chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased and very loud bowel sounds (Use of Alka Seltzer). Decreased appetite w/nausea and abdominal cramps (random episodes). increased and constant leg pain that isn't relieved with Ibuprofen or muscle relaxers. Left side pain accompanied by painful gas pockets. Lower back pain that I thought was kidney stones, but CT SCAN only showed inflammation. Reoccurring migraines (ER prescribed anti-inflammatory) . Numbness in my right arm and hand when my arm is bent at the elbow(no medication taken. I just have to let my arm hang down to get blood flow to my fingers before it stops feeling numb).
The client has had throat cancer since getting the vaccine; She also has these cramps that she gets in her stomach; Arms and hand cramps; This spontaneous case was reported by a patient and describes the occurrence of THROAT CANCER (The client has had throat cancer since getting the vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 THROAT CANCER (The client has had throat cancer since getting the vaccine) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (She also has these cramps that she gets in her stomach) and MUSCLE SPASMS (Arms and hand cramps). At the time of the report, THROAT CANCER (The client has had throat cancer since getting the vaccine), ABDOMINAL PAIN UPPER (She also has these cramps that she gets in her stomach) and MUSCLE SPASMS (Arms and hand cramps) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of throat cancer, together with other non-serious events, which occurred on an unknown day after a dose of RNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). The outcome of the event was reported as recovering. No further information was disclosed. The benefit-risk relationship of RNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) vaccine is not affected by this report.
Pt. fell dizzy, felt hot, queasy, almost felt if would have diarrhea, head felt heavy. Gave pt. cold water to drink and cool compress to apply to face and neck. Reaction happened almost immediately. Within less than 5 minutes she felt better. No dizziness, queasiness, cooled off etc, but started headache. Had butalbital already prescribed and she will take it when she gets home.
Myalgia, Fever, Diarrhea & NauseaVomiting Narrative:
4/7/15 at 2:27 pm Patient reported shaking uncontrollably. Her son called ambulance to go to ER. Pt says she also started having difficulty breathing. Contacted and spoke with patient 4/7/15 at 7:28pn; Pt says she declined ER eval. Sxs resolved with taking her lorazepam. Pt believes symptoms were related to the PREVNAR 13 immunization. Pt says she is fine now.
Adverse event started the same night.  Extreme body aches, low grade fever, extreme anxiety, fatigue and headaches.  Fever subsided with 24 hours but the body aches, anxiety, fatigue, and headaches continue to date.  Just not feeling well since I received the vaccine.  I am going on 4 weeks post vaccine.
red swollen upper left arm, warm, painful, tender to touch. started about 1 week after injection. became slightly raised red itchy rash.  lasted about a week.
pt well on 11FEB; pt recvd vax & the next morning had runny nose & many bruises which inc over several days; seen 15FEB94 & found to have platelet count 10,000 adm to hosp;
On 7/27/05 my granddaughter was given all of her 4 month shots at the Dr. office.  On 8/5/05 we were called at home stating that they gave her the adult vaccine PPV instead of PCV.  She was then given the correct vaccine on 8/5/05.  After she was given the first shot on the 7/27/05 she was more cranky and sick.  For 2 days she did run a fever of 101.6 and did not eat all that much.  All she did was cry.  She was given tylenol and was given warm bathes.  Did contact a public health nurse that is assinged to pt and also contacted the CDC on getting the information to make sure she is going to be all right.
Small bumps appeared, eyes began swelling, unable to walk, was diagnosed with Shingles.
RED AT INJECTION SITE (NO PAIN); SWELLING AT INJECTION SITE (NO PAIN); Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypertension.    On 28-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 29-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved. On 02-Oct-2021, VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE (NO PAIN)) and VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE (NO PAIN)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received and added medical history of the patient. added new events and batch number updated.
Evening of vax did not feel well, diarrhea; 10AUG91 exp diarrhea, sick cramps, joint cramps, low grade temp & coffee ground stools; 17AUG & 18AUG91 diarrhea, weakness; 20AUG91 admitted to hosp, dx: acute gastroenteritis & anemia; see WORM..
Pt came to clinic 10/24/03 for her first Hep B. Mother called 10/28 states pt was ill with fever, abdominal pain, vomiting.  Mother called again 10/29 and stated the child was now yellow in her eyes and skin.  Fever was better.  Mother then said she had a similar reaction 2 years ago at clinic, got 1 Hep B then forgot to tell us. Referred to clinic.
Severe body aches and headaches 12 hours after administration of 2nd dose.; Severe body aches and headaches 12 hours after administration of 2nd dose.; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; First dose's administration date 13Jan2021, second dose's administration date: 30Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262, expiry date: not reported), via an unspecified route of administration at left arm on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included polycystic ovary syndrome (PCOS), gilbert's syndrome, bipolar disorder, and allergies to sulfa. The patient received unspecified concomitant medication received within 2 weeks of vaccination. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), at left arm on 13Jan2021 at 06:30 PM for COVID-19 Immunisation. On 31Jan2021 at 04:30 AM, the patient experienced severe body aches and headaches 12 hours after administration of 2nd dose. The reporter considered the events non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The outcome of the events severe body aches and headaches was unknown.  No follow-up attempts are possible. No further information is expected.
So about a month later after the vaccine, I woke up with chills, felt very cold and my heart was beating fast. I took my pulse and it was going up to 123. My oxygen saturation was good 96-98%. I took my temp and I had a low grade fever. I bought a BP monitor and my BP was as high as 145/88 and fluctuated throughout the day and would go back down. I went to an Urgent Care. I got an urinalysis and it was positive for UTI. I was prescribed a medication called Macrobid for the UTI and referred to a cardiologist. By the time I went to see the specialist, most of my symptoms had subside. I went to the cardiologist and did an ECHO and had to wear a monitor. Everything came back normal and all my symptoms has subsided except a little short of breath.
Migraine; nausea; headache; exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021, at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity and penicillin allergy. It was unknown if the patient was pregnant. Concomitant medications included albuterol (MANUFACTURER UNKNOWN); formoterol fumarate/ mometasone furoate (DULERA) and sertraline hydrochloride (ZOLOFT); all for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient experienced migraine, nausea, headache and exhaustion. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, nausea, headache and exhaustion was recovered on 14Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called to tell us she woke up with hives the day after receiving the HD flu shot. Rash on arms & stomach. Itching. Suggested BENADRYL for itching. This is 1st time having HD vaccine.
he tested positive for covid on 30Dec2021; he tested positive for covid on 30Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200036789 (Pfizer).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Lot number: EN6202) at the age of 78 years as dose 2, single and administration date 07Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovered" (08Jan2022) and all described as "he tested positive for covid on 30Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive; (08Jan2022) negative. Therapeutic measures were taken as a result of covid-19. The patient is scheduled to receive Pfizer Covid 19 Booster on 12Jan2021. The patient was treated with over the counter medication to make him comfortable. He and his wife received the first Pfizer Covid 19 Vaccine on 07Feb2021. The second Pfizer Covid 19 Vaccine was recieved on 28Feb2021. Per caller he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior. Caller reports they both tested negative on 08Jan2022. They are scheduled to receive the Pfizer Covid 19 Booster on 12Jan2021. Caller states the hospitals are all full of Covid patients, so they rode it out at home.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200037079 same reporter/drug/event, different patient.
3/13/2021 had migraine aura for 25 minutes followed by moderate headache twice.  3/14/2021 had migraine aura for 20 minutes followed by moderate headache.
About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needles along my whole left side. I am still having this as of today 3/25/21
A few days after the second shot, I started experiencing vertigo, and extreme headaches.  This lasted for 6 weeks.  Although it's better now, I still do not feel 100%.  I had daily dizzyness, whenever I got out of bed, or up from a sitting position
Fever/shivering (99F or so), fatigue and muscle pain started 12 hours after injection and lasted for one day or so; swelling and rash on the injection site, 2 inches area (started on Day 3 and lasted for one day only); other flu-like symptoms (could not sleep well, shivering, headache, poor appetite) lasted for 3 days or so.  Ibuprofen was taken for 2 days and it was helpful.
Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation.  Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication.  On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches.  The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering.  The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
Intense rash on neck and chest a few hours after receiving the dose. Later on throughout the week, smaller less intense rashes appeared all over my body, causing my body to be itchy.
Initial report was received from a health care professional on 05 June 2012. A male patient (age not reported) had received an injection of MENACTRA (lot number U42628C, not a valid Sanofi Pasteur lot number) (date, route and site of administration not reported) and a finger stick for a lipid panel. After the finger stick and vaccination, the patient lost tone, eyes rolled back and he fell onto the floor. The incident lasted less than one minute. The patient's mother and sibling witnessed the event. The staff heard the patient fall and the patient's mother came out for help. The doctor and medical assistant (MA) went into the room and the patient was on the floor on his stomach and was tremoring. They turned the patient to his side, he woke up and stood up. The patient was assisted to the examination table and was examined. He passed examination but there was an area of "adema" near the right eyebrow. The patient was given juice and peanut butter. The patient's past medical history and concomitant medications were not reported. The patient's outcome was not reported. Documents held by sender: None.
2 weeks and 1 day (3/25) after having the 1st shot of COVID 10, Moderna shot, at approx. 5PM I noticed swelling, redness (approx. 2 inch circular around shot area) and itching.  Didn't scratch or apply anything to it.  Took Tylenol before going to bed at 10:30PM EDT and woke up(3/26) with area mentioned above Very red, swollen and itching (more so than first discovered).  I have have applied ice pack for most of day (3/26)and swelling seems to be going down.  I am allergic to Benadryl so am sticking to just Ice on area and will probably take Tylenol again this evening.
Mother of child indicated bruising at site of injections.  While MD was evaluating on related condition in the office.  L/leg had a pink area 1 1/2 x 1 1/2 and it was nodular.
Shortly after getting injection 9/3/03 started getting headache and feeling lethargic, body aches. Dr. appt 9/10/03, no fever. Dx: tonsillitis.
About 1 1/2 hrs post vax pt started crying (high pitch) this lasted 3-4 hrs then pt fell asleep when woke up & cried again; t102, site of DTP inject was red & swollen;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 1 day after receiving dTpa vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that he heard from other pharmacists that patients have complained about pain, with TDaP (did not specify BOOSTRIX), at the injection site the day after vaccination. This case has been linked with case US2018062444, reported by same reporter.
VOMITING (5 TIMES IN TOTAL SINCE THE ONSET); PERSISTENT CONSTANT/LIGHT NAGGING NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 160 pounds, and height was 64 centimeters. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On 04-JUL-2021, the subject experienced vomiting (5 times in total since the onset). On 04-JUL-2021, the subject experienced persistent constant/light nagging nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent constant/light nagging nausea, and vomiting (5 times in total since the onset). This report was non-serious.
Significant stomach pain as if there were hands inside my stomach squezzing it as one would do to a wet rag to remove water; Significant dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 07Mar2021 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included graves disease and hypertension, both on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and fexofenadine hydrochloride (ALLEGRA), all on an unknown date for unknown indication and unknown if ongoing. The patient previously received amlodipine besilate (NORVASC) and experienced drug allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 14Feb2021 at 18:30 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. On 08Mar2021 at 10:30, the patient experienced significant dry heaves for about 4 hours, day after second dose injection. On 11Mar2021, days 4 through day 6 after second dose injection, the patient experienced significant stomach pain as if there were hands inside her stomach squeezing it as one would do to a wet rag to remove water. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent nasal swab and the result was found to be negative. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event significant dry heaves was recovered on 08Mar2021. The clinical outcome of the event significant stomach pain as if there were hands inside her stomach squeezing it as one would do to a wet rag to remove water was recovered on 13Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Moderna Bivalent vaccine on 4/5/23.  This was only the second vaccine of the series and was administered out of turn.  I contacted the CDC and was instructed to have the patient receive the second dose of an age-appropriate covid 19 monovalent vaccine since the Moderna monovalent is not available.  Patient did not have any adverse events.