chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The patient did not received any treatment medication.
I had chest pain. Dr. did an EKG 06/10/2021 and ECO same day.
Patient came to the pharmacy today 3/8/22 and reports that she experienced chills, headache, and localized injection site rash the morning after her first shingrix vaccine which took place on 3/3/22.  Patient feels better now but stated the symptoms lasted about 3 days.  The rash still remains and patient will let us/MD know if rash gets worse or does not go away with the next few days.
pt recv vax 28JAN98 & 29JAN98 pt devel inflammation @ the deltoid @ the inj site A6x3inch red, raised area extended to the elbow which was sensitive to touch;
24hrs p/vax noted facial numbness that persisted for 4 days; Administered 2nd dose of Hep B reported numbness on one side of her nose;
My husband got sick at 4 pm and I got sick at 8:30 PM. Had a fever 101 degrees, chills, shaking could not stop & couldn't get warm. Headache, slept all next day, pains in joints, felt better 10/5/11.
injection site became markedly red, hot and swollen.  headache, 101.7° temp, tremendous body aches
28 year old female administered Pfizer vaccine, 0.3 mL, EW0179 at 1610. At 1617 she reported feeling a tightness in her throat, accompanied by difficulty swallowing and agreed to be monitored more closely.  She stated that she had not experienced this level of a throat sensation after the first Pfizer dose, but that this sensation was more similar to the throat swelling she experienced after exposure to shell fish, which was followed by anaphylaxis.  She carries her own epi pen and diphenhydramine for such emergencies.  She stated that she self administered diphenhydramine after her first immunization, which controlled the throat sensation at that time.  She agreed to take a 50mg diphenhydramine at 1625.  BP was approximately 152/107, 97% pulse ox on room air, HR 112.  At 1635 no change in how her throat was feeling, or that it was any easier to swallow.  She agreed to have EMT services called.  911 was called and the dispatch instructions were followed, including the administration of 0.3mg of epinephrine via an Mylan EpiPen (Mylan, Lot 0FM544, Exp 9/22) at 1642.  Soon after, she stated she was feeling significantly better and breathing was easier.  At 1645 EMT teams from  arrived and assessed the situation; the patient agreed to be transported to  for further evaluation.
Information has been received from a physician concerning a male patient who on approximately 03-DEC-2008 was vaccinated with 1 dose of GARDASIL vaccine and was referred to his primary physician for completion of the series. No adverse effects were reported.  Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a group of patients of unspecified number and demographics. On 16-FEB-2017, those patients were vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was reported that the vaccines were improperly stored for 30 minutes, in the temperature of 10 degrees Celsius (C). It was reported that there was no previous temperature excursion and that it was a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact. Sender's Comments: US-009507513-1702USA008447: US-009507513-1702USA011948: US-009507513-1702USA011950.
Monday May 20th around midday felt funny, Used  a blood pressure pump 130 over 93, resting  heartrate was 112. On May 24th, dropped a bowl picked it up, cut hand in 4 places and thought it was weird because didn't sting after running under water. Next morning numbness in arms and legs.  That evening burnt hand didn't feel heat though. Only after blistering realized what happened. On May 27th, saw primary he Guillaine Barre as a result of the vaccine. He put in a referral for a Neurologist. Neurologist visit was in June around 5th,.  bladder and gastro intestine issue
Extreme fatigue; nausea; lightheadedness; diarrhea; muscle ache; inability to sleep; sickness; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular (left arm) on 21Dec2020 16:00 at single dose for COVID-19 immunization. The patient has no medical history. No known allergies. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient has received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 (18:00), the patient experienced extreme fatigue, nausea, lightheadedness, diarrhea, muscle ache, inability to sleep, and worst sickness of entire life (as reported). The patient received over the counter medication as treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious (as reported).  Information on the lot/batch number has been requested.
C/O dizziness, blurry vision, weakness. VS 138/70, pulse 82, resp 18.
Shortness of Breath, Chest Pain; SIQ 24 hrs, increase fluid intake.
bloody stools; This is a spontaneous report from a contactable consumer (patient). 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 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bloody stools in Apr2021. Caller is a consumer, asking if bloody stools are a common occurrence after getting the vaccine and should he be worried. Caller reported that he received his first vaccine dose yesterday (18Apr2021) and afterwards he had had bloody stools 3 times (in Apr2021). He reported never experiencing anything like this before. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4220902-00.  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15May2020 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single and intramuscular, administration date 15Apr2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid-19". The action taken for adalimumab was unknown.   The reporters assessment of the causal relationship of the events with the suspect product  bnt162b2 was reported as possible  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) and the suspect drug BNT162B2
Systemic: Lymph Node Swelling-Medium, Additional Details: patient experiencing swelling that started in her armpit after inject and has migrated into her side
Pain in the bones; Tiredness; Little pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the bones), PAIN IN EXTREMITY (Little pain in my arm) and FATIGUE (Tiredness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little pain in my arm). On 26-Mar-2021, the patient experienced BONE PAIN (Pain in the bones) and FATIGUE (Tiredness). At the time of the report, BONE PAIN (Pain in the bones) and FATIGUE (Tiredness) outcome was unknown and PAIN IN EXTREMITY (Little pain in my arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient described shooting pain in left breast and swelling of the breast the day following vaccine administration. Patient applied ice to the area and reports that there was no pain in the arm the vaccine was received in.
I woke up with a headache 2 days in a row. I lost my sense of smell on Monday so I went to get tested on that Wednesday. On Tuesday I was fatigued but stayed in bed all day sleeping. The test was positive but I was mostly symptom free outside of loss of taste. I was instructed to quarantine for 10 days and was not given any medication. I completely recovered with no lingering exhaustion and I do have my sense of smell back.
pt recvd vax which would not stop bleeding; went to ER dx'd w/ITP adm to hosp for 24hrs to recvd gammaglobulin; platelet count dec to 15,000
This spontaneous report as received from a nurse of unknown age refers to herself. On 03-JAN-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # was unknown) intramuscular rather than subcutaneous. No adverse event reaction reported. This is one of several reports received from the same source. Follow-up information was received from the licensed practical nurse. Patient demographics were updated. On 20-DEC-2011, the patient had already a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported) intramuscularly instead of subcutaneously. Since 10-APR-2012, the patient had herpes zoster outbreak 3 times on left upper back. The outcome of herpes zoster outbreaks was unknown. Additional information is not expected.
After 1st dose on 2/9/21 My breasts were extremely sore, like I was going to get my period. (Which I have not had in 4 years) I am in menopause. 5 days after 2nd covid shot again breasts were tender & I had vaginal bleeding & cramping. Ultrasound showed inflammation of my uterus.
Child developed fever to 104 degrees with redness, swelling, warmth and tenderness of bilateral anterior thighs the morning after receiving his DTaP, Hib and Prevnar vaccines. He returned the following day for evaluation and was started on Keflex as well as continuing on Tylenol.
Pt called me today and let me know that he was admitted to the hospital on April 01, 2021 with COVID
About 10 to 15 minutes after receiving both immunizations and leaving the doctor's office.  I started to experience a cold sensation starting in the left side muscle of my upper back at the shoulder level.  It slowly radiated to the center of my back just below my neck and went across to the right shoulder area.  The sensation was also in noticeable to the touch on my skin.  The left side and middle of my back were the coldest.  I had someone touch my skin in those areas about 15 minutes after the sensation started and they said that it felt like I had been using ice packs on my skin.  The sensation lasted for about three to four hours before it finally started to warm back up.  At no time was it ever painful, either muscular or on the surface of my skin.  I have never felt a sensation like that before.  I would liken it to putting on icyhot or biofreeze and it staying at the cold feeling of either of those.   I experienced the start of this while I was driving home and phoned my doctor's office as soon as I reached home.  I talked with my doctor's assistant.  She told me that my symptom was not what they would consider 'normal' and is the one who advised me to report it to you. I got flu like symptoms on the following Saturday (10/03/2020) that eased up and went away by Tuesday (10/06/2020). Those symptoms were fever, chills, general fatuige and weakness.
Patient had throbbing, and pain in the left arm starting the day of the vaccination. About a day afterwards patient noticed limited range of motion in the left arm (limited abduction) along with the other symptoms. Patient began massaging the arm and also did shoulder exercises(abduction/adduction, full rotation movements), with no improvement in symptoms. Patient denies any fever entire time, noted minimal swelling, and no redness or warmth from the area. However, initial symptoms have not abated (it is now about a month and half post-vaccination). Patient will be following up with his orthopedic surgeon soon.
Flu-like symptoms, aches, numbness/weakness and pain doctor appointments on 10/10/12. Collapsed while walking on evening of 10/11/12 and could only crawl, doctor appointment 10/12/12 and 10/16/12. Went to ER on 10/18/12 admitted on 10/19/12.
This is a spontaneous report from a contactable physician via a sales representative. A 17-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician would like and information on meningitis like symptoms, such as neck stiffness, lethargy and chills after a dose of meningococcal group B rlp2086. This patient was involved. Outcome of the events was unknown.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed
Lips and tongue tingly/numb. Fever 101.4, body ache, muscle pain, headache, chills, pain at injection site, fatigue.
Flu like sx 3 days p/shots. P/vax #4,T102 w/aches & pain in joints, pt placed on quarters due to severity of sx; On 20May99-difficulty clearing lt ear, dx w/allergic rhinitis, eustachian tube dysfunction typical of seasonal sx.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
After exactly one week, at the injection site  - redness and soreness, itching, swelling, and hot to the touch. This lasted for 2 or 3 days then cleared up.
I received the first dose of the Moderna Covid vaccine. I have had body pain for many years however after receiving the first dose the pain in my joints has become much worse. I have pain in places that previously had been less difficult to manage. My low back pain has increased and in my knees to the point it is often difficult to walk.
pt called 1/26/07 to report she did experience a raised welt at the injection site/ it was about 1-1/2" long. not sore,no other symptoms.  I spoke with patient today, welt is less today, no further complaints. form submitted as fyi only.
Itchiness on neck, upper chest, sides of belly, lower back, left arm; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 29Jan2021 at 13:45 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration on 21Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had experienced itchiness on neck, upper chest, sides of belly, lower back (not at vaccination site - left arm) which began mildly about two weeks after first shot (on an unknown date in Feb2021) and increased markedly after 2nd shot, over three weeks after 2nd shot with no relief. The treatment received for the event included benadryl. The clinical outcome of the event itchiness on neck, upper chest, sides of belly, lower back was not resolved.   No follow-up attempts are needed. No further information is expected.
Soreness in the right arm; Redness on her right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and developed soreness in the right arm and redness on right arm. The follow up consent was granted.
10 days after receiving one dose of varicella virus vaccine live the pt experienced chickenpox. Pts mother, who is also a physician, stated the pt did not have any vesicles and this was not a reaction.
Patient presented with a red, itchy patch on skin on the back of the left arm at the injection site. It was about the size of a half dollar. It started the day after the vaccine and lasted about 4 days.
Client was vaccinated with Pfizer vaccines in July and August 2021 (client not sure of dates).  Symptoms started 10/4: nasal congestion, cough, fatigue, fever 102 x 2 days, myalgia, sore throat.  Went to hospital ER on 10/8 and was given IV electrolytes and Tylenol and sent home.  Reported as breakthrough Covid illness in previously vaccinated person
Developed subjective wheezing, throat "scratchiness," and periorbital swelling approx 90 minutes after receipt of 2nd-dose Pfizer COVID-19 vaccine (no reaction after first dose).
OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 15 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced off label use. On 05-JUN-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
After arising the morning following injection @ 0645, walked downstairs and had syncopal episode @0650
per patient he received vaccine in the morning that is when he started experiencing feelings of the "ear clog", as it progressed towards the end of the night the pain gradually increased. patient took naproxen to help with the pain so that he could sleep. since then it has been ok but patient still feel blockage, vibration, and can hear himself speak. pain has however reduced since.
In 2013 was diagnosed with vasculitis [Henoch-Schoenlein purpura} and was resolved with prednisone treatment with no recurrence. About two weeks after receiving 2 dose of Moderna vaccine, bright red rash was appearing on  all areas of body - head to toes.  Made an immediate appointment to see a provider to obtain prednisone.  Second day after dosing rashes were fading and totally resolved within  a week.
Bleeding gums.  There have been no changes to daily habits nor diet that might cause bleeding gums.
Post vaccine, the patient experienced redness, swelling, tenderness to the touch and nausea. The patient felt hot and sick after the injection. The patient was treated with Atarax and Zyrtec.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of M-M-R II (lot # 667879/0788Z expiration date 16-JUN-2012), SQ on 11-JUN-2012. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever up to 104 only reducing slightly with fever reducers. Large red, painful and warm area to injection site.
Patient received injection and had a little pink area around injection. I called to follow up a few hours later and mom said she was busy but that a few minutes after leaving the phamacy she was fine and no redness around inj site. I received a call from mom today stating last night the area began to turn blue/red (it would come and go) and began to experience tingling and soreness. She took her to ER last night concerned it may be a blood clot and ultrasound confirmed not blood clot. She was given Vicodin and Motrin, she said she is almost all cleared up now but wanted to let me know. I told her to please folow up with her Dr if any changes.