chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reverse blood flow; babies were in the same sack; Maternal exposure; Low birth weight; premature birth; Live birth; This retrospective pregnancy case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a female patient exposed to Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) in utero. The mother received the product for prophylaxis.   On 26th October 2018, the 23-year-old mother received Fluarix Quadrivalent 2018-2019 season .5 ml. The mother's last menstrual period was on 18th July 2018 and estimated date of delivery was 25th April 2019. The patient was exposed to Fluarix Quadrivalent 2018-2019 season at week 14 of gestation and during the second trimester of pregnancy. At 31 weeks and 1 day, the patient was born via cesarean delivery. The patient was diagnosed with birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the mother case.  Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.
It started as a rash on his head, then made it's way down the side of his face, then down the rest of his body. The rash has been severely red, slowly covering his body, until all his skin was red. It looks like a severe sunburn. The skin has been peeling off and flaking, even his feet.  He's also swelling on his hands, arms, and legs. Last few weeks his eyes have been dry and now they are severely inflamed and both his eyes and the skin (the waterline) are puffy. Almost like conjunctivitis, but a lot worse.  Very rough timeline: Head rash - Middle/end of May Slow body rash & swelling- all through June Skin peeling - Beginning of July Feet/hands splitting and cracking - Beginning of July Full body rash - Mid July Eye dryness/inflammation  - Mid July
pt recv vax 15APR98 & 20APR98 pt exp a local reaction;
About 30 minutes to an hour after getting the injection the site started itching & was red, hot to the touch & raised in an area about the size of a quarter. 35 hours later the redness, swelling, itchiness & heat are still there but has grown to the size of a silver dollar. Under the skin is a big lump. It's only painful to the touch.
Parkinson's symptoms amplified.  I became extremely dehydrated rapidly.  I lost memory and body control.  Fell on floor and could not walk or get in or out of bed.  No core body strength.
No reaction to the vaccine. On February 19 I had a COVID-19 test at home and it was Negative, but I started a bad headache, I went to the doctor on 20th, to the UC and doctor saw my ears and I had some fluid in the ear, medicine was prescribed for 10 days, but on the seven day I still did not feel well. On the 29th I did not feel good. on the 30th my back was hurting bad and moved to my left side of my chest. I went to work, and they sent me to hospital and they did blood work, chest Xray. EKG. Lungs were clear, blood were normal.  they did Covid- 19 and flu tests and the next day I got the results, and it was Positive. On I called my PCP and saw the nurse Practioner and he prescribed Paxlovid. Saturday on the 5 day, my back was bothering again and yesterday I had a bad headache. I did not go to work today. I had another COVID-19 test in pharmacy and I am waiting for the result.
Pt received this Bivalent Pfizer Dose in error.  RN should have completed this patient's 2nd monovalent dose not given her a Bivalent dose.
pt had a positive COVID test on 7/4/22 and was in the hospital with COVID pneumonia and respiratory failure after a fall; dc'd to SNF; 7/15/22 pt back to ED with increasing dyspnea; respiratory failure; placed on BiPAP; another positive COVID test; pt made slow improvement then became weaker with worsening hypoxia; family transitioned pt to comfort care and he passed away in the hospital
Patient received her first dose of shingrix on 8/9/23 in her left deltoid. Patient came to the pharmacy today on 8/14/23 and showed her arm was red. Patient reported the following symptoms that started on the day of vaccine administration: Redness at the site of injection, low grade fever, lethargy, itching, shooting pains, swelling of the left arm, administration area hot to touch, stomach ache, nausea and vomiting, "shingles like feeling". Patient reported taking ibuprofen which has helped her symptoms. Patient has not sought treatment yet.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.   Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Expiration date was reported as 09-Nov-2021.   Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021.   The vial did not undergo any temperature excursions.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up recieved contains non-significant information.
Covid eye returned (red, burning eyes) heart racing with the slightest movement, higher than normal resting heart rate. Painful breathing, fever, serious fatigue. Treating with Tylenol, eye drops and fluids.
Patient broke out in rash 2.5 weeks post vaccination that covered upper torso, both arms and starting on both legs. The rash is very itchy but patient had not tried to take anything over the counter for it yet, will try BENADRYL. Patient states she has no known med allergies and has not ever had a reaction to a vaccine before. She did get this years flu vaccination from someplace else on 8/19/2018.
Thursday 5/6/04: AM swelling, hard, warm, red spot at sight, complaint of pain, called dr and was told to call in the morning if worse (3"). Friday 5/7/04: am swelling, hard, warm, red area was almost doubled in size (6?), complaining , called dr and was told NOT to come in, that it would be better by Sunday. Sat 5/8/04: heat, swelling and hardness down but sill red, no complaint unless touched. Sun 5/9/04: all symptoms gone, except small, red, hard spot (2"), complains if spot is touched. Friday 5/14/04: all symptoms gone, small red spot and child complains if spot is touched. (1"). Hard lump.
rash all over; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date, the patient experienced rash all over. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Additional information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 16-MAR-2016, the patient was inadvertently administered an expired dose of M-M-R II lot # K003823, expiration date 14-MAR-2016 (dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
sweaty and itchy from zoo mild sunburn around neckline of shirt and on face sunscreen had been applied after sunburn noticed hives around neckline and on R flank within minutes of getting Imovax vaccine #2 Benadryl liquid 12.5 mg given at 4:15PM welts diminished significantly after  Benadryl given P 123 B/P 115/78 O2SAT 98% br sounds clear no swelling of lips and tongue drinking water and swallowing without problem advised to go to nearest ER for follow up-given directions to Hospital 7 miles away
The pt developed a bump and 1 hour post vax, the pt started limping and the bump got bigger throughout the night and was hot to the touch. Mom gave her son Tylenol and put an ice pack on the site.
Pain on the left arm, rash that runs toward the front of the shoulder, warm to the touch. No itchiness in the area.
9 pm fever went in 15 minutes to 101, 102 , 103.4 by 10 pm 106.4  Packed neck with ice packs to protect my brain.  Fever down to 102.3 but by 2.30 back to 108.8 degrees,  Muscle loss, pain in joints, extreme fatigue, shivering, chills, front lob of head hurt, can't function by myself.  New ice packs around my neck, cold compress on my head,   45 minutes later temperature down to 102.3.  Next morning up to urinate, blood in urine, urine was clear however could see red.   Next day only up 3 times for 15 minutes each.   Forced myself to drink water and Gatorade all day.  Use wall to walk,  unable to do any daily activities, hurt all over, so weak.  Temperature throughout day low 101 with various highs 104.7, 105.2.  No energy, no longer in control of my body.  4.30 am. Sunday 4/11/2021 woke up soaking/drenched wet.  Sat up muscle control is back, pain is gone.  Long 31.5 Hours!
Pt received vaccine on 9-5-14; within 24 hrs pt developed shaking, chills, dry heaves, a 101 degrees temperature, and stomach pains and went to emergency room.
Experiencing Chills; Experiencing / Fever; Experiencing / Body aches; Injection site pain; Discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, general body pain, injection site pain and discomfort. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the fever, general body pain, injection site pain and discomfort were unknown.   It was unknown if the reporter considered the chills, fever, general body pain, injection site pain and discomfort to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 2nd dose on an unknown date and experienced chills, fever, body aches and injection site pain. The patient asked any treatment for his discomfort.
Received adult Td on 3/26/04. Arm was sore for several days but continues to be sore through range of motion. Biceps area feels swollen to touch. No redness . Pt states is painful to touch.
swelling of face & eyes p/4th dose in series;took DPH & sx resolved;
bruise; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise). At the time of the report, CONTUSION (bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
pt recv vax 28FEB96 & 19MAR96 pt devel a gen itchy rash described as vesicles, & a fever;tx w/Atarax for the itch;it was noted that some of the vesicles scabbed;pt recovered;
A few hours after the second dose of the Pfizer covid-19 vaccine, I had a very sore arm. About 36 hours after the shot, I discovered two very large hives/welts on my back that were very itchy and stung. I took my daily Allegra during the day and then a Benadryl at night. I also applied hydrocortisone cream on both. Today is April 14 and they are both feeling much better with treatment and seem to be going away.
Rash over entire body with itching, no fever, rash developed 18 hours after immunizations. Benadryl given in office.
Fever; Body aches; Mild to moderate and increasing dizziness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 42321) via an unspecified route of administration in the left arm on 24Apr2021 at 11:15 as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 as a single dose for COVID-19 immunisation. On 25Apr2021 at 21:00, the patient experienced mild to moderate and increasing dizziness, fever, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, 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 event mild to moderate and increasing dizziness, fever, body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
LUMP AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included none, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced lump at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at site of injection. This report was non-serious.
Patient reports headache, high fever, chills 4 days after vaccination. Resolved in 12 hrs. 4 days after 1st episode reported same symptoms with less severity.
Shocking/tingling sensation (felt like a electrocution) in private area - started moving up to stomach and then to foot, back, arm them to around whole body. Same day as the shocking sensation - felt pressure on elbow and knees. Diarrhea for duration of 3 days. Join paint knees. Lasted for the whole day - no longer occurring.
On Sunday, January 24, I woke up with an itchy left arm close to the injection site.  Thought it was a mosquito bite.  The itch stopped for the rest of the day until I showered that night.  I realized it was  an itchy rash and found   it to be large.  About 4 inches long and 1 1/2 inch wide.  I applied alcohol and the itch stopped.  Since then, the rash has felt itchy about 2 times.  It is not hot, I do not have a fever and there are no other problems.  Except for the occasional itch, I do not even know it is there.
pt recv vax & devel gen varicella rash w/early blisters; pt seen by MD on 9MAY95; no further details were provided;
01/26/22 presents to ED for "chest pain, SOB, and productive cough". PMHx of "CAD and MI s/p stents, HFpEF (EF 45%), chronic neck pain, CVA, DM type 2 (on Levemir), HLD, DVT s/p IVC filter (on Lovenox), HTN, CKD stage IIIb, macrocytic anemia, PAD, neuropathy, seizure, and TIA"
My right hand is sleeping in the finger and stays like that this whole time; my hand like numb; My neck little warm like swelling and then in my legs got the same swelling; My neck little warm like swelling and then in my legs got the same swelling; It was very painful very sensitive; It like my ganglia are swelling; In my face in my right side like a little bump; The second shot felt very bad; It is very hard to work with these side effects; It scares me a little bit because I don't feel good and strong / feeling sick; my ganglia are swelling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185, UPC/ NDC number / Expiry Date of COVID Vaccine: Unknown), via an unspecified route of administration on 12May2021 (at the age of 49 years) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included headache, fever, tired and feeling sick; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot Number: EBK33) on 02Apr2021 for covid-19 immunisation. It was reported as, the patient was called because I have the Pfizer Vaccine (COVID Vaccine) the second shot and 10 days ago patient right hand was sleeping in the finger and stays like that this whole time. The patient doesn't know you have any side effect like that with another person, patient know everybody was different. The concern in patient hand was sleeping like my fingers and little bit my hand like numb. The patient had the headache, fever and patient was so tired after getting the first shot, for next sixteen hours patient was feeling sick and then patient took Tylenol, and everything was perfect. After the second vaccine on 12May2021, the patient started feeling my hand numb and then the other side effect was patient neck got little warm like swelling and then patient legs got the same swelling. The patient have to take medication for the pain, because it was very painful very sensitive. It like my ganglia are swelling. In my face in my right side like a little bump but no acne. Patient don't know if there are more people like me with the side effect because I went to emergency room I was there for 5 hour on 16May2021, because in patient legs and all this I think it is related to patient heart but everything was okay. The second shot felt very bad. It is very hard to work with these side effects. It scares the patient a little bit because patient don't feel good and strong. The patient feeling sick." consumer stated on Lab work as, "They did blood test in the emergency room like on 16May 2021. I don't have the results, but everything was okay." Therapeutic measures were taken as a result of events with Just Ibuprofen (as reported). Outcome of the events was unknown.  Further information has been requested.
Patient reported feeling light headed after receiving  second vaccine (Fluarix) and quickly loss consciousness. The technician called for the pharmacist to assist and 911 was called.  Patient was unresponsive for approx. 1min. At which time a pulse was found and normal breath sounds were present. She was seated on the bench where the vaccine was administered. Her head was supported and began to respond. She reported being able to hear, but not respond. EMS  checked glucose and did an EKG . No issues found. Patient reported that these episodes occurred frequently as a child. but had been without an episode in many years. She decided not to go to the hospital and her parents arrived to take her home.
9/10/19 vaccinated. Initially had fatigue + aches 9/14/19 burning, itchy rash (R) back 9/18/19 office exam - Diagnosed with Shingles
All symptoms developed overnight day of injection 9/28/21  Swelling and pain at injection site. Muscle and joint pain in arms, legs, neck, base of head, chest muscles, upper shoulders and lower back. Headaches. Loss of appetite and nausea every time I try to eat something.
Metallic taste  after around 20 mins after the shot Muscle pain around the injection site - 20 mins after  Mild headache after around 4 hours after the shot Mild headache on and of until two days after the shot Mild sore throat until two days after  No treatment done
Post nasal drip, test  taken 12/30/2022 evening of 12/29/2023 symptoms of a cold, cold cough and fever.
Brain clot; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL THROMBOSIS (death, medically significant), outcome "fatal", described as "Brain clot". The patient date of death was unknown. The reported cause of death was cerebral thrombosis. It was not reported if an autopsy was performed. It was reported that 2 men was died from a brain clot after receiving Pfizer Covid Vaccine. One of the patients died on the way to the emergency department before they got to the hospital, but reporter was unable to clarify which of those 2 patients that was. Reporter did not know if patient died last night, several days ago or when.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200106634 same reporter/product/event, different patient; Reported Cause(s) of Death: Brain clot
Redness decrease injection in muscle tissue - hot to touch. Advised to watch closely and call if not improvement. Reaction occurred 5 days later.