chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following the injection on Monday (9/29/08) it was itchy & sore.  Didn't bother me too much until the following Monday (10/6/08)it became more itchy with pain and a rash that keeps enlarging.  Tuesday (10/7/08) it was worse and the rash area seems to be puffy/swollen.  Today (Wednesday-10/8/08)the rash has become more wide spread and more itchy.  Last night I took 2 Benadray and one this morning.  Will take more during the day today.  If it doesn't get better I will call my doctor.
Registry assessed. Child due for 2 month immunizations. I chose Pentacel combination vaccine for Dtap/IPV/Hib. However, I did not reconstitute and administed only DTaP and IPV. Child had no immediate adverse reaction. However, I acknowledge that this is a vaccine administration error. Child needs to be immunized for Hib. Supervisor notified of error.
pt was exposed to natural chicken pox 2 wk prior to onset of sx pt recv chicken pox vax 1 wk prior to onset; exposed to sunlight then severe vesicular rash
pt received their 2nd dose and it was past the 6 hour puncture expiration date. We are offering another 2nd dose due to pt per cdc guidance.
Felt fine until 3:00 a.m. next morning - approx. 11 hrs. after vaccine. Extremely nauseous. Took (3) doses (at ok prescribed intervals) of ZOFRAN 4 mg sublingual tablets. Did not work. Vomiting spurts last 12 hours. No fever. No rash or pain at injection site. Did have minor joint pains. Severe headache. Could have been from ZOFRAN. Brushed teeth at 10:00 p.m. on the 16th. 5 mins. later noticed severe lip swelling. No tongue or throat swelling. Nausea came back at approx. 2:00 a.m.  Did not sleep well. Woke up at 4:00 a.m. swelling still there. Headed to ER.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients. No information regarding medical history and drug reactions or allergy was provided. The reporter stated that on an unknown date an unspecified number of patients were vaccinated with doses of ROTATEQ (dose, frequency, product lot/expiry date not reported) taken orally that were improperly stored. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
11/19/2021- Syncope with Collapse  I was getting ready for work when I felt my heart start racing, and strong palpitations, became very hot and nausea, had tunnel vision occur before passing out.   I was able to get into bed to lay down and was able to recover from the event. I have had minor dizziness and lethargy months leading up to the event. and the days after the event.
A couple of hours after receiving the 1st dose of the Pfizer vaccine my ears started to buzz. I?ve been waiting to see if this would improve but 1 week later I still have  fairly loud tinnitus in both ears.
Local reaction at site of vaccination (left posterior arm), 5x4cm erythema, induration, mild tenderness; no fever, no chills, no rash elsewhere.
no adverse effects; the administration of one separate dose of an improperly stored vaccine, VARIVAX, to one separate patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.   On 22-APR-2019, the patient was vaccinated with one separate dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number: R026548, expiration date: 17-SEP-2020) administered subcutaneously (dose was not provided) that was diluted in properly stored sterile diluent. The vaccine was still experiencing a temperature excursion at the reporting time. On 16-APR-2019, there was a previous temperature excursion in 11.28 degrees Fahrenheit for 15 minutes and 9.1 degrees Fahrenheit for 45 minutes. Digital data lodger was involved.   No adverse event was reported.
dose of the vaccine in his left arm 6 hours after first vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (dose of the vaccine in his left arm 6 hours after first vial puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Swelling of the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the face) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling of the face). At the time of the report, SWELLING FACE (Swelling of the face) outcome was unknown. Not Provided          concomitant medications were not reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Muscle atrophy; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left deltoid on 14Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 medication included clonazepam (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication and unknown if ongoing. On 17Apr2021, the patient had muscle atrophy and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, 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 muscle atrophy and muscle pain was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Joint pain, joint stiffness, muscle pain, muscle jerks, twitching, headache, tremors, brain , fog, fatigue, numbness in hands and feet, facial tingling.
Feeling bad, went to bed, work up with headache, slurred speech, couldn't speak correctly, high blood pressure all day.  Next morning improved.
11-11-2008 Developed rash on right buttocks and right legs with itchiness and pain.  Saw Dr. on 11-13-08 Diagnosis Shingles Rx Zovirax pills and Kenalog cream given.  Spoke with patient on 11-18-08 patient states rash looks like it is getting better.
Patient reported redness in the arm that she received the vaccine, 2 days after receiving the vaccine. The red patch started 2-3 inches below the injection site and spanned 5 inches long and 3 inches wide. Patient was referred to a medical facility for further evaluation, but instead decided to come to the pharmacy to present the red patch (financial limitations). She was recommended an ice pack to the area and was told to seek further medical treatment if the patch worsens with redness or swelling. The patient was contacted a few days later to assess progress/improvement, but the patient did not answer. A voicemail was left for the patient to return our call.
Patient seen in clinic on 04/07/21 reporting 2 weeks of right leg swelling and calf pain. Vascular ultrasound on 04/07/21 showed blood clots in legs. Lovenox injections started 04/07/21. Warfarin started 04/08/21.
Brain fog and trouble with short term memory/ It feels like the description of COVID BRAIN FOG but with the vaccine; Trouble with short term memory; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 17:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and cosmetic surgery on 17Mar2021, 10 days before second dose. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), somatropin (HGH), testosterone (MANUFACTURER UNKNOWN), ergocalciferol (VIT D) and multiple (as reported) (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 25Feb2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021, about a week or so after second dose, the patient had brain fog and trouble with her short-term memory. The patient thought it might be the anaesthesia and pain pills related to cosmetic surgery, but the brain fog had not gone away at almost 6 weeks. It felt like the description of COVID BRAIN FOG but with the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. 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 brain fog and trouble with short term memory/ it feels like the description of COVID BRAIN FOG but with the vaccine and trouble with short term memory was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Immediately after the injection, she had pain in her shoulder - took ibuprofen with only minimal relief.  On 10/28/10 she was seen by her Primary Care Provider and diagnosed with bursitis.  Physical therapy was initiated on 11/2/10 and will continue for 12 sessions over 6 weeks.  Has affected the range of motion in her right arm significantly.
her cold is much worse; runny nose/ nose is running; headache/her head started to hurt; her cold is much worse; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included cold from 16Feb2021 to an unknown date. Caller reported that her and her husband received first dose of vaccine yesterday. patient would like to know if it is okay for her to take Tylenol or acetaminophen. She was coming down with a cold and has had a runny nose, and headache since AM. She was taking OTC Claritin because she thought it was allergies and enquired if she can take any medication over the counter since she had a cold. It started actually yesterday she started to feel like she had a cold but she didn't feel that bad so she thought she should be able to get the vaccine still, but today her cold is much worse. After vaccine she had been coming down with a cold and her nose is running and now she has a headache and she wanted to know can she take any over the counter meds for a headache. She has just been blowing her nose so much she has a headache she wonders if there is any reason not to take Acetaminophen. It was just a head ache from blowing her nose so much from a cold, her head started to hurt. She had a headache that started today and was ongoing at this time but is about about the same as when it started. She was basically healthy. She doesn't take medications only vitamins. Therapeutic measures were taken as a result of her cold is much worse, runny nose/ nose is running. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A) for COVID-19 immunization. Concurrent medical conditions included shellfish allergy. Concomitant products included lisinopril and Pepcid AC (famotidine) for an unknown indication. On Jun 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 1, 2021, patient experienced pain in extremity (sore arm). At the time of the report,  pain in extremity (sore arm) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. Treatment medicine not reported. Most recent follow-up information incorporated: On Jun 2, 2021: Added medical history, updated action taken: no change; updated verbatim of event to pain in extremity.
Drawing up .6ml vaccine instead of .5ml of vaccine; Drawing up .6ml vaccine instead of .5ml of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A201107) for COVID-19 immunisation.     The patient's past medical history included No adverse event (Product used for unknown indication).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up received and included no new information pertaining to the patients involved with the events. It was reported that the clinic was no longer using the device in question and they have notified the manufacturer.
Long term COVID vaccine illnesses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ILLNESS (non-serious), outcome "unknown", described as "Long term COVID vaccine illnesses".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient felt dizziness come on about 10 minutes after administration of flu shot. Emergency personnel were called and he was taken away in ambulance for precautionary reasons.
The spot was warm; The spot was itchy; Red spot (the size of an egg) on her arm close to the injection site; Injection site hurt a little on the next day following the vaccination; A spontaneous report was received from a consumer, concerning herself, a 73-year-old female patient who received Moderna's COVID-19 vaccine and developed the spot was warm, the spot was itchy, red spot (the size of an egg) on her arm close to the injection site and injection site hurt a little on the next day following the vaccination.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscular in her left upper arm for prophylaxis of Covid-19 infection.  On 15 Jan 2021, the next day following vaccine administration, the patient's injection site was a little hurt. On 21 Jan 2021, the patient developed red itchy and warm spot (the size of an egg) on her arm close to the injection site which disappeared after two days. The patient did not take any treatment medication for events.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, spot was warm, the spot was itchy, red spot (the size of an egg) on her arm close to the injection site were considered resolved on 23 Jan 2021. The outcome of event injection site hurt a little on the next day following the vaccination was considered resolved on an unspecified date in 2021.; Reporter's Comments: This case concerns a 73-year-old female who experienced a NS unexpected events of vaccination site warmth and NS expected events of vaccination site pruritus, vaccination site erythema, and vaccination site pain.  The events occurred 8 days after the first dose of mRNA-1273. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vomiting every day/ Vomiting multiple times a day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting every day/ Vomiting multiple times a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting every day/ Vomiting multiple times a day). At the time of the report, VOMITING (Vomiting every day/ Vomiting multiple times a day) outcome was unknown.            Patient received the first dose on May-2021.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
101 fever within 24 hours of being vaccinate to include muscle aches.  Took Tylenol 800mg
Developed cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Developed cancer". Clinical course: Reporter stated that their brother developed cancer because of the Pfizer shot, not a vaccine but the shot because it does not prevent anything.  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-202300352863 Same product, different patient/event;
pt recvd vax; dx w/ GBS;adm to hosp x 2 wks;recovering well;apparently no long term effects;no certainty that flu vax was the culprit
Persistent/Severe nasal drip, phlegm, coughing, wheezing
By 6 pm fever,  shakes, chills, severe pain in lower back.  Could not walk, laid in bed, Fever broke at 4 am next day . No energy, exhausted the next day.
This spontaneous report as received from a physician via company representative refers to a female patient in her early 70's. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, route not reported). On an unknown date (reported "about a year" after her ZOSTAVAX dose, the patient developed shingles that were "very severe". The patient had lesions on her trunk which were on her chest and on her back. An unspecified amount of time after the patient received ZOSTAVAX, the patient was diagnosed with breast cancer. The physician did not have information as to whether the patient had a medical history of any cancers or information as to the patient's cancer treatment. The patient was prescribe unspecified pain medications for severe shingles related pain and treated with VALTREX. The physician stated that he "believed the patient had recovered, but he had not seen her for follow up in a couple months". The outcome of breast cancer was unknown. Upon internal review, breast cancer was considered as medically significant. This is one of the two reports from the same source. Additional information is not expected.
I had no adverse effect from Pfizer dose #1.  The night following dose #2, I awoke with atrial fibrillation.  I remained in aFib for about 36 hours and it then resolved.  The night following dose #3 (booster), I awoke with atrial fibrillation.  I remained in aFib for 6 days prior to resolution.
A month apart / they said to get the second one 3-6 months after the first one; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient reported case for himself/herself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was vaccinated with 2nd dose of Shingles vaccine a month apart from the 1st dose which led to shortening of vaccination schedule. The patient got shingles shot and it was said to get the second one 3-6 months after the first one. The patient was advised if the patient got the Covid shot, the patient had to wait and start over with the shingles two doses.  The repoter got the second shingles vaccine then found out cannot have the Covid vaccine for six months.  The patient was said to not get vaccine for six months before the patient gets the Covid shot. The patient did not always get vaccines but did not want shingles and sure did not want covid. The reporter was asked if was it supposed to be a year between the first and second or a month.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100421:Same reporter.