chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe upper arm pain beginning hours after injection and lasting 2 days. Upper left arm soreness persisting 2 weeks after injection and still ongoing. Red, itchy rash at injection site appearing 8 days after injection and lasting 3 days. Skin sensitivity across back and arms following resolution of arm rash; ongoing.
Pt vaccinated with DTP/OPV and developed focal seizures, admitted to hospital had culture negative CSF pleocytosis & discoveredto have middle cerebral artery infarct. Now significant devel delay, hemiparesis
Malaise, fever of 100.6, chills, feeling of shortness of breath, headache, myalgias, arthralgias Lasting less than 6 hours  Relieved by oral antiflammatory
Breakthrough case admission after 2 vaccines  Moderna 11/28/21 lot# 045J21A ; Moderna 12/26/21 lot# 041J21A
This was a Moderna booster shot  (Moderna shots 1 and 2 received on 3/13/21 and 4/28/21). No problems blend the day of the shot, but developed noticeable  ?COVID arm starting around the next night (24 hours later) that worsened over the following 48 hours and is now persistent. Big red reaction circumference the size of my hand around the injection site. Has been itchy and skin feels rough like a rash. Also warm to the touch. Experienced a headache, fatigue and mild nausea within 48 hours too but that went away.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-OCT-2015 20:15, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.4 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Severe lethargy; Ache; Fever 102degree F; Headache; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 01LJ20A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation chronic (Chronic constipation for past 5 Years) since 2016 and Shellfish allergy. Concomitant products included LINACLOTIDE (LINZESS) and MACROGOL 3350 (MIRALAX) for Constipation, BIFIDOBACTERIUM INFANTIS (ALIGN) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache). On 07-Apr-2021, LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) 102 degree. In April 2021, SARS-CoV-2 test negative: (Negative) In Emergency room Covid-19 test was negative. In April 2021, Viral test negative: (Negative) In Emergency room Viral panel was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided   This case was linked to MOD-2021-009535; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache (Migraine), intermittent abdominal pain, and exhaustion for 34 straight days straight post 2nd dose of vaccine.
The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021; HCP said that 606 doses were given after expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date.) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. No temperature excursion was reported.
Sweating, low-grade fever, chills, body aches, exhaustion, headache. I took Tylenol for 24 hours starting when I woke up at  6am to help with symptoms. It took about 36 hours for my symptoms to be gone after they started. I was also on my period when I received the vaccine. My period seemed to slow down almost completely while my symptoms were happening, and then my period resumed with abnormal cramping and clotting after my symptoms were gone.
Information has been received from a pharmacist concerning a 63 year old female patient, with no pertinent medical history and no known drug reactions/allergies, who on 23-DEC-2008, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 663199/1557X). There was no concomitant medication. The pharmacist reported that on 23-DEC-2008, the patient developed pain and erythema at the injection site. She had been treated it with ice. The patient stated to the pharmacist that she had always developed injection site pain and erythema after vaccinations, but this was worse than usual. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen by the pharmacist. Additional information has been received from a Registered Pharmacist who reported that a patient received first dose of ZOSTAVAX (Oka/Merck) (Lot # 663199/1557X) intramuscularly on 23-DEC-2008 at 14:40 hours. On 23-DEC-2008 at 18:00 hours patient experienced red, hot, swollen at injection site. Also she experienced itching for 3 or more weeks. Additional information is not expected.
Headache, Tachypnea, upper extremity paresthesia, radiating arm pain, arm weakness Narrative:
Chest pain, chills, myalgias, fever 102.0F, fatigue, headache, general malaise, localized pain in injection muscle (left deltoid)
The same swelling and pressure in my throat occurred after the second Pfizer shot; burning and tingling at the site of the FIRST vaccine at this time.; The pressure in my throat lasted throughout the afternoon; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old o-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Apr2021 11:30 (Batch/Lot Number: EW0153; Expiration Date: 21Jul2021) as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 08Apr2021 at 01:15 (Batch/Lot Number: Er8737; Expiration Date: 21Jul2021) as DOSE 1, SINGLE for covid-19 immunization and experienced swelling .The patient experienced the same swelling and pressure in my throat occurred after the second pfizer shot, burning and tingling at the site of the first vaccine at this time, the pressure in my throat lasted throughout the afternoon on an unspecified date. Just under 48 hours after the vaccine, the patient experienced a large swelling on either side of neck, up and down the neck. She assume it was my lymph nodes. She felt as if someone was pushing my Adam's apple. Unpleasant and scary as she though it might get worse and I would choke. This lasted most of the day Saturday. The same swelling and pressure in throat occurred after the second Pfizer shot on 29Apr2021 (Lot Number: EW0153 ; 21Jul2021). This time it happened more quickly. Five hours after received the shot. (Vaccine received at 11:30 am). The pressure in throat lasted throughout the afternoon. Also felt burning and tingling at the site of the FIRST vaccine at this time. She got a headache on 10Apr2021 and have had one ever since. The only other symptom have had is a sore arm. She did not feel ill. She was not tired. In fact she was awake at night (not normal for me). It felt like had an adrenaline rush. The outcome was recovered on an unspecified date.  No follow-up attempts are required. No further information is expected.
heart palpitatoins; mild chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (mild chest pain) and PALPITATIONS (heart palpitatoins) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHEST PAIN (mild chest pain). On 08-Apr-2021, the patient experienced PALPITATIONS (heart palpitatoins). At the time of the report, CHEST PAIN (mild chest pain) and PALPITATIONS (heart palpitatoins) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided No concomitant medications were reported
Sore arm; Slight headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the shot Wednesday.  The patient experienced sore arm and slight headache was all he/she had as far as side effects. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II (rHA) injection 0.5mL, lot number N023149 with expiration date on 24-AUG-2019 (dose was not reported) for prophylaxis with sterile diluent (MERCK) lot number N027783 with expiration date on 17-NOV-2019. It was stated that the patient inadvertently received a dose via the intramuscular route instead of the intended subcutaneous route. No adverse effects reported. Lot number N027783 has been verified to be a valid lot number for sterile diluent (MERCK).
Nausea/vomiting for 30 minutes, 12 hours after vaccination; severe chills but no fever starting 12 hours after vaccination lasting 10 hours,  This was a booster shot. Original doses were Moderna on 01/20/2021 and 02/17/2021
Extremely bad headache, body chills, very painful muscle aches, congested nose, frequent urination. Symptoms lasted for 24 hours.
Patient in observation area for approximately 10 minutes when she began to experience mild itching to general body.  Patient placed in reclining chair for direct observation Vital signs recorded as BP - 130/78  P- 112, SPO2 - 98%, R- 16.  Administered 50 mg Diphenhydramine orally per provider direction.
pt recvd vax & exp unspecified react; DEC88 lab eval revealed anti-HBS pos; APR93 lab eval revealed anti-HBS 0; No further details were provided
5x10cm area erythema of skin @ inject site w/warmth, mild tenderness, + pruritus; ? cellulitis vx allergic rxn;
This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 04-NOV-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
This report concerns a 15 month old male who received Prevnar, Comvax, Varivax and MMRII vaccines on 7/19/00. On 7/26/00, the child developed a cough and congestion. On 7/28/00, he experienced a febrile seizure which lasted for 4 to 5 minutes. ER services was called and the child was treated with albuterol. He was seen in an ER and dx'd with an ear infection. The child was treated with amoxicillin.
Received call from patient asking if Gamunex-C could possibly cause Hepatitis B. She tested positive in November and is concerned as to where she may have gotten it. She is in a monogamous relationship and her husband tested negative. She stated that she does not receive therapeutic phlebotomy and also has a PORT that is accessed often. She first noticed it when she had her COVID booster, which caused her to become ill. She then decided to have some tests run and found out that she has Hep B.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-MAY-2017, the patient was vaccinated with an expired first dose of M-M-R II (lot # M032153 exp date 22-APR-2017) (dose and route not reported) reconstituted with sterile diluent that was not expired. No adverse effects were reported. Additional information has been requested.
31AUG93 grand mal sz, meds given caused resp/cardiac arrest, requiring 3 days ventilation; had had diarrhea x 1 wk; dx w/herpes & encephalitis, sz, bronchitis; cont w/sz-see MD (neurologist);
dose was administered in error- patient's caregiver said she needed her 2nd dose of Moderna but she had already received it.
little fatigue on first two days; This is spontaneous report from a contactable consumer.   A patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown route, on 15Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant drugs were unknown. The patient reported so far there are no side effects except little fatigue on first two days from 15Dec2020. The action taken in response to the events for BNT162B2 was not applicable. The outcome of the events was recovered on 17Dec2020  Information about lot/batch number has been requested.
fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Feb2021 at single dose for COVID-19 immunisation at the age of 68-year-old. Medical history and concomitant medications were unknown. On 22Feb2021, the patient experienced fatigue. The patient did not recover from the event. No follow-up attempts are possible; information about lot/batch number cannot been obtained
Got mine 3 days ago. Horrible pain iny arms; I couldn't sleep; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and insomnia. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm and insomnia were unknown.   It was unknown if the reporter considered the pain in arm and insomnia to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got 1st dose 3 days ago of reporting date. The patient experienced horrible pain in arms and the patient could not sleep.  The patient took Motrin. The patient was advice to go back after two months for the second shot.
Pt c/o dizziness tensed body and diaphoretic, passed out - pt recovered - initial VS at 1656 111/58 HR 58 99% RAR. VS 1707 100/62 HR 61 99% RAR - eating sucker, drinking water. Time out at 1721. Left with mother.
This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored (Oka/Merck) VARIVAX (strength, formulation, lot#, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
within 2 minutes after receiving vaccine I became flush, tightness in base of my throat and chest and heart starting racing faster and faster. A few nurses came over and saw my fit bit heart rate going higher (max 136 BPM) my fingertips started to get numb. They quickly injected me with .05 epinephrine.  They brought me up to the emergency room and put me on  a heart monitor. The racing heart subsided after approx. 7 min then started again. It happened 3 times in the emergency room. They ran a few EKG's to try to catch the tachycardia episodes. They started an IV and ran fluids. After 2 hours the symptoms stopped and they released me from the hospital.
Headache, arthralgia, fatigue, mouth ulcers, rash and insomnia (lupus flare).
patient was administered an expired dose of Havrix by someone else on Friday; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 10-NOV-2023, the patient received Havrix. On 10-NOV-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix by someone else on Friday). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: The Pharmacist reported that the patient had administered expired vaccine of havrix . The reported that vaccine expired in January 2023. The caller declined to provide more information. The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # M032149, expiration date: 18-APR-2019 (dose, site and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion in the range 47 to 77 degrees Fahrenheit for 40 minutes.  Data logger was involved. There were no previous excursions reported. Additional information has been requested.
MA administered Hep B in Right thigh and immediately saw bright red blood pulsate out of the injection site.  Bleeding stopped with pressure.  Patient was crying for longer than usual ~ 5 minutes after administration.
well until 730AM 21OCT94 started w/relatively short grand mal sz x 5;
Tdap vaccine given on 12/22/15 - client called 12/24/15 c/o s/s of swelling, warmth pain to bruising.
WRONG BOOSTER WAS GIVEN. MONOVALENT PFIZER GIVEN INSTEAD OF BIVAL PFIZER
After I received my first vaccination on 1/19/2021, I developed a heart arrhythmia. My condition worsened after I got the second vaccination on 2/16/2021. On 2/20/2021 at about noon, I noticed that the fluttering sensation in my chest worsened. Also, my exercise intolerance grew even worse than it was after the first vaccination. My doctor doubled my metoprolol dosage. It helped a little, but it didn't eliminate the symptoms. The arrhythmia persisted until about August 2021, when it finally resolved itself.
Information has been received from a 64 year old male physician's assistant with hypercholesterolaemia, arthritis, gastrooesophageal reflux disease (GERD) and allergic rhinitis and no drug reactions or allergies reporting on himself who in December 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included simvastatin (manufacturer unknown), FELDENE, PRILOSEC, ZYRTEC, fluticasone propionate nasal spray, aspirin, minerals (unspecified) CENTRUM and vitamin D (unspecified). The physician's assistant reported that on 01-AUG-2011 he might have experienced an attenuated zoster after vaccination with ZOSTAVAX (Merck). On 01-AUG-2011, the patient currently was experiencing unilateral, right side third cranial nerve palsy with visual disturbance in the right eye, headaches and some nausea. The patient sought medical attention by office contact. No treatment was given for the adverse events. Magnetic resonance imaging (MRI) and unspecified blood tests were performed (results not reported). At the time of reporting, the patient had not recovered. Double vision could not function was considered to be disabling by the reporter. Upon internal review, unilateral, right side third cranial nerve palsy was considered to be an other important medical event. Additional information has been requested.