chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syringe malfunctioned; Incomplete dose; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SYRINGE ISSUE (Syringe malfunctioned), INCORRECT DOSE ADMINISTERED (Incomplete dose) and VACCINATION SITE PAIN (Soreness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SYRINGE ISSUE (Syringe malfunctioned), INCORRECT DOSE ADMINISTERED (Incomplete dose) and VACCINATION SITE PAIN (Soreness). On 04-Mar-2021, SYRINGE ISSUE (Syringe malfunctioned) and INCORRECT DOSE ADMINISTERED (Incomplete dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to event was not provided.   Follow-up received on 31-MAr-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: NNI; Reporter's Comments: This report refers to a case of a 66-year-old, male patient who experienced syringe malfunctioned (Syringe issue and he received an incomplete dose (Incomplete dose administered) for mRNA-1273 (Lot number: unknown). The patient experienced soreness which is consistent with the known safety profile of the vaccine.  The events of syringe issue and incomplete dose administered are considered not applicable
Local reaction (erythema and induration 1 1/2" in diameter causing pain and difficulty walking) on left thigh. Treated with acetaminophen initially followed by Ibuprophen after calling LHD.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; DOSE 5 (BOOSTER); DOSE 5 (BOOSTER); DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 18:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 18:00, outcome "unknown", described as "DOSE 1,2,3 and 4 as Unknown manufacturer and DOSE 5 (BOOSTER) BNT162b2"; OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 09Sep2022 at 18:00, outcome "unknown" and all described as "DOSE 5 (BOOSTER)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 5 days after testing negative; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as no. Patient started the Paxlovid from 16Sep2022 and stopped on 21Sep2022 for the treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
extremely suck after the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (extremely suck after the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (extremely suck after the booster). At the time of the report, VACCINATION COMPLICATION (extremely suck after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
How long after first shot if they forgot get second shot is it still ok to get Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on unknown date received 1st dose).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: How long after first shot if they forgot get second shot is it still ok to get Shingrix).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-SEP-2023 The sales representative submitted the following via database for a physician:  The reporter asked how long after 1st shot if they forgot to received 2nd shot was it still ok to got the Shingrix  The patient forgot to receive the 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
On 08/17/2021, I had to pee a lot and a weird sensation when I peed. Because I never had a UTI in my life, I did not know what it was, so I started taking over the counter Azo- 2 caplets per day and D-Mannose 1000 mg bd and drinking cranberry juice.  After talking to my boss she said because I had it over a week I should see a doctor.  08/24/2021- I went to Urgent Care- they ran a urinary test, did not find anything. The doctor asked if I had a fever, nausea, and I said no to both. But my back started to hurt. They to sent a culture test to the lab.  I went home and within an hour,  I had a fever, headache,  loss of appetites.  I slept on and off for 3 day and  couldn't eat.  I went back to the urgent care-08/27/2021-COVID -19- test- negative and the culture did show I had a urinary traction and they gave me antibiotics and sent me home. 08/27/2021-the 1st round- Nitrofurantoin mono/mac 100 mg 14 pills, 1 bd.   Those did not work so I returned for a different antibiotic for a second round.  09/13/2021 I went back and they  prescribed -cephalexin 500 mg 30 tablet 3 x day.
This case was reported by a sales representative and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, when the subject was 8 weeks of age, the subject received 1st dose of ROTARIX (oral). Less than one year after vaccination with ROTARIX, at 4 months of age, the subject experienced intussusception, vomiting, blood in stools and nausea. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.
No additional AE; PROQUAD administered post temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 21-AUG-2020, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S031881, expiration date 07-APR-2021) as prophylaxis, post temperature excursion (product storage error).  The vaccine underwent a temperature excursion between minus 9 degrees Celsius (C) to 8C (-2.8C) for 5 hours and 2 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001249: US-009507513-2009USA001227:
Missed to take Second dose of Covid-19 Vaccine exceeded 90 days; Sore arm with first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm with first dose) and PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm with first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days). At the time of the report, PAIN IN EXTREMITY (Sore arm with first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed to take Second dose of Covid-19 Vaccine exceeded 90 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
patient received vaccine @ 6pm. waited the 15 minutes and was walking to her car with mom. Mom notified RN that patient was c/o nausea, vomiting, tremors, phlegm build up in throat. Nursing staff evaluated patient and per protocol gave 50mg IM Benadryl. Patient unable to have PO due to vomiting. Patient was aox4, lungs clear. 911 was called at 627. Benadryl given at 629. pt tolerated IM Benadryl. 911 arrived at 632 and assessed the patient and transported to medical center for further evaluation
My arm or shoulder pain started where shot given only one day after which was April 2nd Friday morning (April 1st shot given). But only on Friday evening and  Saturday and may be Sunday I had chills. Today--April 6th is 5th day after shot was given. My shoulder pain is improving but still hurts. My husband who is a physician just wants to make sure that it is not cellulitis since it is still there but of course pain is subsiding very slowly. So hopefully it will completely go away within two or three days. I also had from Friday till Monday a red patch of rash on same arm underneath vaccine shot site. But that also went away but at times especially in the evening it shows up but disappears in the morning time. If arm pain does not completely go away I will visit my primary doctor to make sure no cellulitis is there.
Swollen lymph nodes in right arm (same as injection arm) going on for four days now.
Headache; tennis ball sized lump on her right arm at injection site; This is a spontaneous report from a contactable consumer (patient's mother). This report is 2 of 3.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration at right arm on 16Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included seizure which started when patient was of 18 months (they were so bad that caller had to learn how to do a tracheotomy and she had to learn triage). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) on an unspecified date for COVID-19 immunisation and experienced headache. The patient's mother reported that she experienced headache, a tennis ball sized lump on her right arm at injection site on 16Jun2021. The outcome of headache was not recovered and a tennis ball sized lump on her right arm at injection site was unknown.    Information on the lot/batch number has been requested.
I became sick the next afternoon with a low grade fever and cough. I have had body aches, a cough, congestion for a week. I have had no throat pain.
Patient experienced an episode of vertigo, sudden increase in blood pressure, and feeling anxious. Patient had similar episodes at prior vaccinations.
Received moderna COVID #2 early.   Patient was scheduled to return on 5/11.  however, presented to vaccination site on 5/1 and received dose #2.   checked with CDC, dose #2 is considered valid.
fever; Back ache; body tremors; nausea; moderate chills; A spontaneous report was received from a consumer concerning a 76 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced moderate chills,. nausea, body tremors, back ache and fever.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included certain unspecified diabetes and arthritis medications.    The patient received first of two planned dose of mRNA-1273 (Batch No-unknown) intramuscularly  in right arm on 22-JAN-2021  for prophylaxis of Covid 19 infection.  On 29-JAN-2021 ,the patient started to experience moderate chills, nausea, body tremors, and a back ache. The patient went to an urgent care clinic where she was told she had a fever. The patient was not tested for Covid. The treatment for the event include Tylenol and two injections(unknown by reporter).  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, moderate chills, nausea, body tremors, and a back ache and  fever were unknown/not provided by reporter.
Immediately started itching, and then developed tendonitis in the arm where the shot was given....she said exacerbated by flu shot.
This is second vaccine. Patient reported same symptoms: Around 36 hours after vaccination pt had same burning sensation in soles of feet and a little bit in palms. Told to go to urgent care if worse. Went away in 12 hrs.
pt recv 3 doses of vax w/no adverse event p/vax;8MAY96 pt drowned;parents wanted to donate pt organs, & pt hepatitis status was checked;lab eval on 8MAY96 or 9MAY96 revealed HBsAg positive & anti-HBc positive;
Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster).    No concomitant medication was reported.    The reporter stated that she has a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. No treatment information was reported.
Patient had MMR, Chicken Pox, and Hepatitis A on 1/17/12 at about 3:45 pm.  He received Tylenol at 4:15 pm and again at 8:30 pm.  He woke up once in the middle of the night around 1:30 am and I gave him Tylenol and some milk. He was feverish on 1/18/12 as usual after vaccines and we alternated giving him Tylenol and Ibuprofen regularly. On 1/18/12 at about 6:00 pm hives were evident on his lower body.  Each thigh had one enormous hive that spread from the knee to the hip covering the entire top of the thigh, with jagged edges, raised, red, darker red on the edges, and hot to the touch.  He had other hives on the back of his legs and butt as well.  His left eye was red and watering.  As the night went on the hives on his thighs got better but more hives developed on his lower legs.  His face was puffy, but there were no hives.  He was restless all night and feverish, sleeping for only 2 hours and then crying for 20-30 minutes followed by playing for 1-2 hours and then sleeping for 2 hours. By 1/19/12 the hives on his thighs were gone other than the outline of the largest ones.  I continued to give him Tylenol regularly because he was still feverish.  We went to the doctor at 10:30 am at which time all but three small mosquito bite sized hives on his left calf were gone.  The nurse practitioner stated that he had an adverse reaction to one of the shots, but that there was no way to determine which shot it was because all three shots that he received were new and because the reaction was the same on both legs where the shots were administered.  She stated that he was fine now and advised on the amount of Benadryl and Tylenol allowed at his current weight for reference.  After leaving the doctor's office by around 12pm one hive the size of a quarter developed on his right upper arm.  He ate lunch and then took a nap.  When he woke up from his nap at 3:45 pm both arms had developed large patches like he had on his thighs the previous day.  We administered 6mL of 12.5 strength Benadryl and once it set in the hives went away by approximately 6-6:30 pm.  He woke up at 1:30 am and drank a few ounces of milk and went back to sleep until the morning. 1/20/12 he seemed normal other than he was still somewhat feverish.  He woke up from a nap at 4:00 PM where hives were evident on his butt.  We gave him 6 mL of Benadryl and the hives went away within 2 hours.  He has been okay since.
hair loss; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 2021) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix. In March 2019, 3 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the left deltoid and after 3 to 4 days experienced hair loss. The patient's symptoms did not change when the reporter had last spoke with the patient a few weeks ago. As of the reporter knowledge, the patient has not sought medical attention for this event. The reporter was not able to provide expiration date due to an error in the pharmacy computer system, but the expiration year was either 2020 or 2021.
Pt was seen in OV on 4/29/2019 and received the Shingrix vaccine in her Right Deltoid. Pt went home and had soreness to her arm along with headache and the chills.  Pt woke up yesterday morning and noted to have a rash on her neck - front and back, abdomen - across breasts and on her abdomen both upper/lower. The rash looks similar to red splotchy areas with no itching or pain noted. Pt reports the rash is starting to fade today but she just wanted to notify the office. RN advised pt the triage note would be sent to the provider for further recommendations. Pt is asking if she should receive the 2 ND injection of the Shingrix. RN provide pt with home care instructions to include: - take a cool bath/shower, 1 cup of oatmeal in water and make paste and apply to the areas of itching  - avoid scratching  - apply baking soda paste mixed with white vinegar and apply the areas  - antihistamines to include Claritin, Allegra and Zyrtec during the day and Benadryl at night. Please use caution as Benadryl will cause drowsiness and pt to avoid driving a car and working with machinery,  - pt advised once further advise received from the provider RN would contact him on provided number.  - pt advised if no improvement in home care instruction in 24-48 hours, please contact the PCP office and if he develops chest pain, shortness of breath, severe facial/eye swelling pt advised to go to the ED. Pt verbalized understanding of the instructions provided and is in agreement. Triage note sent to the provider. Telephone Triage Protocols for Nurses.   Reviewed and agree with plan.  Antihistamine if itching. I do not recommend the second dose of vaccine for her.
Information has been received from a nurse practitioner referring to a 12 month old male patient with mild anaemia and no drug allergies. The patient's medical history included failure to thrive. On 04-SEP-2015 the patient was vaccinated with 0.5 ml single dose of MMR II (therapy type: rHA) (lot # K016154, expiration date 24-SEP-2016) subcutaneously for routine vaccination. Concomitant therapy included POLY-VI-SOL WITH IRON DROPS (reported as "POLY-VI-SOL WITH IRON"). On 04-SEP-2015, the patient was diagnosed with an ear infection during the examination at the same office visit. On 05-SEP-2015 the patient experienced a rash and was seen by the physician who described the rash as a "blanching, pink, macular rash, generalized on the body". No treatment was given for the rash. The nurse practitioner was informed by the patient's mother that since 05-SEP-2015, the patient also experienced "fevers on an off, up to 101F". The patient did not receive AUGMENTIN which was prescribed on 04-SEP-2015 for the ear infection, until 08-SEP-2015. When the patient was seen on 17-SEP-2015, the rash that began on 05-SEP-2015 had resolved and the patient had no fever. However the patient was experiencing a villiform rash on trunk, which had spread over the body including the face, palms of hands and soles of feet. No treatment was provided for the rash on 17-SEP-2015. No lab diagnostics studies were performed. Outcome of the event ear infection and rash generalised was unknown. The nurse practitioner described the patient as "happy, irritable and stable". Causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse refers to a male patient of unknown age with Ceclor allergy. The patient's medical history included Gastrooesophageal reflux disease (GERD). On unknown dates in 1998, the patient was vaccinated with 3 doses of unspecified hepatitis B vaccine (recombinant) (Manufacturer unknown). Concomitant therapies included PRILOSEC. On an unknown date a recent lab work showed the patient had negative antibody levels against hepatitis B. No treatment was given. Patient sought medical attention (unspecified). The outcome of patient has negative antibody levels against hepatitis b was unknown. Causality was not reported. Additional information has been requested.