chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna it was my 2 nd shot 14 hrs later headache then chills and nausea then muscle aches in my whole body . It lasted 2 days . On 3 rd day just headache and red rash around my neck and down my shoulders . All set now but feel short of breath sometimes .
Hospitalized 7 days post last dose lungs with fluid, shortness of breath, heart cardiac overload
This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 60-year-old male patient who received SHINGRIX. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovering/resolving. The reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 59 or 60 years. The nurse reported to the field representative that her husband received SHINGRIX and afterwards had a swollen lymph node. The lymph node was golf ball sized. When the representative spoke with the nurse on 4th May 2018, it was resolving. The vaccine was not administered at the nurse's office.
Itchy and warm red area around the injection site. I also had fatigue the day after vaccination.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials. No treatment medication was reported. This case pertains to the 161th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient reported vaccination site rash/rash to right upper arm above the elbow where she had the shot, vaccination site erythema/rash still has redness and vaccination site warmth/rash feels hot; all with outcome of unknown. Follow-up (Nov 24, 2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the attempts made. Follow-up attempts completed. No further information expected.
Very cold, had chills and shakes, weak, dizzy, bad head ache trouble with balance,  trouble walking and in bed Monday after noon  all day Tuesday.  Still weak today but doing better
SHORTNESS OF BREATHE; HEAD, FORHEAD AND EARS ARE HOT; HEADACHE; LITTLE EXTRA FATIGUE; This spontaneous report received from a patient concerned a 22 year old of unspecified 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 not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced shortness of breathe. On 10-APR-2021, the subject experienced head, forhead and ears are hot. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced little extra fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, head, forhead and ears are hot, shortness of breathe, and little extra fatigue. This report was non-serious.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Fever of 105.2 with running nose red eyes, low appetite 12 hours after vaccines were administered.
threw up after the shot and now persistent pain, and redness in the arm, turning black and blue at times
opthalmic herpes zoster, oral steriods, steriod eye drops, zirgam eye gel, combigan eye drop, valtrex
Patient describes experiencing intense hallucinations and confusion to the severity that he was hospitalized.  Incoherent speech, and repetitious speech. Muscle coordination difficulty (could not button a shirt or tie shoe laces). Got lost while tring to get home at night. Patient states he felt that he was temporally insane.
5-7 minutes after vaccine administration, patient experienced shortness of breath, dizziness, hoarse voice. Immediate improvement after epinephrine was administered
Headache, Myalgia, Arthralgia, Fever, stomach cramps Narrative:  Other Relevant History:
The day after my vaccine I developed hives on my inner thighs and two whelps appeared on my hand and one whelp on my abdomen. They were raised, red and very itchy. I took an antihistamine and they faded over the next several hours. The next day I noticed no other adverse reactions.
received the vaccine after the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine after the 6 hour vial puncture expiry) had resolved.        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.   No concomitant product use was provided. Treatment information was not available.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012M20A)  with no associated AEs.
Passed out while standing about 8 minutes after receiving vaccination, hit head on the counter and then fell back and hit head on the floor, out for less then 1 minute, was awake by the time a person could get to her side.
Very swollen at injection site-Patient states baseball size swelling. Redness, pain and itching at site.
No adverse effects; Received an intramuscular dose of MMR II; This spontaneous report was received from a female pharmacist of unknown age referring to herself. The patient's concurrent conditions, medical history, drug reactions/allergies, concomitant drugs were not reported. On 30-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: Albumin status of rHA (recombinant human albumin), (lot # R000557; expiration date: 08-JAN-2020) via intramuscular route (incorrect route of product administration) for prophylaxis. No adverse effects (no adverse event) were reported. No product quality complaint involved.
Large deep red rash of small dots ranging from 8 inches bellow the knee to 8 inches above the knee.  Rash and/or hives are itchy.  The red bumps are very small.  Below the knee the bumps are very close together and there are a lot more of them.  Above the knee, the bumps are far apart and there are very few of them.  Contacted doctor via online interface.
Firm warm patch upper R arm near delt. at injection site. No discharge, no fluctuance treatment-cephalexin 250 mg/5 ml, 5 milliliter three times daily x 7 days, 105 milliliters, 7 days, 07/20/2013.
Information has been received from a physician concerning a male (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy not reported.  Subsequently, within a couple of days post vaccination the patient developed an annular area of redness and vesicular bumps around the injection site, and along the arm there were linear erythema with small vesicles.  The patient experienced a little burning and itching.  Outcome of the patient was not reported.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
No reaction on day if vaccine. A delayed swelling, redness an itching on the vaccine site, about 8 or 9 days after vaccination. No other reaction. Redness has diminished bit not completely after 4 days of said symptoms. Checked CDC and MGH and apparently sounds like ?COVID arm?
1st vaccine 12/28/2020. 1/5/2021 new onset of rash from the shoulder halfway down toward elbow. slightly itchy but not painful or tender to touch. no raised bumps. just redness. this was at the injection site, same arm same area though first noticed 1/5/2021 not immediately after injection
My son woke up with a large, red, itchy, hot circle (approx. 5" diameter) around the injection site.
A report was received from a vaccinee's family member on 12/10/02 concerning a 44 year old female vaccinee who experienced transverse myelitis 10 days after receiving Fluvirin on approximately 11/19/02. The vaccinee's past medical history was reported to be unremarkable and no concomitant medication was reported. The vaccinee had never previously received a flu vaccine. On 11/29/02 the vaccinee was hospitalized secondary to loss of the use of both legs, paralysis and numbness below the waist. A neurologist diagnosed the vaccinee with transverse myelitis. It was reported that the vaccinee had good bilateral reflexes and that her muscles were fine, however, the vaccinee could not feel anything in both legs below the waist. It was reported that the vaccinee was being treated by a neurologist and was unresponsive currently to unspecified therapy.
Dizziness and flushing with chest pain and back pain began on day 5. Then progressively got worse. Cardiologist believe my condition is POTS or IST. Heart rate increases 30-60 bpm with minimal activity.
Pt noted blister + red streak on (R) arm 48 hours after immunization given no fevers.
Information has been received from a physician concerning a 20 year old female with a history of syncope who on 18-JAN-2008 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 18-JAN-2007 the patient "looked like she was going to faint."  Unspecified medical attention was sought.  On 18-JAN-2007, the patient recovered.  Additional information has been requested. Information has been received from a physician concerning a 20 year old female with a history of syncope who on 18-JAN-2008 was vaccinated with a first dose of HPV vaccine. On 18-JAN-2007 the patient "looked like she was going to faint." Unspecified medical attention was sought. On 18-JAN-2007, the patient recovered. Conflicitng information was received from a medical assistant. The medical assistant reported that an adverse event did not occur. Additional information has been requested.
Patient arrived to Emergency department of Medical Center 4/18/21 around 5:00 PM and reported that she had received a COVID vaccine dose #2 at outside clinic a day before this and today is experiencing significant side effects.  She presents here with dizziness, headache, myalgias, and urinary incontinence. Around 1:00 PM today she had started to develop body aches, headache, myalgias in the hips, back and arms, chills and sweats. She had a urge to urinate but was unable to get up from reclining due to weakness in her legs and pain when moving. She states it took her an hour to get off the couch and then had difficulty walking due to severe dizziness, and she fell to the floor in her bedroom and fell back and hit the back of her head on the ground but denies any loss of consciousness. She has no visual changes, no nausea or vomiting, no chest pain, no shortness of breath, or hematuria or dysuria, also no numbness in the groin. She states it is painful to move.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: experienced lightheadnee and headache for 15 minutes
administered 0.4 mL doses of the Moderna COVID-19 vaccine; administered 0.4 mL doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (administered 0.4 mL doses of the Moderna COVID-19 vaccine) and INCORRECT DOSE ADMINISTERED (administered 0.4 mL doses of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .4 milliliter. On an unknown date, the patient experienced UNDERDOSE (administered 0.4 mL doses of the Moderna COVID-19 vaccine) and INCORRECT DOSE ADMINISTERED (administered 0.4 mL doses of the Moderna COVID-19 vaccine). At the time of the report, UNDERDOSE (administered 0.4 mL doses of the Moderna COVID-19 vaccine) outcome was unknown and INCORRECT DOSE ADMINISTERED (administered 0.4 mL doses of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported. No relevant concomitant medications were reported.
got Covid-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 07Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that she had the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and she got Covid-19 on 11Apr2021. She got out of quarantine on past Friday and she would like to consult if she could take the second dose tomorrow or if she needs to reschedule. The patient underwent lab tests and procedures which included Covid-19: positive on 11Apr2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red, warm area about 4 in below injection site. Bruising at inj. site. Slight shakiness, weakness overall fully recovered by 10/7/2016.
Pt recv vax on 1/26/99; on 1/27/99 pt exp red/warm/ tender around vax site w/ abscess; tx=Keflex PO, incision & drainage
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ that were exposed to a fridge excursion on 21-JUL-2017 (lot # L044476, expiration date 07-JUL-2017, lot: L020865, expiration date 09-FEB-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
First dose was not much of an issue, I had the expected soreness in my arm where the shot was administered.  I would get an occasional twinge of pain ( as if I had the shot again).  However, since I have had the second dose on 4/29/21 _ I am experiencing horrible pain in my deltoid, upper bicep and tricep.  To the point that I cannot sleep due to the constant stabbing pain.  I have rested the arm, iced it, heated it.  I have seen the chiropractor, had massage therapy, and cannot find relief.    The pain is AWFUL and stabbing and sharp.  Yesterday I went to the orthpedic specialist and they say that it seems to be all muscular and likely inflammatory reaction from the vaccine. this is 6 weeks of a reaction.
Pt was given Varivax on 9/28/01. Pt seen at clinic 11/27/01 with rash that appeared to be chicken pox.
Largely swollen lymph node in armpit, with moderate/severe pain in armpit preventing normal use of arm. Accompanied by shaking chills, fever, fatigue, overall muscle soreness, and injection site pain.
Fatigue,  sore arm at injection site, headache,  fever,  body aches,  swollen lymph node in neck and armpit,  nauseous  and vomiting  and hives on hans and feet.
After receiving my first vaccination on 08/14/2021, I had a random outbreak on 09/17/2021 of hives starting on my neck and chest, and then on my hips, but only had this one incidence. I received my second dosage of the vaccine on 09/21/2021 and then began to break out in these spontaneous hives almost every day. They occur most commonly on my waist, hips, chest, and neck. I do not have any difficulty breathing, facial swelling alongside the hives. I also do not have any known contact with skin irritants or a history of allergies or any kind.
9JUL97 pt found a red, round, rash under rt breast in the evening;it is itchy;no c/o hives, SOB etc;rash has not spread;may use calamine lotion for the rest;
A nurse reported the occurrence of swelling around the eyes in a 21 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical history, concurrent conditions and concurrent medications were not provided.  Follow-up information revealed that the hepatitis B vaccine recombinant (Engerix-B) injection was the first vaccine the subject had ever received.  The subject's parents had refused all childhood immunizations.  On 11/05/02, the subject received the first injection of hepatitis B vaccine recombinant (Engerix-B) (Lot # ENG5229B9).  On 11/11/2002, the subject experienced swelling around her eyes and hives and rash on her legs.  The subject "denied exposure to possible allergic substances (tomatoes, peanuts, fish etc.)" Subject was seen by physician who prescribed loratadine (Claritin).  By the time of the initial report, 12/27/02, the events had resolved.
(R) arm - swelling, erythremia, warmth, tenderness to touch around injection site Pt stated pain 9- on 1-10 scale.
Delayed vasovagal syncope. I woke up with a slight fever and dizziness next day by 7am. Just after 9am (about 20 hours after vaccine) sat down on stool and passed out to the floor without warning for at least 30 seconds witnessed  by my husband. Had fever about 100 which lasted until noon. I also passed out with the very first covid vaccine in February 2020.
The booster knocked me out; increased urination; woke up dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (dose 2, single), for COVID-19 immunization.  The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "The booster knocked me out"; DYSURIA (non-serious), outcome "unknown", described  as "increased urination"; DEHYDRATION (non-serious), outcome "unknown", described as "woke up dehydrated". The events "increased urination" and "woke up dehydrated" required physician office visit.  Additional information: The patient was not taking medications or anything like that. The booster knocked the patient out. After the first dose patient had a lot of the typical symptoms such as a sore arm, etc. After the booster all night long, every 45 minutes, patient had to go to the bathroom. It was not a big stream, but it was constant. She woke up dehydrated, it was such an excessive urination. Her doctor told that she had heard about similar cases and recommended patient to stay hydrated. The patient was anxious about getting a fourth shot of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200557881 Same pt/drug, diff event sep in time
Patient's left arm was swollen and she states felt heavy like iron. her neck and face swelled alittle and turned red