chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 102.5; headache; chills; Cold and numb feet; body aches, particularly in leg; body aches, particularly in leg; ringing in ears; Cold and numb feet; Vaccine administered at inappropriate site; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 47-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Leg Left on 01Mar2021 11:00 (at the age of 47-years-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included high cholesterol and known allergies to shellfish. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no covid prior vaccination. The patient was not tested post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Un-known), dose 1 via an unspecified route of administration, administered in Leg Left on 08Feb2021 02:30 PM (at the age of 47-years-old), as DOSE 1, SINGLE for covid-19 immunisation. On 01Mar2021 (time: 11:00 pm), the patient experienced fever 102.5, headache, chills, cold and numb feet, body aches, particularly in legs and ringing in ears. The patient not received treatment for the events. The outcome of the events was reported as not recovered, and the outcome of vaccine administered at inappropriate site was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained.
Began experiencing full body itchiness about 1.5 weeks after receiving her first COVID vaccine dose.  She takes benadryl at night to help with the symptoms.  When the benadryl wears off the symptoms return.  Still experiencing itchiness.
This spontaneous report was received from the registered nurse regarding a 10 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 24-OCT-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Hepatitis A vaccine #2 given 7/2/11. Pt was well until febrile illness 8/19/11. Developed weakness, leg pain, difficulty walking on or around 8/28. Presented 8/29/11 with weakness to ED - admitted and treated for presumptive GUILLAIN BARRE Syndrome.
cellulitis (warmth and edema to left thigh); symptoms x 2 days- redness improving; tx with antibiotics with f/u in 3 days.
Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
inadvertently given second Shingrix dose about 5 weeks after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 5D5Z4, expiry date 25-OCT-2024) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 04-AUG-2023, the patient received the 2nd dose of Shingrix. On 04-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inadvertently given second Shingrix dose about 5 weeks after the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 14-AUG-2023 Pharmacist reports 75 year old immunocompetent patient was inadvertently given second Shingrix dose about 5 weeks after the first dose which led to shortening of vaccinations schedule.   The doses were given on 26June 2023 and 04 August 2023. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Reporter gave permission for follow-up.
A small blister appeared approximately two inches from the injection site.  At the time of the injection, I felt a sharp pain (similar to a scratch) and mentioned this to the nurse at the time.  The blister itself has not changed except to get a bit smaller in size as of today, 04/05/2012.
sore arm, body aches, headaches, red and swollen arm, diarrhea, fatigue
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 09-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
After the 2nd dose of vaccine, I became very ill and missed 6 days of work. I have never been so cold in my life but I was completely drenched in sweat. I was exhausted and it hurt to move every part of my body - any movement hurt. I felt groggy, lightheaded. At one point I think I was a little delirious based on my texts and trying to form thoughts. These major side effects started the evening of the shot and lasted 3 days. I continued to be tired and groggy and sweaty for 2 more days. After that for probably another 7-10 days I was still more tired than usual, felt a little more winded, and still had an issue with my head I can't really describe. This brings me to the evening of May 2, when I got a fever and chills and sweat all night. May 3, I was exhausted to the point of falling asleep while driving, and my face was on fire. By May 4, I was miserable and left work for a Covid test (which came back negative). The 5th and 6th I continued with the symptoms, the high fever and chills and unable to stay hydrated. 6th I got IV for fluids. All symptoms were very similar to what happened after 2nd vaccine dose.
Had no s/sx prior to shot. Got it at 4:15 pm. Woke at 4:30 a.m. w/ HA, felt weak; lightheaded; back to sleep; woke later (usual time) felt hot, had chills, muscles in "legs and hip" hurt, skin was sensitive, no rash, resp sx and no N/V/D. Sx gradually decreased over approximately 24h-36h.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for an 18-year-old male patient of an unspecified ethnicity received the second dosage of TRUMENBA (strength 0.5ml), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation, MENACTRA, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The medical history and concomitant medications were not reported. The patient previously took 1st dose of meningococcal group b rlp2086 for immunisation. The patient experienced chills, fever, and body aches on an unspecified date with outcome of unknown. No follow up attempts are possible. No further information is expected.
Rash that extends from the top of left shoulder down to the elbow. The site of the rash is itchy, rash was noticed 4/19 however the arm began to itch on 4/18
Information has been received from a physician concerning a 60 year old male patient with no allergies or drug reaction and no pertinent medical history who on 22-MAR-2011, was vaccinated with the first dose of PNEUMOVAX 23 (route and expiration date not reported) (lot number 667914/1067Z). There was no concomitant medication. On 22-MAR-2011, the patient was complaining of quarter-sized welt on injection site arm and fever to the touch. The physician was notified on 25-MAR-2011, that the patient was admitted to the hospital "with documented pneumonia and severe cellulitis from the shoulders to the elbow". While at the hospital, the patient received an IV antibiotic and a chest x-ray was performed (no results were provided). At the time of the report the patient was recovering. Pneumonia was considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Box 17- Pneumo23  Unable to use/lift left arm for 5 days. Called family doctor the following day, prescribed Doxycycline. Currently experiencing left shoulder pain to the point that it wakes me up an night.
The patient was here for the Pfizer bivalent shot but was given the regular Pfizer vaccine instead.
patchy air loss on head.   got a hair cut, came home and wife freaked out about me having a nickel sized bald spot.    a month later (here at the end of November (2021), got another hair cut, bald spot is now about 2 inches.  No treatment.
I don't know the exact name or manufacturer of the vaccine. It was a routine seasonal flu vaccine. I receive this vaccine every year at this time.  The nurse who gave it to me commented, "Boy, your muscle is really tight".  I experienced nothing out of the ordinary for several days. Then I experienced immense pain between my shoulder and elbow. I was unable to lift my arm because of the pain and intense muscle weakness. I had difficulty sleeping. The pain increased and did not go away. I called the doctor's office and was asked to come in on 10/23/20.  I explained that the pain was directly related to the injection and was in the spot where the shot had been administered. The doctor said it was likely biceps tendonitis and told me to try applying ice for the next couple of weeks. Called the office again on 11/3/20 when there was still no relief. Spoke to the nurse who advised that the doctor suggests a visit to the orthopedic. Nurse suggested applying heat in the meantime. Felt marginal relief with heat for several days and then it returned to constant pain. Called for an appointment on 11/20/20 with an orthopedic, per recommendation.
1710: Patient received H1N1 injection right deltoid. 1712: Patient complained of itching around site. Severe itching, irritation, some swelling, warmth and redness observed. 1714: Symptoms intensified to itching around mouth, left side of face and top of head. 1720: Patient transferred to ER for IV Benadryl; symptoms resolved.
got the first dose of  shingrix, 2.5 yrs ago , never went back for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2.5 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report.  The patient got the first dose and never went back for the 2nd dose, which led to incomplete course of vaccination.  The patient received first dose in another state. They wanted to know if they have to start over. No other information of vaccine available . The reporter consented to follow up. This case has been linked with US2021097932 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097932:SAME REPORTER
Chills 20 min p/Hep B vax recvd, hives 40 min later (starting on arm where inject given & spreading to back & torso); Felt "lousy" & w/"heavy feeling" that persisted into next day; Had couple hives @ site of #2 Hep B vax;
Day 8 of injection: Redness, heat, swelling, skin hardness, and lump at injection site that previously did not exist on day 7.  Pain and tenderness at site as well. Size is about 1 in by 2 inch over injection site.
About 2 hours after receiving the vaccine, my tongue got numb and very thick-feeling so that I could not freely form words. Then the numbness spread to my lips. Then it spread to my checks and chin. The reaction was like getting anesthesia at the dentist for a cavity. I contacted my health provider at this time. The numbness stopped spreading and then about 5:30, it began to slowly dissipate. First my tongue got better, then my lips and then my face. I was completely normal by the morning of the next day, 8/18/21.
I got the vaccine around 12 pm went home and fell asleep at 1 woke up around 4 was felling very tired and my body was beginning to feel very sore fell asleep again and got up at 6 with a fever and awful migraine and chills and laid down until 8 when I stood up I started to feel very nauseous and started to vomit uncontrollably all throughout the night maybe 4 or 5 times and vomited twice the next day I?ve had a continuous migraine and fever soreness muscle aches in head, neck and back.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 01-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and a licensed practical nurse concerning a 5 year old male with no known medical history who on 9/9/99 was vaccinated SC with the first dose of varicella virus vaccine live (lot # 629142/1837H). Concomitant vaccinations on that same day included the first dose of MMR (lot # 628900/1357H) and the first dose of poliovirus vaccine live oral (lot # 458433). There was no illness at the time of vaccination. It was reported that on 6/10/04, the patient developed a rash. On 6/11/04, the patient was diagnosed with a case of full blown chicken pox. Unspecified medical attention was sought and the patient was treated with Acyclovir. No laboratory/diagnostic tests were performed. As of 6/15/04, the patient was noted to be recovering. Subsequently, the patient recovered from the chicken pox. No further information is available.
Information has been received on 14-NOV-2016 from pharmacist referring to a 23 year old patient (gender not reported.) The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-NOV-2016, the patient, age 23, was vaccinated with GARDASIL 9 lot # M032650 expiration 31-MAR-2019, dose 2, intramuscular for prophylaxis which was 1 month after first dose of GARDASIL 9 was administered. No further effects were reported. No further information was provided. Additional information has been requested.
nausea tired Headache body aches no tests; just rest; better after about 40 hours from onset of symptoms
felt dizzy and sick; felt dizzy and sick; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of bnt162b2 (Lot Number: EL9261), via an unspecified route of administration in left arm on 21Jan2021 14:30 at single dose for covid-19 immunization. Medical history included Thyroid issues, whole body hurts, car accident in 2006 (lost her arm and husband, she only has part of her right arm), A-Fib, cardioversion (about a little over a month ago), heart disorder. Concomitant medication included apixaban (ELIQUIS) for heart, thyroid medication. The patient previously received the Shingle shots for immunization and experienced tired the next day. The patient experienced increased heart rate, felt dizzy and sick on 21Jan2021. She got the shot on 21Jan2021. She was ok at first but then about 4pm when got home she felt dizzy and sick. She took her heart rate and it was 156. She had A-Fib but just had a cardioversion about a little over a month ago so this really scared her. She felt really sick and didn't want to go into the hospital. She was ok overnight other than her heart was beating too fast. She took her heartrate this morning (22Jan2021) and it was back to 67-70. Today she is just taking it easy. The events did not require a visit to Emergency Room/Physician Office. The second dose is due on 13Feb2021. She is leery of getting it but is going to talk her heart doctor about it and will also see her primary care doctor on Monday. She had a Thyroid issues, things like that. Basically her whole body hurts, this is something that was going on prior to the shot. The only issue with the shot is the increase in her heart rate. There was no treatment, she had nothing to take for this, she doesn't think Tylenol would have helped but she doesn't know. The patient's mom had cancer. The outcome of the events was recovered on 22Jan2021.
fully vaccinated (pfizer, 12/23/20, 1/13/21); onset of symptoms 8/5/21
Fatigue and injection site pain day of and after. Pain, minor swelling and itchiness at injection site on day 8
couldn't make 2nd dose and it's been 45 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (couldn't make 2nd dose and it's been 45 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (couldn't make 2nd dose and it's been 45 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (couldn't make 2nd dose and it's been 45 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. "About a year ago", in approximately 2014, the patient was vaccinated with her first dose of GARDASIL (injection, lot#, dose and route were unspecified). Currently, in approximately March 2015, the patient received her second dose of GARDASIL in the office (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Information has been received from a RN concerning a male pt (18 to 20 yrs of age) who on 25Jan06 was vaccinated SC in the left tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included influenza virus 3v reassortant vaccine live intranasal (Flumist), hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix), meningococcal ACYW conj vaccine (dip toxoid) (Menactra), MMR vaccine, penicillin G benazathine (Bicillin) and tuberculin purified protein derivative. In less than 24 hrs, on approx 26Jan06 the pt experienced localized cellulitis like reactions, soreness from the tricep to axilla, redness, limited range of motion, hardness at injection site. The pt had a fever of 101. 6 deg F and had a CBC lab test performed. It was noted that in the past no reactions had been noted when the pt received the vaccine IM in the deltoid. Unspecified medical attention was sought. The outcome was reported as unk. No product quality complaint was involved. Additional information has been requested.
Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles  Received steroids and antivirals, no improvements
had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Lot of food allergies including beef and pork.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (had a sore arm at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitants and treatment drugs are provided. The patient had a sore arm at the injection site.   This case was linked to MOD-2021-384105 (Patient Link).
MENOPAUSAL BREAK THROUGH BLEEDING; This spontaneous report received from a consumer concerned a older female of unspecified age, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of administration, and batch number were not reported and expiry: unknown) dose, start therapy date were not reported, frequency 01 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported at the time of reporting.  Reporter stated that, a pharmacist had several females report menstrual abnormalities after receiving a COVID-19 vaccine. On an unspecified date, the older female in menopause experienced break through bleeding and further stated additional females had experienced an abnormal cycle following vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menopausal break through bleeding was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217848-COVID-19 VACCINE AD26.COV2.S-menopausal break through bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).