chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in an unspecified number of patients who received FLULAVAL QUADRIVALENT (batch number AT3CC, expiry date 31st May 2016). This case was associated with a product complaint. On an unknown date, the patients received FLULAVAL QUADRIVALENT (intramuscular). On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patients experienced injection site redness, injection site pain, injection site swelling and pharmaceutical product complaint. On an unknown date, the outcome of the injection site redness, injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the injection site redness, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter stated that, the specific batch of FLULAVAL QUADRIVALENT, was causing redness, pain, swelling at injection site and this was experienced by numerous patients and was more severe then in the past year. It was unknown if the product was available for return. The number of patients, doses were unknown.
This was the second Covid vaccine from Pfizer.  First vaccine was given 1/28/21 . EL3244.   No adverse side effects other than slightly sore arm at site of injection.  Second vaccine was given on  2/18/21 within a couple day I noticed tremors in my hands.  When to the doctor on Feb 25, 2021 , I talked to her about tremors.  No treatment at that time.  March 4, 2021 had a video doctor appointment and talked about tremors. She prescribed Propranolol 40mg.  No previous history of tremors.  Tremors are a little better with medicine after a couple days but not gone.  I can't use fork, button my sleeves or work tools at my job.  I did notice tremors in my back when climbing on a ladder at work.  These tremors started within  2 days of second vaccine.
The day after the shot I had a bad headache, horrible body ache and felt flu like, that lasted through 3//23/2021. Those symptoms dissipated over the week gradually. On 3/29/2021, I woke during the night to my arm left arm itching. By morning there was a oval swath about2?x4? on my left arm, it was itchy, tender, red and swollen. By the afternoon of 3/29/2021 I started to feel all over body aches and joint aches in my shoulders, elbows, hips, hands, legs. The rash waxed and waned getting red/itchy and achy. I was scheduled to do a Stelara shot on 3/31/2021, I gave it in my right abdomen. The rash is still on my arm but waxing/waning, I feel very achy and unwell now. I did take a benedryl at bed on 3/30/2021-4/1/2021. I?m scheduled for my second shot on 4/18/21 and will bring an epi pen just in case. I did not go to my doctor but read info on line about Covid arm.
Dose administered after the expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration) in a 75-year-old male patient who received mRNA-1273  (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Quadrivalent flu vaccine on 21-Jan-2022. Past adverse reactions to the above products included No adverse event with Quadrivalent flu vaccine.    On 25-Feb-2022, the patient received second dose of mRNA-1273  (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration) outcome was unknown.        For mRNA-1273  (Unknown), the reporter did not provide any causality assessments.   The patient had no known history of COVID. No concomitant medications were reported. It was reported that vaccine vial had met the 30-day thawed and patient had dose 2 of primary series and no vaccines were given the same day. The patient received the vaccine as part of an outpatient visit. No adverse events were reported. No treatment medications were reported.   This case was linked to MOD-2022-497238, MOD-2022-504333, MOD-2022-504357, MOD-2022-504347 (Patient Link).
Fatigue, headache, and woke up with minor joint pain in fingers, Achilles? tendons area, and low back..   Gas and indigestion with minor stomachache in the morning the day after. Most of the symptoms subsided within 24 hrs.
Vaccine given at 4:25 pm.  At 4:30 pm, pt noted to feel hot, dizzy, and nauseated. Provider evaluated patient. BP 160/90, HR 100, O2 sat 100% on room air. Lungs CTA. Blood sugar was 145. Pt then noted to feel tight in the chest with reported difficulty breathing and feeling hard to swallow. Pt was given epinephrine0.3 mg IM dose #1 and solu medrol 125 mg IM. O2 applied at 2 L via NC. EMS was called to transport pt to ER. Pt continued to feel like it was hard to swallow and difficult to breathe so epinephrine dose #2 was given at 4:35 pm - at this time O2 sat 100%, BP 152/75 and HR 104. Pt then c/o feeling nauseated but no vomiting that resolved prior to giving any medication for nausea. Pt had relief of symptoms after second dose of epi pen.  EMS arrived at 4:50 pm and pt was transported to ER for further eval and tx.
"Chief Complaint:   Patient had a bad reaction to his 4th covid shot. He has neuropathy in his hand and he feels like his nerve ends in his entire body was woke up. The pain and neuropathy lasted 36 hours. He took Ibuprofen and it helped the pain.  Patient was calling as a warning about the reaction he had to the booster  vaccination"
Hives on both upper arms after 1st dose; Arms itching like crazy after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on both upper arms after 1st dose) and PRURITUS (Arms itching like crazy after 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on both upper arms after 1st dose) and PRURITUS (Arms itching like crazy after 1st dose). At the time of the report, URTICARIA (Hives on both upper arms after 1st dose) and PRURITUS (Arms itching like crazy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant and treatment details were provided.
Dysuria- Information has been received from a physician concerning a 31 year old male who was vaccinated with one dose of varicella virus vaccine live (Site unknown).  Subsequently the patient experienced dysuria.  The reporting physican felt that dysuria was not related to varicella virus vaccine live.  medical attention was sought. No further information is available.
Tinnitus.   Never had the issue before.  Doesn't run in family.   Didn't notice so much early so I wasn't concerned, but by January, it was more pronounced.  Since it persists and I've found others attribute it to the vaccine, I decided to enter it into VAERS.
Began with stiffness in back of neck within first hour. Severe muscle aches, loss of appetite, lightheaded. Within 34 hours, felt a lot better.
The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, feelings of nausea, extreme tiredness, and arm pain. Wednesday 25,2021 most symptoms did not reoccur. Except now there is pain on my right side, back of the neck, shooting down the middle of the right shoulder blade. I took Midol for Wednesday's symptoms and went to bed before 8 pm. Woke up feeling better except for shoulder pain. Thursday I felt like I had a stiff neck so I took Ibuprophen and hubby massaged the area. Massage helped for about 30 min. The pain persisted on Friday still tried massage and Ibuprophen still very painful and now hard to be comfortable sitting and sleeping. Saturday morning I tried a warm shower and heat pad throughout the day pain still persisted. No ibuprofen and still massaged area. Sunday morning I soaked in the tub with Epsom salts and pain still continued throughout the day. Monday called dr. and she encouraged me to fill out a report and take vitamin C seems to think lymph nodes are clogged.
Patient notes sob and cough after the vaccine on 3/10. Escorted to ER. Physician notified.
Not too long after vaccine was given, she stated her ear, neck, and side of face felt tingly and numb. She was givne benadryl.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild, Additional Details: pt stated he got dizzy and was nervous. heart was beating a little faster than normal. he did not appear to be unconcious, but I gave him water and stayed near him for about 10 minutes to make sure he was ok. he left after about 30 mins post injection
A few moments after the vaccination was administered to the patient, the patient begin to turn red in the face and then his body was shaking and he said he was experiencing some kind of muscle spasms and finally his heart rate was palpitating. 10 minutes later, all the symptoms went away and patient returned back to normal state
visual hallucinations from high fever.  Patient had fever T-max 103.0 °F after vaccination.  Fever started 6 hours after second vaccine.  History of visual hallucinations with high fever in the past both as a child and an adult (with influenza B).  Visual hallucinations resolve with control of fever with antipyretics.
She received the vaccines and moved to another chair at the pharmacy.  Within five minutes, she began complaining of lower back pain.  She didn't have any pain at the inject site nor any other adverse events.
Patient was pregnant when given the vaccine, 33 weeks along, estimated delivery date of 9/30/2018.
shortly after, but not like 15 minutes or so like the next day, the patient felt like it was cloudy like no altogether there; took a couple of days to go back to it's normal self; feeling like his brain was foggy and even thought that shouldn't drive; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (shortly after, but not like 15 minutes or so like the next day, the patient felt like it was cloudy like no altogether there), MALAISE (took a couple of days to go back to it's normal self) and FEELING ABNORMAL (feeling like his brain was foggy and even thought that shouldn't drive) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (shortly after, but not like 15 minutes or so like the next day, the patient felt like it was cloudy like no altogether there), MALAISE (took a couple of days to go back to it's normal self) and FEELING ABNORMAL (feeling like his brain was foggy and even thought that shouldn't drive). At the time of the report, FEELING ABNORMAL (shortly after, but not like 15 minutes or so like the next day, the patient felt like it was cloudy like no altogether there), MALAISE (took a couple of days to go back to it's normal self) and FEELING ABNORMAL (feeling like his brain was foggy and even thought that shouldn't drive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
pins and needles in whole his lower body; Itchy in whole his lower body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21) for COVID-19 vaccination.     No past medical history was provided.     On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body). At the time of the report, PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant  product was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Followup received was received from the initial reporter and does not contain new information.
My daughter ran a fever of 103.5 for 3 days. She experienced heaving throughout the night, fatigue and weakness and paleness, excessive crying and severe change in behavior. Required constant holding. Even her day care providers noticed a distinct difference in her daily behavior and her need to be held and contant crying.
Client received adult dosage of Pfizer Lot #30155BA instead of pediatric dosage of Pfizer Lot # FK5127 for second dose in series on 01/15/2022.
sore throat, lower back pain, fatigue, 101.8 fever, stuffy nose, joint pain, difficulty breathing
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 20th May 2018 10:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced fever, tremor, headache and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, tremor, headache and chills were recovered/resolved. The reporter considered the fever, tremor, headache and chills to be probably related to SHINGRIX. Additional details were provided as follows: About 12 hours after receiving the vaccine, the patient experienced high fever, chills and shaking that lasted 1 to 2 hours. The patient also experienced headache and took a dose of Ibuprofen. The patient's body temperature was recorded as 99.6 degrees F in morning on the day of reporting.
My right ear felt like I had an infection. Very painful with swelling and redness. I had trouble with being dizzy and very unsteady a good two weeks. I communicated with my doctor about my symptoms. It was not determined to not me an infection. The symptoms could be related to the vaccine or the allergies. My doctor put me on prednisone, Claritin and nasal spray all for treating as anti inflammatory.
Unusual and increasing high fever, chills, weakness as well as body aches despite taking tylenol and heavy drinking. All symptoms similar to malaria.
20MAR92 started w/flu-like sx; by 10PM weakness on lt upper body; neck, arm progressed weakness-went to both arms-hives; pt considered was paralysis; fever; swelling; 11AUG92 pt continues sympotomatic;
Stated the on 12/25/2006 started with some itching of feet that has contiued with the development of hives progressing to the torso. Has been usunf benadry for the itching and increasing dose.
Had syncopal episode while on field trip on 5/24/11 - in museum. Possible episode of tachycardia evening of 5/23 - not well documented.
GBS (severe peripheral neuropathies); pt recvd flu shot 3 wks PTA; pt devel acute onset swelling, rt popliteal fossal-fat necrosis; also devel tingling; not able to support arms wgt, unable to stand, voice is worse, difficulty writing;
Received FluMist vaccine on Monday, 11/29/04 at approximately 1:00 p.m.  No prior allegry to eggs or the regular flu shot vaccine I received in 2003, 2002, and 2001 without any problems.  Started to develop hives over entire body by about 7:00 p.m. on 11/29/04.  Called doctor on Tuesday afternoon (11/30/04) around 3:00 p.m.  Was told to take Benadryl for hives on body and face.  Called Registered Nurse Phone Line on Tuesday evening (11/30/04) around 11:00 p.m. Called my rheumatologist on Tuesday (11/30/04) about 11:30 p.m.  I was prescribed 20 mg of prednisone with Benadryl to be taken at that time.  On Wednesday (12/1/04) the hives had not diminished at all over entire body and face.  Around 5:30 p.m. called the Registered Nurse Phone Line.  Around 6:00 p.m. called doctor, who prescribed another 20 mg prednisone to be taken with Benadryl at that time.  Benadryl had no effect.  Thursday morning (12/2/04) around 1:00 a.m. had low-grade temperature of 99.2, with sweating alternating with chills, and mild intestinal discomfort.  Saw doctor on Thursday morning (12/2/04) in her office at about 11:00 a.m.  Hives and white-edged ring shaped red spots still covered body and face.  She said the activity on my skin was hives and flu virus. Doctor prescribed a decreasing dose of prednisone, starting with 40 mg, along with Allegra 180 once a day, and topical Lidex.  Lidex had no effect. Thursday (12/2/04) hives were suppressed by prednisone and Allegra 180 for about 10 hours.  Friday (12/3/04) hives were suppressed by prednisone and Allegra 180 for about 14 hours.  Hives and red spots have been suppressed by prednisone and Allegra 180 since Saturday (12/4/04).  As of Wednesday (12/8/04), have two more days of .05 mg of prednisone with one Allegra 180 daily.  Scheduled to take Allegra 180 through Sunday (12/13/04).
Initial case was retrieved from the scientific literature on 28 September 2010.  The safety of immunizing with TDAP less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak.  "Serious adverse events: Three SAEs were identified among HCP, all of whom reported Td/IT > or = 2 years prior to current TDAP vaccination; none were pregnant or aged > or = 65 years.  One case of eosinophilic nephritis was confirmed in a 39-year-old patient who had a cadaveric renal transplant 7 years before vaccination.  The patient was noted to have peripheral eosinophilia during a routine evaluation 2 days after vaccination.  The patient experienced compromised renal function which was diagnosed as eosinophilic nephritis by kidney biopsy 4 weeks after vaccination.  The patient recovered after a course of corticosteroids".  This case is linked to 2010-05552 and 2010-05553.  Documents held by sender:  None.
Flu vaccine administered about 0900. 11:45 c/o blurred vision and sudden onset headache. State left work about 2:45. Fell asleep for 4 hours - atypical. Awakened feeling much better. Vision started to get better at time of report to PHN ( still working) at 11:45. Cleared enough to drive home at 2:45.
Tingling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on left arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling on left arm). At the time of the report, PARAESTHESIA (Tingling on left arm) outcome was unknown.            The patient stated that he didn't had any major side effects and had tingling on their left arm. Reportedly, they were otherwise perfectly fine.  No Concomitant product use was reported. No treatment information was provided.
Neck soreness; arm soreness; Extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 5318), via an unspecified route of administration, administered in Arm Left on 25Feb2021, at 06:45 (at the age of 61-years-old), as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient had not been tested positive for covid and not tested post vaccination for covid. Patient did not have any known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 5318), via an unspecified route of administration, administered in arm left on 04Feb2021, at 06: 30 (at the age of 61-years-old), as dose 1, single for covid-19 immunization. On 25Feb2021, at 06:45, the patient experienced neck soreness, arm soreness and extreme fatigue. The patient did not receive any treatment medication for adverse event. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected
Patient experienced dizziness and lower blood pressure than normal about 25 minutes after receiving her first dose.
Partial complex sz, focal motor in onset lasting 1 min; Upward eyeball rolling, head deviation to lt, rue/rle in extension, lue in flexion, lip smacking; Responded to 1 dose of IV Lorazepam; Had 5-6 episodes at home of above sx.
She reported a 6 inch red, itchy streak down her injection arm. She was going to the ER to have it examined. At the ER, it was determined that she had a reaction to a component of the vaccine and received a prescription for cephelaxin.
pt recvd vax & devel a mild fever & rash; No further details were provided;
3x5 cm area erythema (L) posterior arm. Firmness at the site et heat/warm. Applied heat to site x 15min et provided TYLENOL extra strength (1000mg).
4-5cm area red, hot tender lt arm @ site of DTAP started about 58hr p/vax;lasted 1 1/2 days used hot soaks to area on arm & APAP;
Patient reports feeling like her throat" has a lump in it or mucusy" about 10 minutes after the vaccine. Patient denies any other symptoms. Patient able to swallow, and no shortness of breath. Vital sign checked : BP 134/98, HR 102, oxygen sat 99. Patient declined Benadryl due to concerns of being drowsiness and having recent bariatric surgery. Patient continuously monitor by nurse. Patient called providers office, triage nurse reports to go ED. Vital signs check BP 132/98, HR 82 Oxygen sat 99. Patient doesn't want for staff to call 911, but reports co worker will drive her to ED.  -Called later in the evening, patient is still in ED for observation, patient was given  Benadryl and another medications.
When asked if Pt was there for a booster, not a vaccine, the mother of Pt insisted Pt was there for her Moderna vaccine.  She was then administered her third dose of the Moderna primary series. The mother of Pt made a mistake because Pt needed a booster, not a vaccine.
Information has been received from a female physician via a company rep concerning the physician, about 35 yrs old, with asthma and unk drug reactions/allergies, who on 13Feb06 was vaccinated IM into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant therapy included montelukast sodium (Singulair). The physician reported that on 13Feb06 she experienced pain at the injection site, and developed swelling at the injection site and could not move her arm for 1 full day. Unspecified medical attention was sought. Subsequently, on an unk date she recovered. No product quality complaint was involved. Additional information has been requested.