chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6/12/2022, I woke up with a pounding, severe headache.  I also had pressure in the ears and behind the eyes, congestion, body aches, and fever. I didn't take my temperature, but I'm certain that I had a fever, since I had chills and was sweating. I was extremely fatigued and slept until noon; this is unusual for me, since I'm usually up at 6 AM. On 6/13/2022, I had nausea with diarrhea. I never threw up, however, and I took an anti-nausea pill. My throat also felt scratchy and I would sometimes cough, but the cough wasn't constant. I also had no appetite, and at the time of this writing, I have not had an appetite since 6/12/2022. On the morning of 6/12/2022, I took a home test for COVID, and the result was positive. Later that afternoon, I took a PCR test at pharmacy, and it also yielded a positive result. I called my doctor's office on 6/13/2022 to notify him of my diagnosis via the receptionist, and I have not heard back from him. On the afternoon of 6/13/2022, I experienced an increase in head pressure, an increase in nausea, a constantly runny nose; at the time of this writing, the symptoms have continued in conjunction with diarrhea and fatigue. I have not vomited at any point, however. On 6/14/2022, I had abdominal pain, which consisted of sharp stomach pains. In 2019, I had a gastric sleeve surgically inserted; I don't know if this is in any way related to the abdominal pain, but I mention it, as I had never experienced the pain until I was infected with COVID. At 4 AM on 6/15/2022, I woke up with a dry cough. From 4 AM to about 5 AM, the cough was constant. After I took Tylenol, though, it became intermittent. Since I have been sick, I have taken Tylenol every 4-5 hours and anti-nausea medicine. The Tylenol helps reduce the head pain and pressure, though it doesn't completely alleviate it. The Tylenol alleviated much of the cough. It also made the body aches much less intense. I only take the anti-nausea medicine PRN, so I have only taken two doses: once on 6/13/2022 and once on 6/14/2022. It provided immediate relief for the nausea, though it didn't help the abdominal pain.
right injection site swelled up size of golf ball, sore arm, painful to move arm (right arm) 11-29-07
Nausea; Upset stomach; Stomach Cramps; 1st dose years ago, not received his 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of nausea in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nausea, upset stomach, stomach cramps and incomplete course of vaccination. On an unknown date, the outcome of the nausea, upset stomach and stomach cramps were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nausea, upset stomach and stomach cramps to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments:  The reporter states that he received his first dose of Shingrix about 2 years prior to the reporting and had not yet received his second dose. The reporter stated after the first dose, the patient experienced stomach cramps, upset stomach, and nausea which lasted many days. The reporter give consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 59-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# 331208A), at the age of 59, in right arm, on Jan 11, 2022, at 10:00, 0.3mL, single dose, for COVID-19 immunisation. Medical history included pre-diabetic, start date: 2021 (unspecified if ongoing), notes: diagnosed late last year. There were no concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# EN6207, expiration date: unknown), at the age of 58, in left arm, on Mar 17, 2021; and received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EN0150, expiration date: unknown), at the age of 58, in the left arm, on Apr 7, 2021; both single dose, for COVID-19 immunization. The patient experienced neck pain, and arthralgia/horrible pain in back of neck and top of shoulder blade; onset Jan 11, 2022, at 07:00, with outcome of not recovered. The patient also had influenza (felt like she has the flu), onset Jan 12, 2022, with outcome of not recovered; headache, onset Jan 11, 2022, with outcome of not recovered; chills, onset Jan 12, 2022 09:00, with outcome of not recovered; neuralgia (excruciating nerve pain on right-side, from bottom of foot to top of shoulder blade, where she got the injection), onset Jan 11, 2022, at 10:00, with outcome of not recovered; and myalgia/muscle pain, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (intervention required) with onset 20Feb2023, described as "Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication". Clinical course: The reporter was asking what should be done if Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication. She stated that she was not sure why it sprayed as they made sure the needle was on snugly. As of 20Feb2023, Clarified that the medication sprayed in the staff member's eye. Just happened today (20Feb2023), going on about 15 minutes ago. Staff member was not having any visual changes, not having any burning, or anything like that. Was not really sure how much she did get in her eyes.   The information on the batch/lot number for pneumococcal 20-val conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.  Follow-up (20Feb2023): This is a spontaneous follow-up report received from a contactable nurse. Upon received follow up information on 20Feb2023, this case now upgrade to serious.  Updated information: Reporter address added, patient's gender added, event onset date added, seriousness updated to intervention required, clinical course updated.    The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Occupational exposure to product via eye is an accident due to incorrect technique in administration with the suspect vaccine.  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
really achy; whole neck hurts; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really achy), NECK PAIN (whole neck hurts) and PAIN (pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Feb-2021, the patient experienced PAIN (pain). On 28-Feb-2021, the patient experienced PAIN (really achy) and NECK PAIN (whole neck hurts). At the time of the report, PAIN (really achy), NECK PAIN (whole neck hurts) and PAIN (pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever/chills, body aches/malaise and developed searing pain in entire left arm. Anytime I tried to lift it, I got a jolt of excruciating pain.
Pt. received Menigococcal B. Redness/swelling and soreness at injection site. No streaks and swelling minimal.
I had a sore throat and fatigue. The next day I was feeling chills, fever, body aches, stuffy nose, runny nose, sneezing, and headache. I called my doctors office and they recommended that I take my temperature and take TYLENOL if needed. I scheduled an appointment to learn about PAXLOVID but I did not end up taking PAXLOVID. I have been sleeping a lot. I have isolated myself. I also called the state to report to the state. I tried to get PAXLOVID through the state but they said the couldn't because I was pregnant but my doctor had told me they could. My doctor told me it all depends on who you get because they are not supposed to turn me away because I'm pregnant. Estimated date of delivery is July, 2023.
2 hrs. after receiving 4 month old vaccine child with generalized erythematous macular rash with subjective fever.
Vaccine done 2/07/05 at 7 PM. Temp 101-102. Coughing, irritable, diarrhea. Post 2 months shots: Temp, fussiness, diarrhea. Was hospitalized 1 week later with gastro-dehydration for 2 days. Medical record received on 2/21/2005 states post vaccination syndrome.
he does take medications for heart issues; wondering if there is any contraindication for using Augmentin and getting the vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 73-year-old male patient received first dose of BNT162B2 (BNT162B2, formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration in Arm Left on 09Mar2021 at 12:40 as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On 05Apr2021, it was reported by patient that he had an oral surgery after first dose of vaccine and as a precaution after his surgery HCP want him to take Augmentin for 5 days starting today which will take him until Saturday. His second shot was scheduled for Wednesday 07Apr2021 and he is wondering if there is any contraindication for using Augmentin and getting the vaccine on an unspecified date in 2021. he had a dental implant and states this surgery had been planned prior to receiving his first dose of the Pfizer COVID vaccine. Patient stated that he does take medications for heart issues and takes statins on an unspecified date in 2021. Outcome of events was unknown.  No follow up attempts are possible because patient declines to provide details. No further information is expected.
Pt was administered Pfizer COVID vaccine and developed anaphylaxis.  No available information for VAERS. Pt reported that when she received the Pfizer COVID vaccination (~3/1/21) she experienced SOB, dizziness and blurred vision with an onset ~15mins post vaccination.  Patient was given benadryl 50mg IM into the right arm.  SOB, dizziness, and blurred vision resolved but pt experienced numbness and heaviness in the right arm that continued for ~3hrs post benadryl injection.  Pt remained at the COVID vaccination clinic for 2hrs.
Muscle Pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (For tolerance to 1st dose please refer case US2019117691).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had about significant myalgia with second shot. So, the reporter did not receive the that he really needed to make intelligent decision about continuing with the Shingrix injection or not. And that it was frustating that he was unable to get any information regarding any guidance of how to help ameliorate the negaive side effects.
Woke up next morning with headache. Around 1 PM got very tired. Woke from a nap at 4 with indigestion and reflux. Low grade fever (99-100) and chills started at 6 PM. Two mornings later most symptoms were gone except fatigue (Sun). Lingering symptom: aerobic capacity seems diminished during vigorous exercise.
Site soreness, swelling, fever, blisters on mouth and face, malaise, headache, 2 days.
Sore in mouth, with strong salty taste in mouth. Metallic flavor in mouth with certain acidic foods and water. The metallic flavor has persisted for over 6 months.
Patient received the wrong vaccine. Received PPV23 instead of PCV7. No Adverse Event
Based upon report received from caller her 2 month old female baby was inadvertantly administered two doses of Prevnar instead of one dose of Prevnar and one dose of DTaP vaccine. Caller stated the pt was fussy, had increased wet burps and had restless sleep. The Prevnar injections were given on 10/16/2001 and the onset of reactions were on 10/17/2001. Field alert being issued for a medication error that resulted in an adverse event.
Pt received IMOVAX + 3 in 2012. Pt given Hep A, TYPHIM and IMOVAX 4/13/17.due to misunderstanding of initial vaccine series he received a 2nd Rabies shot 4/20/17 with plans for 3#.
Toddler developed measle-like rash over entire body and face about 10 days following MMR vaccine.
This case was reported by a consumer via call center representative and described the occurrence of painful urination in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 10th March 2019, the patient received the 2nd dose of SHINGRIX. On 10th March 2019, less than a day after receiving SHINGRIX, the patient experienced painful urination and urinary tract infection. On an unknown date, the outcome of the painful urination and urinary tract infection were resolved with sequelae. It was unknown if the reporter considered the painful urination and urinary tract infection to be related to SHINGRIX. Additional details were provided as follows: The patient got her 2nd dose of SHINGRIX on Sunday. During the night she started having pain during urination. She saw a physician on Monday and was diagnosed with a urinary tract infection and started on an antibiotic. She was feeling better now.
On 12/16/2022 an employee received the Pfizer Bivalent Booster shot. The does was gave from a vial that had been open for longer than the recommended 12 hours. The employee has had no signs or symptoms due to vaccine administration. At this time, we need guidance on effectiveness of vaccine and/or if the patient should receive another does with a current vial.
Pt experienced 8cm X 5 cm swelling of left upper leg down to left knee.
Developed crying (persistent) and fussiness after immunizations-lasting 3-4 hours. Left thigh with 5x5cm area of erythema, warmth and swelling. No induration, no fever.
runny nose; weak and tired; muscle aches; loss of appetite; weak and tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of runny nose in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 24-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced runny nose (Verbatim: runny nose), weakness (Verbatim: weak and tired), muscle pain (Verbatim: muscle aches), appetite lost (Verbatim: loss of appetite) and tiredness (Verbatim: weak and tired). The action taken with Shingrix was unknown. The outcome of the runny nose, weakness, muscle pain, appetite lost and tiredness were not resolved.   It was unknown if the reporter considered the runny nose, weakness, muscle pain, appetite lost and tiredness to be related to Shingrix.     It was unknown if the company considered the runny nose, weakness, muscle pain, appetite lost and tiredness to be related to Shingrix.   Additional Information: GSK Receipt date:25-May-2023 The patient experienced lost of appetite, runny nose, muscle aches and was weak and tired. Education provided per content. Referred to HCP. Did not consent to follow-up.
myalgia x 12 hrs noc of vax, dec taste, salivation, micturation, devel w/low back pain & mild radicular sx x 1-2 days then upper thoracic pain & on & off w/paresthesias & dysathesia T3-T6 dermatomes; polyneuritis; dx aseptic meningitis;
Patient's immunizations were given by CMA as prescribed. Within several moments, patient developed an erythematous raised rash on her face and fine erythematous papules on her body. Rash on her face was most consistent with urticaria. Patient also developed a large wheal at the site of Ipol injection. She was given 6.25 mg of Benadryl PO and referred to allergy for evaluation prior to her next set of immunizations.
Rash under arms / Rash behind knees; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced rash under arms and rash behind knees. The adverse event was collected. The reporter enquired about any information on this type of reaction and on how to proceed with 2nd dose of Shingrix. The reporter did not consent to follow up.
Rash (diffuse, urticaria-type, pruritus) treated w/BENADRYL and prednisolone. Fever (102) treated w/TYLENOL. Nausea/vomiting (1x).
Information has been received from a health professional concerning a patient who was vaccinated with a dose of MMR. It was reported that the patient experienced slight stinging or a little pain. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
The day after I got my first dose of the Covid 19 vaccine, I started an extremely heavy period during a time when I shouldn't have had a period. The bleeding did not stop but was slowing down when I got my second dose. After the second dose, the bleeding started getting heavy again and has not stopped. I have a doctor's appointment next week. I'm reporting this because I saw some news articles where other women are having unusual bleeding from the Covid vaccines.
That same evening, started aching - had fever/chills (flu like symptoms) woke up next morning aching everywhere. Biggest concern was I was  having trouble breathing and had excruciating pain.
On 01/24/2022 it was discovered by the clinic staff that the ProQuad vaccine was being stored in the fridge and not the freezer.  Patient was identified as someone who was given a dose of the vaccine that was stored improperly and will need to come back to clinic to be revaccinated.  There were no other complaints of adverse reactions from the vaccine.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer treated with surgery, hormones and radiation" (unspecified if ongoing), notes: treated with surgery, hormones and radiation; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN HCTZ, start date: Jul2017, stop date: Jan2023; PRAVASTATIN, start date: Jan2008, stop date: Jan2023. Past drug history included: Lisinopril, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Original symptoms runny nose, congestion, headache, scratchy throat, cough. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swelling right deltoid. BENADRYL-BACITRACIN OINTMENT-Cold Compress
Hole in heart; Difficult breathing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in left arm, on 15Mar2021 at 14:00 (at the age of 71 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. On 30Apr2021 at 14:00, the patient experienced hole in heart and difficult breathing. The events were considered serious as life-threatening and requiring hospitalization for 2 days in 2021. It was unknown if treatment was given for the events. Since the vaccination, the patient has been tested with COVID-19 nasal swab that was negative on 30Apr2021. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.