chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had a stroke; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Apr2021 (lot number and expiration date were not reported) as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization. The patient had the second Pfizer dose on unspecified date and the next day he had a stroke. The patient's wife was very concerned because she was reading other symptoms faced from the Pfizer product. The patient's wife wanted to know if anybody else faced a stroke after having the Pfizer shot. The outcome of the event was unknown.   Information about lot/batch number has been requested.
1 of 3 pts vaxed from same Tetramune vial who exp extreme irritability described as crying for an extended period following vax;no fever reported;treated w/APAP-recovered;No further clinical details available
Information has been received from a registered nurse (RN) concerning a 17-week-old male who on 03-AUG-2006 was vaccinated by mouth with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653915/0389F).  It was unknown if medical attention was sought and no adverse events were reported. Additional information has been requested. 12/01/06 This is in follow-up to report(s) previously submitted on 9/8/2006. Information has been received from a licensed practical nurse (LPN) concerning a 17-week-old male with no medical history who on 03-AUG-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #653915/0389F). Concomitant vaccinations administered on that same day included the second IM dose in the left thigh of PEDIARIX (Lot #AC21B065AA), the second IM dose in the right thigh of ACTHIB (Lot #UE856AA) and the second dose in the right thigh of PREVNAR (Lot #B08658C). Medical attention was not sought and no adverse events were reported. Additional information is not expected.
Broke out in shingles in left eye cornea - forehead and head on 7-8-2018. I had shingles in October 2014 in same place. The SHINGRIX shot was my 2nd dose. My first dose was given March 13, 2018. Still have pain in right arm where administered 2nd dose.
Patient states rash started within 3 days, rash with itching, patient describes rash as round, raised areas of redness with the biggest area being the size of a quarter.  Rash on chest, 1-2 spots on upper back and 1 small spot on arm.  Patient states no fever or trouble breathing.  Patient saw doctor and was given an antibiotic.
w/in 3 hrs of vax pt became lethargic & dizzy w/vomiting; also fever thru night; sx improved next morning but by 4PM next day (16th) t103.1; also lethargic, apparent loss of balance, difficult to arouse; MD recommended no more pertussis;
5 hours post vaccine- sore arm, low grade fever, 12 hours post vaccine cold symptoms (stuffy nose, sneezing, coughing), 24 hours post (severe cold symptoms listed above, fever, body aches). Also- I'm pregnant (5 weeks).
Cannot walk right; Her balance was horrible; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in 2021 as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient stated she was having second side effects from the Pfizer covid vaccine that she got. She said that she had a reaction to the first COVID shot. Her balance was horrible and could not walk right in 2021. She stated that the first time she called in about at the end of Feb or beginning of Mar. Patient confirmed that she was experiencing the same symptoms that she was experiencing when she called in Feb or Mar and she just wanted to walk normally again. The outcome of events was unknown.  Information about lot/batch number has been requested.
Patient called Pharmacy 12-5-13 in the morning to report she is still currently having a reaction that she believes is from the ZOSTAVAX Vaccination that she received 11/6/2013. She received vaccination on 11/6/2013. On 11/13/13 she went to ER because she almost blacked out. She went again to the ER on 11/19/13. She says she may have had a stroke. She is till complaining of Numbness in hands, and foot. Feeling dizzy and disoriented. She said no doctor has told her that her symptoms were a result for this vaccination.
Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date and experienced flu like symptoms).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient was sick after vaccination. For tolerance to 1st dose, refer case US2020025207.
Influenza vaccine given 11/11/02. Patient developed total body urticaria for which she was evaluated on 11/19/02. Hives were resolving well. Canadryl oly was needed. She developed total body urticaria. It cleared with benadryl.
Pt re3ceived Rabies vaccine #2 of series on 4/8/02. Next morning, she was sore, redness, but on 04/10/02, she woke up with lymph gland swelling in right armpit under right clavicle and in groin. Saw nurse practitioner @ clinic who did blood test-said it was viral.
HOSPITAL AQUIRED. ADMITTED 12/8 TESTED POSITIVE 12/24
pt experienced tingling up and down her right arm about 8 mins after vaccination. Given 2 x 25 mg diphenhydramine given history of anaphylaxis with cipro. Pt was observed for 35-40 mins and felt OK to drive home.
Brief fainting episode w/ "jerking movements", headache, abdominal pain and dizziness. Sent to ER for eval.
Chest pain, fatigue, shortness of breath, night sweats, coughing, fever. After I went to the doctor, I was diagnosed with pericarditis, and I was prescribed NSAIDs for 2 weeks, but my symptoms got worse after 14 days. Then I went to the ER, and was admitted to cardiology for pericardiocentesis. I exited the hospital after 4 days, but then went back to the ER because I had a persistent cough. I was admitted again for thoracocentesis, to have a tap and get rid of my detected pleural effusion. I exited the hospital after 3 days.
On 9/8/21 severe nosebleed with clots. Returned to ER  9/9/21 and 9/10/21 same condition despite intervention. Cauterization at Ear Nose Throat specialist necessary on 9/13/21.
Tingling sensation of throat at 2:12pm.  Monitored patient and he stated ?i feel fine this happened last time i got my first dose, but my whole body was tingling.? Continued to monitor and asked if he has health conditions or took medications/drugs etc, felt dizzy, felt his through closing up and he stated ?no.? Water provided, and continued to monitor, suggested to wait an extra 30 minutes for monitoring. After 10 minutes, he felt better. Benadryl provided at 2:24pm, educated patient about the therapeutic effects, and potential side effects of Benadryl. He consented to taking it. He waited until 2:45-2:50 pm and chose to leave because he felt better. Educated patient about the Pfizer information sheet and advised to call 911 or go to nearest hospital (ER) if the states severe effects occur.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 01-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # K003596) (dose and route not reported) that had expired on 12-MAR-2015. No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
heavy period; cramping/spotting; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 27-years-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EP7533) via an unspecified route of administration, administered in left arm on 06Apr2021 at 14:00 (age at the time of vaccination was 27-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included was just being treated for very bad allergies to nature. Concomitant medications which were taken in 2 weeks included birth control, antihistamine and allergy injections. The patient had no known allergies. The patient did not have COVID prior to vaccination and was not treated for COVID post vaccination. The patient had no other vaccine in 4 weeks. On 22Apr2021, the patient experienced heavy period and cramping/spotting. A few days after the first dose, experienced cramping/spotting and had some bleeding, but on the 22Apr2021, a heavy period began which was early and experienced heavy bleeding for over a week. This included large clots and bleeding through pads/tampons. Lighter bleeding continued after the clots stopped. She was still spotting some when had second dose. Two days after, had light bleeding and now she experienced more heavy bleeding with quarter sized clots. Prior to this birth control, had her periods very regular and nowhere near as heavy as this bleeding. Now her cycle was completely off from the pills. No treatment was received for the adverse events. The clinical outcome of events was Not recovered.  No follow-up attempts are possible. No further information is expected.
approximately  12 hours after receiving the Covid 19 vaccine on 12/18 that I had nausea and vomiting. The vomiting lasted about 2 hours from approx 5:30 AM to 7:30 AM on 12/19. Also, I was extremely fatigued for the rest of 12/19. I slept the entire day only being awake for approx 4 hours. The next day I was slightly nauseated but able to go about my day as normal.
Information has been received from a physician concerning a 7 year old pt who  on 02/26/04 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 01/19/2004  the pt experienced a case of breakthrough varicella. There were 60 lesions. Unspecified medical attention was sought, but there was no tx and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. 39 other cases (WAES 0407USA01446 and 0409USA01855 through 0409USA01877 and 0409USA01879 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Incessant crying for over 5 hours, hypothermia (35.3°C) checked by rectal way.
I got very dehydrated. I had cramping in both legs and feet. I drank a lot of water before and after I received the vaccine. I had to keep waking up to drink more water. After drinking  2 bottles ( 23.7 fl oz each)  I was hydrated enough that the cramping stopped.  4/3 and 4/4 I am still feeling a little dehydrated.
Uncontrollable tantrums, crying, stuttering.  Very agitated and just not like himself.  The symptoms started not long after his vaccination with the MMR shot.  He had been talking from the time he was 1 year old with no problems.  After this shot he started stuttering and having problems with his thought processes. For days he had problems with crying and tantrums.  I took a good 6 months before he stopped stuttering.  He still has some neurological issues that may be associated with this vaccination.
covid test result:Positive; covid test result:Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 1, single (Lot number: FF2589), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "covid test result:Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive, notes: Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states that he was given the shot and it hurt like it normally does but this particular time he also had irritation at the site in the form of redness and swelling a few hours after getting the vaccine. Pt went on to say that a couple of days went by and he noticed some pain in the left jaw as well as an inability to open his mouth past a certain point. This went for a couples of days and then subsided with no other symptoms. Pt denies any other symptoms, being sick, SOB or recently being treated for an illness around the time, so just assumed it was due to the vaccine. Pt did not report this until just yesterday because he had been temporarily assigned to another location immediately after getting the vaccination, then once his symptoms went away, he didn't think it was a big deal and forgot about it.
4yr old presents to clinic 2/22/2019 for swelling on left arm since vaccine administration 2/19. Mother endorses significant swelling, redness and heat 2/20 of the left arm. Slightly painful to palpation. No discharge. Worsening symptoms 2/21 with extension of redness and swelling of left arm. Initially pain with movement with arm. Now resolved. Mother gave Diphenhydramine x12/21 due to symptoms. Slight improvement in symptoms. No fever. No nausea. No emesis. No shortness of breath. Pt received MMRV vaccine and DTAP/IPV vaccine on the same arm. Left arm. Physical exam with 3.5cm redness on left upper arm. Nontender to palpation. Slight associated swelling. Full ROM of left arm.
My son had a chicken pox and flu vaccine given in the same arm on thursday December 11th. On the 12th his shoulder was swollen and was hurting, I put some ice on it. On the 13th the swelling got worse. It felt leathery,hot and it was red. The swelling also started heading down to the elbow, so I called the Dr. who told me to put some ice on it and give him some pain medication and some Benadryl, and watch it for 48 more hours more. I gave him the Benadryl only and this helped with the itching a little, he was still able to move his arm and I felt his brachial and radial pulses, so that made me a little more comfortable. The swelling continued on the 14th and was now at his elbow and was itching. The swelling in his arm was 2 times the size of his other arm. It was still hot. I gave him another dose of the Benadryl and fluids to drink. On Monday while I was getting ready to take him to the doctor, the swelling in his arm was the same size a little hot, but the leathery feeling was less. I didn't take him in. Today the 17th the swelling is all gone except a little bit near his shoulder and some itching last night.
A report has been received from a Health Professional concerning a 7 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 16-Oct-2012. The patient experienced BUMPS THAT LOOKED LIKE IMPETIGO and RUNNY NOSE which started on 16-Oct-2012. The patient recovered from the event of BUMPS THAT LOOKED LIKE IMPETIGO on an unspecified date and the outcome of the event of RUNNY NOSE is unknown. The report was considered to be non-serious.
Lack of Efficacy; Initial Report Received on 14-Apr-2023 and 17-Apr-2023  A patient reported that she, a 47-year-old female patient (race and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a negative titer.   Medical history and concomitant medications at the time of vaccination were not reported. Allergies included penicillin (unknown reaction) and Neosporin (neomycin-bacitracin-polymyxin) (caused severe rash).  On 07-Nov-2022, the patient received the first dose of HEPLISAV-B vaccine (Lot #, expiration date, an NDC # unknown) in the left bicep.  On 07-Dec-2022, 1 month after receiving the first dose, the patient received the second dose of HEPLISAV-B vaccine  (Lot #, expiration date, NDC #, and injection site unknown) in the left bicep.  On 01-Mar-2023, 115 days after the first dose of HEPLISAV-B and 85 days after the second dose of HEPLISAV-B, the patient had a titer drawn and it was negative. On an unknown date, at "the end of March" another titer was redrawn and it was still negative. The patient did not report any adverse effects related to HEPLISAV-B.  No additional information was provided.  Company Comment: The company assessed the event as non-serious. The event was not immunologically confirmed since the serological test was not specified.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed since the serological test was not specified.
She woke me up in early morning - and she felt feverish and she had a headache. I gave her Tylenol and she went back to sleep. When she woke up around 08:00 a.m. she felt like she had the flu - terrible headache, chills, 100 degree fever, body aches and nauseous and really restless. By the morning, her left arm at injection site was also sore. We gave Ibuprofen at 10 am to help with aches and pain. About 20 min later, she threw up a lot. I called the doctor and talked to nurse. Told me to wait four hours before giving pain meds again. We gave her Pedialyte. at 02:00 pm, I gave her a dose of Tylenol and in within 30 seconds after giving it to her she threw up again, a lot. I called the doctor again. Nurse said to give her more Tylenol when she was able to feel better. She took a bath and drank some Pedialyte and that helped rehydrate her and then we gave her Tylenols when she was feeling up to it. On Sunday, when she woke up, she had swollen and painful lymph nodes on armpit on her left side and those are still persisting - not as swollen but painful a bit. She was tired still on  Sunday but feeling a lot better. Tiredness, sore arm and pain in lymph nodes under her left arm were what persisted on Sunday. She still has pain under her left arm with swollen lymph nodes but did go back to school today.
Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021.  The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.
Patient fainted approximately 5 minutes after receiving  the vaccine.  He fell to the ground hitting his head on some shelving while falling.  He was quickly revived by his father, but still felt dizzy and complained of blurred vision.  Patient was given a bottle of water and comforted by his father and brother.  When I checked on him about 20-30 minutes later, he said he felt fine.  He  looked a lot better too.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 13-NOV-2012, patient received improperly stored VARIVAX dose 1, from lot # 0610AE (dose and expiry date unknown). On 12-DEC-2012, the patient received second dose of VARIVAX from lot # 0610AE (dose and expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A and 010M20A) for COVID-19 immunization. No medical history reported. On Mar 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced  pain in extremity (soreness of arm). At the time of the report, pain in extremity (soreness of arm) resolved. No concomitant medications provided. Treatment medications unknown. The patient received both scheduled doses of mRNA-1273 prior to the event. The action taken with the drug in response to the event: not applicable. Most recent follow-up information incorporated: On May 4, 2021: Follow-up received on May 4, 2021, event outcome updated.