chrisvoncsefalvay/vaers-outcomes huggingface dataset:
welts in her arm and armpit; arm started to get itchy; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), INJECTION SITE PRURITUS (arm started to get itchy) and INJECTION SITE URTICARIA (welts in her arm and armpit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On 09-Jan-2021, the patient experienced INJECTION SITE PRURITUS (arm started to get itchy). On 11-Jan-2021, the patient experienced INJECTION SITE URTICARIA (welts in her arm and armpit). The patient was treated with HYDROCORTISONE on 09-Jan-2021 at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles), INJECTION SITE PRURITUS (arm started to get itchy) and INJECTION SITE URTICARIA (welts in her arm and armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up report included no new information; Sender's Comments: Very limited information regarding these events has been provided at this time. The shingles event may be related to the patient's pre-existing conditions. A causal relationship cannot be excluded for the injection site urticaria and pruritus events.
Arm started swelling around site. Sore, achy pain radiating down the arm.
vision loss/issues with his vision; Bell's palsy/numbness on the left side of his face; The vaccine did not prevent; pain; headache; Information has been received from a lawyer and the patient 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 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. Shortly after receive zoster vaccine live (ZOSTAVAX), the patient developed headaches, numbness on the left side of his face and issues with his vision. It was stated that the vaccine did not prevent shingles(vaccination failure), but rather caused to the patient contract pain, vision loss and Bell's palsy. In response to these symptoms, the patient went to the physician and continue under his/her care. At the time of the report, the patient continued suffering significant medical expenses, pain and other damages. The outcome of facial paralysis, headache, vaccination failure and blindness was unknown.   The reporter considered all the events to be related with zoster vaccine live (ZOSTAVAX).  Upon internal review, the events facial paralysis  and blindness were considered to be medically significant.
patient fainted and fell out of chair onto face. We called 911, EMS came and took his vitals. He recovered rather quickly and said he was feeling much better.
shingles; Information has been received regarding a case in litigation from a lawyer and consumer, referring to the currently 66 years old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) at a medical office.   The patient was treated by a healthcare provider at a clinic for the following injuries resulting from zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
fully vaccinated. He got them/ suspected vaccination failure; got them; lesions; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin lesion. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin lesion were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and skin lesion to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient was fully vaccinated for shingles and he got them anyway but had no pain. The patient had very few lesions. The patient took an antiviral prescription pill and shingles were gone in 5 days. The reporter stated that the vaccines work. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
06/15/21 Patient's mom called and states that Patient had his 2nd Pfizer COVID Vaccine on 06/09/21. On 06/11/21 Patient started to have dizziness & vertigo, lethargy, decrease sense of touch, fever (100.2), leg twitching, sensitivity to light, body aches, nausea, and diarrhea. Patient has been taking tylenol and ibuprofen. Patient's mom states that she has an appointment with the doctor today at 2 p.m. I encouraged her to keep this appointment. RN 06/16/21 I received a phone call from Patient's mom. She states that Patient was seen by the doctor yesterday and the doctor feels the symptoms he is having are from the vaccine and they were instructed to monitor him for the next few days and return if symptoms worsen. She also stated that Patient has been feeling better since this morning. RN
Covid arm- large, hard, hot to touch swollen circle on arm about 2 inches just diameter. Getting worse 2 days later. Itchy at injection site.
This spontaneous prospective pregnancy report as received from a registered nurse refers to her pregnant female friend of unknown age. Date of last menstrual period was on approximately on 22-SEP-2014, date of conception was on approximately 06-OCT-2014 and estimate delivery date would be on approximately 29-JUN-2015. On 09-MAR-2015 at six month pregnant, the patient was inadvertently vaccinated with a dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the pregnancy outcome was pending. Additional information has been requested.
30 minutes after flu vaccine administered pt complained of tingling to lower lip - swelling to lower lip - BENADRYL 25 mg given. Pt then c/o lump in throat - MD called  pt went to MD office.
dose given was not during the time frame of 6 hours after punctured and was past the 6 hour limit. customer will be coming in on 1.27.2022 to get another shot at 3pm that will be in the potency time frame
14 hours after receiving MENVEO, patient vomited once & has been nauseated. No fever. I talked to the patient & she said she's nauseated but able to tolerate toast the ff. morning.
Severe pain at site of injection - 1 hour after injection  Malaise - 6 hours after injection Nausea and vomiting - onset- 22hours after injection
7cm x 7cm area of erythema, warmth treated with KEFLEX BID for 10 days.
Initial report was received from literature on 11 February 2014. The following is verbatim from the article abstract: Although influenza vaccines have saved millions of lives, some have been associated with extremely rare adverse effects such as Guillain-Barre syndrome, Bell's palsy, and optic neuritis. Despite the fact that olfactory loss after an influenza vaccination is noted in one case report, no quantitative olfactory testing was performed. Hence, it is unclear whether, in fact, olfactory dysfunction can be associated with such vaccinations. This study was designed to (1) identify patients from the Center who attributed their empirically determined chemosensory disturbances to influenza vaccinations and (2) determine whether influenza vaccinations add to the degree of olfactory or gustatory dysfunction due to other causes. Methods: A retrospective analysis of self-reported etiologies of 4554 consecutive patients presenting to the Center with complaints of chemosensory dysfunction was performed. Those who reported dysfunction secondary to influenza vaccinations were identified. Additionally, in a subset of 925 patients for whom detailed inoculation histories were available, it was determined whether the number of lifetime inoculations added to the deficits due to other causes. Results: Nine of the 4554 patients (0.19%) attributed olfactory disturbances to an influenza vaccination. None complained of taste dysfunction. All nine had abnormally low scores on the Smell Identification Test (p < 0.001), with three being anosmic and six microsmic. Seven had elevated phenyl ethyl alcohol detection thresholds (p < 0.05). Two cases exhibited mild-to-moderate loss of whole mouth taste function. Of the 925 patients, no association was evident between the number of lifetime vaccinations and the chemosensory test scores. In accord with previous studies, age and sex were significantly related to the test scores. Conclusion: A very small percentage of the 4554 patients evaluated (0.19%) attributed their chemosensory dysfunction to a prior influenza vaccination. No influences of the number of lifetime influenza vaccinations on the test scores were evident in the subset of 925 patients whose dysfunction was due to other causes.
Pfizer-BioNTech COVID-19 Vaccine EUA Symtoms within 30 minutes after the shot: 1. Dizziness, Vertigo-like, head and eye-sight feels different, everything seems spinning and blurred. Feels like fainting. 2. Sweating even though weather is chilly and I am wearing tank tops for easy access for vaccines. 3. Kept on burping, feels a little bit nauseous.  They let me sit down and wait until I feel better.
off label use; Interchange of vaccine product; The last one they got was the Pfizer because she was hoping she wouldn't get sick but did get really really sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024492 (Moderna), 149206 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack" (unspecified if ongoing); "stroke" (unspecified if ongoing); "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PRADAXA; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; LATUDA; ASPIRIN [ACETYLSALICYLIC ACID]; SENNA [SENNA ALEXANDRINA LEAF]; COLACE; KLONOPIN; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]. Vaccination history included: coviD-19 vaccine moderna (Dose:01, Lot: 024M20A), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache"; coviD-19 vaccine moderna (Dose:02, Lot: 038A21A), administration date: 13Mar2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "head felt like a ocean", "very very dizzy", "headache"; coviD-19 vaccine moderna (Dose:03, Lot: 0466210), administration date: 24Oct2021, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache"; coviD-19 vaccine moderna (Dose:04, Lot: 064L21A), administration date: 29Apr2022, for COVID-19 Immunization, reaction(s): "got very very sick", "arm hurt", "nauseous", "diarrhea", "very very dizzy", "head felt like a ocean", "headache". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine product"; ILLNESS (non-serious), outcome "unknown", described as "The last one they got was the Pfizer because she was hoping she wouldn't get sick but did get really really sick".  Additional information: Two blood pressure meds  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sixteen days after receiving the Moderna vaccine, I began noticing my lips felt odd under my mask.  After I got off work at 6:00 p.m, I realized I could not suck through a straw.  Soon after I went to the emergency room and was diagnosed with Bell's Palsy after ruling out a stroke with an MRI.
Patient presented 11/23/21, 1 month after booster shot, with chest pain, then again 11/29/21- found to be Pericarditis
Patient described that the site of injection was vary stiff for 3-4 days. The site of injection was in a lot of pain for 2 days. There are 2 bruises with purple and yellowish color near site of injection, but patient denied taking any blood thinner (Aspirin, COUMADIN, etc).
This spontaneous report was received from a phlebotomist and refers to a 60 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 10-MAR-2016, the expired dose of ZOSTAVAX (lot # K023623, expiration date: 20-FEB-2016, dose, route of administration and injection site were not reported) was administered to the patient. The patient has not reported any adverse effects. Product quality complaint (PQC) was not involved. Additional information has been requested.
Second year patient was diagnosed with shingles in a row - 12/22/10 - shingles - treatment Acyclovir 2/28/10 - varicella - treatment Acyclovir.
Patient got nauseated, blurred vision, sore neck, chills that would not go away. 911 called and ambulance transported
pt recv 2nd dose of vax 8JAN96 & exp a migraine h/a requiring therapy w/IV pain med in ER;11JAN96 pt devel a mild rash; pt was exposed to chicken pox 8JAN96 & varicella antibody titer was neg;
exp very severe h/a, ear pressure, neck pain, nausea, diarrhea x 3, vomited; slept took Ibuprofen x 3
No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: S031881, expiration date: 07-APR-2021) 0.5 ml (route of administration was not provided) diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
1/14/2021 2am-chills & body aches 4am- chills & body aches 9am- body aches/fatigue  11am- slight chills/body aches/fatigue 12am-2pm- body aches/fatigue 2pm- nauseous/body aches/fatigue 4pm- vomiting/body aches/fatigue 6pm-7am- nauseous/body aches/fatigue/headache 1/15/2021 7am-12pm- fatigue 6pm-9am- nauseous/fatigue  9am-9pm- nauseous/fatigue  1/16/2021  7am-9pm: nauseous/fatigue  1/17/2020  no symptoms
long-term (6 months) urticaria; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  An adult patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "long-term (6 months) urticaria".  Additional information: The reporter wanted to know that post the vaccination with dose 3 of BNT162B2, the event of urticaria has been reported before.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myopericarditis - 22 yo man with no significant PMH presented to the ED on 7/26/21 with 4 days of constant, progressively worsening chest pain. Pain is sharp and pressure over mid-chest, 8-9/10 at worst, worse when laying flat on back and deep inspiration, improved with Tylenol at home but then pain returned. Pain controlled with Tylenol, colchicine, high-dose ASA, later switched to colchicine and Ibuprofen given improved creatinine. Pain improved and w/u including EKGs, CXR, Echo, CT chest, Cardiac MRI completed over following days. Discharged on 7/29/21 with plan to continue 3 months of colchicine and taper ibuprofen.
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the facility and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the facility given the increase in dose administered.
red place that was moving down her arm from where she got the shot; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the arm, administration date 26Feb2021 (Lot number: EN6198) at the age of 82 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Lot Number: EL9269), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "red place that was moving down her arm from where she got the shot".  Additional information: The patient also described the event as big red blotch that was 2 inches down from where she got the shot. This second shot was on 26Feb2021 and she noticed the red spot almost immediately, she would say the next morning and it seemed to be getting bigger. She confirmed it was ongoing and has worsened. She clarified the spot was 2 inches down from the needle injection site so the reddened area was not directly over the injection site it was 2 inches down from that. The red area was probably over an inch wide.   No follow-up attempts are possible. No further information is expected.
Patient reported redness from the injection site and travelling down her arm 2 days after receiving the ZOSTAVAX vaccine. She came into the pharmacy and showed me the area. To me it looked blush pink and a little swollen. The area was about 6 in. in length and 2-3 in. in width.
Chills 24 hrs after receiving vaccine - lasted 4 hours Fatigue 26 hours after receiving vaccine - lasted 8 hours Red, warm, itchy rash approximately 2 inches below injection site - appeared 48 hours after vaccine; rash still present 5 days after vaccine
No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD.; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (1 dose, lot # X002292, expiration date was reported as 21-JUN-2024, but upon internal review was established as 21-JUL-2024, strength and route of administration were not reported) for prophylaxis.  On 12-JUL-2023, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored at temperature of 6.93 F, the time frame was 1 hour and 13 minutes, and the vaccine was administered to the patient (product storage error). There was also a previous temperature excursion on unknown dates that the vaccines were stored at 52.01 F for 2 hours and 6 minutes and stored at 9.74 F for 4 hours and 34 minutes. No additional AE/no PQC (no adverse event).
The day after the vaccine I had normal body aches, an extreme headache. My neck was so stiff and had a serve headache. The pain in my neck and head didn't go away I went to the Urgent care they gave me IV meds and tested me for Covid, and came back positive.  I went on a leave and was out for 10 days and had a repeat test and came back negative, by then my symptoms went away but took a while.
October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037a21b and 001a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN, LEVOTHYROXINE, MONTELUKAST, LOSARTAN, DILTIAZEM, ALBUTEROL [SALBUTAMOL] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice). At the time of the report, NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to the doctor that gave him antibiotic and also mention that he is going on a trip and that wanted to know if these is a normal side effect. Lastly he stated that he will be  going to go to the doctor   This case was linked to MOD-2021-368936 (Patient Link).
Per patient report, entire left side of body became numb 48 hours after vaccine was administered. Patient has refused to seek medical attention for symptoms.
3 inch warm, raised, red area developed within 12 hours of the inoculation. No itching, sensitive to touch. Also had slight headache & neck pain. The rash persisted for 5 days