chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported expiration date 09-JUN-2012) on 11-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Around noon, pt has redness and swelling to injection site, complains it was itchy and hurt, was given hydrocortisone cream and 1 Benadryl for relief, eval by nurse and PA
Vomiting, Diarrhea, high fever 103.5, lethargic, not eating, drinking very little.  Not playful.
Pt w/smoking hx and strong family hx of premature CAD p/w worsening severe, dull ache pain radiating in left arm that's been intermittent over past week and associated w/tightness in neck/chest & diaphoresis/SOB.  Did receive 2nd Moderna vaccine prior week (5/7 & 6/4) and described feeling poorly x24hr, then started feeling above symptoms.  EKGs showed sinus rhythm w/ST elevations (V3-V6), II, & aVF w/troponin 8.32 and 3-hr troponin 13.58. Was admitted & started on hep & nitro gtt, ASA, beta-blocker/ACE-I. CRP=6.1, ESR= 17. CXR was clear. MRI confirmed myocarditis & heart cath revealed no obstructive CAD. Pt improved & was ultimately discharged w/weekly CRP & clinic f/u in 1 mos.
Arm began to itch at injection site, and began to become a bit swollen and red. Father reported applying an anti-itch cream and giving him diphenhydramine syrup. At time of follow up contact 1230 pm father reported that patient was doing fine, did not see any signs of difficulty breathing. Patient reported that his arm was a bit sore but felt fine otherwise.
This spontaneous report as received from a physician refers to a 48 year old male patient. The patient's medical history included bone marrow transplant 5 years ago. The patient was vaccinated with 0.5 ml  (Merck) VARIVAX (lot# unspecified) subcutaneously on 26-SEP-2012 with no concomitant medications. No other co-suspects were reported. on 17-OCT-2012, the patient was diagnosed with widespread varicella. The patient had widely distributed lesions of varying stages. Some lesions were papular/pustular with an erythematosus base and some lesions were vesicular. The patient had been prescribed VALTREX. The outcome of widespread varicella was reported as recovering. The patient had sought medical attention via office visit. Additional information is not expected.
Site: Pain at Injection Site-Medium, Systemic: daughter described it as \"ants crawling under skin\"-Severe
Raised red rash, burns, itches, 2"x 1" oval, slight swelling. No treatment. 11:30 A.M.
No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022) 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 (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022).    No concomitant medication was reported.  It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. No treatment information was reported.  This case contains information for patient 5th out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case patient 1
Patient was 12 years old at time of vaccination and  received the pediatric formulation of the COVID19 Pfizer-BioNTech vaccine. No adverse reactions occurred during or after the vaccination and 15 minute observation period.
Body aches, Intense Migraine that lasted over a week (included aura and nausea), upper respiratory tightness and cough.  I continue to have fatigue, body aches, and an upper respiratory cough that seems to be worsening. I am going to the urgent care 9/9 as I cannot get into my primary care physician until 9/24. I have continued to test weekly for covid and continue to come up negative.
Chills, fever, achy joints, metallic taste in mouth.  Chills/fever- day into evening after. Metallic taste in mouth, 2 days after vaccine.
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-Jul-2023 This case was reported the patient via interactive digital media. The patient got the shots over a ago and on the recent time had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Pt vac with Influenza developed pulling in legs & arms about 4 days after shot. Also experienced weakness & numbness in arms, hands, legs & feet 7 days after shot. Seen by neurologist - no nerve damage, thinks may be caused by flu shot.
I received the MMR vaccine again in 1983 due to the fact my testes said I had no immunities, I had a huge joint flare which was my first exposure to RA,. Now this vaccination and within 5 days broke through my treatment of 32 years with horrific psoriasis and joint pain, which is why I have been on these toxic drugs for 32 years.
arm got swollen firm at injection site; red at the injection sight; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever). At the time of the report, VACCINATION SITE SWELLING (arm got swollen firm at injection site), VACCINATION SITE ERYTHEMA (red at the injection sight) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant medical history or concomitant medications provided.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that she had heard from other pharmacists that patients were reporting flu like symptoms with SHINGRIX. The symptoms were lasting for about a day.  No specific numbers or patient identifiers known. She was unaware if these events have been reported to GlaxoSmithKline by those pharmacists. This case has been linked with US2018147980, reported by the same reporter.
Fever, pain, swelling at vaccine site. Improved the following day 3-9-11 with treatment of BENADRYL & TYLENOL.
Pt completed COvid 19 Vaccine series 01/22/2021, tested positive for Covid 19 03/29/2021
Lots of severe painful and scarring acne, I've never had a problem before in my life, deep rooted black head forming in my hair follicles. I've been my GP and gotten some cream that somewhat helps but doesn't make it go away, my mom who will be submitting a report later is experiencing the same thin. We were vaccinated at the same location at the same time.
Congestion, Runny Nose, Headache, Body Ache, loss of taste and smell, Cough
numbness and tingling all over, shortness of breath,  left arm pain  Narrative:   Other Relevant History:
At ~12 hours of receiving the pfizer COVID-19 vaccine, I noted several hives on my right forearm and experienced some body itching and onset of chest tightness and wheezing. The chest tightness and wheezing could be alleviated with inhaled albuterol which a would use every 4-6 hours as needed. Wheezing episodes lasted for 2-3 weeks after the vaccine.
1) Pain & tenderness at injection site began within 24 hours.  2) Tenderness and swelling of the lymph nodes in the armpit of the same arm of the injection began within 72 hours and has since expanded into tenderness and swelling of lymph nodes in chest to collarbone within 96 hours of injection. Side effect still present at time of submission. 3) Fatigue and muscle pain began within 24 hours of injection and last for approximately 24 hours.
On day following immunization he felt tired and achy. Two days after immunization he also experienced sinus drainage, slight headache and was sleepy. Treatment was rest. All symptoms have resolved.
Vaccine liquid conjugate component drawn up and administered to pt. Powder component not reconstituted prior to administration and thus not administered to patient.
Patient received yellow fever vaccine 2 weeks prior to visit. Co of vague malaise and nausea 3 days after vaccine followed by large hives. When seen on 3/26/08, patient had fine papular ithcy rash on trunk, face and limbs.
petechiae; This is a spontaneous report from a contactable pharmacist (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the arm on 27Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced 6 spots of petechiae on the inside of the arm that she received her vaccine. She stated that she got shot on outside of arm. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
High fever, severe swelling on entire right side of vaccine injection, severe headache, racing heart, heaving chest, lethargic behavior for 3 days
BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature: This report concerned a patient of unspecified age, sex, race and ethnicity. The objective of this was to analysis the SARS-CoV-2 specific antibody and cellular responses in healthy vaccine recipients who experienced breakthrough infections a median of 50 days after receiving a booster mRNA vaccine. The patient's height, and weight were not reported. The patient had no comorbidities. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient received non-company suspect vaccine Elasomeran (Moderna) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had mild upper respiratory tract symptoms and experienced breakthrough infection (Dose number in series: 2) which was confirmed clinical vaccination failure (Dose number in series: 1). It was reported that, the days between booster shot and symptom onset was 50, days between symptom onset and blood drawn was 7, and days between booster shot and blood drawn was 54. Laboratory data (dates unspecified) included: Angiotensin converting enzyme (ACE inhibiting antibodies) (NR: not provided) slightly higher, and Antibody test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran (Moderna) was not applicable. The outcome of the confirmed clinical vaccination failure and breakthrough infection was not reported. The author emphasized that breakthrough infections with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested. This case, from the same reporter is linked to 20220430845 and 20220452198.; Sender's Comments: V0: 20220452187- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20220452187- covid-19 vaccine ad26.cov2.s - breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient was very nervous prior to administration.  After receiving the vaccination, pt walked back to his waiting area, then asked for assistance.  He lost consciousness for a few seconds and briefly convulsed/arms contractured up.  This lasted less than 20 seconds in total but he was slow to fully regain awarenesss/consciousness.  This returned over the course of 1-2 minutes.  EMS was called and responded.  They spoke with the patient but by this time he had consumed 8-16oz liquid, eaten a snack, and was fully aware and alert.
Fever 103F with chills, vomiting X2, Severe Headache and 4-5cm local injection induration/pain.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant and treatment medication were reported. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. This case pertains to the 141 patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
The second vaccine caused swelling in arm directly after being vaccinated, caused itchiness on about 3/4 of my arm.  It took 8 days for symptoms to clear. After the first vaccine it caused arm swelling as well and I was given antibiotics by primary care physician which helped reduce the swelling.
Within 24 hours of the Omicron booster, I had signs of a mini-Covid infection that kept me in bed for 24 hours.  Prior to that I had never had Covid.  This was on 10/23/22.  Approx 3 weeks later, I started to see burst micro vessels in my R upper arm. Within 24 hours my R forearm was tight and my hand was slightly swollen.  Being a pharmacist I was suspecting a DVT at this time. I waited 24 hours and when the R forearm tightness and R hand swelling did not subside with icing, I presented to the Emergency Room.
Facial nerve sensory disorder, palpitations, dyspnea. Treated with prednisone, treated in ER along with multiple labs and tests
Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022; Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Patient received the vaccine on 09-Apr-2022 but it had got expired on 01-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that he thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. Caller stated 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022 Date the vial was initially stored in refrigerator- 04-Apr-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided.
arm swelled up really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelled up really bad". The event "arm swelled up really bad" required emergency room visit. Additional information: Many years ago she was talked into getting the pneumonia shot by a doctor. She had to go to the Emergency Room because arm swelled up really bad. It was many years ago and not provided with details. Ever since then she never got a shot. Relevant Tests: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) formulation coded under Solution for injection in pre-filled syringe instead of unknown.
Case number PHEH2012US005261 is an initial spontaneous report received from a physician on 02 Mar 2012 with a follow up information received on 24 Apr 2012. This report refers to a 17-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not provided. Her vaccination history included administration of MENACTRA (other manufacturer, batch number: unspecified) on 23 Jun 2008 and it was well tolerated. She was vaccinated with second dose of MENVEO (batch number: M10127B) intramuscularly on the left deltoid on 23 Feb 2012. On 27 Feb 2012, she experienced blurred vision, headache, pain on the right side of neck and numbness on fourth and fifth right fingers and arm. It was reported that subsequently she experienced tingling in her right arm. A history of injury was not reported. Magnetic resonance imaging (MRI) without contrast of brain was negative. It was reported that MRI with and without contrast was performed and the findings were compatible with intracranial hypertension. She was admitted in hospital for spinal tap and the pressure was up. Drainage was performed. The outcome of the event was reported as condition improving causality was assessed as possible to vaccine administration. Follow up received on 24 Apr 2012: Vaccination history added, vaccination date of MENVEO, events, outcome and causality updated.
Thigh red and warm to the touch the day after receiving Dtap vaccine at the site. Red the evening of the vaccine.
09/29 Soreness, swelling, redness, heat at inject site. Unable to raise arm that evening. Tylenol, ice on site. Better 09/30. Devel rash around site 10/1, then rash other arm. Face flushed. Face, neck, ear itched. Benadryl. Not resolv 10/8.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: After patient received covid moderna bivalent and flu vaccine, he asked for water. I was going to get water for him but his head suddenly dropped down on the right side and he got unconciuos.  I hold him so he would not fall off the chair and call for help. RN came and help me to put him straight on the chair. The patient regained conciuosness but he did not awared of what happened.  the patient's BP was low 78/52 HR 74 but he did not want to call paramedic. Pt 's BP was 113/74 after 10 mins