hydrocortisone cold pressure and Tylenol/Ibuprofen. 09-29-2020: Patient went to urgent cAre received Prescriptione for BActrim DS, Banophen and MethylPrednisone
REDNESS, SWELLING WARM TO TOUCH ADVIL AND BENADRYL CREAM
Pfizer-BioNTech COVID- 19 Vaccine: Vaccine recipient experienced near syncopal episode during the observation period. Vaccine recipient was monitored EMS for 30 minutes. They felt better and exited the site on their own.
PARENT LISTED BIRTHDAY AS 8/1/2012. VACCINES WERE BASED ON THIS BIRTHDAY. NO OTHER IMMUNIZATION RECORDS WERE AVAILABLE. ON 1/22/2014, WHEN REVIEWING RECORD, A SECOND BIRTH DATE WAS NOTED AS 2/1/2013. IT WAS THEN CONFIRMED THAT THE 2/1/2013 BIRTH DATE WAS CORRECT. VACCINES GIVEN ON 1/21/2014 WILL NEED TO BE REPEATED AFTER 2/1/2014.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot number unspecified). Other suspect therapies included KINRIX (dose, route and lot number unspecified). On an unknown date the patient experienced "hard, red, and hot" around the injection site of KINRIX. The outcome of the events was unknown. The relatedness of the events to PROQUAD (Merck) was unknown. The patient did office visit on an unspecified date for medical attention. Additional information has been requested.
Constant sore neck, left side. Body Aches, inability to focus and concentrate, lethargic and sleeping too much