chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 15th June 2022, the patient received Havrix. On 15th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist reported that expired dose of Havrix administered. The reporter consented to follow up. Additional Supportive Information: The patient received expired havrix which led to expired vaccine used. The case has been linked with case US2022093621 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093621:Same reporter
Redness, warm to touch, edema, soreness dx with localized reaction. Treatment Ibuprofen 600 mg TID x 7 days, ice pack.
Sore arm - muscle ache for 3 days,  redness,  swelling,  red rash at site - started on day 2, worsened day 3, fading but not decreasing in size day 4, nausea,  tiredness,   swelling,  headache,  shivering,   upper left arm tender to the touch
Cold chill, 102 temp, night sweats. During the following day large rash going down from needle point to bicep approximately 3"x5" and very tender. Cold sweats the following night and rash larger and tender.
Friday early morning woke up with a 101.1 fever. Took ibuprofen for it also had headache and nauseous. Every muscle bone and joint just hurt. Throughout thr day fever just kept getting higher, up to 103. Along with by 4 pm walking felt like a chore and the pain was so bad could barely walk without crying. Kept on taking ibuprofen. By Saturday morning fever finally broke woke up sweating at 3 am then again at 9 am. Now just feeling really exhausted, headache and a little sore. A lot better.
Patient had tonic movements of extremities approximately two minutes after immunizations were given. Oxygen saturation was 99-100%, P92-97. 911 called and ambulance transported to ER.
Facial itching and belly itching 25 mg of benadryl given by EMS
Developed a severe food allergy to green peas, chick peas and lentils.  He was eating a cereal that morning made of chickpeas and lentils and also had a pouch containing green peas shortly before being vaccinated, with the wrong vaccines (two hibs and a polio 3 years early).
Began experiencing symptoms of COVID-19 on 7/16/2022 - tightness in chest and scratchy throat. I had a positive COVID-19 antigen test (at home) on 7/17/2022. I experienced cough, body aches, headache, ear pain, runny nose and congestion; in addition to symptoms I experience with what is believed to be reoccurring viral myositis (muscle pain, muscle weakness, swelling, fatigue, shortness of breath, and rapid heart rate). I also had discharge from my eyes. The continuation of symptoms and worsening of some symptoms prompted me to seek care at a local Urgent Care on 7/23/2022. I was diagnosed with an eye infection and an ear infection. Treatment included Ciprofloxacin 0.3% eye drop and Amoxicillin-Clav 875-125 mg tab. I also received an order for a chest X-ray given my cough and two previous occurrences of pneumonia. I got the chest X-ray at the Hospital on 7/24/2022, which did not indicate signs of pneumonia.
On day 9 p/1st vax devel temp of 105.8 & sz x 2 at home one in ER;
glands in my neck swelled up; rash with blisters; pneumonia and  flu shot in my right arm; both arms were sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and PNEUMONIA SHOT for prophylaxis.   On an unknown date, the patient received Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA SHOT. On an unknown date, 1 day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm, swollen glands, blistery rash and labeled drug-drug interaction medication error. The patient was treated with hydrogen peroxide and neosporin (nos) (Neosporin). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swollen glands and labeled drug-drug interaction medication error were unknown and the outcome of the blistery rash was recovering/resolving.   It was unknown if the reporter considered the pain in arm, swollen glands and blistery rash to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. The patient received dose of Shingrix in the left arm and dose of Pneumonia and flu shot in the right arm. Next day after vaccination, the patient's both arms were sore but the next day were back to normal. About a week later the glands in the neck swollen and developed a rash with blisters on the right side of the neck. As the patient received Pneumonia and Flu vaccine on the right arm, which led to labeled drug-drug interaction medication error. The patient received hydrogen peroxide and neosporin as a treatment medication. The reporter stated that, the blisters have gone down and the rash was getting better. The patient asked if this reaction to or a side effect from the shingles shot and If so, was this treatment appropriate or should some other action be taken.
DTPA reaction, left upperarm, unable to move shoulder.  warm, swelling.  Treated with Keflex, possibly Cellulitis.
patient received an IPOL dose that expired two days ago (13-Mar-2021)/no AE; Initial information was received on 15-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was vaccinated with expired dose of IPV (VERO) [IPOL] (batch number R1B251M and expiry date 15-Mar-2021) via an unknown route at an unknown administration site on 15-Mar-2021 for prophylactic vaccination (expired product administered).  Caller wanted to know if the patient should be re-vaccinated.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was a case of a actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.   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.
Shingles; This is a spontaneous report from contactable consumer, the patient. A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6204), via an unspecified route of administration in the left arm on 10Mar2021 at 10:30 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included acid reflux, mild fibromyalgia. The patient was known allergic to latex. The patient previously took one shot shingles vaccine a couple of years ago. Concomitant medications included generic protonix (Pantoprazole Sodium) and generic Elavil (Amitriptyline Hydrochloride). 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 vaccine within four weeks prior to the vaccination. On 15Mar2021, the patient noticed shingles outbreak. The patient was diagnosed with Shingles on 17Mar2021. The clinical outcome of shingles was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After 2nd dose of rotashield, the pt experienced severe gassiness. The pt only gained 12 oz from his 4 month to his 6 month checkup. He cried all day, every day for 2 months straight from the day following the 2nd dose.
Around 11 pm I started to shake uncontrollably.  My calves and feet would cramp if I moved the slightest. I was unable to walk on my own. My feet would not work and I was very dizzy. In the bathroom I felt like I was going to either throw up, pass out or have diahreah. I layed on the bathroom floor until I was able to get up with my husbands help. At this point my temperature was 100.8. I was sick all the next day but was able to walk to the bathroom unaasisted. Although my lower legs and feet still hurt. With having CMT, it felt like nerve pain.  I only took my temperature 3 times and the highest was 102.5. I took tylenol and one dose of ibuprofen. The second day, no fever and felt about 90% better.
My wife and daughter had fevers, chills and whole body aches the evening after their vaccine.  I had no symptoms until 5 1/2 days later, fever, chills, whole body aches.  I thought I should have had this side effect much sooner and wondered about a mild case of Covid despite the vaccine.
soreness of the arm; very sore armpit on the same side; very swollen lymph node on their neck near the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone). At the time of the report, PAIN IN EXTREMITY (soreness of the arm), AXILLARY PAIN (very sore armpit on the same side) and LYMPHADENOPATHY (very swollen lymph node on their neck near the collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
A legal complaint was received from an attorney concerning a male child who reportedly received HibTiter, Acel-Imune, Tripedia, Engerix B and Recombivax HB vaccines during the time frame from 1998 through 1999. The legal complaint states, "as a result of the mercury in the thimerosal-containing vaccinations," the child "suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning, including but not limited to autism." Mercury poisoning and autism were considered medically important (OMIC).
Patient was given Moderna as 1st dose for COVID vaccine on 1/4/21 and for 2nd dose was given Pfizer Biontech COvid Vaccine on 2/2/21.  Was observed for 30 minutes after realizing 2nd dose was Pfizer
Red rash and swelling medial and distal slightly to injection site. noted symptoms one week after injection of vaccine
About 2.5 weeks after I received the second dose of the COVID-19 vaccine, I developed a condition called Pelvic Floor Dysfunction/Chronic Pelvic Pain Syndrome.
his left arm is swollen. above elbow to shoulder; tight, hot to touch and red; tight, hot to touch and red; tight, hot to touch and red; big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red), SKIN TIGHTNESS (tight, hot to touch and red) and RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No patient medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash). On an unknown date, the patient experienced PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red) and SKIN TIGHTNESS (tight, hot to touch and red). At the time of the report, PERIPHERAL SWELLING (his left arm is swollen. above elbow to shoulder), FEELING HOT (tight, hot to touch and red), ERYTHEMA (tight, hot to touch and red), SKIN TIGHTNESS (tight, hot to touch and red) and RASH (big rash above his wrist on left arm next to watch, 2 inch by 3 inch rash) outcome was unknown.        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.   The patient notes that they were advised by their health care provider to go to the emergency room and is scheduled to get an ultrasound.  No treatment medication information was provided by the reporter.
Syncope w/in 10 minutes of HPV #2 & Hep A #1. No rxn to HPV #1.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, lot # L023936, expiration date 15-MAR-2017 (dose and route of administration were not reported). The reporter was unable to confirm if the expired doses were administered after their expiration date. There was no adverse effect reported. Administered doses of VAQTA experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA010602: US-009507513-1707USA001093: US-009507513-1707USA001091:
Muscle aches (12 hours) resolved and then tiredness set in (24 hours)
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Vasovagal syncope after administration of vaccine. Patient collapsed as she was walking out of room and bumped her head. moved patient to nearest room sat patient and took vitals and blood sugar. patient was responsive and able to follow directions. pediatrician evaluated patient and advised to lay patient supine and administer oral glutose and hydrate patient. patient A & O x 3. Dr. re-evaluated patient and advised parent to bring patient back to clinic if she noted any changes.
Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  On 22 Oct 2021 vial was initially stored in the refrigerator.   This case was linked to MOD21-156586,MOD21-156570,MOD21-156562, MOD21-156556, MOD21-156443 ,MOD21-156523, MOD21-156524, MOD2 (Patient Link).
Mom stated the patient woke with swelling to his right leg and rash. He did also run a fever. Said she treated him with TYLENOL and BENADRYL. Rash and swelling are gone.
A 73 year old male experienced polymyalgia rheumatica, which resulted in persistent or significant disability or incapacity, 5 days after receiving the Fluvirin vaccine on 05-OCT-2001. He was treated with oral steroids. The pt had not recovered at the time of reporting. There was insufficient information to determine the reporter's causality assessment.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
February 11, 2021: This patient called to obtain guidance regarding post-COVID-19 vaccination side effects. The patient received the first dose of COVID-19 vaccine on Feb. 3, and noticed soreness of the arm at the vaccination site. On Feb. 10 (evening), a hard lump with redness the size of a tennis ball in diameter was observed, and the area was ?itchy?. The side effects have continued, and patient called for further direction. Patient advised to call primary healthcare provider to report the side effects and question if an evaluation and, or treatment is recommended. Patient to call physician?s office. Patient recalled a similar reaction (side effects) following a vaccination years prior to date, but was unable to recall the type of vaccine (thought may have been a flu shot). The patient has continued to receive influenza vaccinations annually without these side effects.  February 12, 2021: TC to the patient to obtain clinical and healthcare provider follow-up information. Patient reported she had an office visit with Dr.  CCF this morning. The MD wasn?t sure if the reaction was related to the vaccination, or an infection. Cephalexin (antibiotic) prescribed x 5 days. The side effects reported yesterday remain present with slight improvement. The patient has not experienced an elevated temperature, or any new side effects.
Within 5 minutes felt tingling on my mouth, and after 15 min I felt tight everywhere. My BP was really high for me 170 ( I usually run 120 very elevated for me). They took me to the ER, sometimes I would feel better, sometimes it would come back,. My throat had spasms, it would feel tightened and then it would be better. They checked me and no anaphylactic shock. All my vitals except my BP were normal. My heart was not beating fast but I had a sense of tightness. 24 hrs later I had just the typical muscle aches, extra tired, like I was going to feel sick, and then a horrible taste in my mouth set in,  I could not get rid of it. I still taste it but it is not as intense. It was very intense for about a week. The muscle aches and things like that (my arm hurt for about 3 days), nothing swelling or itching. I had a COVID test and it was negative. I continued to monitor my BP and  Sunday and Monday I finally got it under 130 and could feel the release of pressure in my body.
Information has been received from a health  professional concerning a 10 year old white male with no known medical Hx or allergies who on 11/05/1997 was vaccinated SQ with a first dose of varicella virus vaccine live . On 02/22/2005 the pt developed  a fever, vomiting, lesions and less than 50 scattered putstules. Subsequently, on 02/28/2005 the pt recovered.
cold sxs 1wk p/shot followed by joint pain 2-2 1/2 wks p/shot; joint pain started in lt foot has progressed to both feet, knees, wrists, hands & elbows;dx rheumatoid arthritis