chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 28-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L02214, expiry date: 21-JAN-2017, lot # L040411 (not valid), expiry date: 13-APR-2017) (route: subcutaneous). Medical assistant was not sure which lot number the patient had received. The vaccine was stored at a temperature of -13 degrees C for 156 hours. Data logger was not involved. There was no previous temperature excursion. No symptoms reported. The outcome of the events was unknown. Additional information has been requested.
First day I but that night I had a lot of pain, chills and little bit of fever and lot of body pain. Very fatigue and could get out of bed. "My body was out of me". By Monday I was okay, just pain in my shoulders and especially in my arms.
Blood blisters, swollen lymph nodes, inability to lift arm, blisters on palm of hand all on the left side where shot was administered.
Very upset stomach, could not eat anything in the AM and broth at lunch time.  Dry heaving.  Ate very little all day and went to bed at 6:30pm  Lasted about 24 hours
Chills began a little after midnight and lasted until 8 a.m. Fever of 101.8 for most of the night; Extreme muscle aches for 24 hours post injection; Headache and Fatigue for 36 hours post injection
No Adverse event; A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No Adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2023 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) 1 dosage form. On 25-Aug-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient had received a dose of the Moderna Bivalent COVID-19 vaccine more than 12 hours after the initial vial puncture).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The vial was initially punctured on 24-AUG-2023 at 12:00 PM. No reported symptoms. No additional doses, medications, or treatments. No treatment information was reported.
On second day of receiving vaccine my arm began to get itchy. Upon looking at it, I seem to have a rash about size of a half dollar where the injection was. It is red and extremely itchy. I have put some cortisone cream on the area. Upon searching the internet, I discovered it looks the rashes that have developed with Moderna but no mention of Pfizer so I thought I'd let you know.
On 10/31/00, 1 day, post vax, parent noticed redness at site. On 11/1/00, there was a 2.5" in diameter, red, swollen and warm to touch, reaction around injection site of DT. Tender. On 11/7/00, no pain, swelling or redness at sites.
Information has been received from a physician concerning a 10 year old female who on 15-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot Number 657446/0518U). On 16-JUN-2007, the patient developed a reaction after receiving her second dose of varicella virus vaccine live (Oka/Merck). The patient developed redness of her arm within 24 hours of vaccination, accompanied by a fever. On 17-JUN-2007, the red area on her arm worsened and spread which required a visit to the emergency room where she was given clindamycin and Benadryl. The patient was not hospitalized. On 19-JUN-2007, the patient was considered to be fully recovered post vaccination. Additional information has been requested.
Trouble breathing, shortness of breath, menstrual cycle is off, sharp menstrual pains, heavy pimples that I did not have before the vaccine because I got into a hormone treatment a couple of years ago to get that under control. After covid vaccine face is flourished with heavy hormone related pimples
10 days after vaccination, pt presented with multiple bruises on body. Platelet count - 0. Admitted at hosp. Treated with IVIG x 2 - Dx: ITP. Responded well. Plat count 236K 1/26/12.
Large simple reaction: erythema, induration, soreness for > 23cm of upper arm and medial lower arm
4/22/21 at 5:00am: started feeling fatigue and chills 4/22/21 at 8:00pm: started noticing chest pains on left side 4/23/21 at 2:00am: continued chest pain, noticed a bulge on left armpit 4/23/21 at 7:50am: started noticing back pain
Right upper arm at injection with pain redness and swelling, some itching, redness spread to 4x4 in circumference. Diagnosed cellulitis and allergic drug reaction.
Patient received the first dose of Pfizer COVID-19 vaccine (batch/lot# EW0168) on 05/04/2021; and the second dose Pfizer COVID-19 vaccine (batch/lot# EW0178) on 05/30/2021. Patient  experienced fatigue one day after the second dose of Pfizer COVID-19 vaccine. Also, patient received the Moderna booster 9 days early from the recommended 6-month time frame per the physician on call.
I received the vaccine at College.  Initially my hand had numbness for a week, right wrist ached.  My jaw and right side of head, ear, neck experienced sharp pain and swelling. My arm stayed red and swollen in a goose egg at the injection site, warm to touch, felt like a burn. After a week it changed shape and grew larger. I had a rash in the local area. You could clearly see the injection site. It was a white bump. It has gone down at three weeks but is still there and feels like a throbbing bruise. The area is darker than surrounding skin.  I have photos and I am afraid to take the second shot next week.
Red, swollen right deltoid 4" x 4" in size. Warm to the touch.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-DEC-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-JUL-2011, the patient was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe shingles. On or about 01-AUG-2011, the patient sought subsequent treatment at physician office for ongoing and worsening symptoms of herpes zoster and shingle outbreaks. The patient has been prescribed Lidoderm for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Call very nauseated, body aches and slight fever. taste buds on liquids not normal taste. Little bit dizzy.
Vaccine was given in the left arm, about 20 minutes after receiving the vaccine he became pale and diaphoretic. His pulse was 89 BP was 80/50 (right arm) and he was complaining of vision changes. I gave him some water and waited about 5 minutes and rechecked the BP (right arm) and it was 152/117 with a pulse of 78. I waited another 5 minutes and rechecked the BP on the opposite arm (left arm) and the BP was 159/117 with a pulse of 80. He was complaining of pain and numbness in the left arm. I sent him to the ER for evaluation.
Red, swollen arm down to elbow, completely encirling arm.  Intense itching.  Used benadryl, cold packs and itch cream, and nothing helped.  Lasted for  1 week. Developed tinnitus and that continues.
Body aches, HA, nausea, fever, sore throat, back pain. Pt to appt and stated onset of symptoms and was adamant it was a reaction to HPV. Family member had the flu and missed 1 wk of school - same symptoms.
I got my second shingles vaccine yesterday and I feel crappy today. Achy, tired, a little nauseated, muscle pain, etc... No fever or anything extreme. I took Aleve.
The pt developed fine papular rash on the trunk and legs with increased redness at the leg injection site.
Patient called to say that she was having "manic" symptoms which started about 12 hours after receiving Shingrix (first dose) and continued for at least 5 days after. She described the symptoms as being similar to "nesting" behaviors that occur in expecting mothers - she was doing a lot of cleaning and  organizing, and not sleeping much (max 5 hours a night), and also could not sit still and was talking a lot. She stated she'd had this happen once before when she took Levaquin, but never other than that. I called the manufacturer (GSK) to see if they had any information about other incidents like this but they did not. Patient reported no mental health history other than some depression, non-manic, controlled by venlafaxine. I advised her that the venlafaxine may have contributed to the symptoms - possibly made them worse - as it is known to cause mania in some patients. However, she has been on it for a long time and never had this issue. Spoke to patient again on 6/14/22 and symptoms still had not resolved. She stated her provider had her taper off of venlafaxine, and that she tried Belsomra to help with her sleep, to no avail. She is now trying Vraylar, started on 6/13/22.
Two days after the injection both feet and both arms, as well as the back right leg became numb. The patient is not diabetic. The back of the right upper leg also became swollen. The numbness is still ongoing in the feet and upper right leg.
On 01/04/2006 received flu vaccine in left deltoid.  Shortly thereafter developed swelling, induration, pain and erythema around injection site which has progressively worsened.  Area involved is size of ping-pong ball.
Varicella - 1cm swelling - red, MMR - 3cm swelling - red
Patient passed out immediately following administration of the vaccine to the left deltoid. His head fell backwards and limp. The Rph administering the vaccine moved in front of the patient and gently moved his head into an upright position. The patient had mild muscle spasms and twitches while passed out but when he regained consciousness he immediately began talking saying he was ok. Father came into the consultation room at that point and Rph explained what had occurred. Patient looked a little pale and eyes were having a hard time staying open so with the help of his dad Rph helped him down to the ground in the corner of the room so he could have back and head support from the wall. Patient was given a glucose tablet and water, and later orange juice. Patient stayed in the consultation room for about 20 minutes before leaving on his own and saying he was feeling much almost back to normal.
Itchy bumps on tops of forearms and some bumps on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest). At the time of the report, RASH PRURITIC (Itchy bumps on tops of forearms and some bumps on chest) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment medication included "cream". It had been going on for 3 days and was not bad as the put cream on it and he felt great.
PATIENT STARTED EXPERIENCING LIGHTHEADEDNESS, DISSINESS AND FELL ASLEEP IMMEDIATELY POST VACCINE. Patient started falling sleep on and off for 10 minutes. Patient was given pedialyte/water and after 10 minutes regained full consciousness. Blood pressure was 114/80 post vaccine.
18 year old male patient administered an expired dose of IPOL vaccine with no reported adverse event; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Global Medical Information (Reference number- 00716235).  This case involves an 18 year old male patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Aug-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1D973M and expiry date: 17-Jul-2021) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
dropping platelets; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "dropping platelets". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased. Additional information: The caller said she had experienced problems with all three shots; however, the first two shots were severe. She further added, with every shot with every vaccine, she have had a dropping platelets. In both cases, being on 20 mg of Prednisone has reversed the incident.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300179280 Same patient/vaccine/event, different dose;US-PFIZER INC-202300352576 Same patient/vaccine/event, different dose;
Received Influenza vaccination on Tuesday 11-13-12 noted redness and swelling below injection site on morning of 11-14-12 - presented to Health Dept on 11-15-12. Note: Erythema on (L) upper arm 130mm wide by 85 mm high - indurated & very hot to touch, denies itching, sore to touch.
Axial tension. Dull HA. Low grade fevers 99-101. Fatigue/malaise, arthralgias, elevated C-reactive protein, leukopenia, thrombocytopenia.
This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 83-years-old patient of an unspecified gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number was not reported) via an unspecified route of administration on 24Sep2021 as dose 3, booster, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number was not reported) via an unspecified route of administration on unspecified date in 2021 (at the age of 83 years) as, single dose for covid 19 immunization. On 26Sep2021, two days later, the patient experienced one episode of diarrhea and next one was a loose stool. Patient stated small side effect of the third booster shot. Consumer stated that patient got third extra strong booster shot on the 24th of September when patient was 83. Two days later patient had one episode of diarrhea and the next one was a loose stool. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever up to 102, Sleeping most of the day, after a few days of this, crying all the time, could not lye baby flat had to sleep sitting up. Congestion, vomiting over the course of next week, then odd behaviors, repetetive banging of objects, would not look at us, crawling into small spaces, appeared to have had a stroke, dragging back leg, slurring speech of the few words the baby had, then lost speech within the month.
This spontaneous report as received from a medical assistant refers to a 20 year old female patient. There was no pertinent medical history or drug reactions/allergies. On 02-AUG-2017 the patient was vaccinated with an improperly stored (7 Fahrenheit for 60 hours) dose of VARIVAX (lot # M036292, expiration date 18-AUG-2017, subcutaneous) for prophylaxis. On 03-AUG-2017, the patient experienced redness and swelling at the injection site and was seen in the office on 04-AUG-2017. No treatment was provided to the patient. No lab diagnostics or studies were performed. Outcome of the events was reported as recovering. There was no temperature excursion previously. It was called because of a data logger.
pt devel welts @ the inj site following vax;pt also exp back aches & neck pain;no further details known as of the date of this report
Pt had a fever, took tylenol for that. redness in the site of location and warmth to touch. she was going to call her pcp for it
* 1.0 ml of COVID 19 Vaccine (Janssen) administered IM to Left Deltoid.  Tolerated Well.  Without observed or reported incidences or adverse events. *  Order reviewed Post Administration and  confirmed that the Prescribed Standing Order Dose was 0.5ml IM for one dose.   *  Immediate notification by RN to other RN,  Staff (on-site) of administered dosage discrepancy.  Patient was  monitored/notified of dosage discrepancy and instructed to contact PCP/Emergent Assistance for any adverse reactions:  shortness of breath, nausea/vomiting, chills, fever, diarrhea, difficulty swallowing and/or acute anaphylactic reactions. *  Patient reported excellent verbal return demonstration of instructions to include confirmation of contact information.   *  Patient left Work Site Clinic with steady and even gait.  Respiratory effort even and unlabored.  No bleeding or bruising at site of vaccine administration.
Have had flu shots for several years. This year my shoulder locked up, terrible tendonitis, muscle pain, etc. Has been over 2 weeks and still have stiffness and pain, although less than a week ago.
burning tongue, like she ate spice food; mouth dry, like she ate metal; peeling subsided is little better; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better). At the time of the report, TONGUE DISCOMFORT (burning tongue, like she ate spice food), DRY MOUTH (mouth dry, like she ate metal) and SKIN EXFOLIATION (peeling subsided is little better) outcome was unknown.            No treatment information was provided.
4-5 hours after receiving h1n1 vaccine, pt c/o "tingling" in left foot. (note) pt had acl repair in the leg this past spring
Hives on left leg on the third day after Moderna vaccine; Headaches; Felt burning in her chest area on the left side; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat), URTICARIA (Hives on left leg on the third day after Moderna vaccine) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat) and HEADACHE (Headaches). On 03-Apr-2021, the patient experienced URTICARIA (Hives on left leg on the third day after Moderna vaccine). At the time of the report, CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat), URTICARIA (Hives on left leg on the third day after Moderna vaccine) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Heart rate increased: rapid (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Events Chest burning, Palpitation, Hives, Headache- outcome was updated from unknown to resolved.
Pt had a syncopal event immediately post vaccination.  Pt was taken to med bay.   Vitals: 12:44 100/60, 85, 100% -- > 12:46 98/62, 88 -- > 12:48 103/70 VSS  Pt flushed but color improved when placed in lying position with legs elevated.  Pt stable upon release.  No S/S of distress.  No swelling of the lips or tongue.  Gait strong and steady.  mother instructed to call 911 if pt has s/s respiratory distress.