chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting; This is a spontaneous report from a contactable healthcare professional (patient). A 32-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 05Jan2021 10:15 at a single dose for COVID-19 immunization at a hospital. Medical history included idiopathic hypersomnia and allergies to eggplant. The patient has no covid prior to vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA), methenamine, levonorgestrel (MIRENA), propranolol hydrochloride (PROPRANOL) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient had no other vaccine in four weeks. The patient previously took cefazolin and levaquin and experienced allergies to both. The patient has a Mirena IUD and never get her period at all. Within 6 hours of her first Pfizer injection (02Feb2021 16:00), the patient experienced crippling lower abdominal pain followed by very very heavy bleeding and clotting. Resolved within 48 hours as quickly as it came and didn't occur with second dose 1 week out. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was recovered on 04Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and known drug profile it  is unlikely that the reported events were causally  related to   BNT162B2.  These are intercurrent  conditions.   A contributory role of the patient's Mirena IUD  should be  evaluated.  Case will be reassessed if additional information is received.   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.
seizure described by parents; called 911; not hospitalized; seen by MD 1PM 25AUG was fine; pt had 2 more seizures & was hospitalized; 2 prior DTP w/o problems;
Each vaccine dose and booster I received resulted in tennis ball sized swelling and rash at the injection site (with pictures to document), and intense fatigue, body aches, fever, fainting, high blood pressure, and arrhythmia (irregular heartbeat) for 7-10 days after each dose with necessary bed rest.
I have been experiencing hyperhidrosis since receiving my 2nd dose of pfizer vaccine. I've never had issues with excessive sweating in my life until the day I received my 2nd dose. I've had two other people tell me they're experiencing the same problem and I should report it.
allergic reaction with hives up and down her body; allergic reaction with hives up and down her body/ on her neck, arms, chest, back, buttocks, and down her legs; This is a spontaneous report from a contactable consumer on behalf of his wife. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure high diagnosed a month before 18Jan2021 (Dec2020), she had no new medications though. There were no concomitant medications or recent vaccinations. The patient started experiencing an allergic reaction with hives up and down her body on unspecified date in Jan2021, so she sought care from her primary care provider (PCP) who prescribed her steroids (clarified to being prednisolone) methylprednisolone (lot number: 20C0087P, Expiry Date: Mar2022), she was taking 4mg doses as directed by the day, she was on third day of that medication; Benadryl, she had been taking 50mg every 4-6 hours by mouth; Zyrtec (lot number: 120026688, Expiry Date: Aug2022), she had been taking 10mg twice a day by mouth; and Pepcid (lot number: SMF084, Expiry Date: Jul2023), she had been taking 10mg once a day mouth. The reporter says her hives were all over her body: on her neck, arms, chest, back, buttocks, and down her legs. The event outcome was recovered on 18Jan2021, reported as the hives were gone. The only different thing she had recently was the vaccine, so she was concerned about getting the second dose on the 25Jan2021 and she was worried. The reporter said his wife sought help from her PCP along with another provider but they have no answers for them.  Information on the batch number has been requested.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age and gender. On 01-SEP-2016 the patients were vaccinated with VARIVAX lot # M009766, expiry date 23-FEB-2018. On 01-SEP-2016, 1 day after onset of therapy the patient experienced incorrect product storage. The VARIVAX was reconstituted with properly stored sterile diluent. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. There was previous temperature excursion (no details were provided). A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA004143: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148.
I had hives or dermatitis starting  mid February 2021.  Recieved  my first covid shot on March 25, 2021 followed by a sunburn rash on face.  I had my second covid shot on April 15, 2021 followed by same suburn rash on face, neck and chest.  Covid shot site was a giant hive, red and swollen for days.  I have been suffering with a very bad rash since.
the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT CONTAMINATION (the first 2 vials there is only saline, in the third vial there is Aluminum Carbide Lifeforms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Significant Live follow up received included QE number updated.
Patient had second Covid Pfizer vaccine at 1429. After 30 min wait patient had BP, daughter brought her back into observation via w/c, patient c/o dizziness. Daughter reports last vaccine patient had dizziness and high blood pressure and needed to see doctor. Ate breakfast, given apple juice. At 315 BP-168/65, P-73, O2sat-98%. Denies shortness of breath or pain. Skin warm and dry to touch, color pink. Continued to observe. Patient drinking apple juice. Injection site without swelling or discoloration. At 325 BP-161/82, P-72, O2 sat 98%. Patient reports to daughter her upper lip is tingling like last vaccine. Daughter reports upper lip was tingling three hours after last vaccine, no medication taken. Duration up to three hours to go away per daughter. Lips without swelling or numbness at this time. Team Alert called. Report given to RN
Per mom ,  the child has red bumps  all over body and a knot  at site of  right deltoid were vaccines given.  Patient was seen by provider and per provider it may be varicella or MMR vaccine. Patient mom advise to use ice and  NSAIDS
sores in my mouth; my tongue felt like I burned it; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 09Apr2021 at 15:00 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunization. Medical history included no medication or food allergies, but the patient did reach mildly to insect bites. The patient swells up more than normal, but not strong enough to need medical attention. Concomitant medications included multivitamins; no other vaccine in four weeks. The patient was not tested post vaccination. The day after the vaccine, on 10Apr2021 at 12:00PM, the patient's tongue felt like she burned it and 3 days after the vaccine (12Apr2021), she had sores in her mouth. No treatment was administered for the events. The events resolved on an unspecified date in Apr2021.
Received 2nd vaccination Wed, Thursday  had body aches, headache and was very tired.  Saturday morning my right arm was red, swollen and hot. Was better through the day.  Then Saturday evening my arm was red, swollen and hot again but more than in the morning.  Sunday started getting the hives.
Redness, swelling and itchy on right arm. Refer to his PCM in clinic because of nationality.
Per mother at 4 m/o imms: about 2 hrs after 2 month imms pt was sleeping. Went to wake and pt was grey/ashen. Stimulated pt to wake and pt was ok in 30 minutes.
4 days post COVID vaccine I began developing numbness in my right lower leg, numbness both ascended and descended through the leg and presented weakness by late afternoon. I was seen in my PCPs clinic by the covering MD, I advised him there was n recent injury or illness and I had just received my second shot of the Moderna vaccine. He referred me for an MRI of my low back to rule out any issue-MRI was unremarkable. I was told to contact the office if my symptoms worsened, spread, or pain developed. By that evening my left lower leg had begun and I had small muscle spasms in the right leg. I called the doctors office and was told by the triage nurse go the ER. I went to medical center and was admitted and eventually discharged with multiple follow up appointments. Tests conducted listed below.
no known side effects; temperature excursion/administered to a patient; This spontaneous report was received from a medical assistant and refers to a 22-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot # T025943, expiration date 30-JUL-2022 (formulation, strength, dose, anatomical location and route of administration were not reported) for prophylaxis. The patient had no known side effects (no adverse event). The reporter stated they discovered their freezer was having issues and were not aware because the alarm had accidently been turned off after having maintenance performed on freezer. The reporter stated there were 2 excursions in July and they have no data collection at all for temperatures during August and September. Insufficient data to evaluate vaccines. The reporter stated they knew they were warmer than refrigerated temperatures but was not able to provide warmest temperature or length of time out of range.
Headache; Neck was hurting and lymph node was swollen; Neck was hurting and lymph node was swollen; Ache on my left wrist; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Medical history included wrist fracture from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient states, I got the Pfizer Covid 19 shot and wanted to report side effects. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 23Feb2021 and second dose on 16Mar2021, both given in left arm. On 23Feb2021, within 5 hours after the first dose, I got an ache on my left wrist that I broke years ago, which resolved after 2 hours. I developed headache on unknown date, lasting for 2 days. On the 5th day after the shot, my neck was hurting and lymph node was swollen on 28Feb2021. It felt like a lump and it resolved within a week of onset. I got the second dose on 16Mar2021 and was fine. Today, 17Mar2021, I developed fever of 101.6 F and headache. I took some of my daughter liquid Tylenol. I also have an ache in my left wrist, in left thumb and pointer finger. She agreed to be transferred to Safety but unable to connect due to high call volume. The outcome of the event arthralgia was reported as recovered on 23Feb2021 and while other events was recovered in 2021.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Nausea, body aches, fever chills, left arm pain, left axilla  pin with adenopathy. Fatigue. Headache.
Streaking on left arm near PNEUMOVAX injection site, sore, tender to touch, red and warm.
Patient stated his heart was racing and he did not feel well during his post vaccine 15 minutes in observation.  VS obtained. Water provided. Patient waited an additional 15 minutes and he said he felt better and he was okay to walk to his car and drive home. Per vital signs, his HR was elevated, and he said he did not feel this way with his first dose. 1:15pm P124 Pox98% BP140/90 1:25pm P109 Pox98% BP130/80 1:30pm P106 Pox 99% T98.9 1:35pm P98 Pox 99% BP120/90
No other AE; a patient received VARIVAX after the product was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T010309, expiration date 24-MAR-2022, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The patient did not experience any other adverse event.   The vaccine was stored in a temperature of -12.8 degree Celsius for 9 hours and 6 minutes as recorded by a data logger. There was no previous temperature excursion reported.
12/20: rash on upper thighs, & hips & rt ear red w/boil?; 21DEC rash noted on upper arms; 24DEC rash scattered on body - fading - no c/o itching. Given Erythromycin.
Numbness of mouth and tongue with mild difficulty swallowing. Resolved in 15 mins and improved with Benadryl 25 mg orally. VS and examination was normal.
a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products. The patient did not have COVID positive test or diagnosis. The patient no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The event did not cause patient to seek medical care.  No treatment details were reported.   This case was linked to MOD-2022-556239, MOD-2022-556237, MOD-2022-556238 (Patient Link).
12 hours post vaccine injection I had a slight fever.  Fever lasted until 20 hours post injection.  When measured, my temperature was 100.1.  36 hours post vaccine, I started itching and at 50 hours post vaccine the itching has turned to hives.  As of right now, 51.5 hours post vaccine i still have hives.
9/15/2021 presented to EC with with shortness of breath, cough and fever with nausea.
Severe brain fog. Persisting all day. Akin to an extreme marijuana high. Unable to focus. Brings severe anxiety, propranolol seems to have little impact.  Feeling of swollen or inflamed brain. 400mg of ibuprofen seems to mitigate feeling temporarily.
Horrible sore throat; Scratchy tongue; Esophagitis; Mouth ulcers; Difficult to swallow; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, chronic pain (reported as recovering), spinal lumbar fusion, allergy to penicillin, allergy to latex and allergy to food. 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 medications included escitalopram oxalate (LEXAPRO), alprazolam (XANAX), ethinylestradiol / ferrous fumarate / norethisterone acetate (LO LOESTRIN FE), topiramate (TOPAMAX) and gabapentin (GABAPENTIN) all for unknown indication from an unknown date and unknown if ongoing. The patient previously took nabumetone and metronidazole (FLAGYL) for unknown indication on an unknown date experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 00:30, the patient experienced horrible sore throat, scratchy tongue, esophagitis, mouth ulcers and difficult to swallow. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with antibiotics and mouth washes (unspecified). Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021, the patient underwent SARS CoV-2 test via nasal swab and the result was pending. On an unknown date, the patient underwent blood work and culture tests and the result were unknown. The clinical outcome of the events horrible sore throat, scratchy tongue, esophagitis, mouth ulcers and difficult to swallow was not recovered 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.
Cranial Nerve 4 palsy (and resulting diplopia). Evaluation by ophthalmologist, eye exercises given. Symptoms improving as of 7/27/21 but not resolved.
10 days after my first shot my feet were swollen and  I didn't feel well by 18 days after it was not getting better.  I got my 2nd shot on day 21 and the day after I got an alert on my  Watch regarding resting heart rate exceeding 125bpm and have been inactive for 10mins, so my husband call the doctor's office to make an appointment.  They said we could go to the appointment or hospital, so we went to the hospital.
Information has been received from a health professional concerning a patient (24 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix) (batch number 84853, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called to report that the day before reporting an expired dose of Havrix was administered to a patient. The reporter consented to follow up via email but requested for name not to be captured in database. Additional Supportive Information: The expired dose of Havrix was administered to a patient, which led to expired vaccine used.
headache, fever (100 F), chills.  Symptoms started at about midnight. The chills lasted for a few hours throughout the night but were gone after a few hours (2-6). I took 325 mg of aspirin in the morning at about 10 am. I did not remeasure my temperature, but my head still felt warm. I took 500 mg of acetaminophen 1-3 hours afterwards. The fever went away and I felt normal again by the time I went to bed (11 pm).
Severe pain and limited range of motion in the rotator cuff area of shoulder. Onset was 5am the morning following the injection. Three and 1/2 weeks later, very little change.