chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st Shingrix vaccine on 04/27/2018; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th April 2018).   On an unknown date, the patient received the 2nd dose of 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: The age at vaccination was not applicable for this report. The patient was back for 2nd Shingrix vaccination. At the time of the reporting, it was unknown if patient received 2nd Shingrix dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who experienced body aches, swollen lymph nodes and fever, while he received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; and HPV VACCINE. On 08-Aug-2018, the patient received 0.5 ml first dose of suspect MENACTRA lot U6015AA via intramuscular route in the left arm. On 12-Aug-2018 he also received a second dose of the same vaccine lot M17037. On an unknown date, the patient developed a non-serious body aches (pain), swollen lymph nodes and fever, following the administration of MENACTRA. It was also a case of actual medication error due to extra dose administered. As the patient received two MENACTRA vaccinations within 4 days. Relevant tests were not reported. Final diagnosis was fever, swollen lymph nodes and body aches. The patient was treated with TYLENOL. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: None.
allergist reports that pt had recvd vax & had an allergic reaction (sx unspecified);
Information has been received from a nurse practitioner and a licensed practical nurse concerning a 13 year old female with mild asthma, asymptomatic and no any known drug allergies who on 17-AUG-2011 was vaccinated IM with the first dose of GARDASIL (lot# 669300/0636AA), 0.5 mL. On 25-NOV-2011 she was vaccinated IM with the second dose of GARDASIL.
A straight purplish line of about 8 inches that diminished to 4; Rash that looks like a dry spot or eczema at the site where the injections; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (A straight purplish line of about 8 inches that  diminished to 4), RASH (Rash that looks like a dry spot or eczema at the site where the injections) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 0838A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Oct-2021, the patient experienced SKIN DISCOLOURATION (A straight purplish line of about 8 inches that  diminished to 4) and RASH (Rash that looks like a dry spot or eczema at the site where the injections). The patient was treated with AVENA SATIVA (EUCERIN ECZEMA RELIEF) for Dry skin, at an unspecified dose and frequency. On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 10-Oct-2021, SKIN DISCOLOURATION (A straight purplish line of about 8 inches that  diminished to 4) was resolving. At the time of the report, RASH (Rash that looks like a dry spot or eczema at the site where the injections) outcome was unknown.            no concomitant medications are provided. patient used facion body cream to try to alleviate the dryness of the spot. purplish line on the skin noticed a week after vaccination, nurse looked it up and only diagnosed it as strange.no medication taken by the patient when the first side effect appeared.
Extreme tiredness/fatigue began at 10:30. At 11:30, I experienced intense chills and shivers. My body was tender and sensitive to touch and I was sweating and felt feverish. Experienced slight fatigue into the next day but slept most of it off.
pt recv vax & the following day exp fatigue, hot flashes, generalized muscle aches, facial & dental pain, heaviness in chest, fever of 101, chills & nausea; sx lasted 24hr & pt recovered;
Temperature of 105, irritability, lethargy and glassy eyes. Symptoms started between 14-18 hours, post vax.
Pt claims to have pain right after shot was worse next day and continued to get worse to the point where she couldn't lift her arm she call on 11/29 and stated this information and that she received her flu shot here on 11/14 she was directed to see a Dr to have it checked out.
Nausea developed after shot.  Vitals good.  Monitored for extended period and no problems.
- Diarrhea, vomiting, stomach discomfort. Currently resting and hydrating, monitoring for outcomes.
After the 2nd COVID 19 vaccine shot, the  tingling and numbness at the tips of my fingers and toes become worse the next day. I am now also experiencing severe joint pain, and muscle spasm during sleep at night.
Tdap administered 12-28-12, 7 days later (L) upper arm red, swollen, tender to touch, redness and warmth spreading to (L) upper inner arm. Temp 99.4 (O).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Very achy the next day but my arm continues to worsen 4 days after vaccine. It?s very red and irritated.
Sickness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    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 and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form once a day. On an unknown date, the patient experienced ILLNESS (Sickness) and COVID-19 (COVID-19). At the time of the report, ILLNESS (Sickness) and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
One hour after vaccine, had hives. Still have some problems with hives as of 8/19/02 even after taking Benadryl but it resolving.
got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient
Within 20-30 minutes of vaccination (around 1:10PM), started to feel short of breath while walking and a very very slight pain in the heart region of my chest. Generally symptoms were lessened when walking more slowly. Noticed having a fast-beating and/or fluttering heart while laying in bed after waking up from a nap 3 hours later.
PATIENT STATED THAT THEY GOT BURSITIS AND HAD TO GET STEROID INJECTIONS/MASSAGE THERAPY
This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Dec2020 (Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 07May2021 (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from 25Sep2020 to 25Sep2020, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got vaccine 18Dec2020. got covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021 on an unspecified date, got vaccine 18Dec2020. Received second vaccine 07May2021. The patient underwent lab tests and procedures which included covid-19: positive on 25Sep2020, covid-19 positive on 30Dec2020. Covid-19 positive on 06Aug2021. Therapeutic measures were taken as a result of experienced got vaccine 18Dec2020. Covid infection 30Dec2020, received second vaccine 07May2021. 3rd covid infection on 06Aug2021. Got COVID infection 30Dec2020 monoclonal therapy on 15Jan2021 out of work for over 100 days. I have RA but have been off my medication since Jan2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Rash on whole body starting 5 minutes after getting the shot. Mouth became itchy. Heart rate increased and felt dizzy.  The rash lasted four days.
10 hours after administration severe headache, chills, muscle aches, low grade fever all lasting 3 days. Injection site raised red painful swollen despite ice pack application continuously after administration; grew in size over 4 days to approximately 3"x4", extreme tenderness, red, painful.
Patient received Pediatric dose (5-11 year) on his 12th birthday.  Wrong vaccine given.
This spontaneous report was received from a pharmacist concerning an unspecified patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX with a lot # L021612 and Expiration date: 10-SEP-2016, "one vial" subcutaneous (dose and anatomical location of administration were not reported) after an initial excursion on 18-APR-2016. No concomitant therapy was provided. A previous temperature excursion of 14 F occurred for 1 hour on 18-APR-2016. Another temperature excursion of 11 F occurred for 1 hour and 30 minutes. It was reported as a Digital Data Logger. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient had second dose of Moderna vaccine on 3/11, had no allergic symptoms then, but today noticed a rash that began at injection site, 10 cm in diameter, similar to when she had dose 1 on 2/11 on her L arm, which progressed and was treated empirically in the Emergency Department as a superimposed cellulitis with 5 days of cephalexin, resolved.  No systemic symptoms.
I experience joint pain and symptoms similar to arthritis. 36 hours after I got the vaccine, the symptoms dissipated. Now, months after the vaccine, the pain has started to come back.
Pounding headache, body aches, nausea on the night of shot.  I took 2 extra strength Tylenol.  In the middle of the night I had diarrhea.  11am the next morning the body aches started back.  By 1 pm chills had started.  This lasted until the next day.
generalized viral type exanthem starting 5 hrs p/inject; somewhat less active/fussy; no other sx; no tx-resolved the next afternoon;
Pregnant at time of injection. Due date 10/29/2021. Dr advised of miscarriage of baby 4 days later 3/17/2021. Baby measured what it would have on day of Injection and stopped growing.   I am filing a second report as well. Pregnant at time of booster Injection 12/3/2021. Due date was 07/20/2022. I was informed at next ultrasound 5 days later baby stopped growing around the time of booster injection and no heartbeat. 12/8/2021.
injection site pain; tiredness; headaches that come and go; muscle pain; few chill; severe joint pain; fever; This is a spontaneous report from a non-contactable healthcare professional (patient).  A female patient of an unspecified age (Age: 60; Unit: Unknown) received single dose of (BNT162B2, batch/lot number and exp date not reported), via an unspecified route of administration on 21Dec2020 (last Monday), around 11amfor immunization. The patient's medical history and concomitant medications were not reported. Patient reported experiencing 7 side effects after receiving the COVID-19 vaccine on an unspecified date in Dec2020. She experienced injection site pain, tiredness, headaches that come and go, muscle pain, few chill, severe joint pain, and fever. Her temperature ranged between 99.9-100, at the low grade. Patient asked how long the symptoms would last and to what point does she assume that they relate to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt called 5 days after shot and said she had red streak/rash at inj.site. Didn't know how long it had been there, someone else noticed it. Wasn't sore and did not itch.
Pt went to hospital 8/16/11- redness, swelling pain. Was told to give MOTRIN prn given BENADRYL and use ice packs for swelling.
Around 8 PM post vaccination, the pt developed a large, local, red, warm, area at the injection site which spread from the upper arm to her elbow. The physician also added that the subcutaneous tissue is indurated to a size of 16 cm X 30 cm if spread out and there is no fever or lymphadenitis. The pt sought unspecified medical attention. Additional information has been requested.
Right deltoid area erythematous, swollen area 6"x6"in. Warm, slightly tender. (local reaction only) Pt in no acute distress and reaction slowly evolved on 2-3 days. Benadryl 25mg PO given and also started on oral steroids.
pt reported difficulty breathing and swelling of throat/oral passage in 1 hour. she went to the emergency room and received epinepherine
Headache/migraines more frequently. Had a terrible one after dose 1, but after dose 2 they've become more regular and consistent, last for much longer and not being resolved by usual means
pt was brought to clinic on 25APR97 w/a rash;MD called to have adverse event form filled out for the rash;rash crusting over now mom reported on 28APR97;
About 9 hours after the vaccine I started having muscle and joint pain (bad low back pain, pain in neck, arms, wrists, knees, ankles) and arm soreness. This pain lasted until about 2:00 a.m.on 2/27/21. Chills developed around 11:00 a.m. on 2/26/21, then a fever that got to 100.7 around 12:00 p.m. the same day. Both effects lasted until about 2:00 a.m. 2/27/21. A headache started about 6:00 a.m. on 2/27/21 and got worse in the evening and following morning. I have also felt fatigue and a little off balance for the duration of all these symptoms.
HEADACHE/MILD COMES AND GOES HEADACHE; LIGHT-HEADED FEELINGS; PAIN; UNABLE TO SLEEP; BLURRED VISION; SLIGHT CHEST PAIN; NECK PAIN; CANNOT MOVE; HOT FLASHES; COULD NOT WALK; COULD NOT STAND WITHOUT ASSISTANCE; CHILLS; INTENSE JOINT PAINS IN THE GROINS, KNEES, ANKLES, ELBOWS; FATIGUE; WEAKNESS/SEVERELY WEAK; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy, Patient was not diagnosed with COVID previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-AUG-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced light-headed feelings. On 12-AUG-2021, the patient experienced pain. On 12-AUG-2021, the patient experienced unable to sleep. On 12-AUG-2021, the patient experienced blurred vision. On 12-AUG-2021, the patient experienced slight chest pain. On 12-AUG-2021, the patient experienced neck pain. On 12-AUG-2021, the patient experienced cannot move. On 12-AUG-2021, the patient experienced hot flashes. On 12-AUG-2021, the patient experienced could not walk. On 12-AUG-2021, the patient experienced could not stand without assistance. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced intense joint pains in the groins, knees, ankles, elbows. On 12-AUG-2021, the patient experienced fatigue. On 12-AUG-2021, the patient experienced weakness/severely weak. On 13-AUG-2021, the patient experienced headache/mild comes and goes headache. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight chest pain, and headache/mild comes and goes headache, and the outcome of light-headed feelings, weakness/severely weak, fatigue, blurred vision, chills, intense joint pains in the groins, knees, ankles, elbows, neck pain, cannot move, hot flashes, could not walk, could not stand without assistance, unable to sleep and pain was not reported. This report was non-serious.
2FEB93 high pitched scream started 2PM, temp checked ax; it was nl; pt felt warm & sweaty; Thursday night high pitched cry & it lasted for 5 hrs; rt leg was warm & it shook; pt vomited; MD states no pertussis;
This spontaneous report was received from a Registered Nurse regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. on an unknown date in March 2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
axillary temp 100;27NOV same day as vax-vomiting, lethargic-28NOV vomiting; lethargy;to see MD; 29NOV phone call dx ear infect, sore throat
Swelling 1/2 tricep, dark red, hot to touch and both shoulders have severe joint pain.
I received my first Pfizer Covid-19 vaccine on January 19, 2021.  I didn't have any immediate reaction after receiving the injection, aside from a sore arm.  I'd like to note that when I received the vaccine I was breastfeeding as I do not know if this contributed to my reaction.  About two days after receiving the vaccine, on January 21, 2021, I noticed a red itchy rash underneath my left breast.  I initially thought this could be a complication associated with breastfeeding known as Mastitis.  By the weekend the symptoms had decreased around my left breast and I developed a strong itchy sensation on the left side of my back.  On January 25, 2021 I noticed I had a red rash on the left side of my back, on my left side and on my left breast.  On January 27, 2021, I contacted my dermatologist and made an appointment thinking I had a rash.  On January 28, 2021 I went to see Physician Assistant.  During this visit diagnosed with Shingles.  I do not know if the Covid-19 vaccine lead to developing Shingles.  I wanted to share my experience in case there were other patients who received the Covid-19 vaccine and developed Shingles as a rare side effect.