chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a company representative on behalf of the pharmacist concerns a currently 62 year old female patient. The patient's concurrent conditions and concomitant medications were not reported. The patient was taking valacyclovir (VALTREX) daily (unknown dosage, indication, formulation, strength, lot# and expiration date). On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (formulation, dose, frequency, route of administration, lot # and expiration date were not reported) for an unknown indication. No adverse effects were reported. Additional information has been requested.
noc of vax pt refused to eat, t101.2, screamed for hrs; given DPH; days later taken to ER-no tx; several days later seen by MD; 10-12 days post vax arching of head; adm to hosp to r/o spinal meningitis; screaming cont til hospitalization;
The patient had developed a rash, fatigue, difficulty breathing, stomach pain, possible fever and began to cough up blood. He took Tylenol and a Chinese herbal medication called Lianhua Qingwen Jiaonang on 5/5/21. It is unclear when his symptoms began, as he did not share that information with his wife until 5/5/21.
pt recvd vax; devel bell's palsy 23nov; now resolving;
Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine). At the time of the report, FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event fibromyalgia occurred after 2-3 months.  No treatment medication provided by the reporter . No concomitant medication provided  by reporter.
Began having sore throat in Scotland and tested negative. Sore throat continued and cough developed the next day but still tested negative. On flight home symptoms worsened and I tested again, testing positive. Symptoms worsened entire flight home and went to ER.  ER prescribed meds for symptoms and steroid.  Still experiencing cough and mild symptoms.
Pt rec'd 3 doses of Engerix-B (IM/Deltoid) & did not respond.
Pt c/o HA & flushing/sweating. BP 109/61; HR 82; RR 18. Pt was stable & released from vaccination site
Chills, fatigue, muscle aches, brief throbbing pain at injection site. Treated with Tylenol and rest. Resolved after a day.
WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 year old female. 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 not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Called CDC in regards to a vaccine error. Patient had received pfizer for 1st primary shot and was given a moderna for his 2nd dose 0.25 ml. This is a vaccine error according to the CDC, they had no answer on if it needed to be repeated or if it counts but to contact the regional Health district. Parents have been notified.  Interchangeability of COVID-19 vaccine products Primary series In general, the same vaccine product should be used for all doses in the primary series. A mixed primary series composed of any combination of Moderna, Novavax, and Pfizer-BioNTechCOVID-19 vaccines is not authorized; data on the safety and efficacy of a mixed primary series are limited. If a mixed primary series is inadvertently administered, the series is complete, and doses do not need to be repeated. Children ages 6 months?4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered at least 8 weeks after the second dose to complete the 3-dose primary series. In the following exceptional situations, a different, age-appropriate COVID-19 vaccine may be administered to complete a primary series at a minimum interval of 28 days from the last COVID-19 vaccine dose. No VAERS report is required. The same vaccine is not available The first dose is unknown A person starts but is unable to complete a primary series with the same COVID-19 vaccine due to a contraindication. People who receive Janssen COVID-19 Vaccine after a dose of another COVID-19 vaccine should be considered to have received a valid, single-dose Janssen primary series.  A person from CDC called me back giving me the above information. The patient will need to return 8 weeks from today for a third dose of either series. This is NOT considered error and told I do not have to report online to vaers.
pt devel hives 24hrs p/vax which have not subsided as of the date of this report;pt denies history of allergy to eggs or thimerosol
redness now a 3 inch circle; hard inside a week after vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness now a 3 inch circle) and VACCINATION SITE INDURATION (hard inside a week after vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness now a 3 inch circle) and VACCINATION SITE INDURATION (hard inside a week after vaccine). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Red rash, at a dose of 1 dosage form and CORTISONE (topical) for Redness, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (redness now a 3 inch circle) and VACCINATION SITE INDURATION (hard inside a week after vaccine) 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.   Caller stated that there is no Patient Name or Date Of Birth on the fax form they received letting their office know who the patient is.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up Information received and additional reporter details were added.
Participant woke up on June 20th with nasal drip and congestion. She went to the doctor's 3 weeks after her symptoms did not get any better. He gave her gentamicin spray and doxycycline hyclate. She felt better after of the end of her antibotics.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that vaccines had remained in freezer at -24 degrees F up until the day of use ,then added each vial to refrigerator as needed. The temp of the refrigerator was kept at 4 degrees C.  Treatment information was not provided.
Area became red and inflamed on 5-24 1 week after the injection.  Is is sensitive to touch. Hydrocortisone and lidocaine applied topically do not relieve symptoms and are painful when applied. The patient had initial tenderness at the injection site form 5-17 to 5-19 that had resolved and was fine until 5-24 when new inflammation and redness presented.
Patient came into clinic the morning after PNEUMOVAX inj with left upper arm swollen, hot to the touch and fevers. Fever, Erythema Multiforme, Purpura and hot to the touch near injection site. Acetaminophen 650 mg PRN.
Heart palpitations, racing, difficulty breathing, chest pain, shortness of breath, flutters after receiving second dose. Symptoms still occurring.
Seizure, fever, pneumonia. Possible reaction to MMR? Discharge Summary received on 1/14/2004 states otitis media.
Pt immun DTP#3-Disappearing wheal to lt shoulder noted-mom said nothing perhaps mosquito bite.@ 3pm mom brought pt to clinic more apparent wheals to shoulder noted.Sent pt to ER/evaluation.9Dec91 mom said pt given shots @ hosp & released
pt recv vax 130PM;140PM c/o throat tight, chest tight, PE gen wheezing;145PM P 90 reg now labored; BP 90/50;pale coloring;given epi & DPH;dec wheezing feels better;155Pm amb arrived 02 given;
With in 5 to 7  hours, pt developed fever, headache, restlessness that night and injection site reaction characterized by redness and swelling. This is 1 of 2 reports from this facility.
pt brought to ED via Ambulance from home with c/o AMS x 3 days; lethargy, no BM x 1 wk, thinks may have UTI; admitted with  metabolic encephalopathy, sepsis, UTI; found to be positive for COVID; COVID protocols initiated (specific protocol not listed in medical records); DNR; ABX; pt's condition deteriorated and she passed away in the hospital
Client began c/o abnl sym. 10 min post vaccination: numbness and decreased strength in hands moving to legs, nausea, throat fullness, trouble breathing, anxiety - crying. Gave epinephrine and BENADRYL based on above. Vital signs normal prior to administration.
VAQTA that had undergone temperature excursion was administered to a patient before calling; no adverse event; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis (lot number U026782 was an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX). Lot number U026782 does not match any Company product as confirmed by Lot Verification team) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 49.6° Fahrenheit (F) for 32 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
A few hours after vaccine my arm hurt severely.  The following day (March 3, 2021) I had a severe headache, nausea, ear ringing, body ache, arm pain, chills and then felling hot. Today, I still had the headache until noon time it finally went away.
pt recvd vax 11DEC95 afternoon & that noc exp severe swelling of the rt arm (deltoid) swollen shoulder & neck;12DEC95 pt feels like knot on muscle
Feeling really sick from my chills; Feeling really sick from my chills; My throat is very red and it hurts me a lot; I just feel really terrible from my throat; My throat is very red and it hurts me a lot; I just feel really terrible from my throat; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6205) as UNKNOWN SINGLE DOSE for covid-19 immunisation Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient experienced feeling really sick from chills, throat is very red and it hurts him a lot, the patient just felt really terrible from my throat. The reporter want to know if this has to do something with vaccine or the patient was getting Covid again. The reporter had Covid already (further clarification unknown) and thought getting the vaccine would prevent it from getting it again. The reporter do not have any other symptoms since that." On an unspecified date with outcome of unknown ,    No follow up attempts are possible. No further information is expected.
fever and chills started at 9pm, pain  and numbness in the  entire arm  and neck on side of vaccination. Applied ice to injection site, took Alleve, minimal relief. Continued pain and swelling x 5 days, taking Alleve every 6-8 hrs.
No adverse reactions or symptoms. Patient had come in for 2nd dose of Moderna but received the booster dose amount instead of the full amount of Moderna. Patient was unable to come back in to clinic on same day so patient will be receiving full dose as a repeat dose on 12/29/21.
I got sick; Flu-like symptoms; Headache; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown date and also experienced influenza-like symptoms and headache, refer case US2021AMR205337).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, influenza-like symptoms and headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness, influenza-like symptoms and headache were unknown.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingles vaccine.  Additional details were provided as follows:  The reporter was the patient.  The age at vaccination was not reported.  The patient got sick from the vaccine, but he/she stated that it was far better than having shingles.  The patient had flu-like symptoms and a headache. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205337:Same reporter,same patient, same suspect, 2nd dose
swell up a lot; sores on tounge; sores on throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat). At the time of the report, SWELLING (swell up a lot), STOMATITIS (sores on tounge) and PHARYNGEAL ULCERATION (sores on throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
155 patients were vaccinated with expired doses; Vial was stored in refrigerator on 04 Apr 2022/ Patients have received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (155 patients were vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 04 Apr 2022/ Patients have received expired vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (155 patients were vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 04 Apr 2022/ Patients have received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (155 patients were vaccinated with expired doses) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 04 Apr 2022/ Patients have received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial was initially stored in refrigerator on 04 Apr 2022. The vial did not undergo any temperature excursion.
red welt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red welt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced URTICARIA (red welt). At the time of the report, URTICARIA (red welt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Itchy red rash started Sunday morning (5/30/2021) at 11am on left upper arm. By 3pm it was on my right upper arm. At around 9pm it spread to both lower arms within the hour. Tuesday morning (6/1/2021) about 2am rash on arms was almost gone but started on both legs.
numbness and tingling in hands and spread to calves and feet; numbness and tingling in hands and spread to calves and feet; This is a spontaneous report from a contactable Consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history included nerve issues. The patient's concomitant medications were not reported.  On 12Jan2021, the patient received vaccine and developed numbness and tingling in hands and spread to calves and feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Initial and follow-up information has been received from a pharmacist concerning a 62 year old male consumer who has not had chickenpox in the past who on 21-MAR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at the time of vaccination. Subsequently, on 22-MAR-2008 the patient noticed a local rash 3 inches in diameter consisting of small pimple-like bumps near the injection site surrounded by a dark red ring. The area also appeared to be warm. Medical attention was sought, the patient called the pharmacist. There were no lab studies performed. On 26-MAR-2008, the patient recovered. There was no product complaint involved. Additional information is not expected.
Received VZV vac. on 10/24/11. Started having fever on 11/4/11, then developed rash a few days later. Saw PMD x2 before being dx with chicken pox via serology.
Grandmother phoned 4/10 reports that child had hives, rash and itching all over body approximately 1 hour after immunizatins. States was not having any problems breathing but took child to ER; seen by doctor and given Benadryl IV and an oral steroid to take for 6 days. Home at approximately 17L30 and child fine. Rash, hives gone. Denies fever or redness at injection site. Seen by family doctor on 4/4 as directed by ER. Doctor oral steroid stopped. No further problems noted.
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 15:00 (Lot number: EN6198) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Potassium, reaction(s): "allergies: potassium", notes: allergies: potassium. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Feb2021 03:00, outcome "recovered" (27Feb2021), described as "injection site pain".  Additional information: No other vaccines received in four weeks of COVID-19 vaccination. Facility at which vaccine was administered reported as Hospital. Reported that 12 hours after the 1st dose, patient experienced the injection site pain, which woke her up, but it was gone within a day. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
PT BEGAN TO EXPERIENCE A METALIC TASTE IN HER MOUTH AFTER RECIEVING THE DOSE WHILE WAITING DURING THE OBSERVATION PERIOD. A COUPLE OF MINUTES LATER PATIENT THEN BEGAN TO FEEL NUMBNESS ON THE LEFT SIDE OF THE FACE, DESCRIBED IT AS RADIATING FROM THE INJECTION TO HER CHEEK. PT WAS GIVEN ONE DIPHENHYDRAMINE 25 MG TABLET BY MOUTH AND WAS ASKED TO REMAIN AND BE OBSERVED FOR AN ADDITIONAL 15 MINUTES. AFTER 30-45 MINUTES OF OBSERVATION PATIENT WAS SYMPTOMS SUBSIDED AND WAS INSTRUCTED TO USE HER EPI PEN IF NEEDED AND CALL 911 IF ANYTHING OCCURED AT HOME OR LATER ON