chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid and has not had the 2nd dose of the vaccine yet; 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid; This is a spontaneous report from a contactable consumer (a pharmacy intern). This consumer reported on behalf of a 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 30Jan2021 as single dose for COVID-19 immunization. Medical history included chronic kidney disease (CKD) requiring weekly dialysis. The patient's concomitant medications were not reported. The patient was not enrolled in the clinical trial. The consumer reported that the patient received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet. The consumer also stated the patient has had several COVID tests recently that were negative. The patient was tested negative on COVID tests on unspecified dates. The consumer was calling to find out if the 2nd dose is ok to give now or if the patient can go without the 2nd dose or if they need to restart the series. The clinical outcome of the patient "received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet" was not reported at the time of reporting on 21Apr2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Information has been received from a Nurse Practitioner concerning a 20 month old female patient who in approximately September 2010 ("12-15 months of age"), was vaccinated with VARIVAX (Merck) (lot # not reported). On 31-JAN-2011 the patient was seen in the office presenting with a rash on her legs that looked like insect bites. On 02-FEB-2011 the patient was seen in the office again with classic shingles on her right leg. The patient experienced significant pain from the shingles. ZOVIRAX was given to the patient for treatment of the adverse event. On 10-FEB-2011 the patient was seen in the office and was better. The patient's mother was 33 weeks pregnant. The mother had natural chicken pox as a child and shingles when she was young. Additional information has been requested.
Bled a little right after injection from the way it was injected, then around 8 pm heaviness/soreness in arm, pain at injection site, pink raised hive at injection site about 2 inches in diameter. Around 2 am arm still heavy/sore, pain at injection site, hive is gone.
Arm hurt so bad I couldn't move it, called my Doctor he gave me a Cortisone shot. Which helped it but to this day I'm rubbing it, still hurts. Can't sleep with out help.
Information has been received from a medical assistant concerning an old male patient in his 50s who was vaccinated with PNEUMOVAX 23. The patient experienced a cellulitis reaction after being administered PNEUMOVAX 23. The patient was on methotrexate. Therapy was discontinued. The patient was recovered a week later from the cellulitis reaction. The patient did not seek medical attention. Follow up information was received concerning the patient with no illness at time of vaccination and pre-existing allergies, birth defects, medical conditions unknown who vaccinated with PNEUMOVAX 23 (exp. 03-JAN-2012) IM on deltoid. The patient experienced edema and redness to the arm below the injection site which cleaned within 1 week. No further information is available. This is one of several reports received from the same source.
Diarrhea GI upset, Night Sweats, Chills x 2 days Narrative:
This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 18-SEP-2017, the patient was vaccinated with properly stored expired dose of GARDASIL 9 (exact dose and dose number were not reported; lot # was reported as L040459, expiration date 06-APR-2017), intramuscularly for prophylaxis. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
Pain at site worsened as day went on continues a little more sore and weak as time went on. 1/15/2017 increase soreness/ weakness in left shoulder and left upper arm decrease ROM, unable to put hand over head/ behind back/ lift out on side.
Within 12 hours of Booster, both my knees were in extreme  pain (which have had zero  pain since getting cortizone injections Bilaterally a month earlier) The  pain seemed to "mimic" the exact  pain( behind the knees) I had BEFORE injections.  Lasted about 2 days and then gradually went away. The right knee has a mild discomfort that has remained.  I did also have other more common expected issues including headache, general aches, flu-like again for only 24 hrs and then went away. I had these common ones with the first vaccine, BUT not the knee issue.
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
fever up to 100.5; fatigue; chills; soreness, mostly in legs  symptoms lasted approximately 12 hours, then subsided after taking Tylenol and sleeping.  Sore throat began the next day, and lasted for several days.
Cellulitis on outer left thigh, post imms < 24 hr. Treated with Keflex 250/5ml .6cc tid for 7 days.
I received the vaccine at 4:45 PM on 5/16/2023 in my left arm.   I woke up with diarrhea and have had diarrhea now for 3 & 1/2 days with no signs of relief.   I took Imodium A-D but that has not helped.   I have never had this problem before in my life.  I am now extremely worried.
12/31/2020 Weakness, acid reflux, 1/1/2021 Weakness, chills, diarrhea No fever, cramps in abd. 1/5/2021 1320 pm - Left message. 1/6/2021 1021 pm - " ".
arm was a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore). At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
High fever 103 and diarrhea for 3 days  Fatigue, strong headache, sensitivity to smell, sensitivity to light and nausea for 24 h Dizziness and brain fog for 1 week
within 2 weeks of the vaccine the patient noticed soreness in the shoulder on the side of the injection along with discomfort in back of the neck.  She's had persistent neck discomfort and shoulder soreness.  she also has stiffness and achiness in the fingers which improves as the day progresses but never resolves. She sought help from a chiropractor afterwards.
Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of MMR II. Subsequently the patient developed a fever and a localized measles-like rash. Additional information is not expected.
pt recvd vax 26OCT95 & 6NOV95 pt exp itching & devel a hard lump @ the inj site;No further details were provided;
3RD MODERNA COVID VACCINE GIVEN 11/18/21, #069F21A; pt resides in a local healthcare facility; 10/23/21 pt positive for COVID; no specifics in medical records; pt passed away in the SNF; was under hospice care
vomiting beginning 9PM cont until 11AUG92 9PM lasted x 24hrs; home tx only; completely recovered p/24 hrs;
About 25 hrs after 2nd injection; experienced violent shaking and cold.  My husband took me to place in our home that is warmer.  After about 2 hrs, felt better.  Shaking and cold had ceased.  I had a cup of Tomato Soup.   Dozed on and off before going to bed.  Slept until 5:00 AM as usual, got up at 6:00AM  My husband got soufflés from store. I've been taking it very easy today.  Feeling better though tired.
1st dose was given to the patient more than 6 months ago; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received more than 6 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The pharmacist did not administered the patient, and did not have information about the 1st dose and about the patient. The reporter consented to follow up.
Narrative:  Event occurred ~9 weeks post patient's booster (third) dose of Pfizer vaccine. This was in a 58 y/o M with a pmhx sig for bladder cancer, sinus node dysfunction s/p pacemaker implantation. Patient presented to ER after describing an episode of "legs giving out" and falling on three occasions". After workup was found to have right frontal/parietal lobe intraparenchymal hemorrhage 2/2 to cerebral sinus thrombosis. Patient relatively stable and was discharged home on anticoagulation with plans for follow up in several clinic Unsure if any relation to vaccine, however, given relatively close temporal relationship, will report out of an abundance of caution.
Patient noted fatigue, severe new onset HTN refractory, night sweats, dyspnea on exertion, abdominal bloating and epigastrict pain/rib cage area, shoulder blade pain starting in first week of April with progressive symptoms   Evaluated with labs etc.  D dimer ordered and 4 times upper limit of normal.  ED end of June CTA showed large portal vein thrombosis, as well as right heart strain on echo- normal EF.  HTN resolved off medications once started heparin drip and now on Eliquis.
With in 5 minutes, Patient went from usual reddish complexion to pale, white.  Complained of extreme dizziness, and that his sight was ?fuzzy?.  Remained this way for approximately 10 minutes.  Had him remain sitting and place head between knees.  After 15 minute observation, he had regained some color, was able to stand, and left the pharmacy.  He has a very sore arm today(4/10/2021), stated he is tired and feels feverish.
felt "so sick"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) 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, single), administration date: Mar2021, for Covid-19 Immunisation, reaction(s): "No adverse event". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "felt "so sick"".  Additional information: Reporter states, she and her husband got their primary series of Pfizer BioNTech Covid-19 Vaccine in Mar2021. She felt fine after the first dose but felt "so sick" after the second dose. She was asking if the booster dose of the Pfizer BioNTech Covid-19 Vaccine is a half dose or a full dose like the first two doses and if now was appropriate timing for the booster dose since her primary series was in March. She was asking if the side effects will be the same for the booster dose as the first two doses.  Follow-up attempts completed. No further information is expected.
About an hour after receiving the vaccine, my arm started to itch and my skin started to feel hot and prickly. after a few hours, i had a rash all over, a low grade fever, with hives on my chest and back. arm continued to swell, get bigger, more red and more itchy for several days. today, it is slowly getting better but is still hot and very itchy. the body rash is slowly subsiding with the use of benadryl.
Patient had Pfeizer Vaccine lot EK 9231 on 1/6/21, and 2nd  dose Pfeizer lot no EL 3246 on 1/27/2021. We have checked her 4 times along with other patients and she has not produced any antibody response. All our other patients had a strong antibody response. We are concerned to see if she needs a third dose of pfeizer or a dose from a different vaccine. Please advice. No one is offering any help.
Pt. Deceased, Confirmed Unknown 1st Dose 3/13/2021 -- Moderna - 024M20A 2nd Dose 4/11/2021 - Moderna - 018B21A
Interchange of Vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 Clinical course: Patient received Paxlovid (01May2023 to 13May2023) as Treatment of COVID-19. Other medication in 2weeks: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Patient was feeling dizzy, some tightness in the chest, some weakness in arms/legs.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: Patient fainted 5 minutes after vaccine.  called 911. Nurse practitioner came to assist. Customer regained consciousness. Paramedics arrived and took customer.
light headache; my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work) and HEADACHE (light headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work). On an unknown date, the patient experienced HEADACHE (light headache). On 19-Feb-2021, GAIT DISTURBANCE (my legs wouldn't work started in the morning when I woke up/"woke up the next morning and my legs wouldn't work) had resolved. At the time of the report, HEADACHE (light headache) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369149 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up Appended- Event dates updated - contact info, patient details updated and suspect dates updated.
Received first dose on Feb 4, 2021, second dose Mar 4, 2021  Three weeks later I developed severe tinnitus in both ears.
This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender (reported as baby). No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with a improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported) lot # M031574, expiration date: 11-NOV-2018. There were no adverse effects reported. The vaccine was stored in a temperature between 47 and 77 degrees Fahrenheit for 18 hours. It was detected by a 'Digital Data Logger'. There were no previous temperature excursions. Additional information has been requested.
On 5/28/21 started to feel odd that evening, anxious and restless for no reason, elevated heart rate (in the 90's while laying in bed) at 3 am the next day 5/29/21 woke up with chills, shakes, body aches, headache.  Fever, chills, body aches, headaches lasted for 4 days.  Left sided abdominal pain started 2 days into this illness; went to urgent care, negative covid test, told to wait another 48 hours.  6/1/21 went to my PCP, unable to determine what was wrong and sent me to the ER
rash on stomach & legs 22 days p/inj;observation return to clinic if rash increases;
Generalized urticaria Treated with loratadine, diphenhydramine and famotidine Resolved after 3 days
I developed eosinophilic asthma at some point after the first vaccine and the booster.
Hard knot/Redness shoulder to elbow by 7pm. Fever/chills/swelling upper arm/pain when trying to lift arm first 2 days/ knot moved down arm/itchy hot. Dr. suggested  Benadryl. Symptoms letting up day 5
PAINFUL VERY LARGE  RED SWELLED AREA  AT INJECTION SITE.  UNDERARM LYMPH NODES ARE SWOLLEN. AND PAINFUL
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE PULMONARY EMBOLISM
Patient reported that her symptoms began the morning of October 5th, 2022. The patient noted waking up with her right eye being unable to close, and with a twisting of her mouth that made it difficult for her to drink fluids. She endorsed eye dropping and facial weakness. Patient stated she had similar symptoms when she had Bell's Palsy about 12 years ago. Patient was diagnosed with Bell's Palsy at a clinic visit on October 5th. Prednisone 60 mg daily for 7 days and Acyclovir 800 mg three times a day for 7 days were prescribed for treatment. Patient was also instructed to use eye drops in her right eye, and to place a patch on it at night to assist in maintaining moisture. On a follow up call on October 6th, the patient reported that her symptoms had not yet resolved.
Information has been received from a physician concerning a 26 year old female with a history of depression, who on 24-OCT-2007 was vaccinated intramuscularly with Gardasil vaccine. Concomitant therapy included Effexor XR. On 21-OCT-2007, about an hour after the vaccination, the patient experienced severe headache and nausea. The patient sought unspecified medical treatment. The patient was treated with Darvocet-N. The patient's severe headache and nausea persisted. Additional information has been requested. Information has been received from a physician concerning a 26 year old female with a history of depression, irritable bowel syndrome, and ulcerative colitis who on 24-OCT-2007 was vaccinated intramuscularly with HPV (lot # 668558/1061U). On 24-OCT-2007, about an hour after the vaccination, the patient experienced dizziness, severe headache, and nasuea. The patient sought unspecified medical treatment. The patient was treated with DARVOCET. A neurological exam was performed. The patient recovered on 26-Oct-2007 from the dizziness, severe headache, and nausea. Additional information has been requested.
Family reported death from unknown cause. Coroners report did not identify cause of death. Patient died driving on the way to work 8 hours after receiving vaccination.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. Lot number reported as J014129, expiration date 05-OCT-2015. Other suspect therapies included VAQTA 0.5ml, intramuscular. Lot number J009441, expiration date 23-AUG-2015. On 09-JUN-2014, the patient received improperly stored GARDASIL, and improperly stored VAQTA exposed to 15F for 86 hours. No adverse event were reported. This is one of several reports from the same source. Lot number J014129 in an invalid lot number for GARDASIL. It is a Lot number valid for VARIVAX (Merck). Additional information has been requested.
EXTREME PAIN DOWN RIGHT SIDE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced extreme pain down right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme pain down right side was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Hospitalization 7/28/21 for Covid19 and death 8/07/21. Received dexamethasone 6 mg IV daily and Remdesivir for 8 doses
Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is spreading up her arm
Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored PROQUAD (lot # L045678/expiry date 09-MAY-2017, lot # L045676/expiry date 09-MAY-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.