chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light sensitivity; low grade headache; muscle pain; joint pain; felt very exhausted; Injection site very very red/Redness around injection site has spread to a much larger area; brain fog; did not sleep very well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache) and MYALGIA (muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well) and VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area). On 13-Mar-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-Mar-2021, FEELING ABNORMAL (brain fog), INSOMNIA (did not sleep very well), PHOTOPHOBIA (light sensitivity), HEADACHE (low grade headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt very exhausted) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site very very red/Redness around injection site has spread to a much larger area) outcome was unknown.            No concomitant medication was reported.  Patient initially took Tylenol which did not help and later ibuprofen which made her feel better.  Action taken with mRNA-1273 with respect to events was not applicable.
Severe body ache; headache; chills; fever; loss of appetite; severe sore throat- illness lasted 2 weeks; bedridden
Pt came to pharmacy 11/11/11 to discuss adverse event experienced. Patient had redness at injection site on right arm, pain, & some swelling. Pt reported having a fever & chills on 11/9/11 but that resolved in about 24 hours. Pt told to ice site and take 25mg-50mg BENADRYL tid. Pt also told if the redness spread/got worse to call his MD. Pt was called 8 hours later to see if symptom improved. Pt said he iced the site and it was improving (decreased pain & redness).
A report has been received from a physician concerning female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient was administered FLUMIST twice in one day. The outcome of the event of administered FLUMIST twice in one day is unknown. The report was considered to be non-serious.
Tingling/ Numbness in the middle of the upper outer left arm, 2 inches or so below the injection site. Sensation moved up into shoulder and into upper forearm. Sensation felt on occassion on left cheekbone and jawline. Persisted for 12 hours. 12/02/09 ED Records received for DOS 11/17/09. Pt., who is 30 weeks pregant, presented with left arm tingling, radiating to l shoulder and face. Discharged stable. DX: Paresthesias 12/02/09 prenatal records received for DOS 6/23/09-11/12/09. Pt requesting vaccine on 11/12/09.
Pt was given an expired flu shot. Given 8/18/11, expired 6/30/11.
On 1-26-2021, he presented to ED after waking up at 1AM with lip swelling and diffuse itchy rash.  Rash involved both forearms, scalp, chest, abdomen, back, and legs.  He took 50 mg of Benadryl at home, but woke up with worsened symptoms.  Denied unusual foods, soaps, detergents, colognes, or medications.   Patient denied shortness of breath, throat or intraoral swelling or pain, chest pain, palpitations, cough, sore throat, nasal congestion, rhinorrhea, fever, chills, loss of sense of taste or smell, abdominal pain, n/v, diarrhea or dysuria.    Patient was treated with epinephrine 0.3 mg SQ, Solu-Medrol 125 mg, Benadryl 25 mg IV, and Pepcid 20 mg oral.  Patient was re-evaluated an hour and a half after receiving medication and lipedema and urticarial improved.  Patient was provided with an Rx for EpiPen kit, prednisone 40 mg daily for 3 days.  He was told to follow up with his PCP.
Vaccine expired on 03-OCT-2021 and placed in refrigerator on 17-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 17-NOV-2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 17-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-OCT-2021 and placed in refrigerator on 17-NOV-2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not had any temperature excursion and the patient had no adverse event.  No concomitant medication information was provided. No treatment medication information was provided.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 72 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: yes-penicillin" (unspecified if ongoing). The patient had no other medical history. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 01Jan2021, stop date: 13Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive, notes: home test; (12Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included nirmatrelvir, ritonavir (PAXLOVID).
Information was received on 23-APR-2019 from a lawyer regarding a case in litigation concerning a female patient, age and medical history unknown. In or around 22-APR-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. One day after received the vaccine, the patient suffered a rash on her upper left thoracic region and into her back and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX the patient symptoms have results in physical limitations not present prior to the vaccine.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patients condition. As a result the patient experienced severe and permanent personal injuries. Shingles was considered to be disabling. Additional information has been requested.
Nausea roughly an hour after vaccine, then fever 100.6 one day after vaccine, extreme fatigue resulting in having difficulty caring for my children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. Those effects only lasted about 24 hours. Then, the next day, I awoke with a swollen lymph node in my left armpit which has been causing pain all day, if my arm is at my side, requiring ibuprofen and cold compresses to treat.
Pts vams record stated she received pfizer, although pts card stated she received moderna, pt received pfizer vaccine due to vams, but upon further exploration and a note found in the system stated to "ignore vams, pt received a moderna".  Therefore patient received a pfizer dose for her second dose, although according to the note in vams and her CDC card she received moderna. Pt was educated and VAERS filled out.
Fever, diarrhea, vomiting, headache, red swollen painful arm, fatigue, muscle cramps, short period of involuntary muscle contractions, body aches. It is hard to explain but it feels as though I feel a shakiness on the inside.
Severe pain and palsy on left arm and neck. Pain not resolved with a variety of treatments according to patient.
Patient had Moderna for 1st vaccine on 7/13/2021 at the Health Department. She came in today for her 2nd dose and was inadvertently given Pfizer instead. Patient monitored, seemed to be okay. No adverse effects during time of monitoring.
Stinging when she got the shot - then she could taste vaccine. A migraine started immediately. She was then achy and fatigue for a few days. Issues are now resolved.
No additional AE.; expired diluent was used to reconstitute VARIVAX; expired diluent was used to reconstitute VARIVAX and administered to a patient; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2022, expired sterile diluent solution for injection/infusion (lot #T000495, expiration date: 03-JUN-2022) was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U039722, expiration date: 15-DEC-2023, indication: prophylaxis) and administered to the patient (product preparation issue and expired product administered). Regrading the suspect drug/vaccine, strengths, doses and routes of administration were not reported. Varicella virus vaccine live (oka/merck) (VARIVAX) was not expired, neither product experienced a temperature excursion.  No additional AE details provided, no additional adverse event was reported.
4/15; 11:30AM - Left arm began to have intense pain around the injection site (up to the shoulder and down to the inner elbow). 4/15; 11:30AM-onwards - more frequent urination despite lack of drink intake 4/16; 7:30AM - began to experience severe headache, some nausea, and an increase of pain the left arm 4:16; 8:12AM - headache and nausea intensify, eyes begin to hurt and light and sound sensitivity develop, pain in left arm increases and the inner elbow of the right arm begins to mirror the left arm.
Adverse Events: Shot received at 11am Friday (5/14).  That night at 3am had extremely bad chills, shivers, which ended after about 3 hours.  Temperature all day on Saturday was 101.5.  By Sunday temperature was gone, just residual headache throughout the day.   Treatment: Advil and sleep Outcome: by Monday (5/17) everything ok.
dizzy/lightheaded/about to faint; head was spinning; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 27Mar2021 at 18:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN), herbal (MANUFACTURER UNKNOWN); all for unknown indication. The patient did not have allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6199), via unspecified route of administration in the left arm on 06Mar2021 at 18:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 27Mar2021 at 22:00, 4 hours after the vaccine, the patient had experienced extremely dizzy, lightheaded, where her head was spinning and about to faint. She immediately lay down on kitchen floor. It took many repeats of standing up and lying down for her to move to bedroom, where she stayed for the next few hours. Eventually, the patient was able to prepare for bed but moved slowly and would not fall although the dizzy, light headed feeling was not as intense. 16 hours later, she felt comfortable to move around and did not experience to dizzy feelings. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizzy/light headed/ about to faint and head was spinning was resolved on unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
DIZZINESS; RASH ON NECK; HEADACHE; LOW GRADE FEVER; WEAKNESS; CHILLS; RINGING IN THE EARS; HEART RACING; This spontaneous report received from a patient concerned a 58 year old female. 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 not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. vaccinated on left arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced ringing in the ears. On 20-MAR-2021, the subject experienced heart racing. On 20-MAR-2021, the subject experienced weakness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced dizziness. On 24-MAR-2021, the subject experienced rash on neck. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, weakness, chills, headache, and low grade fever on 22-MAR-2021, dizziness, and rash on neck on 25-MAR-2021, and had not recovered from ringing in the ears. This report was non-serious.
pt stated that she developed horrible itchy total body rash that she still has.  She said it very itchy but slightly better today 2/22/2021.  Pt contacted her allergist doctor and had a virtual appt.  Pt was prescribed hydroxyzine and Zyrtec.
initial report received from a pharmacist on 10/20/05. A 53 year old female pt developed lower back pain, right side radiating to the left side two days after receiving the IM injection of Fluzone, lot number U18811AA in the left deltoid on 10/4/05. The pt is on Vicodin which was prescribed for pain 2 months ago. The type of pain was not reported. The pt had no illness at the time of vaccination. Symptoms resolve don their own. No medical treatment prescribed and the pt did not see a physician. follow up information received on 2/3/06 from a health care provider. The pt did not have a previous history of back pain and had not done anything to aggravate her lower back within seven days prior to vaccination. The duration of the lower back pain was a week. The pt had received the flu vaccine every year for 20 years. Same reporter and reporting facility in cases 2005-02155, 2005-02157.
low grade fever; diarrhea; headache; achy; fatigued; runny nose; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "low grade fever"; DIARRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 08Aug2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "fatigued"; RHINORRHOEA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "runny nose"; ILLNESS (non-serious) with onset 08Aug2021, outcome "not recovered", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The attached report concerning your product, PFIZER/ BIONTECH VACCINE, is being forwarded to you on behalf of Moderna in compliance with the FDA regarding post-marketing adverse event reporting dated March 1992 and posted 1998, Section VI (i).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Same day- burning in chest & stomach immediately. 10/29- sharp, painful pain at top of head front  to back, nauseous. Used ice, Advil & Tylenol. Didn?t help pain. Lasted all day Friday into Saturday morning. The worst pain ever experienced in my lifetime.
p/vax pt devel massive red swelling @ inj site & T102-104;massive was not defined;f/u info from MD indicated pt did require specific tx for adverse exp;MD had never seen this exp p/vax;MD returned the batch, but did not recall lot# ;
Local swelling and redness at shot. (Rt) and (Lt) shot site within 24 hours of vaccination. No Rx needed.
anaphylactic reaction; milk allergy; Initial information was received on 21-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-professional.  This case involves child female patient (age unknown) who experienced anaphylactic reaction and milk allergy, while she received IPV (VERO) [IPOL] and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP].  Medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported for both the suspects) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious anaphylactic reaction (unknown latency) following the administration of IPV (VERO) and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed non-serious milk allergy (unknown latency) following the administration of IPV (VERO) and DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The reporter mentioned that anaphylactic reaction was traced to a milk allergy, and that now people with milk allergies were warned not to get DTaP, but that was not known at the time. No other information provided.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome was unknown for both the events at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient (age unknown) who experienced anaphylactic reaction and milk allergy after vaccination with IPOL and DTAP vaccine. The time to onset is unknown. However, medical condition at the time of vaccination, laboratory data and other investigations ruling out alternate etiologies were not reported. Based upon the reported information the role of the individual vaccine cannot be assessed.
ACUTE PULMONARY EMBOLISM 7/26/2021 ACUTE PULMONARY EMBOLISM HYPOXIA 7/26/2021 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 7/26/2021 MALIGNANT PLEURAL EFFUSION HYPOXIA 7/26/2021 MALIGNANT PLEURAL EFFUSION
Patient had two syncopal events the morning after vaccinations. Vaccines given 11/21/2017 around 3:00 PM and patient had syncopal events 11/22/2017 around 11:00 AM. Patient seen in office around 11:40 AM on 11/22/2017 and orthostatic blood pressures obtained. Orthostatic hypotension identified (sitting BP 106/73 to standing 83/53). Encouraged patient to increase intravascular volume by increasing fluid intake of water and GATORADE, eating salty snacks, and decreasing caffeine intake. No sudden changes in position. Will follow-up in 3-5 days.
Right thigh with 3 inch diameter erythema with non tender swollen area; itching.
Woke up at 2am (Sunday) after getting the shot at 0837am Saturday with severe chills and body aches.
Extremely itchy and swollen still on day 8 but slightly improving. Used ice packs did not seek medical attn
pt recvd vax;pt appears to exp more pain & cry more readily than when recving oth vax;reporter states that tetramune inject seems to shock pt more sharply;
Spiked high fever, and had febrile seizure the night of the day the vaccines were administered.  Fever resolved by the next day.