chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; body aches; arm pain; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body aches), PAIN IN EXTREMITY (arm pain) and PERIPHERAL SWELLING (swelling in arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 HEADACHE (headache) and MYALGIA (body aches). In February 2021, the patient experienced PAIN IN EXTREMITY (arm pain) and PERIPHERAL SWELLING (swelling in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, HEADACHE (headache) and MYALGIA (body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) and PERIPHERAL SWELLING (swelling in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Pt. was given Menactra vaccine, when she went to leave the room she fainted (which is not uncommon with teenagers, she had not eaten anything and it was about 10:30)  We laid her down and gave her some crackers and drink.  Her color did not come back and she did not feel well.  Dr. checked her blood pressure and it was 80/40.  It was 110/70 before the vaccine was given.  We monitored the patient for about two hours at the office her BP finally got back to 110/60 at 12:45 and she felt some better, her color had come back. We let her go home.  Our concern was not that she fainted but that her BP dropped so low and it took us a while to get her back to an acceptable reading.
Patient complained that around 130-145 she started having numbness and tingling in her arms, light headedness, sweats,SOB and felt like she was going to pass out.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 11-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Ok so well on May 15 I had a confirmed pregnancy test however on May 27, 2021 I had sharp pains in my stomach. I passed blood clots. I went to the ER and they confirmed there was no fetus, and they did testing. It came back that I had passed the embryo. They performed some blood work, which included a test for antibodies and that came back elevated so therefore I was told to have Hashimoto's Disease. Prior to the vaccine I was not diagnosed, so this is the information that I have. The time of miscarriage, I would have been 5 weeks pregnant so it was considered an early pregnancy loss. So I have had one pregnancy three years ago and since then, I have been trying to get pregnant and through IVF. My estimated date of delivery would have been January 27, 2022.
patient came in with painful arm and redness from  mid upper arm to elbow. Area was swollen near elbow and warm to touch. No complaints fever or chills
Reviewed Covid questionnaire with employee pre injection - Employee had  requested to be put on waiting list for Johnson and Johnson, when became available reported to POD for J and J .  It  was noted  on 5/7/21 that he  received first Covid vaccine of Moderna on 1/3/2021 , unable to come back for second dose at 28 day interval,  employee stated "that Moderna  unavailable at site was on back order" .  Interview with employee on 5/10/2021, stating no adverse effects to the J and J covid vaccines
Shoulder muscle is sore; Soreness is restricting his movement; Soreness keeps him up at night; it hurts / soreness has worsened; This case was reported by a consumer and described the occurrence of muscle pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMONIA VACCINE.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, several days after receiving Shingrix, the patient experienced muscle pain, mobility decreased, nocturnal awakening and pain. On an unknown date, the outcome of the muscle pain, mobility decreased, nocturnal awakening and pain were not recovered/not resolved.   The reporter considered the muscle pain, mobility decreased, nocturnal awakening and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 1st dose of Shingrix in his right arm and a Pneumonia shot and within a couple of days he had a problem with his shoulder, he claimed that his shoulder muscle was sore, and the soreness was restricting his movement.  The patient reported that the soreness keeps him up at night and it hurts, and he felt that the soreness had worsened. The patient stated that the pharmacist was careful while injecting the pneumonia shot in his left arm, but he was not careful when injecting the Shingrix in his right arm. The patient related his symptoms to the Shingrix vaccine. The reporter consented to follow-up.
Symptoms started at 3pm 1/5/2021 were: Chills Muscle anf joint aches Low grade Fever Runny nose Severe headache Reaction were: Swelling of face arm Tightening and Heavy chest deep breathing Tightening of throat when upright
1015PM awoke w/a high pitched scream, red cluster of bumpy splotches on cheeks & a red spot @ inj site; no temp noted by parent, head not hot-so temp not taken; cried approx 1 hr; APAP given; TC to MD no hospital; rash reappeared;
received a dose of Havrix on 19 Aug 2022 that had expired on 9 Aug 2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-Aug-2022 Reporter's comment: The nurse reported that the patient received a dose of Havrix on 19th August 2022 that had expired on 09th August 2022. The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
vaccine was stored in the freezer instead of the fridge and given to the patient, no adverse reactions  have been reported after administration.
On 02/08/05 at 10:30 a.m., patient received Rabavert and Td. Nausea and vomiting began at 5 p.m. that day lasting 2 hours. By 9 p.m., her face was flushed "red". She reports feeling dizzy and throat tightness. She took 2 Benadryl pills around 10:30 p.m., after feeling "like throat was swelling". 30 minutes to an hour after 2 25mg benadryl she felt better and symptoms subsided, per phone conversation on 02/09/05.
This spontaneous report was received from registered nurse and refers to a 14 year old male patient. The patient's concurrent conditions and medical history were not reported. On 15-MAY-2014 (also reported as "4 years ago"), the patient was vaccinated with a first dose of GARDASIL (dose, route, frequency, lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient wished to receive GARDASIL 9 at the reporting time (reported as "now"). The patient had not received the second vaccinations yet. No adverse symptoms were reported.
2hrs p/vax pt exp dizziness, tingling lips, weakness in upper body & nausea.
Pt experienced Mild SOB and instant fatigue 5 min after receiving the dose. Pt c/o tingling/numbness in her lips.  Pt was given 50 mg diphenhydramine 50mg PO.
"Lightheaded, increased HA, elevated BP, fever 101.3. Diabetes mellitus. Pt reported they were going to ER. Current BS - 193.
Tired,body felt as though it weighed 500#,vertigo,muscle pain on off,restless legs, visual disturbances
Shaking chills for thirty minutes followed by a fever of 102 degrees till about 3:30 AM. I took 2 ibuprofen tablets at 10:00 PM.
Could be a potential adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Could be a potential adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Could be a potential adverse event). At the time of the report, VACCINATION COMPLICATION (Could be a potential adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
I was diagnosed on 09/17/2022 with COVID-19 after completing an at home COVID-19 Test. I was quarantined at home for 5 days. I did not feel quite right and when I woke up Saturday morning, that's when I realized I was sick. My fever was 101.3 initially and about an hour later it was up to 103.0. He took me to a doctor after getting the positive result. That did the COVID-19 PCR Test and advised me to get the Monoclonal Infusion Therapy, but I did not take the treatment. I had a terrible sore throat where it was difficult to swallow. I had some difficulty breathing but nothing that was alarming. It just felt like this heaviness so trying to move around was not easy. I lost my taste and smell and ran a fever for about 3 days. I contacted my primary care provider who recommended I take Robitussin DM and take Tylenol.  I had a terrible headache. The sore throat eased up but I am still able to feel discomfort. I am still recovering from some symptoms.
Found unconscious at nursing home. Temp 104.4, intubated, in septic shock and with aspiration pneumonia
Felt like chin was wind chapped, tried lotion but burned. about 8:30 pm cheeks began to swell, chin is red, rash, had runny nose and face itching. 12/21/2009 still reports face feels itchy the rash went up around Rt. eye, down neck, and on chest. Swelling improved. Taking Benadryl and Advil.
Itchy/watery eyes, trouble breathing, headache, vomiting, diarrhea. - Started afternoon/evening of 11/3/11 & ended am of 11/4/11.
03/18/2021. 3:25pm. Strange tickle in throat and coughing but couldn?t really stop. Kept trying to drink water.  03/19/2021. 3:00am. Woke in the night with a horrible headache, shivering and freezing. Took 2 Advil, bundled up and went back to bed.  03/19/2021.  7:00am.  Woke with horrible headache that won?t go away, body aches all over, muscles feel weak and slight fever of 99.4 (my base is 97.7).  These are all the same symptoms I had when I actually was positive for Covid  11/15/2020.
Muscle spasms 15 hours after vaccination. Lasted about 3 hours.  Convulsions  35 hours after vaccination. Lasted about an hour.
I had cold/sore throat symptoms from October 16, 1922.  4 positive 'at home' Covid -19 tests October 19, 21, 22, and 25, 2022.  I tested negative on October 28 and 30.  Lost taste and smell on October 29, 2022, and regained those senses on November 10, 2022.   That was followed with a sore muscle on my left hip.  On December 3, 2022, while visiting my family I awoke with a skin irritation that looked like shingles. It was on the  left side of my waist near the sore muscle. I immediately went to Immediate Care facility.  I was diagnosed with Shingles (herpes zoster without complication) and was perscribed Valtrex 500mg 2/day 3 times daily. As the rash expanded, I found comfort using capsaicin cream, lavender and teatree oils in water bath and Calamine lotion.  Symptoms persisted for a total of 6 weeks.   By mid January, 2023, I seem to have been finished with Shingles symptoms.  Aside from having low energy for another week or so, I am fully recovered now and full of energy - much as I was before the vaccine or the events that followed.    You may find it interesting that using only a face mask and being careful to keep my hands clean, I had not contracted any flu virus or even a cold for the 2 -1/2 years prior to the Moderna booster on September 13, 2022. (March of 2020-October 2022)  Besides my Moderna booster on 9/13/22, the only other vaccines I have had in the past few years are: Janssen Covid single vaccine 3/9/21 Moderna covid  booster   12/29/21  Please, if possible, let me know what your research results are, as I am very interested.  Thank you,
pt recv vax 13JUN96 & on 16OCT96 pt devel a generalized rash of approx 50 lesions, which reporter felt was a nl case of chickenpox;
Pt several hours after vaccination experienced fatigued and  malaise. Pt. went to sleep at home approximately 6 hours, upon waking had severe facial swelling, global itching, and continued malaise and fatigue. Pt took diphenhydramine, 50 mg. Resolved itching and swelling to a point where pt did not need to take additional antihistamines. Went back to sleep and slept for approximately 10 hours. 2nd day, called out sick from work, experienced malaise and fatigue, and slept for additional 6 hours during the day.  Experienced fatigue and malaise for the next two additional days. Experiencing continued soreness in right shoulder,  experienced with movement, not debilitating and does not affect activities of daily living.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from non healthcare professional (office manager). This case is linked with 2018SA280895 (same reporter). This case involves a six-years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV via intramuscular route in the right thigh on 05-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given on the day of the visit. At the time of the event, the patient had ongoing egg allergy (allergic to eggs). It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse events have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Headache, Myalgia, NauseaVomiting, CHILLS, EXTREME FATIGUE, ACID REFLUX Narrative:
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 10-year-old female patient who received FLULAVAL QUADRIVALENT (batch number XZ3SP, expiry date 30th June 2015). On 11th November 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular). In November 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL QUADRIVALENT was continued with no change. In November 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL QUADRIVALENT. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL QUADRIVALENT. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
First pains started in my elbows, shoulders and ribs. About 1.30 pm.  Then the pain went across my shoulders and up my neck into my head. This continued for several hours. I took paracetamol and water.  I went to bed about 6.30 pm.  Then I started with pains in my stomach, these continued until I went to the bathroom and had explosive diarrhoea and vomiting. I my vomit was dark green..  this continued at various intervals.  My husband rang MI DOC.  And described my symptoms to the doctor this was about midnight or so.  They wanted me to go to them but I couldn?t leave the house because I was passing diarrhoea and vomiting about every 30 minutes.    This continued all night with the vomit turning from green to yellow.   Eventually my GP sent me for a covid test, the results came back negative. After about 4 to 5 days the vomiting stopped but the diarrhoea continue then a couple of days later the vomiting started again.  All in all I?ve been very ill for two weeks and I remain very weak.  I have been unable to speak to my GP. He is busy.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 68 years old male patient and reported that patient received expired dose of FLUZONE HIGH-DOSE vaccine and suspect vaccine was FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 09-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI842AB) (expiry date:04-Apr-2018 and dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to expired product administered. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
first dose in January 2021; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired if it was too late to get the second dose.
On the 12 I felt like I had a chest cold and my husband was sick as well. We were then informed that a close friend was positive. I then tested and was positive for COVID-19. According to the box they had expired so we went and got some more test. My husband was worried because I have cancer. I tested again on Monday and was positive and then given PAXLOVID and I am on the third day.
within 1 hr post-vaccine on 1/7 I had a mild headache that resolved with Tylenol. At about 12 hours post-vaccine I developed nausea, fever (100.4) and chills and secondary to this had poor sleep. The next day I took scheduled alternating Tylenol & ibuprofen during the day and then overnight 1 episode of chills that woke me up. no events Saturday or Sunday. Then Monday 1/11 in the early morning I started to develop a rash on my b/l elbow and right foot 3rd toe. I applied mometasone topical cream to these locations. while at work the rash extended down both forearms then by 5pm it was on both hips and extending along both legs. I applied Benadryl cream to the most irritated sites and took PO Benadryl 50mg at bedtime and again at 1am when the itching woke me up. I repeated Benadryl 25mg at 8am. The rash seems to be getting better on the arms but then by noon I had a new breakout on my neck and face. I took Benadryl 50mg at 1pm. The rash continued to have a rapid progression over the next hour and resulted in angioedema with my throat swelling, lips puffed and numb and eye swelling. I was injected with an epi pen and sent to the ED where I received PO prednisone, famotidine, and Benadryl. The face/neck rash then greatly improved and I was sent home on prednisone 40mg daily for 3 days.
Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 min later, restless, can?t stay still, moaning. Muscle cramping getting worse in abdomen.  Get up to get more water and urinate, starting to salivate as if going to throw up. Lean over toilet for 20 min, burning hot , weak, throw cold water around face and neck. Take another Advil, lay back down in bed, muscle convulsions for next 20 min, slowly dissipating. Entire episode took 3 hours. Felt like worst period cramping with fever on top of food poisoning. Next day was mildly nausea and sore, tired.
Death.  Per the death certificate the immediate cause of death was a myocardial infarction with hyperlipidemia, hyperglycemia and pulmonary embolism as contributing factors.  No autopsy was performed.
seizure; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced seizure. Reporter stated warning this video shows a mom have a seizure after taking the jab. I trust this gives you all the information you need at this time for this event. Please contact me for further information if required. The outcome of the event seizure was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No fur-ther information is expected.
Fever ranging from 100.4-101.9. Severe body aches & burning skin. Shooting pains down legs and arms. Strange and painful  pins & needles sensation in right food. Aches in bones and joints. Headache. Alternating freezing and heat flashes.
Large localized redness, swelling, with lots of localized tenderness and pain over 3 days, then slowly improving by time of evaluation when seen 2 days after it started.