chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm numbness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Arm numbness), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
This spontaneous report was received from a nurse prescriber via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose, and frequency were unspecified), subcutaneously, for prevention of shingles (prophylaxis). On an unknown date, the patient experienced pain at the injection site (vaccination site pain) and then, on an unspecified date, was diagnosed with shingles in the back (herpes zoster). The patient sought for medical attention with the reporting nurse prescriber, and received an unspecified anti-viral medication. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster and vaccination site pain was reported as recovered on unspecified dates. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Day after vaccination (18/MAR/2021)--fatigue, body aches, chills.  Physically felt as if temperature was elevated--but when measured, no temperature elevation was found.  Symptoms lasted entire day, were gone the following day.  Two days after vaccination (19/MAR/2021)--injection site soreness.  Note that site was not at all sore on either date of injection (17/MAR/2021), or day after.  Soreness lasted approximately two days.
Information has been received from a registered nurse and a pharmacist concerning an approximately 67 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z). On 14-OCT-2010 the patient returned to the practice complaining of chills, swelling and tenderness below the injection site. Nurse reported that the physician stated that the swelling appeared to be consistent with cellulitis, and that he started the patient an unspecified dose of MINOCIN. At the time of this report, the patient's outcome was not reported. The physician is concerned about this lot number and was hesitant to give other vaccinations with the same lot number. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning a 67 year old male (previously reported as female) patient with no other pertinent medical history who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot#667912/0933Z) into the right deltoid and a dose of FLUZONE (lot#M3654AA) into the left arm. There was no illness at time of vaccination. On 14-OCT-2010 the patient developed red, swollen and tender from injection site to elbow. He was diagnosed with cellulitis. There were no diagnostics laboratory studies performed. On 20-OCT-2010, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
High Fever reached 103.4, chills, headache, body ache, nausea, dry cough, loss of taste, feel of bitter taste.
Within 12 hours, I had a headache and slight fever.  Ever since receiving the vaccines, I have been experiencing diarrhea on and off, until 10/29/2021.  I will be having a stool sample done on 11/1/2021 to see if there is anything else going.
Several hours after vaccination, pt experienced pain at site and to entire upper left arm that kept her up. Patient came into clinic next day for assessment, site was warm to the touch with swelling and slight redness covering 90 % of her upper outer left arm.
Injection site hives; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced an allergic reaction kind of hive-like around the injection site.  No laboratory details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event is not recovered/ resolved.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt experienced profuse sweating and some lightheadednes.  Also had some tingling in the fingers.  After sitting for awhile with fan and ice pack on back of neck patient recovered and was able to leave on his on accord.
Patient received second pediatric COVID Pfizer vaccination and immediately complained of throat tightness, difficulty breathing and began making choking noises. When asked to rate how difficult it was to breathe (1 = no difficulty, 10 = impossible to breathe), patient stated their breathing was at a 6. 911 was called and an ambulance was dispatched to vaccination location. Patient then felt better without any medical intervention. Patient was able to swallow without difficulty and left with no complaints.
The day after my second dose of the Pfizer-BioNTech vaccine I started to feel tingling and numbness in my right arm.  I am attributing this to the second dose, because the first dose was administered in my left arm several weeks prior.  Over the course of the next six months, I continued to feel numbness and tingling my my right arm.  The numbness started in the upper part of my arm and migrated to my hand and fingers.  The problem eventually went away, but it was uncomfortable for about six months.  I liken the sensation to what one feels when your "arm falls asleep" due to lake of blood flow.
COVID 19 Treatment; COVID 19 Treatment; tested positive again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "breast cancer", start date: 2018 (unspecified if ongoing), notes: breast cancer 4 years ago (no current treatment). Concomitant medication(s) included: OMEPRAZOLE; FAMOTIDINE. Past drug history included: Known allergies: codeine, reaction(s): "known allergies: Codeine". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "tested positive again"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Covid-19 treatment; (25Aug2022) Negative, notes: testing negative for two days; (26Aug2022) Negative, notes: testing negative for two days; (27Aug2022) Positive, notes: tested positive again for two days; (28Aug2022) Positive, notes: tested positive again for two days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Product for COVID 19 treatment, treatment start date 20Aug2022, treatment stop date is 24Aug2022 Indication for treatment of COVID-19. Experienced relapse and re-emergence of symptoms on the 4th day after finishing Paxlovid; tested positive again for two days after testing negative for two days. Adverse event start date: 28Aug2022.adverse event start time is 02:00 AM, no treatment for adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After a couple minutes of receiving vaccine, patient stated she felt a little light headed. She appeared to pass out in the chair and was not responding to her name for a couple seconds. After less than a minute, she opened her eyes and was responsive again.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN PULMONARY EMBOLISM, UNSPECIFIED.
Breakthrough COVID-19 case. Pt contracted COVID after receiving both doses of the Moderna Vaccine.
Large red circular welt at the site of injection measuring approximately 6cm in diameter.  The thigh swelled up, the welt felt very hard and hot to the touch.  At one point it resembled a blister.  It slowly appears to be fading.  3 weeks since the injection, it looks like a large bruise (though much lighter than it was originally) and still has some hardness to the touch. This was all a reaction to a Prevnar vaccine - her 4th dose with no prior reaction.
10 hours after receiving the second vaccine, nausea, all over body ache, chills lasted 3 days, about week later right arm was so sensitive and ached from wrist to side of neck for 2 months, couldn't life anything.  3 weeks after vaccine client developed a "severe chest cold symptoms"  felt like everything was in her lower lungs and she coughed until her muscles were excruciating sore and separate a rib on the left back area.  Still having issues and following up with PMD having labs, xrays to assess concerning continuous symptoms, and is nauseated daily without vomiting.  Client is  very weak.  heaviness in chest and throat still.
Information has been received from a RN concerning a 6 month old female pt who, post vax, within minutes, mother notified office staff that the pt's legs became blotchy, turned purplish, and had a dusky appearance (mottling). The pt was seen by the physician, who noted that only the left leg appeared as the mother reported. The pt's left thigh appeared blue/red dusky, post vax. The color of the leg improved after the pt's diaper was removed.  Follow up on 03/15/2001: "Information has been received from a RN concerning a 6 m;onth old Caucasian female patient who on 05/19/1999 was vaccinated with a third dose of hepatitis b vaccine recombinant (yeast) IM in the right lower thigh.  Concomitant vaccinations that same day included a third dose of diphtheria toxoid (+) pertussis
Red, hot, swollen double the size of his shoulder and all the way down to his elbow.
Teeth chattering chills off & on for two days. Now just chills. Upset stomach  for 5 days. Fever , 2nd day bad; fever off & on since then. Upset stomach. Eaten 3 pieces of toast, saltine crackers, soup (just the broth). My stream is painful and weak but comes on me in seconds.having me rush to the bathroom. Small peeing accidents continue to happen.
Headache, Myalgia, Fever, chills, day after fatigue and headache
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 15-DEC-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Caregiver started feeling flush, light headed, tunnel vision and was escorted to lay down. BP 196/102, HR 119 O2 100%. No shortness of breath. No hx of any reaction. Just had a snack, came to work for vaccine and to work nights.  1836 BP 187/104 HR 122 O2 99%,  1846 BP 175/93 HR 97 O2 99%, started having a headache and nausea and dry mouth. Water provided 1903 BP 177/91 HR 97 still flushed but reduction in dizziness 1949 BP 141/84 HR 85,  improved all sx, still felt off but was able to stably walk around. Called husband for transport home, did not work.
Patient reported about 5 minutes after the shot that she was feeling itchy over her entire body and was having some trouble breathing. She was wheezing, but reported she also has asthma. We administered 35 mg of diphenhydramine intramuscularly and asked her to use her emergency inhaler (albuterol). She reported after about 10 minutes that she felt completely normal, and her symptoms remained resolved thereafter.
Redness and swelling on (L) arm 4 1/2 x 5 1/3 induration MOTRIN was given cold compressions to be applied.
Sometime following vaccination, the pt developed [[name]] Barre Syndrome. The pt was hospitalized on 1/22/01. Further information is requested. F/U correspondence rec'd on 2/27/01 additional pt and the vaccine administrator info were provided. From faxed f/u correspondence rec'd on 6/18/01 for the doctor,stated that the pt was transferred from one hospital to another hospital on 2/8/01. Teh following info was sent to the doctor on 6/26/01. Date of admission to hospital 2/9/01, date of expiration 3/28/01 at 12:28pm. Dx at time of death Guillian-Barre' syndrome immediate cause of death due to respiratory failure due to problems associated with [[name]] -Barre' syndrome.  Follow up 07/26/2001: "final diagnosis was GBS.  Diagnosis was not made by a neurologist.  it is not known if the patient experienced any other illnesses previous to GBS."
Post-exposure rabies series. Pt received Tdap 6/15/15, IG 6/16, Rabies #1 6/16, Rabies #2 6/19. Pt states bilat. calf muscle twitching with tingling 30 min after #2 dose intermittent. State epi contacted. Dose #3 given. Pt denies numbness/weakness bilat x4 ext.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Hypotension; symptoms lasted 1 day
1 .red, tingling, burning tongue    2. sweating with slightest warmth    3. heart pounding with excitement or upset    4. slight chest pains   5.  headache    6.ears hurt    7.loss of balance    8.no appetite    9.neck hurts    Patient has not contacted nor seen her physician.
Administration error, 2 doses 0.25mL instead of one fully dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose). On 22-Oct-2021, PRODUCT ADMINISTRATION ERROR (Administration error, 2 doses 0.25mL instead of one fully dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was administered with a 0.25 ml booster dose instead of second dose and after 30 minutes, received another 0.25 ml to complete the full dose.  No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up received contain patient details (patient initial, date of birth, gender), start date of drug and added reporter details.
Hypotonic-Hyporesponsive episode after first dose of DTaP lasting approximately 24 hours.
On around 1/26/2021 at about 6 PM, I began having arrhythmias with rapid, fluttering heartrate. Anytime I tried to exert myself, my heart would pound. My normal heartrate is between 60 or 70, but it would now jump to about 130 whenever I tried to do my normal activities. I usually walk for exercise, but I wasn't even able to do that, because I would then develop shortness of breath. The arrhythmias continued until about August 2021 and worsened after I got my second vaccination on 2/16/2021. I went to a cardiologist who specializes in arrhythmias, and I was prescribed Flecainide on 5/26/2021. The Flecainide didn't help the condition at all.
about 7PM noticed was groggy & sl incoherant & crying & uncomfortable most of the evening; went to sleep @ 10PM; found not breathing 1210AM; never recovered; pronounced dead on 6APR92 about 5PM;
Janssen inadvertently given to 15 year old, rather than Pfizer due to haste of nurse. I had spoken with the grandmother that had requested he be vaccinated during a home visit with her. She is homebound due to a double amputation and they have no transportation available. We had discussed the different options and she had requested the "one and done" over the phone. Since we had discussed it several times on the phone and I am sure she told me he was 18 I only brought the one product with me. He was very slow to fill out the form, and I asked about allergies and such and gave the shot. I was then filling out the cards and asked the date of birth and found out he was only 15 years old. It was then that the grandmother stated that she had wanted Pfizer for the both of them. She wanted him to be considered vaccinated for school in two weeks. I told her that the Janssen was the only product that would be able to do that since the Pfizer requires two shots 21 days apart and then another 14 days after that he would be considered fully vaccinated. She then asked if he will be considered fully vaccinated in two weeks for school, to which I said I was uncertain because of the mix-up.
Neck really itching; Gland on neck; Nausea; Allergic reaction; Fever; Hard time breathing; Dry cough non stop; Dry mouth; Been really really sick; Not sleeping well at all; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), COUGH (Dry cough non stop), DRY MOUTH (Dry mouth), INSOMNIA (Not sleeping well at all) and ILLNESS (Been really really sick) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had IV for treatment) in August 2021.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INSOMNIA (Not sleeping well at all). On 29-Dec-2021, the patient experienced DYSPNOEA (Hard time breathing), COUGH (Dry cough non stop), DRY MOUTH (Dry mouth), ILLNESS (Been really really sick), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and NAUSEA (Nausea). On 01-Jan-2022, the patient experienced PRURITUS (Neck really itching) and LYMPHADENOPATHY (Gland on neck). At the time of the report, DYSPNOEA (Hard time breathing), COUGH (Dry cough non stop), DRY MOUTH (Dry mouth), INSOMNIA (Not sleeping well at all), ILLNESS (Been really really sick), PRURITUS (Neck really itching), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever), LYMPHADENOPATHY (Gland on neck) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was on two blood thinners. No treatment information was reported. It was reported that the patient was fine before the shot and went to the doctor on an unspecified date.
BLURRED VISION; SWEATING WHILE EATING; SHAKING WHILE EATING; DIZZY FOR 8 WEEKS STRAIGHT; NUMBNESS IN HAND AND ARMS; This spontaneous report received from a patient via a company representative 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 AUG-2021, the patient experienced blurred vision. On AUG-2021, the patient experienced sweating while eating. On AUG-2021, the patient experienced shaking while eating. On AUG-2021, the patient experienced dizzy for 8 weeks straight. On AUG-2021, the patient experienced numbness in hand and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision, sweating while eating, shaking while eating, dizzy for 8 weeks straight, and numbness in hand and arms. This report was non-serious.
about 36hr p/vax pt woke up w/redness & tenderness over inj site;about 16x16cm raised red, itchy, warm, indurated area covering most of lt thigh inj site visible @ lateral third of lesion-rt thigh involved;
Patient reported tingle in the hands and feet, also her hands were cold. I took her blood pressure and it was 143/86 and her heart rate was 82. She also said she had drymouth and dry lips. I made her stay longer. I also called her doctor. She wasn't having any breathing issues, so the doctor said to send her home and have her call. She also reported having a headache. She called her son and he picked her up. She didn't want an ambulance called.