chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-APR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # J006681, expiration date 05-DEC-2015; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 72, 32 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Left arm became tingly, got hot and tingly all over,  then face became itchy, then lips and tongue became numb and tingly. All from 12:30 - 1pm (30 min to 1 hour post vaccination). Took 50mg Benadryl at 1pm. Symptoms continued to intensify until 3pm. Currently 27 hours post vaccination and experiencing sore site, itchy face, tingly lips and tongue.
Blistering on back; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLISTER (Blistering on back) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Blistering on back). At the time of the report, BLISTER (Blistering on back) 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.
MILDLY SORE UPPER ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mildly sore upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mildly sore upper arm was not reported. This report was non-serious.
Patients mother reports swelling, redness, tenderness, hotness at vaccination site. States swelling was approx. 6 x 2 inches, started just beneath deltoid (right) , extended to just above elbow. Lasted 5 days, mom called local ER, gave daughter TYLENOL and applied ice. Redness resolved. Redness resolved, swelling resolving, but still present.
It is reported that appx 10 minutes after receiving vaccine, client complained of shortness of breath, was diaphoretic, and complained of nausea before vomiting. BP was reported to be apprx 172/95 with pulse in 90's. Patient continued to be short of breath. Nurse administered 0.5 mg of epinephrine and called 911. It is reported that near immediately, the client began to breathe easier, color returned and while a bit shaky called her family. Client was at medical facility so oxygen at 2 liter/min was applied. Supervisor had a portable pulse oxyimeter and reported that O2 sats were 98/99 during the entire event. It is reported that BP dropped down a bit but exact number were not provided. EMS arrived and took client to the hospital. It is reported that she was in no apparent distress when leaving the clinic.
Pt was given adult dose 0.3 mL of the covid vaccine, when she was supposed to receive the 5-11 0.2 mL dose.
Symptoms of severe rashes under both arms. Prednisone cream applied helps but it continues.
I was exposed to Covid on 05/14/2022 at a funeral. I didn't realize that until I received a call on 05/17 when the pastor from the church called to inform me that 8 people had tested positive for Covid. On Monday, 5/16, I had a headache which is uncommon for me and I took extra strength TYLENOL. After I was informed of my exposure, on 5/17, I took an at home Covid test which was positive. That same afternoon my cousin who works in a health center, tested me for Covid and it was also positive. I spoke with my doctor that day who prescribed PAXLOVID which I took for 5 days. My symptoms began to improve after starting the anti-viral. My symptoms consisted of headache, congestion, fatigue, a cough, and a runny nose. All of my symptoms had basically cleared up after the 5 days on PAXLOVID. On 05/27, I took another at home Covid test and it was negative. On 05/31, however, I was tested at the local health department and my results were positive. The nurse informed me that it was possible to test positive for up to three months. I spoke with my doctor who advised that since I am no longer showing symptoms, and as long as I social distance and wear a mask when in public, I no longer needed to isolate. My doctor recommended that I receive my next Moderna booster on 07/12/2022 which I fully intent to do.
On October 5, 2018, a 4 year old female incorrectly received an injection of MassBiologics' Td vaccine (Lot # A104B1) intramuscularly in her arm; the intended drug for this patient was a routine booster dose of DTaP. The patient also received a dose of PROQUAD, manufactured by Merck Sharp & Dohme Corp., lot # unknown, during the same visit. The patient did not experience any adverse reactions after Td administration. The responsible physician reported that the reason for the medication error was unknown and that DTaP was ordered but Td was administered. Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to a patient that was under the prescribed age for the vaccine.
w/in 30min of vax pt devel violent vomiting w/blood streaks, diarrhea & had a sz;this initially resolved, then pt exp another sz;pt was taken back to MD office for exam then hosp for observation;positive for rotavirus;
Swollen lymph node, painful, under left arm; slightly swollen lymph under right, no pain
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a female patient of an unknown age 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 COVID-19 (covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient received Moderna COVID-19 Vaccine and she had COVID. On an unknown date, patient started Paxlovid and at the time of report it was day 2 or 3 of the 5 days. She confirmed that patient started with diarrhea and stomach cramping after taking Paxlovid.  She was taking the Paxlovid at the time of report because she had COVID.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Off label use; Booster; I was out sick with the 3rd Covid Pfizer shot; This is a spontaneous report from a contactable consumer or other non-health care professional re-ported for a male consumer(patient). A male patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose and second dose of BNT162B2 for COVID-19 immunization. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced off label use, booster and i was out sick with the 3rd covid pfizer shot. The clinical outcome for all the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a health professional concerning a patient who on 30-APR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). There was no adverse event. No product quality complaint was involved. Additional information has been requested.
Symptoms started 01/21/22, symptoms consist of cough, fatigue, body aches, fever, diarrhea, rapid test positive on 01/24/22, PCR tested positive for COVID on 01/25/22 and 01/28/22, rapid test negative on 01/31/22, stayed home/quarantine, and self medicated with OTC medicine, no hospital or physician care.
3x2inch area of erythema swelling on upper arm at injection site with complaint of warmth, itching.
Thursday night-chills, temps of 100, left upper arm swollen and red 3" above elbow to shoulder. Redness all around. Quarter size bruise to shoulder. Patient said that nurse gave both flu and pneumonia in both arm and about 1" from top of shoulder.
Rash on back, started in the evening, was better by the next day but bumpy eczema type skin remains on back and traveling up back of neck.
Large area of redness on Lt thigh. Intermittently painful and red x 2 d, lump at vaccine site. BENADRYL given. RTC if increase redness, pain or fever.
got the second in 8/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comments: The pharmacist had disconnected the call, while proceeding to ask for further questions about the vaccine and patient. The reporter did not consent to follow-up. Additional supportive information: The patient had received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
This spontaneous report as received from a nurse refers to 6 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. Post 16-JUL-2014, date unspecified, 6 patients were vaccinated with VARIVAX (lot #J014129, expiration date 07-NOV-2015, injection, 0.5ml) subcutaneously. The nurse reported that there were two times temperature excursions affecting these VARIVAX products. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek for medical attention. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 26-year-old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: asthma. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported) and PPV 223 (batch number not reported). On an unspecified date, (onset after vaccination not documented), the patient experienced anaphylaxis. The symptoms included wheeze (bilateral), shortness of breath, increased heart rate, nasal congestion and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with nebulizer. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Information has been received from a medical assistant concerning an 85 year old female with chronic obstructive pulmonary disease, hypertension, potassium low, "chronic back pain-problems with disc disorder", atrial fibrillation and penicillin allergy, who in 2000 was vaccinated with the first dose of PNEUMOVAX 23, in 2005 the second dose and on 11-NOV-2009 the third dose (lot # 664000/0621Y, 0.5ml, IM). The vaccination was recommended every 5 years because the patient had chronic obstructive pulmonary disease. There are "quite a few" unspecified concomitant medications. On 12-NOV-2009 the patient experienced injection site reaction with redness, swelling, and painful that was at the top of the shoulder area to the most top of the elbow all the way around the arm. The patient's reaction was cellulitis like. The medical assistant felt the patient need an antibiotic as an intervention. There were no labs and diagnostic tests performed. The patient received the first dose and the second dose of PNEUMOVAX 23 with no reactions. The patient visited office and recovered on 17-NOV-2009. The medical assistant considered the redness, swelling and pain that was at the top of the shoulder area to almost to the top of the elbow were other important medical events. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
12  hrs after  vaccine  fever, chills,  sweats. arthralgia,  myalgias.  over  next  12  hrs developed  left  deltoid  painand left axillary  adenopathy. fatigue/lethargy no resiratory  or  gi  or   specific  neurological reaction. no rash
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported. On 15-OCT-2014, the patient was vaccinated with ZOSTAVAX vial (dose, route and frequency not reported). Concomitant medications were not reported. On 15-OCT-2014, expired dose of ZOSTAVAX (expiry date: 14-SEP-2014, Lot number-J0006830) was administe4red and no adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
30 mins after receiving FluMist pts. left eye began watering every time he blinked and his lip became numb and started getting hot flashes. Pt. came to the office the following day c/o left eye going from excessively watering to excessively dry.  Left side of face became droopy the morning after he got Flumist.  Pt. diagnosed with Bells Palsy, treated with Acyclovir, DexPak, and Lacrilube.
This case was reported by a pharmacist and described the occurrence of inappropriate age at vaccine administration in a male patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration and vaccine underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and vaccine underdose were unknown. Additional information received: INFANRIX administered to a 40 decades adult. Reporter did not have any additional details to provide.
2/23 in the afternoon chills and body aches started that night, 2/24 coughing, congestion, aches and pains, hips hurt tested for COVID-19 with an at home COVID-19 test, positive. 2/25 urgent care tested positive on rapid COVID-19 test, PAXLOVID and albuterol inhaler and to treat symptomatically. I saw symptom improvement after a couple of days with gradual improvement over the next few days. Had rebound after PAXLOVID on the 3/3. Rebound was not terrible, coughing was worse, but congestion level returned to the level it was pre PAXLOVID. Congestion, cough, and wheezing lingers to time of reporting.
SHOT #2: -  Much bigger rash area than last time. -  Much more tender, & VERY swollen. -  Took Doxycycline 100mg, & used Betamethasone cream. -  Lasted for 10 days.
Patient became dizzy and light-headed a few minutes after vaccine administration.  No meds given at clinic. Pt brought to emergency department.
Following vaccination, patient reported throat scratchiness in the right side. She has had previous allergic reactions to allergy shot and stated that this is how she felt before. VS: 0740- HR 127, O2 100%, BP 127/75. 0752- HR 100, O2 100%, BP 134/82. 0805- HR 103,O2 100%, BP 159/80. Patient evaluated by physician and monitored in clinic for additional 30 minutes. 0841 HR 104 O2 98 BP 135/77; 0847 HR 100 O2 100 BP 136/73. Discharged from clinic. On 1/4/21 patient presented to urgent care reporting that over the course of the evening and next day she developed intermittent fevers with a T-max of 103 degrees as well as headache and lightheadedness.  She has had intermittent symptoms ongoing since her vaccination prompting her to come for evaluation at urgent care.  She denies difficulty swallowing.  She had been intermittently taking antihistamines. Positive for sore throat. COVID antigen testing was negative, patient discharged.
Extreme pain at time of needle piercing. Entry was too high up in the arm/shoulder area. Pierced Bursa. Pain in the entry area shortly afterwards.
Patient has diabetes. Received influenza vaccine at doctors office on 10/7/04 (non-live virus vaccine). Received varicella vaccine at health department on 10/8/04. Developed ketoacidosis (hospitalized 10/9/04 and 10/10/04). Discharge summary states nausea, vomiting. msv
Initial report received on 11/17/2005 from a health care professional. A 47 year old male patient with a history of passing out when giving blood, had received an intramuscular injection of Fluzone SV 2005-2006 USP, lot number U1911AA, site not reported, on Nov 17 2005. Within minutes, his color turned green, his eye rolled back in his head and he became unconscious. the patients blood pressure 90/60 and he was sent to the ER for evaluation. Per the reporter, the patient did not have hives or difficulty breathing. The status of his recovery as the time of this report was not reported.
This pt. is a 9 day old baby who has the same last name as a 2 month old pt that was also seen on the same day - there was a slight language barrier however that parents did not ask for a interpreter. The nurse administered a 2 month set of shots the the 9 day old pt. When the error was realized the parents were asked to wait in the room and a Doctor went in to see them - there has not been in reaction noted - however this is a medication error that we felt needed to be reported.
Pt developed transverse myelitis after receiving flu shot. He is now in the ICU and receiving IVIG.  11/16/07 Received hospital medical records which corrected DOB & reveal patient experienced LLL pneumonia approx 5-7 days prior to hospitalization.  Tx w/antibiotic.  Developed increasing bilateral LE weakness & numbness beginning 11/6.  Bowel & bladder incontinent.  Admitted 11/6-11/9/2007.  LP done.  Neurology & ID consult done.  Tx w/steroids & IVIG x 3 days.  Transferred to another hospital per pt request. FINAL DX: Guillain Barre syndrome. 11/27/07 Reviewed pcp med record of 11/05/2007 when patient received IM dose of antibiotic.  11/27/07 Reviewed hospital medical records which reveal patient experienced acute onset of weakness & paresthesias of bilateral LEs, urinary retention & diarrhea.  Patient had respiratory infection approx 2 weeks prior to onset of these symptoms. Tx at outlying hospital initially where he received the IVIG & steroids. Admitted 11/10-11/15/2007 for acute care & then rehab 11/15-11/21/2007.  Upon d/c to home required use of cane & needed assist w/transfers & bathing.  Referred to outpatient PT & neuro clinic for f/u.  D/C summary requested from hospital. FINAL DX: post infectious or post vaccination transverse myelitis. 11/30/07 Reviewed d/c summary.
Covid arm. Days after getting the shot, my arm got a large red and hot bump that developed. It was also itchy. It lasted for over a week.   Same thing happened with the second shot.
NO SXS REPORTED, WRONG DOSE GIVEN. WAS SUPPOSED TO GET PEDIATRIC PFIZER BIVALENT BOOSTER.
3 days post vax, onset of lymphadenoathy, neck stiffness, pain and lethargy. Sx's became so severe, pt couldn't neck.  Pt prescribed Toradol.
Swollen lymph nodes/entire armpit swollen, also on the arm; Reddening or of the skin below the vaccination or injection site/reddening; It was not pain just the reddening and inflamed; Reddening or of the skin below the vaccination or injection site/reddening; Chills; whole arm hurts; upset; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FJ1620) at the age of 71 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "She is a heart patient" (unspecified if ongoing), notes: Verbatim: She is a heart patient. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot EN6205), administration date: 02Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot ER8733), administration date: 30Mar2021, for COVID-19 Immunization, reaction(s): "TAVR Surgery, Heart Valve Replaced", "TIA"; Pneumonia, reaction(s): "it hurt". The following information was reported: INFLAMMATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "It was not pain just the reddening and inflamed"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "recovering", described as "Swollen lymph nodes/entire armpit swollen, also on the arm"; ERYTHEMA (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "Reddening or of the skin below the vaccination or injection site/reddening"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "whole arm hurts"; DEPRESSED MOOD (non-serious) with onset Nov2021, outcome "unknown", described as "upset". Therapeutic measures were taken as a result of inflammation, chills, lymphadenopathy, erythema, vaccination site erythema.  Additional information: Friday she had chills which she took aspirin for and it went away. She took a lot of Tylenol throughout the day.  No follow-up attempts are possible. No further information is expected.
'infected' COVID; 'infected' COVID; Pneumonia; Having difficulty breathing; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 59-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (lot number unknown, expiry date unknown) as DOSE 2, SINLGE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's height and weight was unknown. Patient's family number stated that the patient was infected with COVID-19 after fully vaccinated Pfizer vaccines on an unspecified date. Then the patient was hospitalized on 16Oct2021 for 5 days (till 21Oct2021). The patient experienced with pneumonia and felt difficulty to breath on an unspecified date. Outcome for all the events was unknown. Therapeutic measures were taken for all events. (oxygen put for difficulty breathing and other medication was performed)  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.