chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-NOV-2013, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed bacitracin/polymixin ointment and tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Approximately 60 hours after my second injection I was awoken from my sleep with the most intense, excruciating pain in my right arm (arm where the vaccine was injected), It felt like every muscle was being torn off. I had been laying on my back at the time and the pain did not go away by repositioning my arm. The pain would eventually radiate all the way down to my right hand and my ring and pinky fingers experienced numbness as did my right hand which also felt colder than my left hand. The pain also ran up to my shoulder around to my scapula, under my arm and up my neck. The pain still exists today 18 days post vaccine. I have been taking ibuprofen and Tylenol around the clock to alleviate the pain. I also was given a steroid dose pack by my neurologist. Sometimes the pain subsides but it always comes back. Sometimes I still feel like I have been punched in the arm where the injection occurred and other times it is my scapula that is so tender I cannot lay on my back. I have to sleep on my back at night and if I try to roll over on my left side, the side where I was not injected, my right arm feels tingly.
vaccinated with Moderna on 2/27 and 3/27/2021.  Symptoms developed on 11/22 - chills, nasal congestion Reported as case of breakthrough Covid in previously vaccinated person.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 15th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
All joints in fingers, wrists, elbows, shoulders, neck; shot given in left shoulder hurt bad, blood ran down arm. Very exhausted rest of day. Unbelievable pain on arising. Went to "internist" regular doctor couldn't explain. Been 7 weeks and still suffering, never had this kind of pain before shot.
pt recv vax & lt knee started hurting;has had problems w/knee being inflamed;takes motrin & pain goes away prev-but not since 16OCT97;
Pt received Gardasil injection-then-<1 minute collapsed onto floor. Patient did c/o pain during and after injection. Pt's legs were raised and she was observed for 20 min and given juice. Small amt of diaphoresis to forehead noted after collapse
Patient received Janssen Covid-19 vaccination at 04:24pm on 05/07/2021 and was counselled to remain in the patient's waiting area per protocol. At approximately 04:32pm a patient in line to pick up their prescription alerted pharmacy staff that someone just slumped over in the chair. 911 was called immediately but pt. stated he did not need them as he did not want to pay and declined EpiPen which was made available to him. He verbalized that it might be "mental"?? and it usually happens to him when he "gets blood". He remained under observation and stated that he felt better. At approximately 04:54pm patient departed from the pharmacy area.
Information has been received from a pharmacist concerning a 4 year old patient who on 29-APR-2010 was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR. There was no adverse effect reported. It was unknown if medical attention was sought. Additional information has been requested.
1989 pt recv vax. p/vax pt devel fever 101,arthralgia & malaise. Recovered in 1 wk. Reporter notes (Manufacturer unknown) in box 7, but box 13 notes Lederele
3AUG91 c/o weakness, vertigo,h/a; 4AUG91 dev sore throat, ear ache, cough on inspiration & rash (small red dots over face & entire body); 5AUG91 Had strep screen & blood count both neg; 6AUG91 seen by MD feeling better;
Fainted, recovered in 15 seconds. Felt cold & sleepy - observed & recovered, no residual effect.
Female patient had injection site swelling after was administered PNEUMOVAX 23; Information has been received from a physician concerning an elderly female patient between the 70's to 80's years old. The patient's concurrent condition included cancer in remission. The patient's historical conditions, concomitant medications and drug allergies or reactions were unknown.  On an unspecified date in 2002 or 2003, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot number, anatomical site of injection,  and expiration date were not reported) for prophylaxis.   Subsequently, on an unknown date in 2002 or 2003, the patient experienced injection site swelling, after the administration of the vaccine. Therefore, the patient received methylprednisolone (MEDROL) as treatment for the event. It was reported that the patient sought medical attention and it was unknown if the patient performed any studies or laboratories diagnostics.  The patient recovered from injection site swelling on an unknown date.   The causality assessment between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the event was unknown.
No additional adverse effects reported; on 20-AUG-2020, the patient was administered improperly stored PROQUAD; This spontaneous report was received from a nurse, referring to a 4-years-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 20-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously (strength, dose, vaccination scheme frequency and anatomical site of vaccination were not reported; lot number T001187 has been verified to be valid, expiration date reported and validated as 11-JUL-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).  The administered dose of the vaccine was stored in a temperature of 6 degrees Fahrenheit (F) to 14 degrees F (10.9 degrees F) for 2 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse effects were reported.
Approximately 1 day post-vaccination, I experienced right hip pain. The pain was also present in my lower back and right leg. It was exacerbated with movement; particularly sitting and standing. The pain was continuous and daily until resolving approximately 6 weeks post-onset. Pain also continued on my left-side during this time until approximately 4-5 weeks post-vaccine (as reported in initial VAERS report). Pain was severe in nature, gradually subsiding as course progressed until baseline reached approximately 2nd week of March 2021.
Body ache; Chills; Tiredness; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced chills, tiredness, body ache, fever. Therapeutic measures were taken as a result of chills, tiredness, body ache, fever and included treatment with Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events chills, tiredness, body ache, fever was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Pt received PREVNAR 13 on 10/15/14 and 12/9/14.
Fine red rash to arms, trunk, thighs. Bilateral lower back/flank pain.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 24-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Public fund. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
child given expired polio vaccine by accident.  Nurse thought expiration date was 03/31/2021 but it was 03/13/2021.  No adverse reaction or side effects noted.  Parent informed and child re-vaccinated the next week.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Fever-Mild, Additional Details: pt reports feeling \"feverish\" 10 min post vaccine, did not have fever when screened. Tongue began to feel \"heavy\" at around 15-20 min. We administered 50 mg of benadryl. After 30 min, pt reported feeling better, tongue felt \"a little sore\", we offered to call 911, but pt declined. she was with caregiver who was driving her home.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
EXTREME ITCHING  AND RED RASH OVER BODY FROM NECK TO FEET
4/15/21 Pt called stating that she has had some of the symptoms that everyone is talking about with the vaccine.  She stated that Friday after her shot on Monday she had severe tremors, so bad it shook the car, and she went to the ER.  They ordered an MRI without contrast and she is scheduled for an MRI with contrast soon.  She cannot remember the date, but she began having blurry vision in her left eye.  She went to her eye doctor and he stated she had an "eye stroke".  She had injections in her eye today.  I asked her to please call her primary physician as well and she agreed.  I told her I was going to report her symptoms.
No Adverse Event; She states that the vaccination card states Bivalent but the paperwork states Monovalent; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She states that the vaccination card states Bivalent but the paperwork states Monovalent).    Concomitant product use was not provided by the reporter. Patient received additional booster shot. Treatment information was not provided.
arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt). (Dechallenge was negative). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine was put in her arm and same for her husband. Her arm hurt only for 3 days but did not hurt her husband. The patient stated that there were two injections initially and second one was 2 months later she thought. The follow-up could not be possible as no contact details were available.
Narrative: Pt was not treated with medication, was offered water and snacks. Pt reported feeling better at end of visit.
On 07/17/2018, patient received the PPSV23 vaccine 0.5 ml IM into his left deltoid while at a VA primary care clinic appointment. The following morning, 07/18/208, patient presented to walk-in clinic C/P swollen red arm near injection site. Symptoms began that morning when he woke up. No redness or heat was seen at the injection site. The upper left arm was slightly swollen but not tender to palpation. Patient was instructed to ice the area and then use moist heat, and to contact the clinic if he noticed any increased swelling, redness, heat, or streaking. Patient did not have any further issues and this was considered a mild reaction to the PPSV23 (PNEUMOVAX) vaccine.
This spontaneous report as received from a consumer reporting on herself refers to a 69 year old female with no allergies. The patient's medical history included arthritis, back pain, ear pain and breast cancer. The patient stated that at an unspecified time in the past she took ARMIDEX (Manufacturer unspecified) and it made her fell sick and caused pain in her joints. She also stated that Tamoxifen (Manufacturer unspecified) made her dizzy. On an unspecified date between May or June of 2013 MAY-2013, the patient reported that she developed shingles over her left eye a week or two after her husband received ZOSTAVAX. She believes it (shingles) was caused by touching the ZOSTAVAX injection site of her husband's arm after he received ZOSTAVAX. On 25-NOV-2013, the patient was vaccinated with ZOSTAVAX (Dose, route and lot # were not provided). Concomitant therapies included PERCOCET and Methadone Hydrochloride. In November 2013, the patient stated that she developed redness, swelling and soreness of her left arm, at the injection site after receiving ZOSTAVAX. The patient stated that she received ZOSTAVAX to prevent a second outbreak of shingles. The outcome of shingles caused by touching the injection site of her husband's arm is unknown. The outcome of redness, swelling and soreness of her left arm, at the injection site was reported as not recovered. No laboratory tests were performed. The primary reporter considered shingles to be related with ZOSTAVAX. This case is linked to 1311USA012678 (husband experience), from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 6 mins after vaccination pt fainted.  She recovered on her own within a minute and was very diaphoretic and pale, but was alert and oriented x 3.  Pt then stated she was feeling very nauseous and proceeded to vomit.  911 was called and B/P 87/58, HR 91 and O2 99.   EMS arrived B/P was fluctuating and pt was brought to ED for evaluation
This spontaneous report was received from a physician and refers to an unspecified female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 15-MAY-2018, the patient was vaccinated with an expired dose of M-M-R II injection, lot # M006544, expiry date 03-FEB-2018 (exact dose and route of administration were not reported) for prophylaxis. The lot# of the sterile diluent used was N011475, expiry date 08-AUG-2019 (also reported as 31-AUG-2019). No adverse effects were reported.
Case number PHEH2011US07253 is an initial spontaneous report received from a consumer on 18 Oct 2011: This report refers to an adult female patient. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date while she was pregnant and was one month away from giving birth. After vaccination she started to bleed. No further information was provided.
large, red, local site reaction; extreme exhaustion; chills; body aches; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2792L, expiry date 27th September 2021) and (batch number 23JK5, expiry date 13th September 2021) for prophylaxis.   On 23rd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose (.5 ml daily). On 23rd April 2019, several hours after receiving Shingrix, the patient experienced injection site erythema, exhaustion, chills and general body pain. On 26th April 2019, the outcome of the injection site erythema was recovered/resolved. On 30th April 2019, the outcome of the exhaustion, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, exhaustion, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The physician reported that the patient developed a large, local, red, tennis ball size site reaction within a few hours of the injection that lasted for 3 days.  The patient also developed intermittent extreme exhaustion, chills and body aches that started later in the day on 23rd April 2019.  He states these symptoms came and went and lasted for one week, reported that they were all resolved at the time of reporting. The reporter did not consent to follow-up.
feeling feverish; soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of left arm) and PYREXIA (feeling feverish) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm). On an unknown date, the patient experienced PYREXIA (feeling feverish). At the time of the report, PAIN IN EXTREMITY (soreness of left arm) and PYREXIA (feeling feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.