chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching and/or rash on Both ankles, scalp, face, both arms, chest and back. With sporadic itching t/o entire body. Received prednisone  20 mg 2 tab  for 7 days, 1 tab for 7 days.  Continued to have random itching over entire body the whole time taking meds.  Also got TMJ in L jaw joint. Got hives a week later t/o body.  Done with prednisone and continue to have itching mainly in scalp and face, and sporadically t/o the body.  When I scratch where it itches, then get a burning sensation in that area..  it will be 4 weeks of itching on Monday since taking the shot
Received high dose flu vaccine at approx. 11:30 AM on 12/2/10. Approx. 1-2 hours later noted some cough, followed by throat tightness. Within 4 hours she was hypotensive and hypoxic.
Information has been received from a Doctor of Pharmacy candidate concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient developed acute disseminated encephalomyelitis (ADE). At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review patient's acute disseminated encephalomyelitis was considered to be an other important medical event. Additional information has been requested.
Started around shot area and grew to 1 inch from elbow, wrapping around arm, leaving about  1 inch from edge to edge on inside of arm very red, swollen and hot, very painful, and unable to raise arm. lasted about 3 days.
Developed left arm pain around 9 pm that evening that she called into work the following day for. Reports her job requires lots of lifting and she didn't feel she could do that. Rates left arm pain as a 6/10 "heaviness and discomfort". Describes "Moderate swelling" at injection site. No redness. Able to use arm without problem. Used Ibuprofen 400mg every 4-6 hours, icy hot, and hot tub. All resolved within 48 hours.
After the shot I began having pain in my left arm and very sharp. It started from the injection site to the bottom of my arm.
that needed hurts me so bad n my arm sore; This case was reported by a consumer via media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's 41 years old daughter got the shingles).   In July 2021, the patient received the 1st dose of Shingles vaccine. In July 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient's daughter got shingles and was so much in pain, able to hardly sleep and eat. The reporter stated that shingles were contagious and her daughter had rash. Hence patient's daughter advised her to took shingles vaccine. The patient got 1st dose of vaccine a week before reporting day that hurts the patient so bad and her arm was sore like the she had the covid shot. The patient would get the other shot in September 2021.  The reporter stated that it still bothors her a little bit that her daughter told her that it hurt like labor pains that's the worst pain ever.
Day one - extreme fatigue - unable to function, tenderness at injection site Day two - extreme body pains from head to toes, activation of fibromyalgia pain symptoms and tenderness all over to touch, tenderness at injection site, headache, chills, nausea, loss of appetite,  heartburn,  bowel discomfort, unable to stand up or move without a cane - severely impacted and unable to function - bedridden Day three - better body pains less, chills gone Day four - side affects resolved
The  day after receiving the vaccine,  I noticed Bells Palsy in the left side of the face along with extreme pain on the side of the face. I went to the ER and was treated for Bells Palsy and ear infection. The next few days resulted in extreme dizziness, nausea, headaches and nerve pain.  I was extremely weak and could not move due to the pain and vertigo like symptoms.
A week after the shot I developed a red rash around the injection site. The site is somewhat tender to the touch and itches slightly.
had COVID-19 once after the second dose and then following the booster; had COVID-19 once after the second dose and then following the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID-19 once after the second dose and then following the booster". Clinical Course: It was reported that patient received the Comirnaty vaccine and booster and then had COVID-19 once after the second dose and then following the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
break out in a rash on her forearm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Dec2021 17:40 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bee sting", start date: Jul2021 (unspecified if ongoing), notes: she had a prior bee sting this summer in Jul2021. There were no concomitant medications. The following information was reported: RASH (non-serious), outcome "unknown", described as "break out in a rash on her forearm". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
we elected to have our 11 year old twins vaccinated; their resistance to allergens was better; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 11 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "we elected to have our 11 year old twins vaccinated"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "their resistance to allergens was better".  Additional information: When announced the vaccine safe for 12-16 year old, we elected to have our 11 year old twins vaccinated. We only had to give verbal approval, parental signature etc, so we advised they were of age to receive the vaccine. Technically, they'll be 12 this year, we didn't want them to be restricted for summer camps/events planned. We wanted to share our information and the fact they have NOT had any adverse effects, not even a sniffle, and if anything noticed their resistance to allergens was better.  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-202101198729 same reporter/drug/AE, different patient
Red from shoulder to elbow, hard, hives and hot plus pain. Went to urgent care on 12 Sep 2016. Was given an antibiotic shot, steroid injection and 10 day treatment of oral antibiotic.
When patient returned to the Covid Vaccine clinic for her second Covid vaccine on 3-1-2021, she stated after receiving her first Covid Vaccine on 1-25-2021 she experienced a vivid dream/nightmare that night. She stated she does not have a history of nightmares.  Patient woke up crying she stated. Also stated had mildly sore arm for one day after vaccine.  It was suggested to her she sign up for V-Safe after receiving her second vaccine.
pt recvd vax 14OCT91 & 16DEC91 & 13 APR92 pt dx as having pneumonia & blood cult revealed haemophilus pos septicemia;
AFTER THE 2ND SHOT ON 4/30/21 AFTERNOON, PT HAD SORE ARM AT AROUND 7 PM AND WENT TO BED AT 8PM.  HE SLEPT THROUGH SATURDAY AND WOKE UP ON SUNDAY 5AM . HE NOTICED THAT CAN'T FOCUS HIS EYES TO READ OR SEE HIS COMPUTER SCREEN. BUT HE CAN SEE FROM BIG ITEMS FROM AFAR.  HE TOOK THE DAY OFF FROM WORK ON MONDAY, AND SAID THAT HE HAS  STILL HAS A HARD TIME READING OR SEEING COMPUTER SCREEN. HE HAS TO CLOSE HIS EYES FOR SEVERAL SECONDS AND FOCUS AGAIN BEFORE HE CAN READ ANYTHING. THIS CONDITION IS STILL ONGOING AS OF TODAY (5/4/21). HE SAID HE NEVER NEEDED READING GLASSES BEFORE. WE ADVISED HIM TO SEE EITHER TRY READING GLASSES IF THAT WILL HELP HIM OR IF NOT, HE CAN CONSULT WITH AN EYE  DOCTOR FOR THIS REASON
Arm sore, headache, shoulder ache,  headache became pounding, sleepy, then developed fever, awoke with bad sore throat which went away after sleeping more and fliuds . I took Tylenol.  500mg 2 caps  every 6-12hrs  only when I couldn't stand the pounding head. Arm progressed to hard red warm at site.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022). No concomitant medication was reported by reporter. Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot was MOD. Patient was administered with half dose. No treatment medication was reported by reporter.
Became symptomatic on 8/8/21 feverish, chills, runny nose, headache, fatigue, cough, vomiting, and tested positive for COVID-19 on 8/10/21. Died on 8/17/21 due to upper respiratory infection d/t COVID-19, HTN, hyperlipidemia, T2D, obesity, per death certificate.
CHILLS, TREMBLING, TOOK TYENOL WHICH HELPED.  PAIN TO DELTOID FOR 2-3 DAYS.  CURRENTLY FEELING BACK TO HIMSELF
Swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection.; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 36 years of age), via an unspecified route of administration in the left arm on 23Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS) and allergy to nickel. Concomitant medication included interferon beta-1a (AVONEX), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), colecalciferol (VITAMIN D [COLECALCIFEROL]), and bupropion hydrochloride (WELLBUTRIN). The patient previously took REGLAN [metoclopramide] and experienced allergy. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose (at 36 years of age) on 02JAN2021 08:30 AM via unknown route of administration in the left arm for COVID-19 immunization. The patient was not pregnant. She had not had other vaccine in four weeks prior to covid vaccine. She had no covid prior vaccination and she was not tested for covid post vaccination. The patient experienced swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection on 25Jan2021 with outcome of recovering. There was no treatment received for the events. The event resulted to Doctor or other healthcare professional office/clinic visit.  Information on the lot/Batch number has been requested.
Delayed cutaneous hypersensitivity reaction. Narrative:  4 day onset after first dose on 2/3/2021. Duration 6-7 days then resolved.  Other Relevant History:
Chest discomfort 24 hrs post injection #1. Chest discomfort, rapid heart beat within one hour of injection #2 (8/30/13) and (9/27/13).
SWELLING IN JOINTS/ Joint swelling; REALLY ACHY/ Ache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CITRATE FREE. On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache). At the time of the report, JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache) was resolving. Relevant concomitant medications were not reported. Treatment information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
First shot had no reaction, second shot had chills, fever of 101.4 and started taking tylenol, body aches and pains, headache, soreness in left arm joint pain nausea and just felt unwell.
Severe right shoulder and upper & lower arm pain, numbing of hand and fingers, Dr. visit 02/01/2010 8:00 AM.  Dr. says it's a strained muscle. She prescribes muscle relaxers and Aleve.  Nothing helps the pain, a week later, still suffering severe pain. Self diagnosed Brachial Neuritis, Parsonage Turner due to vaccine.
Seen for markedly tender swelling w/o redness of lower 2/3 of left inner arm on 10/29. Tx'd w/Ibuprofen 600mg. On 11/3/99, seen for mildly tender swelling of lower 2/3 of R/inner arm. L/inner arm got better.
Post vax, the pt stopped talking, speech was evaluated at a 12 month level when she was 24 months old. No eye contact; spinning in circles and flapping arms.
Elevated temperature of 101.2 noted by parents at 7pm. Generalized tonic clonic type seizure with 15 minute postictal phase noted by parents at 10pm. Taken to ED dx'd with ROM, seemed to have a febrile seizure. Rx amoxicillin.
Employee started itching and hives 45minutes after dose administerd. Took benadryl. started with wheezing and coughing.  GIven nebulizer, pepcid, prednisone, epi pen
Within 5 minutes of vaccination, patient began sweating profusely and had pale coloring.  He stated he did not feel well.  He may have lost consciousness and fallen down.  We had him sit down, gave him orange juice to drink, and fanned him.  Within about 20 minutes he stated he all of a sudden felt completely normal again and left under his own power.
Information has been received from a pharmacist and a RN concerning a retired 59 year old white female with increased cholesterol, reflux and chronic bronchitis who in August 2003, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645247/1171M). Illness at the time of vaccination included sinusitis. It was reported that on 09/01/03 the pt developed facial flushing, arm swelling, cellulitis, shortness of breath and was warm to the touch. The pt was seen in the ER and subsequently recovered from her events. The pharmacist also reported that another pt developed redness at the injection site after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent from Lot # 645247/1171M (WAES # 0309USA00432).  Additional information is not expected.
Case number PHHY2016US011497, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603012) website on 18 Jan 2016. This report refers to a 32 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) intramuscularly in right arm on 14 Oct 2015. It was reported that the patient received 1 ml of FLUVIRIN instead of the recommended 0.5 ml dose. No adverse event was reported following this maladministration (overdose).
Soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received Shingrix shot yesterday.  The reporter just wanted to knew if he/she could took Tylenol for soreness. The follow-up could not be possible as no contact details were available.
At 16:00 on 01/08/04, child had fever 101 ax and per verbal report from mom had what appeared to be a seizure that lasted about <3 minutes.
Chills Fever of 100.5 F Muscle Aches and Pains Fatigue Headache Used Ibuprofen to aid/alleviate symptoms. All symptoms dissipated after 32 hours.
The right upper quad (thigh) became swollen and red. He spiked fever of 101F.
Left upper arm red, warm, swollen and itchy. Symptoms began 08/09/2011 and got progressively worse on 08/10/2011.
No adverse event or reaction.  Pt was given a does for a 5 year old.  Pt is 4 yrs, 8 months.  Pt was observed by nurses and left clinic well.
1 hour after shot (2) & ROTATEQ pale - diaphoretic - for minutes - at office - normal - then 2nd episode & hospitalized.
HEADACHE; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from headache. This report was non-serious.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743, 2016SA191744. (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date in 1993. The patient's medical history and concomitant medications were not reported. On an unknown date and time frame, after vaccination, the patient got sick. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Ravenous hunger on first day, lethargy, nausea and loss of appetite 2nd day, headache for about 36 hours
Patient was given DTAP vaccine today after having a DTAP 21 days ago.  Patient didn't have any signs or symptoms per mom after vaccine.  Per doctor no treatment required.
A non-serious spontaneous report of only half dose of H1N1 LAIV was given to son was received from a mother/consumer concerning her 29-month-old son. Neither relevant medical history nor concomitant medications have been reported for this patient. In 2009, the patient received the first dose of H1N1 LAIV. On 23-Dec-2009, the patient received only half dose of (0.1ml) H1N1, Intranasal via nasal route for an unknown indication. This dose was his booster dose of H1N1 LAIV. There was no adverse event associated with medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved on 23-Dec-2009.