chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was shaken vigorously before she received the vaccine; A spontaneous report was received from a consumer who was a female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced out of specification product use.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   Prior to the administration of the vaccine, the vial was vigorously shaken.  The patient received their first of two planned doses of mRNA-1273 on 07 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. Because the dose was administered from the vial that had been vigorously shaken, the patient experienced out of specification product use.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, product preparation error, was not provided.   The event, out of specification product use, was considered recovered/resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
she felt weak; arm swelled and hurt; arm swelled and hurt; light headedness; fast pulse; had a hard time hearing; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021, the patient got the second dose of vaccine and early evening of that day, her arm swelled and hurt. On 16Mar2021, she felt weak and stayed in bed the whole day. On an unspecified date in Mar2021, she experienced light headedness, fast pulse, and had a hard time hearing. The patient just called to report these events and wanted to know how long would her reactions would last. At the time of report, the outcome of the event arm hurt was recovered on an unspecified date in Mar2021; while the other events was unknown.  Information on the lot/batch number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant products were not reported. The reporter's causality for Humira with event 'felt that Humira was not working' was reported as not provided and no reasonable possibility for event 'Covid'. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Treatment medications were not reported. Company Comment: This spontaneous case concerns an adult female patient who received the non-company product, co-suspect drug Adalimumab for hidradenitis suppurative and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation including SARS-CoV-2 test, and treatment information were not provided in the report. The event has not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an adult female patient who received the non-company product, co-suspect drug Adalimumab for hidradenitis suppurative and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation including SARS-CoV-2 test, and treatment information were not provided in the report. The event has not resolved at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Allergies where there were none before. Excessive sneezing, gunky eyes, running nose wheezing and coughing. Sinus congestion and strange pains in my head. The pains could not be fixed by Tylenol or congestion medication. The pains are sharp and tugging in a single spot. This started exactly 5 days after receiving the 2nd dose of Pfizer.   The allergies are persistent. Nothing seems to work well. I tried benadryl and Claratin, but they failed. I also experienced unusual pain in the deep tissue of my left breast, like there was a swollen and painful lymphnode. The pain lasted for several days.
Patient had received 2 doses of Prevnar on 10/31/07 and on 01/03/08.  Admitted to hospital on 01/30/08.  Diagnosed with strep pneumo sepsis. 5/6/08-records received for DOS 1/30-2/5/08-DC DX: Streptococcoal pneumonia, sepsis. Bronchiolitis. Otitis media. Fever resolved. Emesis resolved. Presented with 2 day history of vomiting and diarrhea. Increasing lethargy and temperature 101.8. 1/29/08 reevaluation with fever up to 103. Developed red man syndrome after Vancomycin administration. Cough developed 2/1/08 CXR suspicious for mild infiltrates.
The area where the vaccine was given in my left arm was red, swollen, and there was a big knot. I would guess the inflammed area was approx 2-3in and it would hurt significantly when I would lay on that arm when in bed. I took 800mg Ibuprofen (one the night of the Dec 23, one the following morning and then night) and the swelling has reduced significantly. The knot still exists but it no longer hurts as it did in the beginning and it's nowhere near as big as before. I didn't have any of these symptoms until well after the vaccine was given but it was in the exact area where it was administered.
Information has been received from a physician concerning an adult female with no known drug allergies who on Nov 18 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine at state health department. Subsequently the patient experienced red, swollen left arm, and paresthesia with splotchy rash. Client had first dose of pneumococcal 23v polysaccharide vaccine approximately 5 years ago. the patient had not recovered as of Nov 19 2004. The patient sought unspecified medical attention. Additional information has been requested.
From telephone contact with reporting physician, it was stated that a 3 month old male infant received first dose of a Tripedia,an ActHIB and an IPOL vaccination on 08/08/01. One to two hours after injections the patient cried inconsolably. His right thigh where Tripedia was given was red and swollen On 08/09/01, the patient was very sleepy. From additional correspondence received on 10/10/01 it was reported that the patient recovered from this experience. Additional vaccine and patient information was also provided.
First dose given to patient under eighteen years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old). On 18-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
PT started to feel "dizzy and complain of body burning". PT slumped over with no LOC. Reaction tam notified. PT remained slumped over for 10 minutes, then said she was starting to feel better. Talking normal, drinking water with no complaints. Sitting up on phone. PT stayed extra 30 minutes per reaction team order. Vitals as follows: 1426 Lying BP 137/89 HR 84 RR 16 SPO2 98%  1501 Lying BP 142/83 HR 60 RR 18 SPO2 96% 1520 Sitting BP 130/68 HR 84 RR 18 SPO2 98
w/in a few hrs p/vax pt began to cry-steady for 5 hrs; remained very irritable 3 hrs p/that; parents recvd meds; t102;
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 38-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006659; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684. Follow up information received 18-Apr-2008 and incorporatedinto the narrative: no adverse event occurred.
On 3/11/2021 the patient presented to the ED for rectal bleeding after a bowel movement and rectal pain. The patient had apparent external hemorrhoids. The patient denied diarrhea.
walked to the bathroom had a loss of balance; 8-9 hours body aches, recovered fine; lost balance of walking, lost balance again, loss control of his body while sitting on toilet.; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.), GAIT DISTURBANCE (walked to the bathroom had a loss of balance) and MYALGIA (8-9 hours body aches, recovered fine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.). On an unknown date, the patient experienced GAIT DISTURBANCE (walked to the bathroom had a loss of balance) and MYALGIA (8-9 hours body aches, recovered fine). At the time of the report, BALANCE DISORDER (lost balance of walking, lost balance again, loss control of his body while sitting on toilet.) and GAIT DISTURBANCE (walked to the bathroom had a loss of balance) outcome was unknown and MYALGIA (8-9 hours body aches, recovered fine) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Diarrhea - green stool with mucous. Persistent for more than 48 hours and resulted in nappy rashes that caused the patient cried in pain. Unusual crying is also observed. No treatment is given at the time of reporting as parents have not seek medical intervention.
Chills, shaking, headache,  flu like symptoms but no fever I also experienced blurred vision, extreme dizziness, nausea and went to urgent care were I was diagnosed with BPPV positional vertigo which I?ve never had or experienced ever.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of M-M-R II (lot number L024268 and expiration date 01-JUL-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations.   Vision (only have one eye) has been hazy when looking at computer.  This is still on going.  Work up done by optometrist  at this point eye checks ok but problem persist.    Referral to ophthalmologist is place.  Feeling of fogginess in head - "drunk like feeling" persisted for several weeks.  This still seems to be on going.  Palpitations and some check pain.  - This was never a finding prior to 2nd dose of vaccine.   This has resolved.
Itchy red patches and bulls-eye circles on arms, torso, neck, back, hands
My face was a little puffy for a few hours; Rash on both forearms; Puffy eyelids; I'm allergic; This is a spontaneous report from a contactable other hcp from a Pfizer Sponsored Program. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity, allergic to gentamycin from an unknown date and unknown if ongoing I am allergic to antibiotics, food allergy from an unknown date and unknown if ongoing Reminded me of my food allergies that I avoid. The patient's concomitant medications were not reported. On an unspecified date, patient experienced my face was a little puffy for a few hours, rash on both forearms, puffy eyelids, i'm allergic. The case was reported as non serious. The outcome of the event my face was a little puffy for a few hours was recovered on an unspecified date and the outcome of rash on both forearms, puffy eyelids, I am allergic was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a healthy 41 year old adult white female patient with environmental allergies, who on 12/29/97 and 2/11/98 was vaccinated with a first and second dose of varicella virus vaccine live (lot # not available). The registered nurse reported that a recent titer on 7/27/04 was negative (<1:4), non-immune status for varicella. On 8/20/04, the patient was administered a third dose of varicella virus vaccine live (lot # 647088/0852N) in the left deltoid. Concomitant medication included birth control pills. A repeat titer was done on 9/24/04 and was <1:4 again, a non-immune status for varicella. There was no other information available. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown.  Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours No previous temperature excursion The call was not because of a "data logger". Additional information has been requested.
5/3/2022-Presents to ED, sore throat, body aches, cough and diarrhea. Baseline 02 use, 1L NC sitting and 4L while ambulating. Afebrile, BP 164/78. CXR: bilateral pulmonary infiltrate. Covid + test. Admit acute resp failure s/t covid pna. Decadron and remdesivir.  5/5/2022-Currently on 2L via NC.  5/7/2022- BP increased to 175/97 prn hydralazine.  5/8/2022- O2 maintained on 15 L 98%. VSS afebrile.  5/9/2022- D/C to home, d/c decadron. D-Dimer <150.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced minor irritation and arm felt heavier. The action taken in response to the events for the vaccine was not applicable. The clinical outcome for the event was recovered, as reported a couple weeks late, the patient returned and the symptoms were not present.
Patient developed a rash 3 days after receiving the SHINGRIX vaccination. He saw his physician on 4/24 who confirmed the diagnosis of shingles. Patient is taking VALTREX.
6x5 cm redness, warmth induration at injection site (first noted several hours after injection) c/o itching.
Infanrix was administered to a 40 year old pregnant woman; Infanrix was administered to a 40 year old; Infanrix / Instead of Boostrix on 7/21/2020. No reactions reported.; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   On 21st July 2020, the patient received Infanrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 21st July 2020, unknown after receiving Infanrix, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The reporter stated that, the pregnant patient received dose of Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. The reporter stated that, no reaction reported. The reporter consented to follow up.   Follow up information was received on 19th May 2021. Upon follow up information, this pregnancy case was updated as lost to follow up.
fever; body aches; didn't feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization.  The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported.  Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven't changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it's burning really hard again and it's all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Exacerbation of Multiple sclerosis; This case was reported by a nurse via call center representative and described the occurrence of multiple sclerosis exacerbation in a adult male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 8th August 2022) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple sclerosis exacerbation (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis exacerbation was unknown.   It was unknown if the reporter considered the multiple sclerosis exacerbation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up