chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills all day; Headache; injection site pain over 24 hours plus; pain under arm when lifting; Muscle pain; Joint pain; tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 47years-old-male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ER 8727) via an unspecified route of administration in right arm on 20Mar2021 at 10:00 (at the age of 47 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies to medication, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient did not have symptoms associated with COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 11:00, the patient experienced chills all day, headache which was gone with 3 hours, vaccination site pain over 24 hours plus, pain under arm when lifting, muscle pain, joint pain, tiredness. The patient was not treated with any medication for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of chills, Vaccination site pain, pain in arm, muscle pain, joint pain and tiredness was recovering and for headache it was recovered on the same day.    No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a pharmacist referring to a 66 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 08-MAY-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received. Sender's Comments: US-009507513-1704USA006516: 1705USA013606: 1705USA013607: 1705USA013608: 1705USA013610:
numbness in both feet on 3NOV92, then on 5NOV92 was out of work for kidney infection & hospitalized on 8NOV92; in critical condition now in hosp w/resp assistance through tracheostomy;
No adverse event occurred.  Patient received a booster dose of the covid-19 vaccine in an off-site clinic provided by a local pharmacy. Patient was 17 at the time of vaccination and not eligible per CDC guidelines
Spiking fevers for 3 days (highest >103 F),  general weakness, malaise
Injection site painful and warm. When seen in office on 8/27/18, (L) arm injection site slightly warm to touch at triceps injection site.
her O2 levels have dropped, the lowest level reached was 72; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 2021 the patient experienced her o2 levels have dropped, the lowest level reached was 72. The patient underwent lab tests and procedures which included oxygen saturation: 72 on 15Jun2021. The outcome of the event was unknown.   Information about the lot/batch number has been requested.
she tested positive for covid virus.; she tested positive for covid virus.; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for herself. A female patient of an unspecified age received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 12Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021, patient tested positive for covid virus. She was supposed to get #2 covax on 02Feb2021 but was told she had to wait 14 days after the virus test. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
pt recv vax; 2 wk later, devel fever & chicken pox like rash;
Extreme swelling and redness around injection site. When pressed on feels hard. Over the course of two days worsened and spread near groin. Took to urgent care 10/01/2017 at 3:30 pm. Diagnosis were cellulitis of left lower extremity and vaccination reaction, initial encounter. Amoxicillin was prescribed.
Pt recvd 2nd dose of Hep B vax on 30JUL91 & devel serum sickness; no further details were provided;
I had Peripheral Neuropathy in my feet for many years. It was well managed and little trouble. I am not diabetic. Similarly I have had fibromyalgia. I worsened in symptoms of both shortly after the second booster shot and I had additional discomfort in legs and lower back. These kept getting more serious. This became cause for a trip to the ER on 5th May. This result in a new diagnosis of Polyneuropathy and a prescription for Gabapentin. As of today,  13th June, symptoms are worsened and/or break through the medication. Note that this was my second booster shot for Covid and that I had *absolutely* no reaction to any of the other three shots. All were administered at the same pharmacy. I did notice that the second booster shot was "Grey cap" and the earlier three shots were "Purple cap"
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 28th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site pain. The patient was treated with TYLENOL. In August 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm and immediately after receiving the injection, she had redness at the injection site. The patient stated that the redness went away after 1 week. The Patient was experiencing pain at the injection site and stated that she felt the pain whenever she lifted her arm or reached for something. The patient was not sure when the pain started. The patient stated that she had been taking TYLENOL for the pain.
Entire upper arm, which vaccine was administered, was very red, hot to touch, very swollen, and the injection site was still bleeding/seeping clear fluid.
injection site redness; injection site Swelling; Injection site itching; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain). At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (injection site Swelling), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Employee reported 2 episodes where she felt she had an elevated heart rate.  Vital Signs:  139/94   HR 81, O2 Sat 98%  Observed employee x 30 minutes.  At report of second episode, employee sent to ER.  Patient reports cleared by ER physician, condition stable, no further episodes of elevated heart rate.
Swelling & redness @ site started day of vax; 2 days later had injury to arm @ school & since then the site drained greenish waterish fluid x 3 days; seen by MD, meds given; 29AUG abscess completely healed;
Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant products were not provided. Treatment medication were not reported. It was reported that there was a mistake given during phone call regarding lot 012H21B. That lot was not affected, but lot 042J21A should have been reported with a BUD of Feb 17, 2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient didn't experienced Adverse Events  Date the vial was initially stored in the refrigerator: 27-SEP-2021.  No Treatment information was reported.
rash on chest and face started 11 days after vaccination, reported he had facial flushing, burning and itching significantly for 5 days and then it started to decrease. 3 weeks later still has some facial flushing but not as significant. Some numbness and tingling in left arm that comes and goes. About18 days after vaccination started having significant sinus drainage that turned dark bloody with clots. Took Benadryl routinely for 4-5 days.
Upper aspect of left hand and arm hives denies any SOB, throat irritation c/o purititis at site of hives.
Chills and  102 degree fever that began around 10 pm the night of the 14th and lasted until around 9 am the morning of the 15th. On the 15th I woke up with a massive headache and fatigue that lasted the entire day until the morning of the 16th.
Pain in afternoon of 11/2/17. Woke at 11:00 PM that night with pain. 11/3/17 AM woke with redness, pain, swelling the size of a silver dollar. This progressively got larger to the size of a baseball, had redness, pain, warm to touch. No fever. 11/6/17 - pain free today, swelling is very minimal. Mom feels it will be back to normal by tomorrow.
Mom referred that patient was lethargic, difficult to wake up. Event happened 3 days post vaccine.
Pt recvd vax 11AM & 6PM cranky, vomiting inconsolable crying interittantly three noc & next day; fever 103-104 ax;
On 01/14/14, 70 yo F was seen in clinic for evaluation. During visit, pt was ordered to receive vaccination with pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23) [IMM53] (Order 169086882). Per immunization records, pt received 0.5 mL IM in right deltoid (lot #J009689, NDC #0006-4943-01). On 01/15, pt called clinic & reported a large, painful (8/10) rash at the injection site. Pt reported chills, but no fever, SOB or any other sytemic symptoms. Pt returned to clinic. By time of arrival, pt reported improvement in pain to 6/10. Exam found an oval area of erythema over the right deltoid, ~5 cm x 6 cm. No fluctuance. MD characterized the symptoms as an injection site reaction rather than a cellulitis, given no fever & good response to ibuprofen. Pt with multiple allergies & past drug reactions. The area of erythema was marked with a pen & pt was instructed to monitor for spread of the redness, fever, increasing pain, etc.
Mom called to report rash on abdomen, which started the evening of vaccination. He developed another area on elbow the next day. No other symptoms.
Had the expected fever of 101, tiredness,  chills, sweats.   However at 1:52am I woke up not feeling well and my heart rate spike, when checking with my oximeter, my heart rate was 168 when it is normally in the 50-70?s.  This lasted about 5 minutes.  I wanted to report this in case others have this problem. I reported it to my physicians as well.   Thank you.
Pt had a syncope about 3 to 4 minutes after getting a flu shot (AFLURIA). Paramedics arrived shortly after. Monitor basic vitals and was evaluated to be well so pt didn't have to acquire further treatment.
Received a PNU 23 vaccine at clinic. Flu vaccine in (L) deltoid. PNU IM in (R) deltoid at 1pm. At 7pm acute (R) arm paralysis from deltoid to elbow. Hands & fingers on (R) side weak. Unable to move arm laterally. Approximately 24 hrs. later, limited ROM returned. From 7pm - 7am pain in (R) arm a '10'. Full ROM (with some difficulty returned in 48 hrs). Merck called 9/13. Report given. Rep denied ever having this problem! Stated they'd send "complaint form" & rpt to my PCP. Never received anything from Merck.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of improperly stored GARDASIL (dose and route were not reported) lot # K010215, expiration date 05-MAY-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
AT APPROXIMATELY 10 AM THIS MORNING(01/202021) I EXPERIENCED A SHARP PAIN TO MY BRAIN WHICH LASTED ABOUT 8 SECONDS
Initial report was received on 31 October 2011 from a consumer who is also the patient's wife. A 67 year-old male patient had received "on Saturday afternoon at 2p.m." FLUZONE HIGH-DOSE (lot number, route, site and exact date of administration not reported) and a "few hours later", began feeling ill, progressed to being ice cold, aching, very nauseous and had a low grade fever. According to the reporter, the patient only had the low grade fever for a short time and "felt better" on Sunday, but was "still not up to par". No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour.
Information has been received from a health professional concerning a 68 yr old white retired male with no pertinent medical history who on 13Jul05 was vaccinated IM in the deltoid with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). There was no concomitant medication. Two hrs after the injection on 13Jul05 the pt experienced upper arm swelling, redness and skin warm to touch at the injection site. Unspecified medical attention was sought no laboratory or diagnostic tests were performed. It was reported that the pt recovered. No product quality complaint was involved. Additional information is not expected.
tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported similar event for two patients (mother and father). This is first of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive after the first dose on an unspecified date in 2021. Outcome of the event was unknown. Reporter was asking if they could take the second dose after they tested positive or they had to wait for a certain time before getting the second dose.  Information for lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206551 Different product, same product/event
3 hours after shot I could not raise my right arm. The night of taking shot, I run a high fever. The second day the pain moved into my back. The third and fourth days the pain was so bad that I couldn't walk without help. Then it started getting a little better every day. It took 2 weeks to get well.
Redness itchyness at injection site some days its a bruise other days its red and itchy its been 9 days since injection..tye redness is a circle about 2x2.
This is a spontaneous report from a contactable physician reporting for himself via a Pfizer sales representative. A 54 (unit unknown) male physician received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site and flashback on an unspecified date with outcome of unknown. Pain at the injection site lasted for at least a year, it did not happen all the time but at occasional use of that muscle. It was exactly at the spot where the patient had the injection.
about 9-10 hours later woke  up with strong pain throughout shoulder areas, severe shivers, I wasn't this bad when I had covid back in Nov 2020.  Fever of 100.8, takes about 2-2.5 hours to get it down.  Symptoms continuing on 4/1 to 9:30 am.  Fever is 100.7 after 90 mins of taking 2 ibuprofen, small cough developing as i go through shivering
Patient states he can't see very well out of his left eye. Pinpoint vision. He went to the doctor and they said it was from the shot and not to get the second dose. Patient wanted me to report this because his doctor told him he wanted it reported.
Onset of hives the morning following vaccine.  Continued at the time of this report. Taking Benadryl per Dr. Will update with symptoms as needed
low MMR II titers; Caller believes the patient had received the vaccine per Prescribing Information/Patient received 1st dose of the most recent administration of the vaccine; Route of Administration: IM; This spontaneous report as received from a pharmacist refers to a female patient of unknown age.     Patient's current condition, medical history and concomitant therapy were not reported. On an unspecified date, when patient was a child, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date not reported) (reporter believed the patient had received the vaccine per Prescribing Information guidelines) for prophylaxis of measles, mumps, rubella. On unspecified date, patient had low MMR II titers and her nursing school requested revaccination. The nursing school requested 2 doses of the vaccine.  On 23-DEC-2020 the patient was revaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscular for prophylaxis of measles, mumps, rubella (dose, lot # and expiration date were not reported).        Pharmacist was going to re-draw MMR titers (date undecided yet) to confirm most recent dose of the vaccine was successful. The outcome of low MMR II titers was reported as recovering. Causality assessment was not provided.
Redness, itching rash at vaccination site.  Itch went away after 1.5 weeks. Red spot drying up and flaking after aprox 3 weeks.
sicker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I already had Covid" (unspecified if ongoing), notes: I already had Covid. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sicker".  Additional information:  I already had Covid and I got a first vaccine and it made me sicker then actually having Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced swelling of arm starting 1.5 hours after vaccination with redness. Also reported severe headache, chills and nausea without vomiting. Used heat blanket for chills, other symptoms resolve without treatment.
Myalgia, Fever, sore left arm trouble lifting it Narrative:  Projected return to work date (RTW): 1-29-21