chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart felt heavy; fuzziness in her mouth; the joint where the thumb meets the wrist started hurting; She stated her legs felt like she ran a mile/arms felt like she lifted weights/couldn't use both hands to open doorknobs without hurting; aching going up the steps; almost like she had the flu; she received the injection she said she bled but they said oh we got muscle; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age (reported as 63 no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration in the left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, when she received the injection she said she bled but they said "oh we got muscle". On 01Apr2021, 2 days after, the patient reported that she did not get any fever or chills, however, her heart felt heavy a little bit. She got the shot in her left arm and, oddly enough, the joint where the thumb meets the wrist started hurting. She had fuzziness in her mouth but no anaphylactic reaction. She thought maybe it was psychosomatic. Her joints and extremities ached moderately, not mildly. She stated her legs felt like she ran a mile and her arms felt like she lifted weights and she never did. She stated this progressed for 10 days. It went to her other hands. She is very active and this is unusual. She couldn't use both hands to open doorknobs without hurting. Both arms and both legs hurt. She stated she lives in a 4 story home and has 3 flights of stairs and can run them no problem usually but was aching going up the steps and it was kind of crazy almost like she had the flu, it just never exploded. Today (unspecified date), for the first day, she is almost feeling back to herself, she's getting better now. The caller asked if she should get her second dose of the vaccine after these symptoms. She asked if the second dose would make these symptoms worse? She stated she is unsure if it is related. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; Took the COVID vaccine; Rapid Antigen Test turned out positive, PCR test came out negative; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine, and a few days later they took the Rapid Antigen Test, the COVID test. And it turned out positive. The person took other tests as well, PCR test which came out negative. The reporter didn't know if there was any research or data if that was done maybe during clinical trials of whether it is possible to come out positive on an antigen test which tests for bio-protein. The reporter believe that was what in the vaccine. The reporter guess the vaccine causes the reaction in the body to make that protein in the body. The reporter wonder if it was possible it could be false positive on one of those tests because of the vaccine, because of the way that rapid test works. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
heart started racing, dizzy, did not sleep all noc, agitated, anxiety arm swollen & red;rx beta blocker, DPH oral & site application;
Observed to have an altered level of consciousness. Very difficult to arouse. the resident could barely open eyes w/ drooping to R side of the mouth. Nurse asked resident to smile resident could not smile. Nursed asked the resident to talk, speech came out incoherent. Assessed resident's pupils which were found to be PERRL. LUE found to have weakened grip strength with decreased ability to control. RUE flaccid, unable to respond with this extremity when asked Dr advised educating pt on what it would mean to not go to hospital following what she believed to be a symptom of a stroke. After education resident expressed that he would like to go to the hospital despite DNR/comfort care. We asked him again and eventually, he clearly said "yes" which was witnessed by one other nurse and 2 CNAs. The order was given by previously stated MD to send out the resident.
Lt arm discolored, swollen, hard, hot to touch. Also has blisters on left arm. 7/7/05 saw Dr. , diagnosed mild local reaction and Impetigo.
SHINGRIX given to 16 year old patient by accident instead of Menveo.; SHINGRIX given to 16 year old patient by accident; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2021, the patient received Shingrix. On 11th May 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The Nurse reported that Shingrix was given to 16 year old patient by accident instead of Menveo, which led to  wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Around 4 o'clock after 2nd dose patient felt like she got hit by a truck. She had severe aches that lasted until Tues 3/2/21.  She had similar side effects with the first dose.  She had tested positive for Covid July 2020.  Developed cellulitis in the right arm.  She was seen by PCP.
Patient admitted with h/o PV now with c/f progression to AML vs High Grade MPN with excess blasts. COVID screen + on admit, repeat RVP was negative. Recent uncomplicated COVID infection in 8/2021. Was asymptomatic at time of COVID test, was only tested due to wife being COVID+. Per pt, received Regeneron on 8/27/21, ivermectin and a Z-pack. Per pt, had 2 negative COVID tests on self-tests at home. Only sx on admission are post-nasal drip with dry cough; afebrile and VSS on RA. CT chest 09/23 with pulmonary edema and multifocal pneumonia. With recent COVID infection c/f bacterial pneumonia post recent COVID.
ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/1/2023 DIVERTICULOSIS OF SIGMOID ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/1/2023 ABDOMINAL PAIN
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 53 year old female of unknown race, and ethnic origin. 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: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, few days before the date of reporting the patient contracted Covid-19. Although she tested negative before coming back to the country she started to experience symptoms shortly after her return. She started to experience severe headaches and extreme fatigue.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210805573-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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
This case was reported by a physician via other manufacturer and described the occurrence of seizure in a 16-year-old female patient who received MENVEO (batch number M14072, expiry date 30th November 2015). Co-suspect products included Meningococcal B vaccine (batch number L13514, expiry date 31st July 2016). Previously administered products included MENVEO (1st dose received on 3rd June 2011). On 4th September 2015, the patient received the 2nd dose of MENVEO (intramuscular) .5 ml and the 1st dose of Meningococcal B vaccine (intramuscular) .5 ml. On 4th September 2015, less than a day after receiving MENVEO, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), photosensitivity, walking difficulty and extra dose administered. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the seizure, photosensitivity and walking difficulty were recovering/resolving and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the seizure, photosensitivity and walking difficulty to be related to MENVEO. Additional details were provided as follows: The reporter preferred not to answer the medical history details of the patient. On 3rd June 2011, the patient received the 1st dose of MENVEO vaccine. On 4th September 2015, at 12.26 pm, the patient again received a dose of MENVEO vaccine in the left deltoid, which led to an extra dose administered. On the same day, the patient also received TRUMENBA in the right deltoid intramuscularly. The patient experienced psycho seizures, photosensitivity and she was not able to walk very well at the time of reporting. On 5th September 2015 to 15th September 2015, the patient was hospitalized for duration of 10 days. The patient did not experience any illness at the time of vaccination. The patient was not deceased. The reporter considered the psycho seizure, photosensitivity and walking difficulty to be related to TRUMENBA.
I had 3 vaccines and I have the shingles/ suspected vaccination failure; I have the shingles; had 3 vaccines; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 dose of Shingles vaccines which led to extra dose administered. Post vaccination the patient had shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Pharmacy administered bivalent dose instead of monovalent dose for dose 3 of primary series
I received vaccine at 2:45 PM at my jobsite and at approximately 9:00 PM, I began to get chills and at 11:00 PM took my shower at the end of my 8 hour shift and had chills while taking hot shower. I arrived home at 11:45 PM on evening of 11/07/02 and was extremely chilled and short breathed and wrapped up in blankets and went to bed and woke up approximately 7:00 AM on morning of 11/8/02 and was soaked from sweat and had severe headache.
Information has been received from a pharmacist and an assistant director of nursing concerning an approximately 97 year old female nursing home patient concerning an nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1416U), and developed severe adverse reactions including redness and swelling at the injection site. Unspecified medical attention was sought. The director of nursing reported that the patient had improved. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
give this shot to people knowing that it kills them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "give this shot to people knowing that it kills them". The date and cause of death for the patient were unknown. It was not reported that is unknown if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200037222 same reporter/suspect drug/event, different patient;US-PFIZER INC-PV202200037221 same reporter/suspect drug/event, different patient;; Reported Cause(s) of Death: give this shot to people knowing that it kills them
No additional adverse event; Vaccine was administered after temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.  On 19-JAN-2023, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# was reported as W02294, and expiration date was 13-JUL-2024; strength and route were unknown) for prophylaxis after temperature excursion (product storage error).  Temperature excursion of this vaccine was 6.9 Fahrenheit degrees (F) for 15 minutes. Previous temperature excursion was reported as 7.1 F for 30 minutes and 11.6 F for 1. No additional adverse event was reported.
1. Upper shoulder achiness , increasing temperature ( peaked at 100.2 degrees F), body chills, slight nausea, overall body weakness. 2.  Symptoms  began decreasing  Friday 19Feb21, disappearing by late afternoon, except for slight headache. 3. Symptoms almost gone as of this writing (9:30 P.M. 19Feb21).
Patient reported feeling flushed after the vaccine. Vitals below. Benadryl 25mg PO given.  BP 110/70 Pulse 100  Noticeably red around the ears and neck, was itchy. Monitored for 20 minutes after Benadryl administration, discharge with father driving
This spontaneous report was received from a Medical Assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, RECOMBIVAX HB, was stored to a temperature of 1 °C for 12 hours. Data logger was involved. Furthermore, it was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001712: US-009507513-1705USA002380: US-009507513-1705USA002383: US-009507513-1705USA002382: US-009507513-1705USA002384:
Today I am 36 weeks and 4 days pregnant, due on January 19, 2021.  This is my first pregnancy, and going well so far.  This is not a bad adverse event just something I noticed:  I developed 2 ulcers in my mouth and one inside my vagina today.  I had ulcers pop up in my mouth when I tested positive for COVID on May 1, 2020.  Just interesting, not bad.
Received immunization on Fri had convulsions and fever. Mother called 911. Taken to hospital. Fever 104.1 at ER. Treated with Tylenol and Motrin. Seen at clinic 3/2/04. No fever. Per RN at clinic- child had febrile seizure. "Ears WNL, cough + fever x 15 days" per ER MD.
Patient reports severe soreness and pain in muscles and joints as well as periods of extreme fatigue that began approximately 5 days after receiving first dose of vaccine.  She states that there has been an instance in which the fatigue was sudden and occurred as she was driving. She states the pain in muscles and joints has become debilitating and she is unable to move around freely.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-AUG-2018, the patient may have received an improperly stored dose of PNEUMOVAX 23 lot# N029303, expiration date: 21-APR-2019 via intramuscular route (exact dose, site of administration were not reported) for prophylaxis. The vaccine was exposed to temperature in the range between 47 to 77 degrees Fahrenheit for 30 minutes. Temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse events were reported.
Information has been received from a consumer who stated that a pediatrician informed that children in her area who on unspecified dates were vaccinated with two doses of VARIVAX (Merck) (Lot # unknown) were getting chickenpox despite the two doses of the vaccine. At the time of the report, the patients' outcomes were unknown. This is one of several reports obtained from the source. It was unknown if the patients sought medical attention.
Extremely painful arm, shoulder. Pain continuing through day and night 6 days after vaccination. Took advil, Aleve and then prescribed Diclofenac for pain. None of these have helped.
Common solicited: pain, redness and swelling at the injection site, headache. Other symptoms included itching and nausea. Treatment recommendations included OTC (diphenhydramine HCL 25 mg) according to directions on box. Outcome: currently monitoring.
Information has been received from a licensed practical nurse concerning a 12 month old hispanic male who on 14Apr2003 was vaccinated in the left thigh SQ with the first dose of varicella virus vaccine live, 0.5mL. (Lot #0549B not valid) Concomitant vaccinations on that same day included the third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (MSD) (Lot #645024/1169M) in the right leg and the third dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacterer unknown). On 26Apr2003, the pt's vaccine injection site area became red, slightly swollen and a lump also noted. On that same day, the pt developed pimple-like areas on his left breast, his upper lip and left ear. The pt was noted to be afebrile (96.2), irritable and was not sleeping well. A diagnosis of mild varicella was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Menstrual cycle is off by a few days. I am a clockwork regular person, no changes in my life (ie stress, meds, illness).  Only change was the moderna vaccine in January and February.  There may not be proof of causality but there isn?t any proof that there isn?t a correlation either.
Pt had redness and itching at vaccination site LA and then increasing pain. SMZ-TMP Dg #20 1 tab PO BID x10 day given.
Pain in back of knees, pain in hips, pressure in back of head, dizziness, lightheaded, dry heaving, blurred vision  Wide spread symptoms of an auto immune or neurological response started 2 weeks after vaccination
Left side of face paralyzed. Called my doctor but they can?t see me for another 2 weeks which isn?t helpful
Chills, dry heaves, vomiting, cramps, rectal bleeding, fever, weakness
Patient got the vaccine on 27Apr2021; her arm started to get swollen; The rash came back, but worse; her arm started to get swollen and was very painful; body was sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021), PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# C007C21A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE), ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. On 10-May-2021, PERIPHERAL SWELLING (her arm started to get swollen), CONDITION AGGRAVATED (The rash came back, but worse), PAIN IN EXTREMITY (her arm started to get swollen and was very painful) and MYALGIA (body was sore to the touch) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got the vaccine on 27Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   steroid shot used for treatment, delayed reaction was observed both time   This case was linked to MOD-2021-029157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant follow up updated on 06-Jul-2021
Pt developed hives on 6/19/01 on left leg. By the next morning, the rash was over entire body from bottom of feet to head. Pt treated with Benadryl and calamine lotion.
Blood pressure rose throughout the morning the day after vaccination.  I currently take 5mg Lisinopril daily to manage high blood pressure and maintain a morning average around 118/80.  The morning after the vaccination my blood pressure rose throughout the morning to 158/115.  At noon, I took an additional 2.5mg of Lisinopril (in a addition to the 5mg I took before bedtime the night before). Also, to manage anxiety, I took 0.5mg Alprazolam.  My blood pressure returned to normal by 5pm; and has been normal up to the day of this report.