chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix adult) (expiry date 30-JAN-2023) for prophylaxis.   In MAR-2023, the patient received Havrix adult. In MAR-2023, an unknown time after receiving Havrix adult, [the patient experienced expired vaccine used (Verbatim: expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-MAR-2023 Pharmacist reported that he/she just gave a vaccine and had not checked the expiration date, the expiration was 30th January 2023. Pharmacist asked does he/she need to have the patient redo the dose and if so, after how long of an interval. The reporter consented to follow up. The pharmacist gave a dose of Havrix adult vaccine which was already expired, which led to expired vaccine used.
This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Occasional Constipation), DIARRHOEA (Occasional Diarrhea) and PAIN IN EXTREMITY (Sore arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. Concurrent medical conditions included Crohn's disease (Moderate to severe adult crohn's disease). In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On an unknown date, the patient experienced CONSTIPATION (Occasional Constipation), DIARRHOEA (Occasional Diarrhea) and PAIN IN EXTREMITY (Sore arm). At the time of the report, CONSTIPATION (Occasional Constipation) and DIARRHOEA (Occasional Diarrhea) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Patient had no known allergies. No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SORE ARM was not provided. The reporter's causality for the event(s) of OCCASIONAL CONSTIPATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of OCCASIONAL DIARRHEA with HUMIRA(ADALIMUMAB) was a reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Have had unusual eyelid and eye inflammation for previous couple months, but on April 21, 2022 I experienced large eye floaters and lightening flashes especially in the right eye.  Eyesight was compromised. I had grittiness in eyes that my Refresh Classic eye drops could not control.  This persists, although not as bad now. Had sensitivity to light and sleepiness due to grittiness. This persists also, although not as bad now.
Itching, burning rash on hands, stomach, and back. As of 01/15/2013, rash has not cleared up. Still experiencing tenderness in armpits, bruising on arms and legs, and joint pain.
At 11:40am on 5-2-21, patient went into anaphylaxis approximately 10 minutes after receiving vaccine. Patient's breathing was labored and patient indicated that her throat was constricted.  0.3mg of epinephrine was administered IM via EpiPen into left thigh at 11:45am.  Patient breathing improved, began coughing and deep breathing noted. HR stable at 55 BPM: BP machine was registering BP at >200/100 but machine constricted her arm so numbers were unclear.  Patient remained conscious and responded to verbal commands until EMS arrived and took over care at approximately at 11:50am. EMS ordered another dose of epinephrine at approximately 12:05pm. Albuterol administered at 11:50am. Pt transported to  Clinic in Hospital via EMS
Vaccine was given after it was reported to be non viable due to temperature drop in refrigerator.
A bruise covering most of her left arm; Pain at injection site; This is a spontaneous case, reported by pharmacist to Company (reference number: SEQ19-06756) and initially received on 18-Nov-2019, concerning an 80-year-old female patient.   The patient's relevant medical history was not reported.   The patient's concomitant medications were not reported.  On 15-Nov-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100107887 and expiration date: 20-Jun-2020] for influenza prophylaxis.  On an unspecified day in Nov-2019, the patient developed a bruise covering most of her left arm and pain at injection site.  Outcome for the events of vaccination site pain and bruising of arm was not reported.  The reporter did not provide causality or seriousness assessment.  Company Comment: The patient experienced contusion and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced contusion and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Had burning at time of injection. Next day arm was red & swollen, hot, 1/16 spot extended to forearm & hands, swollen, pain in arm, 1/17, arm better, was in hospital telemetry with few PVS.
24 hours after shot patient began experiencing chest pain, worse with leaning forward. Being evaluated for pericarditis. Treating w NSAIDs. Echo and labs pending.
A pharmacist reported that a pt received an injection of Prevnar and subsequently, developed dry, patchy, red, scaly skin. No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
75 y.o. male who was admitted with covid pna. He was started on steroids supplemental oxygen as well as monoclonal antibodies. He was out of the window for remdesivir. He had a mild AKI which Improved. His oxygen slowly improved however he was much weaker overall and physical therapy recommended rehab at discharge. He was discharged to rehab in stable condition
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1:18:50 hours. The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Tachycardia that was self resolving after 36 hours, swollen lymph node in the armpit (onset ~40 hours after dose) and ongoing
Severe headache, stabbing pain that traveled around my body, fatigue, muscle aches, lymph nodes under both arms swollen to size of baseballs and painful.  Lymph nodes were back to normal by 8/23/21.  Other symptoms resolved on 8/22/21 with the exception of the stabbing pain in my left trapezius neck muscle.  That continues.
This spontaneous report was received from a quality coordinator who reported that an unspecified number of patients were administered an unspecified number of PNEUMOVAX23, from 24-SEP-2013 to 31-OCT-2013, that were exposed to temperatures as high as 55F to 126 hours and 55 minutes and as low as 29F for 188 hours which was not supported. No adverse events were reported. This is one of several reports from the same reporting source. Additional information has been requested.
18 hrs after receiving the new COVID 19 booster I went to ER for chest pain radiating to my neck and down my back that started about 8 hrs after receiving the shot. Blood test revealed abnormally high NT-ProBNP levels. Other symptoms that continued beyond resolve of the chest pain (24 hrs) & are described as severe/worst in personal experience with no decrease or relief of pain appreciated with opioid use are: neck stiffness, headache, full body muscle pain and stiffness, continuous shivering, excessive and continuous sweating, unquenchable thirst, uncontrollable and unintended sedation for 12 hours with severe intermittently breif periods of coherence (5-10min), bilateral swelling of breast tissue (lymph), and injection site redness (2 inch diameter circle), swelling, pain and itching. The Full body muscle pain/stiffness was replaced with full body itching starting approx 36 hours after vaccination and continues (42hrs out)
Underage patient got 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 3545x, expiry date 31st August 2023) for prophylaxis.   On 11th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received first dose of Shingrix into the left arm. It was determined when the patient came back to the pharmacy on the day of reporting to receive her second Shingrix vaccine that she did not fall into the category of being immunocompromised and was underage.  The reporter attempted to contact the patient's health care professional and they would not provide any information due to Health Act.  The patient reported that her health care professional would give her the second dose of Shingrix.  The reporter consented to follow up. Additional Supportive Information: The underage patient received a dose of Shingrix, which led to inappropriate age at vaccine administration.
One month after 2nd vaccine I experienced extreme lower abdominal cramping and pain. This was accompanied by a fever for 2 days with chills. I am almost 60 years and have not had a menstrual cycle for over 5 years. It felt like my whole uterus and female parts had dropped into the lowest depths of my pelvic area. Pain radiated from hip to hip for over 5 days. I am a very healthy, fit woman and spending 3-5 days on the couch in lethargic pain is not normal. I thought it was a Flu bug until one month later on June 12th the exact same thing thing  occurred...I mean exactly as described above, only one month later.  I can't wait to see what happens in July...hopefully nothing...fingers crossed!!
Pt. came in to pick up her medications today (7/3/23) and informed me that MD had diagnosed her with Guillain-Barre Syndrome after hospital admission 2 weeks from vaccination (3/7/23).
This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Got the shot got shingles twice; Got shingles twice; Still has pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got the shot and then had shingles twice. The patient was still in pain at the time of reporting. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Patient stated that she experienced nausea, vomitting, itching on arms, legs, and back, as well as dizziness after receiving shot.  She reported this 10 days after vaccination.  Additionally, patient said that her arm has hurt for an entire year since she got her last vaccine
This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 27-JUN-2014 at 13:11pm (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 deg (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 deg (units were not reported). Additional information is not expected due to all follow ups requested to complete the case was received.
Adult dose of 50 units was given to 13 year old patient instead of the ped/adolescent dose of 25 units.
Received flu shot ~ 230pm 10/24/19, first flu shot in lifetime. Was fine until ~ 840pm - felt tense/anxious, took 1/2 Xanax went to sleep. Awoke 1am nauseous, itching, w/hives, then felt throat swelling. Took own epi pen & called 911. Was seen in ER, given IV Benadryl & steroids. Sent home on oral steroidsx5 days. No further issues. Had scheduled w/allergist.
Information has been received from a physician concerning a female attended the same church who completed the GARDASIL injection series and developed ulcerative colitis.  It was unknown if the patient had sought medical attention.  At the time of report the patient's status was unknown.  The girl was not a patient of the physician.  Additional information has been requested.
10-11" raised red circle which traveled around arm into axillary area and down almost to elbow on her R arm.
On 26JUN91 the pt woke up w/swollen hands & pain in both knees & rt ankle; On 28JUN91 seen by MD;
Patient received PNEUMOVAX 23 in right deltoid. Arm started swelling and painful and red few hours after receiving the injection.
Given 1st dose of Pfizer-hx of allergic reaction/anaphalaxis to flu vaccine 6-7 yrs prior. Covid Vaccine ok'd by PCP. after 15 min of observation (being observed for 30) face became extremely flushed, given water, no difficulty breathing, no SOB. Rash contained to face, slight pink area to chest wall that subsided. given 50mg of Benadryl po-observed x 30 more, symptoms lessened, no new sx's.
Hives and rashes throughout body - 5 days - took Benadryl ?contacted  doctor was told to wait it out
No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from an other health professional and refers to an 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1st dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in right deltoid for prophylaxis (strength and route of administration were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
HAD THE SIDE EFFECTS OF THE VACCINATION SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported,  batch number: unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The  company is unable to perform follow-up to request batch/ lot numbers. No concomitant medications were reported. On 2021, the subject had the side effects of the vaccination shot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from had the side effects of the vaccination shot. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Moderna  vaccine  ( NDC  80777-0273-98 )  lot #  039D21A  + GTiN  00380777273983 was  administered  after the beyond date of 10/23/2021 .  Contacted  Manufacturer Moderna = no need  to repeat the dose  .
Information has been received from a physician's assistant concerning an 18 year old female with obesity and no other pertinent medical history or drug allergies who on 04-MAY-1998 was vaccinated with the first 0.5ml IM dose of Recombivax HB (lot# "2515A2") The patient was also vaccinated with second and third 0.5ml IM doses of Recombivax HB (lot# "2559A2", "2797A2") (dates unknown). There was no concomitant medication. Subsequently after completely the vaccination series, the patient's labs revealed a non-reactive hepatitis b surface antigen test. Unspecified medical attention was sought. The patient's present status was unknown. There was no product quality complaint. Additional information has been requested.
No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report was received from a Vaccine Coordinator, referring to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.    It was reported that between 03 3-OCT-2019 and 28-OCT-2019, the patients might have inadvertently administered with an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot# S000961 had been verified to be valid lot number; expiration date 19-OCT-2020).  The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours, and not had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This case was determined as non-valid due to lack of patients identifiers.  Follow up information was received from Vaccine Coordinator on 27-APR-2020: This spontaneous report refers to a 6 month old male patient. On 09-OCT-2019 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ).   This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA008135: US-009507513-2004USA008139: US-009507513-2004USA008136: US-009507513-2004USA008137: US-009507513-2004USA008138:
The individual is 17 years and 2 months old. The report is made as it was given to an individual out of the date range for the EUA for Moderna. There were no adverse medical signs, symptoms or outcomes. She was advised by her Public Health to be vaccinated as she is a care worker and vaccinating workers as priority. She had been bulk uploaded into VAMS and Our clinic did not catch her age when she came for first dose. I have spoke with her Mother and explained the events and the information provided me from Moderna after notifying the vaccine producer. Mother has no issues at this time. We discussed the option for completion  of the Vaccination with a second dose at lenght. Mother indicated she would come for her second dose as scheduled and I agreed our clinic would administer.
Patient experienced local swelling extending from right deltoid injection side to her neck with localized bruising. Fever spiked last night to 100.6 F with vomiting. Patient had been applying ice packs to injection site and swelling has gone down along with fever and pain. Patient reported pain still persists making it difficult to use her right arm still, however it is better than yesterday.  Patient called clinic back on 1/3/20 to report steady dull ache continues with difficulty using right arm.
Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine moved to fridge on administration date. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error. No Concomitant medication information was reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Added Patient demographics, Lot number, date of administration and Added dose number.
Two events. First in March 2021 and Second Sept 2023 my Triglycerides rose to dangerously high levels in the days after receiving the Covid 19 vaccine. I have received 4 Covid shot and had blood labs taking soon after administration on two occasions. In 2021, my Triglyceride level was measured at 1000 and most recently my level was measured at 890. Back in 2021 my levels went back to normal (~200) within two or three months.