chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced COVID-19; The patient experienced COVID-19; Felt like allergies; Felt like allergies; Lost taste, smell eight to nine days; Lost taste, smell eight to nine days; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157790-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; risankizumab (SKYRIZI), first regimen subcutaneous (Batch/Lot number: unknown) at 150 mg and second regimen subcutaneous (Batch/Lot number: unknown) at 75 mg (75 mg (1 in 1 once)) for psoriasis. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2021, outcome "recovered" (2021) and all described as "The patient experienced COVID-19"; FEELING ABNORMAL (non-serious), HYPERSENSITIVITY (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Felt like allergies"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Lost taste, smell eight to nine days". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Apr2021) positive. The action taken for risankizumab was temporarily withdrawn.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter assess the causality for the events COVID-19 and Feeling abnormal as possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the  reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Covid Arm, itching, hot, small welts/little hives in armpit, headache, tired, nausea
Patient said area of vaccination turned red, swollen, and painful to touch on the evening of vaccination 10/28/19.  After about 10 days, spots began to appear in the area close to vaccination.  Patient brought issue to the attention of their nurse practitioner after spots began to appear.  The nurse practitioner then diagnosed patient with Shingles when upon visit.  As of reporting to pharmacy on 12/9/19, the shingles spots have scabbed over, and are disappearing.
02/15/23 presents to ED for "shortness of breath". PMHx of "CAD s/p CABG, atrial fibrillation on AC, SSS s/p PPM, HTN, HLD"
Hives one hour after receiving the above listed vaccines. No shortness of breath, no wheezing, no increased work of breathing. Examined in office on 4/15/2020
Cried, inconsolably for 12 hours after vaccine administration. Both thighs swollen, tender to touch. Right greater than left. ? Fever (not checked) Tylenol infant drops for 2 doses. Crying subsided within 12 hours, leg swelling diminished after 24 hours.
Anaphylaxis - received Epi-Pen x 2 and Benadryl 50 mg - resolved.
Patient was inadvertently given Flublok when he should have received Flucelvax due to his age.
Patient vitals at time of presentation 135/96, HR 105, SP02 98%. Patient states that she has hx of health anxiety and took 0.5mg Lorazepam prior to appt. however, after injection, she became cold and tearful and states "I'm starting to have a panic attack". Patient brought to tent, vitals above. pt starting to feel better after being distracted. Pt left at 1113 feeling back to baseline. at 1058 BP 131/95.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017, dose and route were not provided) (Incorrect product storage). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician assistant via a field representative refers to a 21 year old female patient with asthma. Drug allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, concentration and lot number were not reported). Concomitant medication was not reported. On an unknown date, the patient felt very warm, developed hives and had what the physician assistant believed was an anaphylactic reaction after receiving PNEUMOVAX23. The patient sought medical attention, she saw the physician assistant. Lab diagnostics studies were not performed. The patient was given BENADRYL (dosage unspecified) to treat the reaction. The outcome of anaphylactic reaction was reported as recovered. Additional information has been requested.
10/15/2022  I had a fever when I woke up. I had no other symptoms. I took an at home COVID test which was positive. I took Dayquil around the clock for four or five days and had no symptoms after taking the Dayquil. The fever went away after the first day. I tested at 10 days and was still positive. On 10/30/22 I had a negative at Home COVID test.
This is a spontaneous report from a contactable consumer (patient). A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Jan2021 (Batch/Lot Number: EL8982; Expiration Date: May2021) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) taken for an unspecified indication, start and stop date were not reported. The patient reported that she noticed after 2 or 3 days, she can't remember when she got a lump on her neck, 'she got the drug then the lump' (not clear nor clarified) then she had the second shot because she thought you know she didn't pay no attention to the lump. Second shot on the 12th and she still have the lump, so she went to the hospital and had a scan, she had dye put in her, they can't find nothing wrong with her and she was just wondering is it possible that this is one of the side effects. She had both shots. One was on 22Jan2021 and then on 12Feb2021. It was the Pfizer shots. She had no reaction and felt great. Her arm didn't hurt. She got a lump not on the side she got the shot but the other side of the neck. It is on the right side of the throat. The lump was smaller and seems bigger now. She noticed the lump about 2 to 3 days after she got first one. She didn't say anything to them because she wanted the second one. The shot was given on the left side, but the lump is on the right side. Sometimes it is below the chin and sometimes it seem in the middle. It seems like it moves. She can't see it when she looks in the mirror. Other people can feel it. She went to the doctor who sent her to hospital to get a scan. The lump was 9 x 20mm. The doctor said they should go further and get MRI with the dye. From that he couldn't find anything. He even checked the sinuses. Nothing is coming from her head or ear. There is no infection. They are kind of baffled. They sent her to the dentist to make sure it is not like an infection in the teeth. The dentist is also baffled. He is not stopping because he is concerned. He sent her to an oral surgeon. The oral surgeon doesn't want her to worry because of her age. He is not sure either. The oral surgeon didn't want her to do anything invasive. He said to wait until 16Mar2021 and come back and let him look at it. If he is still concerned and they will do biopsy. No one mentioned cancer but she is concerned and scared. The patient underwent lab tests and procedures which included investigation: unknown results on Jan 2021, magnetic resonance imaging: no reason for it or infection on an unspecified date, scan: can't find nothing wrong with me  on an unspecified date, x-ray: no reason for it or infection on an unspecified date. Therapeutic measures were taken as a result of the event which included hot packs. The outcome of the event was unknown.Second dose given on 12Feb2021, lot number: EL9266, expires May 2021.
Pt had outbreak of varicella 12 days after receiving vaccine. Reports mild case, 5 day duration with no fever, only headaches. Was seen by emergency care unit and diagnosed. Lesions were on back, chest, arms and legs.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Severe, Additional Details: Wife called saying that husband has had severe body aches and difficulty breathing for the past day after getting the shot, although he was ok in the 15 minute monitoring period the day-of.  Counseled her to use the epi-pen at home on hand and call 911 immediately.  She did not want to call emergency services, saying that it takes a long time for emergency services to respond in city.  Told her to call 911 anyway so that they can give her further emergency instruction to better assist her.
Pt reported general itching and rash like symptoms in the evening of receiving the vaccine. Self treated with Benadryl and otc hydrocortisone. Following morning reaction is much less severe.
Patient reports edema, redness, warmth and pain to injection site as well as the left armpit.
Redness, swelling along with warmth and firmness in the left arm. Pt was having pain which on the Wong-Baker scale is a 10/10. Pt reports cough along with SOB. Treatment: cool compress, ibuprofen 800 mg, empiric Bactrim, follow up next day for re-evaluation.
2nd dose Pfizer given too early.  1st dose Pfizer was on 04-07-2021
High fever (102-103), dizziness, nausea and stomach discomfort, chills, aches, pain at injection site. Fever lasted 2 days. Able to resume normal activities after 3-4 days.
1/3/23  I was having a little bit of congestion, slight aching and a slight fever.  I took an at home COVID test and it was positive.  I went to the Urgent Care. I was prescribed Paxlovid. I started taking it the next day for five days. On 1/8/23, I had a rebound. I had fever, congestion and aching like before, but only worse. This lasted until 1/16/23. I was better, but continued to have slight congestion for another 2-3 weeks.
A spontaneous report was received from a Consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diagnosed of positive covid-19 after getting the first dose of moderna coivd-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. Diagnosed of positive COVID-19 after getting the first dose of Moderna COIVD-19 vaccine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), diagnosed of positive covid-19 after getting the first dose of moderna coivd-19 vaccine was unknown.
Fever- 103  for 2 days Heart palpitations  Chills Joint pain Shallow breathing
the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; minutes after shot my left foot fell asleep (Tingley); my left arm and hand fell asleep; This is a spontaneous report from a contactable other HCP (Patient). A 45-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 01Aug2021 11:00 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE (at the age of 45-year-old) for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included doxycycline (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated after minutes after shot his left foot fell asleep (Tingley), about 1 hour later my left arm and hand fell asleep. Also stated the left side of his face felt numb like after I've been to a dentist but not severe enough I couldn't drink or had droopy features on 01Aug2021 at 11:30. These symptoms lasted 3 days. Since the vaccination, the patient not tested for COVID-19. No treatment received for the events. The outcome of the events reported as recovered with sequelae on 04Aug2021.  No follow-up attempts needed. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported event Facial paralysis cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Coldness on legs and upper body, shakiness and weakness. Nurse assessed and cleared  patient.
delayed hypersensitivity reaction at injection site (red, raised, itchy, 5 cm) appeared 8 days after injection
Started to get rash on left breast then other breast, waist, then groin. However no rash at injection site. Pt went to PCP & inconclusive whether it was due to flu vaccine. Pt taking BENADRYL & hydrocortisone cream.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
This is a spontaneous report from a contactable other healthcare professional. A male patient of an unspecified age and ethnicity received on 29Apr2015 PREVNAR 13, via an unspecified route of administration at single dose. Relevant medical history and concomitant medications were not reported. The patient behaved hypertensive on 29Apr2015, two hours later the vaccination and he was hospitalized. The patient was in septic shock in Apr2015. The outcome of the events was unknown.
Headache from 9pm 3/31/21 to ~1pm 4/1/21. Muscle weakness and aches, fatigue, general feeling of being unwell from 9pm 3/31/21 to 3pm 4/1/21. No fever.
One 1 week after getting 2nd dose of Pfizer vaccination, September 10, 2021, at around 2:50 p.m. Patient got a sharp pain in chest and started having what felt like flutters in heart area. The pain in chest would come and go, so we took her to see cardiologist the same day. She got an EKG and the doctor prescribed medication for 30 days. She will follow up with blood work in 10 days and then follow up with an office visit with cardiologist in three weeks or earlier, if anything else should arise before then.
Chills, malaise, Temperature of 101F. PRN Tylenol and increas fluids. Resident is feeling better fever decresed 98.2F.
20 hours after 2nd injection and normal immune response (fever, chills, aches, shaking, sore arm)...awoke to intense Tinnitus ringing in the right ear and significant sudden hearing loss on the right side. Symptoms lasted several days before Tinnitus began to subside. 2 weeks later some hearing loss was still present and confirmed at PCP checkup.  2 months later the lost hearing had fully returned with only slight worsening of tinnitus symptoms remaining permanent and on-going.
Dizziness, sore throat, pale. He was administered Benadryl 25mg and was treated by paramedics.
More aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More aches and pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (More aches and pain). At the time of the report, PAIN (More aches and pain) was resolving.            No concomitant medications were reported. On an unknown date, the patient experienced more aches and pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
has not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose of Shingrix series in 2019 and had not received second dose till the time of reporting, which led to incomplete course of vaccination. The reporter called on behalf of physician and did not have exact date of vaccination, patient information other than gender, or vaccine lot number expiration date. The reporter consented to follow up.
At 00:30 on June 23, under no stress or other situation, my vision went away for about 5 seconds.  It was like if I had a shield on and mud was being thrown at me from the sides, specks covered my vision in both eyes coming in from the side to the middle until everything was dark.   While this happened, I felt some pressure on the upper sides of my skull, and my heart felt like it was beating very fast.  It cleared up after about 5 seconds - the smattering of specks went away in the opposite of when they came on.  Afterwards I felt ok, did the basic stroke test, but went to the emergency room.  Since this occurred, my lower lip kind of flops out when I lie on my side.  It was more noticeable in the weeks after June 23, but maybe I am just used to it now.
seven days after given shot on the left arm I developed itching and swelling at injection site..  treated two days with benadryl but had adverse effects with prostate.  Switched to zyrtex and pepsid twice a day for two days then once a day,.  stoped progression and started to get better. still a little itching and discoloration at injection site.
Skin flushing of the neck and chest, felt very hot, then became lightheaded.  Lips also felt like they were tingling.  Elevated blood pressure.
Premature menstruation post-vaccination. Started evening of first dose. Have been spotting/bleeding for going on 20 days. Am scheduled to receive my second Pfizer-Biontech vaccination tomorrow, Tuesday, May 11th 2021 at 9:50 am. Will file secondary VAERS report if bleeding continues after second dose.
shoulder that received the vaccine; shoulder that received the vaccine still felt sore; shoulder that received the vaccine still felt sore / heavy; shoulder that received the vaccine still felt sore / heavy / numb; shoulder that received the vaccine still felt sore / heavy / numb/ tight; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 15th January 2020, the patient received Shingrix. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced shoulder pain, sensation of heaviness, numbness in shoulder and shoulder muscle stiffness. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, sensation of heaviness, numbness in shoulder, shoulder muscle stiffness and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, sensation of heaviness, numbness in shoulder and shoulder muscle stiffness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient received vaccine in shoulder, which led to vaccine administered at inappropriate site. The patient stated that their shoulder that received the vaccine still felt sore, heavy, numb and tight. The reporter consented to follow up. This case is linked with US2020AMR031239, reported by same reporter.
Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.