chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. Between late June 2016 and 12-AUG-2016, the patients were vaccinated with doses of PEDVAXHIB (lot # M001814 with expiration date 15-OCT-2018; dose and route were not reported), which were improperly stored (Excursion details: Time/Temperature: 9 degree centigrade for 1 hour; Previous excursion: Y, 12 degree centigrade for 2.5 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
On 3rd day after DTaP was given left deltoid area became red & swollen with hard raised center. Complained of headache and decreased appetite. Next day headache continued. Red area continued to spread & developed fever with itching.
Redness at site progressing to shoulder and upper back. No fever or pain. Treated in ER as possible cellulitis. Sx completely resolved within 3 days of Tx, 5 days after injection.
nausea, migraine, hot/cold sweats, chills, fever of 103.5 for over 30 hours, muscle and joint pain.
Headache, Myalgia, Chills, rigors, fatigue, syncope, and tendernes at injection site Narrative: patient reports symptoms completely resolved on Sunday 1/24/21
Itch / Itching started in his middle ear, and then spread to his back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, immediately after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: In July 2019, the patient received 1st dose of Shingrix and did not experience any events. Almost immediately after 2nd dose of Shingrix, the patient began to itch. The itching started in his middle ear and then spread to his back. At the time of report, the symptoms have not improved. The reporter consented to follow up.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "breast cancer" (unspecified if ongoing); "Shiitake mushrooms" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Other medication in 2 weeks (Plaquenil). Patient received Anti-viral treatment for COVID-19 with Paxlovid from 06Jun2022 to 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
loss of apetite; loss of energy; Hard Time Staying Awake; Vomiting; Aches; Fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), DECREASED APPETITE (loss of apetite), ASTHENIA (loss of energy), HYPERSOMNIA (Hard Time Staying Awake) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 13-Oct-2020 and Cardiac pacemaker insertion. Concurrent medical conditions included Atrial fibrillation and Blood pressure fluctuation. Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), PROPAFENONE HYDROCHLORIDE and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE TIMOLOL) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Aches), FATIGUE (Fatigue) and PYREXIA (fever). On 02-Feb-2021, the patient experienced ASTHENIA (loss of energy), HYPERSOMNIA (Hard Time Staying Awake) and VOMITING (Vomiting). On an unknown date, the patient experienced DECREASED APPETITE (loss of apetite). On 07-Feb-2021, ASTHENIA (loss of energy), HYPERSOMNIA (Hard Time Staying Awake) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN (Aches), DECREASED APPETITE (loss of apetite), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-210380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received : Updated reporters contact details (address), patient demographics, lab test, concomitant medications and additional events (asthenia, decreased appetite) were provided; outcome of events (vomiting, hypersomnia) were updated to recovered.
Patient came to get vaccines just after getting bit by a cat in the face. She did not report this to us. She got her vaccinations, they went to dinner after. Her arm started to get hot,itchy and red. She went to the ER and they were so busy they were not seen by 4:30am and they left. She saw her regular doctor today.  By then the itching in her left arm went away, but it was still red and the wound from the cat bite on her face was worse. The dr diagnosed her with a allergic reaction, but also with a cat bite infection on her face. She is 81, her immune system is probably overloaded by the two vaccines and the infection from an animal bite. She reported to have not have had any problems with vaccinations before, including being vaccinated with both covid/flu last year together.
c/o pain hip/leg & back 3wk p/dose 1 (early JAN98);
Patient said after she received the vaccine she went home and slept for 14 hours and woke up very dehydrated. Her arm was also sore and there was swelling at the injections site. She came in on 5/7/21 to report her reactions. She says she feels fine and the swelling and soreness has gone down.
Swollen lips; Swollen neck; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications included NORVASC, LANTUS, lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 08:00, the patient experienced swollen neck and lips. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the swollen neck and lips was not recovered at the time of this report. Information about lot number cannot be obtained. No further information expected.
being sick; forgetting to get the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose). At the time of the report, ILLNESS (being sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (forgetting to get the second dose) 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.   No concomitant medications reported.  The patient had no adverse reaction and had Pfizer vaccine previously.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received updated significant information in narrative.
Extreme exhaustion; blurred vision; feeling drunk; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 17:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to sulfa and carrots. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021 at 05:00 the patient experienced extreme exhaustion, blurred vision and feeling drunk. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme exhaustion, blurred vision and feeling drunk was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Immediate site reaction with large whelp, within 10 mins both arms and face were red with hives.  Dose of benadryl given after apt. At 12noon Second dose given at 9:30pm. After hives returned. 3rd dose at 4am, 4th dose 11am.  Medicine switched to zyrtec 5mls bid, first dose given at 6pm.  10pm hives continued 5mls of prednisone given.
vaccine was administered while undergoing a temperature excursion; This spontaneous report was received from an office manager (also reported as customer) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-OCT-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number W012163, expiration date: 12-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered while undergoing a temperature excursion (temperature: -10 Celsius degrees (oC) up to 8 oC, time frame: 35 hours; and 9 oC to 25 oC, time frame: 47 hours); no previous temperature excursion) (product storage error).
I feel that the lymph node is swollen, but it's only in the left side, the side that I got the injection; This is a spontaneous report received from a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on left upper arm on 11Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, after vaccination the patient experienced that "it was her left side, right above her clavicle, where she felt that the lymph node was swollen, but it was only in the left side, the side that she got the injection". She stated that "I feel that the lymph node is swollen, but it's only in the left side, the side that I got the injection was coded as vaccination site lymphadenopathy". The patient stated that she was curious about 0.3% of participants experiencing swollen lymph nodes during the clinical study and asked how many participants were enrolled. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.; little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.). At the time of the report, PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.
developed redness, itching and irritation about 3 inches away from the injection site; developed redness, itching and irritation about 3 inches away from the injection site; developed redness, itching and irritation about 3 inches away from the injection site; This is a spontaneous report from a contactable Pharmacist based on information received by Pfizer from Merck & Co. Inc. (Case Number: 01395915).  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient developed redness, itching and irritation about 3 inches away from the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained
pt recv vax MAR97 & 2DEC97 pt devel a very severe case of chickenpox;
feeling sick; scratchy throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling sick"; THROAT IRRITATION (non-serious), outcome "unknown", described as "scratchy throat".  Additional information: This is a spontaneous report from a Pfizer-sponsored program. Patient wanted to know if it was okay to get vaccine after having scratchy throat and feeling sick. This was for the patient's second dose as she was scheduled for her 2nd shot on Monday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
increased appetite; fatigue; feels unwell; spaced out/spacy; Muscle pain; felt feverish; chills; This is a spontaneous report from a contactable 78-year-old Female consumer(patient). The consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 08Apr2021 at 1600 hours in left arm (78-year-old) as dose 1, single for COVID-19 immunization. Medical history of the patient included a bad case of COVID-19 Virus in Jan2021. Was bad and lasted most of the month. After several days went to the local hospital who was giving infusions and she took that. Still, it was a bad case of COVID-19 Virus. No further details provided. The patient went to an ENT doctor and had been taking allergy shots for 2.5 years as a treatment for an acute sinus infection thing or upper respiratory problems she got from time to time. She saw an ENT doctor on regular basis for last several years. Had completed allergy shots. No further details were provided. The patient's concomitant medications were not reported. No investigation assessment was done. History of all previously immunizations, additional vaccines administered on same date, the events require a visit to emergency room, family medical history, relevant tests, prior vaccinations within 4 weeks and events following prior vaccinations were reported as none. On an unknown date she had increased appetite and fatigue. On 09Apr2021 she had chills and she felt feverish. The same afternoon she had muscle pain. On 10Apr2021 she was spaced out/spacy. On the same day 10Apr2021 the chills and fever had already subsided, but she still felt kind of spacy. She wanted to know if this was a common reaction to the vaccine, and if she should still receive the 2nd dose. She did not take her temperature. She felt this way for two days. Now she just feels like she was in a cloud as if she was walking around in a cloud. She did not feel like herself and just felt unwell. Wondering if she should take the second dose or not. Caller's primary doctor stated a month ago he was not going to treat anyone with COVID-19 virus. Feels like her doctor was just a prescription writer and there is no point in talking with him about guidance on the second shot. Feeling spacey, like walking around in a cloud was the biggest thing that was bothering her now. She was not feeling this way before the COVID-19 Vaccine. Stated that feeling not like herself and unwell encompasses this feeling of being in a cloud or walking around in a cloud. The outcome of increased appetite, fatigue and feels unwell was unknown. On 11 Apr2021 chills, felt feverish and Muscle pain recovered. The event of spaced out/spacy was recovered.  No follow-up attempts were needed. No further information was expected  PSCC Communication: Report reference number provided to caller. The caller was provided with phone number, and hours of operation, prior to attempted warm transfer. Unable to warm transfer due to high call volume. Caller agreed to cold transfer.  No follow-up attempts were needed. No further information was expected
Developed a bad rash on left arm about one inch lower than injection site. Rash was non itchy, but slightly painful to the touch. Identical to ?Covid arm?
something going on with his kidneys; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) at the age of 62 years as dose  1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "something going on with his kidneys"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". Therapeutic measures were taken as a result of hypertension. Additional information- it was reported that patient received the first dose of the vaccine on 24May2021. Caller stated he was in the hospital for something going on with his kidneys. Been in the hospital off and on since April. Reports he has high blood pressure and they can't figure out why his medications aren't working. 62 year old male. Declined to be warm transferred to safety. Stated the reason he was in the hospital had nothing to do with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 1/17/00, one lesion appeared at injection site w/itching. It was gone on 1/20/00, but 3 papules appeared on ear, neck & cheeks. No treatment.
tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "tremor in her left hand". The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremor in her left hand".  Additional information: Patient is a Registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small pharmaceutical company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  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-PV202300017881 Same patient/drug/event, different dose;