chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine After First Dose of Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine After First Dose of Vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Osteoarthritis.   On 02-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) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced MIGRAINE (Migraine After First Dose of Vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Headache, at a dose of UNK dosage form. On 05-Mar-2021, MIGRAINE (Migraine After First Dose of Vaccine) had resolved.            This case was linked to INC.-MOD-2021-069583 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-069583:CROSS LINKED WITH DOSE 2
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with diabetes and has not been eating well routinely. On 09-FEB-2013 the patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # H017447, exp. date: 20-DEC-2013). The patient had experienced intermittent migraine headaches, chills, and intermittent confusion since having receiving ZOSTAVAX at the pharmacy on 09-FEB-2013. No treatment was given for the events. None lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness for the events with the therapy was unknown. Additional information is not expected.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 8th August 2022, the patient received Havrix. On 8th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Aug-2022 Reporter's comment: The pharmacist reported that a patient received an expired dose of Havrix. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
The injection was done in my shoulder capsule too high. I can?t move my arm fully and any small movements cause severe pain.
Patient is a 32 y.o. female who received the Janssen Covid vaccine Lot# 1805020  on 3/12/2021. The patient experienced the following reaction(s) during the immediate   of observation: Shakiness Dizzy  Patient was treated/managed as follows:    Pt was given gatorade and VS checked: 0928: 120/84 HR:87 O2: 98% on room air 09:38: 116/80 HR: 79 O2: 97% on room air Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt reports feeling better and escorted out by RN:
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. On or about 28-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Patient presenting with axillary lymphadenopathy of the left armpit that started either 4/16/2021 or 4/17/2021
Minutes after receiving the injection (4pm) my blood pressure dropped and I lost consciousness. I recovered well enough to drive home within 15 minutes afterwards. That night (10pm) I began shivering, which escalated to periods of convulsions, to which a mouth guard was needed to prevent chipping teeth and/or biting my tongue. There was no fever present, and to subside the uncontrollable shivering I sat in a very hot shower until motor functions gradually returned. Periods of headaches, joint pains and sweating ensued for the remainder of the night. There were no other symptoms in the following days.
Received pneumonia vaccine 02/13/2003 at apprx 5pm that evening. Pt noted right arm swollen and tender. Sun 02/14/2003 at her PCP where her right deltoid swollen ,red, hout to tiuch down to her elbow. Pt had done warm compress to affected area. M. D. presented ice compresses and Tylenol #4. Symptomatic at present
Parent brought patient in stated that his R leg was swollen. Pt was given injection on 3/18/09 on his R leg was his IPV and DTP. Dr look at Pt and informed parent to use warm compresses.
tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.
June1995 pt recv 1 dose vax. 02Feb98 pt exp rash w/lesions "over his entire body" & fever 102.
Patient received COVID vaccine on 8/3.  He developed acute ITP requiring hospitalization on 8/25.
An unaccompanied minor who was 15 years of age was given a dose of Pfizer COVID vaccine in error. The client had a valid appointment and the vaccinating RN did not register that the individual was underage. The vaccinator stated she did verify birthdate but did not ask the client his age and because client was presenting for a second dose assumed he was ok to vaccinate. The client did not suffer any adverse reactions to the vaccine and reported no signs or symptoms of reactions.
8 hours after cold like symptoms - headache, body aches, low energy.  1st menstrual cycle (April 19, 10 days later) now heavy and 2 days longer  2nd menstrual cycle (May 18) continues to be heavy and 2 days longer  Overall decrease in motivation and energy, slight weight gain,  breasts appear slightly larger.
Swollen lips a few hours after injection, nausea, stomach cramps, itchy throat
growth under my eyelid; chickenpox looking things on right side of my face; This case was reported by a consumer via media and described the occurrence of eyelid cyst in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included pneumonia vaccine (dose received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eyelid cyst (serious criteria clinically significant/intervention required) and varicella-like rash. On an unknown date, the outcome of the eyelid cyst and varicella-like rash were unknown.   The reporter considered the eyelid cyst and varicella-like rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingles vaccine and it caused chickenpox looking things on right side of face, also caused a growth under eyelid that grew to the size of a pea. It had to be surgically removed. The patient also mentioned that pneumonia vaccine literally almost killed her/him and the patient was able to get the flu shot. The follow up would not be possible as no contact details were available
The day after the vaccine I was lethargic and had a headache. Day two after the vaccine I still had the headache and I developed swollen glands in my neck and head. I went to my doctor on the Monday, day 4 after the vaccine, and was diagnosed with shingles. The shingles cover the right side of my head.
On 9/19/2011 noticed itching of hands. On 9/20/2011 eye swollen shut, hands red, hot itching. Went to Urgent Care. 9/21/2011 noticed swelling of lips. Advised to go to ER.
This  68 year old female received the Covid shot on   4/7/21  and  died on  4/13/21  .  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Got Fluad Quadri 0.5 flu shot on Monday night 11/2/20 in the left arm at Supermarket. Noticed on Tuesday 11/3 that my left hand was itchy and somewhat swollen. It continued and last night I could see light rash on my arms and legs and this morning on my chest. My feet are also somewhat swollen and reddish. I'm taking benedryl and trying to keep myself cool so that the rash doesn't get drawn out more. Its also keeping me from feeling itchy. My doctor has advised me to watch for any trouble breathing or tightening of my throat and to go to ER immediately if any of those things start happening. I'm hoping that it won't get any worse.
I felt dehydrated; didn't feel like talking to her children and husband; Any sounds were making her very sick; really bad vomiting,Vomiting was every 10-15 minutes; Headache was throbbing and excruciating pain; fever; chills; really really bad migraine; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA OR 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced MIGRAINE (really really bad migraine), ASTHENIA (weakness), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick). At the time of the report, MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband), ILLNESS (Any sounds were making her very sick), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known.  Information on the lot/batch number has been requested.
Patient became "light-headed" and "pale" shortly after vaccines. Sx lasted "a few minutes"
MIGRAINE; FEVER; HEADACHE; ARM PAIN; POTENTIAL BLOOD CLOT; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included non-smoker, and sulfa allergy (anaphylactic). The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, patients arm was hurting and on the 11-APR-2021, night patient started having a headache. On 11-APR-2021, the patient had a fever of 103 and a migraine on 12-APR-2021. Patient took 2 Tylenol and rested in bed for the whole day. On 12-APR-2021, patient saw the physician due to her migraine. The physician was concerned that the patient may have a potential blood clot since the patient has had a stroke in 2016. Physician wanted her to get a MRV (Magnetic Resonance Venography) with contrast of the brain to make sure patient does not have another stroke and also prescribed baby aspirin until she can get the MRV The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, fever, and headache, had not recovered from migraine, and the outcome of potential blood clot was not reported.. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443400-Covid-19 vaccine ad26.cov2.s-Potential blood clot. 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: MEDICAL HISTORY
cannot lift left leg; cramps in leg; soreness on her entire left side; her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot lift left leg), MUSCLE SPASMS (cramps in leg), MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included FLUPHENAZINE, SERTRALINE, CLONAZEPAM, METFORMIN, INSULIN GLARGINE (LANTUS) and LOVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.). On 11-Mar-2021, the patient experienced MOBILITY DECREASED (cannot lift left leg) and MUSCLE SPASMS (cramps in leg). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (cannot lift left leg), MUSCLE SPASMS (cramps in leg), MYALGIA (soreness on her entire left side) and ARTHRALGIA (her left knee is killing her. She states she cannot bend her knee, cannot lift it up and it is hard to walk right.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drugs were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: concomitant medications were added, treatment medication was added, patient details were added, event were added. On 22-Jul-2021: Non significant information received: Patient wanted to get follow-up form to mailing address
pt recvd vax & the next day had rash on face that disappeared the next day;
Approximately 2 in rash on arm, warm, pain @ injection site, muscle pain in leg, fever/chills. Leg pain & fever/ chills resolved with ibuprofen.
arm red elbow to shoulder itching;DPH given c/o SOB;epi given;c/o throat discomfort;improved p/epi;
Pt had mild dizziness 7 mins after vaccination. Improved in less than 5 mins after drinking water and eating crackers.  States ?I?m hungry?.  Pt stable and released from vaccination site.
Dizziness; Shaky; Couldn't able to get up and walk over; Nauseous; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the site of injection), DIZZINESS (Dizziness), TREMOR (Shaky), NAUSEA (Nauseous) and GAIT INABILITY (Couldn't able to get up and walk over) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 diabetes mellitus) and Hypertension. Concomitant products included LISINOPRIL, METFORMIN, INSULIN GLARGINE (BASAGLAR) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain at the site of injection). On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness), TREMOR (Shaky), NAUSEA (Nauseous) and GAIT INABILITY (Couldn't able to get up and walk over). On 11-Mar-2021, INJECTION SITE PAIN (Pain at the site of injection) had resolved. At the time of the report, DIZZINESS (Dizziness), TREMOR (Shaky), NAUSEA (Nauseous) and GAIT INABILITY (Couldn't able to get up and walk over) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a physician and refers to a multiple patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Physician reported that, on unspecified dates, multiple patients were vaccinated with improperly stored VARIVAX, (lot # N007930, Exp date: 08-MAR-2019), (dose, frequency were not provided) for prophylaxis and properly stored sterile diluent (dosage therapy not reported, (Lot # L025375, Exp Date: 14-MAR-2018). No adverse effects were reported. No additional information was provided. Product was stored at a temperature of 9 (degree Centigrade) °C to 8°C. Time frame was for 25 minutes. There was no previous temperature excursion. It was reported that call was because of a digital data logger.
A NERVE GOT IMPACTED DURING THE PROCESS OF VACCINATION; This spontaneous report received from a physician via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, it was reported that "a nerve got impacted during the process of vaccination and patient had to have surgery". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a nerve got impacted during the process of vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220865061 -covid-19 vaccine ad26.cov2.s- A nerve got impacted during the process of vaccination. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Got the 2nd shot of the vaccine three months after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Got the 2nd shot of the vaccine three months after the 1st dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After vaccine administration patient had a vasovagal reaction - no redness or swelling at injection site. States previously no other problems or reactions with previous vaccines. Per pt did not eat any breakfast. No seizure activity noted.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number and manufacturer unknown) and had a reaction to the vaccine. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Possible breakthrough COVID infection. The patient tested positive, asymptomatically, on  5/3/2021. He received two doses of the COVID vaccine on 3/11/21 and 4/8/21.  He states that members of his household tested positive for COVID 6 weeks prior to 5/3/21 and he experienced anosmia and sore throat at that time but never got tested to confirm if he had COVID.