chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/20/2023 I came in to get the annual flu vaccination and my right upper arm has been in pain and its hard to hyperextend and stretch my arm. During the administration, It was painful (Intermittently) but as usual I thought it is only just for a little bit and it wont last. but up until now my arm has been really in pain, decreased range of motion, general right shoulder weakness as well as stiffness. I tried taking pain reliever and move my arm more as i thought it is going to be effective and it will relieve the pain but it is still there, specially when waking up in the morning.
Headache (serious), nausea, cough, fatigued, fever of 105 F.  Fever for 3 days which was treated with Advil but persisted at 99 to 101 F.  Acute symptoms of fatigue for 5 days and lack of ability to function normally.  Mental problems i.e. unable to collect thoughts for 3 weeks and cognition problems.
Patient had Moderna for first 2 doses and requested Pfizer for 3rd. He reported ear ringing that started the day after his vaccine.
Menstrual symptoms changed: prior to second dose, symptoms included mild cramps and persistent headaches for 3-4 days. New symptoms included severe, nearly debilitating back pain, NO headaches, and stronger cramps.
Right arm pain, large hard nodule development, swelling, redness along with fever/chills, body aches and cough. Seen and treated by private physician with labs obtained and Antibiotics x 5 day course provided. Presently with overall reduction in symptoms of pain, swelling and size of nodule and resolution of symptoms of fever/chills, body aches and cough.
Spontaneous hives appeared the night of 12/4 that spread across entire body. The hives come and go and move around but are always there and have persisted every day since. I am also experiencing dermatographia. Taking Xyzal helps manage the hives but it does not completely stop the itching.
She was given Dtap and IPV in the left lateral thigh. She now has a hematoma with an area of erythema 5 cm diameter.
Severe joint pain in ALL joints just like it felt when I had interferon injections (many years ago) with a fever of 101* for about 8 hours with the chills. This was my first shot.
She received her vaccine on 12/26/2020.  She did not have any initial symptoms to the vaccine. On 1/3/2020 she noticed a small "bug bite" size redness at her injection site that had mild pruritus.  This morning the area is more the size of a "sand dollar" It is warm to the touch, but she does not have any other symptoms, denies any fever.   Her past medical history includes asthma and anxiety. She is only on Prozac and PNV (she is not currently pregnant). Encouraged to use ICE, NSAIDS, and 2nd generation antihistamine to manage symptoms.
itchy eyes, then itching spread to other areas of body (no rash). face and eyes completely swelled up. Took oral benedryl (OTC) over course of 3 days.
Syncope following vaccination.  Patient reported blurry vision, dizziness.  Had patient rest with feet elevated and gave patient bottle of water.  Observed patient for 30 minutes.  After 30 minutes patient reported feeling back to normal.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Mild
This is a spontaneous report from a contactable consumer (patient). An unspecified age female patient received an unknown dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. In 2021, patient got COVID and was in bed for about 5 days. The test of COVID-19 had done with result was positive on an unspecified date. Female patient approximately age 50. The outcome of bedridden was recovered in 2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate swelling-5 mm to 1 1/2 inch x 3/4 inch hive like swelling, erythema on L thigh proximal (immediate proximity) to DAPTACEL injection site occurred while still injecting. Child pinching the site (?itch). DTAP. VS: T=96 degrees axilla, HR 123, RR 28. Treatment given on 10/9/09 1. epinephrine 1:1000 0.1 cc SC at 9:55 AM. Decreased swelling on site of DAPTACEL injection 5 min after epinephrine. 2. BENADRYL (diphenhydramine hydrochloride) 3 ml PO given at 10 AM, to continue q 6 hours x 3-5 days. 10/9/09 2 PM follow up call-child's L thigh's swelling decreased, not itchy, redness, no pain, walking well as per mom. Follow up visit 10/12/09 at the clinic.
Information has been received from a pharmacist referring to a 54 year old female patient. The patient's medical history included unspecified reaction to penicillin and had rheumatoid arthritis prior to ZOSTAVAX. On 17-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L003218, expired date 30-APR-2015, dose and route were unspecified). There was no concomitant medication. On 24-JUL-2015, the patient experienced multiple rashes all over her body. The pharmacist reported the patient was diagnosed with shingles on 27-JUL-2015. The patient saw a physician to seek medical attention on an unknown date in 2015. No treatment or lab test was conducted for the patient. At the time of reporting, the patient did not recover from the event. Additional information has been requested.
No additional AE information provided; The patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a registered nurse referring to a patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On 03-FEB-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S008730 and expiration date on 23-JAN-2022, for prophylaxis (dose and anatomical location were not reported).  The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to a temperature excursion of above 9 degrees Celsius (°C) during a time frame of 1 hours 30 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.
The pt experienced an onset of wheezing, asthma. The pt also experienced a rash, that was pruritic on the arm at the injection site, lasting greater than one week. Treated with hydrocortisone cream.
Within 5 minutes of administering vaccines pt had vasovagal syncope episode.  Episode lasted a few seconds. Ice applied to back of neck, pt laid flat with knees bent and pillow under knees, apple juice given. Pt stated she felt extremely tired like she just wanted to go to sleep.  We kept pt in clinic x15 minutes after episode for evaluation. Color came back to face and pt was able to walk out of office on her own. Dr. examined patient and cleared her to leave. Follow up call was done in the afternoon to check on patient with report of patient doing better with no concerns at this time.
Patient has ongoing right side arm weakness. Patient can't lift right arm above horizontal to the ground. Patient developed a knot near or on the right trapezius muscle that has waxed and waned since onset of adverse event.
PATIENT RECIEVED 1ML DOSE INSTEAD OF 0.5ML DOSE
COMPLETELY BLIND; HORRIBLE PAIN IN EYES; This spontaneous report received from a consumer via social media  via a company representative concerned a female of unspecified age, race and ethnicity. 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 (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reported stated that, "Johnson & Johnson my cousin went completely blind after the j&j vaccine. Thank God it only lasted 3 days but it scared her half to death! She also had horrible pain in her eyes." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely blind, and the outcome of horrible pain in eyes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20211256346 -covid-19 vaccine ad26.cov2.s -Completely blind. 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).
Extremely swollen lymph nodes by the left clavicle; Very painful to the touch.Even hurt to have clothes laying on them; Hurt to turn neck, pick anything up with left arm.Very sensitive; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration in Arm Left on 12Mar2021 08:30 (age at vaccination:30 years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was NuvaRing, Zyrtec, singular within 2 weeks to post vaccination. Medical history included asthma from an unknown date and unknown if ongoing, food intolerance from an unknown date and unknown if ongoing known allergies: Egg intolerance, covid-19 from an unknown date and unknown if ongoing if covid prior vaccination: Yes. Concomitant medications included ethynylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported; Montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced extremely swollen lymph nodes by the left clavicle on 13Mar2021 20:00, very painful to the touch. Even hurt to have clothes laying on them on 13Mar2021 20:00, hurt to turn neck, pick anything up with left arm. Very sensitive on 13Mar2021 20:00. Patient had Physician office visits for the events. Therapeutic measures were taken as a result of extremely swollen lymph nodes by the left clavicle, very painful to the touch. Even hurt to have clothes laying on them, hurt to turn neck, pick anything up with left arm. Very sensitive was Ketorolac 10 mg every 6 hours. The outcome of the events lymphadenopathy, pain, neck pain was recovering. No follow-up attempts are possible. No further information is expected.
Horrible flu symptoms. Vomiting nausea shaking uncontrollably. Chills.
After taking my fourth dose, I experienced a fever, sore arm, fatigue, and dizziness. In October 2022, I contracted COVID-19. I had severe fatigue, low grade fever, dizziness, nasal congestion, and a terrible taste in my mouth. I was prescribed Paxlovid.
This spontaneous report as received from a female consumer refers to her 18 years old daughter with migraine headaches. Sometime in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot# and batch# unspecified), formulation and route unspecified, (dose and frequency unspecified). Concomitant therapies included with birth control pills with unspecified "low dosage". Sometime in June 2013 the mother of the patient was reported that her 18-year-old daughter experienced vomiting, restless sleep, acute abdominal pain "like a punch in the stomach" and headaches after receiving the first dose of GARDASIL. The reaction has been reported to the patient's physician, although it was reported that the vaccine was administered at an unspecified clinic. Product lot, expiration date, and full physician information, were unavailable at the time of call but will be provided in a follow-up. The adverse symptoms began about 12 hours after administration of the vaccine and subsided within 24 hours. At the time of report, the second and third doses have not yet been administered. At the time of report, the outcome of the vomiting, restless sleep, acute abdominal pain and headaches were recovered. Additional information has been requested.
2nd vaccine is scheduled on 4th may 2021; sinus infection from allergies; coughing up flehm; soreness in arm; severe fatigue; numbness to hand; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified, Emphysema and COPD.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOAESTHESIA (numbness to hand) and PERIPHERAL SWELLING (Swollen arm). On 28-Feb-2021, the patient experienced PRODUCTIVE COUGH (coughing up flehm), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue). On 26-Mar-2021, the patient experienced SINUSITIS (sinus infection from allergies). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021). At the time of the report, SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was scheduled to receive his 2nd vaccine but he had a tick bite so he had to cancel. From the tick bite he had a swelling and irritation on the back of his knee and redness. HCP gave him an antibiotic for the tick bite. His new 2nd vaccine appointment has been scheduled for 04MAY2021.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Day 2 post vaccine ? pac?s, pvc?s, bigeminy intermittent (palpitations, resolved over next 2 days) Day 3-5 post vaccine ? hand arthralgias (resolved over next 4 days) Day 7 post vaccine ? bilateral LE petechaie. None elsewhere and no bleeding (so far no progression, observing)
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 80-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without any adverse event). On 4th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 5th October 2018, 1 days after receiving SHINGRIX, the patient experienced itchy rash and erythematous rash. On 6th October 2018, the patient experienced nausea and headache. On an unknown date, the outcome of the itchy rash, headache and erythematous rash were not recovered/not resolved and the outcome of the nausea was recovering/resolving. It was unknown if the reporter considered the itchy rash, nausea, headache and erythematous rash to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left deltoid. Approximately 24 to 48 hours following the dose of SHINGRIX, the patient experienced the red, itchy rash which appeared below the injection site (from deltoid to elbow) and was unresolved, at the time of reporting. The patient also had a complaint of headache and nausea. Both the headache and nausea began 2 days after the vaccine. The headache had been continuous and was unresolved. The nausea had been intermittent, occurring approximately every other night waking the patient up from sleep. The reporter was uncertain if the nausea had resolved as the symptoms had not been continuous. The reporter did not fully certain of timelines above. Lot number and expiry date was seem to be from the pharmacy stock and not from vaccination record, so they might not reflect the actual dose received.
reconstituted with a sterile diluent and not the supplied liquid; reconstituted with a sterile diluent and not the supplied liquid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18-MAY-2023, the patient received Menveo. On 18-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent and not the supplied liquid) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent and not the supplied liquid). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-May-2023 The reporter was a nursing supervisor. The reporter did not have dose lot number or expiration date and she did not had any patient information. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. A nurse administered a dose of Menveo which was reconstituted with a sterile diluent and not with the supplied liquid CYW-135 conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
The patient experienced syncope while seated after receiving the Pfizer covid vaccine and was unconscious for at least 10-15 seconds. I fanned the patient to cool them off and the partner got them a water to drink. The patient stated that she has experienced this before and that it was nothing I did, that they just got too hot.
Erythema, pain, warmth and fever later on day of vaccination.  CBC, BCX and Keflex 250mg per mouth CID.
Patient called the pharmacy on 9/15/17 around 10 am. She stated she was concerned because she was still having pain, swelling, and heat at the injection site. She told me she had a large red whelp that was swollen from the injection site to her elbow. The area itched, was painful, radiated heat, and was about the size of her hand. I told the patient to take 2 Benadryl 25mg pills and call her primary care doctor. I told her if her symptoms got worse to call 911 or go to the emergency room if able. She agreed and the conversation ended. I called her back at 12:15 pm to check on her. She told me that she had taken the Benadryl after we talked, but could not reach her doctor. I asked if there was any change in her condition. She stated there was some improvement. The area was not as hot and had decreased in size to about the size of her palm. I told her I was glad she was doing better and that I would call her in another few hours. I also left a messsage with the nurse and am waiting for a call back.
temperature of 102-103; This case was reported by a physician via sales rep and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received the first dose of Shingrix (for tolerance please refer to case US2018158673).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient experienced temperature of 102 to 103 degree F, which resolved on its own.      Lab Comments: On an unknown date, the lab test was performed.
This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. A female patient of an unspecified age received PREVNAR 13 at a single dose; and PNEUMOVAX 23 at an unknown dose; both via an unspecified routes of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date after both shots and after visiting a foreign country. The outcome of the event pneumonia was unknown. Information on batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Still a band of pain under my breasts; Pain right arm; Pain upper back; Pain neck; Pain; Dry cough; Felt like throat was closing; 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 PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing). On 28-May-2021 at 4:30 AM, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck). On 27-May-2021, COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing) had resolved. At the time of the report, PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) had not resolved.            Treatment provided include an unknown medication. Concomitant medication list was not provided.
ARM SORE THAT NIGHT THAT INJECTION WAS GIVEN, AND SMALL KNOT FELT UNDERSKIN. THE NEXT DAY, I WAS COMPLETELY UNABLE TO GET UP OUT OF BED DUE TO BODY ACHES. BY MONDAY THE BODY ACHES WERE GONE BUT ARM, SHOULDER AND NECK ON THE LEFT SIDE REMAINED EXTREMELY SORE. IT FELT LIKE MUSCLE PAIN FOR A LITTLE OVER A WEEK AND THEN I STARTED HAVING A LOT OF BURNING GONE DOWN MY ARM AND SPARATIC SHARP PAINS, IT SEEMED TO HURT WORSE AT NIGHT MAKING IT UNBEARABLE TO SLEEP. THURSDAY MORNING 8/4/2022 THE RED CLUSTERED RASH APPEARED, DIAGNOSED BY PROVIDER AND PRESCRIBED VALTREX, GABAPENTIN AND AMITRYPLINE (FOR SLEEP). RASH IS SPREADING DOWN THE ARM TODAY AND ON THE BACK OF SHOULDER. VERY PAINFUL
Migraine, fever, chills, vomiting and body aches for 24 hours