chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is sore at the injection site; Had thoughts of killing myself; Had a psychotic episode; A spontaneous report was received from a consumer concerning a 29-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced psychotic episode and arm is sore at the injection site.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 013M20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient experienced a psychotic episode after the vaccination in which she had thoughts of killing herself and other people. Treatment information was not provided. She reported that it happened once before in March 2020 when her epilepsy medication was not at the correct dose.  On 04 Feb 2021, the patient reported that her arm was sore at the injection site.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events psychotic episode and arm is sore at the injection site was unknown.; Reporter'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.
9:45 AM c/o itching (L) arm at site. BP 120/80. Administered 50 mg BENADRYL IM (L) arm.
4 hrs p/flu immun pt devel itching around eyes exp trouble taking a good breath, had brief tingling in legs; felt jittery & nervous 24 hrs p/sx; pt had a cough;
Pfizer Covid-19 vaccine EUA - pt received second dose of pfizer vaccine today, 5/13/21 after receiving first dose on 4/22/21.  Pt indicated at both instances that she was receiving her first and second doses of the pfizer vaccine.   However, in our state vaccine registry, pt shows also receiving the moderna covid-19 vaccine on an earlier date,  at a different facility.  We have confirmed with the other facility that pt did receive the vaccine.  We have also contacted the pt to make them aware and follow up.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 29-MAR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Body aches; joint pain; tiredness; injection site soreness; feeling unwell; swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 26Mar2021 at 15:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis) and blood pressure high. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 05Mar2021 at 10:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 15:00, the patient experienced body aches, joint pain, tiredness, injection site soreness, feeling unwell swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events The clinical outcomes of the events body aches, joint pain, tiredness, injection site soreness, feeling unwell swollen lymph nodes were unknown.   No follow-up attempts are possible. No further information is expected.
Feeling very bad 2 days after 2nd booster; Terrible bloating after 2nd booster; Stomach pain after 2nd booster; Short Breath after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 045C21A, 010A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster). The patient was treated with DICYCLOMINE [DICYCLOVERINE] at a dose of 20 milligram and SIMETHICONE at a dose of 125 milligram. At the time of the report, FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 74 (Inconclusive) 74 BPM. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. The HCP called her and notified her that they gave too much (same as initial shot) for the 2nd booster. Patient went to her doctor on 07APR2022 The doctor thinks it might be stomach flu.. The patient states that the treatment medications did not help.
Vertigo on several occasions including today starting a week after first dose Increased hot flashes incidents ( never had hotflashes any more) Severe tiredness first 14 days, now that is less promindnt
No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent. There was no information about the patient's concurrent conditions, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot # U031360 was confirmed to be valid, with expiration date 07-OCT-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).; Sender's Comments:  US-009507513-2209USA002722:02242097 US-009507513-2209USA002779:02242131 US-009507513-2209USA003021:02242077 US-009507513-2209USA002510:02242136 US-009507513-2209USA002557:02242137 US-009507513-2209USA002540:02242138 US-009507513-2209USA002566:02242139 US-009507513-2209USA002746:02242132 US-009507513-2209USA002481:02242135 US-009507513-2209USA002745:02242092 US-009507513-2209USA002570:02242096 US-009507513-2209USA002574:02242099 US-009507513-2209USA002469:02242101 US-009507513-2209USA002559:02242113 US-009507513-2209USA002573:02242103 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109
after the Astra Zenica Covid-19  vaccine, I had a fever, body malaise, and the following day I experienced rashes and hives on my lower and upper extremities and bulging lips until now, April 22, 2021.
severe body aches; chills; headache/headache returned, intensified at my temples and behind each ear, feeling like my head was in a vise; Arthritis; Six days after the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 09:45 (Lot number: FF2590) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "arthritis" (ongoing); "sulfa allergy" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "allergies"; Naproxen, reaction(s): "allergies".   Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer , Prev dose brand unknown=False, Prev dose lot number=EI9265, Prev dose lot unknown=False, Prev dose administration date=01Feb2021, Prev dose administration time=10:30 AM , Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 01Feb2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer , Prev dose brand unknown=False, Prev dose lot number=EN6201, Prev dose lot unknown=False, Prev dose administration date=22Feb2021, Prev dose administration time=10:30 AM , Prev dose dose number=2, Prev dose vaccine location=Left Arm), administration date: 22Feb2021, when the patient was 75 years old, for COVID-19 Immunization, reaction(s): "headache", "severe body aches", "chills".  The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 09:45, outcome "unknown", described as "Six days after the booster"; PAIN (non-serious) with onset 08Oct2021 11:00, outcome "not recovered", described as "severe body aches"; CHILLS (non-serious) with onset 08Oct2021 11:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 08Oct2021 11:00, outcome "not recovered", described as "headache/headache returned, intensified at my temples and behind each ear, feeling like my head was in a vise"; ARTHRITIS (non-serious) with onset 08Oct2021 11:00, outcome "not recovered", described as "Arthritis". The events "severe body aches", "chills", "headache/headache returned, intensified at my temples and behind each ear, feeling like my head was in a vise" and "arthritis" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, chills, headache, arthritis.  Additional information: During the next eleven days she took Tylenol Arthritis extra strength only achieving 2-3 hrs relief. On 25Oct2021 (Monday), her primary care physician (PCP) ordered a prescription for headache. The patient did not receive other vaccine in four weeks. The patient did not have covid prior to vaccination nor was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
06/02/2021 Vaccination 06/04/2021 I started to experience mild symptoms but it progressed as the day went on. L arm pain at injection site. It felt like being stung by a bee. It has gone down my arm now. I did put heat on it and ice. I swapped between ibuprofen and Tylenol but it didn't help.  I take Ibuprofen every day. I could not life my arm.  05/2022 I stopped working. Symptoms are persisting and I don't have medical coverage to see a doctor.
fever, resp distress, sz, diff breathing;T102,7, rapid heart rate;some resp difficulty w/eyes rolled back in head;R26;pupils were no reactive & was having gross tonic clonic sz;resp rapid w/great effort;sz poss d/t fever;allerg rxn
Red Rash on Left Arm about 3" -4" around injection site. Treated with Cortisone
mom reported 11MAY98 that pt had 104.4 temp 1wk p/vax w/rash;pt had sz according to mom;eyes rolled back, tremulous, lethargic p/event;mom reports that fever lasted 1wk;
After 15 min from  receiving vaccine I started feeling tightness in my throat, chest and my mouth ,  the nurse were walking around so I told  the  nurse I could not breath and the nurse told the  doctor  and the  doctor looked into my mouth and saw my mouth and throat  were swelling. I was taken into a clinic room and given  a epi shot and another one less then ten mins.  both  given to  left thigh .  Along with oxygen. Ambulance came and given Benadryl and started and IV.   they took me  to the hospital.  once I was at the hospital I was given  a shot of  prednisone and  had  a fast HR, was released  3 hours later (1/7/21)  Was given RX by the ER doctor.  Still have a sore throat, my tonsils are really really bright red , my tongue is still  a little swollen with red dots and a tingle feeling.
pt received both fluarix and pnemovax 23 (merck and co inc lot s012246, exp 02/10/21) in left arm and had severe reaction (arm swelling and redness)--enough to go to ER and be prescribed Doxycycline
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles or zoster-related injuries as intended and the patient subsequently developed zoster-related vision loss and other complications. On an unspecified date, the patient was treated at a hospital for vision loss. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The outcome of the events was unknown. Causality assessment was related. Upon internal review, zoster-related vision loss was considered to be medically significant. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX injection, lot# M023384, expiration date: 11-MAY-2018 (dose and route of administration were not reported). The temperature excursion was ranged between 5 and 14 degrees Fahrenheit for 1 hour. No adverse effects were reported. There was no previous temperature excursion, digital data logger was used and product quality complaint was not involved. Additional information has been requested.
Fever, Aches, Irritability, No appetite nor the want to drink ANY fluids. Tonic Clonic (Grand Mal) Seizures with the first event at 4:21AM on Friday, July 26th along with another confirmed Tonic Clonic (Grand Mal) at 10:42 PM on Friday, July 26th  Was then admitted at Hospital.  Patient continued to show extreme signs of sickness.  Dehydration, Fatigue, inability to hold head up, inability to walk, crawl or sit up on own.  Was incapable of keeping eyes focused on anything nor hold them open for any length of time.  As of 8/7/19 now has rash and hives all over her body that is potentially related to Vaccinations.   EEG performed - Inconclusive/Normal MRI performed - Normal
Pt developed a local erythematous, urticarial rash 5 days post vax which persisted for another 5 days. He was treated with antihistamines.
Pfizer ] use for COVID-19 under Emergency Use Authorization (EUA):[Product name] use for COVID-19 under Emergency Use Auth COVID vaccination Pfizer. Patient came to our unit "passing out" repeatedly 2 hours after receiving vacc. Presented as a nurse alert, unresponsive, with seizure like activity, eyes deviating up and to the left. Pt had no seizure history. Healthy with only history of migraines. Patient was terrified and crying each time she re-awoke and she complained of severe headache pain 10/10, begin staff "no more shots". Patient had immediate IV placed, labs drawn, placed on cardiac monitor. Pt had 3 more syncopal/seizure like activity lasting approximately 1-1 1/2 minutes each time. Patient was sent by 911 to local hospital ER for head CT.
SMALL FIBER NEUROPATHY (DX)-- GABAPENTIN (TX) -- NUMBESS, TINGLING, BURNING FEET/TOES, ANKLE SWELLING (SYMPTOMS)
Legs and arms: rapid onset over 5 days numbness, tingling, weakness and heaviness. Dx: Neuropathy.
Information has been received from a medical assistant referring to a patient of unknown age and unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (0.5 ml, lot # M005286, expiration date 08-OCT-2017) intramuscularly. The vaccine had been stored under the temperature of 47 Fahrenheit degree for 10 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient received flu shot on 11/29/07. On 11/1/07 had headache. On 11/2/07 neck became red with hives. Call b Er Physician who told her to take benadryl 25mg q-4-6 hr. prn. Took it for 2 days. Hives resolved. Patient feet back to normal.
Redness and swelling of thigh started within hours of immunization and infant was inconsolable for several hours that evening.  She was subdued, slightly withdrawn and had decreased appetite for three weeks after vaccination.  Similar symptoms occurred following next set of immunizations at 4 months of age (12/8/15) and behavioral changes again lasted about three weeks before resolving.
No adverse events obs or reported. Patient received # 2 dose BEXSERO was given on 07-14-16. #1 dose given 06-27-16.
Mom noticed that he had redness and swelling around the site of his Pneumovax that night and the next morning he refused to walk on that leg.
lethargy; hand blisters/ oval spots on left hand; arm  soreness; headache; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced shingles. On 16th May 2019, the patient experienced injection site pain and headache. On 19th May 2019, the patient experienced blister. On 22nd May 2019, the patient experienced lethargy. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and blister were recovering/resolving and the outcome of the injection site pain was recovered/resolved and the outcome of the lethargy and headache were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, injection site pain, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. On 16th May 2019, the patient received 1st dose of Shingrix in the left arm, via an unspecified route, from an unspecified batch number and reported soreness in the left arm , which resolved. The patient also reported headaches on the same day and it comes and goes. On 19th May 2019, 3 days after receiving a dose of Shingrix, the patient reported oval shaped spots on the left hand between the index finger and middle finger and went to see a doctor and on 22nd May 2019, was diagnosed with shingles and started on acyclovir 800 mg, 35 pills, 5 pills per day. At the time of this report, the shingles were currently healing and in the bloody and scabby stage. On 22nd May 2019, 6 days after receiving a dose of Shingrix, the patient also reported lethargy which was ongoing. The reporter gave consent to follow up and to contact the pharmacy and provided contact details for the same.