chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Double dose of Moderna's COVID-19 vaccine (1ml) in error; A spontaneous report report was received from a nurse concerning a 60-year-old female patient, who received double dose (1ml) of Moderna's COVID-19 vaccine in error.  The patient's medical history and relevant concomitant medications were not reported.   On 06-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   Nurse reported that, she had double dosed patient in error. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event double dose (1ml) of Moderna's COVID-19 vaccine in error was not reported.   The outcome of the event double dose (1ml) of Moderna's COVID-19 vaccine in error was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (lot number 025L20A), where incorrect dose (1 ml) was administered to a 60-year-old, female patient. There were no reported AEs associated with this case of Product administration error.
Urticaria, dyspnea, pallor, approximately 15 minutes, post vax. Treated with epinephrine, IM, and Atarax, albuterol and Solu-Medrol in ER all in right deltoid. Follow-up with allergist is recommended.
Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150 and expiration date not provided) via an unspecified route of administration, administered in the left arm on 03Apr2021 11:30 as a single dose for COVID-19 immunization. Medical history included high blood pressure and allergies to Penicillin. Concomitant medication included amlodipine besilate (NORVASC). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. The patient had blood in stool 14 days after first COVID shot on 17Apr2021 10:30. No treatment was given in response to the event. The patient has not been tested for COVID post vaccination. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
pt recv vax 18APR95; sx started 12hr later-edema/redness @ inj of JE site; nausea &  vomiting 12 hr later w/diarrhea & low grade temp, lasting 48-72hr;
I experienced hip joint and leg pain on my left side at night typically commencing three hours into sleep cycle.  In the first week after the vaccine, the pain was quite sharp and severe in my left hip.  Over time the pain spread further down my leg and was a searing ache.  I did not experience leg or joint pain when awake and up and around.  About four days I awoke having what seemed like one of my sleep cycle panic attacks with the exception that I did not experience mental panic, only very rapid heart beat and high blood pressure and arm tingling.  I took alprazolam as prescribed by my physician.  The symptoms were very slow to abate.  I was concerned I was having a stroke or heart attack but decided it was just a panic attack.  By week four following my first vaccine the leg pain had lessened.  After the second vaccine, the entire scenario above reoccured including  hip and leg pain on my left side.  The pain in my joint was not as sharp but it is severe enough to wake me up.  It occurs at about 3:30 am at night and lasts 2-3 hours.  I had a second panic attack with the same description of symptoms (severe rapid heart beat (153) high blood pressure (can provide exact measure - I recall the upper number was 165 and I typically have normal blood pressure).  Took alpralozam and the cardiac synptoms were slow to abate and in fact resurged even after medication.  I continue to have left-side hip and knee join pain and leg pain in my sleep to this day on the same very regular, predictable schedule and the pain continues to be enough to wake me up and make me very uncomfortable, thereby disrupting my sleep every night.  I have had no further "panic" attacks.  At this time, my left side joint and leg pain is somewhat noticeable during the day but I do not have mobility issues.  Am able to walk, exercise etc. normally.
Fatigue, headache, injection site redness and swelling, malaise, muscle pain and injection site pain.
Patient presented to Emergency Dept 6 hours after vaccination, stating she had flushing, nausea, palpitations, fatigue and was sweaty.  She was treated for nausea attributed to a reaction to the COVID vaccine and discharged home.
One week after receiving the first COVID vaccine, I went and got my weekly allergy shot at my allergy clinic.  I did not have an adverse reaction (no swelling, redness) at the allergy injection site in my right arm; however, the place where I received my COVID vaccine (in my left arm) became swollen, warm,  and itched.
Patient's mother reports that since patient has received her series of the Covid vaccine she's had 3 syncope episodes with unknown cause.  Currently, cardiac monitoring is being conducted.  Labs have been normal.
Had normal immune reaction symptoms going to sleep, work up at about 12:30 and went downstairs to get water. Felt very weak and was walking out of kitchen when I felt extremely nauseous for about 10 seconds then started to stumble and dropped my water as I fell. Got back up and tried getting more water and then I fully fainted and woke up slightly confused on the floor.  Felt slightly better after and called my PCP?s on call doctor who told me I did not need to go to the ER. Woke up with body aches/mild fever still and a headache from hitting my head
Fever to 102 degrees with medication; severe all-over body pain, severe migraine, vomiting/nausea, sore/swollen arm at site of vaccination.
Left knee hurting when arrived, voice coarse - had gone to party over weekend for 5 yo. Reported lightheadedness, palpitations, and feeling warm after vaccination. Denies chest pain, arm pain, difficulty breathing, nausea, and other s/sx. Recommended 911, ED, EMS, ambulance, client declined. 11:14 client was wearing face shield and mask, removed face shield and mask, s/sx of warm and lightheaded improved. 11:30am RUE 160/98 P72 R16. 11:30am applied O2 palpitations improved. 11:40am off O2 lightheadedness, warm, and palpitations resolved. 11:55am 136/90 P92 R16, reports warm, lightheadedness, palpitations, all s/sx resolved. Counseled follow up with her provider call today & call 911 for any return s/sx, verbalized
Narrative:  Patient reported chest tightness following 2nd dose of pfizer covid vaccine. Patient also stated they had localized swelling following 1st covid vaccine. Patient was observed without improvement and local ambulance service was called. The patient was evaluated and released without further intervention. Unclear if patient had allergic reaction or panic attack/anxiety.
No additional AE; Improperly Stored ROTATEQ was administered to patient; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 06-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form, orally, lot number 1691133 and expiration date 28-NOV-2021 for prophylaxis. No additional adverse events were reported.  The vaccine underwent a temperature excursion of 35.2 degrees Fahrenheit (°F) for 45 minutes (occurred at 1:30 am). There were no previous temperature excursions. The call was due to digital data logger.  This is one of 2 cases reported by the same nurse; Sender's Comments:  US-009507513-2101USA003974:
Pulsatile tinnitus and general tinnitus - developing in April 2021, continuing and worsening in the months afterward.
Narrative: COVID infection following COVID vaccine series 03/10, Pfizer, dose #1 03/31, Pfizer, dose #2 09/03 pt cc: chills, cough, diarrhea, fatigue, headache, myalgias, rhinorrhea exposure: unknown 09/07 COVID swab, result: detected 09/07 SARS-COV-2 Variant Sequencing result: pending
Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision (resolved)-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
The first one made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR018248   Additional Information: GSK receipt date: 03-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot of shingles vaccine. After the first shot, the patient was sick. The consumer reported skip the shot. The reporter think that the event might have been related to the product/device. Additional Supportive Information: The follow up would not possible, as no contact, details were available. For tolerance of 2nd dose refer case US2023AMR018248.; Sender's Comments:  US-GSK-US2023AMR018248:Same reporter.
Allergic reaction w/severe localized reaction, edema, induration and warmth present right deltoid. Prednisone 10 mg dose pack Rx given.
Systemic reaction. Injection site on arm swollen to 12cm, red,hot, hard, very painful, fever, body/joint aches, breathing challenges, fatigue and weakness.
This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received BEXSERO (batch number 154101, expiry date 31st May 2017). On 18th August 2016, the patient received BEXSERO .5 ml. In August 2016, less than a week after receiving BEXSERO, the patient experienced tiredness. On 18th August 2016, the patient experienced injection site lump, fever, feeling unwell, feeling hot and injection site swelling. In August 2016, the outcome of the injection site lump and injection site swelling were recovered/resolved. On 20th August 2016, the outcome of the fever, feeling unwell and feeling hot were recovered/resolved. On an unknown date, the outcome of the tiredness was unknown. the reporter considered the injection site lump, fever, feeling unwell, feeling hot, injection site swelling and tiredness to be almost certainly related to BEXSERO. Additional details were provided as follows: the patient received BEXSERO vaccine in the right deltoid. the patient experienced multiple symptoms which included swelling at injection site, hot to touch, fever (103.5 degrees F), malaise and was just not feeling well. On 19th August 2016, the patient went to the emergency room experiencing the same symptoms from the day before. On 20th August 2016, the patient went to the physician's office with swelling at injection site, but fever had gone away and overall he was feeling better. On 23rd August 2016, the patient's mom stated that the patient felt tires, but all symptoms had gone away. the healthcare professional had pictures documented if the safety department wanted to see those.
Erythematous, multiple papular lesions on both ant-lat thighs with small bruise on injection sites. Adv. local ice, HC cream 1%.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756527A, A0756529A - A0756526A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Bubbly hematoma at injection site; Blood blister at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site hematoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 23rd December 2022, 7 days after receiving Shingrix, the patient experienced injection site hematoma and injection site blisters. On an unknown date, the outcome of the injection site hematoma and injection site blisters were unknown.   It was unknown if the reporter considered the injection site hematoma and injection site blisters to be related to Shingrix.     Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment:  The patient was on oral chemotherapy received 1st dose of Shingrix and 7 days later developed a big bubbly hematoma almost like a blood blister at the injection site. On 23rd December 2022 the patient went to the physician's office with a hematoma that took up a large space in the upper arm which was not specified.  The reporter wants to know if patient should receive the 2nd Shingrix vaccine at 1 month or 2 months or even if the patient should receive the 2nd vaccine. The vaccine administration facility was the same as primary reporter. The physician provided their information to be contacted for follow-up.  The reporter consented to follow up.
Employee received the influenza vaccine on 10/18/99, in the afternoon at 15:30 and experienced a "sore arm and had a suspician of a "hot ache" at the site. She has experienced "some weakness when raising her arm in a perpendicular position. The achiness is worse at night but the arm doesn't bother her "all the time." She can lift children with no discomfort. The site remains sore to touch.
partial dose of the Pentacel was given with no reported adverse event; only received the liquid part, the DTaP-IPV, and they didn't mix it with the other part the Hib component with no reported adverse event; Initial information received on 12-Jan-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-month-old and 6-month-old of unknown gender patients who had partial dose of the Pentacel was given and only received the liquid part, the DTAP-IPV, and they didn't mix it with the other part the Hib component with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number; formulation; strength: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events "partial dose of the pentacel was given with no reported adverse event" (incorrect dose administered), "only received the liquid part, the dtap-ipv, and they didn't mix it with the other part the hib component with no reported adverse event" (product preparation issue) (unknown latency).  It was reported "caller states that the patients only received the liquid part, the DTaP-IPV, and they didn't mix it with the other part the Hib component. She would like to request two of the proper diluents, the 0.4% NaCl (Sodium chloride) saline solution. She would like to know if they can call the patient and have them come in to get the Hib component now or do they have to wait until they get the diluent."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event partial dose of the pentacel was given with no reported adverse event and for the event only received the liquid part, the dtap-ipv, and they didn't mix it with the other part the hib component with no reported 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 the guidelines. 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.; Sender's Comments:  US-SA-2022SA014669:
multiple instances of heart rate over 140 and a top heart rate of 155 hives - daily since injection psoriasis outbreak - first time in 4 years
No additional AE information provided.; Customer report that PROQUAD LOT U017137 expiration date 11/28/2022 was administered to a 4-year-old patient on 31-MAY-2022 after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 31-MAY-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot #: U017137, expiration date: 28-NOV-2022, administered subcutaneously at left leg (exact dose and strength was not provided) for prophylaxis. Temperature excursion information: due to loss of electrical power to freezer where vaccine was stored, temperature went out of suggested manufacturer range of -30 degree Celsius to -15 degree Celsius, with warmest reading of -3.6 degree Celsius for a duration of 40 minutes (reported also as: -14 degree Celsius up to -10 degree Celsius for 50 minutes; -10 degree Celsius up to 8 degree Celsius for 10 minutes). Temperature excursion occurred as a result of a reading from a digital data logger. The vaccine did not experience any prior temperature excursions. There was no additional adverse event reported  The event of improper storage of product in use was considered as an important medical event by a reporter.
on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey.  Due to the fact I have no chronic conditions, live a pretty healthy life, I was told by EMS and various ID doctors it was most likely from the vaccine.  Today is day 21 and I still have no movement in face
Severely swollen, hard and painful lymph nodes in the L axillary region. / other swollen glands; fever; muscle aches; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 12:00 at a single dose for Covid-19 immunisation. Medical history included Covid-19. Concomitant medication included sertraline hydrochloride (ZOLOFT). Prior to vaccination, patient was diagnosed with COVID-19. The patient received the vaccine at a workplace clinic and experienced severely swollen, hard and painful lymph nodes in the L axillary region, other swollen glands; fever; muscle aches; chills; and headache, all on 18Dec2020 12:00. It was unknown if patient received treatment for the events. The events were reported as non-serious. Outcome of the events was not recovered.    No follow-up activities are needed. No further information is expected.
Within 24 hrs of being given MMR pt developed erythema multiforme requiring treatment with oral.
She said her arm been hurting and haven't been able to move it.  She said she got an MRI today and the MRI says it there is damaged do to the vaccine going too deep.
Information has been received from a 71 year old female consumer with high blood pressure and high cholesterol and with no allergies who on 30-APR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported) in the left arm. Concomitant therapy included LIPITOR and unspecified "blood pressure medication". On 03-MAY-2012, three days later, the patient experienced bright red oval at the injection site of the left arm and "intense itch" at the site, but no rash. The consumer stated that she would call follow up with her doctor on the day of the report. At the time of reporting the consumer did not recovered. Follow up information was received from a physician refers to the 71 years old female patient with no adverse events following prior vaccinations who on 30-APR-2012, at 10:09 a.m. was vaccinated with the first dose of ZOSTAVAX subcutaneously in her left arm (lot # 672563/1649AA, Exp. Date: 21-JAN-2013) at private doctor's office/hospital. It was reported that on -07-MAY-2012 at 09:06 a.m. (previously reported as 03-MAY-2012) the patient experienced intense itch at injection site-red oval on left arm. No relevant tests and laboratory data were performed. No illness at time of vaccination. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Very sore arm which limits range of motion and sleep.  A pretty bad headache that lessened with tylonol. Fatigue. Low grade fever (99.4). Basically not feeling great. First 2 doses did not have these side effects.
General itching over body with extreme itching of the scalp. Took Claritin and Benadryl to no avail. Prednisone alleviated symptoms a little. Used a steroidal skin cream and natural remedies the following day for final relief. Reported symptoms to doctor over telephone.
3 hours after injection patient had tremendous amount of GI GAS, very odd oder (smell).  Buildup of gas came suddenly and was unstoppable.   Patient feels better after release of gas and cleanup of bowel movement.
The next day, the patient developed a headache and stiff neck. She was seen the following day in the office due to symptoms as well as new onset of rash. This was felt to probably be viral but we opted to see her again the next day to monitor. By day 3, the rash developed further and is clearly an erythema multiforme minor. Her other symptoms are now improving.
This case was reported by a healthcare professional and described the occurrence of nausea in a 21-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Typhoid vaccine (manufacturer unspecified) given on 21 January 2011. On 21 January 2010 the subject received 1st dose of HAVRIX at 1.0 ml in the right arm. On 23 January 2010, 2 days after vaccination with HAVRIX (approximately 36 hours after dose), the subject experienced nausea and vomiting. The events lasted for 36 hours and then resolved.