chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was administered to the patient.  The patient waited in the assigned chair in the waiting area.  He was observed to lose conscious and fall out of the chair onto his head.  He regained conscious and began conversing with the staff.  He remained supine for 10 minutes and then sat up.  He reported feeling fine, except for the headache, and was allowed to leave with his spouse.
Itching in the arm of the injection site; Redness at the injection that spread to to her elbow/ big red ring; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site itching and erythema of extremities. On an unknown date, the outcome of the injection site itching and erythema of extremities were recovered/resolved.   The reporter considered the injection site itching and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix in left arm and experienced redness at injection site that spread to the elbow and she described it as big red ring and itching in the arm of injection site, which lasted for about 3 weeks. The reporter did not consent to follow up.
Information has been received concerning now a 4 year old female who on 12/19/1996 was vaccinated with one dose of varicella vaccine. On 11/21/2000 the pt experienced breakthrough varicella. On 11/21/2000 the pt recovered. No further info is available.
Information has been received from a pharmacist concerning a female patient in her sixties who on approximately 10-APR-2007 was vaccinated SC in the back of the arm with a dose of Zostavax. A few hours later, the patient developed an injection site reaction, swelling, and redness at the injection site which was one half inch wide and two inches long in a rectangular shape. The patient went to her physician and no treatment was required. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Woke up 36 hours after receiving vaccine in the ER with muscle aches and chills. Had low appetite throughout day and felt lightheaded and headachey. By early evening had begun to break out in spontaneous hives all over body. Hives progressed and continued for about 7 daya while muschle aches, chills, and headache persisted.
Patient reported pain in shoulder and neck area and also the occurrence of headache. She also repots that her neck is hot to the touch.
Pt reports that the day after she had her vaccine she started having some pain where she had shingles before.  That evening she started feeling really bad and knew she was having a shingles flair again.  Reports she was nave able to finish her shingles vaccine series because she developed shingles a week after her first vaccination.   She was still within the 6 month period to wait to get the second dose when this occurred.  She called her doctor who advised her it was ok to take her antiviral for the shingles and that she could still get her second injection for the COVID vaccine.
pt recv vax 12SEP95 & devel fussiness & a fever of 103.104 8-9 days p/vax;2 other children & pt twin were given same lot# & exp t103-104;
Patient with an acute hepatitis with Tb 6.5, ALT 2165, AST 1288.  Serologies for all chronic liver disease negative. Autoimmune serologies negative. LFTs normalized by June 2021. Jaundice resolved.
Patient fainted 5 minutes after immunization. Patient hit head upon falling out of chair. Pt regained consciousness immediately. Ambulance was called due to hitting head. Patient refused treatment by ambulance. Patient felt passing out was due to low blood sugar. She drank 7-up and was helped cleaning up blood and given band aid.
Projectile vomiting 5PM 10JUN91, sz started 6PM 10JUN91 cont 11JUN91 1AM, fever Seen in ER required ventilator;
felt anxious; hot; had a fast heart beat for a minute; This is a spontaneous report from a contactable consumer.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) (at the age of 61- year-old) as single dose for covid-19 immunisation.  The patient had received first dose of vaccine on an unknown date. The patient medical history was not reported.  The patient's concomitant medications were not reported.  History included she has an allergy to Penicillin.  After a few minutes of vaccine administration, the patient felt anxious, then really hot, she was fanning herself, had a fast heart beat for a minute, after a minute it went away and she didn't tell anyone. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
OB GYNE provider ordered HPV injection to be given due to no previous history was seen on the chart at the time. no adverse events noted. pt was called and no symptoms noted per patient.
2 hours after vaccine was administered the patient called back to the pharmacy to report moderate-severe lower back pain (around L5 - per patient) that she was experiencing. She stated that she had the hairs on her neck and right side of her body were standing up and related it to her epileptic aura. She also stated that it was somewhat difficult to breathe only because of the discomfort. Instructed the patient to seek urgent care and directed to nearest facility. She had an epi pen in her purse and I reminded her that she could use that if she began having swelling in lips/mouth/throat.
Headache, chills, body aches, Injection site pain and swelling, general malaise, fever, poor sleep, waking dreams (hallucinations?)  Used imitrex for the headache (2x doses 6 hours apart, 50mg) Used ibuprofen 400mg/tylenol 1000mg alternating for fever/swelling  Symptoms resolved approx. 26 hours after they began.
sore arm; wondering if you have discomfort in the injection site after the first dose, and no; This is a spontaneous report from a contactable physician (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Shingrix and experienced sore arm. The patient received both doses of Pfizer's COVID vaccine 22 days apart. The reporter stated that she had a mild response to the first vaccine with a sore arm, but had no fever nor headache and for her second dose, she had no symptoms whatsoever. Caller asked what statistics do you have in having less adverse reactions of the second dose compared to the first dose, How likely is it that a vaccine recipient would have injection site soreness after dose 1, but no symptoms/no reaction after dose 2. Would there be any concern that the second dose had been mishandled and this was ineffective. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1 hour, post vax, pt started crying and wouldn't eat. He was screaming and shaking (possible seizure). His upper left leg was bright red and hot. Started fever on 3/12/02 at 07:00 of 102.3F.  Gave Tylenol. Went to MD at 09:00.  MD checked baby and told to continue Benadryl. Pt's fever was 104.5F at 13:00. MD said to change to Motrin if he had a fever after 14:00. Went to ER at 15:00. Both legs were purple. No temperature at ER; stayed about 2 hours. Cold packs and gave him Benadryl. Slept. Told to continue Benadryl for 48 hours.
Pt exp an inject site rxn which included redness, swelling, pain & vesicles w/in 4-6 hrs p/immun; rxn covered the arm 7 underarm down to the waist; tx Antihistamines;
Patient received MRNA COVID-19 vaccine on approximately 1/22/2021.  Uncertain whether Pfizer or Moderna. 1.5 weeks later presented wtih tachycardia, hypotension, and Hb of 6.3 with labs consistent with PNH flare.  Patient has PNH with a baseline Hb of 9.5 and has been well controlled on ultomiris for quite some time.  Ultomiris last given 1/14/2021. Patient is being hospitalized for further management.
Patient reports that she received the Johnson & Johnson vaccine on Sunday 4/11/21. She reports feeling no symptoms until Tuesday 4/13/21. She is experiencing tenderness under her left armpit and feels that her breathing is tighter than normal (COPD, emphysema, smoker).
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent patient and unknown gender. On 24-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Irritableness, fever t103; fatigue, sore arm, vomiting x1; pt had adverse rxn to 2mo DTP; had DT 6FEB87, 3APR87 & 8JUL88;
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
Varivax on 2/23/04 - has presumptive case of Varicella on 9/12/07 50 - 249 lesions covering entire body.
28AUG91 PM mom notified clinic that pt had been crying for over an hour; Mom was told to contact MD; Pt taken to Hosp & given APAP supp in ER & told by MD not have pt receive Pertussis again; Mom states pt cried nonstop x 2hr, t100.6 R;
I?m currently 11 weeks postpartum and exclusively breastfeeding my infant. I experienced typical vaccine adverse effects on day 0-1 (fatigue chills muscle aches weakness arm pain and fainting episode (I have a history of fainting and with other vaccines)) followed by mastitis on day 2 after my vaccine second dose.  Mastitis symptoms included fever chills muscle aches weakness breast pain swelling redness and decreased milk production from blocked duct(s). I had no symptoms of blocked duct prior to the vaccine or prior to day 2. My prescriber ordered an antibiotic and ibuprofen which helped.  We believe that the blocked ducts/mastitis occurred in relation to lymph node swelling that has been seen with the vaccine although we did not have a physical exam to determine if that is true.
01/05/2022: 70-year-old female seen in the ED for further evaluation management of being positive Covid while living in her nursing home. Patient at this time was brought in by EMS from nursing home reporting that she tested for positive Covid, patient does endorses that she does have a "head cold" which started 1 day ago. Patient endorses nasal congestion as well as sinus pressure. denies any fever chills no cough or shortness of breath or difficulty breathing or active chest pain. No abdominal pain no nausea vomiting diarrhea. tested at nursing home. 01/10/2022: Remdesivir now completed Decadron to run through 1/14. Still in hospital.
First noted swelling and pain in left ankle/foot on 3-27 that progressed up calf and right foot/ankle began visibly swelling with +2 pitting edema bilaterally evident by 3-31.
feeling some tingling again where she had shingles awhile back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history included shingles from an unknown date and unknown if ongoing she (had shingles awhile back). The patient's concomitant medications were not reported. The patient previously took Valtrex which she had to stopped taking a day and half before the vaccine. On an unknown date, the patient felt some tingling again where she had shingles awhile back and would like to known if she could go back to Valtrex or would it interfere with the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient was admitted for acute kidney injury in the setting of cirrhosis and c. diff.  Thought to be unlikely related to vaccine.
This case was reported by a physician via sales rep and described the occurrence of glossitis in a female patient who received SHINGRIX. Concurrent medical conditions included seasonal allergy. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced glossitis. On an unknown date, the outcome of the glossitis was unknown. It was unknown if the reporter considered the glossitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported an episode of glossitis 3 to 4 weeks after receiving SHINGRIX. The healthcare professional mentioned that she did not think the event was related vaccine. The reporter told the patient that glossitis might had been due to seasonal allergies.
Aches, incurable chills, headache, dizziness. Took ibuprofen and acetaminophen on rotation for 18 hours and felt better after lots of rest
7 months old received DTap/IPV of the Pentacel without reconstitution of the HIB/no AE; Initial information received on 27-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 months old female patient who received DTAP/IPV of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstitution of the HIB (product preparation issue) via intramuscularly at the left upper thigh on 27-Apr-2020 for prophylactic vaccination [batch number UJ195AAA; expiry date 12-Mar-2021; dosing details - third dose 0.5 ml of the partial Pentacel]. Batch number and expiry date of HIB was reported as UJ195AA and 12-Mar-2021 respectively.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
6 weeks post-injection, left arm remains painful, especially with use of biceps or deltoid muscle. Pain is not debilitating, but is enough to disturb sleep and cause discomfort in dressing.
"My arm where I received the tdap booster shot in is very warm to touch, red, and has progressively become more swollen. It feels and looks like there is a hard golf ball in my arm. I have taken 2 Advil 2x a day starting yesterday and just started ice last night."
Recipient of influenza vaccine reports that vaccine administered into the very top of the deltoid muscle, causing immediate discomfort/mild pain.  The discomfort/pain has continued for two and a half weeks, ranging between mild discomfort to pain.  Left shoulder range of motion has been affected and this has limited reciepients life style. No treatment given by a practitioner yet, though she has an appt. for an evaluation.
Patient was experincing diffeuclty breathing, diffucult swallowing, migraine, dizziness, sob and nausea. Pt vitals were stable and was rapidly transported to the ER
Patient reports headache noticed on 11/15 along with generalized muscle aches and local pain, heat, swelling and redness around injection site. She treated the symptoms with Excedrin Migraine, which the headache and muscle aches have resolved. The injection site pain, heat, and redness have increased since onset. No other treatments have been tried. Affected area measures 4.5 x 5.5 cm.
Developed 10-12 lesions on abdomen, thighs, buttocks and cheeks. All lesions are papules only (<2mm in size), non-vesicular.
Employee began to feel ill at 2am the night following the vaccine. Suffered from weakness, fever/chills, nausea, body aches, headache, sweats. Employee missed 3 work days but returned to work once symptoms subsided.
Mother states the night following the vaccines she spiked 105 degrees fever and started seizing-went to ER.
died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient's spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death
Good; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021, at 10:00 as first single dose for covid-19 immunization.  Medical history included penicillin allergy.  The patient's concomitant medications were not reported.  The patient experienced Good on 22Jan2021, at 10:00. The event was reported as non-serious.  No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination, nor has he been tested for COVID-19 following vaccination.  The outcome of Good was recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Temperature of 102 degrees, body aches, chills and neck pain that lasted for 24 hours.
This spontaneous report as received from an 84 year old female consumer refers to herself. The patient' medical history included dry eyes, cataract surgery years ago. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous, injection, one single shot (dose unspecified). Concomitant medications were unspecified. On an unknown date, the patient was experiencing dry eye and can't be exposed to bright light. She went to an unspecified ophthalmologist who could not determine a problem but gave her three eye drops for her symptoms samples of REFRESH OPTIVE, ALREX, and SYSTANE BALANCE. However, the patient has not had too much of improvement with these treatments. No product quality compliance involved. The outcome of events was unknown. The reporters causality for the events with the ZOSTAVAX was unspecified. Additional information has been requested.
No adverse reaction observed. Miscommunication at check-in and screening.  Pt received Bivalent booster as Primary dose 1.
pt recvd vax 8NOV95 approx 115PM;by 630 that evening refused to use arm & temp went to104 orally;APAP given;cont to have temp elevation;head cold w/a lot of nasal discharge
UTI  Symptoms  , like Blood in Urine with fever and Headache. Headache with ear pain and Nerve at back side of the ear swollen  . Bell's Palsy  to the right side of the face.
Swollen red area with small rash and itchy.Started two days after injection.  Lasted for 4 days.  Used antihistamine cream. Condition improved
Sensory neuropathy; Balance issues; This case was reported by a physician via call center representative and described the occurrence of sensory neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included triamcinolone acetonide (Kenalog).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 122 days after receiving Shingrix, the patient experienced sensory neuropathy and balance disorder. On an unknown date, the outcome of the sensory neuropathy and balance disorder were unknown.   The reporter considered the sensory neuropathy and balance disorder to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Four months after vaccination, the patient developed sensory neural and balance issues.  The physician stated that he did not believe the neural issue was related to the vaccine.  No additional details were provided.
At time event started I was throwing up, dizzy, and had a burning sensation at the top of my throat. I laid down after being sick and had the chills. I spent the rest of the day and the next day sleeping or laying in bed. By the 3rd day, I was less nauseous at night and was able to eat some dry Cheerios. The 4th day, I became nauseous and dry heaving again, sleep until the early evening. By the 5th day I was a little better that I could work from home. Did not feel completely like myself until the following Tuesday.
patient said he felt like he couldn't see for a  few seconds. he thinks it due to his anxiety/panic attacks. he is able to see clearly now.