chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 17SEP96 & exp swelling, redness, lumps, or bruising; pt c/o hot swelling in deltoid;had t102 the noc a/; temp @ time of report was nl;pt advised to consult MD if any more temp;c/o bones hurting & tightness in chest;
No adverse events: Patient was given 0.6ml instead of the recommended dose 0.3ml.
Marked left thigh swelling, induration, erythema (thigh circumference 35cm on left, 31 cm on right).  Treatment: Benadryl and Motrin.
pt recv ax & pt exp inc in liver enzymes (SGPT 69; SGOT 39) according to pt father who was also MD;
Patient's mom called saying that about 4 hours post Pfizer vaccine administration of her 2nd shot. She was having red bumps on her arm and small patches on her leg. Mom said she did not have any type of reaction when she received her first Pfizer vaccine. I recommended patient to take benadryl and monitor for any additional signs of anaphylaxis. If rash spreads or other signs such as trouble breath, swelling of face, etc happen she should go to emergency room. I will be filling out the VAERS form as soon as I submit this event.
devel chickenpox 5MAR99 approx 40 chickenpox on face, chest, back, legs;DPH given;
After receiving the vaccine she states she had a severe headache that evening and her vision started worsening after that point. States she saw an optometrist at eye dr. They referred her to her private MD. After seeing MD was referred to report to health dept. Dr in the area is doing a work up for diabetes, thyroid and other possible illnesses.
Patient received wrong Moderna vaccine.  She is a bone marrow transplant patient.  She was due for the 3 dose original Moderna.  She had no adverse events.   I have left a message to speak with her cancer doctor.   Based on the guidelines, patient needs the original Moderna now and would then follow up in two months with the bivalent booster.  I discussed this with the patient.  I am waiting to speak with her doctor to discuss the action plan
Sudden onset of flu-like symptoms during evening: high fever, chills, headache, nauseous. Ran 102 degree temp throughout following day (perceived improvement from prior night). Symptoms abated about 6:00pm. Lingering minor symptoms 12/10/11.
Patient requested first dose of Moderna vaccine.  Dose was drawn from a vial left-over from the previous afternoon's use and not discarded at the end of the day.  Discovered after the dose was administered.  Moderna contacted on vaccine viability of dose at room temperature >12 hours but less than 24 hours.  Dose is viable and does not need to be repeated.
Patient was given SC ZOSTAVAX, appeared to be doing fine while sitting in waiting area for other prescriptions. After approximately 10 mins she came to pharmacy counter to pay for prescriptions. She suddenly became confused, then unable to talk or stand. With her son's help she was lowered into a chair. She remained unresponsive but with visible and audible breathing for several minutes. During this time, 911 was called and an ambulance was activated. Eventually, patient was slowly able to regain consciousness and begin talking. She denied any signs of allergic reaction such as itchiness, facial swelling, or difficulty breathing. At that point, the patient and he son requested that the 911 call and ambulance be canceled. The son was comfortable with bringing her to her doctor's office in his own car for her to be seen. Patient was helped out to her car. A follow up phone call to her home about a hour later found that she was doing okay with no recurrence of symptoms. She had discussed event with her doctor and made him aware.
2nd Moderna shot was given 16 days early. Patient did not have this CDC vaccine card and did not remember when his first Moderna shot was given. Access to the EMR was not available at time of vaccine to confirm the first dose date.
Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2  cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with VAQTA lot # J014587, expiry date 15-JAN-2016, (dose, route of administration were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
numbness in arm and shoulder, radiates down to fingers. pain in whole arm, not just localized to injection site. injection site is worse though. have tried ice and tylonol
Pt developed hives over trunk and extremities. Treated with Allegra 180mg X 1. This medicine was not effective and the hives resolved in 5 days.
Pt experienced chickenpox subsequent to receiving one dose of varicella virus vaccine live. There were greater than 50 lesions with a head to toe rash. Pt did have a recent exposure to chickenpox. Pts sibling had a similar experienced following exposure to varicella virus vaccine live.
Very swollen Eyelids 3/22-resolved.  Hives on face, neck, ears, elbows, knees, gluteal muscles 3/23-current, worse on right side of body.  Antihistamine (azelastine) administered and beneficial.  Throbbing, sever intermintant Rt side temporal headache 3/22-current. Slight dizziness
A report had been received from a health professional concerning an adult female patient. No information was provided regarding relevant history, concomitant diseases and concomitant medication of the patient. The reporter stated gas of approximately 203 doses of FLUMENT were being autoclaved for destruction whose expiry date was 24-NOV-2014, patient was exposed to fumes on 28-NOV-2014. On 29-NOV-2014, her dentist noticed that she had flu like symptoms on dental technician. The outcome of the event of flu like symptoms on dental technician exposed to fumes/gas of approximately 203 doses of FLUMIST being autoclaved for destruction was unknown. The report was considered to be non-serious by the reporter. Summary of follow-up information received on 28-DEC-2014, from health professional: Reporter type of other changed to health professional and updated as primary reporter. Primary reporter details added. Ethnic origin added. Lot number of suspect drug added. Start date of exposed to fumes and gas of approximately 203 doses of FLUMIST autoclaved for destruction updated.
Pt recv vax on 10/7/98; on 10/8/98 pt exp indurated & warm LA
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm was really sore for a while, slight fever, really tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, really tired, headache, arm was really sore for a while and felt like shit was not reported. This report was non-serious.
Information has been received from a health care professional via Pfizer referring to a currently 57 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, dose, frequency and route were unknown) for prophylaxis. On an unknown date, the patient experienced swelling. The outcome of the event was unknown. The causality was not reported. On an unknown date, the patient was also developed dexamethasone sodium phosphate (DECADRON) anaphylaxis (captured in MARRS# 1706USA002026). Additional information has been requested.
I had a traveling itch right after injection, frequent, moving every 1 to 2 minutes it would move through my body. I started to felt like swelling in my face and arms and body started getting red and my face got puffy. Within five hours I started to feel chills, body aches, feverish, and diarrhea. I had horrible brain fog, couldn't remember passwords. I had under arm swelling and pain in my lymph nodes, extreme fatigue.
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lot # L038534, expiration date 19-AUG-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002598: US-009507513-1701USA003706:
Patient was given Pfizer on 4-12-21 2nd dose but her 1st dose was Moderna on 3-12-21
Continuous numbness in my left arm and hand. I've been referred to see a Hand Surgeon & specialist.
Extreme arm pain that evening of the injection along with tiredness; awoken from sleep with severe abdominal pain which 30 minutes later resulted in diarrhea and shaking chills. Continued bouts of diarrhea for 5 hours. The pain did not begin to subside until 4.5 hours after initially presenting.
Itching, redness, swelling at injection site notified to use BENADRYL, TYLENOL & ice.
Symptoms started that night with extreme fatigue. Extreme fatigue the next day, followed by fly/stomach flu symptoms the next two days. Not a huge deal, just reporting so there's info out there:) Just took Tylonel and drank a lot of fluids, as I would if I had the flu.
Immediately felt the vaccine ? pain in arm site,  headache and nausea.  Muscle aches and a slight tightness in chest about 12 hours later. Three days later (now) still have headache, muscle aches and an uncomfortable feeling in chest, although no chest pain.
This spontaneous report as received from a physician, as part of a marketing research program conducted refers to a pre-adolescent female patient. On an unknown date the patient was vaccinated with the fist dose of GARDASIL dose, route and lot # not reported. On an unknown date, reported as when administering GARDASIL, the patient experienced injection site reaction. Action taken for GARDASIL was reported as unknown. The outcome of injection site reaction was reported as recovering/resolving. The reporter considered injection site reaction to be related to GARDASIL. The reporter considered injection site reaction to be a non serious adverse event. Additional information is not expected.
Swelling in her hands/the swelling went down mostly, but not completely/left arm had the more intense swelling; experiencing redness, like a glove effect where the redness cuts off at the wrist; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-022222-4609.  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RESTYLANE, start date: 2013. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling in her hands/the swelling went down mostly, but not completely/left arm had the more intense swelling"; ERYTHEMA (non-serious), outcome "not recovered", described as "experiencing redness, like a glove effect where the redness cuts off at the wrist"; BURNING SENSATION (non-serious), HYPERSENSITIVITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "not recovered" and all described as "Burning and when using her hands a lot she experiences hypersensitivity and loss of strength". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient reported the day after her injection with Restylane in the hands she developed swelling in her hands and after a few days was started on a prednisone dose pack and antibiotics fearing an infection. Patient stated the prednisone helped the swelling but now since the swelling went down mostly, but not completely, she had been experiencing redness, like a glove effect where the redness cuts off at the wrist, burning and when using her hands a lot she experienced hypersensitivity and loss of strength, and that all symptoms were still ongoing since Oct. Patient reported that she got the first dose of Covid 19 vaccine by Pfizer the day before she was injected with Restylane. NP stated she believed this reaction was since she got the Covid vaccine and not as much from the Restylane because she had Restylane in the past, several times since 2013, as well as Juvederm and Sculptra all with no problems. She got the Covid vaccine in her left arm and her left arm had the more intense swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of SHINGRIX and at the time of reporting the patient experienced pain that lasted for several months to the point that they received both a MRI and X-RAY. It was unknown if the patient experienced pain after receiving the 1st dose or 2nd dose of SHINGRIX. No other resolution or details were provided.
Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 12-APR-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-FEB-2016, the patient was treated at an eye institute for herpes zoster keratitis, or herpes that had spread into the eyes. On or about 27-MAR-2017, the patient was also treated for new and worsening symptoms of blistering vesicular rashes, which were diagnosed as herpes zoster or shingles. On or about 12-DEC-2016, the patient sough subsequent treatment for continued and worsening symptoms of shingles pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to shingles. The patient has been prescribed gabapentin and gabapentin (NEURONTIN) for management of her extensive and lasting 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 and pain and suffering and other damages. Upon internal review, herpes zoster keratitis/herpes that had spread into the eyes was considered to be medically significant. Additional information has been requested.
Patient presented to clinic with erythema, swelling and warmth to the left upper arm where the pneumonia vaccine was given.
Extreme pain  Dizziness Passing out Ocular migranes Headaches Zero use of the arm even years later Random numbness and tingling over body Lack of coordination  Headaches Ringing in ears Joint pain
Large localized reaction > 10 cm, erythema, no discharge on rt lat thigh/injection site.
Rash that went over my entire body; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:30 (Batch/Lot Number: EW0167) (at the age of 54-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, was the patient was diagnosed with COVID-19). The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EW0153) for covid-19 immunisation and had no adverse effect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced rash that went over my entire body. Seriousness criteria was considered as non-serious. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with oral steroid. The outcome of the event was not recovered.  Information on Lot/Batch number is available; Further information has been requested.
sore arm after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 026B21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant  medicines include low dose aspirin, multivitamin, B12 shot once a month.   This case was linked to US-MODERNATX, INC.-MOD-2021-069278 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069278:2nd dose
h/a frontal starting 26OCT; cont to the present; soreness lt side of neck;
I contracted COVID-19 while traveling on 05/29/2022 with symptoms sore throat, cough, congestion, body aches, and hives on my ankles. It was recommended I take Vitamin C, and Zinc. I was ill for 5 days before my symptoms began to resolve. I do have a recurring rash and blisters on my ankles and finger.
her hair started falling out; Sore Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and ALOPECIA (her hair started falling out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (It took a while for the pain from the knee replacement to go away.) in July 2019 and Hernia repair (Hernia surgery 9 days before getting her vaccine).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced ALOPECIA (her hair started falling out). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown and ALOPECIA (her hair started falling out) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-044695 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received, added new event Alopecia, historical condition and event outcome.