chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UPPER BACK PAIN (BETWEEN  SHOULDER BLADES) RADIATING TO  THE CHEST CALLED MS HUG; SWEATS; ALLOVER WEAKNESS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. 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 11-APR-2021 in left arm  for prophylactic vaccination. Concomitant medications included diazepam for multiple sclerosis. On 11-APR-2021, the subject experienced upper back pain (between shoulder blades) radiating to the chest called ms hug. On 11-APR-2021, the subject experienced sweats. On 11-APR-2021, the subject experienced allover weakness. On 11-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper back pain (between shoulder blades) radiating to the chest called ms hug, sweats, allover weakness, and soreness at injection site. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
By 8 hours post vax facial tingling. By 9 hours, some numbness to the nose and chin. Some pain or tightness to the lower jaw.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ANGIOEDEMA, INIT  8/20/2022 & 9/21/2022 -- RECURRENCE OF SAME SYMPTOMS
pt recvd vax & devel localized swelling at inject site, a pruritic rash over torso, & GI symptoms including n & d;
Soreness around vaccination site. Loss of vision in upper right eye. Mild headache. Loss of energy.
Itching, rash. rapid heartbeat, nausea, light headedness, elevated blood pressure.  Received treatment at Urgent care ...EKG, steroid injection.  RX Hydroxyzine, Prednisone, Ondansetron.  Initial reaction appeared 10 days after vaccine.  Currently experiencing  intermittent out breaks of itching, numbness in lips and lower jaw and rash.  When the itching begins its simultaneously in the same area right and left side.  Example right thigh, left thigh etc.
Received vaccine at 1pm, was observed for 15 minutes and returned to work. 345pm wheezing while working, took Albuterol, 2puffs, prior to returned to Clinic. 1610 arrived at Clinic with audible wheezing. Team was called and was taken to the ER.
This spontaneous report as received from a registered nurse refers to a currently 5 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-201, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Left arm became swollen, red,painful, itching from shoulder to elbow. There was no definition from shoulder to elbow d/t swelling.
This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 51-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles (several times) and systemic lupus erythematosus. Concomitant products included SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site warmth, blotchy, pain in arm, erythema of extremities and injection site muscle pain. The patient was treated with (NOS) Steroids and Antibiotics (Brand Names Not Known). On 11th July 2018, the outcome of the extensive swelling of vaccinated limb was recovered/resolved. In July 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the cellulitis, blotchy, pain in arm, erythema of extremities and injection site muscle pain were unknown. It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site warmth, blotchy, pain in arm, erythema of extremities and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 7th May 2018 and did not have any adverse reactions with the 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX vaccine in right arm.  She reported that she told the pharmacist administering the vaccine that she had a massage prior to arriving at the pharmacy so her arm was oily. The pharmacist told her that was not a problem and applied hand sanitizer to the injection site prior to administering the vaccine. She did not wipe off the hand sanitizer prior to injecting the SHINGRIX. She reported that her arm was a little sore and red Saturday morning. However, by late Saturday, her arm was swollen from her right shoulder down to her elbow. She described an intense red area at the injection site and it was very hot. The injection site was not painful but the arm hurt due to the swelling. By Monday, 9th July 2018, her entire right arm was swollen, the red circle had moved down her arm, and her right hand was red and blotchy. She went to see her physician and was given a steroid injection, oral steroids, and an antibiotic because she was diagnosed as probably having cellulitis. By Wednesday, 11th July 2018, her arm was back to its normal size. She said the muscle where the injection was administered had deep pain but it did not hurt when you roll over on it or touch it. She could still see the red area but it was very light and the injection site was not as hot. The patient was concerned that this reaction was due to the pharmacist using the hand sanitizer on her arm and not wiping it off. The pharmacy manager told her that she had never seen a reaction to the vaccine like this before. The patient did not know the name of the pharmacist that administered the vaccine but reported she was new to the pharmacy.
Had redness blanchable with hives about 1 inch area near vaccine - reaction seen 5 min after administered then resolved by 8 min after administered
Woke up with a headache, a 101.3 fever, muscles feel like Charlie Horses, all my joints are painfully stiff, my head is ?muddled,? and I have painful white dots that are sensitive to touch all over my back.
Patient admitted 9-23-22 to medical center with complaints of generalized muscle cramps and hypocalcemia.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Mom reports that pt. taken to daycare after office visit. Parents contacted to pick her up from daycare about 1520 due to temp. 102 degrees. Father was on his way to pick her up when notified pt. having seizure at 1540. Daycare workers told Father seizure lasted less than 5 minutes and was back to normal within 15 minutes. Fever free by evening. "Doing great today," according to mom 1-11-17
Dose 1 - Very swollen, red, and hot at the injection site Dose 2 - Fatigue, achy, low grade fever - the day after vaccine
Per patient the nurse was talking when she gave vaccine and patient felt like she hit the bone, felt like she gave it higher up than usual. Denies any redness or fevers. Feels like a bruise, hurts to move shoulder. She has limited range of motion of left shoulder.
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. Concomitant medications included ALLEGRA-D and ethinyl estradiol, LOESTRIN. On an unknown date the patient experienced nausea, headache, hives, severe "shaking" of legs, sensation of legs "burning", fast heart rate, diarrhea, swollen gland in neck and sore throat. No treatment information was reported. The outcome of sore throat, headache, hives, sever "shaking" of legs, sensation of legs "burning", fast heart rate, diarrhea and swollen gland in neck is unknown. The relatedness for nausea, headache, hives, severe "shaking"of legs, sensation of legs "burning", fast heart rate, diarrhea, swollen gland in neck and sore throat is unknown for GARDASIL. She took ADVIL and is going to see her general care physician tonight. No further AE information provided. Additional information has been requested.
Pt reported pain and tingling near injection site and around arm and into breast area. Unable to wear bra/clothing comfortably. No visible rash, but pt. reports skin feels "rough." Started on 1/24/14.
This spontaneous report was received from a health professional refers to a 55 year old male patient. On an unknown date the patient was vaccinated with GARDASIL with unspecified doses (dosing regimen unspecified). No concomitant medications were reported. The reporter reports that the 55 year old male patient received unspecified doses of GARDASIL on unspecified dates. No adverse effects reported. No product quality complaint involved. No further information was provided. Additional information has been requested.
I had an allergic reaction to my renflexis infusion on 12/30/2020 for the first time ever after receiving my first COVID vaccine on 12/16/2020. Flushing, chest pressure, tachycardia in the 130?s, tachypneic, dizzy, tingling. I received my second Pfizer vaccine on 1/4 /2021, and had my next renflexis infusion on 2/10/2021, to which I had another allergic reaction despite premeds (hives, urticaria). I?ve been receiving this infusion for well over a year without any issues, and only started reacting since I got the Pfizer vaccine.
TYPE 2 MI ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
12/29/2020 07:00AM Mild body aches,  low grade fever 100.0; 12/29/2020 PM same day-- fever 102.6, severe body aches and fatigue and headache, Tylenol and ibuprofen-- some relief to fever. 12/30/2020 mild headache,  left armpit swollen, tender knot -- all other symptoms have resolved.
Pt stated she was given flu vaccination on 11/1/18 around 1730. Pt stated she started itching around 4am the next morning, noticed a rash around her neck and shoulder areas. Pt stated she went to work and felt nauseous. Pt stated she stayed at work. After she came home from work she took an OTC  Benadryl 25mg, pt stated she felt better. The next morning on day 3, she started breaking out in a rash all over arms. Pt stated she took another Benadryl, after 30 minutes she started feeling better, rash was going away. Pt stated she took another Benadryl that night before going to bed. Pt stated she woke up Sunday, felt fine, went to church. Pt stated she came home and rash reappeared, felt like she was burning. Pt started taking 2 Benadryls (25mg each) at one time on Sunday afternoon at 4pm. Pt made appt to see MD on Monday morning.
aches; Fever; Chills; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EN5318) at the age of 65 years for covid-19 immunisation. The patient's family history included: "multiple myeloma" (ongoing), notes: her daughter has multiple myeloma; "stem cell transplant" (unspecified if ongoing), notes: daughter had a stem cell transplant; "neutropenic" (ongoing), notes: daughter was neutropenic from all the chemotherapy. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose injected in left arm, LOT: EJ1686), administration date: 13Jan2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Feb2021, outcome "unknown"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Fever"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021); PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "aches". Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient had booster on 30Sep2021 and experienced nausea the back of her thighs felt achy and kind of weak, was almost like she had been working out and had lactic acid buildup which lasted a few days then went away, fever was about 100.8 or 101.5 degrees Fahrenheit, it was not horribly high, she was sick, had headache, got nausea, aches, chills.
pt recv vax 1AUG95 & 29FEB96 pt was found to have not seroconverted;no further details were provided;
On February 10, 2021 I began to have a constant cough that was not improved with any cough syrup, I had to visit an emergency room since the cough was very strong and it was not removed I was tested for COVID, influenza and mycoplasma and they came out negative I did not present other symptoms only a very strong and severe cough I was 4 times in emergency rooms to seek treatment for cough.
PATIENT STATED SHE HAD IMMEDIATE BACK PAIN FOLLOWED BY ACHES AND PAINS ALL OVER HER BODY. SHE ALSO HAD NAUSEA AND DIARRHEA. PATIENT REPORTED SHE WENT TO THE ER AT 5PM SAME DAY DUE TO HER REACTION.
Increased resting heart rate for 48+ hours (from 55 bpm to 115  bpm) Heart went into a-fib
most likely a documentation error - no adverse reactions at the time the patient came into the clinic to receive a covid vaccine. Patient had no symptoms of any allergic reactions as assessed by the nurse who attended the patient at the time of vaccination.
As an elementary school teacher, I don't hesitate to get the flu shot every year.  However, this year I am experiencing something quite different.  I have been experiencing muscle pain in my left arm since I had the shot 2 weeks ago.  I woke the next morning with severe back and shoulder pain radiating from my left arm for over 2 weeks.  My muscles and joints ache all the time and grow worse with long periods of standing.  The pain keeps me from performing daily activities and sleeping.  It awakens me in the night.   I have been taking Advil several times daily to function and have seen my chiropractor with little relief.
ALLERGIC REACTION, INIT 1/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awoke with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pain. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way.
possible exposure to COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She reported that she was scheduled today at 2 pm for her second dose, however she asked if she should get second dose today after a possible exposure to COVID-19. She stated that her brother tested positive for COVID-19 and both wore their masks when she drove him to the Doctor. Outcome of the event was unknown.   No follow-up attempts possible. No furthermore information expected.
Approx 30 minutes after vaccination --Sensation dryness, need to clear throat, tickly feeling later felt short of breath. Evaluated in Emergency Dept-Epinephrine, Benadryl, Dexamethasone.  Discharged home to use Benadryl as needed.
Woke up 4/11 with pounding headache, nauseous, with fever at 530am. Headache subsided by 2pm. Felt like I had clogged ears. On 4/12 my arm felt like a wasp sting and I was nauseous and some foods smelled terrible. Injection site was hot to touch and ears were still very full. 4/13 nauseous all day and arm still hurt. 4/14 everything was better but waves of nauseous and arm a little less sore. 4/15( today) still nauseous here and there.
Patient left clinic approximately 15 minutes after receiving the vaccine without having any reactions. About 1200pm we received a phone call from patient reporting that approximately an hour after receiving the vaccine (10am) she started to experience tingling around her mouth, roaring in her ears, swelling in her lips and nasal passages. Patients reports that she had a bottle of Benadryl with her took 2 "big swigs" of the Benadryl. Patient reports swelling went away an hour after taking the Benadryl. Patient called to make us aware of the issue. Patient was not seen in clinic as a follow up, but was directed to notify her PCP. Patient verbalizes understanding.
5cm erythematous, pruritic wheal anterior upper arm (anterior and distal to injection site). Appeared 48hrs post-injection. Some symptomatic relief with topical steroid and oral antihistamine (no effect on rubor/calor).
9/ 7 weakness, dizziness, headaches, fever 100.9, chills, nauseous                                                                                                                                                                                                                                    9/8  weakness, dizziness, headaches, fever in the morning 100.3, nauseous, diarrhea
joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint aches) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, 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 experienced ARTHRALGIA (joint aches). At the time of the report, ARTHRALGIA (joint aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications or treatment details were reported.   Reporter did not allow further contact
Blood pressure low 88/49; heart rate over 100 beats per minute; fever 103 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Blood pressure low 88/49), HEART RATE INCREASED (heart rate over 100 beats per minute) and PYREXIA (fever 103 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hypertension, GERD and Pain. Concomitant products included VALSARTAN for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for Hyperlipidemia, MELOXICAM for Pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low 88/49), HEART RATE INCREASED (heart rate over 100 beats per minute) and PYREXIA (fever 103 F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, HYPOTENSION (Blood pressure low 88/49), HEART RATE INCREASED (heart rate over 100 beats per minute) and PYREXIA (fever 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: abnormal (Low) BP: 88/49. On 02-Apr-2021, Body temperature: abnormal (High) 103F.         This case was linked to MOD-2021-114539 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: follow up received on 4-jul-2021 no new information was received
Had a fuzzy head; Big red mark with white patch in middle at injection site; Rash on forehead off and on,Rash on neck off and on; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Had a fuzzy head), RASH (Rash on forehead off and on,Rash on neck off and on), VACCINATION SITE REACTION (Big red mark with white patch in middle at injection site) and VACCINATION SITE PAIN (Sore arm at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Had a fuzzy head). In February 2021, the patient experienced RASH (Rash on forehead off and on,Rash on neck off and on), VACCINATION SITE REACTION (Big red mark with white patch in middle at injection site) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, FEELING ABNORMAL (Had a fuzzy head), RASH (Rash on forehead off and on,Rash on neck off and on), VACCINATION SITE REACTION (Big red mark with white patch in middle at injection site) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About 5 minutes after receiving MMRV vaccine, child developed a hive lesion proximal to the injection site on (R) upper arm (lesion measured 10mm and was about 15mm from injec. site) - no other sx. Pt sent home to take BENADRYL and parents to monitor.