chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 10-DEC-2011, the patient was vaccinated with ZOSTAVAX at a pharmacy as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2015, the patient was treated for a painful condition called herpes "keratis", which is shingles in the eye and can cause vision loss and permanent blindness. She was prescribed acyclovir to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events were unknown. Upon internal review, ophthalmic herpes simplex was considered medically significant. Additional information has been requested.
COVID restrictions / impeded her / to receive the second dose on time; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 82-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of limb operation (1st dose received on October 2019, refer case US2021086465).   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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable. Till the time of reporting patient had hand surgery and COVID restrictions began which  impeded her ability to receive the second dose on time which led to social problem. The patient was referred back to her health care professional. No further information was provided. Consented to follow up was unknown This case has been linked with case US2021086467, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086467:Same reporter US-GLAXOSMITHKLINE-US2021086465:Same reporter. US-GLAXOSMITHKLINE-US2021086467:Same reporter
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029617, expiration date 19-MAY-2017; lot # L033543, expiration date 30-MAY-2017 (exact dose was not reported, orally). There were no adverse effects reported. Administered doses of ROTATEQ experienced the temperature excursion of 9.5 degrees Celsius for 12 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. The patient had no known drug allergies. On an unspecified date in June 2015 (reported as "about a week ago"), the patient was vaccinated intramuscularly with a dose of GARDASIL lot # K014191, expiry date 10-MAY-2017, for prevention of HPV. The reporter stated that when the dose was withdrawn into a syringe and inserted into the patient's muscle, upon plugging the syringe the dose leaked out of the patient's injection site. During the same visit, the physician gave the patient the second full dose of GARDASIL (lot # and expiry date unspecified). No treatment was given for reported events and none lab diagnostics test were performed. The outcome and causality of the event was unknown. Additional information has been requested.
Smell has been affected since the vaccine.  Coffee no longer smells like coffee, this is the most affected smell I have noticed
Patient received Pfizer booster of COVID vaccine. She had a syncopal episode and diaphoresis
I feel pain in the upper side of my left lung near the scapula when I inhale, yawn, and squat. The pain started around  4/12/2021 11:00 pm. From the start date, the rank (1-10) of pain I felt was 3.  The pain worsened in the past two days. These two days I feel the rank of pain is 5. I only took Panadol medicines to relieve pain.
Nausea, mild headache. VSS. BP 149/78, HR 65, O2sat 100% RA. Denies chest pain, sob, difficulty breathing. Mild nausea, headache improved. Discharged home with spouse in stable condition.
very sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th August 2020, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient had a very sore arm for 2-3 days after receiving first dose of Shingrix. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020253858.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020253858:2nd dose, same reporter
"Moderna Arm" - Large, hot, red, painful lump formed at the injection site a little over 24 hours after receiving the vaccine. It is slightly painful when I move my arm. I have been putting cold compresses on it in hopes it will reduce the swelling. Hasn't really worked yet.
This spontaneous report as received from a health care student refers to a patient of unkonwn demographics. The patient's current conditions or medical history were not reported. On 03-SEP-2014, the patient was vaccinated with an expired dose of M-M-R II (SDV, MDV or additive) subcutaneous injection (lot number reported as J008882, expiration date 27-JUL-2014). No known adverse effects. Additional information is not expected.
Have been menopausal for over year with no menstrual cycle in over a year. Since vaccine have been bleeding .
on 10/16/19 patient noticed a red, raised mark at injection site that was very sore to the touch. Also had body aches and cough that started 10/15/19. Body aches and cough resolved 10/16/19 after 24 hours. Injection site redness and tenderness has continued without change.
Skin rash to left posterior upper arm. Moderate in severity. Duration is 1 day. Associated symptoms are erythema, and raised above the skin. Patient's temperature at visit was 97 degrees F. Patient received varicella vaccine to left posterior upper arm, subcutaneously. Patient states there was slight itching to site on 8-14-14 but states on 8-15-14 there is no itching. Treated for allergic reaction and was prescribed Prednisone and Hydroxyzine. Mother advised to purchase OTC Hydrocortisone 1% cream.
Initial report received from a nurse on 13 Jan 2010: This patient (under four years of age) was vaccinated with 0.25 ml of FLUVIRIN (batch number: 102133P) intramuscularly on 13 Jan 2010. No adverse event was reported. The reporter also reported two other companion cases (See case PHHY2010US01708 and PHHY2010US01693).
fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare professional (consumer) reported that a 57-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. On an unspecified date after the second shot, the patient ran a fever and had body aches and chills, which took 2 days to recover. It was unknown if the patient received treatment in response to the event. The patient recovered from the events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient felt hot, profusely sweating, dizzy, and nauseous almost immediately after the vaccine.  Patient was dosed with benadryl 25mg prophylactically. After about 15 minutes, patient began to feel better.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) on 29-JUL-2010. No other co-suspects were reported. No concomitant medications were reported. On 24-JUL-2012 the patient received the second dose of GARDASIL which was late. No symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
BREASTFEEDING GETTING VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination.The batch number was not reported, the company is unable to performed follow up to request batch/lot no. No concomitant medications were reported. On an unspecified date, the patient experienced breastfeeding getting vaccine. reporter inquired possibility passing of antibodies from his nursing wife to their baby. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding getting vaccine was not reported. The reporter provided causality assessment between covid-19 vaccine ad26.cov2.s and event breastfeeding getting vaccine. Company causality between covid-19 vaccine ad26.cov2.s and event breastfeeding getting vaccine was possible. This report was non-serious.
This spontaneous report as received from a Registered Nurse regarding a 6 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 15-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Two hours after flu vaccine administered experienced headache, extreme fatigue, wheezy cough, dizziness, loss of balance. Next (AM) fatigue, nausea, dizziness, slight loss of balance.
3/13/21 at bedtime -- 7 days after the first dose -- vaccination site became itchy and stiff. The next morning, the area around the site (left shoulder) was slightly swollen and tender, and stiffness has increased. No treatment so far (today is 3/14/21).
Chest pain and SOB  Symptoms: CHEST PAIN, UNSPECIFIED(R079).
patient received improperly stored vaccine on 08/26/2021; This spontaneous report was received from a medical assistant, referring to 4-year-old male patient. The patients' historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live albumin status rHA (recombinant Human albumin)  (PROQUAD) 1 dose, lot# U009262, expiration date 19-SEP-2022, for prophylaxis (strength, dose, route, frequency were not reported).  The temperature excursion was of -3.3 centigrade degrees (°C), for 4 hours 52 minutes. A previous temperature excursion of was not reported.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The medical assistant also stated that one of the unspecified patients first received a dose of ENGERIX B, which is not going to be counted due to the improper storage, then received a dose of RECOMBIVAX HB, then received another dose of ENGERIX B and will be receiving another dose of RECOMBIVAX HB so that he actually completes a full hepatitis B series. The outcome of the event reported is unknown. This case is linked to the case 1405USA004386 via same reporter link. Follow up information had been received from the certified medical assistant refers to the 6 month old male patient. The patient received a first dose of ENGERIX B at an unspecified hospital on an unspecified date; it was reported the vaccine was stored improperly, reported as "too cold". The certified medical assistant was instructed by GlaxoSmithKline to revaccinate the patient. The patient was vaccinated with RECOMBIVAX HB on 22-NOV-2013 and 19-MAY-2014 (lot numbers and expiration dates unavailable at this time) and the patient was due to receive his third dose of RECOMBIVAX HB at his 9 month appointment (date unspecified) at the time of report. The reporter also stated the office did not have any storage issues with RECOMBIVAX HB. Additional information has been requested.
Information has been received from a nurse concerning a 21 year old female with a history of an allergic reaction to penicillin and sulfonamide who on 21-SEP-2006 was vaccinated with HPV. On 21-SEP-2006, following vaccination, the patient broke out in hives all over her upper body particularly in the face, chest, and arms. Unspecified medical attention was sought. Subsequently, the patient recovered on 26- SEP-2006. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved.  This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Soreness, rash, swelling. Soreness started 2 days after injection and rash started 5 days after injection.
On 2/16/2000, in the afternoon, the pt's left upper arm began to swell and became ware to touch at the injection site. Pt also, complained of feeling tired, lightheaded and nauseated. These symptoms lasted for 2 days until the morning of 2/18/2000. Pt still has a slight amount of edema in left arm today. Took Tylenol for the 2 days the symptoms were present.
Covid vaccine #2 administered at hospital. During 15 minute observation time post vaccine, 13:12, become pale and lightheaded, 12 minutes after vaccine. Improved with laying down and juice 13:15. Sat up, feeling improved, color continued to improve. Left room at 13:25, walking and no complaints.
Patient states woke up with extreme pressure on left side from forehead down to chin and his left eye wouldn't stop watering.  He took cold and sinus medication to relieve the pressure which helped.
pt woke up around midnight with stomach pains on the right side under rib cage, stated that it got to about 6-7 pain level.  Pt was able to have a bowel movement, but stated that every time you would try and lay back down that the pain would get worse.  Pt will be going to the ER.
This spontaneous report was received from a nurse via company representative, referring to an approximately 4 weeks old patient of unknown gender and ethnicity. The patient's concurrent conditions, medical history and concomitant medications were not reported. The reported stated that on an unspecified date, an unspecified patient started ROTATEQ, oral (dose, frequency, lot/batch number and expiration date were not provided) series at 4 weeks of age instead of the recommended 6 weeks of age. (Inappropriate age at vaccine administration) for prophylaxis. No Adverse event was reported.
Friday 12th Feb was tested positive; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had her 1st dose of the vaccine on the 8th of Feb (2021), and Friday 12th Feb (2021) was tested positive. The outcome of the event was unknown. Information about lot/batch number has been requested.
expired vaccine is stored and then administered/Vial refrigerated on 14 Oct 2021 after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/Vial refrigerated on 14 Oct 2021 after expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/Vial refrigerated on 14 Oct 2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered/Vial refrigerated on 14 Oct 2021 after expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was mentioned that the vial was initially refrigerated  on 14 Oct 2021, the vial did not undergo any temperature excursion and the patient did not experienced any adverse events
RAT 0.5 - 0.7 mm induration with mild erythema at injection site - Advised cool compress x 2 days and then warm soaks.
Fever, chills, severe dizziness. Unable to even sit at the side of the bed without baseline out. (I do have pots but have been fully function without any currently symptoms of that)
Patient signed off of dialysis on 05/31/2021. Patient passed away on 06/07/2021
Pt received #2 GARDASIL vaccine inj 2-17-09.  1st injection was given at another clinic.  Pt called 2-25-09 & stated shortly after she got home felt an " all over itching sensation".  Denied any rash on other sx.  Pt stated the itching was mild, lasted one week & went away on its own.
Inside of right elbow is sore and kind of achy. I cant usually see my veins but I almost have purple spider like veins today.  Not really concerned and pain is like 3/10
Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS .  Pt passed away once at the facility.  Time of Death was: 2011 on 4/1/21; pt was discharged from ER on 4/2/21
Since vaccination of dose #1 (Moderna), experiencing increasingly muscle twitches and spasms. The twitches began in vaccine arm night of vaccination. Have since spread to other areas of body (both legs, both arms, chest) and now there is increasing involuntary spasms and muscle movements causing huge disruption to basic activities.
first dose January 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: Pharmacist called to ask for information about a patient who received the first dose of Shingrix in January 2022. The reporter asked if it was correct to administer the second dose. The reporter did not provide information about the lot number and expiration date of the first dose of Shingrix administered to the patient. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Right side of face went completely numb as if i haded received a novacaine shot; This is a spontaneous report from a contactable consumer (patient herself).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6204) via an unspecified route of administration, administered in right arm, on 05Mar2021 at 08:45 (at the age of 58 years old) as 1st dose, single, for COVID-19 immunisation. The patient's medical history included migraine and known allergies to sulpha medications. Concomitant medications included bupropion; and, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, it was reported that the patient's right side of face went completely numb as if she had received a novacaine shot. The patient received stroke protocol and testing as the treatment. The patient has not been tested for COVID-19 since the vaccination and it was unknown if she was diagnosed with COVID-19 prior to vaccination. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Severe blistering in my mouth, throat, on my hands, feet, underarms. Blistering on face. Rash on abdomen.  Some blistered healing.   There?s a problem with the form - can?t uncheck death as outcome.  Patient is alive.
Developed fever and diffuse rash. Presented to ER and prescribed Benadryl. Presented to PCP and dx with rubeola.
Metallic Taste / Tingly lips.  Observed for 30 minutes.  Only reported symptoms at 15 minute mark in observation and reported improving. denies any symptoms of throat swelling.  Released to home.
Felt lightheaded approximately 1 1/2 - 2 hours post taking the oral typhoid. Also has slight nausea. VSS 100/82 (NL Low BP for PT0 86 -R16, Blood sugar 112, Rest, fluids oral, ate cracker.
Joints swollen and hot, knees, left shoulder shots completely erased effects of steriod shots in knees. Pain in right side under the ribs as of now no treatment.